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F.No.10-7/2020-OTC) (M-79)
Page 1 of 408
Government of Pakistan
Ministry of National Health Services, Regulations & Coordination
Drug Regulatory Authority Of Pakistan
Health & OTC Products Division (Non-Drugs)
*****
Islamabad, the 15th June, 2020
SUBJECT: Submission of deficient information / documents
The applications of following applicants were placed before the Enlistment Evaluation
Committee (EEC) in its 79th meeting held on 14th May, 2020 and the same have been deferred being
deficient of the information / documents as specified in column (3) of the Table below which may be
furnished within 20 days of uploading of this letter on official website of DRAP but not later than 6th July,
2020. Replies received after due date shall not be entertained:-
S.No Brand name Decision
(1) (2) (3)
M/s Darul Adviat (0036)
B-87, Block-D, North Nazimabad, Karachi-74700
Agent of M/s Deutsche Homoeopathic-Union, DHU-Arzneimittel GmbH & Co, KG, International Division, Ottostrabe 24, D-76227 Karlsruhe,
Germany
1. Darul Adviat’s
Natium Phosphoricum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches and only 3x tablet has
been provided. Moreover, the conditions of stability studies are not according to
Zone IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided.
The GMP certificate of the principal manufacturer has expired.
2. Darul Adviat’s
Calcium Phosphoricum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches and only 3x tablet has
been provided. Moreover, the conditions of stability studies are not according to
Zone IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided.
The GMP certificate of the principal manufacturer has expired.
3. Darul Adviat’s
Essentia Aurea Oral Liquid
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
“SAY NO TO CORRUPTION”
F.No.10-7/2020-OTC) (M-79)
Page 2 of 408
S.No Brand name Decision
(1) (2) (3)
The Stability studies data (60 Months) of two batches of Goldtropfen DHU S
mother tincture has been provided. Moreover, the conditions of stability studies
are not according to Zone IVA.
According to copy of COPP provided, the product is freely available in
country of origin with the brand name Goldtropfen DHU S with the same
formulation
The GMP certificate of the principal manufacturer has expired.
4. Darul Adviat’s
Kalium Phosphoricum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches and only 3x tablet has
been provided. Moreover, the conditions of stability studies are not according to
Zone IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided
The GMP certificate of the principal manufacturer has expired.
5. Darul Adviat’s
Calcium Sulfuricum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches and only 3x tablet has
been provided. Moreover, the conditions of stability studies are not according to
Zone IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided.
The GMP certificate of the principal manufacturer has expired.
6. Darul Adviat’s
Kalium sulfuricum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches and only 3x tablet has
been provided. Moreover, the conditions of stability studies are not according to
Zone IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided.
The GMP certificate of the principal manufacturer has expired.
7. Darul Adviat’s
Ferrum Phosphoricum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches and only 3x tablet has
been provided. Moreover, the conditions of stability studies are not according to
Zone IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided.
The GMP certificate of the principal manufacturer has expired.
8. Darul Adviat’s
Tonsiotren Tablets
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
The Stability studies data (60 Months) of only two batches has been provided.
Moreover, the conditions of stability studies are not according to Zone IVA.
According to copy of COPP provided, the product is available in exporting
country under the name Tonsiotren-H with the same formulation while the
applied brand name is Tonsiotren.
The GMP certificate of the principal manufacturer has expired.
9. Darul Adviat’s
Bryorheum Oral Drops
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
F.No.10-7/2020-OTC) (M-79)
Page 3 of 408
S.No Brand name Decision
(1) (2) (3)
The Stability studies data (60 Months) of only two batches of Bryorheum Nhas
been provided. Moreover, the conditions of stability studies are not according to
Zone IVA.
According to copy of COPP provided, the product is freely available in
country of origin with the brand name Bryorheum N with the same
formulation.
The GMP certificate of the principal manufacturer has expired.
10. Darul Adviat’s
Kalium muriaticum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches of 3xtablet has been
provided. Moreover, the conditions of stability studies are not according to Zone
IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided
The GMP certificate of the principal manufacturer has expired.
11. Darul Adviat’s
Nisylen Oral Drops
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
The Stability studies data (60 Months) of only two batches has been provided.
Moreover, the conditions of stability studies are not according to Zone IVA.
The GMP certificate of the principal manufacturer has expired.
12. Darul Adviat’s
Natricum Sulfuricum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches of 3xtablet has been
provided. Moreover, the conditions of stability studies are not according to Zone
IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided.
The GMP certificate of the principal manufacturer has expired.
13. Darul Adviat’s
Natrium Muriaticum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches of Natrium
chloratum 3x tablet has been provided instead of Natrium Muriaticum Tablet.
Moreover, the conditions of stability studies are not according to Zone IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided.
The GMP certificate of the principal manufacturer has expired.
14. Darul Adviat’s
Magnesium Phosphoricum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches and only 3x tablet has
been provided. Moreover, the conditions of stability studies are not according to
Zone IVA.
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided.
The GMP certificate of the principal manufacturer has expired.
15. Darul Adviat’s
Calcium Fluoratum Tablet
3x, 6x, 12x, 30x, 200x
Deferred since the application is deficient of following documents/information;
The copy of fee challan provided, has not been endorsed.
Separate application is required to be submitted for each remedy.
The Stability studies data (60 Months) of only two batches and only 3x tablet has
been provided. Moreover, the conditions of stability studies are not according to
Zone IVA.
F.No.10-7/2020-OTC) (M-79)
Page 4 of 408
S.No Brand name Decision
(1) (2) (3)
Free sale certificate/COPP of the product clearly showing the availality status of
the product in country of origin, not provided.
The GMP certificate of the principal manufacturer has expired.
M/s. BM (Private) Limited.,
located at 22-Anam Road, Industrial Estate (Glaxo Town), 20-KM, Ferozepur Road, Lahore
16. BM 1 (Hepar sulph Compound)
Each 30 mL Contains Apis Mell D4 (HPUS)……..0.10 mL
Baryta Carb D8 (HPUS)…….0.03 mL
Belladonna D3 (HPUS)…… 0.10 mL
Calc lod D6 (HPUS)….. 0.03 mL
Hepar Sulph D12 (HPUS)…… 0.03 mL
Kali Bich D4 (HPUS) ……0.10 mL
Lachesis D12(HPUS)……0.10 mL
Mercurius D8 (HPUS) ……0.10 mL
Phytolacca D4 (HPUS) ……0.10 mL
Spongia D3 (HPUS) ……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
17. BM 2 (Paeonia Compound)
Each 30 mL Contains Aesculus Hip D4 (HPUS)……..0.10 mL
Hamamelis D3 (HPUS)……..0.10 mL
Hydrastis D3 (HPUS)……..0.10 mL
Nitric Acid D6 (HPUS)……..0.10 mL
Nux Vom D4 (HPUS)……..0.10 mL
Paeonia off D3 (HPUS)……..0.10 mL
Sulphur D4 (HPUS)……..0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
18. BM 3 (Chelidonium Compound )
Each 30 mL Contains Berb.Vulg. D3(HPUS)…….. 0.10 mL
Carduus. Mar D2 (HPUS)……..0.10 mL
Chelidonium D2 (HPUS)……..0.10 mL
Cholesterinum D3 (HPUS)……..0.04 mL
Hydrastis D3 (HPUS)……..0.10 mL
Ptelea D3(HPUS)……..0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
19. BM 4 (Veratrum Alb Compound)
Each 30 mL Contains Aloe Soco D8 (HPUS)……..0.10 mL
Colocynthis D6 (HPUS)……..0.05 mL
Ipecac D7 (HPUS)……..0.10 mL
Myrica Cer. D7 (HPUS)……..0.10 mL
Podophyllum D8 (HPUS)……..0.20 mL
Sulphur D5 (HPUS)……..0.04 mL
Verat Alb. D6 (HPUS)……..0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
20. BM 5 (Echinacea Ang Compound )
Each 30 mL Contains
Apis Mell D3 (HPUS)……..0.10 mL
Baptisia D4 (HPUS)……..0.30 mL
Conium Mac D8 (HPUS)……..0.05 mL
Echinacea D2 (HPUS)……..0.10 mL
Eupatorium Perf D4 (HPUS)……..0.05 mL
Silicea D6 (HPUS)……..0.05 mL
Thuja Occi. D8 (HPUS)……..0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
Page 5 of 408
S.No Brand name Decision
(1) (2) (3)
21. BM 6 (Sepia Compound)
Each 30 mL Contains Agrimonia D6 (HPUS)……0.10 mL
Alumina D12 (HPUS)……0.10mL
Hydrastis D4 (HPUS)……0.10 mL
Kali Bich D6 (HPUS)……0.04 mL
Pulsatilla D5 (HPUS)……0.10 mL
Sepia D4 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
22. BM 7 (Petroleum Compound)
Each 30 mL Contains Echinacea D5 (HPUS)……0.10 mL
Graphite D10 (HPUS)……0.10mL
Hydrocotyle D3 (HPUS)……0.20 mL
Kali Mur D6(HPUS)……0.10 mL
Petroleum D12 (HPUS)……0.10 mL
Sulphur D7 (HPUS)……0.10 mL
Viola Tricolor D5 (HPUS)……0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
23. BM 8 (Formica Rufa Compound)
Each 30 mL Contains Ars Alb D12 (HPUS)……0.10 mL
Cinnabaris D8 (EHPI)……0.10 mL
Formica Rufa D6 (HPUS)……0.05 mL
Hydrastis D5 (HPUS)……0.10 mL
Kali Bich. D5 (HPUS)……0.10mL
Sabadilla D5 (HPUS)……0.04 mL
StictaPulm D6 (HPUS)……0.10 mL
Teucrium M.V. D4 (HPUS)……0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
24. BM 9 (Scrophularia Compound)
Each 30 mL Contains Baryta Carb D10 (HPUS)……0.04 mL
Belladonna D10 (HPUS)……0.10 mL
Cistus Can. D10 (HPUS)……0.10 mL
Conium Mac. D8 (HPUS)……0.04 mL
Merc Sol D12 (HPUS)……0.04mL
Sarsaparilla D8 (HPUS)……0.05 mL
Scrophularia D4 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
25. BM 10 (Uranium nit Compound)
Each 30 mL Contains Acid Phos. D12 (HPUS)…….0.43 mL
Lycopodium D4 (HPUS)……. 0.05 mL
Nat Sulph D7 (HPUS)……. 0.04 mL
Syzygium jambol D8 (HPUS)……0.30 mL
Taraxacum D8 (HPUS)…….0.10 mL
Uranium Nitricum D6 (HPUS)….0.04 mL
Uva Ursi D8 (HPUS)……. 0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
26. BM 11 (Usnea barb Compound)
Each 30 mL Contains Acidum Salicylicum D12 (HPUS)..0.04 mL
Belladonna D4(HPUS)……0.10 mL
Coffea Cruda D5 (HPUS)……0.10 mL
Gelsemium D4 (HPUS)……0.10 mL
Iris Vers D3 (HPUS)……0.10mL
Melilotus Off. D4 (HPUS)……0.20 mL
Spigelia D3 (HPUS)……0.10 mL
Usnea Barb D2 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
Page 6 of 408
S.No Brand name Decision
(1) (2) (3)
27. BM 12 (Anti crud Compound)
Each 30 mL Contains Ornithogalum D4 (HPUS)…….0.10 mL
Abies Nigra D5 (HPUS)……. 0.04 mL
Anti Crud D8 (HPUS)……. 0.10 mL
Condurango D4 (HPUS)…….0.10 mL
Nux Vom D5 (HPUS)……. 0.20 mL
Symphytum D4 (HPUS)…….0.10 mL
Lycopodium D5 (HPUS)……. 0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
28. BM 13 (Drosera Compound)
Each 30 mL Contains
Belladonna D4 (HPUS)……..0.10 mL
Cuprum Aceticum D6 (HPUS)….0.04 mL
Drosera D3 (HPUS)……..0.10 mL
Grindelia D4 (HPUS)……..0.10 mL
Ipecac D5 (HPUS)……..0.10 mL
Lobelia Inflata D2 (HPUS)……..0.10 mL
Naphthalinum D12 (HPUS)……..0.04 mL
Yerba Santa D4 (EHPI)……..0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
29. BM 14 (Gossypium Compound)
Each 30 mL Contains Gossypium D3 (HPUS)……0.10 mL
Lilium Tig D4(HPUS)……0.04 mL
Mag Phos D7 (HPUS)……0.04 mL
Pulsatilla D4 (HPUS)……0.10 mL
Sepia D7 (HPUS)……0.10mL
Viburnum Opulus D6 (HPUS)…0.10 mL
Xanthoxylum D5 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
30. BM 15 (Lithium carb Compound)
Each 30 mL Contains Arnica Mont D4 (HPUS)…….0.10 mL
Bryonia Alba D5 (HPUS)…….0.20 mL
Causticum H. D5 (HPUS)…….0.04 mL
Colchicum D5 (HPUS)…….0.10 mL
Inula D7 (HPUS)…….0.10 mL
Lithium Carb D4 (HPUS)…….0.04 mL
Rhus Toxicoden D6 (HPUS)…….0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
31. BM 16 (Crataegus Oxy Compound)
Each 30 mL Contains Arnica Mont D4 (HPUS)……0.10 mL
Cactus Grand D1 (HPUS)……0.10 mL
Crataegus Oxy Ø (HPUS)……0.30 mL
Spigelia D2 (HPUS)……0.04 mL
Valeriana D2 (HPUS)……0.10mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
32. BM 17 (Passiflora Compound)
Each 30 mL Contains Aconite D7 (HPUS)……..0.20 mL
Agaricus Mus D6 (HPUS)……..0.10 mL
Anacardium D7 (HPUS)……..0.10 mL
Gelsemium D5 (HPUS)……..0.20 mL
Ignatia D5 (HPUS)……..0.10 mL
Moschus D12 (HPUS)……..0.10 mL
Passiflora Inc D1 (HPUS)……..0.30 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
Page 7 of 408
S.No Brand name Decision
(1) (2) (3)
33. BM 19 (Fucus Ves Compound)
Each 30 mL Contains
Adonis Vern. D3 (HPUS)……0.10 mL
Calc. Carb. H. D10 (HPUS)……0.10 mL
Fucus Ves D1 (HPUS)……0.30 mL
Graphite D10 (HPUS)……0.10 mL
Phytolacca Ber D2 (EHPI)……0.30 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
34. BM 20 (Sulphur Compound)
Each 30 mL Contains Baptisia Tinc D4 (HPUS)……0.10 mL
Echinacea D3(HPUS)……0.10 mL
Euphorbium D6 (HPUS)……0.04 mL
Galium Apar. D12 (HPUS)……0.10 mL
Rumex Cris D3 (HPUS)……0.10mL
Sarsaparilla D6 (HPUS)……0.10mL
Sulphur D6 (HPUS)……0.04mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
35. BM 21 (Mag mur Compound)
Each 30 mL Contains Plumbum D7 (HPUS)…….0.04 mL
Alumina D5 (HPUS)…….0.04 mL
Mag Mur D12 (HPUS)…….0.04 mL
Opium D30 (HPUS)…….0.02 mL
Hydrastis D3 (HPUS)…….0.20 mL
Bryonia D5 (HPUS)…….0.20 mL
Graphite D10 (HPUS)…….0.04 mL
Nux Vom D5 (HPUS)…….0.20 mL
Lycopodium D4 (HPUS)…….0.10 mL
Colocynthis D6 (HPUS)…….0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
36. BM 22 (Adonis Ver Compound)
Each 30 mL Contains Adonis Ver D10 (HPUS)……0.10 mL
Arnica Mont D3 (HPUS)……0.10 mL
Convallaria D3 (HPUS)……0.04 mL
Crataegus Oxy D1 (HPUS)…0.10 mL
Laurocerasus D5 (HPUS)……0.04 mL
Oleander D4 (HPUS)……0.04 mL
Valeriana D4 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
37. BM 23 (Equisetum Compound)
Each 30 mL Contains Belladonna D5 (HPUS)……0.10 mL
Causticum D7 (HPUS)……0.10 mL
Equisetum D5 (HPUS)……0.10 mL
Kali Phos D5 (HPUS)……0.10 mL
Plantago Maj D2 (HPUS)……0.10mL
Pulsatilla D5 (HPUS)……0.10mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
38. BM 24 (Kali phos Compound)
Each 30 mL Contains Anacardium D7 (HPUS)……..0.04 mL
Aswagandah D2 (EHPI)……..0.20 mL
Belladonna D7 (HPUS)……..0.04 mL
Gelsemium D5 (HPUS)……..0.10 mL
Kali Phos D3 (HPUS)……..0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
Page 8 of 408
S.No Brand name Decision
(1) (2) (3)
Phosphorus D12 (HPUS)……..0.04 mL
Sepia D7 (HPUS)……..0.10 mL
39. BM 25 (Humulus Lup Compound)
Each 30 mL Contains Avena Sat D1 (HPUS)……0.20 mL
Coffea Cruda D5 (HPUS)……0.10 mL
Humulus Lup D5 (HPUS)……0.10 mL
Ignatia D5 (HPUS)……0.04 mL
Nux Vom D4 (HPUS)……0.05 mL
Passiflora D1 (HPUS)……0.20 mL
Valeriana D1 (HPUS)……0.05 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
40. BM 26 (Napthalinum Compound)
Each 30 mL Contains Arsenic Alb D7 (HPUS)……0.04 mL
Atropin Sulph D6 (HPUS)……0.10 mL
Blatta Ori D3 (HPUS)……0.20 mL
Grindelia D3 (HPUS)……0.10 mL
Ipecac D6 (HPUS)……0.20 mL
Napthalinum D7 (HPUS)……0.10 mL
Spongia Tosta D4 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
41. BM 27 (Crocus sat Compound)
Each 30 mL Contains Arnica Mont D3 (HPUS)……0.10 mL
Crocus Sat. D3 (HPUS)……0.10 mL
Hamamelis D2 (HPUS)……0.10 mL
Millefolium D4 (HPUS)……0.10 mL
Sanguinaria D4 (HPUS)……0.04 mL
Secale Corn D5 (HPUS)……0.04 mL
Trillium Pend D3 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
42. BM 29 (Juniperus Compound)
Each 30 mL Contains Capcilla B.P. D3 (HPUS)……0.10 mL
Hamamelis D2 (HPUS)……0.10 mL
Helleborus D6 (HPUS)……0.10 mL
Juniperus D3 (HPUS)……0.10 mL
Plumbum D10 (HPUS)……0.04 mL
Solidago D5 (HPUS)……0.10 mL
Terebinthinae D3 (HPUS)……0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
43. BM 35 (Colocynthis Compound)
Each 30 mL Contains Belladonna D7 (HPUS)……0.10 mL
Bryonia Alba D7 (HPUS)……0.20 mL
Calc Phos D6 (HPUS)……0.10 mL
Colchicum D16 (HPUS)……0.04 mL
Colocynthis D7 (HPUS)……0.10 mL
Dioscorea D14 (HPUS)……0.04 mL
Rhus Tox D5 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
44. BM 36 (Fraxinus Compound)
Each 30 mL Contains Calc Flour D12 (HPUS)…….0.02 mL
Cistus Can. D10 (HPUS)…….0.02 mL
Fraxinus D3 (HPUS)…….0.20 mL
Fucus Ves. D4 (HPUS)…….0.20 mL
Oophorinum D16 (HPUS)…….0.02 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
Page 9 of 408
S.No Brand name Decision
(1) (2) (3)
Secale Cornut. D3 (HPUS)…….0.10 mL
Thuja Occ D4 (HPUS)…….0.10 mL
45. BM 37 (Thyroidinum Compound)
Each 30 mL Contains Baryta Carb D10 (HPUS)……0.10 mL
Bromium D7 (HPUS)……0.10 mL
Calc. Iod D8 (HPUS)……0.10 mL
Conium Mac. D7 (HPUS)……0.04 mL
Iodium D14 (HPUS)……0.08 mL
Spongia Tost. D6 (HPUS)……0.10mL
Thyroidinum D12 (HPUS)……0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
46. BM 38 (Kali brom Compound)
Each 30 mL Contains Berb Aqui D2 (HPUS)……0.20 mL
Graphite D18 (HPUS)……0.08 mL
Hydrocotyle D2 (HPUS)……0.30 mL
Kali Brom D7 (HPUS)……0.04 mL
Kali Iodat D7 (HPUS)……0.04 mL
Natrum Phos D12 (HPUS)……0.10 mL
Sulphur Iodat D7 (HPUS)……0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
47. BM 39 (Urtica Uren Compound)
Each 30 mL Contains Apis Mell. D (HPUS)……0.10 mL
Ars. Alb. D4 (HPUS)……0.04 mL
Calc. Carb D10 (HPUS)……0.04 mL
Dulcamara D5 (HPUS)……0.04 mL
Ledum Palu D10 (HPUS)……0.04mL
Rhus. Tox. D4 (HPUS)……0.10 mL
Urtica Uren D3 (HPUS)……0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
48. BM 40 (Zincum Acet Compound)
Each 30 mL Contains
Alumina D7 (HPUS)……..0.04 mL
Causticum D8 (HPUS)……..0.04 mL
Gelsemium D3 (HPUS)……..0.10 mL
Moschus D14 (HPUS)……..0.10 mL
Plumbum D9 (HPUS)……..0.10 mL
Secale Corn. D4 (HPUS)……..0.04 mL
Zincum Acet. D9 (HPUS)……..0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
49. BM 41 (Angustura Compound)
Each 30 mL Contains
Absinthium D4 (HPUS)……0.04 mL
Alfalfa D1 (HPUS)……0.20 mL
Angustura D2 (HPUS)……0.04 mL
China Off. D4 (HPUS)……0.10 mL
Cinnamon D3 (HPUS)……0.20 mL
Foeniculum vulg D1 (HPUS)……0.20 mL
Nux Vomica D7 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
50. BM 42 (Baptisia tinc Compound)
Each 30 mL Contains Aconite Nap. Ø = D2 (HPUS)……….0.20 mL
Baptisia Tinc. Ø = D1 (HPUS)……….0.20 mL
China Off. Ø = D1 (HPUS)…0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Eupatorium Perf. Ø = D1 (HPUS)….0.10 mL
Filipendula Ulm Ø = D1 (GHP)…….0.10 mL
51. BM 44 (Cimicifuga Compound)
Each 30 mL Contains Aletris Far D4 (HPUS)……0.20 mL
AshPlease a Jano D2 (HPUS)……0.10 mL
Aswagandha D3 (EHPI)……0.10 mL
Caulophylum D6 (HPUS)…0.04 mL
Cimicifuga D6 (HPUS)……0.20 mL
Helonias D4 (HPUS)……0.20 mL
Sepia D14 (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
52. BM 45 (Clematis Compound)
Each 30 mL Contains Capcilla B.P. D4 (HPUS)......0.10 mL
Chimaphila Umb.D6 (HPUS)..0.10 mL
Conium D4 (HPUS)…………0.04 mL
Clematis. D4 (HPUS)..............0.10 mL
Pulsatilla D4 (HPUS)……….0.20 mL
Sabal Serr. D2 (HPUS)……0.20 mL
Solidago D6 (HPUS)……..0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
53. BM 46 (Chamomilla Compound)
Each 30 mL Contains Aconite D4 (HPUS)……0.10 mL
Belladonna D3 (HPUS)……0.10 mL
Chamomilla D6 (HPUS)……0.20 mL
Mag. Phos D12 (HPUS)……0.04 mL
Merc. Sol. D18(HPUS)……0.04 mL
Millefolium D7 (HPUS)……0.10 mL
Staphysagria D9 (HPUS)……0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
54. BM 47 (Ginkgo Biloba Compound)
Each 30 mL Contains
Acid Salicylic D8 (HPUS)…0.040 mL
Caffeinum D5 (HPUS)……..0.10 mL
Colocynthis D3 (HPUS)…….0.20 mL
Gelsemium D3 (HPUS)……..0.20 mL
Ginkgo Biloba D4 (HPUS)..0.20 mL
Mag. Phos. D7 (HPUS)……..0.10 mL
Spigelia D3 (HPUS)……..0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
55. BM 50 (Baryta Carb Compound)
Each 30 mL Contains Baryta Carb D18 (HPUS)……0.10 mL
Calc. Phos. D10 (HPUS)……0.10 mL
Ferrum Phos D10 (HPUS)……0.10 mL
Kali Phos D10 (HPUS)……0.10 mL
Magnesia Phos D10 (HPUS)……0.04 mL
Natrum Phos D10 (HPUS)……0.10 mL
Pituitrinum D16 (HPUS)……0.02 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
56. BM 52 (Carduus mar Compound)
Each 30 mL Contains
Andrographis D8+100C (EHPI)...........0.10 mL
Baptisia Tinc D1+100C (HPUS)..............0.30 mL
Beta Vulg D6+100C (HPUS)...................0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Carduus Mar D4+100C (HPUS)...............0.50 mL
Ceanothus Amer D3+100C (HPUS).......0.40 mL
Chelidonium Majus D2+100C (HPUS)...0.50 mL
Echinacea August D3+100C (HPUS).....0.20 mL
57. BM 58 (Chionanthus Compound)
Each 30 mL Contains
Berb Vulg D1+10C (HPUS)……0.40 mL
Carduus Mar D1+10C (HPUS)…0.30 mL
Chelidonium D1+ 10C (HPUS)…0.50 mL
Chionanthus D2+20C (HPUS)……0.40 mL
Dioscorea D1+10C (HPUS)……0.20 mL
Fel Tauri D2+ 20C (HPUS)……0.30 mL
Hydrastis D1+ 10C (HPUS)……0.50 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
58. BM 60 (Fuligo Compound)
Each 30 mL Contains Cimicifuga D6+60C (HPUS)……...........0.40 mL
Drosera D6+60C (HPUS).......................0.10 mL
Formica Rufa D6+60C (HPUS).............0.10 mL
Fuligo D6+60C (EHPI).........................0.10 mL
Inula Hel D6+60C (HPUS)....................0.20 mL
Kali Mur D6+60C (HPUS)....................0.30 mL
Lapis Albus D6+60C (HPUS)..............0.40 mL
Silicia D6+ 60C (HPUS)........................0.30 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
59. BM 62 (Ammonium benzoicum Compound)
Each 30 mL Contains
Ammonium Benzoicum D20+200C (HPUS)…..0.20
mL
Aurum Mur D20+ 200C (HPUS)…0.20 mL
Calc Ars D200+ 200C (HPUS)…0.20 mL
Carduus Mar D50+ 50C (HPUS)..0.20 mL
Crotalus Horridus D50+50C (HPUS)……..0.20 mL
Muriatic Acid D200+200C (HPUS)……..0.20 mL
Nux Vom D200+200C (HPUS)…0.20 mL
Phosphorus D200+200C (HPUS)..0.20 mL
Vipera D200+ 200C (HPUS)……..0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
60. BM 63 (Kali mur Compound)
Each 30 mL Contains
Ceanothus D1+ 10C (HPUS)……..0.20 mL
Kali Arsen D12+ 100C (HPUS)…0.20 mL
Kali Mur D10+ 100C (HPUS)…0.20 mL
Oophorinum D25+ 100C (HPUS)…0.20 mL
Selenium D18+ 100C (HPUS)……0.20 mL
Thallium D18+ 100C (HPUS)…0.20 mL
Wiesbaden D100+ 100C (HPUS)..0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
61. BM 64 (Chloramphenicol Compound)
Each 30 mL Contains
Chloremphenicol D200+100C (HPUS)……..0.20 mL
Hypophysis D200+100C (HPUS)…0.20 mL
Lobelia Erenus D30+30C (HPUS)……..0.20 mL
Streptomycin D200+100C (Martindale)……..0.20 mL
Urea D200+100C (HPUS)……..0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
62. BM 69 (Orchitinum Compound)
Each 30 mL Contains Agnus Cast D1+10C (HPUS)……0.30 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
China Off. D1+10C (HPUS)……0.20 mL
Damiana D1+10C (HPUS)……0.30 mL
Helonias D1+10C (HPUS)……0.20 mL
Orchitinum D20+100C (HPUS)…0.20 mL
Ratanhia D1+10C (HPUS)……0.10 mL
Testis Bovis D20+100C (Martindale)……0.20 mL
Use of formulation to be provided
63. BM 72 (Pareira Brava Compound)
Each 30 mL Contains Naphthoquinone D200+200C (Martindale)…0.20 mL
Pareira brava D200+200C (HPUS)……0.20 mL
Sulphonamide D200+200C (HPUS)……0.20 mL
Thymol D200+200C (HPUS)……0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
64. BM 80 (Aletris far Compound)
Each 30 mL Contains Aletris Far D4+40C (HPUS)………...0.2 mL
Agnus Cast D4+40C (HPUS)…0.2 mL
Aur.m. Nat D20+200C (HPUS)…….0.2 ml
Caulophyllum D5+50C (HPUS)…….0.2 ml
Helonias D3+30C (HPUS)…………..0.2 ml
Pulsatilla D4+40C (HPUS)………….0.2 ml
Senecio D4+40C (HPUS)……………0.2 ml
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
65. BM 84 (Lycopodium Compound)
Each 30 mL Contains Baryta Carb D6+60C (HPUS)……0.20 mL
Camphor D10+100C (HPUS)……0.20 mL
Helonias D3+30C (HPUS)……0.20 mL
Kali Brom D6+60C (HPUS)……0.20 mL
Lycopodium D6+60C (HPUS)……0.20 mL
Phosphorus D6+60C (HPUS)……0.20 mL
Thuja D6+60C (HPUS)……0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
66. BM 86 (Filipendula ulm Compound)
Each 30 mL Contains Ambra grisea 3x+3C (HPUS)……0.04 mL
Ammonium mur 6C+30C (HPUS)..0.06 mL
Arnica mont Ø +3C (HPUS)……0.06 mL
Baptisia Ø +3C (HPUS)……0.12 mL
Belladonna Ø +3C (HPUS)……0.04 mL
Carbo veg 8C+30C (HPUS)……0.12 mL
Secale cor 2x+6C (HPUS)……0.10 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
67. BM 90 (Helonias Compound)
Each 30 mL Contains Calc carb 30C+200C (HPUS)……0.07 mL
Helonias 3x+30C (HPUS)……0.24 mL
Nux vomica 3x+30C (HPUS)……0.18 mL
Phosphorus 30C+200C (HPUS)…0.06 mL
Secale cor 3x+30C (HPUS)……0.08 mL
Terebinthina 3x+30C (HPUS)…0.04 mL
Thuja 3x+30C (HPUS)……0.12 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
68. BM 99 (Guaiacum Compound)
Each 30 mL Contains Aesculus Hip D3+30C (HPUS)…0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
F.No.10-7/2020-OTC) (M-79)
Page 13 of 408
S.No Brand name Decision
(1) (2) (3)
Apis Mellifica D1+10C (HPUS)…0.12 mL
Arnica Montana D4+40C (HPUS)..0.20 mL
Bryonia Alb D1+10C (HPUS)…0.20 mL
Guaiacum D6+60C (HPUS)……0.20 mL
Lachesis Mutus D17+100C (HPUS)……0.10 mL
Ledum Palustre D4+40C (HPUS)...0.30 mL
Rhus Tox D3+30C (HPUS)……0.15 mL
Use of formulation to be provided
69. BM 110 (Rhus tox Compound) )
Each 30 mL Contains Aesculus D1+10C (HPUS)……0.30 mL
Baryta Carb D6+60C (HPUS)……0.20mL
Calc Fluor D6+60C (HPUS)……0.20 mL
Cimicifuga D1+10C (HPUS)……0.30 mL
Kali Carb D10+10C (HPUS)……0.20 mL
Rhus Tox D1+10C (HPUS)……0.20 mL
Sepia D3+30C (HPUS)……0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
70. BM 111 (Ars Alb Compound)
Each 30 mL Contains Anti Crud D10+100C (HPUS)…0.20 mL
Ars Alb D6+60C (HPUS)……0.20 mL
Graphite D10+100C (HPUS)……0.20 mL
Mezerium D6+60C (HPUS)……0.20 mL
Rhus Tox D6+60C (HPUS)……0.10 mL
Sulphur D6+60C (HPUS)……0.20 mL
Zinc Met D10+100C (HPUS)…0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
71. BM 118 (Anacardium Ori Compound)
Each 30 mL Contains Anacardium Ori D15+ 100C (HPUS)……0.14 mL
Arsenic Alb D15+100C (HPUS)…0.14 mL
Aurum Mur D15+ 100C (HPUS)…0.14 mL
Kali Brom D15+ 100C (HPUS)…0.14 mL
Lachesis Mutus D200 + 200C (HPUS)……0.14 mL
Lycopodium D15+ 100C (HPUS)...0.14 mL
Natrum Carb D15+ 100C (HPUS)..0.14 mL
Natrum Sulph D15+ 100C (HPUS)……0.14 mL
Phosphoric Acid D15+ 100C (HPUS)……0.14 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
72. BM 136 (Lathyrus sativus Compound)
Each 30 mL Contains
Formic Acid D200+200C (HPUS)……..0.20 mL
Lathyrus Sativus D200+200C (HPUS)……..0.20 mL
Para Benz D200+200C (MMH)….0.20 mL
Plumbum Met D200+200C (HPUS)……..0.20 mL
Poliomyelitis D200+200C (MMH)……..0.20 mL
Tetanus Antitoxin D200+200C (Martindale)….0.20
mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
73. BM 144 (Rosmarinus off Compound)
Each 30 mL Contains Apis mell 3x+30C (HPUS)……0.12 mL
Arsenic alb 3x+30C (HPUS)……0.12 mL
Caffeinum 3x+30C (HPUS)……0.12 mL
Dolichospru 3x+30C (HPUS)……0.12 mL
Juniperus com Ø +3x (HPUS)……0.16 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Kali carb 6x+30C (HPUS)……0.12 mL
Rosmarinus off 6x+30C (HPUS)…0.12 mL
Solidago virg Ø +3x (HPUS)……0.16 mL
Stigmata may Ø +3x (HPUS)……0.16 mL
74. BM 153 (Apocynum Compound)
Each 30 mL Contains
Adonis ver D2+20C (HPUS)…….0.10 mL
Apis Mell D3+ 30C (HPUS)……..0.20 mL
Apocynum D3+ 30C (HPUS)…….0.20 mL
Colchicum D6 + 60C (HPUS)…0.10 mL
Digitalis D4+ 40C (HPUS)……..0.10 mL
Helleborus D4+ 40C (HPUS)….0.10 mL
Stigmata May D2+ 20C (HPUS)...0.30 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
75. BM 165 (Angelica Atro Compound)
Each 30 mL Contains
Angelica Atro D7+70C (HPUS)……..0.20 mL
Balsam Per Ø +10C (HPUS)…….0.40 mL
Barium Mur D6+60C (HPUS)….0.20 mL
Grindelia D7+70C (HPUS)……..0.20 mL
Kali Bich D6+60C (HPUS)…….0.20 mL
Kali Iod D6+60C (HPUS)……..0.20 mL
Kali Mur D6+60C (HPUS)……..0.20 mL
Silphium Lac D6+60C (HPUS)…0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
76. BM 197 (Hypericum Compound)
Each 30 mL Contains Arsenicum Album D7+70C (HPUS)……0.20 mL
Bryonia D4+40C (HPUS)……0.20 mL
Chamomilla D6+60C (HPUS)…0.20 mL
Colocynthis D4+40C (HPUS)……0.20 mL
Gnaphalium D5+50C (HPUS)……0.20 mL
Hypericum D6+60C (HPUS)…0.20 mL
Rhus Toxicodendron D4+40C (HPUS)……0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
77. BM 203 (Gnaphalium Compound)
Each 30 mL Contains Cimicifuga D100+ 100C (HPUS).........0.20 mL
Formic Acid D100+ 100C (HPUS).......0.20 mL
Gnaphalium D100+100C (HPUS.........0.20 mL
Medorrhinum D100+ 100C (HPUS).....0.20 mL
Proteus D100+ 100C (HPUS)............0.20 mL
Ranunculus Bulb D100+ 100C(HPUS)..0.20 mL
Salicylic Acid D100+ 100C (HPUS)...0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
78. BM 217 (Cobra Compound)
Each 30 mL Contains Acid Lact D4+40C (HPUS)………….0.20 mL
Calc Flour D6+60C (HPUS)…………0.20 mL
Cobra D25+100C (EHPI)…………….0.20 mL
Radium Bromat D10+100C (HPUS)...0.20 mL
Scrofularia Nod D6+60C (HPUS)…..0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
79. BM 222 (Eugenia jambosa Compound)
Each 30 mL Contains Arnica mont D7+70C (HPUS)…0.20 mL
Baptisia D4+40C (HPUS)……0.20 mL
Echinacea D4+40C (HPUS)……0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
Page 15 of 408
S.No Brand name Decision
(1) (2) (3)
Eugenia jambosa D4+40C (HPUS)……0.20 mL
Hepar sulph D10+100C (HPUS)…0.20 mL
80. BM 246 (Pituitrinum Compound)
Each 30 mL Contains
Aesculus D200+200C (HPUS)…0.20 mL
Aurum Met D200+200C (HPUS)..0.20 mL
Cocculus D200+200C (HPUS)…0.20 mL
Morphin D200+200C (HPUS)……0.20 mL
Nux Vomica D200+200C (HPUS)..0.20 mL
Pituitarinum D200+200C (HPUS).0.20 mL
Sulphur D50+100C (HPUS)……0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
81. BM 248 (Mucormucedo Compound)
Each 30 mL Contains
Calc phos D200+200C (HPUS)…0.20 mL
Cortisone D200+200C (HPUS)…0.20 mL
Crocus sat D200+200C (HPUS)…0.20 mL
Cup met D200+200C (HPUS)……0.20 mL
Dysentery co. D200+200C (OAJMM)……0.20 mL
Mucormucedo D200+200C (EHPI)..0.20 mL
Zinc met D200+200C (HPUS)……0.20 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
82. BM's
Alfalfa Tonic Syrup (Regular) & (Sugar Free) SF
Each mL Contains
Alfalfa Ø (HPUS)……1.92 mL
Avena Sat Ø (HPUS)……0.96 mL
Cinnamonum D1 (HPUS)……0.48 mL
CuminumCyminum (D.K EMP)……0.24 mL
ElettariaCarda (D.K EMP)…0.48 mL
Foeniculum vulg (HPUS)……1.68 mL
Gentiana D3 (HPUS)……0.48 mL
Hyoscyamus Niger D2 (HPUS)……0.24 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
83. BM's Arnica Hair oil
Each mL Contains Acasia Con (MM)………..1.75 mL
Arnica mont Ø (HPUS)…..0.07 mL
China Ø (HPUS)………..0.14 mL
Crataegus Oxy Ø (HPUS)..0.14mL
Embelia Off (EHPI) ………..1.75 mL
Pilocarpus Ø (HPUS)…..0.07 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
84. BM's Arnica Hair Shampoo
Each mL Contain Arnica mont Ø (HPUS)……….1.4 mL
Cinchona Off Ø (HPUS) …0.056 mL
Crataegus Oxy Ø (HPUS)…0.112 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
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S.No Brand name Decision
(1) (2) (3)
Jaborandi Ø (HPUS)………….1.4 mL
Saponaria Off Ø (HPUS)…...0.056 mL
85. BM's Arthribid Drops Compound
Each 30 mL Contains Ammonium Phos D3 (HPUS)……0.04 mL
Caulophyllum D3 (HPUS)……0.05 mL
Bryonia D4 (HPUS)……0.2 mL
Colchicum D2 (HPUS)……0.2 mL
Ledum Pal D3 (HPUS)……0.1mL
Rhus Tox Ø (HPUS)……0.2 mL
Urtica Urens Ø (HPUS)……0.2 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
86. BM's Arthribid Compound Tablet
Each one tablet Contains Ammonium Phos D3 (HPUS)…0.0003 mL
Bryonia D4 (HPUS)……0.5 gm
Caulophyllum D3 (HPUS)……0.5 gm
Colchicum D2 (HPUS)……0.0055 gm
Ledum Pal D3 (HPUS)……0.3gm
Rhus Tox Ø (HPUS)……0.3gm
Urtica Urens Ø (HPUS)……0.0015 gm
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
87. BM's Ash a Cardial Compound Syrup
Each mL Contains
Aletris Ferinosa D1 (HPUS)….0.24mL
As a Janosia Ø (HPUS)……1.92 mL
Cimicifuga D2 (HPUS)…..0.48 mL
Gossypium D2(HPUS)…..0.48 mL
Helonias Ø (HPUS)…..0.24 mL
Xanthoxylum D1 (HPUS)…..0.24 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
88. BM's Baptisia Plus Compound Syrup
Each mL Contains Baptisia Ø (HPUS)……….0.24 mL
Belladonna Ø (HPUS)....0.24 mL
Cinnamonum Ø (HPUS)…..1.68 mL
Cinchona off Ø (HPUS)…...0.36 mL
Eupatorium perf Ø (HPUS)…..0.36 mL
Filipendula ulm Ø (HPUS)......0.24 mL
Gelsemium Ø (HPUS)......0.24 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
89. BM's Baptisia Compound Syrup
Each 120mL Contains Aconite Nap Ø (HPUS)………0.96 mL
Baptisia Tinc Ø (HPUS)..2.4 mL
China Off Ø (HPUS)…..0.96 mL
Eupatorium Perf Ø (HPUS)….0.24 mL
Filipendula Ulmaria Ø (GHP)..0.48 mL
Foeniculum Vulg Ø (HPUS)......2.4 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
90. BM's Bestropin HGH
Each 30 mL Contains Somatropin (HGH) / 30DH ……3.0 mL
(HAB 2016, Method 5a as specified by Remedia
Homoeopathy Manufactory, Austria)
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
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(1) (2) (3)
91. BM's Bio Calcium Compound Tablets
Each Tablet Contains Calc Fluor D3 (HPUS)……0.005 gm
Calc Phos D3 (HPUS)………0.005 gm
Echinacea D2 (HPUS)………0.005 gm
Kali Phos D3 (HPUS)……….005 gm
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
92. BM's Bryonia Compound Cough Syrup
Each mL Contains
Bryonia Ø (HPUS)……0.16 gm
Drosera D1 (HPUS)……0.48 mL
Justicia Adhatoda Ø (HPUS)...0.48 mL
Ipecacuanha Ø (HPUS)….0.48 mL
LiquiritiaOfficina Ø D4 (HPUS)………0.96mL
Mentha Piperita D4 (HPUS)…0.24 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
93. BM's Chesty Cough Syrup
Each 120 mL Contains Ammonium Mur D2 (HPUS)……….1.2 gm
Ephedra Distachya D3 (HPUS)………………0.96mL
Hypsus (Ø) (HPUS)…..1.44 mL
Liquiritia Officinalis D1 (HPUS)…...0.48 mL
Mentha Piperita D4 (HPUS)…0.48 mL
Sisymbrium (Ø) (HPUS)......1.44 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
94. BM's Dio Card Compound Drops
Each 30 mL Contains Cactus Grand D2 (HPUS)…..0.4 mL
Camphora D2 (HPUS)…..0.6 mL
Crataegus oxy D2 (HPUS)…..0.6 mL
Ether D4 (HPUS)…..0.04 mL
Strophanthus D3 (HPUS)…..0.2 mL
Valeriana Ø (HPUS)…..0.6 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
95. BM's Doloex Plus Compound Tablet
Each Tablet Contains Ac. a. Sali D2 (HPUS)..........0.0055 mg
Acid Uric D2 (HPUS).............300 gm
Caffeinum D2 (HPUS).......0.00225 gm
Chininum sulph D2 (HPUS)..300 gm
Cinnamonum D1 (HPUS).......300 ml
Filipendula Ulm D1 (GHP)......300 ml
Lithium carb D2 (HPUS).........300 gm
Magnesia Phos D2 (HPUS)..0.0055 gm
Phenacetinum D2 (HPUS)....0.0055 gm
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
96. BM's Doloex Tablet
Each Tablet Contains Ac. a. Sali. D2 (HPUS)…….0.0165mg
Calcium Phos D2 (HPUS)….0.0165mg
Chirata Ø (EHPI)...............0.003mL
Elaterium D1 (DKEMP)......0.003mL
Filipendula Ulm D1 (GHP)....0.003mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
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S.No Brand name Decision
(1) (2) (3)
Caffein D2 (MH)...........0.00675mg
Dioscorea vil (EHPI)..............0.003mL
Magnesia Phos D2 (HPUS)...0.0165mg
Phenacetinum D2 (HPUS)....0.0165mg
97. BM's Euphrasia (Eye Drops)
Each 15mL Contains Euphrasia Off Ø (HPUS)….0.06 mL
Calendula Off Ø (HPUS)….0.03 mL
Boric Acid Ø (HPUS)….0.43 gm
Ruta Grave Ø (HPUS)….0.06 mL
Cineraria Ø (HPUS)….0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
98. BM's Femoline Compound Tablets
Each Tablet Contains Aletris Far D3 (HPUS)….0.0005 mL
As a D1 (HPUS)………0.0005mL
Caulophyllum D4 (HPUS)…0.002mL
Cimicifuga D4 (HPUS)……0.0005mL
Pulsatilla D6 (HPUS)………0.0005mL
Senecio D3 (HPUS)………..0.0005mL
Vibur-op D3 (HPUS)............0.0002mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
99. BM's Golden Stres Compound Tablets
Each Tablet Contains Acid Phos D3 (HPUS)................0.0002 mL
Agnus Castus Ø (HPUS).................2.50 mg
Ambra D5 (HPUS)......................0.0020 mL
Antimonium Crud D3 (HPUS)...0.0002 mL
Avena Sat D1 (HPUS)....................2.50 mg
Damiana D1 (HPUS)......................2.0 mg
Lycopodium D4 (HPUS)............0.0020 mL
Sabal Serrulata D5 (HPUS).........0.0020 mL
Selenium D6 (HPUS)..................0.0010 mg
Staphysagria D4 (HPUS)............0.0005 mL
YohimbinumØ (HPUS).................1.50 mg
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
100. BM's Hair Support Compound Drops
Each 30mL Contains Acid Phos D5 (HPUS)….0.1 mL
Arnica Mont D7 (HPUS)….0.2 mL
Ars. Alb. D6 (HPUS)….0.1 mL
Graphite D12 (HPUS)….0.1 mL
Jaborandi D4 (HPUS)….0.1 mL
Lycopodium D6 (HPUS)….0.1 mL
Phosphorus D7 (HPUS)….0.04 mL
Sulphur D6 (HPUS)….0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
101. BM's Hair Support Tablets Compound
Each Tablet Contains Acid Phos D5 (HPUS)………….0.0001
Arnica Mont D7 (HPUS)………….0.0001
Ars Alb D6 (HPUS)………….0.0001
Graphites D12 (HPUS)………….0.0001
Jaborandi D4 (EHPI)………….0.0001
Lycopodium D6 (HPUS)………….0.0001
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Phosphorus D7 (HPUS)………….0.0001
Sulphur D6 (HPUS)………….0.0001
102. BM Hepa-Care Drops (Compound)
Each 30 mL Contains Baptisia tinc Ø (HPUS)) ……1.0 mL
Beta vulg Ø (HPUS) ……1.0 mL
Carduus mar Ø (HPUS) ……2.5 mL
Ceanothus Ø (EHPI) ……1.0 mL
Chelidonium maj Ø (HPUS) ……2.5 mL
Echinacea Ø (HPUS) ……2.0 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
103. BM's Hepato-Live Syrup Compound
Each 120mL Contains Boldo D3 (HPUS)……….0.048 mL
Chelidonium D2 (HPUS)…..0.96 mL
Fel Tauri D2 (HPUS)……….1.2 mL
Lycopodium D1 (HPUS)…0.336 mL
Podophylum D1 (HPUS)……0.24 mL
SilybumMarianum D2 (HPUS)1.44 mL
Taraxacum D3 (HPUS)…..0.24 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
104. BM's Homoeolax Compound Tablets
Each Tablet Contains Aloes Soco D1 (HPUS)........100 gm
Alumen D3 (HPUS)...............10 gm
Bryonia Ø (HPUS).................100 gm
Croton Tig D1 (HPUS)..........10 gm
Hydrastis Ø (HPUS)..............100 gm
Mag Mur D3 (HPUS)............10 gm
Phenolphthalein D1 (EHPI)...0.060 gm
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
105. BM's Infant Relax Compound Drops
Each 30mL Contains Chamomilla D6 (HPUS)……..0.084mL
Cinnamonum (Ø) (HPUS)…….0.63mL
Colocynthis D3 (HPUS)…….0.21mL
Foeniculum vulg (Ø) (HPUS)…….0.63mL
Mag. Phos D10 (HPUS)…….0.042mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
106. BM's Mullein (Ear Drops)
Each 15mL Contains Aconitum Ø (HPUS)…..0.16 mL
Belladonna D1 (HPUS)…..0.12 mL
Calendula Ø (HPUS)…..0.16 mL
Echinacea Ø (HPUS)…..0.04 mL
Hydrastis Ø (HPUS)…..0.04 mL
Glyceriunm Ø (HPUS)…..0.16 mL
Mulein Oil Ø (HPUS)…..4.2 mL
Viola Odorata Ø (HPUS)…..0.04 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
107. BM's Neu Renecal Compound Drops
Each 30 mL Contains
Deferred since the application is deficient of following documents/information:-
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S.No Brand name Decision
(1) (2) (3)
Berb vulg (Ø) (HPUS)……3.0 mL
Capcilla b.p (Ø) (HPUS)……0.6 mL
Cantharis (Ø) (HPUS)……0.3 mL
Epigea rep (Ø) (HPUS)……0.3 mL
Hydrangea (Ø) (HPUS)……0.3 mL
Sarsaparilla (Ø) (HPUS)……0.3 mL
Stigmata (Ø) (HPUS)……0.3 mL
Terebinthinae (Ø) (HPUS)……0.3 mL
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
108. BM's Nux D.S Compound Syrup
Each mL Contains
Carduus Mar Ø (HPUS)……0.24 mL
China Off Ø (HPUS)……….0.24 mL
Cinnamon D1 (HPUS)……...0.96 mL
Hyoscyamus Niger D2
(HPUS)…………………….0.48 mL
Foeniculum vulg D1 (HPUS)0.48 mL
Mentha Piperita D6 (HPUS)…0.96 mL
Nat Carb D1 (HPUS)………0.048 mL
Nux Vomica D2 (HPUS)……0.48 mL
Robinia D1 (HPUS)………0.048 mL
Zingiber Ø (HPUS)………….0.24 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
109. BM's Nux Vomica Compound Syrup
Each mL Contains Cinnamon D1 (HPUS)……….0.96 mL
CuminumCyminum D2 (DK-EMP)..0.96 mL
Hyoscyamus Niger D2 (HPUS)….1.44 mL
Illicium Anisatum D1 (HPUS)…...0.96 mL
Mentha Piperita D6 (HPUS)…1.20 mL
Nux Vomica D3 (HPUS)......0.48 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
110. BM's Nux Vomica Compound Tablets
Each gm Contains Cinnamon D1 (HPUS)….0.0002 mL
CuminumCyminum D2 (DK-EMP)..0.0002 mL
Foeniculum vulg D1 (HPUS)…...0.0002 mL
Hyoscyamus Niger D2 (HPUS)…..0.0005 mL
Mentha Piperita D6 (HPUS)..0.0015 mL
Nux Vomica D3 (HPUS).....0.0015 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
111. BM's Oleum Jecoris Compound Drops
Each 30 mL Contains
Echinacea D4 (HPUS)……0.3 mL
OleumJeco D8 (HPUS)……0.6 mL
Thuja Oce D7 (HPUS)……0.3 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
112. BM's Plantago Dental Lotion
Each 15mL Contains Acid Carbolic D1 (HPUS)….0.10 mL
Acid tannic Ø (HPUS)….0.21 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Aconitum Nap D1 (HPUS)..0.21 mL
Belladonna Ø(HPUS)….0.42 mL
Camphora Ø (HPUS)….0.33 mL
Kreosotum Ø (HPUS)….0.42 mL
Plantago Ø (HPUS)….0.10 mL
113. BM's Platelets Enhancer Compound Drops
Each 30 mL Contains Avena Sativa Ø (HPUS) ……2.0 mL
Bryonia Alba Ø (HPUS) ……0.50 mL
Carica Papaya Ø (EHPI) ……2.0 mL
Eupatorium Perf Ø (HPUS) ……1.0 mL
Gelsemium Ø (HPUS) ……1.0 mL
Ginkgo Biloba Ø (HPUS) ……0.50 mL
Hamamelis Virg Ø (HPUS) ……0.50 mL
Secal Corn Ø (HPUS) ……0.25 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
114. BM's Podophyllum Compound Syrup
Each mL Contains
Aegle MarmelosØ (EHPI)…0.48 mL
Kurchi Ø (HPUS)……..0.72 mL
Myrtus Communis Ø (HPUS)..0.12 mL
Podophyllum D1 (HPUS)……0.96 mL
Veratrum Album D3 (HPUS)..0.72 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
115. BM's Rauwalfia Compound Drops
Each 30mL Contains AmomumSubulatum D2 (DKEMP)……0.6 mL
CoriandrumSativum D2 (EHPI)………..0.6 mL
Crataegus Oxy D1 (HPUS)…………….1.0 mL
Lavandula D2 (EHPI)..............................0.6 mL
Piper nigrum D3 (HPUS)........................0.2 mL
Rauwolfia Serp. D1 (HPUS)..................1.0 mL
Santalum Alb. D3 (DKEMP)................0.2 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
116. BM's Rauwalfia Compound Tablets
Each mg Contains AmmomumSubulatum D2 (DKEMP)……..8mg
CoriandrumSativum D2 (EHPI)…………...2.5mg
Crataegus Oxy D1 (HPUS)………………..2mg
Lavandula D2 (EHPI)…………………......10mg
Piper Nigrum D3 (HPUS)...........................2.5mg
Rauwolfia Serp D1 (HPUS)........................10mg
Santalum Alb D3 (DKEMP)......................2mg
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
117. BM's Renecure Compound Drops
Each 30 mL Contains
Berberies Vulg Ø (HPUS)……0.8 mL
Cantharis D2 (HPUS)……0.8 mL
Epigaea Rep D1 (HPUS)……0.2 mL
Hydrangea D1 (HPUS)……0.4 mL
Pareira Brava D2 (HPUS)……0.2 mL
Rubia Tinc D1 (HPUS)……0.2 mL
Sarsaparilla D2 (HPUS)……0.2 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
118. BM's Renecure Compound Syrup Deferred since the application is deficient of following documents/information:-
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Each mL Contains Berberies Vulg D1 (HPUS)….1.44 mL
Cantharis D2 (HPUS)………0.72 mL
Epigaea Rep D1 (HPUS)...…0.24 mL
Hydrangea D1 (HPUS)…….0.24 mL
Pareira Brava D2 (HPUS)…0.48 mL
Rubia Tinc D1 (HPUS)…….0.96 mL
Sarsaparilla D2 (HPUS)…….0.48 mL
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
119. BM's Sepia Compound Tablets
Each gm Contains Agrimonia D6 (HPUS)……0.0002 mL
Alumina D12 (HPUS)…….0.0002 mL
Hydrastis D4 (HPUS)……0.0002 mL
Kali bich D6 (HPUS)……0.0003 mL
Pulsatilla D5 (HPUS)……...0.0005 mL
Sepia D4 (HPUS)………….0.001 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
120. BM's Syz-Jambol Tablets
Each Tablet Contains CephlandraindD1 (EHPI)….0.02mL
Gymnema syl D1 (EHPI)….0.02mL
MomordicaCharantia D1 (EPHI)….0.04mL
Santalum alb. D2 (DKEMP)….0.01mL
Syzygium Jambol D1 (HPUS)….0.04mL
Valeriana. R. D2 (HPUS)….0.01mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
121. BM's Tension Releif Compound Drops
Each 30 mL Contains
Crataegus oxy D2 (HPUS)……..…1.50 mL
Gelsemium D4 (HPUS)……..…0.50 mL
Ginkgo biloba D3 (HPUS)……..…1.00 mL
Glycyrrhizaglab D1 (HPUS)……..1.00 mL
Hypericum perf D4 (HPUS)……..1.50 mL
Ignatia amara D3 (HPUS)……..…0.25 mL
Moschus D6 (HPUS)……..…0.50 mL
Oleummor D6 (HPUS)……..…0.25 mL
Piper meth D6 (HPUS)……..…0.50 mL
Valeriana off D4 (HPUS)……..…1.50 mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
122. BM's Vitagene Forte Compound Drops
Each 30mL Contains Acid Phos Ø (HPUS)…….0.4mL
Agnus Castus D4 (HPUS)…….0.6mL
Agaricus Mus D3(HPUS)…….0.4mL
Damiana D6 (HPUS)…….0.4mL
Ginseng Panax D2 (HPUS)…….0.4mL
Sabal Serr D2 (HPUS)…….0.2mL
ScutellariaLat D2(HPUS)…….0.04mL
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
Use of formulation to be provided
F.No.10-7/2020-OTC) (M-79)
Page 23 of 408
S.No Brand name Decision
(1) (2) (3)
Selenium D8(HPUS)…….0.04mL
Yohimbinum D3(HPUS)…….0.8mL
M/s. Kent Homoeopathic Pharmacy,
located at Plot No. 30/D, Sector-15, Korangi Industrial Area, Karachi, Pakistan
123. Acidum Muriaticum Potencies
30,3X,200,1000,10M,Cm
Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
124. Acidum Sulphuricum Potencies
30,3X,200,1000,10M,Cm
Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
125.
Crocus Sativus Potencies 30,3X,200,1000,10M,Cm
Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
126. Coffeinum Potencies Potencies
30,3X,200,1000,10M,Cm
Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
127. Cephalandra Indica Potencies
30,3X,200,1000,10M,Cm
Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
128.
Calcium Silicium Potencies 30,3X,200,1000,10M,Cm
Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
129.
Dna Potencies 30,3X,200,1000,10M,Cm
Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
130.
Kent-56 Drops
Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
131.
Kent-42 Drops
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
132.
Kent-10 Drops
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
133.
Kent-06 Drops
Deferred since the application is deficient of following documents/information:-
Monographs of Aurum coll D3, Melissa D2 & Strophanthum D4 are missing
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
134.
Kent-62 Drops
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
135.
Kent-66 Drops
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
136.
Kent-67 Drops
Deferred since the application is deficient of following documents/information:-
Monograph of Pituitrinum D200+200C is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
137. Kent-16 Drops
Deferred since the application is deficient of following documents/information:-
Monographs of Hypophysis D6, Pancreas D10 & Testes D6 are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
F.No.10-7/2020-OTC) (M-79)
Page 24 of 408
S.No Brand name Decision
(1) (2) (3)
138.
Kent-34 Drops
Deferred since the application is deficient of following documents/information:-
Monographs of Cicuta virosa & Luesinum D12 are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
139.
Kent-35 Drops
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
140.
Kent-36 Drops
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
141.
Kent-37 Drops
Deferred since the application is deficient of following documents/information:-
Monographs of Mercurius praeci & Aranea diadema are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
142.
Kent-38 Drops
Deferred since the application is deficient of following documents/information:-
Monograph of Radix D6 is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
143.
Kent-33 Drops
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
144.
Kent-27 Drops
Deferred since the application is deficient of following documents/information:-
Monograph of Tormentilla D3 & Kurchi is missing
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
marketing evidence of 10 years
145.
Acne Cap Capsules
Deferred since the application is deficient of following documents/information:-
Monograph of Calc phos, Ledum pal & Oophorium
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
146.
Acne Cure Cream
Deferred since the application is deficient of following documents/information:-
Monographs of Berb.Aquif, Hydrocotyle & Thuja are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
147.
Acne Salbe Ointment
Deferred since the application is deficient of following documents/information:-
Monograph of Monographs of active are missing
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
148.
Action-1
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
149. Action-2 Deferred since the application is deficient of following documents/information:-
F.No.10-7/2020-OTC) (M-79)
Page 25 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of Bellis perennis & Cantharis are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
150.
Action-3
Deferred since the application is deficient of following documents/information:-
Active ingredients monographs are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
151.
Active Move Spray
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
152.
Addistop Tablet
(21 Days Slimming Plan)
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
153. Alfalfa Tonic Syrup
Deferred since the application is deficient of following documents/information:-
Monographs of China, Avena sativa & Cinnamonum are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
154. Alfatone ( Suger Free Syrup)
Deferred since the application is deficient of following documents/information:-
Monograph of Acid phosphoricum, kali phos, sterculia & avena sativa
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
155. Ambra Musk Tablets
Deferred since the application is deficient of following documents/information:-
Monographs of Agnus, Ambra & Selenium
Combination homeopathic product. The firm is directed to submit international
reference (COPP) or marketing evidence of 10 years
156.
Ambra Super Capsules
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
157.
Anti Crack Cream
Deferred since the application is deficient of following documents/information:-
Monographs of active are missing
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
158. Anti Rash Ointment
Deferred since the application is deficient of following documents/information:-
Monographs of Balsamum, boric acid, Rhus tox & zinc oxide.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
159.
Anti SmoApplication is complete.ing
Deferred since the application is deficient of following documents/information:-
Monographs of active are missing
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
160.
Arnica Oil
Deferred since the application is deficient of following documents/information:-
Monograph of Chinanthus virginicus is missing
F.No.10-7/2020-OTC) (M-79)
Page 26 of 408
S.No Brand name Decision
(1) (2) (3)
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
161.
Arthrovina Syrup
Deferred since the application is deficient of following documents/information:-
Monograph of Causticum D8 is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
162. Asthavina Syrup
Deferred since the application is deficient of following documents/information:-
Monographs of Arsenum, Blatta orientalis, Ephedra, Napthalinum,
Quebracho & Tartrus stibiati are missing.
Product contains Ephedrine.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
163.
Avene Super Tonic Syrup
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
164.
Eczema Cream
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
165. Ranunculus Bulbosus Potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
166. Lachesis potencies Deferred since the application is deficient of following documents/information:-
Strength of potencies not given
167. Bellis perennis potencies Deferred since the application is deficient of following documents/information:-
Strength of potencies not given
168. Bovista Potencies Deferred since the application is deficient of following documents/information:-
Strength of potencies not given
169. Calcarea arsenicosa potencies Deferred since the application is deficient of following documents/information:-
Strength of potencies not given
170. Carboneum sulphuratum potencies Deferred since the application is deficient of following documents/information:-
Strength of potencies not given
171. Cuprum oxydatum nigrum potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
172. Cannabis indica potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing. Product contains Cannabis.
Strength of potencies not given
173. Calcarea renalis potenciec Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
174. Cobaltum potencies Deferred since the application is deficient of following documents/information:-
Strength of potencies not given
175. Crotalus horridus potencies Deferred since the application is deficient of following documents/information:-
Strength of potencies not given
176. Cucurbita pepo potencies Deferred since the application is deficient of following documents/information:-
F.No.10-7/2020-OTC) (M-79)
Page 27 of 408
S.No Brand name Decision
(1) (2) (3)
Strength of potencies not given
177. Cuprum aceticum potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
178. Cuprum sulfuratum potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
179. Cuprum arsenicosum potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
180. Corallium rubrum potencies Deferred since the application is deficient of following documents/information:-
Strength of potencies not given
181. Comocladia potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
182. Cobaltum nitricum potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
183. Centaurium canadensis potencies Deferred since the application is deficient of following documents/information:-
Strength of potencies not given
184. Diphtherinum Potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
185. Acidum intro muriaticum potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
186. Antimonium sulf aurantiacum potencies Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
Strength of potencies not given
187. Acid Phos Syrup Deferred since the application is deficient of following documents/information:-
Monographs of Abrutanum D3 & Condurango are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
188. East Teething Tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
189. Energizer tonic Syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
190. Fat Burner Tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
191. Female Syrup Deferred since the application is deficient of following documents/information:-
F.No.10-7/2020-OTC) (M-79)
Page 28 of 408
S.No Brand name Decision
(1) (2) (3)
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
192. Ferrum Compound Capsules Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
193. Gyno Compound syrup Deferred since the application is deficient of following documents/information:-
Monograph of Fraxinus is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
194. Korean ginseng syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
195. Glycomol lotion Deferred since the application is deficient of following documents/information:-
Menthol & Thymol monographs are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
196. Grip inhaler Deferred since the application is deficient of following documents/information:-
Product contains methy salicylate and monographs of active are also
missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
197. Grippe aconite syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
198. Gynogesic syrup Deferred since the application is deficient of following documents/information:-
Monographs of Cuprum sativus D4, Naja tripudians D10 & Salina D6 are
missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
199. Siberian ginseng tonic Deferred since the application is deficient of following documents/information:-
Monographs of Chininese astragalus root, Licorice root &Glycyrrhiza
glabra are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
200. Sinus nasal Drops Deferred since the application is deficient of following documents/information:-
Monograph of Euphorbium is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
201. Slim trac ( slimming mixture) Deferred since the application is deficient of following documents/information:-
Monograph of Oleum crotonis D6 is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
202. Spervina capsules Deferred since the application is deficient of following documents/information:-
Monographs of Cabaltum nit, Orchintinum D3 & Seutellaria D2 are
missing.
F.No.10-7/2020-OTC) (M-79)
Page 29 of 408
S.No Brand name Decision
(1) (2) (3)
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
203. Sulphur cream
Sulphur Ø (EHPI)
100%w/v
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
204. Tai ginseng syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
205. Acid phos capsule Deferred since the application is deficient of following documents/information:-
Monographs of Abrotanum D3 & Condurango are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
206. Thymus syrup Deferred since the application is deficient of following documents/information:-
Monographs of Mentholium, Mentha piperita & Spongia tasta are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
207. Tilla cantharidis Deferred since the application is deficient of following documents/information:-
Monographs of Capsicum oil, Fish oil & Olive oil are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
208. Benefix cream Deferred since the application is deficient of following documents/information:-
Monographs of Grape fruit, Phytoestogen, Vitamin C & Vitamin E are
missing. Product contains Vitamin C & Vitamin E.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
209. Badiga dandruff lotion Deferred since the application is deficient of following documents/information:-
Glycerine registered as drug.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
210. Benefix capsules Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
211. Anti dengue and malaria drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
212. Calcium ( Orange tablets) Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
213. Calcium max granules Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
214. Calendula ointment
Calendula Ø (EHPI) 100% v/v
Deferred since the application is deficient of following documents/information:-
Monographs of Euphrasia & Ruta are missing.
F.No.10-7/2020-OTC) (M-79)
Page 30 of 408
S.No Brand name Decision
(1) (2) (3)
215. Cantharis cream
Cantharis (EHPI)
100% v/v
Deferred since the application is deficient of following documents/information:-
Monographs of Carica papaya, Crotalus horridus & Malaria officinalis are
missing. The product claimes for Anti dengue & Anti malarial treatment
216. Hilex syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
217. Itching relief cream Deferred since the application is deficient of following documents/information:-
Monographs of Azasirachta indica & Mentholum are missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
218. Crataegus syrup Deferred since the application is deficient of following documents/information:-
Au8rum colloidale monograph is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
219. Damiagesic syrup Deferred since the application is deficient of following documents/information:-
Monographs of Eleutherococcus sent & ptychopetalum are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
220. Dibalsan drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
221. Haemocor syrup Deferred since the application is deficient of following documents/information:-
Monographs of Acalyphs ind & Millefolium are missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
222. Hair & skin tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
223. Hepakent syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
224. Histamine Capsules Deferred since the application is deficient of following documents/information:-
Monographs of Histamine, Pix liquida & Psprinum nosode are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
225. KenlApplication is complete.id syrup Deferred since the application is deficient of following documents/information:-
Monograph of Baryta corbonica is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
226. Mouthline lotion Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
F.No.10-7/2020-OTC) (M-79)
Page 31 of 408
S.No Brand name Decision
(1) (2) (3)
227. Kent pyrea lotion Deferred since the application is deficient of following documents/information:-
Monograph of Staphysagria is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
228. Khonsaafi syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
229. Kidnivina Capsules Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
230. Max vision syrup Deferred since the application is deficient of following documents/information:-
Monographs of Bilberry & Chrysanthemum are missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
231. Mullien ear drops Deferred since the application is deficient of following documents/information:-
Monograph of Mullein oil is missing. Combination homeopathic product.
The firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
232. Neem cream
Pure Neem extract (EHPI)
100%v/v
Deferred since the application is deficient of following documents/information:-
Product contains Methyl Salicylate
233. Olix capsules
Olive extract (EHPI)
100 % v/v
Deferred since the application is deficient of following documents/information:-
Olive extract monograph is missing
234. Perspiration tablets Deferred since the application is deficient of following documents/information:-
Monograph of Pilocarpus is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
235. Phytogesic syrup Deferred since the application is deficient of following documents/information:-
Monographs of Ilex paraguariensos, Petroselinum crispum & Rhamnus
frangula are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
236. Power booster mouth spray Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
237. Roli balm oinmtment Deferred since the application is deficient of following documents/information:-
Monographs of Terebinthina & Thymol are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
238. Veratrum comp tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
239. W.M.L cream Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
F.No.10-7/2020-OTC) (M-79)
Page 32 of 408
S.No Brand name Decision
(1) (2) (3)
240. Kalkurinal drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
241. Leucovina syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
242. Fever Compound syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
243. Veratrum Compound Syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
244. Gastric Plus syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
245. Addistop Drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
246. kent-4 drops Deferred since the application is deficient of following documents/information:-
Monograph of Myartali D3 is missing. Combination homeopathic product.
The firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
247. kent-7 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
248. kent-11 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
249. kent-14 drops Deferred since the application is deficient of following documents/information:-
Monograph of Spongia D3 is missing. Combination homeopathic product.
The firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
250. kent-18 drops Deferred since the application is deficient of following documents/information:-
Monograph of Pix liquida D10 is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
251. kent-21 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
252. kent-25 drops Deferred since the application is deficient of following documents/information:-
Monographs of Cantharis D30 & Populous treamuloides are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
253. kent-2 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
254. kent-12 drops Deferred since the application is deficient of following documents/information:-
Monographs of Gossypium D2, Helonias diocia, Polygonum D2 &
Vibrunum opulus D2 are missing. Combination homeopathic product. The
firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
255. kent-54 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
F.No.10-7/2020-OTC) (M-79)
Page 33 of 408
S.No Brand name Decision
(1) (2) (3)
256. kent-64 drops Deferred since the application is deficient of following documents/information:-
Monographs of Aralia racenum D1 & Arsenum jadatum are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
257. kent-40 drops Deferred since the application is deficient of following documents/information:-
Monograph of Theriiodion D12 is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
258. kent-51 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
259. kent-19 drops Monographs of Ammonium Brom D4, Coffea D6, Crataegus D1 &
Valeriana are missing. Combination homeopathic product. The firm is
directed to submit international reference (COPP) or marketing evidence of
10 years
260. kent-22 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
261. kent-26 drops Deferred since the application is deficient of following documents/information:-
Monograph of Coffee D3 is missing. Combination homeopathic product.
The firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
262. kent-61 drops Deferred since the application is deficient of following documents/information:-
Monographs of Aralia racenum & Arsenum jadatum are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
263. kent-30 ointments Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
264. kent-32 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
265. kent-43 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
266. kent-46 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
267. kent-55 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
268. kent-59 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
269. Kent 68 drops Deferred since the application is deficient of following documents/information:-
Monographs of Carum curvi, Mentha piperita & Nux moschata D6 are
missing. Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
270. Kent 70 drops Deferred since the application is deficient of following documents/information:-
Monograph of Baptisia tincoria is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
271. Kent 1 Drops Deferred since the application is deficient of following documents/information:-
F.No.10-7/2020-OTC) (M-79)
Page 34 of 408
S.No Brand name Decision
(1) (2) (3)
Product contains Ephedra. Combination homeopathic product. The firm is
directed to submit international reference (COPP) or marketing evidence of
10 years
272. Arnica Plus Oil Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
273. Enerfit Supplement tonic tablet Deferred since the application is deficient of following documents/information:-
Lecithin D3 monograph is missing. Combination homeopathic product. The
firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
274. Energizer sugar free tonic Syrup Deferred since the application is deficient of following documents/information:-
Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
275. Fat Burner Cream Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
276. Ferrolocithin Malt Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
277. Fever Compound tablet Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
278. Gastric Tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
279. Gastrogesic Syrup Deferred since the application is deficient of following documents/information:-
Monographs of Acidum hydrochloricum & Castoreum D6 is missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
280. Ginkgo sugar free syrup Deferred since the application is deficient of following documents/information:-
Monograph of Baryta carbonicum is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
281. Ginsojel Liquid supplement Deferred since the application is deficient of following documents/information:-
Monograph of Royal jelly is missing. Combination homeopathic product.
The firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
282. Gyno compound capsules Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
283. Sharbet-e-faulad Deferred since the application is deficient of following documents/information:-
Monograph of Lecithinum is missing. Combination homeopathic product.
The firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
284. Sinus eaz drops Deferred since the application is deficient of following documents/information:-
Monographs of Potassium Phosphoricum & Testes D3 are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
285. Sinus releif formula tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
286. Solidago syrup Deferred since the application is deficient of following documents/information:-
F.No.10-7/2020-OTC) (M-79)
Page 35 of 408
S.No Brand name Decision
(1) (2) (3)
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
287. Spirulin supplement capsules Deferred since the application is deficient of following documents/information:-
Monograph of active is missing.
288. Super weight gainer powder Deferred since the application is deficient of following documents/information:-
Monograph of Lecithin is missing. Combination homeopathic product. The
firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
289. Terebinthina Deferred since the application is deficient of following documents/information:-
Monograph of Rubia tincorum is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
290. Thypoid syrup Deferred since the application is deficient of following documents/information:-
Monographs of actives are missing. Combination homeopathic product. The
firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
291. Tonsifort tablets Deferred since the application is deficient of following documents/information:-
Monographs of Ammonium broom & Baryta carb are missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
292. Gastric syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
293. Baby tonic syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
294. Bed weeting tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
295. Biovina capsules Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
296. Biovina tonic Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
297. Calcium tablet Deferred since the application is deficient of following documents/information:-
Monographs of Phytoestrogen D2 is missing. The product also contains
Vitamin C D6 & Vitamin E D6 as an active. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
298. Calcium Liquid Syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
299. Calendula extra cream Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
300. Constisen syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
301. Cough syrup Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
302. Damiana capsules Deferred since the application is deficient of following documents/information:-
F.No.10-7/2020-OTC) (M-79)
Page 36 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of Strychonium phos, Kaladium seg & Testis D6 are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
303. Dental remedy lotion Deferred since the application is deficient of following documents/information:-
Monographs of Kerosote & Staphysagria are missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
304. Duodenol tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
305. Hair growth tablet Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
306. Headache tablets Deferred since the application is deficient of following documents/information:-
Cimicifuga racemosa monograph is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
307. Hilex Tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
308. Infant growing tonic Deferred since the application is deficient of following documents/information:-
Monographs of Conchea preap, Sacch alb & Sal marinum are
missing. Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
309. Jam-e-sehat syrup Deferred since the application is deficient of following documents/information:-
Monograph of Apple cidar & Zingeber officinale are missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
310. Kent medicated cream Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
311. Kent skin ointment Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
312. kidnigesic syrup Deferred since the application is deficient of following documents/information:-
Monographs of Pereirra brava & scenecio aureus are missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
313. Liverex syrup Deferred since the application is deficient of following documents/information:-
Monographs of Cardus mananus & Cheledonium are missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
314. Motalien powder Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
315. Multi max syrup Deferred since the application is deficient of following documents/information:-
Brand Name already enlisted. Combination homeopathic product. The firm
is directed to submit international reference (COPP) or marketing evidence
of 10 years
316. Nerve & bone linment Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
317. Pain relief tablets Deferred since the application is deficient of following documents/information:-
F.No.10-7/2020-OTC) (M-79)
Page 37 of 408
S.No Brand name Decision
(1) (2) (3)
Salix alba monograph is missing. Combination homeopathic product. The
firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
318. Piles cream Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
319. Rauwalfine H.B.P capsules Deferred since the application is deficient of following documents/information:-
Monograph of Vibrum opulus D3 is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
320. Ruta kent eye ointment. Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
321. Valixol tablets Deferred since the application is deficient of following documents/information:-
Monograph of Mellisa off extract is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
322. Vertigo tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
323. Yohimbinum caps Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
324. Hervitone drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
325. Kinevina syrup Deferred since the application is deficient of following documents/information:-
Monographs of Calculus ren D5 & Rubia tincoria D2 are
missing. Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
326. Kent Analgesic Plus Cream Deferred since the application is deficient of following documents/information:-
Monographs of Menthe viridis & Symphytum are missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
327. Tonsifort syrup Deferred since the application is deficient of following documents/information:-
Monograph of Mentholum is missing. Combination homeopathic product.
The firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
328. Trifol cough syrup Deferred since the application is deficient of following documents/information:-
Justicia monograph is missing. Combination homeopathic product. The firm
is directed to submit international reference (COPP) or marketing evidence
of 10 years
329. Ferrum Compound Syrup Deferred since the application is deficient of following documents/information:-
Monograph of Lecithin is missing. Combination homeopathic product. The
firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
330. Gastric Plus tablets Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
331. kent-3 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
332. kent-5 drops Deferred since the application is deficient of following documents/information:-
F.No.10-7/2020-OTC) (M-79)
Page 38 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of Argentum D6, Anacardium D6 & Belladona D4 are missing.
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
333. kent-9 drops Deferred since the application is deficient of following documents/information:-
Monographs of Calculus renal, Plumbum lodatum & Rubia tincturum are
missing. Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
334. kent-13 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
335. Kent-15 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
336. kent-17 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
337. kent-23 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
338. kent-29 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
339. kent-8 drops Deferred since the application is deficient of following documents/information:-
Monograph of Sticta is missing. Combination homeopathic product. The
firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
340. kent-53 drops Deferred since the application is deficient of following documents/information:-
Monograph of Andrograph pen is missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
341. kent-57 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
342. kent-39 drops Deferred since the application is deficient of following documents/information:-
Monograph of Orchitinum is missing. Combination homeopathic product.
The firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
343. kent-44 drops Deferred since the application is deficient of following documents/information:-
Monographs of Helonias diocia, Viburnum opulus D2 & Polygonum D2 are
missing. Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
344. kent-49 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
345. kent-65 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
346. kent-20 drops Deferred since the application is deficient of following documents/information:-
Monographs of Filix Mass & Tanacetum D3 is missing. Combination
homeopathic product. The firm is directed to submit international reference
(COPP) or marketing evidence of 10 years
347. kent-24 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
F.No.10-7/2020-OTC) (M-79)
Page 39 of 408
S.No Brand name Decision
(1) (2) (3)
348. kent-28 drops Deferred since the application is deficient of following documents/information:-
Monographs of active ingredients are missing. Combination homeopathic
product. The firm is directed to submit international reference (COPP) or
marketing evidence of 10 years
349. kent-63 drops Deferred since the application is deficient of following documents/information:-
Monographs of Aralia racenum & Arsenum jadatum are
missing. Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
350. kent-31 drops Deferred since the application is deficient of following documents/information:-
Monograph of Ignatia D2 is missing. Combination homeopathic product.
The firm is directed to submit international reference (COPP) or marketing
evidence of 10 years
351. kent-41 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
352. kent-45 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
353. kent-47 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
354. kent-52 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
355. kent-58 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
356. kent-60 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
357. Kent 69 drops Deferred since the application is deficient of following documents/information:-
Monographs of Petroleium D6, Sliva oficinalis D4 & Sambucus nigra D4
are missing. Combination homeopathic product. The firm is directed to
submit international reference (COPP) or marketing evidence of 10 years
358. Kent 71 drops Deferred since the application is deficient of following documents/information:-
Combination homeopathic product. The firm is directed to submit
international reference (COPP) or marketing evidence of 10 years
M/s. M.S. Corporation (00150)
302, Hashoo Centre, Abdullah Haroon Road, Saddar, Karachi-Pakistan
Agent of M/s Laboratories Lehning, SAS 3, rue du Petit Marais 57640 SINTE-BARBE, FRANCE (Human use)
359. Amphosca Orchityn Chewable Tablet Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The copy of COPP provided, has not been notarized and attested by the
embassy.
The GMP certificate of principal manufacturer, has expired.
360. Biocarde Oral Solution Deferred since the application is deficient of following documents/information;
The respective potency or MT has not been mentioned with actives.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The copy of free sale certificate provided, has not been notarized and attested
by the embassy.
F.No.10-7/2020-OTC) (M-79)
Page 40 of 408
S.No Brand name Decision
(1) (2) (3)
The GMP certificate of principal manufacturer, has expired.
361. Biomag Tablet Deferred since the application is deficient of following documents/information;
The quantity of actives per tablet has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
362. Damiapax Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided
The GMP certificate of principal manufacturer, has expired.
363. Diacure Capsule Deferred since the application is deficient of following documents/information;
The stability studies data of all the three batches is incomplete. Moreover, the
conditions of stability studies are not according to Zone IVA.
The copy of free sale certificate provided, has not been notarized and attested
by embassy.
The GMP certificate of principal manufacturer, has expired.
364. L-107 Oral Drops Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
365. Passiflora GHL Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The name of the product mentioned on free sale certificate is Passiflora
Complexe NO 57.
The copy of free sale certificate provided, has not been notarized and attested
by embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
366. Phapax Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The copy of free sale certificate provided, has not been notarized and attested
by embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
367. Sinuspax Tablet Deferred since the application is deficient of following documents/information;
The quantity of actives per tablet has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
368. Soludor Oral Drops Deferred since the application is deficient of following documents/information;
F.No.10-7/2020-OTC) (M-79)
Page 41 of 408
S.No Brand name Decision
(1) (2) (3)
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The GMP certificate of principal manufacturer, has expired.
369. Trim Tablet Deferred since the application is deficient of following documents/information;
The conditions of stability studies are not according to Zone IVA.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
370. Utrinol Vaginal Lotion Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
371. Agnus Castus Complexe N˚ Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
372. Acidum Phosphoricum Complexe NO 5 Oral
Drops
Deferred since the application is deficient of following documents/information;
373. Millefolium Complexe No 7 Oral Drops Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The GMP certificate of principal manufacturer, has expired.
374. Uva Ursi Complexe No 9 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The formulation mentioned on free sale certificate is different from applied
formulation.
The GMP certificate of principal manufacturer, has expired.
375. Natrum carbonicum Complexe No 10 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
376. Kalmia Complexe No 18 Oral Drops Deferred since the application is deficient of following documents/information;
F.No.10-7/2020-OTC) (M-79)
Page 42 of 408
S.No Brand name Decision
(1) (2) (3)
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
377. Sepia Complexe No 20 Tablet Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The GMP certificate of principal manufacturer, has expired.
378. Rosmarinus Complexe N˚24 Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
379. Hypericum Complexe No 26 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
380. Conium Complexe No 36 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The conditions of stability studies are not according to Zone IVA.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
381. Aurum Complexe N˚38 Tablet Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
382. Echinacea Complexe N˚40 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
F.No.10-7/2020-OTC) (M-79)
Page 43 of 408
S.No Brand name Decision
(1) (2) (3)
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
383. Vespa Complexe No 46 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The conditions of stability studies are not according to Zone IVA.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
384. Pulstatilla Complexe N˚60 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The quantity of actives per 30ml has not been provided.
The conditions of stability studies are not according to Zone IVA.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
385. Cetratia Complexe NO 61 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
386. Kreosptum Complexe NO 62 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
387. Ipeca Complexe N˚65 Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
388. Gelsemium Complexe N˚70 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 44 of 408
S.No Brand name Decision
(1) (2) (3)
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
389. Cocculus Complexe N˚73 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
390. Amanita Complexe N˚75 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
391. Oenanthe Complexe N˚78 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
392. Ranunculus Complexe N˚79 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
393. Rhus Toxicodendron Complexe NO 80 Oral
Drops
Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 45 of 408
S.No Brand name Decision
(1) (2) (3)
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
394. Ledum Complexe NO 81 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
395. Cistus Canadensis Complexe N˚86 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, has not been provided.
The GMP certificate of principal manufacturer, has expired.
396. Scabiosa Complexe NO 118 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
397. Calendula Complexe N˚89 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
398. Selenium Complexe NO 99 Tablet Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The GMP certificate of principal manufacturer, has expired.
399. Fucus Complexe NO 111 Sublingual Tablet Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 46 of 408
S.No Brand name Decision
(1) (2) (3)
The free sale certificate provided, has not been notarized and attested by the
embassy.
The GMP certificate of principal manufacturer, has expired.
400. Euphrasia Complexe N˚115 Oral Drops Deferred since the application is deficient of following documents/information;
The application has not been submitted on Form-5.
The Fee Challan has not been endorsed.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The GMP certificate of principal manufacturer, has expired.
401. Iodum Complexe NO 118 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate provided, has not been notarized and attested by the
embassy.
The pack size mentioned on free sale certificate is 20ml while the applied pack
size is 30ml.
The formulation mentioned on free sale certificate is different from applied
formulation.
The GMP certificate of principal manufacturer, has expired.
402. Hedera Complexe NO 20 Oral Drops Deferred since the application is deficient of following documents/information;
The quantity of actives per 30ml has not been provided.
The stability studies data of three batches according to the conditions of Zone
IVA, not provided.
The free sale certificate, not provided.
The GMP certificate of principal manufacturer, has expired.
M/s. Penzi Business Organization (00171)
326, Al-Sadiq, D.M.C.H.S, Hyder Ali Road, Karachi-Pakistan is Agent of M/s Herbamed AG, Austrasse 12, CH-9055 Buhler, SWITZERLAND
(Homoeopathy)
403. Acidum Phosphoricum Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
404. Aesculus Hippocastanum Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
405. Allium Sativum Φ Deferred since the application is deficient of following documents/information;
F.No.10-7/2020-OTC) (M-79)
Page 47 of 408
S.No Brand name Decision
(1) (2) (3)
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
406. Apis Mellifica Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
407. Arnica Montana C30 Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
408. Aspidosperma Quebracho Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
409. Berberis Vulgaris Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
410. Bryonia Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
411. Calendula Officinalis Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
F.No.10-7/2020-OTC) (M-79)
Page 48 of 408
S.No Brand name Decision
(1) (2) (3)
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
412. Ceanothus Americanus Φ Deferred since the application is deficient of following documents/information;
The application for submitted is unsigned and unstamped.
COA of Solidago MT has been provided instead of Ceanothus Americanus
MT.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
413. Echinacea Angustifolia Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
414. Fraxinus Americanus Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
415. FucusVesiculosus Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
416. Hamamelis Virginiana Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
417. Hydrastis Canadensis Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
F.No.10-7/2020-OTC) (M-79)
Page 49 of 408
S.No Brand name Decision
(1) (2) (3)
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
418. Hypericum Perforatum Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
419. Hydrangea Arborescens Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
420. Lemna Minor Φ Deferred since the application is deficient of following documents/information;
The COA of Allium sativum MT has been provided instead of COA of Lemna
minor MT.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
421. Lycopodium Clavatum Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
422. Nuphar Luteum Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
423. Symphytum Officinalis Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
F.No.10-7/2020-OTC) (M-79)
Page 50 of 408
S.No Brand name Decision
(1) (2) (3)
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
424. Teucrium Marum Φ Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
425. Thuja Occidentalis Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
426. Ustilago Maydis Φ Deferred since the application is deficient of following documents/information;
The COA of Lemna minor MT has been provided instead of COA of
Ustilagomaydis MT.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
427. Origanum Majoran Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
428. Panax Ginseng Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
429. Sulphur Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
F.No.10-7/2020-OTC) (M-79)
Page 51 of 408
S.No Brand name Decision
(1) (2) (3)
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
430. Pilocarpus Φ Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
431. Mahonia Aquifolium Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
432. Silybum Marianum Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
433. Smilax Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
434. Turnera Diffusa Φ Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
435. Medicago Sativa Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
F.No.10-7/2020-OTC) (M-79)
Page 52 of 408
S.No Brand name Decision
(1) (2) (3)
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
436. Cinchona Pubescens Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
437. Chamaelirium Luteum Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
438. Marsdenia Cundurango Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
439. Crataegus Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
440. Capsella Bursa-Pastoris Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
441. Serenoa Repens Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
442. Centella Asiatica Φ Deferred since the application is deficient of following documents/information;
COA of solidago MT has been provided instead of Centella Asiatica Φ.
F.No.10-7/2020-OTC) (M-79)
Page 53 of 408
S.No Brand name Decision
(1) (2) (3)
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
443. Delphinium Staphisagria Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
444. Amylium Nitrosum Φ Deferred since the application is deficient of following documents/information;
COA of solidago MT has been provided instead of Amylium NitrosumΦ.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
445. Thuja Occidentalis Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
446. Syzgium Cumini Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
447. Usnea Barbata Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
448. Yohimbinum Ecourtice Φ Deferred since the application is deficient of following documents/information;
The application for submitted is unsigned and unstamped.
F.No.10-7/2020-OTC) (M-79)
Page 54 of 408
S.No Brand name Decision
(1) (2) (3)
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
449. Bellis Perennis Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
450. Strychnos Nux-Vomica Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
451. Packera Aurea Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
452. Ginko Biloba Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
453. Apocynum Cannabinum Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
The common name of apocynum cannabinum is “Indian hemp”, needs
clarification of its use and safety and provision of allocation of quota. 454. Chamaelirium Luteum Φ Deferred since the application is deficient of following documents/information;
F.No.10-7/2020-OTC) (M-79)
Page 55 of 408
S.No Brand name Decision
(1) (2) (3)
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
455. Cimicifuga Racemosa Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
456. Plantago Major Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
457. Pelargonium Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
458. Okoubaka Aubrevillei Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
459. Robinia Pseudoacacia Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
460. Rhus Aromatica Φ Deferred since the application is deficient of following documents/information;
The application for submitted is unsigned and unstamped.
The master formula does not show the quantity of active.
F.No.10-7/2020-OTC) (M-79)
Page 56 of 408
S.No Brand name Decision
(1) (2) (3)
The COA of Solidagovirgaurea MT has been provided instead of COA of
Rhusaromatica MT.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
461. Solidago Virgaurea Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
462. Ferrum Phosphoricum C30 Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
Free sale certificate, not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
463. Calcium Phosphoricum C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
464. Kali Bichromicum C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
465. Bryonia Alba C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
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Page 57 of 408
S.No Brand name Decision
(1) (2) (3)
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
466. Hepar Sulpuris C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
467. Lytta Vesicatoria C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
468. Atropa Belladonna C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
469. Avena Sativa Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
470. Urtica Urens Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
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Page 58 of 408
S.No Brand name Decision
(1) (2) (3)
471. Viburnum Opulus Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
472. Chionanthus Virginicus Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
473. Chimaphila Umbellata Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
474. Oenanthe Crocata Φ Deferred since the application is deficient of following documents/information;
The application for submitted is unsigned and unstamped.
The master formula does not show the quantity of active.
The COA of Solidagovirgaurea has been provided instead of Oenanthecrocata.
The COA of Solidagovirgaurea MT has been provided instead of COA of
Oenanthecrocata MT.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
475. Rubia Tinctorum Φ Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
476. Zingiber Officinalis Φ Deferred since the application is deficient of following documents/information;
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
F.No.10-7/2020-OTC) (M-79)
Page 59 of 408
S.No Brand name Decision
(1) (2) (3)
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
477. Psychotria Ipecacuanha C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
478. Gelsemium Sempervirens C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
479. Kalium Phosphoricum C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
480. Carbo Vegetables C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
481. Calcium Carbonica C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
F.No.10-7/2020-OTC) (M-79)
Page 60 of 408
S.No Brand name Decision
(1) (2) (3)
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
482. Arnica Montana C30 Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
483. Nux Vomica C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
484. Magnesium Phos C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
485. Thuja Occidentalis C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
486. Sulphur C30 Deferred since the application is deficient of following documents/information;
COA of finished product not provided.
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
The manufacturing authorization of principal manufacturer expired on 13-09-
2019.
F.No.10-7/2020-OTC) (M-79)
Page 61 of 408
S.No Brand name Decision
(1) (2) (3)
The copy of GMP certificate of the principal is not notarized and attested by
the embassy. Moreover, the expiry has not been mentioned on GMP
certificate.
M/s Dr. Salim Ahmed & Co., (00980)
310 Hashoo Centre, Abdullah Haroon Road, Karachi
Agent of M/s PharmazeutischeFabrik Evers GmbH & Co. KG, Siemensstraße 4, 25421 Pinneberg, Germany
487. Cimicifuga Racemosus Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
488. Berberis Vulgaris Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
489. Carduus Marianus Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
490. Eupatorium perfoliatum Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
491. Damiana Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
492. Ledum Palustre Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
493. Valeriana Officinalis Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
494. Grndelia Robusta Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
495. Syzigium Jambolanum Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
496. Chimaphila Umbellata Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
497. Calendula OfficinalisΦ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
F.No.10-7/2020-OTC) (M-79)
Page 62 of 408
S.No Brand name Decision
(1) (2) (3)
498. Achilleaa Milefolium Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
499. Cactus Grandiflorus Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
500. Echinaceaa Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
501. Ginkgo Biloba Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
502. Hydrocotyle Asiatica Φ
Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
503. LiliumTigrinum Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
504. Origanum maj.Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
505. Phytolacca Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
506. Rutagraveolens Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
507. Teuctium MarumVarum Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
508. Thuja Occidentalis Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
509. Solidago Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
510. Clematis Rect. Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
F.No.10-7/2020-OTC) (M-79)
Page 63 of 408
S.No Brand name Decision
(1) (2) (3)
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
511. Passifllora incarnata Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
512. China Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
513. Hammamalis virginiana Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
514. Collinsonia canadensis Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
515. Convalleria maj. Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
516. Hypericum perforatum Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
517. Chamomillarecutita Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
518. Verbascum densiflorum Φ Deferred since the application is deficient of following documents/information;
Free Sale certificate or COPP not provided.
Stability studies data of three batches according to conditions of Zone IVA,
not provided.
Paul Brooks Homoeo Labs, Karachi
Plot No. A-69, S.I.T.E., Super Highway Phase-I, Karachi (Homoeopathy)
519. Kidnol Syrup Deferred for following reasons: Fee evidence is required.
It is combination product, In the light of notification No. F.No. 4-
2/2017-DD (H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided. 520. Femicare Syrup Deferred for following reasons:
Fee evidence is required.
Brand name to be changed.
It is combination product, In the light of notification No. F.No. 4-
2/2017-DD (H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 64 of 408
S.No Brand name Decision
(1) (2) (3)
521. Minola Tonic Syrup Deferred for following reasons:
Clear fee evidence is required.
submission of strengths of sterculia, calcarea phosphoricum and
ferrum phosphoricum are required either these are given in mother
tincture/ trituration/ solution or in potencies.
It is combination product. 522. Liver Tonic Syrp Deferred for following reasons:
Submission of strengths of ferrumphosphoricum and
natriumsulphuricum are required either these are given in mother
tincture/ solution/ trituration or in potencies.
It is combination product.
Brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
523. Leuko Stop Syrup Deferred for following reasons: Submission of strength of calcareaphosphoricum is required either it
is given in mother tincture/ solution/ trituration or in potency.
Brand name to be changed.
It is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
524. Osteo Strong Syrup Deferred for following reasons: Submission of strength of orthophosphoric acid is required either it
is given in mother tincture/ solution/ trituration or in potency.
It is combination product.
Brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
525. Ruta Eye Tonic Syrup Deferred for following reasons:
submission of strength of acidumphosphoricum and
kaliumphosphoricum are required either it is given in mother
tincture/ solution/ trituration or in potencies.
it is combination product. In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
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Page 65 of 408
S.No Brand name Decision
(1) (2) (3)
526. Safe Syrup Deferred for following reasons:
Submission of strength of heparsulphuris is required either it is given
in mother tincture/ solution/ trituration or in potency.
It is combination product.
Brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
527. Teething 21 Syrup Deferred for following reasons: Submission of strength of calcareaphosphoricum and
ferrumphosphoricum is required either it is given in mother tincture/
solution/ trituration or in potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
528. Asthabion (asthma care) Syrup Deferred for following reasons: submission of strength of antimoniumtartaricum is required either it
is given in mother tincture/ solution/ trituration.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
529. Brotux Cough Syrup Deferred for following reasons: fee evidence is required.
submission of strength of coralliumrubrum is required either it is
given in mother tincture/ solution/ trituration or in potency.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
530. Arthrocyn Syrup Deferred for following reasons: fee evidence is required.
clarification of angustravera is required as given monograph is of
angustra.
it is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 66 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
531. Asoka Cordial Syrup Deferred for following reasons: Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
532. Babaglow Syrup Deferred for following reasons: Fee evidence is required.
Brand name to be changed.
Submission of strengths of kali phosphoricum,
calcareaphosphoricum, barytacarbinoicum and ferrumphosphoricum
are required either these are given in mother tincture/ solution/
trituration or in potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
533. Broworm Syrup Deferred for following reasons: Submission of strength of natriumphosphoricum is required either it
is given in mother tincture/ solution/ trituration or in potency.
Justification of use of Cina-3 and Cina-30 in same formulation is
required.
It is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
534. Gaspas Syrup Deferred for following reasons: Conversion of strengths of carbo vegetabilis and natrium
phosphoricum are required.
Brand name to be changed.
It is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 67 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
535. Ferroton Syrup Deferred for following reasons:
Submission of strength of ferrummetallicum,
calcareaphosphoricum, kali phosphoricum and
acidumphosphoricum are required either these are given in
mother tincture/ solution/ trituration or in potencies.
it is combination product. In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
536. Alfalfa Aktive tonicSyrup Deferred for following reasons:
Fee evidence is required.
Submission of strength of acid phosphoricum, kali phosphoricum
and sterculia are required either these are given in mother tincture/
solution/ trituration or in potencies.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 537. Iron+Lecithinum Heavy Malt Syrup Deferred for following reasons:
fee evidence is required.
monographs of calcarea, kaliumphosphoricum, lecithinum and
sterculia are required.
submission of strength of acid phosphoricum is required either it is
given in mother tincture/ solution/ trituration or in potency.
brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 538. Minola Plus Syrup Deferred for following reason:
Safety undertaking is required.
539. Acn Pimp Cream Deferred for following reasons:
Clear fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 68 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 540. Boric Calendula kracksCream Deferred for following reasons:
Clear fee evidence is required.
Submission of strength of petroleum is required either it is given in
mother tincture/ solution/ trituration or in potency.
It is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
541. Derma Acn Cream Deferred for following reasons: justification of use of sulphur in herbal product is required.
safety undertaking is required.
brand name to be changed. 542. Eczema Cream Deferred for following reasons:
Brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
543. Graphites Cream Deferred for following reasons: Conversion of % strength of sulphite to gram/ml is required
according to monographs submitted by the firm. 544. Itch Cure Cream Deferred for following reasons:
Monograph/ testing method of borax is required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 545. Yohimbinum Cream Deferred for following reasons:
Monograph of yohimbinum is required.
clear fee evidence is required. 546. OleumJac Cream Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 69 of 408
S.No Brand name Decision
(1) (2) (3)
Submission of strength of oleumjecoris is required either it is given
in mother tincture/ solution/ trituration or in potency. 547. Symphytum Cream Deferred for following reasons:
Conversion of % strength of ingredient to gram/ ml is required
according to monograph submitted by the firm.
548. Silver Stroke Tablets Deferred for following reasons: Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 549. Brosinus Tablets Deferred for following reasons:
Submission of strength of kaliumbichromicum is required either it
is given in trituration/ mother tincture/ solution or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed.
Monograph of tercreummerum verum is required. 550. Bio Com No.01 (anemia) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
551. Bio Com No.02 (asthma) tablet Deferred for following reasons: Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 552. Bio Com No.03(colic) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 553. Bio Com No.04 (constipation) tablets Deferred for following reasons:
Brand name to be changed.
F.No.10-7/2020-OTC) (M-79)
Page 70 of 408
S.No Brand name Decision
(1) (2) (3)
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 554. Bio Com No.05 (coryza) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 555. Bio Com No.06 (cough, cold and catarrh)
tablets
Deferred for following reasons: Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 556. Bio Com No.07 (diarrhea) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 557. Bio Com No.08 (diarrhea) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 558. Bio Com No.09 (dusentary) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 559. Bio Com No.10 (enlarged tonsils) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 560. Bio Com No.11 (fever)tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 561. Bio Com No.12 (headache) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 71 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 562. Bio Com No.13 (leucorrhoea) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 563. Bio Com No.14 (inflammation) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 564. Bio Com No.15 (mensturation trouble)
tablets
Deferred for following reasons: Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 565. Bio Com No.16 (nervous exhaustion) tablets
Deferred for following reasons: Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 566. Bio Com No.17 (piles) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 567. Bio Com No.18 (pyorrhea) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 568. Bio Com No.19 (rheumatism) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 569. Bio Com No.20 (skin diseases) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
F.No.10-7/2020-OTC) (M-79)
Page 72 of 408
S.No Brand name Decision
(1) (2) (3)
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 570. Bio Com No.21 (teething trouble) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 571. Bio Com No.22 (scrofula) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
572. Bio Com No.25 (acidity, flatulence
&indigestion) tablets
Deferred for following reasons: Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 573. Bio Com No.26 (easy parturition) tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 574. Bio Com No.27(lack of virality) tablet Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 575. Bio Com No.28 (general tonic) tablets Deferred for following reasons:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 576. Arthrocyn Tablets Deferred for following reasons:
Clarification of angustravera is required as given monograph is of
angustra.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 577. Arthro Alba Tablets Deferred for following reasons:
Fee evidence is required.
Brand name to be changed. 578. B.P Norma Tablets Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 73 of 408
S.No Brand name Decision
(1) (2) (3)
It is combination product.
Brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 579. Bionic 100 Tablets Deferred for following reasons:
Monograph of yohimbinum is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 580. Calm Tablets Deferred for following reasons:
Fee evidence is required.
Brand name to be changed 581. Health Gold Tablets Deferred for following reasons:
Fee evidence is required.
clarification of 2 tablets/ serving is required.
safety undertaking is required.
brand name to be changed. 582. Kidnol Tablets Deferred for following reasons:
Monograph of vesicaria is required.
It is combination product.
Brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 583. Lexit Tablets Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 584. Pain Killer Global Tablets Deferred for following reasons:
brand name on form 3 and on fee voucher differs from each other.
Submission of strength of kalium phosphoricum is required either it
is in solution/ mother tincture/ trituration or in potency.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
F.No.10-7/2020-OTC) (M-79)
Page 74 of 408
S.No Brand name Decision
(1) (2) (3)
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 585. Spermatone Tablets Deferred for following reasons:
brand name to be changed.
Safety undertaking is required. 586. Selenium Compound Tablets Deferred for following reasons:
Form 3 to be revised regarding acid phos as per monograph
submitted by the firm.
Monograph of Orchitinum 3x is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Clarification regarding 30g as pack size, is required. 587. Tonsicare Tablets Deferred for following reasons:
safety undertaking is required.
submission of strength of kalium and hepar sulphris is required either
these are given in Mother tincture/ Solution/ Trituration or in
potencies.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 588. Teething 21 chewable Tablets Deferred for following reasons:
Clarification regarding strength of atropa belladonna and matricaria
chamomilla is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 589. Urac Tablets Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 590. Asoka cordial Drops Deferred for following reasons:
monograph of viburumopulus is required.
conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
F.No.10-7/2020-OTC) (M-79)
Page 75 of 408
S.No Brand name Decision
(1) (2) (3)
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 591. Baby Diarrhoea control Drops Deferred for following reasons:
brand name on fee voucher (babydiarrhoea drops) and on form 3
differs from each other.
Conversion of % strength of ingredients to gram/mi is required
according to monographs submitted by the firm.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
592. Baby Colic Relief Drops Deferred for following reasons:
Monographs of magnesia, natrum phosphoricum are required.
Conversion of %strength of ingredients to gram/ ml is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
593. Baby Teething Drops Deferred for following reasons:
Monographs of calcarea and ferrum phosphoricum are required.
Brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 594. Baby Flu Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 595. Neurobin Drops Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 76 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name to be changed.
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 596. PB Gold Drops Deferred for following reasons:
Monograph of ignatiaamara is required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 597. Polyura Drops Deferred for following reasons:
Submission of strength of acidum phosphoricum is required either it
is given in mother tincture/ solution/ trituration or in potencies.
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 598. Staphi Complex Drops Deferred for following reasons:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
conversion of % strength of ingredients to gram/ml is required. 599. Teucreum Nasal Drops Deferred for following reasons:
Firm hold oral drop and liquid section only.
Conversion of % Strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
It is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 77 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
600. Uti care Drops Deferred for following reasons: brand name on form 3 and on fee voucher differs from each other.
conversion of % strength of ingredients to gram/ ml is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
601. Enuropaul Drops Deferred for following reasons: Conversion of strength of ingredients to gram/ ml is required
according to monographs submitted the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
602. Br Spondy L Drops Deferred for following reasons: clear fee evidence is required.
conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 603. H.B.P Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 604. Kidnol Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
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S.No Brand name Decision
(1) (2) (3)
Brand name to be changed.
It is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 605. Paul Brooks combination No.12 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ ml is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 606. Paul Brooks combination No.13 drops Deferred for following reasons:
conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 607. Paul Brooks combination No.14 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/mi is required
according to monographs submitted by the firm.
Submission of strength of kalium sulphuricum, ferrum
phosphoricum and kalium phosphoricum is required either these are
given in mother tincture/ solution/ trituration or in potencies.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 608. Paul Brooks combination No.16 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 609. Paul Brooks combination No.22 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
610. Paul Brooks combination No.23 drops Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Free Sale Certificate) or Local marketing of 10 years, not provided. 611. Paul Brooks combination No.25 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 612. Paul Brooks combination No.26 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 613. Paul Brooks combination No.28 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 614. Paul Brooks combination No.34 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 615. Paul Brooks combination No.36 drops Deferred for following reasons:
conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
fee evidence is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 616. Paul Brooks combination No.37 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 617. Paul Brooks combination No.38 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
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S.No Brand name Decision
(1) (2) (3)
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 618. Paul Brooks combination No.41 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 619. Paul Brooks combination No.42 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
Monograph of delphinium is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 620. Paul Brooks combination No.45 drops Deferred for following reasons:
Conversion of strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
Clarification of angustravera is required as given monograph is of
angustra.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 621. Paul Brooks combination No.49 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 622. Paul Brooks combination No.50 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
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S.No Brand name Decision
(1) (2) (3)
623. Chamomilla Baby Drops Deferred for following reason: Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm. 624. Sciatiran Drops Deferred for following reasons:
Monograph of formicarufa is required.
Conversion of % strength of ingredients to gram/ml is required.
Brand name to changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 625. Ginkgo Vit Oral Drops Deferred for following reasons:
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Clarification of pack size is required. 626. Glg Capsules Deferred for following reasons:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Following information is required regarding lecithinum:
Monograph of lecithinum.
Biological source of lecithinum.
Submission of evidence shows that lecithinum source is not
contaminated with transmissible spongiform encephalopathy (TSE)
or BSE. 627. Neuroled Nerve Tonic Capsules Deferred for following reasons:
monographs of avena sativa, acid phosphoricum, passiflora,
valeriana, ferrum, calcarea and kalium are required.
safety undertaking is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
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S.No Brand name Decision
(1) (2) (3)
628. OleumJac Capsules Deferred for following reason:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 629. Prosta Cure Capsules Deferred for following reasons:
Brand name to changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
630. Infanil Capsules Deferred for following reasons:
It is combination product. In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
631. Backbetone Capsules Deferred for following reason:
Safety undertaking is required. 632. Ferroton iron Capsules Deferred for following reasons:
brand name on form 3 and on fee voucher differs from each other.
Submission of strength of acidum phosphoricum is required either it
is given in mother tincture/ solution/ trituration or in potency.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 633. Pregaid Capsules Deferred for following reasons:
Fee evidence is required.
Brand name to be changed.
Monograph of viburnum prunifolium is required. 634. Ruta Eye Tonic Capsules Deferred for following reason:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 635. Spermatone Capsules Deferred for following reasons:
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
F.No.10-7/2020-OTC) (M-79)
Page 83 of 408
S.No Brand name Decision
(1) (2) (3)
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 636. Sciatiran Capsules Deferred for following reasons:
Fee evidence is required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 637. UTI care Capsules Deferred for following reasons:
Clear fee evidence is required
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 638. Leuko Stop Capsules Deferred for following reasons:
Fee evidence is required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 639. Vital Gold Capsules Deferred for following reasons:
Brand name to changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 640. Bryonia Liniment Deferred for following reason:
it is combination product. In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 641. Diabefix Granules Deferred for following reasons:
Submission of strength of kalium phosphoricum is required either it
is given in mother tincture/ solution/ trituration or in potency.
it is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 84 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 642. Super Builder Tonic Granules Deferred for following reasons:
monograph of lecithinum is required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 643. Cardiotone Granules Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 644. School Aid Syrup Deferred for following reasons:
submission of strengths of acid phosphoricum, calcarea are required
either these are given in mother tincture/ solution/ trituration or in
potencies.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
brand name to be changed. 645. Fevernil Syrup Deferred for following reasons:
Brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 646. Gastro Ulcer Syrup Deferred for following reasons:
Submission of strength of anacardium occidentale is required either
it is given in mother tincture/ solution/ trituration or in potency.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 647. Osteo Strong Tablets Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 85 of 408
S.No Brand name Decision
(1) (2) (3)
Lecithinum monograph is required.
It is combination product.
Brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 648. Asthabion (asthma care) Drops Deferred for following reasons:
Brand name on fee voucher (asthabion syrup) and on form 3differs
from each other.
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
649. SabalProsta Tablets Deferred for following reasons: Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 650. Fevergo Tablets Deferred for following reasons:
brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 651. Gastro Ulcer Tablets Deferred for following reasons:
Form 3 is unsigned.
Monographs of atropinum and anacadium are required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 652. Staphi Complex Capsules Deferred for following reasons:
Fee evidence is required.
It is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 86 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 653. Nervocalm Syrup Deferred for following reasons:
Monograph of valeriana is required.
Submission of strengths of acidum phosphoricum, kalium
phosphoricum are required either these are given in mother tincture/
solution/ trituration or in potencies.
Brand name to be changed. 654. Diarrhea relief Tablets Deferred for following reasons:
Brand name on fee voucher (diarrhea tablets and on form 3 differs
from each other.
Monographs of acidum phosphoricum and ferrum phosphoricum are
required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 655. Burns Cream Deferred for following reasons:
fee evidence is required.
brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 656. Paulmens Syrup Deferred for following reasons:
fee evidence is required.
safety undertaking is required.
brand name to be changed. 657. Tone Up Syrup Deferred for following reasons:
Brand name to be changed.
Safety undertaking is required. 658. Anewek Syrup Deferred for following reasons:
justification of use of iron flakes (ferrous sulphate heptahydrate) is
required.
safety undertaking is required. 659. Digiled Syrup Deferred for following reasons:
monograph of triphala is required.
fixed amount of ingredients of triphala is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
safety undertaking is required. 660. Garmi Door Syrup Deferred for following reasons:
Monograph of alhagi is required.
Safety undertaking is required.
brand name to be changed. 661. Digestone Syrup Deferred for following reasons:
clear fee evidence is required.
brand name to be changed.
safety undertaking is required. 662. Baby Gro Syrup Deferred for following reasons:
Brand name to be changed.
safety undertaking is required 663. Alfaled Syrup Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 664. Paultux Cough Syrup Deferred for following reasons:
clear fee evidence is required.
safety undertaking is required. 665. Capsi Calm Ointment Deferred for following reasons:
justification of use of capsicum oleoresin is required.
brand name to be changed.
safety undertaking is required. 666. Calsym Cream Deferred for following reasons:
Fee evidence is required.
safety undertaking is required.
brand name to be changed. 667. Layohi Cream Deferred for following reasons:
Fee evidence is required.
monographs of trombidium, syzgium, roghan e khusia-e-buz, roghan
baiza-e-murgh and roghan e kaner are required.
Clarification of duplication of myristica fragnans is required.
Safety undertaking is required. 668. Paulex Cream Deferred for following reasons:
monographs of winter green oil and turpentine oil are required.
safety undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 88 of 408
S.No Brand name Decision
(1) (2) (3)
669. Paul Pile Cream Deferred for following reasons: brand name to be changed.
safety undertaking is required. 670. Tone Up Capsules Deferred for following reasons:
Safety undertaking is required.
brand name to be changed. 671. Kidnif Capsules Deferred for following reasons:
Monographs of asphaltum, lacerta and helmintholitus are required.
Safety undertaking is required. 672. Tonsicare Syrup Deferred for following reasons:
Submission of strength of baryta and kalium muriaticum are required
either these are given in mother tincture/ solution/ trituration or in
potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 673. Jututux (S.F) Syrup Deferred for following reasons:
Fee evidence is required.
Submission of strength of corallium rubrum is required either it is
given in mother tincture/ solution/ trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 674. 555 Family Tonic Syrup Deferred for following reasons:
Fee evidence is required.
Monographs are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 675. Instant Sex Energy Syrup Deferred for following reasons:
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed.
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S.No Brand name Decision
(1) (2) (3)
676. Infanil Syrup Deferred for following reasons:
submission of strength of ferrum phosphoricum is required
either it is given in mother tincture/ solution/ trituration or in
potency.
fee evidence is required.
it is combination product. In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 677. Malca Syrup Deferred for following reasons:
Submission of strength of chininum and ferrumphosphoricum are
required either these are given in mother tincture/ solution/
trituration or in potencies.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 678. Layohi Syrup Deferred for following reason:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 679. Kidnif Syrup Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 680. Podo Syrup Deferred for following reason:
safety undertaking is required.
681. Orchi Sex Syrup Deferred for following reasons: Brand name to be changed.
Submission of strength of acid phos is required either it is given in
mother tincture/ solution/ trituration or in potency.
Monographs of orchitinum, pytchopetalum and yohimbinum are
required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 682. Neuroled Nerve Tonic syrup Deferred for following reasons:
Safety undertaking is required.
Brand name to be changed. 683. Neuroled Forte Syrup Deferred for following reasons:
Submission of strength of acid phos is required either it is given in
mother tincture/ solution/ trituration or in potency.
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Page 90 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of mag phos, salixnigra are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Stamp paper on brand name and contents of dossier are required 684. Sciatiran Syrup Deferred for following reasons:
Conversion of strength of magnesium phosphoricum to gram/ml is
required according to monograph submitted by the firm.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 685. Royal King Tonic Syrup Deferred for following reasons:
Submission of strengths of sterculiaamd acid phos are required either
it is given in mother tincture/ solution/ trituration.
Following information is required regarding lecithinum:
Monograph of lecithinum.
Biological source of lecithinum.
Submission of evidence that source of lecithinum is not
contaminated with Transmissible Spongiform Encephalopathy
(TSE) and BSE.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 686. Prostacure Syrup Deferred for following reasons:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
brand name to be changed 687. Purifiex Syrup Deferred for following reasons:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 688. Power Up Tonic Deferred for following reasons:
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S.No Brand name Decision
(1) (2) (3)
Monograph of condurango is required.
Clarification regarding strength of acid phos is required either it is
given in solution/ mother tincture/ trituration or in potency.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 689. Pregaid Syrup Deferred for following reasons:
Brand name to be changed.
Monograph of viburnum prunifolium is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 690. Selenium Compound Syrup Deferred for following reasons:
Fee evidence is required.
Form 3 to be revised regarding acid phos as per monograph
submitted by the firm.
Monograph of Orchitinum 3x is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 691. Spermatone Syrup Deferred for following reasons:
Monographs of cobaltum nit and orchitinum are required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 692. Teucreum Cold Syrup Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 693. Typhocalm Syrup Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
It is combination product.
Brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 694. Xtreme Power Syrup Deferred for following reasons:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Monograph of yohimbimnum Q is required.
Brand name to be changed. 695. Vision Plus Syrup Deferred for following reason:
safety undertaking is required.
696. Vital Gold Syrup Deferred for following reasons: Fee evidence is required.
Monograph of yohimbinum is required.
Conversion of % strength of ingredients to gram/ml is required
according to monographs sub mitted by the firm
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 697. Visex Tonic Syrup Deferred for following reasons:
Monograph of cascara sagrada (rhamnuspurshiana) is
required.
Evidence of marketed product/ safety undertaking is
required.
698. Vomit Off Syrup Deferred for following reasons: Brand name to be changed.
Submission of strengths of antimonium crudum and natrium
phosphoricum are required either these are given in mother tincture/
solution/ trituration or in potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 699. Urac Syrup Deferred for following reason:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 700. Acid Phos Complex Syrup Deferred for following reasons:
Submission of strength of acid phosphoricum, sterculia, calcarea
phosphoricum, ferrum metallicum and kalium phosphoricum are
required either these are given in mother tincture/ solution/ tritutation
or in potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 701. Alfalfa Junior Syrup Deferred for following reasons:
Monographs of kali phos and china are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 702. Anti Allergic Syrup Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 703. Arthro Alba Syrup Deferred for following reasons:
Monographs of salix alba, mag phos, formic rufa and angustravera
are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
fee evidence is required. 704. Brocard Syrup Deferred for following reasons:
fee evidence is required.
Monograph of valeriana is required.
Clarification regarding strength of Sterculia in mother tincuture/
solution is required according to monograph submitted by the firm.
Clarification of strength of convalaria maj is required either it is
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
given in mother tincture/ solution/ trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 705. Br Aletris Cordial Syrup Deferred for following reasons:
fee evidence is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 706. Baby Brotux Syrup Deferred for following reasons:
Monograph of mephitis is required.
it is combination product. 707. Baby Flu Syrup Deferred for following reasons:
Monograph of antimonium tartaricum is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 708. Cydonia Syrup (Sugar Free) Deferred for following reasons:
Fee evidence is required.
Submission of strength of acid phos is required either it is given in
mother tincture/ solution/ trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 709. Capsicum Complex Syrup Deferred for following reasons:
brand name on fee voucher (capsicum syrup) and on form 3 differs
from each other.
Submission of strengths of calcium phosphoricum and natrium
phosphoricum are required either these are given in mother tincture/
solution/ trituration or in potencies.
Brand name to be changed. 710. Calci Paul Syrup Deferred for following reasons:
Submission of strengths of calcium phosphoricum, kalium
phosphoricum, ferrum phosphoricum, ferrum metallicum and
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S.No Brand name Decision
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acidum phosphoricum are required either these are given in mother
tincture/ solution/ trituration or in potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 711. Colic Syrup Deferred for following reasons:
submission of strength of carbo vegetabilis and magnesia
phosphoricum are required either these are given in mother
tincture/ solution/ trituration or in potencies.
it is combination product. In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 712. Coldioff Syrup Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 713. Diarnil Syrup Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 714. Diabe Ex Syrup Deferred for following reasons:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Formulation contains uranium, safety evidence is required.
clarification regarding strength of natsulf and silica in mother
tincuture/ solution/ trituration must be given according to
monographs submitted by the firm.
Monograph of insulin is required.
Biological source of insulin.
Submission of evidence that source of insulin is not contaminated
with Transmissible Spongiform Encephalopathy (TSE) and BSE. 715. EpilymHys Syrup Deferred for following reasons:
Monograph of stramonium is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 716. Flexovit Syrup (Sugar Free) Deferred for following reasons:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
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S.No Brand name Decision
(1) (2) (3)
717. Ferro Paul Syrup Deferred for following reasons: Submission of strength of ferrum metallicum, ferrum phosphoricum
and kali phosphoricum are required either these are given in mother
tincture/ solution/ trituration or in potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 718. Flu Off Syrup Deferred for following reasons:
clear fee evidence is required.
brand name to be changed.
safety undertaking is required. 719. Ferroled Syrup Deferred for following reason:
evidence of marketed product/ safety undertaking is required.
720. Paulfen Plus Syrup Deferred for following reasons: Monograph of salix alba is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 721. Ginseng Vital Tonic Syrup Deferred for following reasons:
Submission of strengths of selenium metallicum and titanium
metallicum are required either these are given in mother tincture/
solution/ trituration or in potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 722. Ginseng + Lecithinum Syrup (Sf) Deferred for following reasons:
Conversion of strength of ingredient to to gram/ml is required
according to monograph submitted by the firm.
Monograph of alfalfa is required.
Following information is required regarding lecithinum:
Monograph of lecithinum.
Biological source of lecithinum.
Submission of evidence that source of lecithinum is not
contaminated with Transmissible Spongiform Encephalopathy
(TSE) and BSE.
It is combination product. 723. Gastroliet Syrup Deferred for following reasons:
Submission of strength of carbo veg is required either it is given in
mother tincture/ solution/ trituration or in potency.
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S.No Brand name Decision
(1) (2) (3)
Monograph of rubinia is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 724. Hemornil Syrup Deferred for following reasons:
Clear fee evidence is required.
Monograph of trillium pendulum is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 725. Brooklax Syrup Deferred for following reasons:
submission of strength of hydrastis is required either it is given in
mother tincture/ solution/ trituration or in potency.
clear fee evidence is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 726. Gaultharia Syrup Deferred for following reason:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
727. Ferroton Forte Syrup Deferred for following reasons: Submission of strength of ferrrum metallicum, ferrum
phosphoricum, calcium phosphoricum and kalium phosphoricum are
required either these are given in mother tincture/ solution/
trituration or in potencies.
Monograph of alfalfa is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
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S.No Brand name Decision
(1) (2) (3)
Brand name to be changed. 728. Coldiled Syrup Deferred for following reasons:
fee evidence is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 729. Alfalfa AktiveTonicSyrup (Sf) Deferred for following reasons:
submission of strength of acid phosphoricum, kali phosphoricum and
sterculiaacuminata is required either these are required in mother
tincture/ solution/ trituration or in potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Justification of word “ sugar free syrup” is required. 730. Alfalfa+ Ginseng Syrup Deferred for following reasons:
fee evidence is required.
Submission of strength of acid phos is required according to
monographs submitted by the firm.
Monograph of alfalfa is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 731. Avena +Ginseng Syrup Deferred for following reasons:
Submission of strength of acid phosphoricum, kalium phosphoricum
and ferrum metallicum are required either these are given in mother
tincture/ solution/ trituration.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 732. Pregnee Syrup Deferred for following reasons:
fee evidence is required.
monographs of vanadium met, china off, lecithinum are required.
F.No.10-7/2020-OTC) (M-79)
Page 99 of 408
S.No Brand name Decision
(1) (2) (3)
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
brand name to be changed. 733. Viton Syrup Deferred for following reasons:
fee evidence is required.
submission of strength of ferrumphosphoricum is required either it
is given in mother tincture/ solution/ trituration.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 734. Kidnol Syrup (Sf) Deferred for following reasons:
Fee evidence is required.
Monographs of epigea, rubiatinct and hydrangra are required.
Brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 735. Leucomin Paul Syrup Deferred for following reasons:
Submission of strength of calcarea phosphoric is required either it is
given in mother tincture/ solution/ trituration.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 736. Leukostop Junior Syrup Deferred for following reasons:
Brand name to be changed.
Submission of strength of calcarea phosphorica is required either it
is given in mother tincture/ solution/ trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Free Sale Certificate) or Local marketing of 10 years, not provided. 737. Osteo Strong Syrup (Sf) Deferred for following reasons:
Monograph of panax quinquefolium is required.
brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 738. BrotuxCoughSyrup With Honey Deferred for following reasons:
brand name on form 3 and on fee voucher differs from each other.
Justification of use of honey in brand name is required.
submission of strength of corallium rubrum is required either it is
given in mother tincture/ solution/ trituration.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 739. Asthabion Syrup With Honey Deferred for following reasons:
Submission of strength of sterculia is required either it is given in
mother tincture/ solution/ trituration or in potency.
Monograph of yerba santa is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 740. Str Kid Course Syrup Deferred for following reasons:
Fee evidence is required.
Form 3 of STR kid course syrup is unsigned and unstamped.
Monographs are required.
Justification of formulation is required. 741. Brotux Cough Syrup (Sf) Deferred for following reasons:
Clarification of submission of fee vouchers for “brotux cough syrup”
and “ brotux cough syrup sugar free” is required.
Submission of strength of corallium rubrum is required either it is
given in mother tincture/ solution/ trituration or in potency.
Justification of word “ sugar free syrup” is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 742. Breastone Cream Deferred for following reason:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
743. Mari Gold Cream Deferred for following reasons: fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 744. Sulphur Graphite Cream Deferred for following reasons:
Justification regarding duplication of sulphur and graphites in same
formulation is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 745. Dental Lotion Deferred for following reasons:
Monographs are required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 746. Br Homoeo Balm Deferred for following reasons:
Monographs are required.
Pack size is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 747. Mouth Care Lotion Deferred for following reasons:
Fee evidence is required.
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S.No Brand name Decision
(1) (2) (3)
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Stamp paper on brand name and contents are not of Mouth care
lotion rather they refer brand name “mouth care drops”.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 748. Brosulf Vanishes Kharish Lotion Deferred for following reasons:
Monographs of ingredients are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
749. Brolysis Liniment Lotion Deferred for following reasons:
Monographs are required.
Justification regarding more than one strength of gelsenium is
required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 750. Gasnil Tablets Deferred for following reasons:
Submission of monograph of anacardium is required either it is given
in mother tincture/ solution/ trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 751. Constipan Plus Tablets Deferred for following reasons:
submission of strength of natsulph is required either it is given in
mother tincture/ solution/ trituration or in potency.
Brand name to be changed.
It is combination product.
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S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
752. Paul 21 Tablets Deferred for following reason:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
753. Age Less Tablets Deferred for following reasons: Brand name to be changed.
Safety undertaking is required. 754. Super Ambra Forte Tablets Deferred for following reasons:
Fee evidence is required.
Monographs of moschus, nuxvom, sabalserr and yohimbinum are
required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 755. Pain Relief Tablets Deferred for following reasons:
Monographs of plantagomaj and magnesia phos are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 756. Brocard Tablets Deferred for following reasons:
Safety undertaking is required.
Monograph of camellia sinensis is required. 757. Brochol Tablets Deferred for following reasons:
Following information regarding cholesterinum is required.
Biological source of cholesterinum.
Submission of evidence that source of cholesterinum is not
contaminated with Transmissible Spongiform Encephalopathy
(TSE) and BSE.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 758. BvFeltauri Tablets Deferred for following reasons:
Fee evidence is required.
Monograph of feltauri is required.
F.No.10-7/2020-OTC) (M-79)
Page 104 of 408
S.No Brand name Decision
(1) (2) (3)
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
759. BrotuxchewableTablets Deferred for following reasons: Brand name on fee voucher (brotux syrup) and on form 3 differs
from each other.
Submission of strength of spongia tosta is required either it is given
in mother tincture/ solution/ trituration or in potency.
Monograph of drosera rotendifolia is required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 760. Cholesterium Complex Tablet Deferred for following reasons:
justification of pack size is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
fee evidence is required. 761. Coldiled Tablets Deferred for following reason:
It is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
762. Femicare Tablets Deferred for following reasons: submission of strength of acid phosphoricum is required either it is
given in mother tincture/ solution/ trituration or in potency.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 763. Hair Growth Tablets Deferred for following reasons:
Submission of strength of acidphos is required either it is given in
mother tincture/ solution/ trituration or in potency.
F.No.10-7/2020-OTC) (M-79)
Page 105 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of arunda, jaborandi, china off and equisetum are
required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 764. Kidney Pills Tablets Deferred for following reasons:
Monographs of ononis spinosa, epigea and rubia tinctorium are
required.
The common name of apocynum cannabinum is “Indian hemp”,
needs clarification of its use and safety and provision of allocation
of quota
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 765. Lutem Male Care Tablets Deferred for following reason:
brand name to be changed.
evidence of marketed product/ safety undertaking is required. 766. Liver Fort Tablets Deferred for following reasons:
Monographs of alfalfa, carduus marianus and myrica are required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 767. Menses Cure Tablets Deferred for following reasons:
fee evidence is required.
evidence of marketed product is required.
brand name to be changed.
safety evidence is required. 768. Memo Anacradium Tablets Deferred for following reasons:
Monograph of lecithinum is required.
F.No.10-7/2020-OTC) (M-79)
Page 106 of 408
S.No Brand name Decision
(1) (2) (3)
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
fee evidence is required. 769. Piles Off Tablets Deferred for following reasons:
Monograph of ratanhia is required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 770. Phytolacca Berry + Fucus Tablets Deferred for following reasons:
fee evidence is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
771. Palpi Relief Tablets Deferred for following reasons: Submission of strength of carbo vegetabilis is required either it is
given in mother tincture/ solution/ trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 772. S.M.E Tablets Deferred for following reasons:
Justification of source and testing method of pearl calcium is
required and its use in herbal preparation is also required.
Evidence of marketed product is required.
Master formula and total weight of tablet is required. 773. Vomit Off Tablets Deferred for following reasons:
Submission of strength of antimonium crudum and bismutum are
required either these are given in solution/ mother tincture/
trituration.
brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
F.No.10-7/2020-OTC) (M-79)
Page 107 of 408
S.No Brand name Decision
(1) (2) (3)
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 774. Vision Plus Tonic Tablets Deferred for following reasons:
Brand name on form 3 and on fee voucher differs from each other.
Monographs of physostigma, guareatrich, vaccinium are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 775. Xlimart Tablets Deferred for following reasons:
Fee evidence is required.
Monographs of piper nigrum and zingiberofficinale are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 776. B.B Care Tablets Deferred for following reasons:
Submission of strengths of calcium flour and calcium phos are
required either these are given in mother tincture/ solution/
trituration or inpotencies.
Monograph of conium is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 777. Angiomin Drops Deferred for following reasons:
Submission of strengths of ingredients is required either these are
given in mother tincture/ solution/ trituration or in potencies.
Monographs of latrodectus, spartium scoparium, spigelia and
convalaria are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 778. Anti Allergic Drops Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 108 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs are required.
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 779. Arthrocyn Drops Deferred for following reasons:
conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 780. Axzelax Drops Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
781. BR Spondy C Drops Deferred for following reasons: conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 782. Baby Fever Cure Drops Deferred for following reasons:
conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 783. Breastone Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml, is required
according to monographs submitted by the firm.
It is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 109 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 784. Brogen Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
Monograph of plantago is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 785. Brokid F Drops Deferred for following reasons:
Conversion of % strengths of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Duplication of formulation is there. 786. Brolysis Drops Deferred for following reasons:
Conversion of % strengths of ingredients to gram/ml, is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 787. Purifex Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
Monograph of berberisaquif is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 788. PbDysmoDrops Deferred for following reasons:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
F.No.10-7/2020-OTC) (M-79)
Page 110 of 408
S.No Brand name Decision
(1) (2) (3)
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Monograph of magnephos is required.
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm. 789. Paulfen Drops Deferred for following reasons:
submission of strength of Symphytum is required either it is given in
mother tincture/ solution/ trituration or in potency.
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 790. Piles Off Drops Deferred for following reasons:
conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
Brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 791. Podo Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 792. Spermatone Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 793. StrLvr Drops Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 111 of 408
S.No Brand name Decision
(1) (2) (3)
monographs of lycopodium and chinonthus are required.
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Submission of strength of carduus mar is required either it is given
in mother tincture/ solution/ trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 794. Teething 21 Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/mi is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 795. Visex Drops Deferred for following reasons:
Clarification of active ingredients is required either these are given
in mother tincture/solution/ trituration or in potencies.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 796. Urac Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 797. Teucreum Cold Drops Deferred for following reasons:
Conversion of strengths of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 798. Tone Up Drops Deferred for following reasons:
Monographs are required.
Brand name to be changed.
F.No.10-7/2020-OTC) (M-79)
Page 112 of 408
S.No Brand name Decision
(1) (2) (3)
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
799. Cydonia Drops Deferred for following reasons: submission of strength of acid pos is required either it is given in
mother tincture/ solution/ trituration or in potency.
Conversion of % strengths of ingredients to gram/ml is required
according to moographs submitted by the firm.
Monograph of tribulus terr is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 800. Bb Care Drops Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
801. Br Spondy B Drops Deferred for following reasons: conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 802. Bromunia Drops Deferred for following reasons:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm. 803. Constipan Drops Deferred for following reasons:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
brand name to be changed. 804. Hepakid Drops Deferred for following reasons:
Monograph of vanadium is required.
F.No.10-7/2020-OTC) (M-79)
Page 113 of 408
S.No Brand name Decision
(1) (2) (3)
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 805. Gastropan Drops Deferred for following reasons:
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 806. Gaultharia Drops Deferred for following reasons:
fee evidence is required.
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Prescribed form 3 is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 807. Gastro Ulcer Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/mi is required
according to monographs submitted by the firm.
Monograph of robinia pseudoacacia is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 808. Femagro Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 809. Femicare Drops Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 114 of 408
S.No Brand name Decision
(1) (2) (3)
conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product.
brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 810. Fevernil Drops Deferred for following reasons:
Conversion of strengths of ingredients to gram/ml is required
according to monographs submitted by thefirm.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 811. Layohi Drops Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
812. Leuko Stop Drops Deferred for following reasons: Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 813. Memo Anacardium Drops Deferred for following reasons:
Monographs of acid phos and vanadium are required.
Conversion of % strengths of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 814. Hepafort Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
F.No.10-7/2020-OTC) (M-79)
Page 115 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph of myrica is required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 815. Infanil Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Monograph of Echinacea is required.
Justification regarding duplication of aconite is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 816. Paul Brooks combination No.04 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ mi is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 817. Paul Brooks combination No.05 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 818. Paul Brooks No.06 Deferred for following reasons:
Conversion of % strength of ingredients to gram/mi is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 819. Paul Brooks No.07 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
F.No.10-7/2020-OTC) (M-79)
Page 116 of 408
S.No Brand name Decision
(1) (2) (3)
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 820. Paul Brooks combination No.09 drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 821. Paul Brooks No.11 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 822. Paul Brooks No.15 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 823. Paul Brooks No.17 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 824. Paul Brooks No.18 Deferred for following reasons:
Conversion of % strengthof ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 825. Paul Brooks No.19 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 826. Paul Brooks No.20 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Submission of strength of acid phosphoricum is required either it is
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
given in mother tincture/ solution/ trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 827. Paul Brooks No.21 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Monograph of abrotanum is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 828. Paul Brooks No.24 Deferred for following reasons:
Conversion of % strengthof ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 829. Paul Brooks No.27 Deferred for following reasons:
Conversion of % strength of ingredients to gram/mi is required
according to monographs submitted by the firm.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 830. Paul Brooks No.29 Deferred for following reasons:
Conversion of % strengthof ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 831. Paul Brooks No.30 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 832. Paul Brooks No.31 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
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S.No Brand name Decision
(1) (2) (3)
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 833. Paul Brooks No.32 Deferred for following reasons:
Conversion of % strengthof ingredients to gram/ml is required
according to monographs submitted by the firm.
Monograph of alfalfa is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 834. Paul Brooks No.33 Deferred for following reasons:
Conversion of % strengthof ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 835. Paul Brooks No.35 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 836. Paul Brooks No.40 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 837. Paul Brooks No.43 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 838. Paul Brooks No.44 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Free Sale Certificate) or Local marketing of 10 years, not provided. 839. Paul Brooks No.46 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 840. Paul Brooks No.47 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 841. Paul Brooks No.48 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 842. Paul Brooks No.51 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 843. Paul Brooks No.52 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 844. Paul Brooks No.54 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 845. Paul Brooks No.55 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Free Sale Certificate) or Local marketing of 10 years, not provided. 846. Paul Brooks No.57 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 847. Paul Brooks No.58 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 848. Paul Brooks No.59 Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 849. Mouth Care Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 850. DeafcurecourseOral Drops and external
drops
Deferred for following reasons: Fee evidence is required.
Firm hold oral drop and oral liquid sections (homeopathic) only.
Form 3 of deaf cure oral drop is unsigned and unstamped.
Monographs are required.
Brand name to be changed. 851. Digikid Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 852. Ff Cure Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
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S.No Brand name Decision
(1) (2) (3)
it is combination product (duplication).
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 853. Ff Cure Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
it is combination product (duplication).
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 854. Hair Tone Drops Deferred for following reasons:
Monograph of wiesbadan is required.
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
855. Ginseng Vital Drops Deferred for following reasons:
Conversion of % strength of ingredients to gram/mi is required
according to monographs submitted by the firm.
Monographs of yohimbinum and muira apuama are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 856. Selvimex Drops Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
857. Tonsicare Drops Deferred for following reasons: Fee evidence is required.
Monograph of Mercbiodat is not required.
It is combination product.
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S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm. 858. Mucuna Oral Liquid Deferred for following reasons:
Brand name on fee voucher and form 3 are different from each other.
Monograph of muirapuama is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
clarification of 20ml ampoule as pack size is required. 859. Broslim Course Drops Deferred for following reasons:
Fee evidence is required.
Monographs are required.
Master formula is required.
Stability study undertaking is required.
Stamp papers on “brand name and contents of dossier” are required.
Justification of formulation and pack size is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 860. Hair Growth Course Drops Deferred for following reasons:
Justification is required either hair growth drop is oral drop or topical
drop in nature.
Pack size does not relate with given brand name, needs justification.
Monographs are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Free Sale Certificate) or Local marketing of 10 years, not provided. 861. Bro Rheuma Course (Oral Drops) Deferred for following reasons:
Fee evidence is required.
Monographs are required.
Pack size does not relate with given formulation.
Conversion of % strength of ingredients to gram/ml is required
according to monographs submitted by the firm.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Duplication with bro rheuma course capsule 862. Acn Removal Course Drops Deferred for following reasons:
Form 3 of acne removal course (30’s capsule) is unsigned and
unstamped.
Monographs of ingredients are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Duplication with can removal course capsule
863. Leuco Course Drops Deferred for following reasons: Form 3 of leuco course drop is unsigned.
Monographs of all ingredients are required.
These are combination products in combo pack.
Fee evidence is required.
Conversion of % strength of ingredients to gram/ml, is required
according to monographs submitted by the firm (Leucocouse drop).
Duplication with leuco course capsule
864. Sinus Paul Nasal Drops Deferred for following reasons: The firm holds oral drops section (homeo) only.
Conversion of % strength to gram/ml is required according to
monographs submitted by the firm.
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S.No Brand name Decision
(1) (2) (3)
Monograph of Mentholum 1x is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 865. 555 Family Tonic Capsules Deferred for following reasons:
fee evidence is required.
Monographs are required.
Stamp papers of brand name and contents are required.
It is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
866. Ginkgo Max Capsules Deferred for following reason:
fee evidence is required.
867. FucusPhytoberry Capsules Deferred for following reasons: Fee evidence is required.
Monographs of ingredients are required.
Following information regarding throdinum is required.
Monograph of thyrodinum.
Biological source of thyrodinum.
Submission of evidence that source of thyrodinum is not
contaminated with Transmissible Spongiform Encephalopathy
(TSE) and BSE.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 868. Horny Goat Capsules (Herbal Medicines) Deferred for following reasons:
Brand name to be changed.
Safety undertaking is required. 869. Hepafort Capsules Deferred for following reasons:
safety undertaking is required.
brand name to be changed. 870. Pregnee Capsules Deferred for following reasons:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
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S.No Brand name Decision
(1) (2) (3)
monographs are required. 871. Neuroled Forte Capsules Deferred for following reasons:
fee evidence is required.
monographs are required.
The common name of apocynum cannabinum is “Indian hemp”,
needs clarification of its use and safety and provision of allocation
of quota.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 872. Acn Pimp Capsules Deferred for following reasons:
monograph of skookum chuck is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 873. Anewek Capsules Deferred for following reason:
safety undertaking is required.
874. Avena Ginseng Capsules Deferred for following reason:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
875. Asthabion (asthma care) Capsules Deferred for following reasons: submission of strength of antimonium tartaricum is required either it
is given in mother tincture/ solution/ trituration.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 876. Breastone Capsules Deferred for following reasons:
Monographs are required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 877. Brokid F Capsules Deferred for following reasons:
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S.No Brand name Decision
(1) (2) (3)
Monographs are required.
master formula is required.
stability study undertaking is required.
Stamp papers on “brand name and contents of dossier” are
required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
878. Ginseng Vital Tonic Capsules Deferred for following reasons: Brand name on form 3 and on fee voucher differs from each other.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 879. Derma Acn Capsules Deferred for following reasons:
monographs are required.
Brand name to be changed.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 880. Depwort Capsules Deferred for following reason:
safety undertaking is required.
881. Podo Capsules Deferred for following reasons: Fee evidence is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
It is combination product.
Monographs are required.
882. Paulfen Capsules Deferred for following reason:
fee evidence is required.
883. Stamimax Capsules Deferred for following reasons: Fee evidence is required.
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S.No Brand name Decision
(1) (2) (3)
Safety undertaking is required 884. Kidnol Capsules Deferred for following reasons:
clear fee evidence is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 885. Layohi Capsules Deferred for following reasons:
fee evidence is required.
safety undertaking is required. 886. Malca Capsules Deferred for following reasons:
Monographs are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 887. X-xtreme Power Capsules Deferred for following reasons:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
evidence of marketed product/ safety undertaking is required
brand name needs to be changed. 888. Brokid F Capsules Deferred for following reasons:
Monographs are required.
master formula is required.
Stability study undertaking is required.
Stamp papers on “brand name and contents of dossier” are
required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
889. Garlic Plus Capsules Deferred for following reasons: Allium sativum is single ingredient.
Brand name to be changed. 890. Broslim Course Capsules Deferred for following reasons:
Fee evidence is required.
Monographs are required.
Master formula is required.
stability study undertaking is required.
Stamp papers on “brand name and contents of dossier” are required.
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S.No Brand name Decision
(1) (2) (3)
justification of formulation and pack size is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Duplication with broslim course drop
891. Acn Removal Course Capsules Deferred for following reasons: Form 3 of acne removal course (30’s capsule) is unsigned and
unstamped.
Monographs of ingredients are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Duplication with Can removal course drops 892. Minola Plus Capsules Deferred for following reasons:
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Monographs are required.
Evidence of marketed product is required 893. StrLvr Capsules Deferred for following reasons:
fee evidence is required.
monographs are required.
stamp papers of brand name and contents are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 894. Hamacal Oil Deferred for following reasons:
The firm does not hold oil section (homeo) however, it possess oral
drop and syrup sections (homeo).
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Monographs are required. 895. RhusSym Liniment Deferred for following reasons:
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Monographs are required. 896. Calencitrin Powder Deferred for following reasons:
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Clarification of pack size is required. 897. Happy Baby Granules Deferred for following reasons:
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Fee evidence is required.
Monographs are required.
Stamp paper on brand name and contents of dossier are required.
Master formula is required.
It is combination product.
Brand name to be changed.
M/s W.S Homeopathic Pharmacy & Research Centre (00380)
Plot No.8, Main Canal Bank, Jallo Park Road, near Diyal House Stop, Lahore
898. Agnus Castus Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Agnus Castus Ø (active), not provided.
Specification monograph (EHPI) of Agnus Castus Ø (finished form), not
provided.
899. AlfalfaØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Alfalfa Ø (active), not provided.
Specification monograph (EHPI) of Alfalfa Ø (finished form), not provided.
900. Allium Sativa Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Allium Sativa Ø (active), not provided.
Specification monograph (EHPI) of Allium Sativa Ø (finished form), not
provided.
901. Arnica Montana Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Arnica Montana Ø (active), not provided.
Specification monograph (EHPI) of Arnica Montana Ø (finished form), not
provided.
902. Ashwagandha Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ashwagandha Ø (active), not provided.
Specification monograph (EHPI) of Ashwagandha Ø (finished form), not
provided.
903. Avena Sativa Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Avena Sativa Ø (active), not provided.
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Page 130 of 408
S.No Brand name Decision
(1) (2) (3)
Specification monograph (EHPI) of Avena Sativa Ø (finished form), not
provided.
904. Berberis Vulg Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Berberis Vulg Ø (active), not provided.
Specification monograph (EHPI) of Berberis Vulg Ø (finished form), not
provided.
905. Bryonia Alb Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Bryonia Alb Ø (active), not provided.
Specification monograph (EHPI) of Bryonia Alb Ø (finished form), not
provided.
906. Cactus Grandiflora Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cactus Grandiflora Ø (active), not provided.
Specification monograph (EHPI) of Cactus Grandiflora Ø (finished form), not
provided.
907. Calendula Off Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Calendula Off Ø (active), not provided.
Specification monograph (EHPI) of Calendula Off Ø (finished form), not
provided.
908. Cascara Sagrada Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cascara Sagrada Ø (active), not provided.
Specification monograph (EHPI) of Cascara Sagrada Ø (finished form), not
provided.
909. Chaparro Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Chaparro Ø (active), not provided.
Specification monograph (EHPI) of Chaparro Ø (finished form), not provided.
910. Chimaphila UmbellataØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Chimaphila Umbellata Ø (active), not provided.
Specification monograph (EHPI) of Chimaphila Umbellata Ø (finished form),
not provided.
911. Cynara Scol Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cynara Scol Ø (active), not provided.
Specification monograph (EHPI) of Cynara Scol Ø (finished form), not
provided.
912. Ephedra Vul Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cynara Scol Ø (active), not provided.
Specification monograph (EHPI) of Cynara Scol Ø (finished form), not
provided.
913. Equisetum Hyemale Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Equisetum Hyemale Ø (active), not provided.
Specification monograph (EHPI) of Equisetum Hyemale Ø (finished form),
not provided.
914. Eupatorium Purp Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Eupatorium Purp Ø (active), not provided.
Specification monograph (EHPI) of Eupatorium Purp Ø (finished form), not
provided.
915. Filix Mas Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Filix Mas Ø (active), not provided.
Specification monograph (EHPI) of Filix Mas Ø (finished form), not provided.
916. Fraxinus Americana Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Fraxinus Americana Ø (active), not provided.
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Page 131 of 408
S.No Brand name Decision
(1) (2) (3)
Specification monograph (EHPI) of Fraxinus Americana Ø (finished form),
not provided.
917. Gentiana Lutea Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Gentiana Lutea Ø (active), not provided.
Specification monograph (EHPI) of Gentiana Lutea Ø (finished form), not
provided.
918. Glycyrrhiza Glabra Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Glycyrrhiza Glabra Ø (active), not provided.
Specification monograph (EHPI) of Glycyrrhiza Glbra Ø (finished form), not
provided.
919. Gymnema Sylvestre Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Gymnema Sylvestre Ø (active), not provided.
Specification monograph (EHPI) of Gymnema Sylvestre Ø (finished form),
not provided.
920. Helianthus Annuus Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Helianthus Annuus Ø (active), not provided.
Specification monograph (EHPI) of Helianthus Annuus Ø (finished form), not
provided.
921. Helonias Dioica Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Helonias Dioica Ø (active), not provided.
Specification monograph (EHPI) of Helonias Dioica Ø (finished form), not
provided.
922. Ignatia Amara Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ignatia Amarauh Ø (active), not provided.
Specification monograph (EHPI) of Ignatia Amara Ø (finished form), not
provided.
923. Iris Tenax Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Iris Tenax Ø (active), not provided.
Specification monograph (EHPI) of Iris Tenax Ø (finished form), not
provided.
924. Jalapa Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Jalapa Ø (active), not provided.
Specification monograph (EHPI) of Jalapa Ø (finished form), not provided.
925. Juniperus Com Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Juniperus Com Ø (active), not provided.
Specification monograph (EHPI) of Juniperus Com Ø (finished form), not
provided.
926. Kurchi Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Kurchi Ø (active), not provided.
Specification monograph (EHPI) of Kurchi Ø (finished form), not provided.
927. Ledum Pal Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ledum Pal Ø (active), not provided.
Specification monograph (EHPI) of Ledum Pal Ø (finished form), not
provided.
928. Lilium Tig Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Lilium Tig Ø (active), not provided.
Specification monograph (EHPI) of Lilium Tig Ø (finished form), not
provided.
929. Lobelia Inflata Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Lobelia Inflata Ø (active), not provided.
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S.No Brand name Decision
(1) (2) (3)
Specification monograph (EHPI) of Lobelia Inflata Ø (finished form), not
provided.
930. Nux Moschata Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Nux Moschata Ø (active), not provided.
Specification monograph (EHPI) of Nux Moschata Ø (finished form), not
provided.
931. Nyctanthes Arbo Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Nyctanthes ArboØ (active), not provided.
Specification monograph (EHPI) of Nyctanthes ArboØ (finished form), not
provided.
932. Paeonia Off Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Paeonia OffØ (active), not provided.
Specification monograph (EHPI) of Paeonia OffØ (finished form), not
provided.
933. Pareira Brava Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Pareira BravaØ (active), not provided.
Specification monograph (EHPI) of Pareira BravaØ (finished form), not
provided.
934. Parthenium Hysterophorus Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Parthenium HysterophorusØ (active), not provided.
Specification monograph (EHPI) of Parthenium HysterophorusØ (finished
form), not provided.
935. Phytolacca Dec Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Phytolacca DecØ (active), not provided.
Specification monograph (EHPI) of Phytolacca DecØ (finished form), not
provided.
936. Piper Nigrum Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Piper NigrumØ (active), not provided.
Specification monograph (EHPI) of Piper NigrumØ (finished form), not
provided.
937. Piscidia Ery Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Piscidia EryØ (active), not provided.
Specification monograph (EHPI) of Piscidia EryØ (finished form), not
provided.
938. Plantago Major Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Plantago MajorØ (active), not provided.
Specification monograph (EHPI) of Plantago MajorØ (finished form), not
provided.
939. Polygonum Hydro Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Polygonum HydroØ (active), not provided.
Specification monograph (EHPI) of Polygonum HydroØ (finished form), not
provided.
940. Psoralea Cor-Babchi Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Psoralea Cor-BabchiØ (active), not provided.
Specification monograph (EHPI) of Psoralea Cor-BabchiØ (finished form),
not provided.
941. Raphanus Sativa Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Raphanus SativaØ (active), not provided.
Specification monograph (EHPI) of Raphanus SativaØ (finished form), not
provided.
942. RatanhiaØ Deferred since the application is deficient of following documents/information;
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S.No Brand name Decision
(1) (2) (3)
EHPI monograph of the RatanhiaØ (active), not provided.
Specification monograph (EHPI) of RatanhiaØ (finished form), not provided.
943. Rhus Tox Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Rhus ToxØ (active), not provided.
Specification monograph (EHPI) of Rhus ToxØ (finished form), not provided.
944. Ricinus ComØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ricinus ComØ (active), not provided.
Specification monograph (EHPI) of Ricinus ComØ (finished form), not
provided.
945. Robinia PseudacaciaØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Robinia PseudacaciaØ (active), not provided.
Specification monograph (EHPI) of Robinia PseudacaciaØ (finished form),
not provided.
946. Rosmarinus OffØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Rosmarinus Off Ø (active), not provided.
Specification monograph (EHPI) of Rosmarinus OffaØ (finished form), not
provided.
947. Ruta GraveØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ruta GraveØ (active), not provided.
Specification monograph (EHPI) of Ruta GraveØ (finished form), not
provided.
948. Sabal SerrØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Salix AlbØ (active), not provided.
Specification monograph (EHPI) of Salix Alb Ø (finished form), not provided.
949. Salix AlbØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Salix AlbØ (active), not provided.
Specification monograph (EHPI) of Salix AlbØ (finished form), not provided.
950. Sambucus NigØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Sambucus NigØ (active), not provided.
Specification monograph (EHPI) of Sambucus NigØ (finished form), not
provided.
951. Scrophularia NodosaØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Scrophularia NodosaØ (active), not provided.
Specification monograph (EHPI) of Scrophularia NodosaØ (finished form),
not provided.
952. Secale CorØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Secale CorØ (active), not provided.
Specification monograph (EHPI) of Secale CorØ (finished form), not
provided.
953. Senecio AureusØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Senecio AureusØ (active), not provided.
Specification monograph (EHPI) of Senecio AureusØ (finished form), not
provided.
954. SepiaØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the SepiaØ (active), not provided.
Specification monograph (EHPI) of SepiaØ (finished form), not provided.
955. Solidago VirgØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Solidago Virg Ø (active), not provided.
Specification monograph (EHPI) of Solidago VirgØ (finished form), not
provided.
956. Spigelia AntØ Deferred since the application is deficient of following documents/information;
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S.No Brand name Decision
(1) (2) (3)
EHPI monograph of the Spigelia AntØ (active), not provided.
Specification monograph (EHPI) of Spigelia AntØ (finished form), not
provided.
957. Spongia TostaØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Spongia TostaØ (active), not provided.
Specification monograph (EHPI) of Spongia TostaØ (finished form), not
provided.
958. Stellaria MediaØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Stellaria MediaØ (active), not provided.
Specification monograph (EHPI) of Stellaria MediaØ (finished form), not
provided.
959. Strophanthus Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the StrophanthusØ (active), not provided.
Specification monograph (EHPI) of StrophanthusØ (finished form), not
provided.
960. SymphytumØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the SymphytumØ (active), not provided.
Specification monograph (EHPI) of SymphytumØ (finished form), not
provided.
961. Syzygium JamboØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Syzygium JamboØ (active), not provided.
Specification monograph (EHPI) of Syzygium JamboØ (finished form), not
provided.
962. Taraxacum Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the TaraxacumØ (active), not provided.
Specification monograph (EHPI) of TaraxacumØ (finished form), not
provided.
963. Teucrium Marum VerumØ Deferred since the application is deficient of following documents/information;
EHPI monograph of the Teucrium Marum VerumØ (active), not provided.
Specification monograph (EHPI) of Teucrium Marum VerumØ (finished
form), not provided.
964. Thalaspi Bursa Past Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Thalaspi Bursa PastØ (active), not provided.
Specification monograph (EHPI) of Thalaspi Bursa PastØ (finished form), not
provided.
965. Tribulus Terr Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Tribulus Terr Ø (active), not provided.
Specification monograph (EHPI) of Tribulus TerrØ (finished form), not
provided.
966. Trigonella Foenum Gracecum Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Trigonella Foenum Gracecum Ø (active), not
provided.
Specification monograph (EHPI) of Trigonella Foenum GracecumØ (finished
form), not provided.
967. Tussilago Farfara Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Tussilago Farfara Ø (active), not provided.
Specification monograph (EHPI) of Tussilago FarfaraØ (finished form), not
provided.
968. Usnea Barbata Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Usnea Barbata Ø (active), not provided.
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S.No Brand name Decision
(1) (2) (3)
Specification monograph (EHPI) of Usnea BarbataØ (finished form), not
provided.
969. Ustilago Maydis Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ustilago MaydisØ (active), not provided.
Specification monograph (EHPI) of Ustilago MaydisØ (finished form), not
provided.
970. Uva Ursi Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Uva UrsiØ (active), not provided.
Specification monograph (EHPI) of Uva UrsiØ (finished form), not provided.
971. Valeriana Off Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Valeriana OffØ (active), not provided.
Specification monograph (EHPI) of Valeriana OffØ (finished form), not
provided.
972. Verbascum Thapsus Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Verbascum ThapsusØ (active), not provided.
Specification monograph (EHPI) of Verbascum ThapsusØ (finished form), not
provided.
973. Viburnum Opulus Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Viburnum OpulusØ (active), not provided.
Specification monograph (EHPI) of Viburnum OpulusØ (finished form), not
provided.
974. Vinca Minor Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Vinca MinorØ (active), not provided.
Specification monograph (EHPI) of Vinca MinorØ (finished form), not
provided.
975. Viscum Alb Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Viscum AlbØ (active), not provided.
Specification monograph (EHPI) of Viscum AlbØ (finished form), not
provided.
976. Xanthoxylum Fraxineum Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the Xanthoxylum FraxineumØ (active), not provided.
Specification monograph (EHPI) of Xanthoxylum FraxineumØ (finished
form), not provided.
977. Yohimbinum Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the YohimbinumØ (active), not provided.
Specification monograph (EHPI) of YohimbinumØ (finished form), not
provided.
978. Zingiber Ø Deferred since the application is deficient of following documents/information;
EHPI monograph of the ZingiberØ (active), not provided.
Specification monograph (EHPI) of ZingiberØ (finished form), not provided.
979. Acid Phos. 1DH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Acid Phos1DH (active), not provided.
Specification monograph (EHPI) of Acid Phos1DH (finished form), not
provided.
980. Acid Pic.1CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Acid Pic.1CH (active), not provided.
Specification monograph (EHPI) of Acid Pic.1CH (finished form), not
provided.
981. Arg. Nit.1CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Arg. Nit.1CH (active), not provided.
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S.No Brand name Decision
(1) (2) (3)
Specification monograph (EHPI) of Arg. Nit.1CH (finished form), not
provided.
982. Amyl Nit.1CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Amyl Nit.1CH (active), not provided.
Specification monograph (EHPI) of Amyl Nit.1CH (finished form), not
provided.
983. Arsenic Brom. 4CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Arsenic Brom. 4CH (active), not provided.
Specification monograph (EHPI) of Arsenic Brom. 4CH (finished form), not
provided.
984. Cholesterinum 3DH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cholesterinum 3DH (active), not provided.
Specification monograph (EHPI) of Cholesterinum 3DH (finished form), not
provided.
985. Glonoinum2CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Glonoinum2CH (active), not provided.
Specification monograph (EHPI) of Glonoinum2CH (finished form), not
provided.
986. Iodium1CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Iodium1CH (active), not provided.
Specification monograph (EHPI) of Iodium1CH (finished form), not provided.
987. Kali. Brom.1CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Kali. Brom.1CH (active), not provided.
Specification monograph (EHPI) of Kali. Brom.1CH (finished form), not
provided.
988. Kresostum1CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Kresostum 1CH (active), not provided.
Specification monograph (EHPI) of Kresostum 1CH (finished form), not
provided.
989. Oleum Jec.3DH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Oleum Jec.3DH (active), not provided.
Specification monograph (EHPI) of Oleum Jec.3DH (finished form), not
provided.
990. Phosphorus3CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Phosphorus3CH (active), not provided.
Specification monograph (EHPI) of Phosphorus3CH (finished form), not
provided.
991. Sulphur3CH Deferred since the application is deficient of following documents/information;
EHPI monograph of the Sulphur3CH (active), not provided.
Specification monograph (EHPI) of Sulphur3CH (finished form), not
provided.
992. Asparagus Offi. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Asparagus Offi.Potencies, not provided.
993. Aspidosperma Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the AspidospermaPotencies, not provided.
994. Avena Sativa Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Avena SativaPotencies, not provided.
995. Azadirachta Indica Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Azadirachta IndicaPotencies, not provided.
996. Caladium Seg. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Caladium Seg.Potencies, not provided.
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S.No Brand name Decision
(1) (2) (3)
997. Calotropis Gig. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Calotropis Gig.Potencies, not provided.
998. Cannabis Indica Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cannabis IndicaPotencies, not provided.
999. Cascara Sag. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cascara Sag.Potencies, not provided.
1000. Ceanothus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CeanothusPotencies, not provided.
1001. Chelone Glabra Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Chelone GlabraPotencies, not provided.
1002. Chenopodium Ambros Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Chenopodium AmbrosPotencies, not provided.
1003. Chimaphilla Umb. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Chimaphilla Umb.Potencies, not provided.
1004. Cinnamonum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CinnamonumPotencies, not provided.
1005. Coffea Crud Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Coffea CrudPotencies, not provided.
1006. Croton Tig. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Croton Tig.Potencies, not provided.
1007. Equisetum Hyem. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Equisetum Hyem.Potencies, not provided.
1008. Eucalyptus Globulus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Eucalyptus GlobulusPotencies, not provided.
1009. Eupatorium Perf. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Eupatorium Perf.Potencies, not provided.
1010. Eupatorium Purp. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Eupatorium Purp.Potencies, not provided.
1011. Euphrasia Off. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Euphrasia Off.Potencies, not provided.
1012. Formica Rufa Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Formica RufaPotencies, not provided.
1013. Fraxinus Ame. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Fraxinus Ame.Potencies, not provided.
1014. Gentiana Lutea Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Gentiana LuteaPotencies, not provided.
1015. Gnaphalium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the GnaphaliumPotencies, not provided.
1016. Helianthus Annuus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Helianthus AnnuusPotencies, not provided.
1017. Helleborus Niger Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Helleborus NigerPotencies, not provided.
1018. Helonias Dioica Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Helonias DioicaPotencies, not provided.
1019. Hypericum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the HypericumPotencies, not provided.
1020. Ignatia Amara Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ignatia AmaraPotencies, not provided.
1021. Iodium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the IodiumPotencies, not provided.
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Page 138 of 408
S.No Brand name Decision
(1) (2) (3)
1022. Iris Tenax Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Iris TenaxPotencies, not provided.
1023. Jalapa Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the JalapaPotencies, not provided.
1024. Juniperus Com. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Juniperus Com.Potencies, not provided.
1025. Kali Brom Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Kali BromPotencies, not provided.
1026. Kreosotum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the KreosotumPotencies, not provided.
1027. Kurchi Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the KurchiPotencies, not provided.
1028. Ledum Pal Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ledum PalPotencies, not provided.
1029. Lemna Minor Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Lemna MinorPotencies, not provided.
1030. Leptandra Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the LeptandraPotencies, not provided.
1031. Lilium Tig Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Lilium TigPotencies, not provided.
1032. Lobelia Inflata Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Lobelia InflataPotencies, not provided.
1033. Lycopodium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the LycopodiumPotencies, not provided.
1034. Mentha Piperita Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Mentha PiperitaPotencies, not provided.
1035. Mezereum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the MezereumPotencies, not provided.
1036. Millefolium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Millefolium Potencies, not provided.
1037. Nuphar Luteum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Nuphar LuteumPotencies, not provided.
1038. Nux Moschata Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Nux MoschataPotencies, not provided.
1039. Nyctanthes Arbo. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Nyctanthes Arbo.Potencies, not provided.
1040. Ocimum Can. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ocimum Can.Potencies, not provided.
1041. Oleander Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the OleanderPotencies, not provided.
1042. Oleum Jec. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Oleum Jec. Potencies, not provided.
1043. Paeonia Off. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Paeonia Off. Potencies, not provided.
1044. Piscidia Ery Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Piscidia Ery Potencies tencies, not provided.
1045. Plantago Major Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Plantago MajorPotencies, not provided.
1046. Podophyllum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the PodophyllumPotencies, not provided.
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Page 139 of 408
S.No Brand name Decision
(1) (2) (3)
1047. Polygonum Hydro. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Polygonum Hydro.Potencies, not provided.
1048. Pulsatilla Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the PulsatillaPotencies, not provided.
1049. Raphanus Sativus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Raphanus SativusPotencies, not provided.
1050. Ratanhia Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the RatanhiaPotencies, not provided.
1051. Rauwolfia Serp. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Rauwolfia Serp.Potencies, not provided.
1052. Rheum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the RheumPotencies, not provided.
1053. Rhus Tox Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Rhus ToxPotencies, not provided.
1054. Robinia Pseud. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Robinia Pseud.Potencies, not provided.
1055. Rosmarinus Off. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Rosmarinus Off.Potencies, not provided.
1056. Ruta Grave Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ruta GravePotencies, not provided.
1057. Sabal Serr. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Sabal Serr.Potencies, not provided.
1058. Sabina Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the SabinaPotencies, not provided.
1059. Salix Nigra Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Salix NigraPotencies, not provided.
1060. Sambucus Nigra Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Sambucus NigraPotencies, not provided.
1061. Sanguinaria Can. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Sanguinaria Can.Potencies, not provided.
1062. Sarsaparilla Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the SarsaparillaPotencies, not provided.
1063. Secale Corr. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Secale Corr.Potencies, not provided.
1064. Senecio Aureus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Senecio AureusPotencies, not provided.
1065. Senna Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the SennaPotencies, not provided.
1066. Sepia Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the SepiaPotencies, not provided.
1067. Solidago Virg. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Solidago Virg.Potencies, not provided.
1068. Spigelia Ant. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Spigelia Ant.Potencies, not provided.
1069. Spongia Tosta. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Spongia Tosta.Potencies, not provided.
1070. Stellaria Media Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Stellaria MediaPotencies, not provided.
1071. Strophanthus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the StrophanthusPotencies, not provided.
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Page 140 of 408
S.No Brand name Decision
(1) (2) (3)
1072. Sulphur Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the SulphurPotencies, not provided.
1073. Symphytum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the SymphytumPotencies, not provided.
1074. Syzygium Jambol. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Syzygium Jambol.Potencies, not provided.
1075. Taraxacum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the TaraxacumPotencies, not provided.
1076. Teucrium Marum Verum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Teucrium Marum VerumPotencies, not provided.
1077. Thlaspi Bursa Past Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Thlaspi Bursa PastPotencies, not provided.
1078. Thuja Occi. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Thuja Occi. Potencies, not provided.
1079. Tribulus Terr. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Tribulus Terr.Potencies, not provided.
1080. Tussilago Farfara Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Tussilago FarfaraPotencies, not provided.
1081. Urtica Urens Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Urtica UrensPotencies, not provided.
1082. Usnea Barbata Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Usnea BarbataPotencies, not provided.
1083. Ustilago Maydis Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ustilago MaydisPotencies, not provided.
1084. Uva Ursi Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Uva UrsiPotencies, not provided.
1085. Valeriana Off. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Valeriana Off. Potencies otencies, not provided.
1086. Verbascum Thapsus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Verbascum ThapsusPotencies, not provided.
1087. Viburnum Opulus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Viburnum OpulusPotencies, not provided.
1088. Vinca Minor Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Vinca MinorPotencies, not provided.
1089. Viscum Alb Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Viscum AlbPotencies, not provided.
1090. Xanthoxylum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the XanthoxylumPotencies, not provided.
1091. Yohimbinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the YohimbinumPotencies, not provided.
1092. Acid Pic. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Acid Pic.Potencies, not provided.
1093. Aconite Nap. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Aconite Nap.Potencies, not provided.
1094. Actaea Spicata Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Actaea SpicataPotencies, not provided.
1095. Aesculus Hip. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Aesculus Hip.Potencies, not provided.
1096. Agaricus Musca. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Agaricus Musca.Potencies, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 141 of 408
S.No Brand name Decision
(1) (2) (3)
1097. Agnus Castus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Agnus CastusPotencies, not provided.
1098. Aletris Fari. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Aletris Fari.Potencies, not provided.
1099. Alfalfa Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the AlfalfaPotencies, not provided.
1100. Allium Cepa Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Allium Cepa Potencies cies, not provided.
1101. Allium Sativa Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Allium SativaPotencies, not provided.
1102. Aloes Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the AloesPotencies, not provided.
1103. Ambra Grisea Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ambra GriseaPotencies, not provided.
1104. Amyl Nit. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Amyl Nit.Potencies, not provided.
1105. Apis Mel Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Apis MelPotencies, not provided.
1106. Apocynum Cann. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Apocynum Cann.Potencies, not provided.
1107. Aralia Racemosa Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Aralia RacemosaPotencies, not provided.
1108. Arg. Nit. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Arg. Nit.Potencies, not provided.
1109. Arnica Mont. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Arnica Mont.Potencies, not provided.
1110. Ars. Alb. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ars. Alb.Potencies, not provided.
1111. Aurum Met Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Aurum MetPotencies, not provided.
1112. Baptisia Tinct Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Baptisia TinctPotencies, not provided.
1113. Barium Carb. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Barium Carb.Potencies, not provided.
1114. Belladonna Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the BelladonnaPotencies, not provided.
1115. Bellis Peri. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Bellis Peri.Potencies, not provided.
1116. Berberis Aqui. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Berberis Aqui.Potencies, not provided.
1117. Berberis Vulg. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Berberis Vulg.Potencies, not provided.
1118. Blatta Ori. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Blatta Ori.Potencies, not provided.
1119. Borax Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the BoraxPotencies, not provided.
1120. Bovista Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the BovistaPotencies, not provided.
1121. Bryonia Alb. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Bryonia Alb.Potencies, not provided.
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Page 142 of 408
S.No Brand name Decision
(1) (2) (3)
1122. Bufo Rana Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Bufo RanaPotencies, not provided.
1123. Cactus Grand. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cactus Grand.Potencies, not provided.
1124. Calc. Carb. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Calc. Carb.Potencies, not provided.
1125. Calc. Fluor. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Calc. Fluor.Potencies, not provided.
1126. Calc. Phos. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Calc. Phos.Potencies, not provided.
1127. Calc. Renal. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Calc. Renal.Potencies, not provided.
1128. Calendula Off. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Calendula Off.Potencies, not provided.
1129. Cantharis Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CantharisPotencies, not provided.
1130. Capsicum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CapsicumPotencies, not provided.
1131. Carbo. Animalis Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Carbo. AnimalisPotencies, not provided.
1132. Carbo. Veg. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Carbo. Veg. Potencies, not provided.
1133. Carcinosin Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CarcinosinPotencies, not provided.
1134. Carduus Mari. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Carduus Mari.Potencies, not provided.
1135. Caulophyllum Thali. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Caulophyllum Thali.Potencies, not provided.
1136. Causticum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CausticumPotencies, not provided.
1137. Chamomilla Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the ChamomillaPotencies, not provided.
1138. Chaparro Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the ChaparroPotencies, not provided.
1139. Chelidonium Majus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Chelidonium MajusPotencies, not provided.
1140. China Off. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the China Off.Potencies, not provided.
1141. Chionanthus Virg. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Chionanthus Virg.Potencies, not provided.
1142. Cholesterinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CholesterinumPotencies, not provided.
1143. Cimicifuga Race Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cimicifuga RacePotencies, not provided.
1144. Cina Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CinaPotencies, not provided.
1145. Cobaltum Met. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cobaltum Met.Potencies, not provided.
1146. Cocculus Ind. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Cocculus Ind.Potencies, not provided.
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S.No Brand name Decision
(1) (2) (3)
1147. Colchicum Aut. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Colchicum Aut.Potencies, not provided.
1148. Collinsonia Can. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Collinsonia Can.Potencies, not provided.
1149. Colocynthis Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the ColocynthisPotencies, not provided.
1150. Conium Mac. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Conium Mac.Potencies, not provided.
1151. Crataegus Oxy. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Crataegus Oxy.Potencies, not provided.
1152. Curare Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CurarePotencies, not provided.
1153. Cyclamen Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the CyclamenPotencies, not provided.
1154. Damiana Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the DamianaPotencies, not provided.
1155. Digitalis Purp. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Digitalis Purp.Potencies, not provided.
1156. Dioscorea Villosa Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Dioscorea VillosaPotencies, not provided.
1157. Drosera Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the DroseraPotencies, not provided.
1158. Dulcamara Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the DulcamaraPotencies, not provided.
1159. Echinacea Ang. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Echinacea Ang.Potencies, not provided.
1160. Eel Serum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Eel SerumPotencies, not provided.
1161. Epigaea Repens Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Epigaea RepensPotencies, not provided.
1162. Ferrum Met. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ferrum Met.Potencies, not provided.
1163. Ferrum Phos. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ferrum Phos.Potencies, not provided.
1164. Filix Mas. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Filix Mas.Potencies, not provided.
1165. Fucus Vesi. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Fucus Vesi.Potencies, not provided.
1166. Gelsemium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the GelsemiumPotencies, not provided.
1167. Ginkgo Biloba Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Ginkgo BilobaPotencies, not provided.
1168. Ginseng Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the GinsengPotencies, not provided.
1169. Glonoinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the GlonoinumPotencies, not provided.
1170. Gossypium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the GossypiumPotencies, not provided.
1171. Graphites Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the GraphitesPotencies, not provided.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
1172. Gun Powder Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Gun PowderPotencies, not provided.
1173. Hamamelis Virg Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Hamamelis VirgPotencies, not provided.
1174. Hekla Lava Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Hekla LavaPotencies, not provided.
1175. Hepar Sulph. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Hepar Sulph.Potencies, not provided.
1176. Hydrangea Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the HydrangeaPotencies, not provided.
1177. Hydrastis Can. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Hydrastis Can.Potencies, not provided.
1178. Hydrocotyle Asia. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Hydrocotyle Asia.Potencies, not provided.
1179. Hyoscyamus Niger Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Hyoscyamus NigerPotencies, not provided.
1180. Ipecacuanha Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the IpecacuanhaPotencies, not provided.
1181. Iris Vers. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Iris Vers.Potencies, not provided.
1182. Jaborandi Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the JaborandiPotencies, not provided.
1183. Justicia Adha. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Justicia Adha.Potencies, not provided.
1184. Kali. Bichromicum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Kali. BichromicumPotencies, not provided.
1185. Nux Vomica Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Nux VomicaPotencies, not provided.
1186. Opium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the OpiumPotencies, not provided.
1187. Pareira Brava Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Pareira BravaPotencies, not provided.
1188. Passiflora Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the PassifloraPotencies, not provided.
1189. Phosphorus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the PhosphorusPotencies, not provided.
1190. Phytolacca Berry Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Phytolacca BerryPotencies, not provided.
1191. Phytolacca Dec. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of the Phytolacca Dec.Potencies, not provided.
1192. WS# 1Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1193. WS# 2 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1194. WS# 3 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1195. WS# 4 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1196. WS# 5 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1197. WS# 6 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1198. WS# 7 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1199. WS# 8 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1200. WS # 9 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 146 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1201. WS# 11 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1202. WS# 12 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1203. WS# 13 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1204. WS# 14 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1205. WS# 15 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1206. WS# 17 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1207. WS# 19 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 147 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1208. WS# 21 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1209. WS# 22 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1210. WS# 23 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1211. WS# 24 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1212. WS# 25 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1213. WS# 26 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1214. WS# 27 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 148 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1215. WS# 28 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1216. WS# 29 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1217. WS# 30 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1218. WS# 32 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1219. WS# 33 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1220. WS# 35 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1221. WS# 38 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 149 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1222. Anti-Aging Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1223. Be-Smart Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1224. Blotodine Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1225. Cardi Care Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1226. Cystocin Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1227. Depressnil Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1228. Di-Gold-M Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 150 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1229. Liprol Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1230. Nervosan Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1231. Nervotone Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1232. Nervotone Forte Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1233. Pain Nil Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1234. Renophen Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1235. Spermo Plus Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 151 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1236. Sugar Cure Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1237. Sugar Cure Plus Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1238. Urigone Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1239. AletrisSyrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1240. Aletris Cordial Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1241. AlfalfaSyrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
F.No.10-7/2020-OTC) (M-79)
Page 152 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1242. A-Pyrone Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1243. Asoka Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1244. Avena Super Tonic Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1245. Blotodine Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1246. Bronchon Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1247. Calcium Plus Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1248. Capsodine Syrup Deferred since the application is deficient of following documents/information;
F.No.10-7/2020-OTC) (M-79)
Page 153 of 408
S.No Brand name Decision
(1) (2) (3)
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1249. Colcide Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1250. Family Tonic Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1251. Gastronil Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
The evidence of International availability (COPP or Free Sale Certificate) or
Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1252. Ginkgo Plus Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1253. Hepa-100 Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1254. Histanil Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 154 of 408
S.No Brand name Decision
(1) (2) (3)
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1255. Hi-Up Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1256. Homogor Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1257. Liverox Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1258. Migrol Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1259. Nervotone Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1260. Pulmocef Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 155 of 408
S.No Brand name Decision
(1) (2) (3)
1261. Sepson Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1262. Thyrox Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1263. Vision Up Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/ Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1264. Aletris Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1265. Arthrojin Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1266. Asoka Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1267. Bronchon Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 156 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1268. Calcium Plus Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1269. Capsodine Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1270. Depressnil Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1271. Dicon Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1272. Feminon Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1273. Ginkgo Plus Ginseng Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 157 of 408
S.No Brand name Decision
(1) (2) (3)
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1274. Histanil Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1275. Hi-Up Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1276. Lax Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1277. Liprol Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1278. Nervotone Capsule Deferred since the application is deficient of following documents/information;
Evidence of approval of Capsule (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1279. No-Acne Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 158 of 408
S.No Brand name Decision
(1) (2) (3)
1280. Nucleus Plus Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1281. Pain Nil Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1282. Powergin Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1283. Relaxogin Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1284. Servi Spine Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1285. Smarty Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1286. Spermo Plus Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 159 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1287. Sugar Cure Tablet Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1288. Urigone Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1289. Hair Plus Care Oil Deferred since the application is deficient of following documents/information;
The product is for cosmetic purpose.
Evidence of approval of Topical Liquid (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1290. Jaz Shampoo Deferred since the application is deficient of following documents/information;
The product is for cosmetic purpose.
Evidence of approval of Shampoo (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1291. Mylgine Ointment Deferred since the application is deficient of following documents/information;
The product is for cosmetic purpose.
Evidence of approval of Ointment (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1292. WS # 10 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 160 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1293. WS # 16 Ear Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Ear Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1294. WS # 18 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1295. WS # 20 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1296. WS # 31 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1297. WS # 34 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1298. WS # 36 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1299. WS # 37 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 161 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1300. WS # 39 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1301. WS # 40 Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1302. Calendula Guard Topical Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Topical Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1303. Eczophen Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1304. Facial Hair Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1305. Ferro Up Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 162 of 408
S.No Brand name Decision
(1) (2) (3)
1306. Febrodeal Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1307. Ginkgo Plus Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1308. Hair Implant Topical Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Topical Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1309. Neuro Forte Plus Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1310. No Tension Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1311. Teeth Guard Oral Drops Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Drops(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1312. Baby Tonic Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 163 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1313. Build Up Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1314. Cardril Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1315. Lax Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1316. Nicotrane Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1317. Purifol Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1318. Wormocide Syrup Deferred since the application is deficient of following documents/information;
Evidence of approval of Oral Liquid/Syrup(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
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S.No Brand name Decision
(1) (2) (3)
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1319. Anti-Aging Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1320. Dia-Vit Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1321. Heamaton Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1322. Hepa-100 Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1323. Koldphen Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1324. SOS Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
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Page 165 of 408
S.No Brand name Decision
(1) (2) (3)
1325. Tarang Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1326. Tensomine Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1327. Thyronil Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1328. Vision Up Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1329. Calc. Fluor. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Calc. Fluor. 6X, not provided.
1330. Calc. Phos. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Calc. Phos. 6X, not provided.
1331. Calc. Sulph. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Calc. Sulph. 6X, not provided.
1332. Ferrum Phos. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Ferrum Phos. 6X, not provided.
1333. Kali Mur. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Kali Mur. 6X, not provided.
1334. Kali Phos. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Kali Phos. 6X, not provided.
1335. Kali Sulph. 6X Tablet Deferred since the application is deficient of following documents/information;
F.No.10-7/2020-OTC) (M-79)
Page 166 of 408
S.No Brand name Decision
(1) (2) (3)
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Kali Sulph. 6X, not provided.
1336. Mag. Phos. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Mag. Phos. 6X, not provided.
1337. Nat. Mur. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Nat. Mur. 6X, not provided.
1338. Nat. Phos. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Nat. Phos. 6X, not provided.
1339. Nat. Sulph. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Nat. Sulph. 6X, not provided.
1340. Silicea 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
EHPI monograph of the Silicea 6X, not provided.
1341. Five Phos. -6X Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1342. WS Bio 21. 6X Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1343. Bio Top Acne Cream Deferred since the application is deficient of following documents/information;
Evidence of approval of Cream(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
1344. Hair Plus Care Shampoo Deferred since the application is deficient of following documents/information;
The product is for cosmetic purpose.
Evidence of approval of Shamoo(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1345. Jommes Hair Oil Deferred since the application is deficient of following documents/information;
The product is for cosmetic purpose.
Evidence of approval of Topical Liquid(Homeo) Section is required.
F.No.10-7/2020-OTC) (M-79)
Page 167 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1346. Pain Nil Spray Deferred since the application is deficient of following documents/information;
Evidence of approval of Topical Spray(Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1347. Rad Cool Topical Spray Deferred since the application is deficient of following documents/information;
Evidence of approval of Topical Spray (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1348. Antonil Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1349. Arthrophen Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1350. Broconil Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1351. Gastrophen Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 168 of 408
S.No Brand name Decision
(1) (2) (3)
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1352. Histacide Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1353. Koldphen Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1354. Kurchi Plus Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1355. Panacide Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1356. Tempocide Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
1357. Thyronil Tablet Deferred since the application is deficient of following documents/information;
Evidence of approval of Tablet (Homeo) Section is required.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) not mentioned with active ingredients.
Monographs of actives are required as per specifications to be mentioned.
Brand name undertaking, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 169 of 408
S.No Brand name Decision
(1) (2) (3)
1358. Asterias RubensPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Asterias RubensPotencies, not provided.
1359. Aurum Mur NatroPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Aurum Mur NatroPotencies, not provided.
1360. Aurum MurPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Aurum MurPotencies, not provided.
1361. BadiagaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of BadiagaPotencies, not provided.
1362. Barium IodPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Barium IodPotencies, not provided.
1363. Barium MurPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Barium MurPotencies, not provided.
1364. Bismuthum MetPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Bismuthum MetPotencies, not provided.
1365. Blatta AmericanaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Blatta AmericanaPotencies, not provided.
1366. BromiumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of BromiumPotencies, not provided.
1367. Cadmium SulphPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Cadmium SulphPotencies, not provided.
1368. Calc. ArsenicPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Calc. ArsenicPotencies, not provided.
1369. Calc. HypophosphorosumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Calc. HypophosphorosumPotencies, not provided.
1370. Calc. Iod.Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Calc. Iod.Potencies, not provided.
1371. Calc. SulphuricaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Calc. SulphuricaPotencies, not provided.
1372. Camphor OffPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Camphor OffPotencies, not provided.
1373. Cannabis SativaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Cannabis SativaPotencies, not provided.
1374. CardiospermaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of CardiospermaPotencies, not provided.
1375. Chinium ArsenicosumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Chinium ArsenicosumPotencies, not provided.
1376. Chininum SulphuricumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Chininum SulphuricumPotencies, not provided.
1377. Cicuta VirosaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Cicuta VirosaPotencies, not provided.
1378. CimexPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of CimexPotencies, not provided.
1379. CinnabarisPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of CinnabarisPotencies, not provided.
1380. Cistus CanadensisPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Cistus CanadensisPotencies, not provided.
1381. Clematis ErectaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Clematis ErectaPotencies, not provided.
1382. Cobaltum NitPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Cobaltum NitPotencies, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 170 of 408
S.No Brand name Decision
(1) (2) (3)
1383. Coca Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Coca Potencies, not provided.
1384. Coccus CactiPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Coccus CactiPotencies, not provided.
1385. CondurangoPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of CondurangoPotencies, not provided.
1386. Convallaria MajalisPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Convallaria MajalisPotencies, not provided.
1387. Coralliumm RubPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Coralliumm RubPotencies, not provided.
1388. Cortisone Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of CortisonePotencies, not provided.
1389. CresolumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of CresolumPotencies, not provided.
1390. Crocus SativusPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Crocus SativusPotencies, not provided.
1391. Crotalus CascavellaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Crotalus CascavellaPotencies, not provided.
1392. Crotalus Hor.Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Crotalus Hor.Potencies, not provided.
1393. Cuprum Met.Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Cuprum Met.Potencies, not provided.
1394. DiphtherinumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of DiphtherinumPotencies, not provided.
1395. DnaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of DnaPotencies, not provided.
1396. Dolichos Puriens (Mucuna)Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Dolichos Puriens (Mucuna)Potencies, not provided.
1397. ElateriumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of ElateriumPotencies, not provided.
1398. Equisetum ArvensePotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Equisetum ArvensePotencies, not provided.
1399. Fel TauriPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Fel TauriPotencies, not provided.
1400. Ferrum Iod.Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Ferrum Iod.Potencies, not provided.
1401. GambogiaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of GambogiaPotencies, not provided.
1402. GlycerinumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of GlycerinumPotencies, not provided.
1403. GuaiacumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of GuaiacumPotencies, not provided.
1404. HaemoglobinumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of HaemoglobinumPotencies, not provided.
1405. Hedera HelixPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Hedera HelixPotencies, not provided.
1406. Hepatica TriobaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Hepatica TriobaPotencies, not provided.
1407. HydrophobinumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of HydrophobinumPotencies, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 171 of 408
S.No Brand name Decision
(1) (2) (3)
1408. InfluenzinumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of InfluenzinumPotencies, not provided.
1409. InsulinumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of InsulinumPotencies, not provided.
1410. Kali. ArsenicosumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Kali. ArsenicosumPotencies, not provided.
1411. Kali. Carb. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Kali. Carb. Potencies, not provided.
1412. Kali. ChloricumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Kali. ChloricumPotencies, not provided.
1413. Kali. CynanatumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Kali. CynanatumPotencies, not provided.
1414. Kali. IodatumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Kali. IodatumPotencies, not provided.
1415. Kali. Muriaticum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Kali. Muriaticum Potencies, not provided.
1416. Kali. Phos.Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Kali. Phos.Potencies, not provided.
1417. Kali. SulphuricumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Kalmia Latifolia P Kali. SulphuricumPotencies otencies,
not provided.
1418. Kalmia Latifolia Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Kalmia LatifoliaPotencies, not provided.
1419. Lac Caninum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Lac CaninumPotencies, not provided.
1420. Lac Defloratum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Lac DefloratumPotencies, not provided.
1421. Lachesis Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of LachesisPotencies, not provided.
1422. Lapis Albus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Lapis AlbusPotencies, not provided.
1423. Lathyrus Sativus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Lathyrus SativusPotencies, not provided.
1424. Lecithinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of LecithinumPotencies, not provided.
1425. Lithium Carb Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Lithium CarbPotencies, not provided.
1426. Luffa Amara Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Luffa AmaraPotencies, not provided.
1427. Lycopus Virginicus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Lycopus VirginicusPotencies, not provided.
1428. Mag. Carb Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Mag. CarbPotencies, not provided.
1429. Mag. Mur. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Mag. Mur.Potencies, not provided.
1430. Mag. Phos. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Mag. Phos.Potencies, not provided.
1431. Mag. Sulp. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Mag. Sulp.Potencies, not provided.
1432. Malandrinum Potencies Deferred since the application is deficient of following documents/information;
F.No.10-7/2020-OTC) (M-79)
Page 172 of 408
S.No Brand name Decision
(1) (2) (3)
EHPI monograph of MalandrinumPotencies, not provided.
1433. Malaria Off. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Malaria Off.Potencies, not provided.
1434. Medorrhinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of MedorrhinumPotencies, not provided.
1435. Mephitis Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of MephitisPotencies, not provided.
1436. Merc. Cor. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Merc. Cor.Potencies, not provided.
1437. Merc. Dulcis Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Merc. Dulcis Potencies, not provided.
1438. Merc. Iod. Flav. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Merc. Iod. Flav.Potencies, not provided.
1439. Merc. Iod. Rub. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Merc. Iod. Rub.Potencies, not provided.
1440. Merc. Sol. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Merc. Sol. Potencies, not provided.
1441. Moribilinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of MoribilinumPotencies, not provided.
1442. Moschus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of MoschusPotencies, not provided.
1443. Myrica Cerifera Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Myrica CeriferaPotencies, not provided.
1444. Naja Tripudians Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Naja TripudiansPotencies, not provided.
1445. Nat. Carb. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Nat. Carb.Potencies, not provided.
1446. Nat. Mur. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Nat. Mur.Potencies, not provided.
1447. Nat. Phos. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Nat. Phos.Potencies, not provided.
1448. Nat. Sulph. Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Nat. Sulph.Potencies, not provided.
1449. Okoubaka Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of OkoubakaPotencies, not provided.
1450. Oleum Animale Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Oleum AnimalePotencies, not provided.
1451. Oleum Santali Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Oleum SantaliPotencies, not provided.
1452. Onosmodium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of OnosmodiumPotencies, not provided.
1453. Oophorinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of OophorinumPotencies, not provided.
1454. Ova Tosta Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Ova TostaPotencies, not provided.
1455. Pancreatinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of PancreatinumPotencies, not provided.
1456. Petroleum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of PetroleumPotencies, not provided.
1457. Petroselinum Potencies Deferred since the application is deficient of following documents/information;
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
EHPI monograph of Petroselinum Potencies, not provided.
1458. PhysostigmaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of PhysostigmaPotencies, not provided.
1459. PilocarpinPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of PilocarpinPotencies, not provided.
1460. Piper MethysticumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Piper MethysticumPotencies, not provided.
1461. Pituitary GlandPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Pituitary GlandPotencies, not provided.
1462. Pix LiquidaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Pix LiquidaPotencies, not provided.
1463. Platinum MetPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Platinum MetPotencies, not provided.
1464. Plumbum Met.Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Plumbum Met.Potencies, not provided.
1465. PsorinumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of PsorinumPotencies, not provided.
1466. Pyrogenium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of PyrogeniumPotencies, not provided.
1467. Radium BromPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Radium BromPotencies, not provided.
1468. Ranunculus Bulbosus Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Ranunculus BulbosusPotencies, not provided.
1469. Rhododendron ChrysanthumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Rhododendron ChrysanthumPotencies, not provided.
1470. Rhus GlabraPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Rhus GlabraPotencies, not provided.
1471. RnaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of RnaPotencies, not provided.
1472. Rubia TinctPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Rubia TinctPotencies, not provided.
1473. Rumex CrispusPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Rumex CrispusPotencies, not provided.
1474. SabadillaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of SabadillaPotencies, not provided.
1475. Sambucus Canadensis Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Sambucus Canadensis Potencies, not provided.
1476. Sanguinaria Nit.Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Sanguinaria Nit.Potencies, not provided.
1477. Sanicula EuropaeaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Sanicula EuropaeaPotencies, not provided.
1478. SantoninumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of SantoninumPotencies, not provided.
1479. ScutellariaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of ScutellariaPotencies, not provided.
1480. SeleniumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of SeleniumPotencies, not provided.
1481. SenegaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of SenegaPotencies, not provided.
1482. Silicea Potencies Deferred since the application is deficient of following documents/information;
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S.No Brand name Decision
(1) (2) (3)
EHPI monograph of Silicea Potencies, not provided.
1483. Sparteinum SulphuricumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Sparteinum SulphuricumPotencies, not provided.
1484. Stannum MetallicumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Stannum MetallicumPotencies, not provided.
1485. StaphysagriaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of StaphysagriaPotencies, not provided.
1486. Sticta PulmonariaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Sticta PulmonariaPotencies, not provided.
1487. StramoniumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of StramoniumPotencies, not provided.
1488. Strychninum PhosphoricumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Strychninum PhosphoricumPotencies, not provided.
1489. Strychninum SulphurtcumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Strychninum SulphurtcumPotencies, not provided.
1490. Sulphur IodatumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Sulphur IodatumPotencies, not provided.
1491. Symphoricarpus RacemosaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Symphoricarpus RacemosaPotencies, not provided.
1492. SyphilinumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of SyphilinumPotencies, not provided.
1493. TabacumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of TabacumPotencies, not provided.
1494. Tanacetum VulgarePotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Tanacetum VulgarePotencies, not provided.
1495. Tarentula CubensisPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Tarentula CubensisPotencies, not provided.
1496. Tarentula HispanicaPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Tarentula HispanicaPotencies, not provided.
1497. Tellurium MetallicumPotencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Tellurium MetallicumPotencies, not provided.
1498. Terebinthina Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of TerebinthinaPotencies, not provided.
1499. Thymol Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of ThymolPotencies, not provided.
1500. Thyroidinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of ThyroidinumPotencies, not provided.
1501. Titanium Metallicum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Titanium MetallicumPotencies, not provided.
1502. Trillium Pendulum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Trillium PendulumPotencies, not provided.
1503. Tuberculinum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of TuberculinumPotencies, not provided.
1504. Uranium Nitricum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Uranium NitricumPotencies, not provided.
1505. Urea Pura Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Urea PuraPotencies, not provided.
1506. Vanadium Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of VanadiumPotencies, not provided.
1507. Veratrum Album Potencies Deferred since the application is deficient of following documents/information;
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
EHPI monograph of Veratrum AlbumPotencies, not provided.
1508. Veratrum Viride Potencies EHPI monograph of Veratrum ViridePotencies, not provided.
1509. Wiesbaden Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Wiesbaden Potencies, not provided.
1510. Wyethia Helenoides Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Wyethia HelenoidesPotencies, not provided.
1511. Xerophyllum Asphodeloides Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Xerophyllum AsphodeloidesPotencies, not provided.
1512. X-Ray Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of X-RayPotencies, not provided.
1513. Zincum Metallicum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Zincum MetallicumPotencies, not provided.
1514. Zincum Phosphoricum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Zincum PhosphoricumPotencies, not provided.
1515. Zincum Picricum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Zincum PicricumPotencies, not provided.
1516. Zincum Sulphuricum Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of Zincum SulphuricumPotencies, not provided.
1517. Zingiber Potencies Deferred since the application is deficient of following documents/information;
EHPI monograph of ZingiberPotencies, not provided.
M/s Aman Traders (0030)
11/1 D, People Colony No. 1, Faisalabad
Agent of M/s PEKANA Naturheilmittel GmbH Raiffeisenstrasse 15, 88353 Kisslegg, Germany
1518. PK 71 Fluofin Oral Drops Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to conditions of Zone IVA
has not been provided. Only stability protocol has been provided which shows
that the conditions of stability studies are not according to Zone IVA.
The formulation applied is different from the formulation mentioned on
COPP.
1519. PK 70 Lassitul Oral Drops Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to conditions of Zone IVA
has not been provided. Only stability protocol has been provided which shows
that the conditions of stability studies are not according to Zone IVA.
The formulation applied is different from the formulation mentioned on
COPP.
1520. PK 77 Gastul Oral Drops Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to conditions of Zone IVA
has not been provided. Only stability protocol has been provided which shows
that the conditions of stability studies are not according to Zone IVA.
The formulation applied is different from the formulation mentioned on
COPP.
1521. PK 73 Fattex Oral Drops Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to conditions of Zone IVA
has not been provided. Only stability protocol has been provided which shows
that the conditions of stability studies are not according to Zone IVA.
The formulation applied is different from the formulation mentioned on
COPP.
1522. PK 47 Supren Oral Drops Deferred since the application is deficient of following documents/information;
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S.No Brand name Decision
(1) (2) (3)
The stability studies data of three batches according to conditions of Zone IVA
has not been provided. Only stability protocol has been provided which shows
that the conditions of stability studies are not according to Zone IVA.
The formulation applied is different from the formulation mentioned on
COPP.
1523. PK 72 Pollon Oral Drops Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to conditions of Zone IVA
has not been provided. Only stability protocol has been provided which shows
that the conditions of stability studies are not according to Zone IVA.
The formulation applied is different from the formulation mentioned on
COPP.
1524. PK 48Stimeno Oral Drops Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to conditions of Zone IVA
has not been provided. Only stability protocol has been provided which shows
that the conditions of stability studies are not according to Zone IVA.
1525. PK 76Muliton Deferred since the application is deficient of following documents/information;
The stability studies data of three batches according to conditions of Zone IVA
has not been provided. Only stability protocol has been provided which shows
that the conditions of stability studies are not according to Zone IVA.
The formulation applied is different from the formulation mentioned on
COPP.
M/s. Dr. Masood Homoepathic Pharmaceutical(0016)
56, Quaid-e-Azam Industrial Estate, Kot Lakhpat Lahore
1526. Abelmoschus moschatusPotencies Deferred since the application is deficient of following document/information;
Monograph of Amygdalus has been provided instead of Abelmoschus
moschatus
1527. Ephedrinum muriaticum Potencies Deferred since the application is deficient of following document/information;
Evidence of allocation of quota of Ehedrine Hydrochloride is required.
1528. Camphor Monobromata Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Camphora bromate has not been
mentioned in the EHPI monograph provided.
1529. Murex Purpurea Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Murex Purpurea has not been
mentioned in the EHPI monograph provided.
1530. Natrum Hypophosphorosum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Natrum Hypophoshas not been
mentioned in the EHPI monograph provided.
1531. Boswellia Serrata Ø The Mother Tincture formulation of the Boswellia Serratahas not been
mentioned in the EHPI monograph provided.
1532. Sterculia Acuminata Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Sterculia Acuminata has not been
mentioned in the EHPI monograph provided.
1533. Cholestrinum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Cholestrinum has not been mentioned
in the EHPI monograph provided.
1534. Silicea ɸ Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Silicea has not been mentioned in the
EHPI monograph provided.
1535. Zincum Phosphoricum Ø Deferred since the application is deficient of following document/information;
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
The Mother Tincture formulation of the Zincum Phosphoricumhas not been
mentioned in the EHPI monograph provided.
1536. Sepia Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Sepiahas not been mentioned in the
EHPI monograph provided.
1537. Acid Tartaricum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Acid Tartaricumhas not been
mentioned in the EHPI monograph provided.
1538. Adrenalinum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Adrenalinum has not been mentioned
in the EHPI monograph provided.
1539. Antimonium Tartaricum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Antimonium Tartaricumhas not been
mentioned in the EHPI monograph provided.
1540. Arsenicum Bromatum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Arsenicum Bromatumhas not been
mentioned in the EHPI monograph provided.
1541. Arsenicum Iodatum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Arsenicum Iodatumhas not been
mentioned in the EHPI monograph provided.
1542. Calcarea BromØ Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Calcarea bromata has not been
mentioned in the EHPI monograph provided.
1543. Chininum Sulph Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Chininum Sulph has not been
mentioned in the EHPI monograph provided.
1544. Cinnabaris Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Cinnabaris has not been mentioned in
the EHPI monograph provided.
1545. Cuprum Arsenicosum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Cuprum Arsenicosumhas not been
mentioned in the EHPI monograph provided.
1546. Cuprum Metallicum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Cuprum Metallicum has not been
mentioned in the EHPI monograph provided.
1547. Cuprum Sulph Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Cuprum Sulphhas not been mentioned
in the EHPI monograph provided.
1548. Graphites Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Graphiteshas not been mentioned in
the EHPI monograph provided.
1549. Helix Tosta Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Helix Tosta has not been mentioned in
the EHPI monograph provided.
1550. Lapis Albus Ø Deferred since the application is deficient of following document/information:
The Mother Tincture formulation of the Lapis Alb has not been mentioned in
the EHPI monograph provided.
1551. Lithium Benz Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Lithium Benzhas not been mentioned
in the EHPI monograph provided.
F.No.10-7/2020-OTC) (M-79)
Page 178 of 408
S.No Brand name Decision
(1) (2) (3)
1552. Lithium Carb Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Lithium Carbhas not been mentioned
in the EHPI monograph provided.
1553. Macrotinum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Macrotinumhas not been mentioned
in the EHPI monograph provided.
1554. Magnesia Mur Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Magnesia Murhas not been
mentioned in the EHPI monograph provided.
1555. Magnesia Sulph Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Magnesia Sulphhas not been
mentioned in the EHPI monograph provided.
1556. Naphthaline Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Naphthaline has not been mentioned
in the EHPI monograph provided.
1557. Natrum Sulph Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Natrum Sulphuricumhas not been
mentioned in the EHPI monograph provided.
1558. Pituitary Gland Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Pituitary Gland has not been
mentioned in the EHPI monograph provided.
1559. Placenta Humanum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Placenta Humanum has not been
mentioned in the EHPI monograph provided. Placenta Totalis has been
mentioned in monograph.
1560. Plumbum MetallicumØ Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Plumbum Metallicum has not been
mentioned in the EHPI monograph provided.
1561. Saccharum Off Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Saccharum Off has not been
mentioned in the EHPI monograph provided.
1562. Santoninum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Santoninum has not been mentioned
in the EHPI monograph provided.
1563. Sparteinum Sulph Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Sparteinum Sulph has not been
mentioned in the EHPI monograph provided.
1564. Sulphur Iodatum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Sulphur Iodatum has not been
mentioned in the EHPI monograph provided.
1565. Tellurium Metallicum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Tellurium metalhas not been
mentioned in the EHPI monograph provided.
1566. Thiosinaminum Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Thiosinaminumhas not been
mentioned in the EHPI monograph provided.
1567. Vanadium Met Ø Deferred since the application is deficient of following document/information;
The Mother Tincture formulation of the Vanadium Methas not been mentioned
in the EHPI monograph provided.
1568. Moringa Tablet Deferred since the application is deficient of following document/information;
Monograph of moringa trituration has not been mentioned in EHPI.
F.No.10-7/2020-OTC) (M-79)
Page 179 of 408
S.No Brand name Decision
(1) (2) (3)
Both strengths of the tablet i.e 3x and 6x have been applied on the same
application.
1569. HR# 45 Haemostasis Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1570. HR# 38 Toxina Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1571. HR# 52 Hyper Thyreo Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1572. HR# 42 Veinohaem Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1573. HR# 37 Hystrofen Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1574. HR# 68 Cigdown Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1575. HR# 78 Seborrha Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Zincum Sulph. Mother Tincture formulation has not been mentioned in EHPI.
Brand name undertaking, not provided.
1576. HR# 80 Immu-Step Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Zincum Sulph 1D being used in formulation is solid Trituration in EHPI while
it is being used in v/v ratio in formulation.
Brand name undertaking, not provided.
1577. HR# 57 Vigore-Zee Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Caffeinum 2D being used in formulation is solid potency in EHPI while it is
being used in v/v ratio in formulation.
F.No.10-7/2020-OTC) (M-79)
Page 180 of 408
S.No Brand name Decision
(1) (2) (3)
Lecithin 1D is not mentioned in EHPI. Its 2D Mother solution mentioned in
EHPI.
Monograph of Gentiana Lu Mother tincture, not provided.
Zincum Sulph 1D being used in formulation is solid Trituration in EHPI while
it is being used in v/v ratio in formulation.
Brand name undertaking, not provided.
1578. HR# 79 Rexmens Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1579. CT# 28 Smilo Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1580. CT# 07 Degerd Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1581. CT# 20 Diabox Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1582. CT# 03 Kuff-Col Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1583. CT# 12 Imunax Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
1584. CT# 02 Laxacure Tablet Deferred since the application is deficient of following document/information;
The evidence of International availability (COPP or Free Sale Certificate) or
Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1585. CT# 06 Fevinol Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1586. CT# 26 Hemopil Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1587. CT# 13 Hemosil Tablet Deferred since the application is deficient of following document/information;
F.No.10-7/2020-OTC) (M-79)
Page 181 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1588. CT# 51 Multisup Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
1589. CT# 52 Enurol Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1590. CT# 05 Difton Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1591. CT# 55 Medipan Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1592. CT# 10 Neurafos Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1593. CT# 54 Acnivul Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1594. CT# 09 Leucorid Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1595. CT# 35 Renol Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1596. Broncal Syrup (Sugar Free) Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Monograph of Chloroform 1DH, not provided.
Brand name undertaking, not provided.
1597. Relaxofos Tablet Deferred since the application is deficient of following document/information;
F.No.10-7/2020-OTC) (M-79)
Page 182 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1598. Localen Mouth Wash Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1599. Kalipron Plus Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
The trituration 1X of Guaraninum has not been mentioned in EHPI monograph
provided.
Brand name undertaking, not provided.
1600. Hyperical Topical Liquid Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Evidence of approval of Topical liquid section is required.
Brand name undertaking, not provided.
1601. High Blood Pressure Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1602. HR# 25 Ezinol Oral Drops Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
1603. Alfalfa Tablet Deferred since the application is deficient of following document/information;
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available on
DRAP website), the evidence of International availability (COPP or Free Sale
Certificate) or Local marketing of 10 years, not provided.
Brand name undertaking, not provided.
Dr.Salim Ahmed & Co., Karachi
an agent of M/s Pharmazaeutische Fabrik Dr. Reckweg & Co. GmbH, Berlin Ring 32 city 6425 Benshiem, Hesse, Germany
1604. Dr. Recheweg R22 Najasthe
Deferred for following reasons:
Firm applied the said product on form 5 w.r.t to importer
name i.e M/s Pharmazaeutische Fabrik Dr. Reckweg & Co.
GmbH, Berlin Ring 32 city 6425 Benshiem, Hesse,
Germany.
It is submitted that M/s Dr. Salim Ahmed & Co., located at the
address 310 Hashoo Centre, Abdullah Haroon Road, Karachi is an
importer of following principle manufacturers/ agents:
F.No.10-7/2020-OTC) (M-79)
Page 183 of 408
S.No Brand name Decision
(1) (2) (3)
a) M/s Pharmazeutische Fabrik Evers GmbH & Co. KG,
Siemensstraße 4, 25421 Pinneberg, Germany (E.No. 00980)
b) M/s Dr. Reckeweg & Co. GmbH, Berliner Ring 32, 64625
Bensheim, GERMANY (E.No. 00247) In this regard, Clarification is required according to above mentioned
statement.
Name of product “ Naja- Gastrreu R 22” mentioned on
copy of CPP differs from brand name “ Dr. Reckeweg R22
najasthen” given on product profile document and label
claimed submitted by the said firm, needs clarification.
Fee evidence is required.
Manufacturing license attested by regulatory authority of
country of origin, is required.
GMP attested by regulatory body of regulatory authority of
country of origin, is required.
Original Free sale certificate/ CPP on WHO format, attested
by regulatory authority of country of origin, is required.
Stability data of at least three batches is required.
Monographs/ testing specification of active ingredients are
required. 1605. Drosera Q Deferred for following reasons:
Firm applied the said product on form 5 w.r.t to importer
name i.e M/s Pharmazaeutische Fabrik Dr. Reckweg & Co.
GmbH, Berlin Ring 32 city 6425 Benshiem, Hesse,
Germany.
It is submitted that M/s Dr. Salim Ahmed & Co., located at the
address 310 Hashoo Centre, Abdullah Haroon Road, Karachi is an
importer of following principle manufacturers/ agents:
a) M/s Pharmazeutische Fabrik Evers GmbH & Co. KG,
Siemensstraße 4, 25421 Pinneberg, Germany
b) M/s Dr. Reckeweg & Co. GmbH, Berliner Ring 32, 64625
Bensheim, GERMANY In this regard, Clarification is required according to above mentioned
statement.
Fee evidence is required.
Manufacturing license attested by regulatory authority of
country of origin, is required.
GMP attested by regulatory body of regulatory authority of
country of origin, is required.
Original Free sale certificate/ CPP on WHO format, attested
by regulatory authority of country of origin , is required.
Stability data of at least three batches is required.
F.No.10-7/2020-OTC) (M-79)
Page 184 of 408
S.No Brand name Decision
(1) (2) (3)
Commercial invoice submitted by the firm does not mention
that Drosera Q” has forwarded from Germany to Karachi/
Pakistan, in this regard clarification is sought from importer
regarding exportation of said medicament in Pakistan.
The firms claims that “ there is not recommended use for
single remedy mother tinctures, needs clarification regarding
this point.
Brand name undertaking is required. 1606. Passiflora Incarnata Q Deferred for following reasons:
Firm applied the said product on form 5 w.r.t to importer
name i.e M/s Pharmazaeutische Fabrik Dr. Reckweg & Co.
GmbH, Berlin Ring 32 city 6425 Benshiem, Hesse,
Germany.
It is submitted that M/s Dr. Salim Ahmed & Co., located at the
address 310 Hashoo Centre, Abdullah Haroon Road, Karachi is an
importer of following principle manufacturers/ agents:
a) M/s Pharmazeutische Fabrik Evers GmbH & Co. KG,
Siemensstraße 4, 25421 Pinneberg, Germany
b) M/s Dr. Reckeweg & Co. GmbH, Berliner Ring 32, 64625
Bensheim, GERMANY In this regard, Clarification is required according to above mentioned
statement.
Fee evidence is required.
Manufacturing license attested by regulatory authority of
country of origin, is required.
GMP attested by regulatory body of regulatory authority of
country of origin, is required.
Original Free sale certificate/ CPP on WHO format, attested
by regulatory authority of country of origin, is required.
Stability data of at least three batches is required.
Commercial invoice submitted by the firm does not mention
that Passiflora incarnate Q” has forwarded from Germany to
Karachi/ Pakistan, in this regard clarification is sought from
importer regarding exportation of said medicament in
Pakistan.
The firms claims that “ there is not recommended use for
single remedy mother tinctures, needs clarification regarding
this point.
Brand name undertaking is required. 1607. Dr. Recheweq R26 Remisin Deferred for following reasons:
Firm applied the said product on form 5 w.r.t to importer
name i.e M/s Pharmazaeutische Fabrik Dr. Reckweg & Co.
F.No.10-7/2020-OTC) (M-79)
Page 185 of 408
S.No Brand name Decision
(1) (2) (3)
GmbH, Berlin Ring 32 city 6425 Benshiem, Hesse,
Germany.
It is submitted that M/s Dr. Salim Ahmed & Co., located at the
address 310 Hashoo Centre, Abdullah Haroon Road, Karachi is an
importer of following principle manufacturers/ agents:
a) M/s Pharmazeutische Fabrik Evers GmbH & Co. KG,
Siemensstraße 4, 25421 Pinneberg, Germany
b) M/s Dr. Reckeweg & Co. GmbH, Berliner Ring 32, 64625
Bensheim, GERMANY In this regard, Clarification is required according to above mentioned
statement.
CoA of Ferrum iodatum is required.
Name of product “ Funcktions- Gastreu R 26” mentioned
on copy of CPP differs from brand name “ Dr. Reckeweg
R26 Remisin” given on product profile document and label
claimed submitted by the said firm, needs clarification.
Fee evidence is required.
Manufacturing license attested by regulatory authority of
country of origin, is required.
GMP attested by regulatory body of regulatory authority of
country of origin, is required.
Original Free sale certificate/ CPP on WHO format, attested
by regulatory authority of country of origin , is required.
Stability data of at least three batches is required.
Monographs/ testing specification of active ingredients are
required. 1608. Dr. Recheweq R44 Hypotonol Deferred for following reasons:
Firm applied the said product on form 5 w.r.t to importer
name i.e M/s Pharmazaeutische Fabrik Dr. Reckweg & Co.
GmbH, Berlin Ring 32 city 6425 Benshiem, Hesse,
Germany.
It is submitted that M/s Dr. Salim Ahmed & Co., located at the
address 310 Hashoo Centre, Abdullah Haroon Road, Karachi is an
importer of following principle manufacturers/ agents:
a) M/s Pharmazeutische Fabrik Evers GmbH & Co. KG,
Siemensstraße 4, 25421 Pinneberg, Germany
b) M/s Dr. Reckeweg & Co. GmbH, Berliner Ring 32, 64625
Bensheim, GERMANY In this regard, Clarification is required according to above mentioned
statement.
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 186 of 408
S.No Brand name Decision
(1) (2) (3)
Manufacturing license attested by regulatory authority of
country of origin, is required.
GMP attested by regulatory body of regulatory authority of
country of origin, is required.
Original Free sale certificate/ CPP on WHO format, attested
by regulatory authority of country of origin , is required.
Stability data of at least three batches is required.
Monographs/ testing specification of active ingredients are required. 1609. Dr. Recheweq R45 Laryngin Deferred for following reasons:
Firm applied the said product on form 5 w.r.t to importer
name i.e M/s Pharmazaeutische Fabrik Dr. Reckweg & Co.
GmbH, Berlin Ring 32 city 6425 Benshiem, Hesse,
Germany.
It is submitted that M/s Dr. Salim Ahmed & Co., located at the
address 310 Hashoo Centre, Abdullah Haroon Road, Karachi is an
importer of following principle manufacturers/ agents:
a) M/s Pharmazeutische Fabrik Evers GmbH & Co. KG,
Siemensstraße 4, 25421 Pinneberg, Germany
b) M/s Dr. Reckeweg & Co. GmbH, Berliner Ring 32, 64625
Bensheim, GERMANY In this regard, Clarification is required according to above mentioned
statement.
Fee evidence is required.
Manufacturing license attested by regulatory authority of
country of origin, is required.
GMP attested by regulatory body of regulatory authority of
country of origin, is required.
Original Free sale certificate/ CPP on WHO format, attested
by regulatory authority of country of origin , is required.
Stability data of at least three batches is required.
Monographs/ testing specification of active ingredients are
required. 1610. Cimicifuga Q Deferred for following reasons:
Firm applied the said product on form 5 w.r.t to importer
name i.e M/s Pharmazaeutische Fabrik Dr. Reckweg & Co.
GmbH, Berlin Ring 32 city 6425 Benshiem, Hesse,
Germany.
It is submitted that M/s Dr. Salim Ahmed & Co., located at the
address 310 Hashoo Centre, Abdullah Haroon Road, Karachi is an
importer of following principle manufacturers/ agents:
a) M/s Pharmazeutische Fabrik Evers GmbH & Co. KG,
Siemensstraße 4, 25421 Pinneberg, Germany
F.No.10-7/2020-OTC) (M-79)
Page 187 of 408
S.No Brand name Decision
(1) (2) (3)
b) M/s Dr. Reckeweg & Co. GmbH, Berliner Ring 32, 64625
Bensheim, GERMANY In this regard, Clarification is required according to above mentioned
statement.
Fee evidence is required.
Manufacturing license attested by regulatory authority of
country of origin, is required.
GMP attested by regulatory body of regulatory authority of
country of origin, is required.
Original Free sale certificate/ CPP on WHO format, attested
by regulatory authority of country of origin , is required.
Stability data of at least three batches is required.
The firms claims that “ there is not recommended use for
single remedy mother tinctures, needs clarification regarding
this point.
Commercial invoice submitted by the firm stated that
principal manufacturer is forwarding “Cimifuga/ M.T in
20ml” by seafreight from Germany to Karachi/ Pakistan
while firm applies the product in pack sizes of 20ml, 100ml
and 1000ml, needs clarification.
Brand name undertaking is required. 1611. Dr. Recheweq R69 Intercostalin Deferred for following reasons:
Firm applied the said product on form 5 w.r.t to importer
name i.e M/s Pharmazaeutische Fabrik Dr. Reckweg & Co.
GmbH, Berlin Ring 32 city 6425 Benshiem, Hesse,
Germany.
It is submitted that M/s Dr. Salim Ahmed & Co., located at the
address 310 Hashoo Centre, Abdullah Haroon Road, Karachi is an
importer of following principle manufacturers/ agents:
a) M/s Pharmazeutische Fabrik Evers GmbH & Co. KG,
Siemensstraße 4, 25421 Pinneberg, Germany
b) M/s Dr. Reckeweg & Co. GmbH, Berliner Ring 32, 64625
Bensheim, GERMANY In this regard, Clarification is required according to above mentioned
statement.
Name of product “ intercostal-Gastreu R 69” mentioned on
copy of CPP differs from brand name “ Dr. Reckeweg R69
intercostalin” given on product profile document and label
claimed submitted by the said firm, needs clarification.
Fee evidence is required.
Manufacturing license attested by regulatory authority of
country of origin, is required.
F.No.10-7/2020-OTC) (M-79)
Page 188 of 408
S.No Brand name Decision
(1) (2) (3)
GMP attested by regulatory body of regulatory authority of
country of origin, is required.
Original Free sale certificate/ CPP on WHO format, attested
by regulatory authority of country of origin , is required.
Stability data of at least three batches is required.
Monographs/ testing specification of active ingredients are
required.
M/s Rax Laboratories, Lahore 21-KM, Ferozpur Road, Lahore
1612. RAX No 1 Apis mel compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1613. RAX No 2 Blatta orient compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1614. RAX No 3Conium compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1615. RAX No 4 kuchi compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1616. RAX No 5 Carbo veg compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1617. RAX No 6 Kreosotum compositum Deferred for following reasons:
fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 189 of 408
S.No Brand name Decision
(1) (2) (3)
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1618. RAX No 7 Chelidonium compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1619. RAX No 8 Sticta compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1620. RAX No 9 Kali iod compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1621. RAX No 10 Syzgium compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1622. RAX No 11 Xanthoxylum compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1623. RAX No 12 Ledum pal compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 190 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1624. RAX No 13 Aesculus compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1625. RAX No 14 Acid phos compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1626. RAX No 15 Ginkgo biloba compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1627. RAX No 31 proralea cor compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1628. RAX No 32 Graphites compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1629. RAX No 33 Urtica compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1630. RAX No 34 Eucalyptus compositum Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 191 of 408
S.No Brand name Decision
(1) (2) (3)
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1631. RAX No 35 Merc bin jod compsitum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1632. RAX No 36 Teucrium compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
Monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1633. RAX No 37 Echinacea ang compositum Deferred for following reasons:
Brand name to be changed.
Fee evidence is required.
Monographs are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1634. RAX No 38 Ferrum met compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1635. RAX No 39 Selenium compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1636. RAX No 40 Muria puma compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
F.No.10-7/2020-OTC) (M-79)
Page 192 of 408
S.No Brand name Decision
(1) (2) (3)
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1637. RAX No 41 titanium compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1638. RAX No 42 Bellis per compositum Deferred for following reasons:
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1639. RAX No 43 Ustilago compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
Monographs are required
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1640. RAX No 44 Kali sulf compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
Monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1641. RAX No 45 Symphytum compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
Monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1642. RAX No 62 Baptisia compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
Monographs are required.
it is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 193 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1643. RAX No 63 China sulf compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
Monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1644. RAX No 64 Anti tart compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
Monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1645. RAX No 65 Plantago compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
Monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1646. RAX No 66 Poppulus compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1647. RAX No 67 Cina compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1648. RAX No 68 Baryta carb compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
monographs are required.
it is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 194 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1649. RAX No 69 Kali chlor compositum Deferred for following reasons:
fee evidence is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1650. RAX No 70 Absinthinum compositumq Deferred for following reasons:
fee evidence is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1651. RAX No 71 Mellefolium compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1652. RAX No 72 Origanum maj compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1653. RAX No 73 Granatum compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1654. RAX No 74 Ruta compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 195 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1655. RAX No 75 Ipecac compositum Deferred for following reasons:
fee evidence is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1656. ALOPRAX DROPS Deferred for following reasons:
fee evidence is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1657. RAX BABY COLIC DROPS Deferred for following reasons:
fee evidence is required.
master formula is required.
monographs are required.
it is combination product.
brand name to be changed.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1658. RAX BABY DIARRHOEA DROPS Deferred for following reasons:
Fee evidence is required.
Master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1659. RAX BABY INFLUENZA DROPS Deferred for following reasons:
fee evidence is required.
brand name to be changed.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1660. BRONCHORAX DROPS Deferred for following reasons:
fee evidence is required.
Monographs are required.
Brand name to be changed.
F.No.10-7/2020-OTC) (M-79)
Page 196 of 408
S.No Brand name Decision
(1) (2) (3)
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1661. CALCULIRAX DROPS Deferred for following reasons:
fee evidence is required.
master formula is required.
Monographs of sarkanda and dolichos biflorus are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1662. CARDIRAX GOLD DROPS Deferred for following reasons:
fee evidence is required.
master formula is required.
it is combination product.
stamp paper regarding contents of dossier and brand name is
unstamped.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1663. DEPRAX DROPS (Valeriana off) Deferred for following reasons:
fee evidence is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1664. ENURAX DROPS (Equisetum hyme ) Deferred for following reasons:
Fee evidence is required
Strength of ingredients is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1665. FAIRAX DROPS (Berberis aq) Deferred for following reasons:
fee evidence is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1666. ALFALFA SYRUP Deferred for following reasons:
Strength of ingredients is required.
Fee evidence is required.
It is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 197 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1667. BABY SYRUP Deferred for following reasons:
Monograph of five phos is required.
Strength of ingredients is required.
Brand name to be changed.
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1668. COUGH SYRUP Deferred for following reasons:
Strength of ingredients is required.
Brand name to be changed.
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1669. DIARRHOEA SYRUP Deferred for following reasons:
Strength of ingredients is required.
Brand name to be changed.
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1670. DIGESTIVE SYRUP Deferred for following reasons:
Fee evidence is required.
Monograph is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1671. FERAX COMPLEX SYRUP Deferred for following reasons:
Strength of ingredients are required.
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1672. FEVER SYRUP Deferred for following reasons:
Monograph of triostium is required.
Strength of ingredients are required.
Brand name to be changed.
F.No.10-7/2020-OTC) (M-79)
Page 198 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Monographs are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1673. GENERAL POWER SYRUP Deferred for following reasons:
Fee evidence is required.
It is combination product.
Strength of ingredients are required
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1674. GINSENG SYRUP Deferred for following reasons:
Strength of ingredients are required.
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1675. ACNERAX CREAM Deferred for following reasons:
fee evidence is required.
Strength of ingredients are required.
Monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1676. FAIRAX CREAM Deferred for following reasons:
Strength of ingredients is required.
Brand name to be changed.
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1677. ALOPRAX LOTION Deferred for following reasons:
fee evidence is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1678. BREASTORAX LOTION Deferred for following reasons:
fee evidence is required.
master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 199 of 408
S.No Brand name Decision
(1) (2) (3)
monographs are required.
it is combination product.
following information is required regarding lecithinum:
Biological source of lecithinum is required.
Submission of evidence stating source of lecithinum is not
contaminated with transmissible spongifoam encephalopathy
(TSE) or BSE.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1679. CALENDORAX LOTION Deferred for following reason:
fee evidence is required.
1680. DENTAL LOTION Deferred for following reasons:
fee evidence is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1681. ITCHIRAX LOTION Deferred for following reasons:
fee evidence is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1682. CALENDORAX OINTMENT Deferred for following reason:
Fee evidence is required.
1683. PILESRAX OINTMENT Deferred for following reasons:
fee evidence is required.
Strength of ingredients is required.
Brand name to be changed.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1684. RHEUMATISM OINTMENT Deferred for following reasons:
Fee evidence is required.
Strength of ingredients is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1685. ACNERAX TABLET Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 200 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1686. ALOPRAX TABLET Deferred for following reasons:
Fee evidence is required..
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1687. BRONCHORAX TABLET Deferred for following reasons:
fee evidence is required.
master formula is required.
formulation contains controlled substance i.e ephedra
vulgaris. Clarification regarding its use is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1688. FAIRAX TABLET Deferred for following reasons:
fee evidence is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1689. FEVERAX TABLET Deferred for following reasons:
Fee evidence is required.
Brand name undertaking is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1690. HEPARAX TABLET Deferred for following reasons:
Fee evidence is required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1691. HYPERAX TABLET Deferred for following reasons:
Fee evidence is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 201 of 408
S.No Brand name Decision
(1) (2) (3)
1692. HICHORAX TABLET Deferred for following reasons:
Fee evidence is required.
It is combination product.
following information regarding lecithinum is required:
Biological source of Thyroidinum is required.
Submission of evidence stating source of Thyrtoidinum is not
contaminated with Transmissible Spongifoam
Encephalopathy (TSE) or BSE.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1693. HIGHT GAIN TABLET Deferred for following reasons:
Monograph of barium chloride is required.
Fee evidence is required.
Monographs are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
Brand name to be changed. 1694. OBERAX TABLET Deferred for following reasons:
Monograph of nigella sativa is required.
Fee evidence is required.
Monographs are required.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1695. PAINRAX TABLET Deferred for following reasons:
Fee evidence is required.
Submission of strength of mag phos and cuperum met are
required either these are given in mother tincture/ solution/
trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1696. PROSONO TABLET Deferred for following reasons:
Fee evidence is required.
Master formula is required.
Brand name undertaking is required. 1697. SPERMATORAX-M TABLET Deferred for following reasons:
Fee evidence is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 202 of 408
S.No Brand name Decision
(1) (2) (3)
brand name to be changed. 1698. ULCIRAX TABLET Deferred for following reasons:
Brand name to be changed.
Fee evidence is required.
Strength of Nat Carb is required either it is given in mother
tincture/ solution/ trituration or in potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1699. UPGRADE TABLET Deferred for following reasons:
Brand name to be changed.
Fee evidence is required.
Submission of strength of selenium is required either these
are given in mother tincture/ solution/ trituration or in
potency.
It is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1700. WHITHRAX TABLET Deferred for following reasons:
fee evidence is required.
master formula is required.
monographs are required.
it is combination product.
following information regarding Thyroidinum is required:
Biological source of Thyroidinum is required.
Submission of evidence stating source of Thyrtoidinum is not
contaminated with Transmissible Spongifoam
Encephalopathy (TSE) or BSE.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1701. Abelmoschus Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1702. Abies canadensis Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 203 of 408
S.No Brand name Decision
(1) (2) (3)
it is combination product
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1703. Abrotanum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1704. Acalypha indica Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1705. Acer negundo (Negundium amer) Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1706. Acetanilidinum (Antifebrinum) Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1707. Achyranthes aspara Deferred for following reasons:
form 3 is unsigned and unstamped.
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 204 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1708. Acidum aceticum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1709. Acidum acetylsalicylic Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1710. Acidum benzoicum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1711. Acidum boricum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1712. Acidum chrysophanicum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1713. Acidum fluoricum (Acidum hydrofluoricum) Deferred for following reasons:
fee evidence is required.
pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 205 of 408
S.No Brand name Decision
(1) (2) (3)
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1714. Acidum formicum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1715. Acidum mur Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1716. Acidum mur nitr (Aqua regia) Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1717. Acidum oxalicum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1718. Acidum picricum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 206 of 408
S.No Brand name Decision
(1) (2) (3)
1719. Aconitum ferox Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1720. Adonis vernalis Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1721. Adrenalinum hydrochloricum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1722. Aegle marmelos Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1723. Aesculus glabra Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1724. Aethusa cynapium Deferred for following reasons:
fee evidence is required.
pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 207 of 408
S.No Brand name Decision
(1) (2) (3)
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1725. Agraphis nutans Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1726. Agrimonia eupatoria Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1727. Ailanthus glandulosa Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1728. Alchemilla vulgaris Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1729. Alstonia constricta Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1730. Alstonia scholaris Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 208 of 408
S.No Brand name Decision
(1) (2) (3)
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1731. Alumen Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1732. Ambra grisea Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1733. Ambrosia artemisiaefolia Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1734. Ammonium aceticum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1735. Ammonium causticum Deferred for following reasons:
fee evidence is required.
pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 209 of 408
S.No Brand name Decision
(1) (2) (3)
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1736. Ammonium jodatum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1737. Amygdalus amara Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1738. Amygdalus persica Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1739. Amyl nitrate Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1740. Anacardium orientalis Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 210 of 408
S.No Brand name Decision
(1) (2) (3)
1741. Anacyclus pyrethrum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1742. Ananassa sativa Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1743. Andersonia (Amoora rohituka) Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1744. Anethum graveolus Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1745. Angelica sinensis Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1746. Angustura vera Deferred for following reasons:
fee evidence is required.
pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 211 of 408
S.No Brand name Decision
(1) (2) (3)
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1747. Anisomeles indica Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
monographs are required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1748. Anthemis nobilis Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1749. Antipyrinum Deferred for following reasons:
fee evidence is required.
pack size is required.
master formula is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1750. Apium graveolus Deferred for following reasons:
fee evidence is required.
pack size is required.
it is combination product.
In the light of notification No. F.No. 4-2/2017-DD (H&OTC)(available
on DRAP website), the evidence of International availability (COPP or
Free Sale Certificate) or Local marketing of 10 years, not provided. 1751. Apocynum androsum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1752. Argemone mexicana Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 212 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1753. Argentum metalicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1754. Armoracia sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1755. Arsenicum sulf flav Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1756. Arum triphylum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1757. Arundo maur Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1758. Asarum canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1759. Asarum europ Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1760. Asclepias tuberosa Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 213 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1761. Asparagus officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1762. Asperula odorata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1763. Atista indica (Radix) Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1764. Atragalus mollissimus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1765. Atropinum sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1766. Aurum metalicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1767. Aurum muriaticum natronatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 214 of 408
S.No Brand name Decision
(1) (2) (3)
1768. Baccilinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1769. Barium aceticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1770. Barium jodatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1771. Barium muriaticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1772. Blumia odorata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1773. Boldo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1774. Borago officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1775. Brassica napus Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 215 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1776. Bryophyllum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1777. Buchu Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1778. Bufo rana Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1779. Caesalpinia bonducelia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1780. Calcium aceticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1781. Calcium bromatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1782. Calcium jodatum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 216 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1783. Cannabis indica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
It is controlled substance, clarification is required regarding
its use. 1784. Cannabis sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
It is controlled substance, clarification is required regarding
its use. 1785. Carbo animalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1786. Carcinocinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1787. Cardiospermum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1788. Carum carvi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 217 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required. 1789. Cascarilla Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1790. Cassia fistula Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1791. Castoreum canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1792. Catanea vesca Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1793. Catechu Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1794. Cedron Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1795. Chaparra amargoso Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 218 of 408
S.No Brand name Decision
(1) (2) (3)
1796. Cheiranthus cheiri Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1797. Chelone glabra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1798. Chenopodium album Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1799. Chininium arsenicosum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1800. Chininium sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1801. Chirata indica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1802. Cholesterinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
Following information regarding cholestrinum is required:
F.No.10-7/2020-OTC) (M-79)
Page 219 of 408
S.No Brand name Decision
(1) (2) (3)
Biological source of cholestrinum is required.
Submission of evidence that source of cholesterinum is not
contaminated with Transmissible Spongifoam
Encephalopathy (TSE) or BSE. 1803. Chrysanthemum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1804. Cina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1805. Cistus canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1806. Citrus medicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1807. Citrus vulgaris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1808. Clerodendron infortunatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1809. Cobaltum metalicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 1810. Coccus cacti Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1811. Cochelaria officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1812. Coleus aromatic Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1813. Convallaria majallis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1814. Copaiva Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1815. Corchorus aestuans Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1816. Coriandrum sativum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1817. Corydalis canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 221 of 408
S.No Brand name Decision
(1) (2) (3)
1818. Crocus sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1819. Crotalus horridus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1820. Cubeba officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1821. Cucurbita citrullus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required. 1822. Cucurbita pepo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1823. Cuprum aceticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1824. Curculigo orchioides Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1825. Curcuma longa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1826. Cuscuta chinensis Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 222 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1827. Cyclamen Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1828. Cydonia vulgaris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1829. Cynara scolymus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1830. Cynodon dactylon Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1831. Cypripedium pubescens Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1832. Cyprus rotundus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1833. Daucus carota Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1834. Delphinium denudatum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 223 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1835. Desmodium gangeticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1836. Digitalis purpurea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1837. Echinacea purpurea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1838. Embelia ribes Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1839. Epimedium sagittatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1840. Epiphegus canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1841. Equisetum arvenses Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1842. Erigeron canadense Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 224 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1843. Erynguim aqua Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1844. Eschscholtzia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1845. Euonymus atropurpurea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1846. Eupatorium purpuream Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1847. Euphorbia hypercifolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1848. Euphorbia pilulifera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1849. Euphrasia officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 225 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required. 1850. Eupionum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1851. Fagonia cretica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1852. Fagopyrum esculentum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1853. Fel tauri Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1854. Ferrum aceticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1855. Ferrum metalicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1856. Ficus religiosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
1857. Filix mas Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1858. Formalinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1859. Fragaria vesca Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1860. Fumaria officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1861. Galega officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1862. Galium aparine Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1863. Gentiana kurroo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1864. Geranium macualtum Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 227 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1865. Ginseng panax red Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1866. Ginseng siberian Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1867. Granatum cortex Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1868. Gratiola officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1869. Grindelia robusta Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1870. Gymnocladus canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1871. Haematoxylon Campechainum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 228 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1872. Harpagophytum procumbens Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1873. Hedeoma pulegioides Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1874. hedera hilex Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1875. Helleborus nigra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1876. Hellianthus tuberosis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1877. Helonias dioica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1878. Hemidesmus indicus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 229 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1879. Hepar sulfuris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1880. Hydrangea arborescens Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1881. Hygrophilla spinosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1882. Hyoscyamus nigra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1883. Iberis amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1884. Ignatia amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1885. Ilex paraguariensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 230 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required.
Monograph is required. 1886. Illicium anisatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1887. Indigo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1888. Indolum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1889. Insulinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1890. Inula helenium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1891. Iodum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1892. Ipecacuanha Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Monograph is required. 1893. Ipomoea stans Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1894. Iris germanica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1895. Iris tenax Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1896. Iris vericolor Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1897. Jaborandi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1898. Jacaranda caroba Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1899. Jalapa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 232 of 408
S.No Brand name Decision
(1) (2) (3)
1900. Juglans regia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1901. Juniperus communis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1902. Juniperus virginiana Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1903. Kalamegh Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1904. Kalium arsenicosum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1905. Kalium bichromicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1906. Kalium bromatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1907. Kalium carbonicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1908. Kalium chloricum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1909. Kalium iodatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1910. Kalium nitricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1911. Kalium sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1912. Kalmia latifolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1913. Kurchi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1914. Lachesis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1915. Lachnanthes tinctors Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1916. Lactuca virosa Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 234 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1917. Lapis albus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1918. Lapsana communis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1919. Larrea tridentats Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1920. Lathyrus sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1921. Laurocerasus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1922. Lavadula officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1923. Lecithinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
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S.No Brand name Decision
(1) (2) (3)
Following information regarding lecithinum is required.
Biological source of lecithinum.
Submission of evidence that source of Lecithinum is not
contaminated. with Transmissible Spongifoam
Encephalopathy (TSE) or BSE. 1924. Ledum palustre Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1925. Lemna minor Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1926. Leonorus cardiac Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1927. Lepidium peruvianum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1928. Leptandra virginica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1929. Leucas aspera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1930. Liatris spicata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1931. Lillium tigrinum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1932. Lithium carbonicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1933. Lithium muriaticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1934. Lobelia erinus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1935. Lobelia inflata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1936. Luffa aegyptiaca Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1937. Luffa amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1938. Luffa bindal Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1939. Lupulinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
1940. Lupulus humulus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1941. Lycopus virginicus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1942. Macrotinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1943. Magnesium muriaticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1944. Magnesium phosphoricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1945. Magnesium sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1946. Mallotus philippinensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1947. Mandragora officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1948. Mangifera indica Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1949. Marrubium vulgare Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1950. Melilotus alba Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1951. Melilotus officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1952. Mellisa officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1953. Mentha viridis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1954. Menyanthes trifoliata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1955. Mercurius bin jodatus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1956. Mercurius corrosivus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
1957. Mercurius solubilis hahnemann Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1958. Mezerium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1959. Michelia residences Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1960. Mimosa humilis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1961. Momordica balsamina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1962. Momordica charantia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1963. Moringa oleifera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1964. Moschus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1965. Murex purpurea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required. 1966. Murraya koenigii Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1967. Musa sapientum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Duplication of formuation, clarification is required. 1968. Musa sapientum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Duplication of formuation, clarification is required. 1969. Myrica cerifera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1970. Myristica sebifera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 1971. Myrtus communis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1972. Naphthalinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1973. Natrium arsenicosum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1974. Natrium chloratum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1975. Natrium phosphoricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1976. Natrium sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1977. Nepata cataria Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1978. Nigella sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1979. Nyctanthus arboristis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1980. Nymphaea odorata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1981. Ocimum basilicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1982. Ocimum canum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1983. Ocimum gratissimum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1984. Ocimum sanctaum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1985. Oenanthe biennis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1986. Oenanthe crocata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1987. Okoubaka aubrevellei Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required.
Monograph is required. 1988. Oldenlandia herbacea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1989. Olea europaea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1990. Oleander Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 1991. Oleum jecoris aselli Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 1992. Olibanum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 1993. Onosmodium virginicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 1994. Origanum majorana Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 1995. Origanum vulgare Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 1996. Ornithogalum umbellatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 1997. Oxydendrum arboreum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 1998. Paraffinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 1999. Pareira brava Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2000. Pelargonium reniforme Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2001. Pencillinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
2002. Pepsinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2003. Petroselinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2004. Phaseolus vulgare Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2005. Phellandium aquaticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2006. Phosphorus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2007. Phyllanthus niruri Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2008. Physostigma venenosum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2009. Pichi Pichi Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2010. Picrorhiza kurro Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2011. Pinus lambertiana Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2012. Piper longum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2013. Piper methysticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2014. Piper nigrum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2015. Piperazinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2016. Piscidia erythrine Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2017. Pituitrary gland Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required.
Following information regarding thyroidinum is required:
Biological source of thyroidinum is required.
Submission of evidence stating source of thyroidinum is not
contaminated with transmissible spongiform encephalopathy
(TSE) or BSE. 2018. Podophyllum peltatum Misssing 2019. Polygonum aviculare Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2020. Polygonum punctatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2021. Populus candicans Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2022. Populus tremula Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2023. Pothos foetidus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 248 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2024. Primula veris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2025. Propolis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2026. Prunus spinosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2027. Prunus virginiana Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2028. Psoralea corylifolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2029. Ptelea trifolata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2030. Pteris santalinus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 249 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required. 2031. Pyrogeinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2032. Quassia amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2033. Quercus glandium spiritus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2034. Quillaja saponaria Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2035. Rananculus bulbosus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2036. Raphanus sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2037. Ratanhia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 2038. Rhamnus catharica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2039. Rhamnus frangula Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2040. Rheum officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2041. Rhododendron Chrysanthum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2042. Rhus aromatica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2043. Rhus glabra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2044. Rhus venenata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
2045. Ricinus communis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2046. Rosa canina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2047. Rosmarinus officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2048. Rubia tinctorum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2049. Rubus villosus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2050. salix alba Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2051. Salvia officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2052. Sambucus nigra Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2053. Sanguinaria canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2054. Santalum album Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2055. Santoninum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2056. Sarkanda Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2057. Sarsaparilla officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2058. Saussaurea laapa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2059. Schizandra chinensis Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2060. Scrophularia nodosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2061. Scutelaria latriflora Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2062. Secale cornutum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2063. Sedum acre Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2064. Selenium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2065. Sempervivum tectorum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2066. Senega Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
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S.No Brand name Decision
(1) (2) (3)
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2067. Senna Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2068. Sepia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2069. Silicea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2070. Sinapis alba Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2071. Sinapis nigra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2072. Solanum lycopersicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2073. Solanum nigrum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 255 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required. 2074. Solanum tuberosum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2075. Solanum xanthocarpum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2076. Solidago virgaurea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2077. Spartium scoparium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2078. Spigelia antheimia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2079. Spiroea ulmaria Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2080. Squilla maritima Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 256 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 2081. Stellaria media Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2082. Sterculia acuminata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2083. Stigmata maydis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2084. Stillingia sylvatica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2085. Stramonium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2086. Strophathus hispidus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2087. Strychininum sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 257 of 408
S.No Brand name Decision
(1) (2) (3)
2088. Sulfur jodatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2089. Sumbulus moshatus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2090. Symphytum officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2091. Syphilinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2092. Tabacum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2093. Tanacetum parthenium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2094. Tanacetum vulgare Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2095. Taraxacum officinalis Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 258 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2096. Terebinthina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2097. Terminalia belerica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2098. Terminalia chebula Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2099. Teucrium marum varum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2100. Thea sinensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2101. Thiosinaminum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2102. Thlaspi bursa pastoris Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 259 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2103. Thymolum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2104. Thymus vulgaris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2105. Thyroidinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required.
Following information regarding thyroidinum is required:
Biological source of thyroidinum is required.
Submission of evidence stating source of thyroidinum is not
contaminated with transmissible spongiform encephalopathy
(TSE)or BSE. 2106. Tinospora cordofolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2107. Tongo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2108. Trachyspermum ammi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 260 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required.
Brand name undertaking is required. 2109. Tribulus terrestris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2110. Trichosanthes dioica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2111. Trifolium pratense Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2112. Trigonella foenum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2113. Trillium pendulum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2114. Triticum repens Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2115. Tussilago farfara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 261 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 2116. Ulmus rubra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2117. Uranium nitricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2118. Urea pura Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2119. Urtica dioica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2120. Usnea barbata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2121. Ustilago maydis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2122. Uva ursi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 262 of 408
S.No Brand name Decision
(1) (2) (3)
2123. Vaccinum myrtillus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2124. Valariana officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2125. Vanadium metalicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2126. Variolinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2127. Veratrum album Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2128. Veratrum viride Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2129. Verbacum thapsus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2130. Verbena officinalis Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 263 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2131. Vesicaria Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2132. Viburnum prunifolium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2133. Vinca minor Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2134. Vinca rosea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2135. corydalis canadesis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2136. achyranthes aspara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2137. acidum nitricum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 264 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2138. barium nutricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2139. focus vesiculoses Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2140. herpagophytum procumbens Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2141. hycymus niger Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2142. melissa officialis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2143. myristica sebifera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2144. lillium tig Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 265 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2145. melinotis alba Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2146. luffa amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2147. luphulus humulus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2148. moschus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2149. murex purpura Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2150. myrica cerifera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2151. euphrobia hypericifolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 266 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required.
Brand name undertaking is required. 2152. fragonia fractica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2153. Illicium anisatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2154. Jacaranda caroba Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2155. euphrobia pericifolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2156. Fagopyrum esculentum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2157. frageria vesca Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2158. Gentiana kurroo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 267 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 2159. Ginseng siberian Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2160. helianthus tuberosis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2161. indigo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2162. jalapa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2163. ferrum muraticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2164. jatropha Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2165. lecithium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 268 of 408
S.No Brand name Decision
(1) (2) (3)
Following information regarding lecithinum is required:
Biological source of lecithinum.
Submission of evidence stating source of lecithinum is not
contaminated with transmissible spongiform encephalopathy
(TSE) or BSE. 2166. lenurus caridca Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2167. lucus aspara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2168. lithium muraticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2169. luffa bindal Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2170. Mallotus philippinensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2171. maruvium vulgaris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2172. Menyanthes trifoliata Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 269 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2173. Mercurius solubilis hahnemann Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2174. Momordica charantia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2175. Kalamegh Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2176. Liatris spicata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2177. Luffa aegyptiaca Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2178. Lupulinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2179. mercuris bin iodatus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 270 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2180. mitchella repens Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2181. Moringa oleifera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2182. Musa sapientum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2183. myrrha Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2184. Juniperus virginiana Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2185. kalium muraticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2186. Lavadula officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 271 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required.
Brand name undertaking is required. 2187. macrotinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2188. magnesium sulphurica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2189. Mangifera indica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2190. Momordica balsamina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2191. Myrtus communis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2192. natrum arsenicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2193. Oldenlandia herbacea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 272 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 2194. Pencillinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2195. oenothera biennis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2196. Origanum vulgare Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2197. natrum phosphoricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2198. Tussilago farfara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2199. Abelmoschus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2200. Abies canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 273 of 408
S.No Brand name Decision
(1) (2) (3)
2201. Abrotanum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2202. Acer negundo (Negundium amer) Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2203. Acetanilidinum (Antifebrinum) Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2204. Acidum acetylsalicylic (Aspirin) Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2205. Acidum boricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2206. Acidum chrysophanicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2207. Acidum fluoricum (Acidum hydrofluoricum) Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2208. Acidum formicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2209. Acidum mur Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 274 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2210. Adrenalinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2211. Aesculus glabra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2212. Aethusa cynapium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2213. Ailanthus gland Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2214. Ambrosia artemisiaefolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2215. Ammonium aceticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2216. Ammonium causticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2217. Ammonium jodatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 275 of 408
S.No Brand name Decision
(1) (2) (3)
2218. Amygdalus amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2219. Amygdalus persica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2220. Anacardium orientalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2221. Anacyclus pyrethrum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2222. Ananassa sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2223. Andersonia (Amoora rohituka) Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2224. Anethum graveolus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2225. Angelica sinensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2226. Anisomeles indica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 276 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required. 2227. Antipyrinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2228. Apium graveolus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2229. Armoracia sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2230. Arundo maur Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2231. Asarum candensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2232. Asarum europ Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2233. Asclepias tuberosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2234. Asparagus officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 277 of 408
S.No Brand name Decision
(1) (2) (3)
2235. Atropinum sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2236. Barium aceticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2237. Blumia odorata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2238. Brassica napus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2239. Buchu Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2240. Bufo rana Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2241. Calcium aceticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2242. Calcium bromatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2243. Calcium jodatum Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 278 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2244. Cannabis indica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
It is controlled substance, needs clarification. 2245. Cannabis sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2246. Carcinocinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2247. Cardiospermum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2248. Carum carvi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2249. Cascarilla Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2250. Cassia fistula Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 279 of 408
S.No Brand name Decision
(1) (2) (3)
2251. Castoreum canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2252. Catanea vesca Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2253. Chaparra amargoso Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2254. Cheiranthus cheiri Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2255. Chininium sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2256. Cholesterinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required.
Following information regarding cholesterinum is required.
Biological source of cholesterinum.
Submission of evidence stating source of cholesterinum is
not contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE. 2257. Chrysanthemum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 280 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2258. Cina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2259. Cistus canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2260. Citrus medicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2261. Citrus vulgaris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2262. Coccus cacti Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2263. Cochelaria officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2264. Coleus aromatica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 281 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 2265. Copaiva officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2266. Corchorus aestuans Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2267. Crocus sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2268. Crotalus horridus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2269. Cucurbita citrullus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2270. Curculigo orchioides Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2271. Cuscuta chinensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2272. Cydonia vulgaris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 282 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 2273. Cynodon dactylon Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2274. Cypripedium pubescens Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2275. Daucus carota Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2276. Delphinium denudatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2277. Desmodium gangeticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2278. Digitalis purpurea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2279. Echinacea purpurea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2280. Embelia ribes Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 283 of 408
S.No Brand name Decision
(1) (2) (3)
2281. Epimedium sagittatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2282. Epiphegus canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2283. Equisetum arvense Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2284. Erynguim aquaticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2285. Eschscholtzia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2286. Euonymus atropurpurea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2287. Euphorbia hypercifolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2288. Eupionum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 284 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2289. Fagonia cretica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2290. Fagopyrum esculentum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2291. Ferrum aceticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2292. Ferrum metalicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2293. Ferrum muriaticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2294. Filix mas Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2295. Fragaria vesca Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 285 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2296. Galega officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2297. Gentiana kurroo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2298. Ginseng panax red Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2299. Ginseng siberian Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2300. Gymnocladus canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2301. Hedeoma pulegioides Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2302. Hellianthus tuberosis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 286 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required. 2303. Ilex paraguariensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2304. Illicium anisatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2305. Indigo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2306. Inula helenium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2307. Ipomoea stans Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2308. Iris germanica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2309. Iris tenax Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 287 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required. 2310. Jacaranda caroba Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2311. Jalapa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2312. Jatropha curcas Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2313. Juglans regia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2314. Kalamegh Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2315. Kalium chloricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2316. Kalium nitricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 288 of 408
S.No Brand name Decision
(1) (2) (3)
2317. Kurchi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2318. Lachesis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2319. Lachnanthes tinctors Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2320. Lactuca virosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2321. Lapsana communis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2322. Larrea tridentats Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2323. Lathyrus sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2324. Lavadula officinalis Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 289 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Monograph is required.
Master formula is required.
Brand name undertaking is required. 2325. Lecithinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required.
Following information regarding lecithinum is required.
Biological source of lecithinum.
Submission of evidence stating source of lecithinum is not
contaminated with tramsmissible spongiform encephalopathy
(TSE) or BSE. 2326. Leonorus cardica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2327. Leucas aspera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2328. Liatris spicata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2329. Lithium muriaticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2330. Lobelia erinus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 290 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2331. Luffa aegyptiaca Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2332. Luffa bindal Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2333. Lupulinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2334. Lycopus virginicus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2335. Macrotinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2336. Magnesium muriaticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2337. Magnesium sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2338. Mallotus philippinensis Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 291 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2339. Mangifera indica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2340. Marrubium vulgaris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2341. Menyanthes trifoliata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2342. Mercurius bin jodatus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2343. Mercurius corrosivus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Monograph is required.
Brand name undertaking is required. 2344. Mercurius solubilis hahnemann Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2345. Momordica balsamina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2346. Momordica charantia Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 292 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2347. Moringa oleifera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2348. Murraya koenigii Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2349. Musa sapientum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2350. Musa sapientum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2351. Myrtus communis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required. 2352. Naphthalinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2353. Nigella sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2354. Nymphaea odorata Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 293 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2355. Ocimum sanctaum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2356. Oenanthe biennis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2357. Oenanthe crocata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2358. Okoubaka aubrevellei Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2359. Oleum jecoris aselli Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2360. Olibanum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2361. Oxydendrum arboreum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 294 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2362. Paraffinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2363. Pelargonium reniforme Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2364. Pencillinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2365. Pepsinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2366. Phellandium aquaticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2367. Physostigma venenosum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2368. Pichi Pichi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 295 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2369. Piper longum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2370. Podophyllum peltatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2371. Polygonum aviculare Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2372. Populus candicans Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2373. Populus tremula Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2374. Pothos foetidus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2375. Prunus spinosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 296 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required.
Monograph is required. 2376. Psoralea corylifolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2377. Psorinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2378. Ptelea trifolata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2379. Pyrogeinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2380. Quassia amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2381. Quercus glandium spiritus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2382. Rananculus bulbosus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 297 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required. 2383. Raphanus sativa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2384. Ratanhia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2385. Rhamnus catharica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2386. Rhamnus frangula Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2387. Rheum officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2388. Rhododendron Chrysanthum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2389. Rhus aromatica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 298 of 408
S.No Brand name Decision
(1) (2) (3)
2390. Rosmarinus officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2391. Rubus villosus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2392. salix alba Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2393. Salvia officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2394. Sambucus nigra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2395. Sanguinaria canadensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2396. Santalum album Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2397. Santoninum Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 299 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2398. Sarkanda Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2399. Sarsaparilla officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2400. Saussaurea laapa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2401. Schizandra chinensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2402. Scrophularia nodosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2403. Scutelaria latriflora Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2404. Secale cornutum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 300 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2405. Sedum acre Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2406. Selenium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2407. Sempervivum tectorum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2408. Senega Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2409. Senna Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2410. Sepia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2411. Sinapis alba Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 301 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2412. Sinapis nigra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2413. Solanum lycopersicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2414. Solanum nigrum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2415. Solanum tuberosum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2416. Solanum xanthocarpum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2417. Solidago virgaurea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2418. Spartium scoparium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 302 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required.
Monograph is required. 2419. Spigelia antheimia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2420. Spiroea ulmaria Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2421. Sterculia acuminata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2422. Stillingia sylvatica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2423. Stramonium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2424. Strophanthus hispidus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2425. Sulfur jodatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 303 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required. 2426. Sumbulus moshatus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2427. Symphytum officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2428. Syphilinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2429. Tabacum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2430. Tanacetum parthenium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2431. Tanacetum vulgare Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2432. Taraxacum officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 304 of 408
S.No Brand name Decision
(1) (2) (3)
2433. Terebinthina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2434. Terminalia belerica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2435. Terminalia chebula Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2436. Teucrium marum varum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2437. Thiosinaminum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2438. Thlaspi bursa pastoris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2439. Thymolum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2440. Thymus vulgaris Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 305 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2441. Thyroidinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
Following information regarding thyroidinum is required.
Biological source of thyroidinum.
Submission of evidence stating source of thyroidinum is not
contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE. 2442. Tinospora cordofolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2443. Tongo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2444. Trachyspermum ammi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2445. Tribulus terrestris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2446. Trichosanthes dioica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 306 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2447. Trifolium pratense Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2448. Trigonella foenum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2449. Triticum repens Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2450. Tussilago farfara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2451. Ulmus rubra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2452. Urtica dioica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2453. Usnea barbata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 307 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required.
Monograph is required. 2454. Ustilago maydis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2455. Uva ursi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2456. Vaccinum myrtillus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2457. Valariana officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2458. Variolinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2459. Veratrum album Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2460. Veratrum viride Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 308 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required. 2461. Verbacum thapsus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2462. Vesicaria Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2463. Viburnum prunifolium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2464. Vinca minor Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2465. Vinca rosea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2466. Chininium sulfuricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2467. convallaria majalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 309 of 408
S.No Brand name Decision
(1) (2) (3)
2468. corydalis canadesis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2469. cynara scolymus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2470. cyprus rotundus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2471. clerodendron infortantum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2472. Cucurbita pepo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2473. cyclamen Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2474. chirata ind Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2475. chinium arsenicum Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 310 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2476. cobaltum met Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2477. coriandrum sativum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2478. cubeba offinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2479. cupurum aceticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2480. curcuma longa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2481. achyranthes aspara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2482. acedium aceticum Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 311 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2483. acidium benzoicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2484. acalypha indica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2485. acidum nitricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2486. acidum oxlaicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2487. aconitum ferox Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2488. adonis vernalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2489. alstonia constricta Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 312 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2490. alstonia scholaris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2491. ambra grisera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2492. amyl nitrate Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2493. argemone maxicana Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2494. ars sulph flv Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2495. acidum picridum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2496. augustura vera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 313 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required.
Monograph is required. 2497. anthemis nobilis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2498. argentum metalicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2499. agraphis nutcans Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2500. agrimonia eupatoria Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2501. alchemilia vulgaris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2502. Arum Triphalum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2503. asperula odorata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 314 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required. 2504. aurum met Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2505. carbo annimalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2506. as arum europ Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2507. barium nutricum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2508. boldo Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2509. caesalpinia bonducella Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2510. catechu Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 315 of 408
S.No Brand name Decision
(1) (2) (3)
2511. astragalis mollissimus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2512. baccilinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2513. borago officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2514. bryophyllum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2515. cedron Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2516. chelone Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2517. camphor officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2518. euphrasia officinalis Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 316 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2519. focus vesiculoses Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2520. gallium aparine Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2521. garanium macualtum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2522. Gratiola officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2523. hedera helix Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2524. helonias diocia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2525. hydrangea arborescens Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 317 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2526. hygrophilla spinosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2527. iberis amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2528. insulinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
Following information regarding insulinum is required.
Biological source of insulinum.
Submission of evidence stating source of insulinum is not
contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE. 2529. ipecacuanha perifolatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2530. fumaria officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2531. granatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 318 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required.
Monograph is required. 2532. grindelia robusta Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2533. herpagophytum procumbens Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2534. hemidesmus indicus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2535. hycymus niger Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2536. ignatia amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2537. Ipomoea stans Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2538. iris versicolor Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 319 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required. 2539. fel tauri Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2540. ficus religiosa Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2541. formalinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2542. heamotoxylin campihniam Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2543. hellebore niger Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2544. indolum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2545. iodium Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 320 of 408
S.No Brand name Decision
(1) (2) (3)
2546. jaborandi Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2547. kalium bichromicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2548. kalmia ltifolia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2549. lapis alb Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2550. laurocerasus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2551. Lobelia erinus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2552. melissa officialis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2553. myristica sebifera Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 321 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2554. juniperus communis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2555. kalium bromatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2556. kalium iodatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2557. ladum palustre Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2558. lillium tig Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2559. mandragora officanrum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2560. melinotis alba Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 322 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2561. mezereum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2562. kalium arscnicosum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2563. kalim carbonicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2564. lemna minor Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2565. leptandra virginica Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2566. lithium carbonicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2567. lobelia inflata Deferred for following reasons:
Fee evidence is required.
Pack size is required.
F.No.10-7/2020-OTC) (M-79)
Page 323 of 408
S.No Brand name Decision
(1) (2) (3)
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2568. luffa amara Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2569. luphulus humulus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2570. melinotis officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2571. moschus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2572. murex purpura Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2573. myrica cerifera Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2574. Ocimum sanctaum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
F.No.10-7/2020-OTC) (M-79)
Page 324 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking is required.
Monograph is required. 2575. oleander Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2576. onosmodium virginucum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2577. ornithogalum umbellatum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2578. natrum arsenicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2579. nycthanthis arbortristis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2580. ocimum canum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2581. periera brava Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
F.No.10-7/2020-OTC) (M-79)
Page 325 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph is required. 2582. petroselinum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2583. phosphorus Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2584. picrorhiza kurrora Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2585. pipermethysticum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2586. piscidia erthyrina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2587. primula veris Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2588. prunus virginia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
F.No.10-7/2020-OTC) (M-79)
Page 326 of 408
S.No Brand name Decision
(1) (2) (3)
2589. quillajasaponaraia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2590. nepta cataia Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2591. ocimum gratissimum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2592. olea europea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2593. origanum vulgare Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2594. pinus lambertiana Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2595. piper nigrum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2596. polygonum punctaun Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 327 of 408
S.No Brand name Decision
(1) (2) (3)
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2597. rhus glabra Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2598. rosa canina Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2599. stellaria media Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2600. stigmata maydis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2601. trillium pendullum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2602. silicea Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2603. sqilla maritima Deferred for following reasons:
Fee evidence is required.
F.No.10-7/2020-OTC) (M-79)
Page 328 of 408
S.No Brand name Decision
(1) (2) (3)
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2604. thea sinensis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2605. rubia tincotorum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2606. verbena officinalis Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2607. vanadium matalicum Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required. 2608. urea pura Deferred for following reasons:
Fee evidence is required.
Pack size is required.
Master formula is required.
Brand name undertaking is required.
Monograph is required.
M/s. Warsan Homoeopathic Laboratories (0073)
Qasim Zia Industrial Estate, 23-KM, Link Ferozepur Road, Lahore 2609. Ginkgo Biloba Elixir Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 329 of 408
S.No Brand name Decision
(1) (2) (3)
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2610. Babysal (O.R.W) 240ml Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
Brand name undertaking has not been provided. 2611. Babysal (O.R.W) 500ml Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
Brand name undertaking has not been provided. 2612. Decure Syrup Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
Brand name undertaking not provided. 2613. Dyromex Syrup Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
F.No.10-7/2020-OTC) (M-79)
Page 330 of 408
S.No Brand name Decision
(1) (2) (3)
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
Brand name undertaking not provided 2614. Panax Ginseng Syrup Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2615. Sharbat-e-Folad Extra Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2616. Calton Syrup Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
Brand name undertaking not provided. 2617. Moov Lotion Deferred since the application is deficient of following
documents/Information;
Evidence of approval of lotion section, ot provided.
F.No.10-7/2020-OTC) (M-79)
Page 331 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
Brand name undertaking has not been provided. 2618. Colisan Colic Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
Brand name undertaking has not been provided. 2619. Liver-52 Tablets Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
Quantity of actives per tablet has not been provided.
Brand name undertaking has not been provided. 2620. Silibin Tablets Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 332 of 408
S.No Brand name Decision
(1) (2) (3)
Quantity of actives per tablet has not been provided.
Brand name undertaking has not been provided. 2621. Warsan No.6 (Anti Crud.) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2622. Warsan No.7 (Sepia) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2623. Warsan No.10 (Pulsatilla) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2624. Warsan No.11(Crataegus Oxy.) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 333 of 408
S.No Brand name Decision
(1) (2) (3)
2625. Warsan No.13 (Agnus Castus) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2626. Warsan No.14 (Veratrum Alb) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2627. Warsan No.15 (Chelidonium) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2628. Warsan No.22 (Anti Tart) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2629. Warsan No.23 (Phytolacca Berry) Oral Drops Deferred since the application is deficient of following
documents/Information;
F.No.10-7/2020-OTC) (M-79)
Page 334 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2630. Warsan No.24 (China Off.) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2631. Warsan No.27 (Oenanthe crocata) Oral
Drops
Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2632. Warsan No.29 (Colchicum) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2633. Warsan No.32 (Merc Sol) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
F.No.10-7/2020-OTC) (M-79)
Page 335 of 408
S.No Brand name Decision
(1) (2) (3)
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2634. Warsan No.33 (Syzygium) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2635. Warsan No.39 (Senecio Aur) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2636. Warsan No.42 (Filix Mass) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2637. Warsan No.48 (Cholesterin) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
F.No.10-7/2020-OTC) (M-79)
Page 336 of 408
S.No Brand name Decision
(1) (2) (3)
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2638. Warsan No.82 (Allium sativa) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2639. Warsan No.85 (Alumina) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2640. Warsan No.87 (Ovarinum) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2641. Warsan No.90 (Urtica Urens) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
F.No.10-7/2020-OTC) (M-79)
Page 337 of 408
S.No Brand name Decision
(1) (2) (3)
Monograph of actives are required as per specifications to be
mentioned. 2642. Warsan No.91 (Macrotinum) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2643. Warsan No.97 (Merc Sol) Oral Drops Deferred since the application is deficient of following
documents/Information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with actives ingredients.
Monograph of actives are required as per specifications to be
mentioned. 2644. Aspidosperma Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2645. Baryta Mur. Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2646. Benzenum nitricum Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2647. Cantharis Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
F.No.10-7/2020-OTC) (M-79)
Page 338 of 408
S.No Brand name Decision
(1) (2) (3)
Specifications and preparation monograph (EHPI, HPI, HPUS
etc.) is required as per specifications. 2648. Chininum sulph Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2649. Chloral Hydrate Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2650. Formica Rufa Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2651. Fragaria Vesca Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2652. Agaricus Muscarius Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2653. Haritaki Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2654. Natrum Arsenicum Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications.
F.No.10-7/2020-OTC) (M-79)
Page 339 of 408
S.No Brand name Decision
(1) (2) (3)
2655. Natrum Brom. Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2656. Natrum hypophos Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2657. Natrum nit. Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2658. Paraffinum Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2659. Plumbum acet. Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2660. Resorcinum Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2661. Saccharum off. Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2662. Zincum acet. Ø Deferred since the application is deficient of following
documents/Information;
F.No.10-7/2020-OTC) (M-79)
Page 340 of 408
S.No Brand name Decision
(1) (2) (3)
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2663. Zincum Sulph. Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2664. Eriodictyn Californicum Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2665. Oleum Jac Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2666. Abies Canadensis Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2667. Acalypha indica Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2668. Arum triphyllum Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2669. Kali phos. Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
F.No.10-7/2020-OTC) (M-79)
Page 341 of 408
S.No Brand name Decision
(1) (2) (3)
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2670. Lecithinum Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2671. Manganum aceticum Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2672. Natrum muriaticum Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2673. Spigelia anthelmia Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. 2674. Scrophularia Nodosa Ø Deferred since the application is deficient of following
documents/Information;
Specifications (EHPI, HPI, HPUS etc.) has not been mentioned
with the product.
Specifications and preparation monograph (EHPI, HPI, HPUS etc.)
is required as per specifications. M/s Aman Traders (0030)
11/1 D, People Colony No. 1, Faisalabad
Agent of M/s PEKANA Naturheilmittel GmbH Raiffeisenstrasse 15, 88353 Kisslegg, Germany
2675. Alfalfa Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
F.No.10-7/2020-OTC) (M-79)
Page 342 of 408
S.No Brand name Decision
(1) (2) (3)
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2676. Phytolacca Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2677. Blatta Orientalis Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2678. Syphytum Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2679. Yohimbinum Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
F.No.10-7/2020-OTC) (M-79)
Page 343 of 408
S.No Brand name Decision
(1) (2) (3)
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2680. Berberis Vulgaris Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Original free sale certificate has not been provided. Only a copy
has been provided.
GMP certificate of the principal manufacture has expired. 2681. Ashwagandha Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2682. Echinacea Angustifolia Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Original free sale certificate has not been provided. Only a copy
has been provided.
GMP certificate of the principal manufacture has expired. 2683. Janosia Ashoka Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
F.No.10-7/2020-OTC) (M-79)
Page 344 of 408
S.No Brand name Decision
(1) (2) (3)
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2684. Hydrastis Canadensis Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Original free sale certificate has not been provided. Only a copy
has been provided.
GMP certificate of the principal manufacture has expired. 2685. Ginseng Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2686. Carduus Marianus Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2687. Damiana Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
F.No.10-7/2020-OTC) (M-79)
Page 345 of 408
S.No Brand name Decision
(1) (2) (3)
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2688. Baptisia Tictoria Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2689. Agnus Castus Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2690. Sarsaparilla Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2691. Cantharis Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
F.No.10-7/2020-OTC) (M-79)
Page 346 of 408
S.No Brand name Decision
(1) (2) (3)
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2692. Hydrangea Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired. 2693. Rauwolfia Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Original free sale certificate has not been provided. Only a copy
has been provided.
GMP certificate of the principal manufacture has expired. 2694. Sabal Serrulata Ø Deferred since the application is deficient of following
documents/Information;
COA of the product has not been provided.
Stability studies data of only one batch (60 months) has been
provided and the same stability studies data has been provided for
other products also. Moreover storage conditions have not been
mentioned with the data.
It has been mentioned in storage conditions that “Do not store
above 25 OC.
Free sale certificate of the product, not provided.
GMP certificate of the principal manufacture has expired.
M/s Public Pharma (Pvt) Ltd., (00502)
Khurranwala Industrial Zone, 25KM Lahore Road, Faisalabad
F.No.10-7/2020-OTC) (M-79)
Page 347 of 408
S.No Brand name Decision
(1) (2) (3)
2695. Calculic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2696. Ferrolic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2697. Coolcid Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2698. Stomy Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2699. Ab-E-Hayat Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 348 of 408
S.No Brand name Decision
(1) (2) (3)
2700. Kuflic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2701. Gastolic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2702. NT-Biolic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2703. Tempolic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2704. Bio Plaz No:8 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 349 of 408
S.No Brand name Decision
(1) (2) (3)
2705. Bio Plaz No:9 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2706. Bio Plaz No:10 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2707. Bio Plaz No:11 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2708. Bio Plaz No:12 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2709. Bioplaz No:13 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 350 of 408
S.No Brand name Decision
(1) (2) (3)
2710. Bio Plaz No:14 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2711. Bio Plaz No:15 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2712. Bioplaz No:16 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2713. Bio Plaz No:17 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2714. Bio Plaz No:18 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 351 of 408
S.No Brand name Decision
(1) (2) (3)
2715. Bio Plaz No:19 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2716. Bio Plaz No:20 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2717. Bio Plaz No:21 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2718. Bio Plaz No:22 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2719. Bio Plaz No:23 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 352 of 408
S.No Brand name Decision
(1) (2) (3)
2720. Bio Plaz No:24 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2721. Bio Plaz No:25 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2722. Bio Plaz No:26 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2723. Bio Plaz No:27 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2724. Bio Plaz No:28 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 353 of 408
S.No Brand name Decision
(1) (2) (3)
2725. Oralean Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2726. Arnica Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2727. Aesculus Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2728. Apis Mel Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2729. Belladona Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2730. Berberis Aq Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2731. Calendula Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2732. Echinacea Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 354 of 408
S.No Brand name Decision
(1) (2) (3)
2733. Cantharis Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2734. Graphites Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2735. Hamamelis Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2736. Hypericum Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2737. Rhus Tox Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2738. Ruta G Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2739. Thuja Occ Cream Deferred since the application is deficient of following
documents/information;
More than one specifications (UPUS, HPI etc.) has been mentioned
with active.
Monograph is required as per specifications to be mentioned. 2740. Mathi Chord Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 355 of 408
S.No Brand name Decision
(1) (2) (3)
2741. Constilic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2742. Grolic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2743. Korian Red Gensings Cream Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2744. Urilic Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2745. Alsolic Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 356 of 408
S.No Brand name Decision
(1) (2) (3)
2746. Heptolic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2747. Flulic Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2748. Sharbat-E-Faulad Syrup Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2749. Digesti Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned. 2750. NT-Biolic Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
F.No.10-7/2020-OTC) (M-79)
Page 357 of 408
S.No Brand name Decision
(1) (2) (3)
2751. Vigolic-100 Tablet Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
More than one specifications (UPUS, HPI etc.) has been mentioned
with actives.
Monographs are required as per specifications to be mentioned.
2752. Ghr-10 Nephritis Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2753. Ghr-3 Phytolacca Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2754. Ghr-5 Cascara Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2755. Ghr-7 Thyreo Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2756. Ghr-12 Eczema Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml.
F.No.10-7/2020-OTC) (M-79)
Page 358 of 408
S.No Brand name Decision
(1) (2) (3)
2757. Ghr-13 Pulsatilla Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2758. Ghr-16 Potentilla Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2759. Ghr-21 Crataegus Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2760. Ghr-22 Nervo Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2761. Ghr-24 Acne Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2762. Ghr-25 Thuja Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2763. Ghr-28 Myrtillus Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
F.No.10-7/2020-OTC) (M-79)
Page 359 of 408
S.No Brand name Decision
(1) (2) (3)
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2764. Ghr-29 Hairen Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2765. Ghr-31 Neuralgia Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2766. Ghr-32 Hay Fever Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2767. Ghr-33 Enuresis Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2768. Ghr-37 Broncho Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2769. Ghr-38 Pelargon Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
F.No.10-7/2020-OTC) (M-79)
Page 360 of 408
S.No Brand name Decision
(1) (2) (3)
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2770. Ghr-39 Hyperi Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2771. Ghr-40 Gentiana Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml. 2772. Ghr-41 Migraine Symplex Oral Drops Deferred since the application is deficient of following
documents/information;
In the light of notification No. F.No. 4-2/2017-DD
(H&OTC)(available on DRAP website), the evidence of
International availability (COPP or Free Sale Certificate) or Local
marketing of 10 years, not provided.
Strength per 100ml has been provided while the pack size is 20ml.
Sadiq Pharma Pvt Ltd
Moza Kotli Rawalpindi Road, Jand-Pakistan (Homoeo Veterinary)
2773. Ice-Cool Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Glonium.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
TS Laboratories
5-Km Makkuana Bypass, Khurianwala, Faisalabad-Pakistan
2774. T.S Lazo Syrup Deferred for following reasons:
Firm applied on Form 4 without clinical evidence.
Strength of ingredients is required.
F.No.10-7/2020-OTC) (M-79)
Page 361 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2775. T.S Sharbat Faulad Syrup Deferred for following reasons:
Stamped and signed Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
Following information regarding lecithanium is required.
Biological source is required.
Evidence stating source of lecithanium is not
contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE, is required. 2776. T.S Cough Syrup Deferred for following reasons:
Firm applied on Form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
Formulation contains Ephedra vulgaris (controlled substance/
precursor).
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2777. T.S Podeena White Syrup Deferred for following reasons:
Firm applied on Form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Lycopodium clavatum,
Nux vomica,
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
F.No.10-7/2020-OTC) (M-79)
Page 362 of 408
S.No Brand name Decision
(1) (2) (3)
2778. T.S Anti Allergic Syrup Deferred for following reasons:
Firm applied on Form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2779. Grace Ful Syrup Deferred for following reasons:
Form 3 is unstamped and unsigned.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required .
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Following information regarding lecithanium is required.
Biological source is required.
Evidence stating source of lecithanium is not
contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE, is required. 2780. Ginko Syrup Deferred for following reasons:
Firm applied on Form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2781. Pain Safe Syrup Deferred for following reasons:
Form 3 is unstamped and unsigned.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Rhus toxicodendron,
Guaiacum officinale, Bryonia alba, Belladonna.
F.No.10-7/2020-OTC) (M-79)
Page 363 of 408
S.No Brand name Decision
(1) (2) (3)
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2782. Ulcer Syrup Deferred for following reasons:
Firm applied on Form 4 without clinical evidence. Strength
of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2783. T.S Cina Syrup Deferred for following reasons:
Firm applied on Form 4 without clinical evidence. Strength
of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product.
Rochdale Homeo Pharma,
43-B, Small Industrial Estate, Sahiwal (Veterinary)
2784. Diro-Well Liquid Deferred for following reasons:
Strength of ingredients is required.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2785. Megaforte Liquid Deferred for following reasons:
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2786. Silycol Liquid Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 364 of 408
S.No Brand name Decision
(1) (2) (3)
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2787. No-Stroke Liquid Deferred for following reasons:
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2788. Ostigem-R Liquid Deferred for following reasons:
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2789. Septi-Vet Liquid Deferred for following reasons:
Deferred for following reasons:
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2790. Vet-Mast Liquid Deferred for following reasons:
Deferred for following reasons:
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2791. Notox Liquid Deferred for following reasons:
Deferred for following reasons:
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2792. Pulmo-Roch Liquid Deferred for following reasons:
It is combination product.
Brand name needs to be changed.
F.No.10-7/2020-OTC) (M-79)
Page 365 of 408
S.No Brand name Decision
(1) (2) (3)
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2793. Pyrin-R Liquid Deferred for following reasons:
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2794. Heap-Boost Liquid Deferred for following reasons:
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Sadiq Pharma Pvt Ltd
Moza Kotli Rawalpindi Road, Jand-Pakistan (Homoeo Veterinary)
2795. Carmi Plus Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Pulsatallia and
Antimonium crudum.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2796. Wormas Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Chenopodium
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
F.No.10-7/2020-OTC) (M-79)
Page 366 of 408
S.No Brand name Decision
(1) (2) (3)
2797. Cough Free Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Antimonium tart.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2798. Pet Tonic Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Antomonium crudum
and Pulstallia nig.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2799. Sadiq Birds Cure Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Bellis per.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2800. Multi Max Gold Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
F.No.10-7/2020-OTC) (M-79)
Page 367 of 408
S.No Brand name Decision
(1) (2) (3)
and sale invoices including distribution record for last 10
years, required. 2801. FMD Treat Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Condurango.
It is combination product. 2802. Prolap-S Liquid Deferred for following reasons:
Prescribed Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Aletris far and Aurum
Mur.
It is combination product. According to notification F. 4-
2/2017-DD(H&OTC) dated 21st April, 2020, documents
about company/ firm enlistment and sale invoices including
distribution record for last 10 years, required. 2803. Colic Fit Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2804. Heal Fast Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Bellis per.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
F.No.10-7/2020-OTC) (M-79)
Page 368 of 408
S.No Brand name Decision
(1) (2) (3)
2805. Multi Power Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Iodium, Lycopus and
Zingiber.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product. 2806. Red Bull Super Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Carica papaya and
andrographis panculata.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2807. Dhairrhoea Fit Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2808. Pep Tonic Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
F.No.10-7/2020-OTC) (M-79)
Page 369 of 408
S.No Brand name Decision
(1) (2) (3)
and sale invoices including distribution record for last 10
years, required.
TS Laboratories
5-Km Makkuana Bypass, Khurianwala, Faisalabad-Pakistan
2809. T.S 01 Drops Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Formulation contains Ephedra vulgaris (controlled substance/
presursor).
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2810. T.S Balata Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of bryonia alba.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2811. T.S Piles Cure Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Nux vomica and
Paeonia.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2812. T.S Moschus Men Drops Deferred for following reasons:
Form 3 is un-stamped and un-signed.
Strength of ingredients is required.
F.No.10-7/2020-OTC) (M-79)
Page 370 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product. 2813. T.S Sumri Faulad Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Following information regarding lecithanium is required.
Biological source is required.
Evidence stating source of lecithanium is not
contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE, is required. 2814. Podena Green Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2815. Bed Wetting Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
F.No.10-7/2020-OTC) (M-79)
Page 371 of 408
S.No Brand name Decision
(1) (2) (3)
and sale invoices including distribution record for last 10
years, required. 2816. Super Sakoon Tablet Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
SH Pharmaceuticals
Plot No.867/A, Small Industrial estate, Sargodha Road, Faisalabad
2817. Laxulec Syrup Deferred for following reasons:
Strength of ingredients is required.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
2818. Bio Multi Tonic Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2819. Ginkgo Cerebral Tonic Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
F.No.10-7/2020-OTC) (M-79)
Page 372 of 408
S.No Brand name Decision
(1) (2) (3)
and sale invoices including distribution record for last 10
years, required. 2820. Gasvinol Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2821. Gasonil Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2822. Gripe Water Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2823. Vita Care Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
F.No.10-7/2020-OTC) (M-79)
Page 373 of 408
S.No Brand name Decision
(1) (2) (3)
and sale invoices including distribution record for last 10
years, required. 2824. Urolgin Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2825. Sharbat Faulad Plus Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2826. Arthonol Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2827. Anti Migraine Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
F.No.10-7/2020-OTC) (M-79)
Page 374 of 408
S.No Brand name Decision
(1) (2) (3)
and sale invoices including distribution record for last 10
years, required. 2828. Polyton Energectic Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2829. Peppermint Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2830. Mintox Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product. 2831. Liverin Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
F.No.10-7/2020-OTC) (M-79)
Page 375 of 408
S.No Brand name Decision
(1) (2) (3)
and sale invoices including distribution record for last 10
years, required. 2832. Kuf Tec Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2833. Globiton Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Following information regarding lecithanium is required.
Biological source is required.
Evidence stating source of lecithanium is not
contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE, is required.
According to notification F. 4-2/2017-DD(H&OTC)
dated 21st April, 2020, documents about company/
firm enlistment and sale invoices including
distribution record for last 10 years, required. 2834. Hepa Pro Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2835. Afco-Chest Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
F.No.10-7/2020-OTC) (M-79)
Page 376 of 408
S.No Brand name Decision
(1) (2) (3)
It is combination product.
Brand name needs to be changed.
Formulation contains Ephedra vulg (controlled precursor/
substance).
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2836. Enermax Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2837. Bio Cof Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Formulation contains Ephedra vulg (controlled precursor/
substance). 2838. Afcozym Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product. 2839. Afco-Kuf Syrup Deferred for following reasons:
Breakup of fee is required.
F.No.10-7/2020-OTC) (M-79)
Page 377 of 408
S.No Brand name Decision
(1) (2) (3)
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Formulation contains ephedra vulg (controlled precursor/
substance). 2840. Feminnol Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2841. Dyrolyte Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product. 2842. Dyjx Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product. 2843. Dominent Syrup Deferred for following reasons:
Breakup of fee is required.
F.No.10-7/2020-OTC) (M-79)
Page 378 of 408
S.No Brand name Decision
(1) (2) (3)
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Following information regarding lecithanium is required.
Biological source is required.
Evidence stating source of lecithanium is not
contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE, is required.
2844. Bryofen Syrup Deferred for following reasons:
Breakup of fee is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product.
Sadiq Pharma Pvt Ltd,
Moza Kotli Rawalpindi Road, Jand-Pakistan (Homoeo Veterinary)
2845. Victor Plus Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
SH Pharmaceuticals
Plot No.867/A, Small Industrial estate, Sargodha Road, Faisalabad
2846. Alfaplex Syrup Deferred for following reasons:
Strength of ingredients is required.
It is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 379 of 408
S.No Brand name Decision
(1) (2) (3)
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2847. Kuf-Iq Syrup Deferred for following reasons:
Fee evidence is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2848. Digel Syrup Deferred for following reasons:
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2849. Bull Dog Tonic Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Kali carb.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2850. Pets Dycent Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Arg nit, Arsenicum
alb, Cinchona and Phosphoricum.
It is combination product.
Brand name needs to be changed.
F.No.10-7/2020-OTC) (M-79)
Page 380 of 408
S.No Brand name Decision
(1) (2) (3)
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2851. Lungs Care Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Sadiq Pharma Pvt Ltd
Moza Kotli Rawalpindi Road, Jand-Pakistan (Homoeo Veterinary)
2852. Gesto Bull Stomach Powder Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Iodium, Lycopus and
Zingiber.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product.
Brand name needs to be changed. 2853. Mastitis Vet Powder Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Apis mel, Pulstallia
and Phellandrium.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2854. Mastitis Vet Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
F.No.10-7/2020-OTC) (M-79)
Page 381 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Apis mel, Merc. Sol,
Pulsatallia and Phellandrium.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2855. Pets Biotic Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2856. Pets Vomit Liquid Deferred for following reasons:
Form 3 is required.
Strength of ingredients is required.
Monographs of colocynthis w.r.t Homeopathic compendia
are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
TS Laboratories
5-Km Makkuana Bypass, Khurianwala, Faisalabad-Pakistan
2857. Anti B Dry Powder Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2858. T.S Alfalfa Syrup Deferred for following reasons:
F.No.10-7/2020-OTC) (M-79)
Page 382 of 408
S.No Brand name Decision
(1) (2) (3)
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of rhus toxicodendron
and bryonia alba..
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2859. T.S Fresh Blood Syrup Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2860. T.S Dyronil Dry Powder Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
Pack sizes applied ( ml) do not match with dosage form (dry
powder), needs justification.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2861. T.S Pain Off Dry Powder Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Pack sizes applied ( ml) do not match with dosage form (dry
powder), needs justification.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
F.No.10-7/2020-OTC) (M-79)
Page 383 of 408
S.No Brand name Decision
(1) (2) (3)
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2862. T.S Kidney Safe Syrup Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2863. T.S Leconil Syrup Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2864. Fever Nil Powder Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Bryonia alba and Rhus
toxicocondron..
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2865. Jigree Safe Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
F.No.10-7/2020-OTC) (M-79)
Page 384 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2866. T.S Feverin Syrup Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Brand name needs to be changed. 2867. Fresh Blood Tablet Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Following information regarding lecithanium is required.
Biological source is required.
Evidence stating source of lecithanium is not
contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE, is required. 2868. T.S 02 Drop Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Dulcamara, Rhus
toxicodendron.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product. 2869. T.S Calcium Plus Syrup Signed and stamped Form 3 is required.
F.No.10-7/2020-OTC) (M-79)
Page 385 of 408
S.No Brand name Decision
(1) (2) (3)
Strength of ingredients is required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed. 2870. T.S Anti-B Tablet Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Bryonia alba.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2871. T.S Leconil Tablet Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product.
Brand name needs to be changed. 2872. T.S Jery Vit Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2873. T.S Calcium, Plus Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
F.No.10-7/2020-OTC) (M-79)
Page 386 of 408
S.No Brand name Decision
(1) (2) (3)
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2874. T.S Gel Original Suspension Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of Nux vomica.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2875. T.S Lazo Tablet Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required except that of bryonia and hydrastis..
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2876. Grace Ful Plus Tablet Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
Following information regarding lecithanium is required.
Biological source is required.
F.No.10-7/2020-OTC) (M-79)
Page 387 of 408
S.No Brand name Decision
(1) (2) (3)
Evidence stating source of lecithanium is not
contaminated with Transmissible Spongiform
Encephalopathy (TSE) or BSE, is required. 2877. T.S Baby Mitti Chorr Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2878. T.S Pain Off Tablet Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2879. T.S Gel Yellow Suspension Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2880. T.S 05 Drops Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
F.No.10-7/2020-OTC) (M-79)
Page 388 of 408
S.No Brand name Decision
(1) (2) (3)
and sale invoices including distribution record for last 10
years, required. 2881. T.S 04 Drops Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. 2882. Dairo-T Syrup Deferred for following reasons:
Signed and stamped Form 3 is required.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
According to notification F. 4-2/2017-DD (H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required.
It is combination product. 2883. T.S Gel Pink Suspension Deferred for following reasons:
Firm applied on form 4 without clinical evidence.
Strength of ingredients is required.
Monographs of raw ingredients w.r.t Homeopathic
compendia are required.
It is combination product.
Brand name needs to be changed.
According to notification F. 4-2/2017-DD(H&OTC) dated
21st April, 2020, documents about company/ firm enlistment
and sale invoices including distribution record for last 10
years, required. M/s Huzaifa International (E. No. 00871)
Commerical Area, Aziz Bhatti Town Sargodha
Agent of M/s SUPER’S DIANA, S.L., ubicada a Ctra. C-17, KM 17, del municipi de Parets del Valles, (Barcelona)
2884. Huzaifa International’s
Super’s Hepatic Oral Solution
Deferred since the application is deficient of following documents/Information;
GMP certificate of the principal manufacturer as expired.
The copy of free sale certificate provided, has not been notarized and attested
by the embassy.
Brand name undertaking, not provided.
Undertaking of contents, not provided.
2885. Huzaifa International’s
ELI-PLUS Oral Solution
Deferred since the application is deficient of following documents/Information;
GMP certificate of the principal manufacturer as expired.
F.No.10-7/2020-OTC) (M-79)
Page 389 of 408
S.No Brand name Decision
(1) (2) (3)
The copy of free sale certificate provided, has not been notarized and attested
by the embassy.
Brand name undertaking, not provided.
Undertaking of contents, not provided.
2886. Huzaifa International’s
Super Vita Oral Solution
Deferred since the application is deficient of following documents/Information;
GMP certificate of the principal manufacturer as expired.
The copy of free sale certificate provided, has not been notarized and attested
by the embassy.
Brand name undertaking, not provided.
Undertaking of contents, not provided.
M/s Chemist International (01047)
Alhamd Garden Phase-I, House No. 1, Main Street Near AlsaeedChowkMozaBuddoo, Tehsil FerozWala District Shekhupura
Agent of M/s Labiana Life Sciences, C/Venus 26, Pol. Ind. Can Parellada, Tarrasa 08228, Barcelona, Spain 2887. Chemist International’s
Power Plus ADEK Oral Solution
Deferred since the application is deficient of following documents/Information;
The stability studies data of one batch is complete (24 months) while stability
studies data of the other two batches in incomplete.
2888. Chemist International’s
Easy Immune Oral Solution
Deferred since the application is deficient of following documents/Information;
The stability studies data of one batch is complete (24 months) while stability
studies data of the other two batches in incomplete.
2889. Chemist International’s
Hepa Lab Oral Solution
Deferred since the application is deficient of following documents/Information;
The stability studies data of only two batches has been provided which is
incomplete.
2890. Chemist International’s
Amino Lab Oral Solution
Deferred since the application is deficient of following documents/Information;
The stability studies data of all the three batches is incomplete.
2891. Chemist International’s
Easy Breath Oral Solution
Deferred since the application is deficient of following documents/Information;
The strength provided is per 100L. Steregnth per Liter is required. Moreover
the active ingredients need to be identified.
The stability studies data of one batch is complete (24 months) while stability
studies data of the other two batches in incomplete.
M/s Fair International Trading Co.,(00930)
A-129, Block, Gulistan-e-Jauhar, Karachi
Agent of M/s Cenavisa, S.L, Pedra Estela, s/n°, Reus, 43205 Tarragona Spain
2892. Fair International’s
Selcen-E Oral Solution
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Forem-5).
Brand name undertaking, not provided.
Undertaking of contents, not provided.
2893. Fair International’s
Amicen’sSolucion Plus Oral Solution
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Forem-5).
Brand name undertaking, not provided.
Undertaking of contents, not provided.
2894. Fair International’s
Vita Electrolytes Oral Powder
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Forem-5).
F.No.10-7/2020-OTC) (M-79)
Page 390 of 408
S.No Brand name Decision
(1) (2) (3)
Brand name undertaking, not provided.
Undertaking of contents, not provided.
2895. Fair International’s
Hydracen Complex PM Oral Powder
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Forem-5).
Brand name undertaking, not provided.
Undertaking of contents, not provided.
2896. Fair International’s
Hepatocen Plus Oral Solution
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Forem-5).
Brand name undertaking, not provided.
Undertaking of contents, not provided.
M/s Nascon Pharmaceutical Natural Division (E.no: 00359)
Plot No.66-A, Industrial Estate Hayatabad, Peshawar
2897. NASCON,s
UROFLUX Tablets
Deferred for provision of stability studies undertaking
2898. NASCON,s
DU-CRAN Sachet Deferred due to following shortcomings:
Form-3 not provided
2899. NASCON,s
NUTARZINE-H Sachet
Deferred due to following shortcomings:
Ginger used in crude form
2900. NASCON,s
VELCARE Tablets
Deferred for change of brand name
2901. NASCON,S
CIDLOCK Sachet
Deferred for justification of formulation
2902. NASCON,S
CID-CAN Sachet
Deferred for justification of formulation
2903. NASCON,s
MYOSETOL-D Sachet
Deferred for change of brand name
M/S Nectar Pharmaceutical Nutritional Health Sciences (E.No. 01007)
2-km on East Shahalam Bridge, Charsadda Road, Peshawar
2904. NECTAR’S
ADILOX DROPS
Deferred provision of justification of use of Vitamin E and Corn oil as an excipient.
2905. NECTAR’S
D-III DROPS
Deferred provision of justification of use of Vitamin E and Corn oil as an excipient.
2906. NECTAR’S
GINKO – 3G SYRUP
Deferred provision of justification of use Ginko biloba in formulation instead of
Ginko biloba extract
2907. NECTAR’S
MELATO DROPS
Deferred till the finalization of guidelines for processing of applications of products
containing common molecules being dealt by Division of PE&R and H&OTC.
F.No.10-7/2020-OTC) (M-79)
Page 391 of 408
S.No Brand name Decision
(1) (2) (3)
2908. NECTAR’S
IVY COUGH SYRUP
Deferred for change of brand name
M/S ALAST PHYTOCEUTICALS
Plot No. E-006, H.I.T.E, Hub Lasbela Industrial Estate, Balochistan
2909. ALAST’s
Mintec Syrup
Deferred due to following shortcomings:
i. Form-3, Brand Name and contents undertakings are unsigned/ unstamped.
ii. Official monography of contents of ingredients are not provided.
iii Stability undertaking is not provided.
2910. ALAST’s
Vegan Syrup
Deferred due to following shortcomings:
i. Form-3, Brand Name and contents undertakings are unsigned/unstamped.
ii. Official monography of Fig ABC, Turnip of ingredients are not provided.
iii. Stability undertaking is not provided.
2911. ALAST’s
Qalgro Syrup
Deferred due to following shortcomings:
i. Justification of use of vitamin in herbal section (Formulation).
2912. ALAST’s
Foligro Syrup
Deferred due to following shortcomings:
i. Form-3, Brand Name and contents undertakings are unsigned/ unstamped.
ii. Official monography of Nepata ruderalum, Hydrocotyle asiatica,
Asparagus adseendens are not provided.
iii. Stability undertaking is not provided.
2913. ALAST’s
Zemint Syrup
Deferred due to following shortcomings:
i. Form-3, Brand Name and contents undertakings are unsigned/ unstamped.
ii. Stability undertaking is not provided.
2914. ALAST’s
Hepato Syrup
Deferred due to following shortcomings:
i. Form-3, Brand Name and contents undertakings are unsigned/unstamped.
ii. Stability undertaking is not provided.
2915. ALAST’s
Chastal Syrup
Deferred due to following shortcomings:
i. Form-3, Brand Name and contents undertakings are unsigned/unstamped.
ii. Official monography of Fig ABC is not provided.
iii. Stability undertaking is not provided.
2916. ALAST’s
Neuroba Syrup
Deferred due to following shortcomings:
i. Form-3, Brand Name and contents undertakings are unsigned/ unstamped.
ii. Stability undertaking is not provided.
2917. ALAST’s
WELBON SYRUP
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings are unsigned/unstamped.
2918. ALAST’s
VASAKA SYRUP
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings are missing.
ii. Official monographs of Echium vulgare, Glycyrrhiza glabra, Lavendula
stoechas, Winter cherry and Wild violet is not provided.
2919. ALAST’s
HERBY SACHETS
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings are unsigned/unstamped.
ii. Official monography of active ingredients is not provided.
iii. Common names of the ingredients must be provided.
2920. ALAST’s
APERIC SYRUP
Deferred due to following shortcomings:
i. Justification of mini pepper in the formulation.
ii. Official monography of the Soanum nigrum, Garden rue, prunes, Fennel
fruit and Pomegrante the are missing.
iii. Stability, Brand Name and contents undertaking are unsigned/unstamped.
2921. ALAST’s
Gestcure Syrup
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings are missing.
ii. Official monography of active ingredients is not provided.
2922. ALAST’s
Leculing Multi Tablets
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings are missing.
F.No.10-7/2020-OTC) (M-79)
Page 392 of 408
S.No Brand name Decision
(1) (2) (3)
ii. Official monography of Gallnut and Asteracantha Longifolia are missing.
2923. ALAST’s
Painkil Tablets
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings is unsigned/unstamped.
ii. Official monography of Withania Somnifera and Chebula myrobalan are
missing.
2924. ALAST’s
Aferic Syrup
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings is unsigned/unstamped.
ii. Official monography of Santalum album, Nepata ruderalum, Asparagus
adscendens and Asparagus are not provided.
2925. ALAST’s
E-LAX Syrup
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings is unsigned/unstamped.
ii. Official monography of Ficus carica ABC are not provided.
2926. ALAST’s
VIZIC Syrup
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings are missing.
ii. Official monography of Black cardamom, Spinach oleracea, Ficus Carica
ABC and Turnip are missing.
2927. ALAST’s
Gastcur capsule
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings are unsigned/unstamped.
ii. Official monography of Myrobalan emblic, Solanum nigrum, Fenugreek,
Endive, Omum seed, Garden rue and Lemon grass are missing.
2928. ALAST’s
Ginkofil Syrup
Deferred due to following shortcomings:
i. Stability, Brand Name and contents undertakings are unsigned/unstamped.
M/s. SAMARKAND LABORATORIES
½ Km Makkuana Bypass Satiana Road Faisalabad
2929. Samarkand’s
Lekodon Capsules
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2930. Samarkand’s
Gona-T Capsules
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2931. Samarkand’s
Glycerose Spray
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2932. Samarkand’s
Polyceen Syrup 120ml
Deferred due to following shortcomings:
i. Fee receipt is not endorsed.
ii. Justification of formulation of the product e.g, 10ml formulation and
Triphala extract 18L with other ingredients.
iii. Official monographs of active ingredients are not provided.
iv. Safety, brand name and stability undertaking is not provided.
2933. Samarkand’s
Roghan Long
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Inactive ingredients of formulation are missing in master formula.
2934. Samarkand’s
Amedon Capsules
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2935. Samarkand’s
Amedon Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2936. Samarkand’s
Toot Siah+Malathi
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Fee receipt is not endorsed.
F.No.10-7/2020-OTC) (M-79)
Page 393 of 408
S.No Brand name Decision
(1) (2) (3)
2937. Samarkand’s
Leekosar
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2938. Samarkand’s
Kalosar- S Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2939. Samarkand’s
Pipermint Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2940. Samarkand’s
Calcium-s Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2941. Samarkand’s
Summer kuf Syrup 120ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. The fee is not endorsed by concerned division.
2942. Samarkand’s
Hemoglobin Syrup 120ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Fee receipt is not endorsed.
2943. Samarkand’s
Gynorin Syrup 120ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Fee receipt is not endorsed.
2944. Samarkand’s
Appifer Syrup 120ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Fee receipt is not endorsed.
2945. Samarkand’s
Papermint Syrup 120ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Fee receipt is not endorsed.
2946. Samarkand’s
Antacid suspension 120ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Fee receipt is not endorsed.
2947. Samarkand’s
Samar Gas-kill Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Fee receipt is not endorsed.
2948. Samarkand’s
Dell Cough Syrup 120ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Fee receipt is not endorsed.
2949. Samarkand’s
DY-ZOOL Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2950. Samarkand’s
TRI-APT Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided
2951. Samarkand’s
Faast analgesic Lotion
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2952. Samarkand’s Deferred due to following shortcomings:
F.No.10-7/2020-OTC) (M-79)
Page 394 of 408
S.No Brand name Decision
(1) (2) (3)
Sofo Vit Syrup i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2953. Samarkand’s
ARQ KASNI
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2954. Samarkand’s
ARQ Gaozaban
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2955. Samarkand’s
Heparex Syrup
Deferred due to following shortcomings:
i. Herbal Section can’t use Vitamins in their formulation.
2956. Samarkand’s
DY-STO Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2957. Samarkand’s
Jiger Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2958. Samarkand’s
Cufress Cough Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2959. Samarkand’s
IVY Plus Cough Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2960. Samarkand’s
N-CID Suspension
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2961. Samarkand’s
Gastro-Z Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2962. Samarkand’s
Sharbat Faulad Zafrani
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2963. Samarkand’s
SK Lotion
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2964. Samarkand’s
Hi Garlic Tablet
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2965. Samarkand’s
Mr. Cough Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2966. Samarkand’s
Pulmo-D
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2967. Samarkand’s
Flowerex Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2968. Samarkand’s
Sharbat Anjbar 800ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2969. Samarkand’s
Hazmoleen Phaki
Deferred due to following shortcomings:
i. Stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2970. Samarkand’s Deferred due to following shortcomings:
F.No.10-7/2020-OTC) (M-79)
Page 395 of 408
S.No Brand name Decision
(1) (2) (3)
Silibex Syrup i. Irrational Formulation.
2971. Samarkand’s
Braino Tonic 120ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
2972. Samarkand’s
Sharbat Unaab 800ml
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2973. Samarkand’s
Safi Khoon 120ml
Deferred due to following shortcomings:
i. Stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2974. Samarkand’s
Liquid Parafin
Deferred due to following shortcomings:
i. Liquid paraffin is drug and included in schedule-D of LRA rule.
2975. Samarkand’s
Glycerine
Deferred due to following shortcomings:
i. Not applied on prescribed Form-3.
ii. Safety, stability and Brand Name undertakings are not provided.
2976. Samarkand’s
Sharbat Banafsha
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2977. Samarkand’s
Sharbat Dinar
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2978. Samarkand’s
Chaurka Arq
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2979. Samarkand’s
Tylox-Z
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2980. Samarkand’s
Lebiloba Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2981. Samarkand’s
Ferric Plus Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2982. Samarkand’s
Nodex Lotion
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
iii. Justification of Sulphur in formulation.
2983. Samarkand’s
Ginkobex Syrup
Deferred due to following shortcomings:
i. Ingredients on Form-3 and in master formula are different.
ii. Safety, stability and Brand Name undertakings are not provided.
iii. Official Monographs of the active ingredients are not provided.
2984. Samarkand’s
MoliRex Analgesic Lotion
Deferred due to following shortcomings:
i. Strength of ingredients must be in mg or any other unit. Not in percentage.
ii. Safety, stability and Brand Name undertakings are not provided.
iii. Official Monographs of the active ingredients are not provided.
2985. Samarkand’s
Lacto S Syrup
Deferred due to following shortcomings:
i. Justification of use and safety of Nux Vomica in the formulation.
ii. Safety, stability and Brand Name undertakings are not provided.
iii. Official Monographs of the active ingredients are not provided.
2986. Samarkand’s
Hoping Kuf Syrup
Deferred due to following shortcomings:
i. The product contains Ephedra.
2987. Samarkand’s
Alsah Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
F.No.10-7/2020-OTC) (M-79)
Page 396 of 408
S.No Brand name Decision
(1) (2) (3)
2988. Samarkand’s
Labub Kabir
Deferred due to following shortcomings:
i. The Strength of ingredients are not given.
ii. Justification of formulation.
iii. Safety, stability and Brand Name undertakings are not provided.
iv. Official Monographs of the active ingredients are not provided.
2989. Samarkand’s
Shabab Zafrani
Deferred due to following shortcomings:
i. The Strength of ingredients are not given.
ii. Justification of formulation.
iii. Safety, stability and Brand Name undertakings are not provided.
iv. Official Monographs of the active ingredients are not provided.
2990. Samarkand’s
Hebicol Syrup
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
2991. Samarkand’s
Move On Ointment
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2992. Samarkand’s
ARQ Badian
Deferred due to following shortcomings:
i. The name of the product does not match the formulation of the product.
ii. Safety, stability and Brand Name undertakings are not provided.
2993. Samarkand’s
ARQ-E-Gulab
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
2994. Samarkand’s
KUF Kofe-E
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
2995. Samarkand’s
KUF Kofe-D
Deferred due to following shortcomings:
i. Safety, stability and Brand Name undertakings are not provided.
ii. Official Monographs of the active ingredients are not provided.
Vermon Nutraceutical Pvt Ltd Lahore
Saggian Bridge, Water Land Park, Street No. L-4, R-2 Plot No.2, Faizpur Khurd, Lahore
2996. Vermon’s
Get Smart Sachet
Deferred due to following shortcomings:
i. Official Monographs of green tea extract is not provided.
2997. Vermon’s
Appinol Sachet
Deferred due to following shortcomings:
i. Official Monographs of zingiber Officinale is not provided.
2998. Vermon’s
Feist Diet Food Supplement
Deferred due to following shortcomings:
i. Weight of each sachet is 200g while the require pack size is 140g.
ii. Formulation contains skimmed milk; the firm do not have dedicated (Food
supplement) section for it.
2999. Vermon’s
Crany sachet
Deferred due to following shortcomings:
i. Receiving of file (R&I Section) is not attached.
ii. Weight of each sachet is not given.
3000. Vermon’s
Big Cran Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Stability undertaking is missing.
3001. Vermon’s
Cran-V Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not given.
3002. Vermon’s
Cran Ziff Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
3003. Vermon’s
Revive Cream
Deferred due to following shortcomings:
i. Justify the use of co-enzyme Q10 in cream form.
ii. Justify the use of crocla wax and beez wax as inactive ingredients.
3004. Vermon’s
Pento-V Cream
Deferred due to following shortcomings:
i. Official monographs of winter green oil, crocla wax and beez wax are not
provided.
3005. Vermon’s Deferred due to following shortcomings:
F.No.10-7/2020-OTC) (M-79)
Page 397 of 408
S.No Brand name Decision
(1) (2) (3)
Pain Care Lotion i. Strength of formulation is not given.
3006. Vermon’s
Scabver Lotion
Deferred due to following shortcomings:
i. Strength of formulation is not given.
3007. Vermon’s
Capsinogen Lotion
Deferred due to following shortcomings:
3008. Vermon’s
White Gold Cream
Deferred due to following shortcomings:
i. Formulation (ingredients) as drug.
3009. Vermon’s
S.A Lotion
Deferred due to following shortcomings:
i. Strength of formulation is not given.
ii. The product contains capsicin.
3010. Vermon’s
Permilin Lotion
Deferred due to following shortcomings:
i. Strength of formulation is not given.
ii. The product contains permethrin and camphor.
3011. Vermon’s
Clearasil Cream
Deferred due to following shortcomings:
3012. Vermon’s
Beauteen Cream
Deferred due to following shortcomings:
i. Cosmetic purpose product
3013. Vermon’s
Soft Lotion
Deferred due to following shortcomings:
i. Strength of formulation is not given.
3014. Vermon’s
Citrona Sachet
Deferred till the finalization of guidelines for processing of applications of
products containing common molecules being dealt by Division of PE&R and
H&OTC.
3015. Vermon’s
Ovasitol Sachet
Deferred for change of brand name
3016. Vermon’s
Ostium D Sachet
Deferred for change of brand name
3017. Vermon’s
Scab-DE Lotion
Rejected, the product (having cosmetic purpose) cannot be enlisted under SRO
412 (I)/2014
3018. Vermon’s
Ortho-1 Lotion
Deferred for clarification of formulation as Paraffin come under Schedule D of
LRA Rules, 1976
3019. Vermon’s
Acni Derm Cream
Rejected, the product (having cosmetic purpose) cannot be enlisted under SRO
412 (I)/2014
3020. Vermon’s
Calci RS Sachet
Deferred for change of brand name
3021. Vermon’s
Calci Fit Sachet
Deferred for change of brand name
3022. Vermon’s
Trauma Gel
Deferred till the finalization of guidelines for processing of applications of
products containing common molecules being dealt by Division of PE&R and
H&OTC.
M/s BHP Homoeo Laboratories (Pvt) Ltd., (E.No.00624),
Paragon Industrial Estate, 18-Km, Multan Road, Lahore-Pakistan
3023. BHP’s
ApocynumCannabinum
Potencies
ApocynumCannabinum (HPUS)
(HPUS Specifications)
Deferred due to following reason:
The common name of apocynum cannabinum is “Indian hemp”, needs
clarification of its use and safety and provision of allocation of quota.
F.No.10-7/2020-OTC) (M-79)
Page 398 of 408
S.No Brand name Decision
(1) (2) (3)
3x, 6X, 12X, 30X, 200X, 1000X, 3, 6 , 30, 200, 1M,
10M, 50M, CM
3024. BHP’s
Opium
Potencies
Opium (EHPI)
(EHPI Specifications)
3x, 6X, 12X, 30X, 200X, 1000X, 3, 6 , 30, 200, 1M,
10M, 50M, CM
Deferred provision of allocation of quota
3025. BHP’s HeparSulphur Potencies Lycopodium (EHPI) (EHPI Specifications) 3x, 6X, 12X, 30X, 200X, 1000X, 3, 6 , 30, 200, 1M, 10M, 50M, CM
Deferred for sbumissio f Hepar Sulphur Monograph
3026. BHP’s
Caladium Seguinum
Potencies
Caladium Seguinum(HPUS)
(HPUS Specifications)
3x, 6X, 12X, 30X, 200X, 1000X, 3, 6 , 30,
200, 1M, 10M, 50M, CM
Deferred for provision of monograph
M/s. Dr. Masood Homoepathic Pharmaceutical (0016),
56, Quaid-e-Azam Industrial Estate, Kot Lakhpat Lahore
3027. Dr. Masood’s
Ephedra Vulgaris Potencies
Ephedra Vulgaris (EHPI)
(EHPI Specifications)
3X, 3, 6X, 6, 12X, 12, 30X, 30, 200X, 200, 1000X,
1M, 10M, 50M, CM, LM1-LM11
Deferred for further evaluation w.r.t Ephedra Vulgaris
M/S SALBION HEALTH SCIENCES (PVT.) LTD
23-km, Sheikhupura Road, Lahore
3028. Salbion’s
Diareen Sachet
Deferred due to following shortcomings:
i. Official monograph of Salai guggal is not provided.
3029. Salbion’s
Prone Capsule
Deferred due to following shortcomings:
i. Official Monographs of active ingredients is not provided.
3030. Salbion’s
Probac Capsule
Deferred due to following shortcomings:
i. Official Monographs of active ingredients is not provided.
3031. Salbion’s
Crantik Plus Capsule
Deferred due to following shortcomings:
i. Official Monographs of active ingredients is not provided.
ii. Individual strength of each active ingredient of blend is required.
3032. Salbion’s
Lifilac Capsule
Deferred due to following shortcomings:
i. Official Monographs of active ingredients is not provided.
3033. Salbion’s
Lactocran Capsule
Deferred due to following shortcomings:
i. Individual strength of each active ingredient of blend is required along
with official monograph (Testing).
ii. Clarify the organic prebiotic fiber blend.
3034. Salbion’s
Lacidol Capsule
Deferred due to following shortcomings:
F.No.10-7/2020-OTC) (M-79)
Page 399 of 408
S.No Brand name Decision
(1) (2) (3)
i. Individual strength of each active ingredient of blend is required along
with official monograph.
3035. Salbion’s
Bect Capsule
Deferred due to following shortcomings:
i. Quantities of different strains used in multi strain probiotic required in mg
or gram in master formula.
ii. Official monographs of active ingredients not provided.
3036. Salbion’s
Flosto-P Capsule
Deferred due to following shortcomings:
i. Official monograph of saccharomyces boulardii is not provided.
3037. Salbion’s
Florit Capsule
Deferred due to following shortcomings:
i. Individual strength of each active ingredient of blend is required along
with its official monograph.
3038. Salbion’s
Clostrum Capsule
Deferred due to following shortcomings:
i. Official monograph of clostridium butyricum and Bifidobacterium are not
provided.
3039. Salbion’s
Biocil Capsule
Deferred due to following shortcomings:
i. Individual strength of each ingredient of blend is required along with
official monograph.
3040. Salbion’s
Basilac capsule
Deferred due to following shortcomings:
i. Individual strength of each active ingredient of blend is required along
with official monograph.
3041. Salbion’s
Actobac Capsule
Deferred due to following shortcomings:
i. Individual strength of each active ingredient of blend is required along
with official monograph.
3042. Salbion’s
Acrobol capsule
Deferred due to following shortcomings:
i. Official monograph of saccharomyces boulardii is not provided.
3043. Salbion’s
Sacrom Capsule
Deferred due to following shortcomings:
i. Official monograph of saccharomyces boulardii is not provided.
3044. Salbion’s
Qarheen Sachet
Deferred due to following shortcomings:
i. Official monograph of cochlospermum Gossypium is not provided.
3045. Salbion’s
Remax Sachet
Deferred due to following shortcomings:
i. Official monograph of Lepidium meyenii, Epimedium koreanum and
ptychopetalum is not provided.
3046. Salbion’s
Wintea Joshanda Sachet
Deferred due to following shortcomings:
i. Official monograph of HYSSOPUS OFFICINALIS, CAMELLIA is not
provided.
ii. Strength of each ingredient of herbal extract is required.
3047. Salbion’s
Velesan Sachet
Deferred due to following shortcomings:
i. Official monograph of Borago officinalis and Lavandula stoechas is not
provided.
3048. Salbion’s
Slimmy Sachet
Deferred due to following shortcomings:
i. Official monograph of Green Tea and Cayenne Pepper is not provided
ii. Individual strength of ingredients of blend are required.
3049. Salbion’s
Salboghol Sachet
Deferred due to following shortcomings:
i. Official monograph of Green Tea is not provided.
3050. Salbion’s
Lycran Sachet
Deferred due to following shortcomings:
i. Official monograph of Green Tea is not provided.
3051. Salbion’s
Myo-Lic Sachet
Deferred due to following shortcomings:
i. Official monograph of D-chiro inositol is not provided.
3052. Salbion’s
Cytol – F Sachet
Deferred due to following shortcomings:
i. Official monograph of L-Methyl folate is not provided.
3053. Salbion’s
Utiva Sachet
Deferred due to following shortcomings:
i. Official monograph of cranberry extract is not provided.
3054. Salbion’s Deferred due to following shortcomings:
F.No.10-7/2020-OTC) (M-79)
Page 400 of 408
S.No Brand name Decision
(1) (2) (3)
Stash Sachet i. Official monograph of cranberry extract is not provided.
3055. Salbion’s
Crox – D Sachet
Deferred due to following shortcomings:
i. Official monograph of cranberry extract is not provided.
3056. Salbion’s
Crasta Sachet
Deferred due to following shortcomings:
i. Official monograph of cranberry extract is not provided.
3057. Salbion’s
Asonate-D
Deferred due to following shortcomings:
i. Official monograph of Ossein Mineral Complex is missing.
ii. Composition and strengths of ossein mineral complex is not provided.
3058. Salbion’s
Rewalk Plus Sachet
Deferred due to following shortcomings:
i. Master formula is not according to formulation on Form – 3.
ii. Justify the use of Fish collagen in powder form.
iii. Official monograph of active ingredients is not provided
3059. Salbion’s
Gasty Sachet
Deferred for justification of formulation
3060. Salbion’s
Gaspro Sachet
Deferred for justification of Limestone in the formulation
3061. Salbion’s
Liver-20
Deferred for justification of formulation and change of brand name
M/S Khurshid Unani Laboratories
Pilowal Siddiqia, Tehsil Lallian, District Chiniot.
3062. Khurshid’s
Asaabi Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Paeonia/lacteforiaEmodi, Zedoary roots, winter
cherry/withania somnifera, Indian snakeroot/rauvolfia serpentine, Nux
Vomica(Farmacopeia Brasileira) Are not provided.
iii. Justify the quantity and used of Nux-vomica in formulation.
3063. Khurshid’s
Hab-e-Shifaur Rhem Tablet
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3064. Khurshid’s
Hab Muqawi Kabeer Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
3065. Khurshid’s
Noor E Nazar Kastoori Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monograph of Deer Musk is not provided.
3066. Khurshid’s
Hab-E-Movaled Tablet
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3067. Khurshid’s
ITR GULAB Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Red Sandal wood/Prerocarpus santalinus, Snadal
wood/Santalum Album, cassia fistula/Abus, Indian rhubarb are not
provided.
3068. Khurshid’s
Hab-E-Suaal Tablets
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
F.No.10-7/2020-OTC) (M-79)
Page 401 of 408
S.No Brand name Decision
(1) (2) (3)
3069. Khurshid’s
Hab Masaan Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of active ingredients are not provided.
3070. Khurshid’s
Hab Umeed Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Jaggery, Cannabis sativa seeds are not provided.
iii. Justify the use of cannabis sativa seeds.
3071. Khurshid’s
Zad Jam Ishq Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Salvia haemotodes/officinalis, Deer Musk are not
provided.
3072. Khurshid’s
Hub-E-Jigar Tablet
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3073. Khurshid’s
Hab-E-Muqqavi Tablets
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3074. Khurshid’s
Hab Qalb UL Hijr Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of active ingredients are not provided.
3075. Khurshid’s
Ayyami Jadeed Tablets
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3076. Khurshid’s
Noor E Nazar Khurd Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Aesculus indica, Jaggery and bamboo manna are
not provided.
3077. Khurshid’s
Taryaq-E-Atthra Tablets
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3078. Khurshid’s
Hab Afsanteen Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Wormwood, Agarwood are not provided.
3079. Khurshid’s
Safoof Mughalaz
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Qalai Extract and Silver extract are not provided.
iii. Justify the use of silver extract and qalai extract.
3080. Khurshid’s
Hab-E-Musaffi Tablets
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3081. Khurshid’s
Capsule Rooh E Shabaat
Deferred due to following shortcomings:
F.No.10-7/2020-OTC) (M-79)
Page 402 of 408
S.No Brand name Decision
(1) (2) (3)
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Almonds and Cinnabar are not provided.
3082. Khurshid’s
Safoof Nargandi
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Chlorophytum borivilianum and Angus castus are
not provided.
3083. Khurshid’s
Hab-E-SSandal Tablets
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3084. Khurshid’s
Akseer-E-Meda Powder
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of whiten cumin seed, Ajowain seed, whild
peppermint, salt black, chebulic myrobalan, pomegranate seed and dried
mango powder are not provided.
iii. Weight of formulation is not provided.
iv. Weight of ingredients must be in units e.g. Kg, mg etc
3085. Khurshid’s
Capsule Marjan
i. Deferred due to following shortcomings:
ii. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
iii. Official monographs of *Coral extract and **Iron extract are not
provided.
iv. Justify and clarify the coral extracts and iron extract in the formulation.
3086. Khurhid’s
Fishar capsules
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data
3087. Khurshid’s
Hab Bawashir Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Chebulic myrobalan and cassia absus/ fistula are
not provided.
3088. Khurshid’s
Safoof Khaas
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Borivilianum, Lotus seeds & Qalai Extract are
not provided.
iii. Strength of formulation is not provided.
3089. Khurshid’s
Surkh Capsules
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3090. Khurshid’s
Seelani Casules
Deferred due to following shortcomings:
i. Applied on Form-4 with no clinical studies data.
3091. Khurshid’s
Hab Muqawi Dimagh Tablet
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of active ingredient are not provided.
3092. Khurshid’s
Capsule Ziabitus
Deferred due to following shortcomings:
F.No.10-7/2020-OTC) (M-79)
Page 403 of 408
S.No Brand name Decision
(1) (2) (3)
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of active ingredient are not provided.
3093. Khurshid’s
Safoof Seelani Powder
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Areca nut, Butea frondosa, Rubia cardifolia,
Boerhavia diffusa, Cassia lignea bark and Crushed suger are not
provided.
iii. Strength of ingredients must be in units e.g. mg, kg etc.
3094. Khurshid’s
Safoof Tabkhir Afsanteeni Powder
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Kashneez, Tabasheer, Afsanteen are not provided.
iii. Strength of ingredients must be in units e.g. mg, kg etc.
3095. Khurshid’s
Safoof Maghz Banola
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Cholorphytum seed & Cotton seed kernals are not
provided.
iii. Strength of ingredients must be in units e.g. mg, kg etc.
3096. Khurshid’s
Sharbat Surfa Syrup
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Anjeer, Khatmi, Mulathi, Tukhmkarfas, Zoofa
and Munnaqa are not provided.
3097. Khurshid’s
Qand-E-Shifa Powder
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Hyssopus Officinalis are not provided.
iii. The strength of ingredients must be in units e.g. mg, kg etc
3098. Khurshid’s
Gastro Eez Syrup
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Carum Copticum are not provided.
3099. Khurshid’s
Sharbat Jigar Khaas
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Prunes dried, and chicory seeds are not provided.
3100. Khurshid’s
Safoof Talmakhana
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. The strength of the ingredients not clear in percentages, these must be in
units e.g. kg, mg
3101. Khurshid’s
Safoof Muqawi Powder
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
F.No.10-7/2020-OTC) (M-79)
Page 404 of 408
S.No Brand name Decision
(1) (2) (3)
ii. Official monographs of Soap stone, Orchis mascula, Indian water
chestnut, Psyllium seed and salajit are not provided.
3102. Khurshid’s
Safoof Muffarah Powder
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Bamboo Manna are not provided.
3103. Khurshid’s
Sharbat Banafsha
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of active ingredient are not provided.
3104. Khurshid’s
Sharbat Shahtoot Siah
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of active ingredient are not provided.
3105. Khurshid’s
Sharbat Bazoori Bard
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Chicory roots, Melon seeds, watermelon seed and
milk are not provided.
iii. The firm used “Milk” as an active ingredient however, the firm do not have
dedicated section.
3106. Khurshid’s
Sharbat Mussafia
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Indian balmony, and Indian fumitory are not
provided.
3107. Khurshid’s
Sharbat Faulad Syrup
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of active ingredient are not provided.
3108. Khurshid’s
Safoof Murakab Afsanteen
Deferred due to following shortcomings:
i. Form-3, stability undertaking, brand name and content undertakings are
unsigned/unstamped.
ii. Official monographs of Wormwood & Agarwood are not provided.
M/s Avanza Healthcare (Pvt) Ltd.
45-A Sundar Industrial Estate, Sundar-Raiwind Road, Lahore
3109. Avanza’s
Hiflora plus Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus acidophilus, Lactobacillus rhamnosus,
Bifidobacterium lactis, Bifidobacterium bifidum are not provided.
iii. Master formula is not correct.
3110. Avanza’s Deferred due to following shortcomings:
F.No.10-7/2020-OTC) (M-79)
Page 405 of 408
S.No Brand name Decision
(1) (2) (3)
Avabact Sachet
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus acidophilus, Lactobacillus
rhamnosus, Bifidobacterium lactis, Bifidobacterium bifidum are not
provided.
iii. Master formula is not correct.
3111. Avanza’s
Blife Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Saccharomyces boulardii is not provided.
iii. Master formula is not correct
3112. Avanza’s
Beciga Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus gasseri is not provided.
iii. Master formula is not correct.
3113. Avanza’s
Prozin Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus acidophilus, Lactobacillus bulgaricus,
Bifidobacterium bifidum, Bifidobacterium infantis, Lactobacillus
plantarum , Lactobacillus rhamenosus, Lactobacillus casei are not
provided.
iii. Master formula is not correct.
3114. Avanza’s
Hiflora Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus acidophilus, Lactobacillus
rhamnosus, Bifidobacterium lactis, Bifidobacterium bifidum are not
provided.
iii. Master formula is not correct.
3115. Avanza’s
Probery Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Bacillus coagulans, Turmeric Extract, Cranberry
Extract are not provided.
iii. Master formula is not correct.
3116. Avanza’s
ReuFlora Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus reuteri is not provided.
iii. Master formula is not correct.
3117. Avanza’s
Progut Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Clostridium butyricum , Bifidobacterium are not
provided.
iii. Master formula is not correct.
3118. Avanza’s
Probest sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
F.No.10-7/2020-OTC) (M-79)
Page 406 of 408
S.No Brand name Decision
(1) (2) (3)
ii. Official monograph of Lactobacillus acidophilus, Bifidobacterium lactis,
Lactobacillus sporogenes, Fructooligosacharide are not provided.
iii. Master formula is not correct.
3119. Avanza’s
Prolact Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus acidophilus is not provided.
iii. Master formula is not correct.
3120. Avanza’s
Prozion sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus acidophilus, Bifidobacterium lactis,
Lactobacillus plantarum , Fructooligosacharide are not provided.
iii. Master formula is not correct.
3121. Avanza’s
Osmo-z Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Saccharomyces boulardii is not provided.
iii. Master formula is not correct.
3122. Avanza’s
InfaPro Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus rhamnosus, Saccharomyces boulardii
are not provided.
iii. Master formula is not correct.
3123. Avanza’s
Reuten Sachet
Deferred due to following shortcomings:
i. Weight of each sachet is not provided.
ii. Official monograph of Lactobacillus reuteri, Lactobacillus rhamnosus,
Saccharomyces boulardii are not provided.
iii. Master formula is not correct.
M/s Pharmevo (Private) Ltd,
A-29, North Western Industrial Zone, Port Qasim, Karachi
3124. Greni soft-gels capsule
Deferred for justification of formulation
3125. VellusSoftgel Capsule
Deferred for justification of formulation
M/s Nutra Biomed (Pvt.) Ltd.
Plot No. 17, Street No. E-3, National Industrial Zone, Rawat, Islamabad
3126. Nutra Biomed’s
POLYCID Syrup
Deferred till the finalization of guidelines for processing of applications of
products containing common molecules being dealt by Division of PE&R and
H&OTC.
3127. Nutra Biomed’s
APPIT Syrup
Deferred for justification of formulation
F.No.10-7/2020-OTC) (M-79)
Page 407 of 408
S.No Brand name Decision
(1) (2) (3)
3128. Nutra Biomed’s
DK GOLD Vitamin Spray
.
Dosage form justification
3129. Nutra Biomed’s
MY SLEEP Spray
Deferred till the finalization of guidelines for processing of applications of
products containing common molecules being dealt by Division of PE&R and
H&OTC.
Justification of formulation
3130. Nutra Biomed’s
GARSLIM Spray
Deferred for justification of dosage form
3131. Nutra Biomed’s
EATO Syrup
Deferred for justification of formulation
3132. Nutra Biomed’s
NEURO 6 Spray
Deferred for justification of dosage form
F.No.10-7/2020-OTC) (M-79)
Page 408 of 408
S.No Brand name Decision
(1) (2) (3)
M/s Suas Pharmaceuticals (01032)
Suite 338, 3rd Floor, Land Mark Plaza, 5/6 Jail Road, Lahore
Agent of M/s Natural Fervor Inc., 17801-J, Sky Park Circle, Irvine, California, USA (Principal Manufacturer M/s NHK Laboratories, Inc., 12230
E, Florence Ave, Santa Fe Springs, California 90670, USA)
3133. Suas Pharmaceuticals’
Megaton Gold Tablet
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Form-5) rather
submitted on Form-5 (A) that is from registration of drugs.
The product contains N-Acetyl Cysteine.
Method of assays of actives from finished product, not provided.
Accelerated and real time stability studies data of three batches according to
conditions of Zone IVA, not provided.
The name of the product mentioned on free sale certificate is Megaton Gold
(R) Tablet.
Brand name undertaking, not provided.
3134. Suas Pharmaceuticals’
Vigormax Plus Capsule
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Form-5) rather
submitted on Form-5 (A) that is from registration of drugs.
Method of assays of actives from finished product, not provided.
Accelerated and real time stability studies data of three batches according to
conditions of Zone IVA, not provided.
The name of the product mentioned on free sale certificate is Vigormax Plus
(R) For Men Capsule.
Brand name undertaking, not provided.
3135. Suas Pharmaceuticals’
Libizire Capsule
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Form-5) rather
submitted on Form-5 (A) that is from registration of drugs.
Method of assays of actives from finished product, not provided.
Accelerated and real time stability studies data of three batches according to
conditions of Zone IVA, not provided.
The name of the product mentioned on free sale certificate is Libizire (R)
Capsule.
Brand name undertaking, not provided.
3136. Suas Pharmaceuticals’
Garcitrim Capsule
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Form-5) rather
submitted on Form-5 (A) that is from registration of drugs.
Method of assays of actives from finished product, not provided.
Accelerated and real time stability studies data of three batches according to
conditions of Zone IVA, not provided.
The name of the product mentioned on free sale certificate is Garcitrim (R)
Capsule.
Brand name undertaking, not provided.
3137. Suas Pharmaceuticals’
Glow-N-Grow Advance Tablet
Deferred since the application is deficient of following documents/Information;
Application has not been submitted on prescribed form (Form-5) rather
submitted on Form-5 (A) that is from registration of drugs.
Method of assays of actives from finished product, not provided.
Accelerated and real time stability studies data of three batches according to
conditions of Zone IVA, not provided.
The name of the product mentioned on free sale certificate is Glow-N-
Grow(R) Advance Tablet.
Brand name undertaking, not provided.
(Muhammad Abdul Ghaffar)
Secretary, EEC