kerala medical services corporation ltd., notice...kmscl – e-tender fot the procurement of...

…………………………………………………………………………………………………………………………………………………………………………………………………….

KMSCL – e-tender fot the Procurement of Speciality Drugs for the year 2019-20 of 13

KERALA MEDICAL SERVICES CORPORATION LTD., (Dept. of Health & Family Welfare, Govt. of Kerala)

Thycaud P.O., Thiruvananthapuram-14 Tele Fax No : 0471-2945647,

0471-2337353, 0471-2945646 Email id : [email protected] CIN-U24233KL2007SGC021616

Essential Drugs www.kmscl.kerala.gov.in No. KMSCL/DRG/ED/833/2018(4) Date : 22.01.2019

NOTICE

(SPECIALTY DRUGS)

Sub :- KMSCL – E-tender for the Procurement of Specialty Drugs for the year 2019-20 – Technical Bid Evaluation – Defects noticed/status– Published – reg.

Ref :- 1. E-tender No. KMSCL/DRGED/SPL/RC/2018/017 Dated 21.11.2018. 2. Amendment notices no. KMSCL/DRG/ED/833/2018(4) dated 03.12.2018. 3. Amendment notices no. KMSCL/DRG/ED/833/2018 dated 05.12.2018.

Technical bids submitted in response to the e-tender referred above for the

procurement of Specialty Drugs for the year 2019-20 were opened on 26.12.2018 and

scrutinized. The status is published below.

All the bidders are directed to verify the details of their offered items in the notice

published.Complaints/suggestions/representations, if any, on this notice shall be submitted to

the Tender Inviting Authority in writing on or before 5pm on 31.01.2019.

Sl. No

Drug Code Drug Name Strength Unit

Defects noticed and Status

Bid No. 1 M/s. Boehringer Ingelheim India Pvt. Ltd, Mumbai

1 D12030 ALTEPLASE INJ 50mg Vial

Submitted the required documents

2 D13074 DABIGATRAN CAP 110mg 1 No

Bid No. 2 M/s. Mylan Pharmaceuticals Private Limited, Bangalore

1. D08018 AMPHOTERICIN B LIPOSOMAL INJ 50mg Vial

Submitted the required documents

…………………………………………………………………………………………………………………………………………………………………………………………………….


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Drug Code

Drug Name Strength Unit Defects noticed and Status

Bid No. 3 M/s. AstraZencea Pharma India Ltd, Bangalore

1. D13091 TICAGRELOR TAB 90mg 1 No

1) Market Standing Certificate submitted is issued for the purpose of participating in the tenders invited by ESI Corporation, New Delhi.

2) Performance statement(Annex-IV) submitted is not in the tendered format.

3) Balance sheet and Profit & Loss statement for the year 2017-18 submitted is not attested by Notary Public.

Bid No. 4 M/s. Intas Pharmaceuticals Limited, Ahmedabad

1. D13069 ATORVASTATIN TAB IP 40 mg 1 No

Submitted the required documents.

2. D29008

BOTULINUM TOXIN A INJ (FREEZE-DRIED POWDER FOR INJECTION)

100 units vial

3. D17062 DONEPEZIL TAB IP 10 mg 1 No

4. D32001 MYCOPHENOLATE MOFETIL TAB IP 500 mg 1 No

5. D13094 ROSUVASTATIN TAB IP 10 mg 1 No

6. D21020/

12 IV GAMMAGLOBULIN INJ 5 gm Vial

Bid No.5 M/s. Biocon Limited, Bangalore

1 D14056 TACROLIMUS OINTMENT

0.1%w/w

10 gm tube

Notary attested copy of Balance sheet and Profit & Loss statement for the year 2015-16 not submitted.

Bid No. 6 M/s. Baxter (India) Pvt. Ltd, Haryana

1 D04028 SEVOFLURANE LIQUID 250 ML BOTTL

E

Market standing certificate submitted is issued for the purpose of participating in the tenders invited by Railway.

…………………………………………………………………………………………………………………………………………………………………………………………………….


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Bid No. 7 M/s. Fresenius Kabi India Pvt Ltd, Pune

1. D08023 FLUCONAZOLE INFUSION BP

200mg/ 100 ml

100 ml bottle

1) Notary attested copy of WHO-GMP certificate not submitted.

2) Notary attested copy of original manufacturing license No PD/LVP/1 not submitted.

3) The purchase order issued by the tender inviting authority for D08023- Fluconazole Infusion BP 200mg/100 ml for the year 2018-19 was cancelled due to non-supply.

Bid No. 8 M/s. Unicure India Ltd, Roorkee

1. D17063 AMISULPRIDE TAB IP 100Mg 1 No

Monograph specification not mentioned in the product permit and market standing certificate submitted.

Bid No. 9 M/s. Bharat Serums and Vaccines Limited, Mumbai

1 D08018 AMPHOTERICIN B LIPOSOMAL INJ 50MG Vial

1) Monograph specification not mentioned in the product permit submitted for D16029- HCG (Human Chorionic Gonadotropin) Inj IP 5000 IU Vial

2) Market standing certificate not submitted for the following;

a) D16029- HCG (Human Chorionic Gonadotropin) Inj IP 5000 IU Vial

b) D16030-HMG(Human Menopausal Gonadotropin ) Inj 75IU Vial

3) Product approval submitted is for “Menotrophin BP” for D16030- HMG (Human Menopausal Gonadotropin) Inj 75IU Vial

2 D16029

HCG (HUMAN CHORIONIC GONADOTROPIN) INJ IP

5000 IU Vial

3 D16030 HMG ( HUMAN MENOPAUSAL GONADOTROPIN ) INJ

75IU Vial

…………………………………………………………………………………………………………………………………………………………………………………………………….


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Drug Code


4) Certificate to prove 3 year Market standing not submitted for D08018- Amphotericin B Liposomal Inj 50mg Vial

5) Performance statement in Anx IV not submitted for the quoted items.

Bid No. 10 M/s. NANZ MEDSCIENCE PHARMA PVT. LTD, HP

1. D02102 CLINDAMYCIN GEL 1% 15 gm Details of 5 batches is not mentioned in the performance statement (Anx IV) submitted for D14051- Mometasone Furoate Cream IP 0.1% w/w, 10gm tube 2. D14060

CLOBETASOL PROPIONATE + SALICYLIC ACID OINTMENT

0.05% w/w + 3.00%

w/w

20 gm Tube

3. D14051 MOMETASONE FUROATE CREAM IP

0.1% w/w

10 gm Tube

Bid No. 11 M/s. Emcure Pharmaceuticals Limited, Pune

1. D32001 MYCOPHENOLATE MOFETIL TAB IP

500mg 1 No.

1) Monograph specification not mentioned in the bid offer form (Anx II) submitted for D13084- Nicorandil Tab IP 5mg

2) Monograph specification not mentioned in the bid offer form (Anx II) and product permit submitted for D13072- Cilnidipine Tab IP 10 mg

3) Market standing certificate submitted is not issued for the purpose of participating in the tenders invited by KMSCL or in general terms for all the quoted items.

2. D32002 TACROLIMUS CAP IP 1MG 1 No.

3. D13072 CILNIDIPINE TAB IP 10 mg 1 No

4. D13084 NICORANDIL TAB IP 5mg 1 NO

Bid No. 12 M/s. VERVE HUMAN CARE LABORATORIES, Uttarakhand

1. D01052 MORPHINE SULPHATE TAB IP

10 mg 1 no

Submitted the required

documents.

…………………………………………………………………………………………………………………………………………………………………………………………………….


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Drug Code


Bid No. 13 M/s. Piramal Enterprises Limited, Mumbai

1. D04028 SEVOFLURANE LIQUID 250ML BOTTLE

Noatary attested copy of original manufacturing license in Form 25 not submitted.

Bid No. 14 M/s. Virchow Biotech Pvt. Ltd, Hyderabad

1. D21020

/12 IV GAMMAGLOBIN INJ 5GM VIAL Submitted the required

documents.

Bid No. 15 M/s. Bharat Parenterals Ltd, Gujarat

1 D13069 ATORVASTATIN TAB IP 40mg 1 no.

1) Monograph specification not mentioned in the bid offer form (Anx II) and Product permit submitted for D13069- Atorvastatin Tab IP 40mg

2) Product permit submitted for D13069- Atorvastatin Tab 40mg “for export purpose only”.

3) Market standing certificate not submitted for D13069- Atorvastatin Tab IP 40mg.

4) Performance statement in Anx IV for the quoted items, Details of technical persons employed and details of manufacturing units submitted is not attested by Notary Public.

5) Declaration in Anx V submitted is not in the non-judicial stamp paper of Rs.200/-.

2 D02096 MEROPENEM INJ IP 1gm vial

Bid No. 16 M/s. Baxalta Bioscience India Private Limited,

1. D12018 HUMAN ALBUMIN INJ IP 20% 100 ml


documents.

…………………………………………………………………………………………………………………………………………………………………………………………………….


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Drug Code


Bid No. 17 M/s. Cipla Limited

1 D08018 AMPHOTERICIN B LIPOSOMAL INJ 50mg Vial

1) Tendered monograph not mentioned in the bid offer form (Anx II) submitted for the quoted items.

2) Tendered monograph not mentioned in the product permit submitted for the following;

a) D08023- Fluconazole Infusion BP (product permit for USP submitted)

b) D13087- Olmesartan Tab IP 40mg (product permit for BP submitted)

c) D09008- Entecavir Tab IP 0.5 MG

d) D17068- Lamotrigine Tab BP/USP 50 mg (IP submitted)

e) D16034- Misoprostol Tab IP 25 mcg

f) D13073- Cilostazol Tab IP 50 mg (product permit for USP submitted)

3) Product permit submitted is for “Tablets” instead of “Capsules” for D21056- Tamsulosin + Dutasteride Cap 0.4 mg + 0.5 mg.

4) Brand name only mentioned in the product permit submitted for the following;

a) D14057- Terbinafine Cream IP 1% 10gm tube

b) D14052- Nadifloxacin Gel IP 1% 10 gm tube

5) Tendered pack size is not mentioned

2 D13069 ATORVASTATIN TAB IP 40 mg 1no

3 D03026

BUDESONIDE AND FORMOTEROL FUMARATE POWDER FOR INHALATION IP

100MCG +

6MCG Rotacap

1 no

4 D03028 CAFFEINE CITRATE INJ BP/USP

20mg/ml 3 ml Vial

5 D13073 CILOSTAZOL TAB IP 50 mg 1 NO

6 D02103 COLISTIMETHATE INJ IP

3 miu Vial

7 D21046 DARIFENACIN TAB 7.5 mg 1 NO

8 D17062 DONEPEZIL TAB IP 10mg 1 No

9 D21047 DUTASTERIDE CAP IP 0.5 mg 1 no

10 D09008 ENTECAVIR TAB IP 0.5 MG 1 NO

11 D16028 ETHINYL ESTRADIOL + CYPROTERONE ACETATE TAB

35 mcg+ 2mg

1 no

12 D21049 FINASTERIDE TAB IP 5 MG 1 NO

13 D08023 FLUCONAZOLE INFUSION BP

200mg/100 ml

100 ml bottle

14 D14050 ISOTRETINOIN TAB 10mg 1 NO

15 D09009 LAMIVUDINE TAB IP 100 MG 1 NO

16 D17068 LAMOTRIGINE TAB BP/USP

50 mg 1 NO

…………………………………………………………………………………………………………………………………………………………………………………………………….


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Drug Code


17 D13083 METOPROLOL INJ IP 1mg/ml 5ml Amp in the product permit submitted for D03028- Caffeine Citrate Inj BP/USP 20mg/ml, 3 ml Vial

6) Market standing certificate not submitted for the following;

a) D17062- Donepezil Tab IP 10mg

b) D14050- Isotretinoin Tab 10mg

c) D14052- Nadifloxacin Gel IP 1%, 10gm tube

d) D07031- Oxcarbazepine Tab IP 300 mg

7) Noatry attested copy of WHO- GMP not submitted for the flowing loan license units;

a) M/s.Pegasus Franco India Ltd.

b) M/s.Softgel Healthcare Pvt Ltd

c) M/s.Akums Drugs and Pharmaceuticals Ltd

d) M/s.AditiPharmaceuticals.

8) Non-conviction certificate not submitted for the following manufacturing units;

a) M/s.Golden Cross, Sikkim

b) M/s.Softgel Healthcare Pvt Ltd

c) M/s. AXA Parenterals.

9) Notary attested copy of valid renewal certificate of Loan licence in Form 26-A 148/UA/LL/SC/P-2007 not submitted.

10) The purchase orders issued by the tender inviting authority for D08018-Amphotericin B Liposomal Inj 50mg & D02110- Teicoplanin Inj IP 400mg

18 D16034 MISOPROSTOL TAB IP 25 mcg 1 no

19 D14052 NADIFLOXACIN GEL IP 1% 10 gm tube

20 D13087 OLMESARTAN TAB IP 40 MG 1 NO

21 D07031 OXCARBAZEPINE TAB IP

300 mg 1 no

22 D21056 TAMSULOSIN + DUTASTERIDE CAP

0.4 mg + 0.5 mg

1 No

23 D21057 TAMSULOSIN TAB 0.4 MG 1 NO

24 D02110 TEICOPLANIN INJ IP 400 mg Vial

25 D14057 TERBINAFINE CREAM IP

1% 10gm tube

26 D21059 TOLTERODINE TARTRATE TAB IP

2 mg 1 NO

27 D19010 TORSEMIDE TAB IP 10 MG 1 NO

28 D19009 TORSEMIDE TAB IP 20 mg 1No

29 D17032 VENLAFAXINE TAB BP/USP

75 mg 1 No

30 D08042 VORICONAZOLE TAB IP

200 mg 1 NO

…………………………………………………………………………………………………………………………………………………………………………………………………….


Sl. No

Drug Code


were cancelled due to non-supply.

Bid No. 18 M/s Abbott India Limited, Mumbai

1. D16027 DYDROGESTERONE TAB IP

10 MG 1 NO 1) Bid offer form (Anx II) submitted for

D16027- Dydrogesterone Tab IP 10 MG is in “BP” specification instead of tendered specification of “IP”.

2) Notary attested copy of valid manufacturing license No.13233725 (Sterile-Gene Life science Pvt Ltd) not submitted.

3) Product permit submitted is for “300ml” instead of tendered pack size of “200ml” for D20043- Lactulose Enema 20% w/v, 200ml

4) Brand name only mentioned in the product permit and market standing certificate submitted for D03032- Surfactant(Sterile Intratracheal Suspension) Inj 4ml Vial

5) Market standing certificate submitted is issued for the purpose of participating in the tenders invited by ESI Corporation for D16027- Dydrogesterone Tab IP 10 MG.

6) The purchase order issued by the tender inviting authority for D16027- Dydrogesterone Tab IP 10Mg was cancelled due to non-supply.

2. D20043 LACTULOSE ENEMA 20% w/v 200 ml

3. D04028 SEVOFLURANE LIQUID 250 ml Bottle

4. D03032 SURFACTANT (STERILE INTRATRACHEAL SUSPENSION) INJ

4ml Vial

Bid No. 19 M/s. Reliance Life Sciences Pvt. Ltd., Mumbai

1. D12018 HUMAN ALBUMIN INJ IP 20% 100ml


2. D21020/12

IV GAMMAGLOBULIN INJ 5gm Vial

…………………………………………………………………………………………………………………………………………………………………………………………………….


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Drug Code


Bid No. 20 M/s. MAAN PHARMACEUTICALS LTD, Ahmedabad

1. D02100 CEFTAZIDIME INJ IP 1 gm Vial

Submitted the required documents. 2. D22031 MECOBALAMINE TAB 500mcg 1 NO

3. D02096 MEROPENAM INJ IP 1gm Vial

Bid No. 21 M/s. AUROLAB, Madurai

1 D15054 SILICON OIL INJ 1000 CST 10ML

Valid WHO-GMP certificate not submitted, only application for renewal submitted. 2 D15075

TRYPAN BLUE FOR INTRACAMERAL INJ

0.06% w/v

1ml Glass vial

Bid No. 22 M/s. Gennova Biopharmaceuticals Ltd, Pune

1. D12037 TENECTEPLASE INJ 40 mg Vial


documents.

Bid No. 23 M/s. CIRON DRUGS & PHARMACEUTICALS PVT LTD, Mumbai

1. D09001 ACYCLOVIR INTRAVENOUS INFUSION IP

250 mg Vial


2. D03028 CAFFEINE CITRATE INJ BP/USP

20mg/ml

3 ml Vial

3. D07029 FOSPHENYTOIN INJ

Each ml contains

; Fosphenytoin

Sodium 75mg

equivalent to

Phenytoin

Sodium 50mg

2ml Vial

4. D07027 LEVETIRACETAM INJ 100mg/ml

Amp

5. D12035 MEPHENTERMINE INJ IP

30 MG/ml

10 ML vial

…………………………………………………………………………………………………………………………………………………………………………………………………….


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Drug Code


6.

D29006 PHENYLEPHRINE INJ IP

10mg/ml

1 ml Amp

7. D13069 ATORVASTATIN TAB IP

40 mg 1no

Bid No. 24 M/s. Pulse Pharmaceuticals Pvt Ltd, Hyderabad

1. D05027 LEVOCETIRIZINE TAB IP

5mg 1 No


documents. 2. D22031 MECOBALAMINE TAB 500mcg 1 No

3. D13094 ROSUVASTATIN TAB IP

10mg 1 No

Bid No. 25 M/s. Ravian Life Science Pvt Ltd, Haridwar

1. D05027 LEVOCETIRIZINE TAB IP

5mg 1 No

1) Notary attested copy of market standing certificate is not submitted for D13094 - Rosuvastatin Tab IP 10mg

2) Tendered monograph is not mentioned in the market standing certificate submitted for D32001- Mycophenolate Mofetil Tab IP 500mg

2. D32001 MYCOPHENOLATE MOFETIL TAB IP

500 mg 1 No

3. D13094 ROSUVASTATIN TAB IP

10mg 1 No

4. D01054 TRAMADOL+ PARACETAMOL TAB

37.5mg+325m

g 1 No

5. D08042 VORICONAZOLE TAB IP 200 mg 1 No

6. D07031 OXCARBAZEPINE TAB IP 300 mg 1 No

7. D13069 ATORVASTATIN TAB IP 40 mg 1 No

Bid No. 26 M/s. VIVEK PHARMACHEM (INDIA) LIMITED, Jaipur

1. D02096 MEROPENAM INJ IP 1 gm Vial


documents.

Bid No. 27 M/s. Midas Care Pharmaceuticals Pvt. Ltd, Mumbai

1. D04035 LIGNOCAINE SPRAY 10% 50ml BOTTLE


documents. 2. D03033 TIOTROPIUM BROMIDE

INHALER 9 mcg 120 MD

…………………………………………………………………………………………………………………………………………………………………………………………………….


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Drug Code


Bid No. 28 M/s. Samarth Life Sciences Pvt. Ltd, Mumbai

1. D08019 ARTESUNATE INJ IP 60mg Vial 1) Tendered monograph not mentioned

in the market standing certificate submitted for the following;

a) D08019- Artesunate Inj IP 60mg Vial

b) D13077- Esmolol Inj IP 10 mg/ml, 10ml

2. D13077 ESMOLOL INJ IP 10

mg/ml 10ml

3. D21050 L ORNITHINE L ASPARTATE INFUSION

5 gm/10m

l Amp

4. D29006 PHENYLEPHRINE INJ IP

10mg/ml

1 ml amp

5. D13025 SODIUM NITROPRUSIDE INJ IP 50 MG Vial

6. D02110 TEICOPLANINE INJ IP 400 mg Vial

7. D02111 TIGECYCLINE INJ 50 MG Vial

Bid No. 29 M/s. Synokem Pharmaceuticals Limited, New Delhi

1. D17063 AMISULPRIDE TAB IP 100 MG 1NO 1. Details of 5 batches not mentioned in

the performance statement (Anx IV) submitted for D21058- Teneligliptin Tab 20mg

2. The firm was blacklisted by Haryana Medical Services Corporation Limited (HMSCL) from upto 06.12.2020 Endst.No.3/4A170(T&IT)HMSCL/2016/0489-98dated 07.12.2017

2. D07031 OXCARBAZEPINE TAB IP 300 MG 1 NO

3. D13094 ROSUVASTATIN TAB IP 10MG 1 NO

4. D21058 TENELIGLIPTIN TAB 20 MG 1 NO

Bid No. 30 M/s. Venus Remedies Ltd, HP

1. D02099 AZTREONAM INJ USP 1gm Vial Tendered monograph is not mentioned in the market standing certificate submitted for the quoted items.

2. D02096 MEROPENAM INJ IP 1gm Vial

Bid No. 31 M/s. GLENMARK PHARAMCEUTICALS LIMITED, Mumbai

1. D13073 CILOSTAZOL TAB IP 50 mg 1 NO

Market standing certificate submitted is issued for the purpose of participating in 2. D02065

CLARITHROMYCIN TAB IP 500mg 1 No

…………………………………………………………………………………………………………………………………………………………………………………………………….


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3. D21058 TENELIGLIPTIN TAB 20 MG 1 NO the tenders invited by TNMSCL for D21058- Teneligliptin Tab 20 MG

Bid No. 32 M/s. Gufic Biosciences Ltd, Mumbai

1. D02103 COLISTIMETHATE INJ IP 3 MIU Vial 1) Tendered monograph not mentioned

in the bid offer form (Anx II) submitted for the following;

a) D02103- Colistimethate Inj IP 3 MIU, Vial

b) D16029- HCG (Human Chorionic Gonadotropin) INJ IP 5000 IU Vial.

c) D02110- Teicoplanin Inj IP 400 mg Vial

2) Notary attested copy of original manufacturing license no. G/64 not submitted.

3) Product approval submitted is for “Menotrophin IP” for D16030- HMG (Human Menopausal Gonadotropin) Inj 75IU Vial

4) Product approval submitted is for “Chorionic Gonadotropin Inj IP” for D16029- HCG (Human Chorionic Gonadotropin) Inj IP 5000 IU Vial.

5) Notary attested copy of market standing certificate is not submitted for the following;

a) D02103- Colistimethate Inj IP 3 MIU, Vial

b) D16029- HCG (Human Chorionic Gonadotropin) Inj IP 5000 IU Vial

c) D16030- HMG (Human Menopausal Gonadotropin) Inj 75 IU Vial

2. D02105 DOXYCYCLINE INJ 100 mg Vial

3. D16029

HCG (HUMAN CHORIONIC GONADOTROPIN) INJ IP

5000 IU Vial

4. D16030 HMG (HUMAN MENOPAUSAL

GONADOTROPIN) INJ 75 IU Vial

5. D02110 TEICOPLANIN INJ IP 400 mg Vial

6. D02111 TIGECYCLINE INJ 50 mg Vial

…………………………………………………………………………………………………………………………………………………………………………………………………….


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6) Market standing certificate submitted is not attested by Notary Public for the following;

D02111- Tigecycline Inj 50 mg Vial

D02105- Doxycycline Inj 100mg Vial

7) Performance statement in not submitted for any of the quoted products in the format specified in the tender document (Annex-IV)

8) Notary attested Declaration (Anx V) in the non-judicial stamp paper of Rs.200/- not submitted.

9) The details of manufacturing units (Annex-VII) submitted is not notary attested.

Sd/-

MANAGING DIRECTOR(I/C) KERALA MEDICAL SERVICES CORPORATION LTD.

(TENDER INVITING AUTHORITY)

kerala medical services corporation ltd., notice...kmscl – e-tender fot the procurement of...

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