2 i'l101z, !··,i e t. y - cdsco.nic.in form 10... · andheeri (e), mumbai-400093,...

Central Drugs Standard Control OrganisationDirectorate General of Health Services

Ministry of Health & Family Welfare(Medical Device and Diagnostic Division)

Food and Drug Administration BhawanKotla Road, New Delhi-11 0002

Dated: 2 r:: !' f ..•. { I'l101Z" " ,) r " ",y !"··,i e t. '!

To~ Instrumentation Laboratory India Pvt. Ltd.,

Property No. 21, IInd Floor, Rama Road, Najafgarh Road, New Delhi-110015.

SUbject: Issue of an Endorsement No. 01 to Form 10 License No. NCD-255/11 dated22.09.2011 valid upto 21.09.2014 -regarding.

Please refer to your application No. Nil dated 16.03.2012 received by this office vidediary No. 11489 (FTS No.18627) dated 19.03.2012, regarding the above cited subject.

Endorsement No. 01, to Form 10 License No. NCD-255/11 dated 22.09.2011 validupto 21.09.2014 for the import of drugs manufactured at Mis. InstrumentationLaboratory SpA, V.le Monza 338-20128Milan, Italy having factory premises at Mis.Instr~mentation Laboratory Company, 180 Hartwell Road Bedford~f. 01730-2443,USA IS enclosed hereby. ._.,""II(\':\t (~~(C),\ '

(&)t \:1 \J 1:,.;' \b-.>

The other conditions of the license will remain same.

Yours mi~IIY

(Dr. G.~ingh)Drugs Controller General (I)

FORM 10(Endorsement No. 01)(See Rules 23 and 27)

Licence to import drugs (excluding those specified in Schedule X) to the Drugs andCosmetics Rules, 1945

Mis. Instrumentation Laboratory India Pvt. Ltd.• Property No. 21. IInd Floor, RamaRoad, Najafgarh Road. New Delhi-110015 is hereby licensed to import into India during theperiod for which the licence is in force, the drugs specified below, manufactured by Mis.Instrumentation Laboratory SpA. V.le Monza 338-20128 Milan, Italy having factorypremises at Mis. Instrumentation Laboratory Company, 180 Hartwell Road Bedford, MA01730-2443.USA.

2. This Endorsement No. 01 shall be in force fr&n 5 /\PH 201Z to 21.09.2014unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be irnPort

Produc;l"'·Antithrombin10tlFxa71 n KatS-2222 (Chrotl"1SubstrateS-2765 (Chrosubstrate

semination of heparin in

S.No1.2.3.

uthorityS aI/Stamp

Dr. G. N. SINGH .s controller General (India)

1. A photocopy<>tligeD(;~i~ .ace ~g~e~unfe~ervices

2. ~~c~i~~~~~~~<~~~g~iZ~~~~dinto India shall be ac~ompanied~ft~\1~~~~1;iit5~~~·~:etest report and a batch release certificate, duly signed and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchreports. The imported batch of each drug shall be sUbjected to examination andtesting as the licensing authority deems fit prior to its marketing.

3. The licensee shall be responsible for the business activities of the manufacturer inIndia along with the registration holder and his authorised agent.

4. The licensee shall inform the licensing authority forthwith in writing in the event ofany change in the constitution of the firm operating under the licence. Where anychange in the constitution of the firm takes place, the current licence shall bedeemed to be valid for a maximum period of three months from the date on whichthe change takes place unless, in the meantime, a fresh licence has been takenfrom the licensing authority in the name of the firm with the changed constitution.



Food and Drug Administration BhawanKotla Road, New Delhi·110002

Dated: 2 c:. ..P, ):1:) ?OlZ".,1 ,,,. ,\ <L.

To .LJ'!.I/~.Lilac Medicare (P) Ltd.,8, Sungold, 303, Sher-E-Punjab, Mahakali Caves Road,Andheeri (E), Mumbai-400093, Maharashtra.

Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945thereu nder-regarding.

Sir,1. With reference to your application for import licence forwarded to this office with

your letter No. Nil dated 02/03/2012 recieved by this office vide diary No. 9143(FTS

2 t:J0.!~pJ36h OliWted. 05/03/2?12, I enclose licence(s) No. NCD-59/12 dated.} hi t'{ l. 1£ thIS1these hcence(s) has 1have been granted under the Drugs andCosmetics Act 1940 and Rules1945 thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 andRules1945 are in addition to and not derogation o.f.SIN other law for the time beingin force and as such the Iicence(s) issued urwA'Orags and Cosmetics Act andRules will be in addition to and distinct fro~n~~nce(s) which may be necessaryunder the Import Trade Control.R~. ~~);§ made of the Government of India,Ministry of Commerce. ((~'\f~

3. The import licence(s) mentioned lW para (1) above will not accordingly to itself 1themselves be sufficient authority for import of Drugs covered by that 1 thoselicence(s) if under the Import Trade Control Regulations of the Commerce Ministryseparate Iicense(s) are required for import of such drug(s).

4. I am therefore, to advise you to obtain, where necessary licence(s) for import ofdrugs in question under the Import Trade Control Regulations.

5. Any literature or packing accompanying the drugs or any matter stated on the labelshould not contravene the provisions of the Drugs and Magic Remedies(Objectionable Advertisement) Act.

6. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

7. Please acknowledge receipt of this letter and its enclosures.

YJtrs faithfully

(Dr. . N. Singh)Drugs Controll General (I)

FORM 10(See Rules 23 and 27)


Licence Number: NCD-59/12 Date: 2 S IAPR 2012Mis. Lilac Medicare (P) Ltd., 8, Sungold, 303, Sher-E-Punjab, Mahakali Caves Road,Andheeri (E), Mumbai-400093, Maharashtra is hereby licensed to import into India duringthe period for which the licence is in force, the drugs specified below, manufactured at Mis.Viro-Immun Labor-Diagnostika GmbH, In der Au 29, 61440 Oberursell Germany and anyother drugs manufactured by the said manufacturer as may from time to time be endorsed onthis licence. 2 ,:r: ()

2. This licence shall be in force fror;," n 2012 to 2. !; ;!, '2&tiI~ss it is soonersuspended or cancelled under the said rules.

3. Names of dn .•g~n~(.lt?~iAs per attached:1 /"'ic:;;ensi Authority

2 ,'.f".;+>"'. .' .....- "',

sing AuthoritySeal/StampDr G. N. SINGH

Diugs co~troller General (I~dia)ace dQ ~rraartf ah'h~ervlces

Miri~' f Health & Family Welfarere'1~F'D;!ABJiilY'Wn Kotla Road, 1.1.0.ith a' a~ijdhbabowuthenticated by theof forwarding such

to examination and

1. A photocopypremises, an

2. Each batch 0test report amanufacturer Wireports. The irt)testing as theIjg ' '.,

3. The licensee shall De responsible for the business actlvi les of the manufacturer inIndia along with the registration holder and his authorised agent.

4. The licensee shall inform the licensing authority forthwith in writing in the event ofany change in the constitution of the firm operating under the licence. Where anychange in the constitution of the firm takes place, the current licence shall bedeemed to be valid for a maximum period of three months ·from the date on whichthe change takes place unless, in the meantime, a fresh licence has been takenfrom the licensing authority in the name of the firm with the changed constitution.

Licence Number: NCD·59/12

This licence shall be in force from 2 t~ i\; ':'\ lOll toNames of drugs to be imported

2 Q. IApa 2015

S. No. Product Name Intended Use

Immunfluorescence objekttrager

1. ICA For the semiquantitative detection of IgG-specific islet cell antibodies inhuman serum and plasma.

2. HMA For the semiquantitative detection of polyvalent myocardial antibodies inhuman serum and plasma.

3. NNA For the detection of Adrenal glands polyvalent antibodies in human serumand plasma.

4. ASA For the semiquantitative detection of IgG-specific Pemphigus PemhigoidAntibodies in human serum and plasma.

5. AMA For the semiquantitative detection of Polyvalent Antimitochondrial-Antibodies in human serum and plasma.

6. ASMA For the semiquantitative detection of polyvalent anti-smooth muscleantibodies in human serum and plasma.

7. ANA / AMA / For the semiquantitative detection of polyvalent ts~/ ASMAandASMA/ APCA APCAin human serum and plasma. "i;' \,(~t_

-("'\'~~Immunfluorescence t~'.~

8. Masern - Virus For the quantitative determination of antibodies to Measles virus inhuman serum and plasma.

9. Mumps - Virus For the semiquantitative determination of antibodies against Mumps Virusin human serum and plasma.

10. Varicella-Zoster- For the semiquantitative determination of IgG-specific, IgM-specificVirus Antibodies to Varizella Zoster Virus in human serum and plasma.

11. Respiratory - For the semiquantitative determination of IgG-specific Antibodies toSyncytial - Virus Respiratory Syncytial Virus in human serum and plasma.Epstein • Barr·

For the semiquantitative determination of Antibodies to Epstein Barr virus12. Virus - VCA - IgG,IgM in human serum and plasma.

13. Herpes - Simplex For the semiquantitative determination of antibodies against Herpes- Virus I Simplex Virus Type 1 in human serum and plasma.

14. Herpes - Simplex For the semiquantitative determination of antibodies against Herpes- Virus II Simplex Virus Type 2 in human serum and plasma.

15. Cytomegalovirus For the semiquantitative determination of Antibodies against Cytomegalo- IgG, IgM Virus in human serum and plasma.Chlamydia

For the quantitative determination of IgG-specific, IgM-specific Antibodies16. Trachomatis -IgG,lgM to Chlamydia Trachomatis in human serum and plasma.

17. ICA For the semiquantitative detection of IgG-specific islet cell antibodies inhuman serum and plasma.

~)r G \'4,SINGH ,

;/ r. ' General (India)Drugs ontr~l\er Services

2 4 APt{ 20\5

18. HMA For the semiquantitative detection of polyvalent myocardial antibodies inhuman serum and plasma.

19. NNA For the detection of Adrenal glands polyvalent antibodies in human serumand plasma.

20. ASA For the semiquantitative detection of IgG-specific Pemphigus PemhigoidAntibodies in human serum and plasma.

21. ATA For the semiquantitative detection of Polyvalent Microsomal andThyroglobulin antibodies in human serum and plasma.

22. ANA For the semiquantitative detection of antinuclear antibodies in humanserum and plasma.

23. AMA For the semiquantitative detection of Polyvalent Antimitochondrial-Antibodies in human serum and plasma.

24. ASMA For the semiquantitative detection of polyvalent anti-smooth muscleantibodies in human serum and plasma.

25. ANA / AMA / For the semiquantitative detection of polyvalent ANAl AMA/ASMAandASMA/ APCA APCAin human s.erumand plasma.Borrelia For the semiquantitative determination of Antibodies to Borrelia26. Burgforferi • IgG ,IgM Burgdorferi (Lyme) in human serum and plasma.

27. nDNA. For the semiquantitative detection of native DNA in human serum andplasma. .,'.,,11

Toxoplasma For the quantitative determination of IgG-SP.~~I~~ic"Antibodies28. gondii - IgG, IgM(Poly). to Toxoplasma gondii in human seru'l!1"f~ .. "'"

ELISATest Kits

29. Anti - CMV- IgG, For the semiquantitative determination of IgG-specific, IgM-specificIgM Antibodies to Cytomegalovirus in human serum and plasma.

30. Anti - HSVI - IgG, For the semiquantitative determination of antibodies against HerpesIgM Simplex Virus Type 1 in human serum and plasma.

31. Anti - HSVII - For the semiquantitative determination of antibodies against HerpesIgG,lgM Simplex Virus Type 2 in human serum and plasma.

32. Anti - Mumps· For the semiquantitative determination of antibodies against Mumps VirusIgG,lgM in human serum and plasma.

33. Anti-VZV - IgG, For the semiquantitative determination of IgG-specific, IgM-specificIgM Antibodies to Varizella Zoster Virus in human serum and plasma.

34. Anti - RSV- IgG, For the semiquantitative determination of IgG-specific, IgM-specificIgM Antibodies to Respiratory Syncytial Virus in human serum and plasma.

35. Anti - Rubella - For the quantitative determination of IgG-specific Antibodies to RubellaIgG,lgM Virus in human serum and plasma.

~INGH

r. G. N. S neral (India)Drugs contrOI\~\~~lth servicesOle. General u & I::arnily Welfare. . f Health r ~d I TOMlnlStry 0 \<,-1\8gOd , ..

Bhawan ,.d, "roA•o,' Ih'\-11 000,.I'leW e"

Licence Number: NCD-59/12

This licence shall be in force fr&n 5 201Z -Ld {\FR 2015

36. Anti - Chlamydia For the semiquantitative determination of antibodies against Chlamydia. IgG, IgM, IgA Trachomatis in human serum and plasma .

37. Anti - Toxo - IgG, For the semiquantitative determination of antibodies against ToxoplasmaIgM gondii in human serum and plasma.

38. Anti - Borrelia - For the semiquantitative determination of Antibodies to BorreliaIgG,lgM Burgdorferi (Lyme) in human serum and plasma.

39. Anti - EBV(VCA) - For the semiquantitative determination of Antibodies to Epstein Barr virusIgG,lgM in human serum and plasma.

Anti-Human Globulin (Conjugate)

40. Anti· Human - For detecting presence of specific IgG antibodies in human serum andIgG (H+L . Chain) plasma

41. Anti - Human - For detecting presence of specific IgM antibodies in human serum andIgM (n - Chain) plasma

Anti - Human - For detecting presence of specific IgG/lgM/lgA antibodies in human serum42. IgG I M I A(Polysp.) or plasma

43. Anti - Human - For detecting presence of specific IgG antibodies in human serum andIgG (a-Chain) plasma , J

. (t',,~;,r-'" J

Immunfluorescence Control S~r.A;e '~J'"

/\~#~.,.;~\'f\ .~

ANA - ANA - Homogenous pattern &fttrol is used along with (FAAna-Hep-2-lgG44. Homogenous Kit for the semiquantitative detection of IgG-specific antinuclear

pattern antibodies in human serum and plasma.

Speckled pattern control is used along with IFA Ana-Hep-2-lgG Kit for the45. Speckled pattern semiquantitative detection of IgG-specific antinuclear antibodies in

human serum and plasma.

Nucleolar pattern control is used along with IFA Ana-Hep-2-lgG Kit for the46. Nucleolar pattern semiquantitative detection of IgG-specific antinuclear antibodies in


Centromere Centromere pattern control is used along with IFA Ana-Hep-2-lgG Kit for47. pattern the semiquantitative detection of IgG-specific antinuclear antibodies in


Negative pattern control is used along with IFA Ana-Hep-2-lgG Kit for the48. Negative pattern semiquantitative detection of IgG-specific antinuclear antibodies in


AMA AMA Mitochondrial pattern control is used along with IFA AMA Kit for the49. Mitochondrial semiquantitative detection of Polyvalent Antimitochondrial-Antibodies in

pattern human serum and plasma.

~G"--, . G. \'I. S\\~eral (India)ntro\\er?e n sel"iices

2 1:.;This licence shall be in force from' ,,; I'~ ?fl12

ASMA- against ASMA- against smooth muscle control is used along with IFA ASMAKit for50. smooth muscle the semiquantitative detection of polyvalent anti-smooth muscle

antibodies in human serum and plasma.

51. APCA. against APCA- against parietal cells control is used along with IFA APCAKitparietal cells

ANA / AIM / ANA / AIM / APCA/ ASMA- Negative control is used along with IFA52. APCA/ ASMA- ANAl AMA/ASMAand APCAKit for the semiquantitative detection of

Negative control polyvalent ANAl AMA/ASMAand APCAin human serum and plasma.

HMA- against HMA- against cardiac muscle control is used along with IFA HMA Kit for53. the semiquantitative detection of polyvalent myocardial antibodies incardiac muscle human serum and plasma.

nDNA. - against nDNA - against native DNAcontrol is used along with IFA n-DNA IgG Kit for54. the semiquantitative detection of native DNA in human serum andnative DNA plasma.

Toxoplasma - IgG control is used along with IFA TaXa IgG Kit for the55. Toxoplasma - IgG quantitative determination of IgG-specific, IgM-specific Antibodies to

Toxoplasma gondii in human serum and plasma.

ICA - against islet ICA - against islet cells control is used along with IFA~~,Kit for the56. cells semiquantitative detection of IgG-specific islet5=e~~ _ bdies in human

serum and plasma. f''>'~ ~~. ',\ \\ ~'~-

Herpes Simplex - For the semiquantitative determin~~~ ~rrtibodies against Herpes57. Virus - I - IgG,IgM Simplex Virus Type 1 in human seru and plasma.

Herpes Simplex - For the semiquantitative determination of IgG-specific Antibodies to58. Virus· II - IgG, Herpes Simplex Virus Type 2 in human serum and plasma.IgM

59. Cytomegalovirus For the semiquantitative determination of Antibodies against Cytomegalo- IgG, IgM Virus in human serum and plasma.Chlamydia For the quantitative determination of IgG-specific, IgM-specific Antibodies60. Trachomatis -IgG,lgM to Chlamydia Trachomatis in human serum and plasma.

61. Masern - Virus - For the quantitative determination of antibodies to Measles virus inIgG,lgM human serum and plasma.

62. Mumps - Virus - For the semiquantitative determination of antibodies against Mumps VirusIgG,lgM in human serum and plasma.

63. Varicella- Zoster- For the semiquantitative determination of IgG-specific, IgM-specificVirus - IgG, IgM Antibodies to Varizella Zoster Virus in human serum and plasma.

Respiratory - For the semiquantitative determination of IgG-specific, IgM-specific64. Syncytial - Virus -IgG,lgM Antibodies to Respiratory Syncytial Virus in human serum and plasma.

65. Epstein - Barr - For the semiquantitative determination of Antibodies to Epstein Barr virusVirus - IgG, IgM in human serum and plasma.

(~JU)r. G, N, S\N~~a\ (India)

ru onlro\\erGe \n services

Licence Number: NCD·59/12

This licence shall be in force from Z 5 /l r- ,',;' 2Off> 2 4 :\F'R 2015

FTA - IgG, IgM FTA - IgG, IgM Positive control is used along with IFA FTA IgG Kit for the66. Positive control, semiquantitative determination of Antibodies against Treponema pallidum

in human serum and plasma.

unspecific unspecific control is used along with IFA FTA IgG Kit for the67. control semiquantitative determination of Antibodies against Treponema pallidum

in human serum and plasma.

Virology negative Virology negative control is used along with a virology kit for the68. control semiquantitative determination of antibodies in human serum and

plasma.

Immunfluorescence Objekttrager

69. Herpes - Simplex For the semiquantitative determination of antibodies against Herpes- Virus I Simplex Virus Type 1 in human serum and plasma.

70. Herpes - Simplex For the semiquantitative determination of antibodies against Herpes- Virus II Simplex Virus Type 2 in human serum and plasma.

71. Chlamydia For the quantitative determination of IgG-specific, IgM-specific AntibodiesTrachomatis to Chlamydia Trachomatis in human serum and plasma.

72. Masern • Virus For the quantitative determination of antibodies to Measles virus inhuman serum and plasma.

73. Mumps - Virus For the semiquantitative determination of antibodies against Mumps Virusin human serum and plasma.

74. Varizella - Zoster For the semiquantitative determination of IgG-specific, IgM-specific. Virus Antibodies to Varizella Zoster Virus in human serum an\~,~R!~sma.

"e :C;'-\J Ij J

75. Respiratory - For the semiquantitative deter~'t\(t8G..SP~ciiiC, IgM-specificSyncytial - Virus Antibodies to Respiratory Syncy i s in human serum and plasma.

76. Epsteins - Barr - For the semiquantitative determination of Antibodies to Epstein Barr virusVirus in human serum and plasma.

77. Borrelia For the semiquantitative determination of A.ntibodies to BorreliaBurgforferi Burgdorferi (Lyme) in human serum and plasma.

78. ANA For the semiquantitative detection of antinuclear antibodies in humanserum and plasma.

79. nDNA. For the semiquantitative detection of native DNA in human serum andplasma.

80. Toxoplasma For the quantitative determination of IgG-specific, IgM-specific, IgA-gondii specifi~ Antibodies to Toxoplasma gondii in human serum and plasma.

201l Licens· 9 Authorityeal/Stamp

Dr. G. N. SINGHDrugs Controller General (India)Dte, General 0f Health Services

Ministry of Health & Family WelfareFDA BhaWq1), Kotla Road, IT.D.

NewOelhi-110002



Food and Drug Administration BhawanKotla Road, New Delhi-11 0002

2 r:: 1 PO ~l"l1'b...) h i~ ;', i.. U l.

. ~B.Braun medical (India) Pvt. Ltd.,\/Building No. B, Gala No. 1-10, Prerna Complex, Anjur Phata, Dapoda Road,

At. Val Village, Bhiwandi-421302, Maharashtra.

Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945thereu nder-regarding.

1. With reference to your application for import licence forwarded to this office withyour letter No. BBRAlIMP-572/2009-NCDI03-2012 dated 26/03/2012 recieved bythis office vide diary No. 12828(FTS No.20900) dated 28/03/2012 I encloseIicence(s) No. NCD-61/12 dated 2. 5 t p') ?OtZhis 1 these Iicence(s) has 1 havebeen granted under the Drugs and Cosmetics Act 1940 and Rules1945 thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 andRules1945 are in addition to and not derogation of any other law for the time beingin force and as such the Iicence(s) issued under p~~s and Cosmetics Act andRules will be in addition to and distinct from any liG~(S) which may be necessaryunder the Import Trade Control RegulatiQQ~~e of the Government of India,Ministry of Commerce. _-->~\\V

3. The import Iicence(s) mentioned iOi'r~ (1) above will not accordingly to itself 1themselves be sufficient authority for import of Drugs covered by that 1 thoseIicence(s) if under the Import Trade Control RegUlations of the Commerce Ministryseparate license(s) are required for import of such drug(s).

4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import ofdrugs in question under the Import Trade Control RegUlations.


6. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

7. Please acknowledge receipt of this letter and its enclosures.Yours faithfully

(Dr. ~ngh)Drugs Controlle~~:~al (I)



Licence Number: NCD-61/12 Date: 2 .!:~ i~:F? 201lMis .. B.Braun medical (India) Pvt. Ltd., Building No. B, Gala No. 1-10, Prerna Complex,Anjur Phata, Dapoda Road, At. Val Village, Bhiwandi-421302, Maharashtra is herebylicensed to import into India during the period for which the licence is in force, the drugsspecified below, manufactured at Mis. B.Braun Melsungen AG, OPM, carl-Braun-Str. 1,34212 Melsungen, Germany having factory premises at Mis. Infopia Co. Ltd., 891, Hogye-Dong, Dongan-Gu, Anyang, Kyunggi 431-080, Republic of Korea and any other drugsmanufactured by the said manufacturer as may from time to time be endorsed on thislicence.

2. This licence shall be in force from2 .1:; ;'" ,'< "'D'1l to 2 4 ,t\ P R 2015unless it is sooner suspended or cancelled under the said rules.

3. Namesof dru s·t()beirn orteS.No Product>Narne

1. Omnitest®plu~Blood gluco$etstri s <:>

~

~.~.j.:Icensin ~thority...i %:~/Stamp

Dr. G. N. SiNGHDru9,.SC0J:l\rPllerG~.ner2\ (india)

lace lae~~~<JI Ji>f!eU1leServicesrequiills'd'. of Health & Family \!'felf"rB

with ~Dd'~§~~~~~~' I.TO

qauthenticated by theE;J(I~teof forwarding such

j~pt~g to examination and~rK~ting·

3. The licensee shallberespons tivitiesbf the manufacturer inIndia along with the registration holder and his authorised agent.




Food and Drug Administration BhawanKotla Road, New Delhi·110002

Dated: 2 c" ;:'D ?n-l.J >'_1.;;' u- Z......, , \ •• l, ..,.'

To / -~s..:. s. M. Biotech,

32-E, 2nd Floor, Patparganj, Opp. Una Enclave,Mayur Vihar, Phase-I, Delhi-91.

Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945thereunder-regarding.

Sir,1. With reference to your application for import licence forwarded to this office with

your letter No. AK/SMB/DLD/01/11-12127112 dated 27/01/2012 recieved by thisoffice vide diary No. 5328(FTS No.8940) dated 07/02/2012, and reply received bythis office vide diary No. 10495 (FTS: 17058) dated 13/03/2012, I enclose licence(s)No. NCD-52/12 dated 2 5 ;L"a Z01Z this 1 these Iicence(s) has 1 have beengranted under the Drugs and Cosmetics Act 1940 and Rules1945 thereunder.

2. I am to point out that the provisions of DrUgS~~ Cosmetics Act 1940 andRules1945 are in addition to and not derogation ,,g, ,/. other law for the time beingin force and as such the licence(s) iSSU~d ndet rugs and Cosmetics Act andRules will be in addition to and distinct fr2 licence(s) which may be necessaryunder the Import Trade Control R~ ns made of the Government of India,Ministry of Commerce. 0~-

3. The import licence(s) mentioned in para (1) above will not accordingly to itself /themselves be sufficient authority for import of Drugs covered by that 1 thoseIicence(s) if under the Import Trade Control Regulations of the Commerce Ministryseparate Iicense(s) are required for import of such drug(s).

4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import ofdrugs in question under the Import Trade Control Regulatic;>ns.


6. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs -and CosmeticsAct and Rules thereunder.

7. Please acknowledge receipt of this letter and its enclosures.Yours faithfully

(Dr. G.~ngh)Drugs Controller ct~~~al (I)



Licence Number: NCD·52/12 Date: 2 5 I\PH 201lMis. S. M. Biotech, 32-E, 2nd Floor, Patparganj, Opp. Una Enclave, Mayur Vihar, Phase-I, Delhi-91 is hereby licensed to import into India during the period for which the licence is inforce, the drugs specified below, manufactured at Mis. DLD Diagnostika GmbH, Adlerhorst15, D-22459 Hamburg, Germany and any other drugs manufactured by the saidmanufacturer as may from time to tltlle.be endorsed on this licenc~ n 20\'5

2. This licence shall be in forc~ ft6m'JR 7111 to 2. o~ r\ \' j\ unless it is soonersuspended or cancelled under the said rules.

3. Names of dn.lg~/tpl:)~jAs per ilttilChQdli Authority

1. A photocopypremises, an

2. Each batch 0test report and ,.manufacturerwttreports. The iI'l1RQrt~¢:Itesting as theHc~r'l~ir'lg

3. The licensee shall be responsl e or e uSlness ac Ivities of the manufacturer inIndia along with the registration holder and his authorised agent.


icensi 9 AuthoritySeal/StampDr. G. N. SINGH

DrugsControllerGeneral(India)lace q". ~rpartf e6athteervicesreMjrJI~..JlfHealth& Family Welfare

l.Il"1~~'~\Jv<Jn, Kalla Road I TOith a detaile.chbatmb'. . .uthenticated by theof forwarding such

to examination and

Licence Number: NCD-52/12

This licence shall be in force from 2. 5Names of drugs to be imported

Sr.no Product Name1 ADMA Elisa Kit

Serotonin Sensitive ElisaKit

Nor-/Metanephrine UrinePlasma Elisa Kit

Nor-/MetanephrinePlasma Elisa Kit

Adrenaline in urineand/or plasma

NorAdrenaline in urino \.\and/or plasma

Dopamine in urine orplasma

BI-CAT (Adrenaline,Noradrenaline) in urineand/or lasma Elisa kitBI-CAT (Adrenaline,Noradrenaline) in urineElisa kitCAT (Adrenaline,Noradrenaline,Dopamine) in urineand/or lasma Elisa kitCAT (Adrenaline,Noradrenaline,Dopamine) in urine ElisakitAnti-GAD ELISA KIT

2 ~. ~ "".'·n.,n n ,,' '1• j I j

Intended UseEnzyme Immunoassay for the QuantitativeDetermination of Endogenous AsymmetricDimeth lar inine ADMA in Serum or PlasmaEnzyme Immunoassay for the QuantitativeDetermination of Endogenous SymmetricDimeth lar inine SOMA in Serum or PlasmaEnzyme Immunoassay for the fast andquantitative determination of Serotonin in urine,

lasma and serumEnzyme Immunoassay for Highlysensitive enzyme immunoassay for the

uantitatve determination of SerotoninEnzyme Immunoassay for the QuantitativeDetermination of Normetanephrine andMetane hrine in Urine and lasmaEnzymeimmunoassay for the quantitativedetermination of unconjugated (free)Normetane i e and Metane hrine in lasmaEnzym~ . oassay for the QuantitativeDe r~ on of Adrenaline in Urine and

anzyme Immunoassay for the Quantitative

Determination of NorAdrenaline in Urine andlasma

Enzyme Immunoassay for the QuantitativeDetermination of Dopamine in Urine andlasma

Enzyme immunoassay for the fast andquantitative determination of Adrenaline andNoradrenaline in Urine or lasmaEnzyme immunoassay for the fast andquantitative determination of Adrenaline andNoradrenaline in UrineEnzyme immunoassay for the quantitativedetermination of Adrenaline, Noradrenaline andDopamine in Plasma and Urine

Enzyme immunoassay for the quantitativedetermination of Adrenaline, Noradrenaline andDopamine in Urine

Enzyme Immuno Assay for the QuantitativeDetermination of Antibodies against GlutamicAcid Decarbox lase in S rum

- r G N. SINGHDrugs o~tr~lIer General (India)

te General vf Health ServicesD.. f Henlth & FamHy Welfare

MInistry 0 a IT 0FDA Bhawan, Kotla Road, . . .

NewOelhi-11 0002

Licence Number: NCD-52/12 2 r,This licence shall be in force from "" lOll to 2 ~, A.P H20 i5

15 Anti-lA2 ELISA KIT Enzyme Immuno Assay for the QuantitativeDetermination of Antibodies against IA-2 inSerum

16 ACHRAB ELISA KIT Enzyme Immuno Assay for the Determination ofAutoantibodies against the AcetylcholinReceptor

17 25-0H-Vitamin-D Elisa kit Enzyme Immuno Assay for the QuantitativeDetermination of 25-0H-Vitamin-D in humanSerum or Plasma

18 ACHRAB Assay RIA KIT Radio Receptor Assay for the Determination ofAutoantibodies against the AcetylcholinReceptor

19 LEMS Assay RIA KIT Radio Receptor Assay for the QuantitativeDetermination of Antibodies to the Voltage-gated P/Q-Calcium Channel (VGCC) in Serumor Plasma

20 Anti-21-Hydroxylase RIA Radioassay for the quantitative determinationKIT

,~~~

of IgG autoantibodies against 21-Hydroxylase in.-;'" serum

21 Anti-GAD ~~~ ~'= Radioassay for the quantitative determination of~~\r~ antibodies against glutamic acid decarboxylase\0 (GAD 65) in serum

22 Anti-lA2 RIA kit Radioassay for the quantitative determination ofantibodies against protein-tyrosine-phosphatase(IA2) in serum

23 Anti-Insulin RIA kit Radioassay for the quantitative determination ofantibodies aQainst Insulin in serum

Licens ng AuthorityaI/StampDr. G. N. SINGH

Drugs Controller General (India)Ole. General uf Health Services

Ministry of HealUt & Family WelfareFDA BhawaQ, Kotla Road, I.T.O.

New Delhi-11 0002



Food and Drug Administration BhawanKotla Road, New Delhi·11 0002

To .MIs. Instrumentation Laboratory India Pvt. Ltd.,

~'~~perty No. 21, IInd Floor, Rama Road, Najafgarh Road, New Delhi-110015.

Subject: Issue of an Endorsement No. 01 to Form 10 License No. NCD-252/11 dated20.09.2011 valid upto 19.09.2014 -regarding.

Please refer to your application No. Nil dated 16.03.2012 received by this office vidediary No. 11488 (FTS No.18621) dated 19.03.2012, regarding the above cited sUbject.

Endorsement No. 01 to Form 10 License No. NCD-252/11 dated 20.09.2011 validupto 19.09.2014 for the import of drugs manufactured at Mis. InstrumentationLaboratory SpA, V.le Monza 338-20128 Milan, It~ay ~g factory premises .at Mis.Instrumentation Laboratory Company, 526 Route ,angeburg, NY 10962, USA isenclosed hereby. \C~

The other conditions of the IicenS~lemain same.

Yours faithfully

(Dr. G~ngh)Drugs Controller ?:n:~~1(I)

FORM 10(Endorsement No. 01)(See Rules 23 and 27)


2 r: ''}'11lDate: ... .", .. LVi"

Mis. Instrumentation Laboratory India Pvt. Ltd., Property No. 21, IInd Floor, RamaRoad, Najafgarh Road, New Delhi·110015 is hereby licensed to import into India during theperiod for which the licence is in force, the drugs specified below, manufactured by Mis.Instrumentation Laboratory SpA, V.le Monza 338·20128 Milan, Italy having factorypremises at Mis. Instrumentation Laboratory Company, 526 Route 303 Orangeburg, NY10962,USA.

2. This Endorsement No. 01 shall be in force fr~5 / . LOIZ to 19.09.2014

unless it is sooner suspended or cancelled under the said rules.3. Names of drugst() beirnport

Licensing ~orlty~~~tamp

Dr. G. N. SINGHDrugs Controller General (India)

1. A photocopy .oflicepces l1'lipeHtiplace iOtea3J)afett JIlf.JetmeServicespremises, and tl1e ol'iginal Iicwl1eheVer reqll'r1~ of Health & family Welfare

2 E h b t h f d . rt d . I d' h II b ' . d . h-~iJ§l"3hCl){J~~f}ollii!.\oad, ITO.. ac a c 0 rug Impo e Into n la s a e accompame Wit a uet~UJJ;:ig?~a~l'tl2test report and a batch release certificate, duly signed and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchreports. The imported batch of each drug shall be subjected to examination andtesting as the licensing authority deems fit prior to its marketing.

3. The licensee shall be responsible for the business activities of the manufacturer inIndia along with the registration holder and his authorised agent.


t nded Usedetermination of heparin in

S.No1.2.3.

2 i'l101z, !··,i e t. y - cdsco.nic.in form 10... · andheeri (e), mumbai-400093,...

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