Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi-11 0002

Dated:

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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 dated 22.09.2011 valid upto 21.09.2014 -regarding.

Please refer to your application No. Nil dated 16.03.2012 received by this office vide diary 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 valid upto 21.09.2014 for the import of drugs manufactured at Mis. Instrumentation Laboratory 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),\ '

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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 and Cosmetics Rules, 1945

Mis. Instrumentation Laboratory India Pvt. Ltd.• Property No. 21. IInd Floor, Rama Road, Najafgarh Road. New Delhi-110015 is hereby licensed to import into India during the period 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 factory premises at Mis. Instrumentation Laboratory Company, 180 Hartwell Road Bedford, MA 01730-2443.USA.

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2. This Endorsement No. 01 shall be in force fr&n /\PH to 21.09.2014 unless it is sooner suspended or cancelled under the said rules. 3. Names of drugs to be irnPort S.No 1. 2. 3.

Produc;l"'· Antithrombin10tl Fxa71 n Kat S-2222 (Chrotl"1 Substrate S-2765 (Chro substrate

se mination of heparin in

uthority S aI/Stamp Dr. G. N. SINGH . s controller General (India)

1. A photocopytligeD(;~i~

.ace ~g~e~unfe~ervices

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66.

FTA - IgG, IgM Positive control,

FTA - IgG, IgM Positive control is used along with IFA FTA IgG Kit for the semiquantitative determination of Antibodies against Treponema pallidum in human serum and plasma.

67.

unspecific control

unspecific control is used along with IFA FTA IgG Kit for the semiquantitative determination of Antibodies against Treponema pallidum in human serum and plasma.

68.

Virology negative control

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

Objekttrager

69.

Herpes - Simplex - Virus I

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

70.

Herpes - Simplex - Virus II

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

71. Chlamydia

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

72. Masern • Virus

For the quantitative determination of antibodies to Measles virus in human serum and plasma.

73. Mumps - Virus

For the semiquantitative determination of antibodies against Mumps Virus in human serum and plasma.

Trachomatis

74.

Varizella - Zoster . Virus

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

75.

Respiratory Syncytial - Virus

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

76.

Epsteins - Barr Virus

For the semiquantitative determination of Antibodies to Epstein Barr virus in human serum and plasma.

77.

Borrelia Burgforferi

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

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78. ANA

For the semiquantitative serum and plasma.

detection of antinuclear antibodies in human

79. nDNA.

For the semiquantitative plasma.

detection of native DNA in human serum and

80.

Toxoplasma gondii

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

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Licens· 9 Authority eal/Stamp Dr. G. N. SINGH Drugs Controller General (India) Dte, General 0f Health Services Ministry of Health & Family Welfare FDA BhaWq1), Kotla Road, IT.D. NewOelhi-110002

Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi-11 0002

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. ~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 1945 thereu nder-regarding. 1. With reference to your application for import licence forwarded to this office with your letter No. BBRAlIMP-572/2009-NCDI03-2012 dated 26/03/2012 recieved by this office vide diary No. 12828(FTS No.20900) dated 28/03/2012 I enclose Iicence(s) No. NCD-61/12 dated p') ?OtZhis 1 these Iicence(s) has 1 have been 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 and Rules1945 are in addition to and not derogation of any other law for the time being in force and as such the Iicence(s) issued under p~~s and Cosmetics Act and Rules will be in addition to and distinct from any liG~(S) which may be necessary under 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 1 themselves be sufficient authority for import of Drugs covered by that 1 those Iicence(s) if under the Import Trade Control RegUlations of the Commerce Ministry separate 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 of drugs in question under the Import Trade Control RegUlations. 5. Any literature or packing accompanying the drugs or any matter stated on the label should 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 Drugs Control Organisation at the ports will be Officers authorized to inspect the premises of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics Act and Rules thereunder. 7. Please acknowledge receipt of this letter and its enclosures. Yours faithfully

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

(I)

FORM 10 (See Rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945

Licence Number: NCD-61/12

Date:

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Mis .. 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 hereby licensed to import into India during the period for which the licence is in force, the drugs specified 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, HogyeDong, Dongan-Gu, Anyang, Kyunggi 431-080, Republic of Korea and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence.

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2. This licence shall be in force from .1:; ;'" ,'< to unless it is sooner suspended or cancelled under the said rules.

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3. Namesof dru s·t() beirn orte S.No Product>Narne 1. Omnitest®plu~ Blood gluco$et stri s ~

~.~.j.:Icensin ~thority ...i

%:~/Stamp Dr. G. N. SiNGH

Dru9,.SC0J:l\rPllerG~.ner2\ (india) lae~~~f!eU1leServices

lace requiills'd'. of Health & Family \!'felf"rB with ~Dd'~§~~~~~~' I.TO qauthenticated by the E;J(I~teof forwarding such j~pt~g to examination and

~rK~ting· 3. The licensee shallberespons tivitiesbf the manufacturer in India along with the registration holder and his authorised agent. 4. The licensee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution.

Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi·110002

Dated: To

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/ ~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 1945 thereunder-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 this office vide diary No. 5328(FTS No.8940) dated 07/02/2012, and reply received by this office vide diary No. 10495 (FTS: 17058) dated 13/03/2012, I enclose licence(s) No. NCD-52/12 dated ;L"a this 1 these Iicence(s) has 1 have been granted under the Drugs and Cosmetics Act 1940 and Rules1945 thereunder. 2. I am to point out that the provisions of DrUgS~~ Cosmetics Act 1940 and Rules1945 are in addition to and not derogation ,,g, ,/. other law for the time being in force and as such the licence(s) iSSU~d ndet rugs and Cosmetics Act and Rules will be in addition to and distinct fr2 licence(s) which may be necessary under 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 those Iicence(s) if under the Import Trade Control Regulations of the Commerce Ministry separate 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 of drugs in question under the Import Trade Control Regulatic;>ns. 5. Any literature or packing accompanying the drugs or any matter stated on the label should 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 Drugs Control Organisation at the ports will be Officers authorized to inspect the premises of importers establishments for the purpose of Rule 26 of the Drugs -and Cosmetics Act and Rules thereunder. 7. Please acknowledge receipt of this letter and its enclosures. Yours faithfully

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

FORM 10 (See Rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945

Licence Number: NCD·52/12

Date:

2 5 I\PH 201l

Mis. S. M. Biotech, 32-E, 2nd Floor, Patparganj, Opp. Una Enclave, Mayur Vihar, PhaseI, Delhi-91 is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured at Mis. DLD Diagnostika GmbH, Adlerhorst 15, D-22459 Hamburg, Germany and any other drugs manufactured by the said manufacturer as may from time to tltlle.be endorsed on this licenc~ n 20\'5

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2. This licence shall be in forc~ ft6m'JR 71 suspended or cancelled under the said rules. 3. Names of dn.lg~/tpl:)~j As per ilttilChQdli

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unless it is sooner

Authority

icensi 9 Authority Seal/Stamp Dr. G. N. SINGH

Drugs Controller General (India) lace q". ~rpartf e6athteervices reMjrJI~..Jlf Health & Family Welfare l.Il"1~~'~\Jv