ministry of health - central drugs standard control … drugs standard control organisation...

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 Delhl·110002

Dated: - 8 t~A.Y 201ZTo

~. Vishat Diagnostics Pvt. Ltd.,Shop No. 24, Gaurav garden, Mira Bhayander Road,Dist. thane, Mira Road, Maharashtra.

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

1. With reference to your application for import licence forwarded to this office withyour letter No. VDPU11-12/017 dated 29/12/2011 recieved by this office vide diaryNo. 13061(FTS No.21517) dated 30103/2012, I enclose Iicence(s) No. NCD-72/12dated';.. .R....!.A...C.L..2.Q!!lJhis 1 these licence(s) has 1 have been granted under theDrugs and"'CoStt!hti6SJ~t 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 derogati~ of any other law for the time beingin force and as such the Iicence(s) iss!!~~naer Drugs and Cosmetics Act andRules will be in addition to and dis~n~f.~ny licence(s) which may be necessaryunder the Import Trade Control {~Iations made of the Government of India,Ministry of Commerce. -b~~

3. The import licence(s) men~),d in 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 license(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.Yours faithfully

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

FORM 10(See Rules 23 and 27)

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

Date: ~. 8 fV1AY lOlZLicence Number: NCD-72/12Mis. Vishat Diagnostics Pvt. Ltd., Shop No. 24, Gaurav garden, Mira Bhayander Road,Dist. thane, Mira Road, Maharashtra is hereby licensed to import into India during theperiod for which the licence is in force, the drugs specified below, manufactured at Mis. DSIS.R.L., Via Volonterio No. 361a, Sorrono-21047, (VA), Italy 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 from ~ 8 MAY lOlZ to - 7 MAY 2015unless it is sooner suspended or cancelled under the said rules.

3. Namesof dru9~tAs peraltaI';

1. A photocOPYCltlpremises, andth

2. Each batch oftest report andmanufacturer wireports. The imtesting as the' .. .

3. The licensee the manufacturer inIndia along wi nt.

4. The licensee shall in orm the licenSIng authority forthwi h 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.

~~lcenSinO~ ..uthority~ ~:;l(!ilPm2:i ..

Druqs Controller General (India;

'1' .•.•..•••....•.•.. ' .j)t~.~Ge.o

n.!ll.8 -.:.".1a.f ..l-:;\,;;. 81th s,".,nlic. es.I.e. t· place ~~ln~r)~'4e~ ('I.~.er:iiV \!';db-C'e .·ever requil'e'6J'\!?\'f:n,Xotl3 Roc,c" ITO

/ ',.". '."with a detalf~H)I:MlBhoo2e;{authenticated by theElteof forwarding such

to examination and

Place: New Del,hi ifr:;c

Date: ~ 8 t"1AY 11zu

Licence Number: NCD·72/12

This licence shall be in force iamB {v}AY 2OilN fd t b' rt d

- 7 MAY 2015ames 0 rugs 0 elmpo e

Description Intended use51.No.

DS-EIA-ANTI -HEV-G Enzyme Immunoassay for the qualitative determination1 of IgG class antibodies to Hepatitis E Virus (HEV) in

human serum and plasma

DS-EIA-ANTI-HEV-M Enzyme Immunoassay for the qualitative determination2 of IgM class antibodies to Hepatitis E Virus (HEV) in

human serum and plasma

DS-EIA-ANTI-HSV-1,2-G Enzyme immunoassay for the determination of AvidityAvidity IgG class ant/bodies to Herpes Simplex 1 & 2 virus

3DS-EIA-ANTI-HSV-2-G Enzyme immunoassay for the determination of IgG

class antibodies to Herpes Simplex 2 virus4

DS-EIA-ANTI -EBV-VCA-G Enzyme immunoassay for the quantitative5 t~~ermination of EBVVCA IgG Class antibodies in

(;>((\ ,serum

DS-EIA-ANTI:E.,~~):~~A~~ Enzyme immunoassay for the quantitative6 '" ""-"\\'p' determination of EBVVCA IgM Class antibodies in

,/\\f\" , serum'J Enzyme immunoassay for the quantitative

7 DS-EIA-ANTI-EBV-EA-G determination of EBV EA IgG Class antibodies /n serum

DS-EIA-ANTI-EBV-NA-G Enzyme immunoassay for the quantitativedetermination of EBV NA IgG Class antibodies in serum

8DS-EIA-Gonadotropin -LH Enzyme immunoassay for the quantitative

9 determination of Human luteinizing hormone (LH,lutropln)

DS-EIA-Gonadotropi n-FSH Enzyme immunoassay for the quantitativedetermination of folliclle stimulating hormone (FSH) in

10 human serumDS-EIA-Gonadotro pin-hCG Enzyme immunoassay for the quantitative

determination of Human Chorionic Gonadotropin (hCG)11 in human serum and olasma

DS-EIA-Prolactin Enzyme immunoassay for the quantitativedetermination of prolactin (PRL) in human serum

12DS-EIA-Stero id-Cortiso I Direct immunoenzymatic assay for the quantitative

determination of Cortisol in serum and plasma13

DS-EIA-Steroid- Direct immunoenzymatic assay for the quantitativeProgesterone determination of Progesterone in serum and plasma

14OS-EIA-Steroid- Direct immunoenzymatic assay for the quantitativeTestosterone determination of Testosterone in serum and plasma

15OS-ErA-Thyroid-antl- TG Elisa Test for the quantitative determination of(anti-thyroglobulin) Thyroglobulin (Tg) autoantibodies in human serum and

16 plasma.OS-ErA-Thyroid-anti- TPO Elisa Test for the quantitative determination of Thyroid(anti-thyroid peroxidas) Peroxidas autoantibodies in human seru/ln and plasma.

17

\~ -\""'H" :,,1r" N <) 1'.'-" ,. rrlt;~\Ie~Genera\ (IndiaDrugs "'. f Hec:lth Scr'ilc~

c G_n~\al 0 ',_ ~'I, \""'"

,/

Licence Numbe~7211f. •

This licence shall be in fOice from 8 MA f 2011. - 7 MAY 20i5

DS-EIA-Thyroid- T3 total Elisa Test for the quantitative determination of TotalTriiodothyronine concentration in human serum and

18 olasma.DS-EIA-Thyroid- T3 free Elisa Test for the quantitative determination of Free

Triiodothyronine concentration in human serum and19 plasma.

DS-EIA- Thyroid- T4 total E~tme immunoassay for the quantitative20

CJfCt rmination of Total Thyroxine Concentration in

,~\<? \ ~uman serum and plasma.

DS-EIA-T ,ree Enzyme immunoassay for the quantitative21 O~\} determination of Free Thyroxine Concentration in

human serum and plasma.

DS-EIA-Thyroid- Enzyme immunoassay for the quantitative22 Thyroglobulin determination of Thyroglobulin (Tg) levels in human

serum

DS-EIA- Thyroid- TSH Enzyme immunoassay for the quantitative23 determination of Thyroid Stimulating Hormone in

human serum and oiasmaDS-EIA-IgE total Enzyme Immunoassay for the detection of human IgA

24 antibodies to Chlamydia tr

~ 8 MAY lOlZ

lie O:g Authoritysi~!~~mpDr. G. N. SINGH

Drugs Controller General (India)Ole. General or HeiJlth Services

Mlnisti)! of Heal'JI 1J1JdfareFD/\ .8ha",v;:';i). f<otia LTO.

New[)eL,i110002

Place :New DelhiDate:-------

, Central Drugs Standard Control OrganisationDirectorate General of Health ServicesMinistry of Health & Family Welfare

(Medical Device and Diagnostic Division)

Food and Drug Administration BhawanKotla Road, New Delhi·110002

Dated: - 8 t"1 At 201lTo •.trt::v':.1~~Vishat Diagnostics Pvt. Ltd.,

Shop No. 24, Gaurav garden, Mira Bhayander Road,Dist. thane, Mira Road, Maharashtra.

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

1. With reference to your application for import licence forwarded to this office withyour letter No. VDPL/11-12/005/1L-Scimedx dated 09/06/2011 recieved by thisoffice vide diary No. 28371(FTS No.39122) dated 13/06/2011 and reply received bythis office vide diary No. 1~39h(frS~ 222Reldated 02/04/2012, I enclose Iicence(s)No. NCD-284/2008 dated ~. ~ r1Af lU"llthis 1 these licence(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 and Cosmetics Act 1940 andRules1945 are in addition to and not derogation of any oth~r,f.iw for the time beingin force and as such the licence(s) issued under Dr~~~~ Cosmetics Act andRules will be in addition to and distinct from anY~iC ~which may be necessaryunder the Import Trade Control Regulations ~ of the Government of India,Ministry of Commerce. #"~~

3. The import licence(s) mentioned in par~ above will not accordingly to itself Ithemselves 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.



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

(Dr. G.Drugs Controller G



Licence Number: NCD-284/2008 Date: ~ 8 MAY ZfllZMis. Vishat Diagnostics Pvt. Ltd., Shop No. 24, Gaurav garden, Mira Bhayander Road,Dist. thane, Mira Road, Maharashtra is hereby licensed to import into India during theperiod for which the licence is in force, the drugs specified below, manufactured atMls.Scimedx Corporation, 100 Ford Road, Suite 100-08 Denville, NJ 07834 and anyother drugs manufactured by the said manufacturer as may from time to time be endorsed onthis licence.

. . . . 8 f\jl(,'i 01? • 7 MAY ?0152. ThIS licence shall be In force from - el t4 f IlL to - .unless it is sooner suspended or cancelled under the said rules.

3. Names of drugitop~imp9n:As per attaCh$dlist~

0SisPlace: New Delhi .i'i!<:JDate: :- 8 IV! AYfOlZ

!J.Ju

d by Licensin~,,~~thorityR\~' '.'

'e'- (~))\\" \ ~'.,'X". ' ..

~Licensi~thorityo ~:~IIStampZ c, ~):i\:+:

Drug" Contia:ier General (In..lia)1. A photocopy of I placS::1:;nGan'Dar:f :ef;it1:lfervicc;s

Premises, and th ver r~A:ii~{t~S:l(-Ie":::l f:' r-c:i1:ily, W:~:f~le. ..: 'l'~J: r;;~t.IC:_ii, ;\.odo !-'{02C1, I. r~J.

2. Each batch of ith a detaileckbarohtest report and uthenticated by themanufacturer ate of forwarding suchreports. The im ted to examination andtesting as the lie eting.

3. The licensee sfar ies of the manufacturer inIndia along with the regi Ely ,'" agent.

4. The licensee shall inform t e 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.


This licence shall be in force fr"';m8 fIIAY 201ZN fd b . d

- J MAY L0i5ames a rUQsto e Importe

S.No. Product Name Intended Use

1. Antinuclear Antibody (RL) Detection of Antinuclear Antibodies in humanserum and plasma

2. Antinuclear Antibody Detection of Antinuclear Antibodies in human(HEp2) serum and plasma

3. Austoscreen I Detection of Antinuclear, Mitochondrial, ParietalCell Smooth Muscle and Reticulin Antibodies inhuman serum and plasma

4. Austoscreen I (Ms) Detection of Antinuclear, Mitochondrial, ParietalCell Smooth Muscle and Reticulin Antibodies inhuman serum and plasma

5. Mitochondrial Detection of Mitochondrial Antibodies in humanAntibody(RK)

"-',)

(~uriland plasma,j ,,~~..// .

6. Austoscreen 200, ~\' \~(?c_.J Detection of Antinuclear, Mitochondria', Parietal

'r"' \;~?\ \,.J) ~ Cell Smooth Muscle and Reticulin Antibodies in\~»\fI:'human serum and plasma

7. Austoscreen II Detection of Antinuclear, Mitochondrial, ParietalCell Smooth Muscle and Reticulin Antibodies inhuman serum and plasma

8. Austoscreen II (Ms) Detection of Antinuclear, Mitochondrial, ParietalCell Smooth Muscle and Reticulin Antibodies inhuman serum and plasma

9. Smooth Muscle Antibody Detection of Smooth Muscle Antibodies in human(RS) serum and plasma

10. Thyroid Antibody (MT) Detection of anti-Thyroid Antibodies in humanserum and plasma

11. Endomysial(ME) Detection of anti-Endomysial Antibodies in humanserum and plasma

12. Anti-skin Antibody (ME) Detection of anti-Skin Antibodies in human serumand plasma

13. Endomysial-(PUC) Detection of anti-Endomysial Antibodies in humanserum and plasma

14. Cardiac Muscle Antibody Detection of Cardiac Muscle Antibodies in human(MH) serum and plasma

15. Cardiac Muscle Antibody Detection of Cardiac Muscle Antibodies in human(RH) serum and plasma

16. Islet Cell Antibody (MP) Detection of Islet Cell Antibodies in human serumand plasma

17. Glomerular Basement Detection of Glomerular Basement MembraneMembrane (MK) Antibodies in human serum am plasma

~:Y, G, i~,SibiGH

Dru s Controller G8neral (Indir. .- ' L,.' .

a)Ole, '0PnE,,;C:1 of, lealih Services

~J\jn\~;;ryof Health ~ F~mHY'j\Jelf2!rer:CA ,<olla,RQad, ITO,

'j0002

Lic.ence Number: NCD·284/2008

This licence shall be in force f;;m8 ii/lAY 201l------ - 7 MAY ?n1518. Anti-Reticulin IgA Detection of Anti-Reticulin IgA Antibodies in

human serum and plasma19. Anti-Reticulin IgG Detection of Anti-Reticulin IgG Antibodies in

human serum and plasma20. Stri. Muscle Detection of Anti-Striated Muscle Antibodies in

human serum and plasma21. Stri. Muscle(Rat) Detection of Anti-Striated Muscle Antibodies in

human serum and plasma22. DNA(C. luciliae) Detection of Anti-nDNA Antibodies in human

serum~Cindplasma23. Anti-Adrenal ,",~~ion of Anti-Adrenal Antibodies in human

-' \~ m and plasma24. Anti-Ovary "f"~,.Q Detection of Anti-Ovary Antibodies in human

__r " "~

(\"S \ serum and plasma\\\:(

25. Anti-Testes \.:.di Detection of Anti-Testes Antibodies in humanserum and plasma

26. Legionella Pneumophila 1- Detection of Legionella Pneumophila Antibodies6(S) in human serum and plasma for use with

cat#718427. Legionella Pneumophila Detection of Legionella Pneumophila Antibodies

Gr.1(Mono) (HT) in human serum and plasma for use withcat#7182

28. Legionella Pneumophila Detection of Legionella Pneumophila AntibodiesGr.1 IFA (HT) in human serum and plasma

29. Legionella Pneumophila Detection of Legionella Pneumophila AntibodiesGr.1-6 IFA Poly (HT) in human serum and plasma

30. C-ANCA Detection of Anti~neutrophil CytoplasmicAntibodies in human serum and plasma

31. P-ANCA Detection of Anti-neutrophil CytoplasmicAntibodies in human serum and plasma

32. DNA(C.lucilae) Detection of Anti-nDNA Antibodies in humanserum and plasma

33. Antinuclear Antibody Detection of Antinuclear Antibodies in human(HEp2) serum and plasma

34. Cytomegalovirus IgG ( Detection of Cytomegalovirus IgG Antibodies inhuman serum and plasma

35. Epstein-Barr Virus VCA Detection of Epstein-Barr Virus VCA IgGIgG Antibodies in human serum and plasma

36. Epstein-Barr Virus EA IgG Detection of Epstein-Barr Virus EA IgG Antibodiesin human serum and plasma

37. Herpes Simplex Virus 1 Detection of Herpes Simplex Virus 1 IgGIgG Antibodies in human serum and plasma

(l~,cr G.,']. G~""'r2\ (Ind

tro'I"'r ", 'v ..Drugs o~ ,or '! I ~~ 1.-le.~N\i Servi

i! ..... jenc,d. 01 I •. ~._,.'\ \f'Ii~'.

Ligence Number: NCD·284/2008

- 8 I' LOllThis licence shall be in force f~ ¥ i1"'1 j------ - 7 M t,y lOti

38. Herpes Simplex Virus 2 Detection of Herpes Simplex Virus 2 IgGIgG Antibodies in human serum and plasma

39. Measles IgG Detection of Measles IgG Antibodies in humanserum and plasma

40. Mumps IgG Detection of Mumps IgG Antibodies in humanserum and plasma

41. Chlamydia Trachomatis Detection of Chlamydia Trachomatis IgGIgG Antibodies in human serum and plasma

42. Rickettsia Rickettsii Detection of Rickettsia Rickettsii IgG Antibodies inhuman serum and plasma

43. Rickettsia Typhi Detection of Rickettsia Typhi IgG Antibodies inhuman serum and plasma

44. Rickettsia Prowazekii Detection of Rickettsia Prowazekii IgG Antibodies: in human serum and plasma

45. Rickettsia COnOri!GC)t)'~: Detection of Rickettsia Conorii IgG Antibodies in<,Cr human serum and plasma

46. coxiell~ r:m'r)(i~tii Detection of Coxiella Burnetii IgG Antibodies in?\\{f\'~'::9 human serum and plasma

47. OMntia tsutsugamushi Detection of Orientia tsutsugamushi IgGAntibodies in human serum and plasma

48. Legionella pneumophila Detection of Legionella pneumophila IgGAntibodies in human serum and plasma

49. Legionella Longbeachae Detection of Legionella Longbeachae IgGAntibodies in human serum and plasma

50. Arbovirus Screen Detection of Arbovirus (West Nile Virus, EasternEquine Encephalitis, St. Louis Encephalitis,Powassan, La Crosse Screen) IgG Antibodies inhuman serum and plasma

51. Ehrlichia chafeensis Detection of Ehrlichia chafeensis Antibodies inhuman serum and plasma

52. Goat Anti-human IgA Detection of Goat Anti-human IgA Antibodies inConjugate human serum and plasma for use with IFA slides

53. Goat Anti-human IgG Detection of Goat Anti-human IgG Antibodies inConjugate human serum and plasma for use with IFA slides

54. Goat Anti-human IgM Detection of Goat Anti-human IgM Antibodies inConjugate human serum and plasma for use with IFA slides

55. Goat Anti-human IgA, IgG, Detection of Goat Anti-human IgA, IgG, 19MIgM Conjugate Antibodies in human serum and plasma for use

with IFA slides56. Diphtheria Detection of Diptheria toxid Antibodies in human

serum

~).k,/

c' )ri

~ ,',"*,r c,enero\r· r't ~jondOI ...... _.- (~,~,n';

Licence Number: NCD-284/2008, f) I' c, •

::: 0 r,ijj~'This licence shall be in force from ' / lOll

57. E.histolytica Detection of Entamoeba histplytica Antibodies inhuman serum.

58. Echinococcus Detection of Echinococcus Antibodies in humanserum.

59. Leptospira IgG Detection of Leptospira IgG Antibodies in humanserum\!·

60. Leptospira IgM ~t~ctron of Leptospira IgM Antibodies in human\,~,~\Serum.

61. Toxocara -,,\f \~' Detection of Toxocara Antibodies in human serum"",,~\yl(,,\\:f

62. Schistosma ''-.7 Detection of schistosma Antibodies in humanserum.

63. T.SoJium Detection of Taenia soJium Antibodies in humanserum.

64. Trichinella Detection of Trichinella Antibodies in humanserum.

Place :New Delhi

Date: _ 8 tvili:l ZOil"Lice G ~~ Authority

se~~ampOr, G. N. SINGH

Drugs Controller General (India)Ote. Gen8r21 of HS:'::lnil Sc(vlces

of Healih iI, \I'eliz:rci(G-('j'~1

Central Drugs Standard Control OrganisationDirectorate General of Health Services .


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

Dated: - 8 i~!~Y201ZTo

~. CPC Diagnostics Pvt. Ltd.,New No. 324, Old no. 237/1, Avvai Shanmugam Salai,Khadi Gramodyog Complex, Gopalapuram, Chennai-86.


1. With reference to your application for import licence forwarded to this office withyour letter No. CPCD/GTII001/2012 dated 17/03/2012 recieved by this office vidediary No. 12170(FTS No.19962) dated 23/03/2012, I enclose Iicence{s) No. NCD-75/12 dated';.. R M h,'.( 7011. this 1 these licence{s) has 1 have been grantedunder the DrJgs ~ct 1940 and Rules1945 thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics 'IAct 1940 andRules1945 are in addition to and not derogation of any other la~;{~rethe time beingin force and as such the Iicence{s) issued under Drugs a~Q:}osmetics Act andRules will be in addition to and distinct fror:nany Iicen..ce,,§'*~hYChmay be necess~ryunder the Import Trade Control Regulations mad~(~e Government of India,Ministry of Commerce. /'~(~\:, )

3. The import Iicence{s) mentioned in para (1) ab'otte will not accordingly to itself Ithemselves 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 Regulations.




(Dr.~Slngh)Drugs Controlle~~n~ral (I)



Licence Number: NCD-75/12 Date:_ 8 Mi\Y ZOllMIs. CPC Diagnostics Pvt. Ltd., New No. 324, Old no. 237/1, Avvai Shanmugam Salai,Khadi Gramodyog Complex, Gopalapuram, Chennai-86 is hereby licensed to import intoIndia during the period for which the licence is in force, the drugs specified below,manufactured at MIs. Gen-Probe GTI Diagnostics, Inc., 20925 Crossroads Circle,Waukesha WI, USA 53186 and any other drugs manufactured by the said manufacturer asmay from time to time be endorsed on this licence.

- j MAY 20i52. This licence shall be in force from ~ to _unless it is sooner suspended or cance~aYcf rules.

3. Names of drL/gsto beimPQrteAs per attachEtdlist.,pfQ;.

07";tf~1VI(

i'Q~

~

Z

vedbyLicensing ~~rity~/ «(~ '\S<"'A '--.)','1VA"l.·. .' ,', , :~'N -- . \c:, ",::.)

;~;,~(;<" 061.-fj;'f: "~PCrlngAuthority

<0 Seal/StampZ G. N. SINe;;·,,;Drugs Control!er General (india)

~tplace irl¥t.'aGf:I~:n1;1~lttj~.Scoi:icosMlnls.!.IYofHe;·.:h (" !-cH'::",/e~",~r requ~Ij},l8i·o,i>i,:(oU,: TC).

n1pan~with a detaHec!'4)atcl!fO?gOEr ·······~authenticated by the

~te of forwarding suchcted to examination andeting.

ctiviUes of the manufacturer inIndia along withth~r~~I$tr~ . ....'...'. '. ','qri~~92;l~~t"lt.

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.


This licence shall be in force from - 8 M b,'.' ZOlZ toN fd t b' rt d &: • ,

- J MAY LOl5'ames 0 rugs 0 e Impo e

S. No. Product name Intended use1. PAK 2 LE (Pak2-LE) Used to detect antibodies against the

platelets glycoproteins and HLA class Iantioens

2. PAKAUTO (Pakauto) Sed to screen auto antibodies to plateletglycoprotein

3. THROMBOTYPE Used for the molecular determination of(Throm botype) human platelet alloantigens alleles

4. PF4 ENHANCED (X-HAT45) Used for the detection of antibodiesagainstplatelet factor-4, when it is complexed to PVS

5. PF4 ENHANCED (X-HAT13) ,'<>1\.-c)'

(~~\\"""~:,j

6. PF4 IgG (HAT -45G) {, )JSEfd for the detection of heparin associated

,,(~<\~~1'~ntibodies in human serum

7. PF4 IgG (HAT 13G) """',,'\\-;;})'\' ,

8. FACTOR VIII ANTIBODY Used for the detection of antibodies reactiveSCREEN (F8S) with recombinant human factor -8

9. B-SCREEN (BCSG) Used to detect antibodies to HLA CLASS IIantigens

10. HLA TYPING TRAYS (72, Used to detect HLA surface antigens72BL, 72L, 720R, 72AB 1,72AB2, 72C, 72A,BC1/72ABC2, 96, 96C, DR,C-1)

11. HLA EZ TYPE (LR-ABC) Used to detect HLA Class I Alleles at lowresolution

12. HLA EZ TYPE (LR-DRDO) Used to detect class II alleles at lowresolution

13. OUIK 10 CLASS I (010) Used to detect panel reactive antibodies toHLA class I antigens

14. OUIK 10 CLASS II (C2ID) Used to detect panel reactive antibodies toHLA class II antigens

Place :New DelhiDate:

F 8 MAY ZOlZLlceRsi ~thorlty

seal/~a~~G. N. .sif<'8c"J

Drugs Controller General (India), Ole. General of Health Services,,1i.nistryof Hea/lh & F8mily Welfare

[-iJABhaw~:r,Kalla F(oad, LTO."Ie>,;" ""Ii




Dated: - 8 MAY lOllTO~ s. Peerless Biotech Pvt. Ltd.,

lock-C, 36/37, 'Millenium House, M.K. Srinivasan Nagar Main Road,144, Old Mahabalipuram Road, Perungudi, Chennai-96.

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

1. With reference to your application for import licence forwarded to this office withyour letter No. 021/2011-12dated 14105/2011 recieved by this office vide diary No.24042(FTS No.32945) dated 20105/2011 and reply received by this office vide diaryNo. 13204 (FTS: 21498) dated: 30/03/2012, I enclose licence(s) No. NCD-76/12dated';.. 8Mh'{ _'01' this 1 these Iicence(s) has 1 hav~.been granted under theDrugs 'an~ 1940 and Rules1945 thereun~

2. I am to point out that the provisions of Drugs ~~''cosmetics Act 1940 andRules1945 are in addition to and not derogation qf any other law for the time beingin force and as such the Iicence(s) issued LJ~? Drugs and Cosmetics Act andRules will be in addition to and distinct frorn.~~l1'cence(s) which may be necessaryunder the Import Trade Control Regul~S· made of the Government of India,Ministry of Commerce.) .

3. The import licence(s) mentioned in 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).





(Dr. ~Singh)Drugs Controller i~n~ral (I)



Licence Number: NCD-76/12 Date: - 8 MAY 20tZMis. Peerless Biotech Pvt. Ltd.; Block-C, 36137, 'Millenium House, M.K. SrinivasanNagar Main Road, 144, Old Mahabalipuram Road, Perungudi, Chennai-96 is herebylicensed to import into India during the period for which the licence is in force, the drugsspecified below, manufactured at Mis. IND Diagnostic Inc.,1629 Fosters Way, Delta, BC,Canada, V3M 6S7 and any other drugs manufactured by the said manufacturer as may fromtime to time be endorsed on this licence.

2. This licence shall be in force from = 8 tvlAY 201Z- to - 7 MAY 2015unless it is sooner suspended or cancelled under the said rules.

3. Namesof drug~to beimAs peraUaehedlist ed by Licensing Authority

~<o,",~c) ',:

\~:~nSi~~~Z Drugs Controller General (india)

tplace ~~~~l@~~f~l~~~ye~~;~~~reer require~haW2(1,Kalla Rose! II.).

2. Each batch of with a det~i1~8e~aWWo2test report an authenticated by themanufacturer wi CIteof forwarding suchreports. The irnP6 ad to examination andtesting as the Hcerisi g.

3. The licensee shal/bet the manufacturer inIndia along withth~"~gl~tr~tl '., ,1<4, ,,' ','" ,'., ", .,"" ',.diCl, .,nt.


Licence Number: NCD-76/12

This licence shall be in force from- 8 {"IAr ZOll toN fd t b' rt d

- j MAY 2015ames 0 ruqs 0 e Impo e

S. No. Product name Intended use1. HCG Pregnancy rapid Test in Used for the determination of hCG (Human

Strip and Cassette Format Chorionic Gonadotropin) in urine specimens.2. LH Ovulation Rapid Test in Used for the qualitative determination of LH

Strip and Cassette (Leuteinizing Hormone) in urine3. FSH Menopause Rapid Test in Used for the determination of FSH (Human

Strip and Cassette Follicular Stimulating Hormone) concentrationin urine specimens.

4. Urinalysis Reagent Strips Used for the determination of glucose,bilirubin, ketone, specific gravity, blood, pH,protein, urobilinogen, nitrite, leukocytes andascorbic acid in urine

5. Fecal Occult Blood (FOB) Used for the rapid and qualitativeTumor Marker rapid test in determination of human occult blood inStrip and cassette faeces.

6. Drugs of Abuse Rapid Test Used for the qualitative detection ofsingle and multiple parameters morphine, amphetamine, benzoylecgoninecassettes covering MOP (cocaine metabolite), and 11-nor~9(Opiates/Morphine/Heroine ), tetrahydrocp.~binol-carboxlic acid (THC) inCOC (Cocaine), THC huma?;u@e' .(Marijuna), MET ,'("\{:,,

'\. D '

(Methamph~tamine, AMP ....0\~~\'dJ .-.~(Amphetamine), BZO \Sjl \~ 21(Benzodiazepines), PCp">(Phencyclidine), TCA (TricycleAntidepressants), MDMA(Ecstasy), BAR (Barbiturates),MTD (Methadone)

7. Malaria Rapid Test in Strip and Used for the qualitative detection ofCassette antibodies of all isotypes (lgG + IgA+lgM)

specific to Plsmodium falciparum andPlasmodium vivax simultaneously in humanwhole lood, serum or plasma.

8. AFP-Alpha Feto Protein tumor Used for the rapid detection of alphamarking test strips and devices fetoprotein in serum

9. Gonorrhea Antibody test Strips Used of the rapid visual detection ofand devices gonorrhoea antigen, in the secretory

specimen from urogenital system.

Place :New Delhi

Date:~201Z

Llcensln~orltYseall~t~~tt1

-Jr. G. N. SINGl-lDrugs Controller General (India)Dte. Gen8lal cf H2~'~lthS:3rvlces

fv1inistfy of He~Jth 8; ~/\i':~(~lre

FDA Bh,l\'ic:), ;("[,, i.T.O.,,",(0','1,.',,::1:"

Central Drugs Standard Control OrganisationDirectorate General of Health ServicesMinistry of Health & Family Welfare



Dated: - 8 ~1AY lOIZTo /

,.J/f/s. Lilac Medicare (P) Ltd.,8, Sungold, 303 Sher-E-Punjab, Mahakali Caves road,Andheeri (E), Mumbai-400093, Maharashtra.

SUbject: Issue of an Endorsement No. 01 to Form 10 license No. NCD-447/2009 dated29.03.2012 valid upto 28.03.2015 -regarding.

S· .~rr / c \9) ,,\Please refer to your application No. Nil dated 29/12/2011 rec'e~~'by this office vide

diary No. 7601 (FTS No.12520) dated 22/0212012 and repIYrr~~i~d by this office vidediary No. 12092 (FTS: 19619) dated 22/03/2012, regardi~\~"ij'~bOve cited sUbject.

(j\~.Endorsement No. 01 to Form 10 License No. NCD-447/2009 dated 29.03.2012 valid

upto 28.03.2015 for the import of drugs manufactured at Mis. Monobind Inc., 100 NorthPointe, Lake Forest, California 92630, USA is enclosed hereby.

Yours faithfully

(Dr. G~lngh)Drugs Controller ~~n~ral (I)

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


Date: - 8 MAY 201lMis. Lilac Medicare (PJ Ltd., 8, Sungold, 303 Sher-E-Punjab, Mahakali Caves Road,Andheeri (EJ, Mumbai-400093, Maharashtra is hereby licensed to import into India duringthe period for which the licence is in force, the drugs specified below, manufactured by Mis.Monobind Inc., 100 North Pointe, Lake Forest, California 92630, USA.

2. This Endorsement No. 01 shall be in force fr~ ~to 28.03.2015unless it is sooner suspended or cancelled under the said rules.

3. Namesof drugst()lJeilTlpo~~\JAR.D€()lVfj

S.No ProducfNamfil1. Ferritin ELISA

- 8 MI~~'t~ i.

2. Ferritincq~~U

Licensln ~thOrity~~~~tampiT/dp _'r G, 1'1 S:' ;;, '.

Drugs Controller Geflei~,1 (lflOiC'0

1. A photocopy of licence shall be displayed in a prominent place inca, pal1r'.off:t~'.!, :;'l:,;~.-,premises, and the original licence shall be produced, whenever requi~~11~~1,~;,e,~~l;~;',,:~u':',,'.'-;~("'~

2. Each batch of drug imported into India shall be accompanied with a detailed ibatoill)~ot.test 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




Dated: - 8 t"lAY lOllTo

. Mu(Lilac Medicare (P) Ltd.,"( S-ungold, 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.

1. With reference to your application for import licence forwarded to this office withyour letter No. Nil dated 16/1212011 recieved by this office vide diary No.57615(FTS No.85692) dated 16/1212011 and reply received by this office vide diaryNo. 12091 (FTS: 19616) dated 22/03/2012, I enclose Iicence(s) No. NCD-74/12dated:" 8 MAy 2D12...-this/ these licence(s) has / have been granted under theDrugs and Co~fhetics AJct1940 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 ot.tl~law for the time beingin force and as such the Iicence(s) issued under q~~-arTd Cosmetics Act andRules will be in addition to and distinct from any Ii~n~ which may be necessaryunder the Import Trade Control RegulatiO!1~~~ of the Government of India,Ministry of Commerce. (f~\t\S

3. The import Iicence(s) mentioned in par~(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).





(D~N Singh)Drugs controlli ~~neral (I)



Licence Number: NCD-74/12 Date: - 8 MAY ZQ.1ZMis. 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.TOSOH CORPORATION, 4560, Kaisei-Cho, Shunan, Yamaguchi 746-8501, Japan havingfactory premises at Mis. TOSOH AlA, Inc., 2, Iwasekoshi-machi, Toyama, Toyama 931-8510, Japan and any other drugs manufactured by the said manufacturer as may from timeto time be endorsed on this licence.

2. This licence shall be in force from ~ to - 7 MAY 2015unless it is sooner suspended or cancelled under the said rules.

3. Names of drug~tQ4?EtimAs per attf.lchedredb.Yl..h;.~rlsing Aut~ority

1. A photocopy ofpremises, and

2. Each batch oftest report anmanufacturer WIreports. The if'l'lptesting as theliC~.

3. The licensee shaUbe the manufacturer inIndia along withti'l~.r~. .'" ' , t.

4. The licensee shall illformthe licensing au on y 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.

~LiCe~mg Authorityo Seal/StampZ G, N. SII\!(-)HDrugs Controiler General (IndiCl)

.il.••..e.·.· .•. l.p.l.ace in~, 6artrc()f,f '.J1!:li'.n.s.ervices• .....• .fI.i1m'· try of f-kal',.l '" ,"C) ",,,,1e e.ver requrn f''''',,,''' '"",, ',',,,. . ... ,,_II " .."'--:- .-, .,1.,.:.1 l. 1.\.)mpa .' with a detaj:led:ba:tohJJJ2

>authenticated by thea~e of forwarding such

to examination and

Place: New Delhi

Date:-- 8


This licence shall be in force froru- 8 MAY 2OJ2 toN fd t b . dames 0 rugs 0 e Importe

Description Intended use51. No.

ST AlA-PACK HbAlc Used for the quantitative measurement for percent1 concentration of haemoglobin Alc (HbAlc) in EDTA

whole blood on the TOSOH AlA-GOOII or AIA-3GOimmunoassay analyzer

ST AlA-PACK HbAlc Used for the calibration of the ST-AIA-PACK hbAlc2 Calibrator Set Assay

ST AlA-PACK HbAlc Used for the pretreatment of patients samples or AIA-Pretreatment Solution PACK HbAlc control set for the ST AlA-PACK HbAlc

3 AssayAlA-PACK Substrate Set II Used fOf the AlA-PACK or the ST-AIA-PACK assay

..."'\~\

4 . :c:.~'\\: .AlA-PACK Wash ,,':'

~\:.J'-_.~~5 Concentrate , i("';\?'

"~"'9'?~~ ~,1:9'

G. AlA_PACK Di~tConcentrate

7. AlA-PACK HbAlc Control Used for performing quality control procedures with theSet ST AlA-PACK HbAlc assay

Place :New DelhiDate: -------- 8 MAY ZOll

LicenOt; Authoritysei:~~amp



Food and Drug Administration BhawanKotla Road, New Delhi-110002

Dated: - 8 M/-\Y201Z

To~s. BioMerieux India Pvt. Ltd.,

A-32, Mohan Co-operative Industrial Area, New Delhi-11 0044. ,,)1_ ,O)·~··~

Subject: Issue of an Endorsement No. 01 to Form 10 License .Na:~~~O-397/2008 dated08.12.2011 valid upto 07.12.2014 -regarding. ..\\>;}s, .

\\.~,,\,-

\. \\,{\) .Sir j

Please refer to your application No. BMXl51/11 dated 12.09.2011 received by thisoffice vide diary No. 42631(FTS No.62486) dated 13.09.2011 and application No.BMXl52/11 dated 15/09/2011, received nby this office vide diary No. 43877 (FTS: 64069)dated 20109/2011 and replies received by this office vide diary No. 52969 (FTS: 78073)dated 16/11/2011 and vide diary No. 12200 (FTS:19988) datd 23/03/2012, regarding theabove cited subject.

Endorsement No. 01 to Form 10 License No. NCD-397/2008 dated 08.12.2011 validupto 07.12.2014 for the import of drugs manufactured at Mis. BioMerieux S.A., 69280Marcy L 'Etoile, France is enclosed hereby.

YOIfr faithfully

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



Mis. BioMerieux India Pvt. Ltd., A-32, Mohan Co-operative Industrial Area, New Delhi-110044 is hereby licensed to import into India during the period for which the licence is inforce, the drugs specified below, manufactured by Mis. BioMerieux S.A., 69280 MarcyL 'Etoile, France.

2. This Endorsement No. 03 shall be in force from- 8 r"1AY ZOllto 07.12.2014unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be importe9-tAon r 'As per attached Iist,P{~\\\iHa$tre KiQ~~~d by Licensing A~~drity

S'? ITEM(S} FIVEONJ.« ; , ;,~~"Place :Ney( Delhi i?0 ' ,

,\',ucens· ~:;;"uthorltY150 t~:aIlStampUZ _'j" G. N, SINGI~

Drugs Controller General (India)1. A photocoPYPfff tplace in r,a" pailitr<tl>tf tbelh Services

. d h .'. ,. '~~"try 'If L'e-Yn' "'~4'nil'" \AI~I<ar'"premiSeS, ant ·.e ev...er requi ' .,'. " ."'., ',' 'c:' 'J ',"::'c, ~.......... J.\ B;-<J\'f,;:~l,~'.ULla I"'\O~;cJ,1.1.02. Each batch of<acco.lT1Pg . with a detaiJed,batclru':".:::

test report anslgl'l~ authenticated by themanufacturer aahd te of forwarding suchreports. The imp ctad to examination andtesting as the HCE)n$i eting.

3. The licensee sh,a,··',·..uibe. r ..,•.•,...'•••••,••·,~l,·pJeJo.J,·.,th,·,", . ". "t.ivities.o, f the manufacturer inIndia along withth.eJegil)tratfOflA51'J9~~.. "..•.•.thprisE)dggent.


Licence Number: NCD-397/2008

This licence shall be in force from = 8 j\ilAY 20_12__ to 07/12/2014Namesof drugs to be imported

Intended UsesUsed for the quantitative determination ofhuman ferritin in human serum or lasmaUsed for the quantitative measurement ofhuman alpha feto-protein in serum, plasma

1\ lithium he arin or EDTA or amniotic fluidVIDAS 132 Microglobu~t2 Used for the quantitative measuremet of 132

(;1> micro lobulin in human serum or lasmaVIDAS CA 125 ,u.'~{;' Used for the quantitative measurement of OC

;,.;(/::::>/ 125 antigenic determinants in human serum or\~~ '> lasma

VIDAS T A Used for the quantitative determination ofprostate specific antigen (PSA) levels inhuman serum or lasma.

ITEM(S) FIVE ONLY

S. No.1.

Product NameVIDAS Ferritin

Place:New DelhiDate: ----e-r-IA,Y -lOll

Licensi~thorltYseal~~~~

G.!'l. S!f\\<?HDrugs Controller General (Iildia)Ote. G::;n:~'rc.d;J'r :-;c~djh Services

of H8al!h 2, Walfc;r8'\or!a L T.O.

\'0002




- 8 t"1AY ZOllTo __/

\JVf/S. BioMerieux India Pvt. Ltd.,A-32, Mohan Co-operative Industrial Area, New Delhi-44.

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

1. With reference to your application for import licence forwarded to this office with yourletter No. BMXl54/11 dated 22/09/2011 recieved by this office vide diary No.44612(FTS No.65162) dated 23/09/2011 and reply received by this office vide diaryNo. 12634 (FTS: 20622) dated: 27/03/2012, I enclose Iicence(s) No. NCD-68/12

date<t, ~this / these Iicence(s) has / have been granted under theDrugs a'ridIOO'Mm!tteYAct1940 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 anX,~her law for the time beingin force and as such the Iicence(s) issued und~J(~~gs and Cosmetics Act andRules will be in addition to and distinct from a~ ,;g;'hCe(s)which may be necessaryunder the Import Trade Control Regyl~~~ade of the Government of India,Ministry of Commerce. t~~'\f;

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





(Dr. GO~ngh)Drugs Controller ~~:~~I (I)



Licence Number: NCD-68/12 Date: - 8 ['''1AY 201?Mis. BioMerieux India Pvt. Ltd. A-32, Mohan Co-operative Industrial Area, ~ew Delhi-44is hereby licensed to import into India during the period for which the licence is in force, thedrugs specified below, manufactured at Mis. BioMerieux Inc., Box 15969, Durham,Durham, NC-27704-0969, USA having factory premises at Mis. BioMerieux, Inc., 595Anglum Road, St. Louis, MO-63042-0969, USA and any other drugs manufactured by thesaid manufacturer as may from time to time be endorsed on this licence. tv' A Y 20 i5

2. This licence shall be in force from ~ to _-_1 _unless it is sooner suspended or cancelled"'u~der \h~~am rules.

3. Namesof dru s.tobeim orteS.No Product Name

1. VITEK2 AST"'fS~~~~

<)Place: New Delhi ii!

t:eDate :- 8 M ~.YlfZ

u1. A PhotocOPyqf<il!G ...a

premises, andtl'l139rigina.!H2. Each batch of· imp()rj~

test report anq ehTalmanufacturerreports. Thetesting as the

3. The licensee shaUiba ...India along wifhfneregi$frafl ·otisedageht.





Dated: - 8 MAY 201lTo

~. Beckman Coulter India Private Limited,Solitaire Corporate Park, unit No. 1131, 3rd Floor, Andheri Ghatkopar Link Rd.,Andheri (East) (Mumbai-Zone6), Pin: 400093.


1. With reference to your application for import licence forwarded to this office withyour letter No. Nil dated 19/01/2012 recieved by this office vide diary No. 2779(FTSNo.4695) dated 19/01/2012 and reply received by this office vide diaW1No. 12240(FTS: 19980) dated 23/03/2012, I enclose Iicence(s) No. NC-,?~4t2i2009 dated8 t'?ll1 ?~this / these licence(s) has / have been grantee: u@ fthe Drugs andCos J icsC)(~h940 and Rules1945 thereunder. . .<~\~~;}t0

2. I am to point out that the provisions of Drugs ;Flt\~'t:crismetics Act 1940 andRules1945 are in addition to and not derogation of aF1)i other law for the time beingin force and as such the Iicence(s) issued under Drugs and Cosmetics Act andRules will be in addition to and distinct from any Iicence(s) which may be necessaryunder the Import Trade Control Regulations made of the Government of India,Ministry of Commerce.

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





(Dr. ~ingh)Drugs contro"e~~n~ral (I)



Date: - 8 iliA''i lOllLicence Number: NCD-472/2009

Mis. Beckman Coulter India Private Limited, Solitaire Corporate Park, unit No. 1131, 3fd

Floor, Andheri Ghatkopar Link Rd., Andheri (East) (Mumbai-Zone6), Pin: 400093 ishereby licensed to import into India during the period for which the licence is in force, thedrugs specified below, manufactured at Mis. Beckman Coulter, Inc., 250S Kraemerboulevard, Brea, CA 92821-6209, USA having factory premises at Mis. Beckman Coulter,Inc., 7381 Empire Drive Florence, KY 41042, USAand any other drugs manufactured bythe said manufacturer as may from time to time be endorsed on this licence.

2. This licence shall be in force from _ 8 \";jI~'{ Z01Z- to -; MAY 2015unless it is sooner suspended or cancelled unaer the said rules.

3. Names of dru9stpl;»~.il1lJ?9rt~·

As por ~~Q)ji~~,I*li~~<:> .'.

Place: New Delhi N.f!'Date: - 8 MA'~OlZ

u

l,\r:,

\~:iconsl~horltYo SeaIlStarTlP',JZ '\1" G. N. S!i\' .."l.

Drugs c'ontroller General (India)

1. A photocopy oft 1!·"E:l.l.,P...:,lace irPta·~fr-tt:la~f:l~~~~':'~:;;';:rp. d th ..... ".MjR.i~ry 0 'e3i\h '... I.,'':.'::: ~premIses, an ).e'i~ ver requlr~BhClwr'.I.«0,13 r;~:'>.!,L iv.

2. Each batch of .accomp,with a detaHe€l'llatcHlJuLtest report and ~ignE:ld authenticated by themanufacturer Wit $8(;i i!lte of forwarding suchreports. The irnpaUbeed to examination andtesting as thetice~tlhg.

3. The licensee sl'1al f the manufacturer inIndia along withJh~regj$ 1.

4. The licensee shall ir'lformthe licensing author'ity orthwlfh iri 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.

LicenceNumber: NCD·472/2009

This licenceshall be in force fro;' 8 iV,Ii'( 2Q1ZNamesof dru s to be im orted

Used as a cleaning agent forCOULTERPPLH 500, LH 750, andLH 780 hematology analyzercomponents that comes incontact with blood samples,including apertures and bloodsam lin valves.Used as an isotonic buffereddiluents in conjuction with a lyticreagent for counting and sizingblood cells on COULTER HmXhematolo anal zers.Used as an erythrocyte lyticagent for the quantitative

,.;(J,···tdetermination of haemoglobinLYSE S® III DIFF RGT \C(~~)\: and for leukocyte counting and

..\\~g&'} sizing on COULTER HmX, LH500,. \,;,\,\." LH750 and LH780 hematology

",\ \) ,

J anal zers.A non-fluoresent, azide freebalanced electrolyte solution forue on COULTER Flow cytometerswith light scatter and fluorescenta Iications.Used as a cleaning agent forCOULTER hematology analyzercomponents that comes incontact with blood samples,including apertures and bloodsam Iin valves.Used as an erthrocytic lyticreagent for the quantitativedetermination of haemoglobinand for leukocyte counting andsizing on COULTER HmX, LH500,LH750, LH780 hematologyanal zers.

- 7 MAY 20J5

This licenceshall be in force from - 8 Mr::t ZOlZ to - 7 MAy 7015

8. ACT PAK For use on COULTER AC.T 8 and9. ACT TAINER 4L DIL/80ML LYTIC AC.TIO hematology analyzers

For use as a shutdown diluentsfor COULTER AC.T8, AC.TIO,AC.T diff, and AC.T diff2

10. ACT RINSE SHUTDOWN DIL hematology analyzercomponents that comes incontact with blood samples,includinq apertures and probe.

11. DIFF ACT PAK For use on COULTER A.T diff andA.T diff2 hematoloqy analyzers.For use on COULTER AC.T diff

12. DIFF ACT TAINER and AC.T diff2 hematology. analyzers .

Used a~,'btonic buffereddilue.pt , \ onjuction with a

{i~~~\i€fe:'free lytic agent for

13. ISOTON 4 DILUENT \if unting and sizing blood cellson COULTER HmX, LH500,LH750, and LH780 hematologyanalyzers

14. HMX PAK Used to lyse erythrocytes andpreserve leukocytes.Used as a rinsing agent on

15. ACT 5 DIFF RINSE COULTER AC.T 5diff hematologyananlyzerUsed as an erthrocytic lyticreagent for the quantitative

16. ACT 5 DIFF HGB LYSE determination of haemoglobin onCOULTER AC.T 5diff hematologyanalyzersUed as a stabilized salinesolution, containing an organic

17. ACT 5 DIFF DILUENT buffer and preservative forcounting and sizing blood cellson COULTER AC.T 5diffhematology analyzersUsed as an enhanced lowformaldehyde-producing isotonicbuffered diluents in conjuction

18. LH700 SERIES DILUENT with a lytic reagent for countingand sizing blood cells onCOULTER HmX, LH 500, LH 750and LH 780 hematologyanalyzers

IJJvDr. G. N. SINi",H

diaIler General (In )DrUGS Contro I"~SP.rvic'-"sOte~ General O\tfh~e~~~iI;wel1are

J'" '~tryof Hea 1- 0\"\n;,, _, Kotla Road, . l. 'FDA B\~~~:,~;J)~c!h\_11000?

Licence Number: NCD·472/2009 3/3

This licence shall be in force frorn.- 8 MAY lOlZ to -+M A¥ 2015For use on COULTER HmX, LH500/ LH 750 and LH 780

19. LH700 SERIES PAK hematology analyzers to lyseerythrocytes and preserveleukocvtesFor use on COULTER HmX, LH500/ LH 750 and LH 780

20. LH700 SERIES RETIC PAK hematology analyzers forstaining red cells and stainingleukocytes.Used~with the Access

21. ACCESS WASH BUFFERII Irn~unoassay System and\Specific Access Immunoassay

,\\~::J:P Reaoents<'~.?\> Used with IMMAGE,~_. ,\ '.').

J} Immunochemistry Systems and22. IMMAGE WASH reagents for the quantitative

determinations of components inbiolooical fluidsUsed with the Access

23. UNICEl DxL WASH BUFFERII Immunoassay System andSpecific Access ImmunoassayReaoents

Place :New DelhiDate:__

- 8~M-At""""-Z01ZLicens .~thOritY

sea~;a~~Dr. G. N. SINGH

Drugs Controller General (India)Dte. General of Heallh Services

Ministry of Heallh 8, F:lInily 1NelfareFDA l?,t,'<N"\n,,c~,)2,d, ITO.

''.l2vliJJ::iI·l10002



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

- 8 MAY 201ZvJ!!'s. Medsource Ozone BioMedicals Pvt. Ltd.,

Plot No. 238 (LGF), Sant Nagar, East of Kailash, New Delhi-11 0065.,,;I

,~:;,';'--\Subject: Issue of an Endorsement No. 02 to Form 10 License NQ,~~~D-45/11 dated22.02.2011 valid upto 21.02.2014 -regarding. /"':c:} /r>;~~~

~$};.:;"~/Sir (',\~( $

Please refer to your application No. MOBPLtSrOLAND-Endr-UCS/11-12 dated17/01/2011 recieved by this office vide diary No. 2933 (FTS No.5159) dated 23/01/2012and reply received by this office vide diary No. 12093 (FTS: 19609) dated 22/03/2012,regarding the above cited subject.

Endorsement No. 02 to Form 10 License No. NCD-45/11 dated 22.02.2011 validupto 21.02.2014 for the import of drugs manufactured at Mis. B/OLAND, 644-6, Gak-Ri,Ochang, Cheongwon, Chungbuk, Korea, 363-883 is enclosed hereby.

Yours faithfully

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



Date: - 8 f·t; thY ZOlZMis. Medsource Ozone BioMedicals Pvt. Ltd., Plot No. 238 (LGF), Sant Nagar, East ofKailash, New De/hi-110065 is hereby licensed to import into India during the period for whichthe licence is in force, the drugs specified below, manufactured by Mis. B/OLAND, 644-6,Gak-Ri, Ochang, Cheongwon, Chungbuk, Korea, 363-883.

- 8 r.'2. This Endorsement No. 02 shall be in force from I"'M I ZOll.to 21.02.2014

unless it is sooner suspended or cancelled under the said rules.3. Namesof drUgstot>eimp?~~f\RO

S.No ProductNam1. Uncut Sheet ofma

Pf/Pvantibod QUncut sheetPf/Pv anti en

- 8 i'4AY~ ;:g .••Licensing ~uthority~ eal/Stamp.~ ...•••••.·Co 5« •.•.•.•.. . Drugs C':~~t:~lIt~;~~~~~'~I(India)

1. A photocopy ofHc~e.shaU·.b ~entplace IOtEBGparti ~f,-lfUieSarJlces.l~ffJ" 0. f H..e..•8..li.h...,.8..'.'.'.-C...:.,:.,,-.•,...,.,.!... \N,·-.'".lf8repremises, andtheorigi nceshaIhbe never reqUl: ,., I 0

2. Each batch ofcfrugll1ip<f),§! rnpaniecfwith a e~~e·a~b~tcilu;:'·I.,test report andaOatcl1re >, •. ~, signeclarid'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




Dated: - 8 I'll ~'! 201lI l{i 1

~ Qiagen India (P) Ltd.,39, 2nd Floor, Samyak Tower, Pusa Road, New Delhi-11 0005.

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

1. With reference to your application for import licence forwarded to this office withyour letter No.Q1PUDCGI/RA06/2012/01 dated 02/04/2012 recieved by this officevide diary No. 13595 FTS No.22283) dated 03/04/2012, I enclose Iicence(s) No.NCD-70/12 dated - ' this 1 these Iicence(s) has 1 have been grantedunder the Drugs and Cosmetrcs c 940 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 Drugs and Cosme~IAct andRules will be in addition to and distinct from any Iicence(s) which m~Ge. necessaryu~d~r the Import Trade Control Regulations made of the ,E~e'triri1ent of India,MInistry of Commerce. .,("W\~·.Jj .~

3. The import Iicence(s) mentioned in para (1) above ~~ribt accordingly to itself 1themselves be sufficient authority for import of Drugs covered by that I thoselicence(s) if under the Import Trade Control Regulations of the Commerce Ministryseparate Iicense(s) are required for import of such drug(s).





(Dr. G~~9h)Drugs Controller G~n~~~1(I)



Licence Number: NCD·70/12 Date: :- 8 MAY ZOllMis. Qiagen India (P) Ltd., 39, 2nd Floor, Samyak Tower, Pusa Road, New Delhi·110005is hereby licensed to import into India during the period for which the licence is in force, thedrugs specified below, manufactured at Mis. Qiagen GmbH, Qiagen Strasse 1, D·40724Hilden, Germany and any other drugs manufactured by the said manufacturer as may fromtime to time be endorsed on this licence.

2. This licence shall be in force from - 8 MAY ZOlL to - 7 MAY 2015unless it is sooner suspended or cancelled under the said rules.

3. Namesof dru s tobeimorteS.No ProducfName

1. ~~~s~~~~~~~~~9~a~ia~~1r<kit, CE .<:>... ·cUa

~Place: New Delhi ~

---- N<,-.Date: C: .8 Ml\t;1Z01Z

CDS1. A photocopy of lie.epee sha

premises, andtfi.origip(;il/i2. Each batch ofd.~irl'lP()l"'te

test report anc:ta •••. I.,.releamanufacturer .with {lestireports. The imp . ....tph9f(;l9Pt'i

3. ~hs~i~i~::S~~~~~m~~Qr~~I'~I~ .... i'litiesof the manufacturer inIndia along with the registration holder and his authorised agent.


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