=: No.9671) dated - Central Drugs Standard Control ... · Mls.Standard Diagnostics Inc., ... Mls.SD...

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-110002

~ 9 AUG 2011To #

~/s. Piramal Healthcare Limited,Shop No; 1-2,13, PunitCham~~~L·Secfor':18, Vash-r; D.sITllane-New Bombay~

Subject: ll1ipQrt Licence under the Dl'ugsand Cosmetics Act 1940 and Rules 1945theretmder -regardtng.

1. VVith reference to yguL appiication fOLimport licence forwarded to this· office with. your letter No.· Nil dated 14/02/2011 received by this office vide diary no. 7156 (FTSNo.9671) dated 14/02/2011 I enclose licence(s} No. NCD-230/11 dated=:...9~~~i~~4~~: ~~:~~~Sl~~~~:e~~~:r.beengranted· unoefthe Drugs and

2. I am to· point out that the provisions of :Q"ugs and Cosmetics Act 1940 andRules1945 are in addition to and not de~ian of any other law for the time beingin force and as such the Ijcence(~ i~d under Drugs and Cosmetics Act andRules will be in addition to and d~Yet from any licence(s) which may be necessaryunder the Import Trade C~~'~egulations 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 1themselves be sufficient authority for import of Drugs covered by that i thoselicence(s) if under the Import Trade Control Reguiations 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.

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. II1~6!?sistahLOrugs Gontrollef (Inaia) and +echnieatGfficerofthe Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premises.9f ir'11.P9rre..rs_es.tabJisbmentsfor the plJrpose-ef·Rule-26oHhe-Brtlgsand CosmetIcsAct and Rules thereunder.

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

cg~(Dr. S. Eswara Reddy)

Asstt. Drugs Controller (I)Copy forwarded for information to:

1. Asstt. Drugs Controller (India), Ahmedabadl Chennai/ Cochinl Delhil HyderabadlKandla IKolkatal Mumbai/ Nhava Sheva..

FORM 10(See Rules 23 and 27)

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

Date: - 9 AUG 20tlMis. Piramal Healthcare Limited, Shop No. 12, 13, Punit Chambers, Sector-18, Vashi,Dist. Thane-New Bombay is hereby licensed to import into India during the period for vvhichthe iicence is in force, the drugs specified below, manufactured by Mis. Boule Medical AS,Vastberga Aile 32, Stockholm, Sweden and any other drugs manufactured by the saidmanufacturer as ma,yJrQm tLI118 toJime_be endorsed on tAislicence._ .._-- . ----- --- -------- ----_. -~---- .-- ...• ----

2. T~is Iicerce. shall ..I:>~.il1 force from ••. 9 AUG2illt to . - 8 AUG 2314unless it is sooner suspended or cancelled under the said. n ,I~s

,.-i"'b-n«'l>;_g A ••.••.L __ ~.f-.0 ""........I'\UlIlunlY

~G'~

~iJ'7,~\

~4~DS.,CQ.•. L.i£eQiinQ.,&ltbOFity mOIk+.'

~. Seal/Stamp~ ~~~~~~.qj.J:;il.~.1 fJ Dr. S. Eswara Reddy M.Ph Ph.D.

. ~;;.,~ ~ f.,~!Asstt.Druos Contro:ler. ~'''''' , \ ~• . ; (. ~ ':({r.f .,c,tRc:;~Ii&F!lconJJltilA~o1l!il:ence .i 0< Dt6. Generili of HeatH', Services

1. A photocopyoflicenJ?~llbe d.is_.Play.e..d. in ,,~.~inerlfO!l~;~~';~:PH~"nOo ....J2. ~~~I~~~~~~~ ~r~;~~I~~~:~~~~~;~~~~~:~~~~I~~iled batch'·; - -

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 andtestlngas~Ae4icensingaLtthority-cJeemsfrtprfonoits marKeting. .

3. The licensee shall be responsible for the business activities of the manufacturer in.Jndia alol"lgwith the registration holder-andhis-aotnotls-ed 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.

3. Names of drugs to beimported.:ARD Co(~iX~\J' tv,:.

As per attachedlist,Q'f.,O'higI1QsticKitsa;ppro\,'<)\.YIT-EM(~lT1:NcO -Y

<:;~"'V

ifPlace: New Delhi J...::.<

Date: - 9 AUG mllCDSCO

1/1

_ Q Itllrl)n4t - B AUG 2014This licence shali be in force from ~ to _Names of drugs to be imported

S.No1234567

_8 ..9

110

Product NameSwelab Alfa DiluentSweJab AlfaL seSwelab Alfa ComboPackSwelab Autoton

, Swelab AutolyseI Swelilb Autodeter ent

Be>uleCleanin Kit-Boule-CGn-Diff-N-Boule Con Diff LSoule eon OifUi

Place: New Delhin J.! I,.. ,.nu

Date: """''J:fo\Uu LUn

Intended UseUsed for the measurement ofcomplete blood count



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

ToAs.SD8iO StandardDiagno~csPvt Ltd.,

Plot No 2GG,Sectora,IMT Manesar,Gurgaon,Haryana

SUbjeeelssuifofanEndorsement No. 01 to Form 10 License No. NCD-43/2007 dated13/03/2010 valid upto 12/03/2013 ·regarding.

Sir Please refer to your applicatlon~a IGQ¥,j21/01/2011 received by this officevide diary No. 10243 (FTS No.144.5~;t,~4/03/2011 and reply received vide diaryNo.32996(FTS NO.47162)regardi~VtY~oove cited subject.

Endorsement No. 01 to Form 10 License No. NCD-43/2007 dated 13/03/2010 valid upto 12/03/2013 for the import of drugs manufactured atMls.Standard Diagnostics Inc., 156-68,Haga/-Dong, Giheung-gu, Yo ngin-si,Kyonggi-do,Korea.is enclosed hereby.

~ Yours faithfully

~~{Dr.S."Eswara R~ddy)

Asstt. Drugs Controller (I)

Copy forwarded for information to:1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabad/

Kandla IKolkatal Mumbail Nhava Sheva.

FORM 10(Endorsement No.1)(See Rules 23 and 27)


Date:.-.9 AUG 20nMls.SD Bio Standard Diagnostics Pvt Ltd.,Plot No.266, Sector 6,IMT .Manesar,Gurgaon, HarayanaisJl~!¢J:>Y_IiQensedJojmportJnto-ll"ldiaduring-{he-periedfor-whichthe

- -'-Iicenceis-in force-~ThecirugS specified below, manufactured by MIs. Standard DiagnosticsInc., 156-6~,Hagal-PClng,Giheung~gu,Yongjf1-si,Kyongg;-doiKor~

2. This Endorsement No. 01 shan be in force from - 9 hllr- ?nt'lto 12/03/2013unless it is sooner suspended or cancelled under th~

3. Names Of~~~~~~i:~~~~~(!'lIedbYLTcefiSiil9AuthOrity£ ""S ..7 ' ITEM(S) TEN ONL U.(,

:')V OrO<Jq;:-- -'~" ~~ \J'

Place: New Delhi f...:. '"B.----< .-'.Datee ~ 9 AUGZlll . ~~~

CDS C,..._,~.._~~j,~Q.&Ltb.gI.Ux.-..,;.••~.•-.• "*-~ Seal/Stamp :I. "~A -, ..s....-...~; .......c:

j r, IV ~ ~ _~~q-':I '('~~I ~ '1W1, [51. c:v~~.r: ~- '-!..r.~. Eswars M'(::ddy M.Pl1 1"11.0. I·11 ~~cn 3!T~ ~mlp..~'3tt.Drugs Controlier~ih~ ~. ,.1..". ~ ~ 'it;!f:::;hl,<'n)

CondItions of Licence. <'\ )iJ Dte. Qern;r<'31 of Health Services

1. A photocopy of lioence Sh¥~=.~.ed. ina.prOmi~ ...•..~.a.c.ei.~. ".C~~~~;~~~est00022. ~~~~~a~~~i~:~I~~~~:p~~~~~to India;~~~~~~:!f~;jth a detailed batch test ,~; ~

report and a batch release certificate,duly sign~dand authenticated bytherT"lCll1ufClctljrerwith-dqte-ef test1ng~-dateof-release ana-lhe -(fate-of fOrwaicfrngsuch reports, Theimported batch of each drug shall be subjected to examination and testing as thelicensing authority deemsfitpriorto its-marketing. - -

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

4. The licensee shall inform the licensing authority forthwith in writing in the event of anychange in the constitution of the firm operating under the licence. Where any change inthe constitution of the firm takes place, the current licence shall be deemed to be validfor a maximum period of three months from the date on which the change takes placeunless, in the meantime, a fresh licence has been taken from the licensing authority inthe name of the firm with the changed constitution.

Intended useI Qualitative detection of H.pylorA.Reference panel for QCtesting I

I ~ IUncut Sheet of SOBioline Leishmania Ab Ql!~litativedetection of

. -leishmania-Ab-----~r- . -Ref~rence Quality Control Panels for Leishmani Ref-erencepanel for QCtesting

This licence shall be in force from :: 9 AUG zntt toNames of dru s to be im orted ~S.No Product name1 Uncut Sheet of SO Bioline H.Pyioti Ag

Reference Quality Control Panelsf~

- uncutSheetofSB-BiOlin<~,1

Refer~f'I~~QuCl!i~¥90nt .ClIJ~t~JQ.rIr()p()r1in-

Uncut Sheet of SOBioline HAVIgGllgM

uai fIgG/lgMantibodies in humanseruml lasmaReference panel for QCtesting

-Qualitative defection ofTro onin I_Reference__paneJfo.rQC testing

Qualitative detection of HAVI G/I M antibodiesReference panel for QCtesting

9 AUG 2011• •• bie8lisiag Au~holit,

\"

. ~e \ffi-~~~s~~tf- va. tt.·_ Dr. S. Eswara Rllddy M.PhPh.D.

~ ~ ~'q;/.A.$spprugs Controller

l~mu "lQII~~~I.i(>ltl

Ote. Ge""f,lll of Health Servicescoseo (HO). FDA Bhewan

; KotIa R.oed, New O.,hi·110002----------_.~_.,--



Food and Drug Administration ahawanKotla Road, .New Delhi-110002

Dated: ~ 9AUG Z07fTo

_/Jjls._Jeev DiagnosticsPvt Ltd.,V Door No 2/555 Babu Jagajeevan RarnstrE:!et,

Gerugambakkam _yill@~-,SrLp_er.amhudur-Taluki- --Kancflipuram District,Chennaj ..602101.

Subjecl:l_mport1.icenceunder the Oru s and Cosme'-regar mg.

1. With reference to _your application for importlic~nce forwarded to this -officewith-your t~tt~LNQ.JEE\l[QCANo.1/201-1datecl-06l07f201-t-recei'ledoy thisoffice vide diary No.33174(FTS No.47245) dated 12/07/2011. I encloselicence(s)No.NCD- 228/11 dated_~_.9_l1llr-2Dflli.s 1 these li~~nQ~(~Lbas-

__Lbavebeen-gr-anted\;lnderthe-E)~t~af940~and Rules1945thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 andRules1945 are in addition to an~dt~gation of any other law for the timebeing in force and as such the r ~!(s) issued under Drugs and CosmeticsAct and Rules will be in ~~ and distinct from any licence(s) which maybe necessary und~~\~port Trade Control Regulations made of theGovernment of Indi~iriistry of Commerce.

3. The import licence(s) mentioned in para (1) above will not accordingly to itself1 themselves be sufficient authority for import of Drugs covered by that 1 thoselicence(s) if under the Import Trade Control Regulations of the CommerceMinistry separate license(s) are required for import of such drug(s).

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

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

6. Ih~_8ssistant-Drugs- Contreller --(Ind+aland-Ttrchnical-Officer-of-.fhe-:CentralDrugs Control Organisation at the ports will be Officers authorized to inspectthe premises of importers establ..ishmtmt~ ~forthep[lrpose6f Rule 26 of theDrugs and Cosmetics Act and RuJesthereunder.

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

c6~hfullY

(Dr. S. Eswara Reddy)Asstt. Drugs Controller (I)

Copy forwarded for information to:1. Asstt. Drugs Controller (!ndia), Ahmedabad! Chennail Cochinl Delhil

Hyderabadl Kandla /Kolkatpl Mumbail Nhava Sheva.



Date:~l1

Mls.Jeev Diagnostics Pvt Ltd, Door No.21555Babu Jagajeevan ram street,Gerugambakkam Village, Sri Perambudur Taluk,Kanchipuram District,Chennai-602101is hereby licensed to import into India during the period for which the licenceisiri . force, the drugs specified below, manufactured by Mls.QiJimica ClinicaAplicada,S.A,A-7 Km 1081(formerely CN-340,Km 172)43870 Amposta(-Tarragona)-ESPANA,SPAINandany····other·drugsmanufactl,;lred .by the saidmanufacturer as may from time to time be endorsed on this licence.

1 Thi'_ &,"iiG 28i~u~eS~;~tiS~:aner ~C:pen:ed9o~~-r-t~~~~~~~~-~--'said rules. O~~

3. Namesof drugs to .b;l import&d~\g fON/'.As perattachedustOf~~ticKitsapproved «~icenSingAuthority

<J:.:;S rrE_N1(sJ~JN ONLY. ()1>,...,(J v~

~ ~.'\ ;J'~ -)71<- ::::~ 0

Place: New Delhi U Z

Date. - 9 AUG ~~DSCO ~~~~Ity:{E_"'~

~ .... . SeallSt~mp \~ ~ t- 61'0 ~ ~~ 1(~ tm'f: ..Qt V,'il". ~. II

. 'J-80nditi.~cenc4./ .,,'~F~~~~~.b~;~_~~~;ro"er•.1. A photocopy of licence Sh6lf~.••~.•..•·tPla ..Ye.d In a .•....•.J!.. ~ _~rtti.l~\~!;~erces~

premises, and the ori~inalJicen. •·~5 . <.:' W eneterCfe~rach/>. ~h~"'''.." t.2. Each batch of drug Imported Into .Indfa.s all b~ ac~~~,wi'tf1N~t!f~allg~,,~ ._1

batch test report and a batch release certlficate,~J~I~f1~.;::atJthentlcatgd·1>y-r; •.r .. ,.•

the manufacturer with date of testing, date of release and the date of forwardingsuch reports. The imported batch of each drug shall be sUbjected to examinationand testing as the licensing authority deems fit prior to its marketing. .

3. The licensee shall be responsible for the business activities of the manufacturerin India 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.

1/1

This licence shall be in force from _-_9 __ A_U_G_Z_O_ll_to _-_8_A_U_G_2_0_'4_

GLUCOSE Reagents (Bulk)(GLUCOSA L1QUIOA)GMON31386/EOMA 110201 13CREATININE Reagent A (Bulk)

I (CREATINfNA)GMON 31396/EOMA 11 0201 07CREATININE Reagent B(Bulk)(CREATININA)GMDN 31396/EOMA 11 0201 07TRfGLYCERIOES Reagent (Bulk)::r~fGLl OCRIDes-t.1t1t:tiuOSr-···'GMON 38957/ EOMA 11 02 01 31URIC ACIO Reagent (Bulk)(ACIDO URICO L1QUIDO)GMDN 39860/ CDMA11 02 01 32

Place: New Delhi

Date :- 9 AUG 2011

Intended UseThis reagent is intended for the quantitative in Vitrodetermination of Glucose in serum plasma or C.S.F (notwhole blood

"

This reagent is intended for the quantitative in Vitrodetermination of Creatinine in serum lasma or urine.

This reagent is intended for the quantitative in Vitrodetermination .of Creatinine in serum lasma or urine.

..._---_._~--~-~-"~~~---~~~.~~.~~~.,. ~-,.~~~.~,-~

Tfifs reagent is intended for the quantitative in Vitrodetermination of Tri I cerides in serum or lasma.This reagent is intended for the quantitative in Vitroenzymatic measurement of uric acid concentration inserum lasma or urine.Part of Glucose kit required to standardise the Glucosereagent for IN Vitro determination of Glucose in serum orlasmaorC. 'F Not whole blood .

Part O~f n e kit required to standardise theCreati eagent for IN Vitro determination of Creatininei ru or lasma.

of Triglycerides kit required to standardise theriglycerides reagent for IN Vitro determination of

Tri I cerides in serum or lasma.Part of Uric Acid kit required to standardise the Uric Acidreagent for IN Vitro determination of Uric Acid in serum orlasma or urine.

ITEM(S) NINE ONLY

h~iM'A"""'ib "k f,' #I~~.".... -. --a ~ t

Seal/Stamp It., mo~~ ~ ~ tf>Tlt. tf1. ~t:.. ~ l" Dr. S. Eswara Reddy M.Ph Ph.D. . '\'~ ~ ~ ~-'ffi/Asett.Dru:)s Controller .,I ~ ~f Tr;,sTPr'~'~T'(0Til .•:I Ote. General of Healih Services .

'

" COSCO (HQ), FDp. Bh,:wan..." ...•,.. . .'Koths Road. New Delhl-11l'-., l.- '.. _ _ . _ _ ..• ., - .. ,.Ao • ~L-------




- 9 AUG ZORTo ~ Morepen Laboratories Ltd.

5-49, (Basement) Okhla Indl. AreaPhase-II, New Delhi

~~~~~~~UDJect: Irnpoif[lcenceunder the Drugs and CosmeiicsActn'l94()"and"Rules1945"~~-~~" --"~-thereunder-regardi ng.

1. With reference to your application for import licence forwarded to this office with yourletter No.MLUIMP-2011!5 dated 15.07.2011 received by this office vide diary NO.33606

~ ~T~U(;92H~t~is 1?t~~~~0~i~~n~e(~~c~~~e!~~~~c~~~n ~~nt~dC~~~;~/~~ g~~~~and Cosmetics Act 1940 and Rules1945 thereunder.

2. lam to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules1945are in addition to and not derogation of any other law for the time being in force and assuch the Iicence(s) issued under Drugs and Cosmetics Act and Rules will be in additionto and distinct from any licence(s) which may b~ necessary under the Import TradeControl Regulations made of the Government ~~ia, Ministry of Commerce.

3. The import Iicence(s) mentioned in paf&.0~ above will not accordingly to itself!themselves be sufficient aU~horityf ~~ of Drugs covered by that! those licence(s)if under the Import Trade C egulations of the Commerce Ministry separateIicense(s) are required for i f such drug(s).

4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import of drugsin 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 (ObjectionableAdvertisement) 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 premises ofimporters establishments for the purpose of Rule 26 of the Drugs and Cosmetics Actand Rules thereunder.

7. Please acknowledge receipt of this letter and its enclosures. 4 Yours faithfully

(Dr. s. ~ddY)Asstt. Drugs Controller (I)

Copy forwarded for information to:1. Asstt. Drugs Controller (India), Ahmedabad! Chennai! Cochin! Delhi! Hyderabad!

Kandla !Kolkata! Mumbail Nhava Sheva. .



Date: ~ 9 AUG ZOl1Mis. Morepen Laboratories Ltd., 5-49, (Basement) Okhla Indl. Area, Phase-II, NewDelhi is hereby licensed to import into India during the period for which the licence is in force,the drugs specified beiow, manufactured by Mis. Tianjin Empees Medical Device Co. Ltd,Binhe Rd, Hangu Economic Development Zone, Hangu District, Tianjin, 300480,P.R.Chinaand any other drugs manufactured by the said manufacturer as may from time totime be endorsed on this licence.

2. This licence shall b.e in fOice from - 9 AUG Z~l1 .....to ~_~~~L~_~ __ ~-

-~·~~~---aim;:ssTf IS sooner suspended or cancelled under the said rules.:- 8 AUG 2014

3. Names of drugs to be imported: .,....,1\ Ri\ rOc . ...•..t>.~Vf"\ v"-. Nr;-..

As per attachedlist ~~~g~osticKitsapP~~~~Y...ticen$ingAuthorityITEM(S) TWO ONLY UA

:" It'":''.1"'9:

~V'~..-o

Place: New Delhi Z

Date .:.. 9 AUf z~f= "<4~ ,__ or

~ ..is L'SJ1DIWQ ..~!L~!~., C~·.J I~f"\. ~ •••• ~ Se~IIStarT!p~ .., it

\)",> t"\~~ ;.. ," ~ ~ ~ ~ ~ qrr;t, l\1.~. Gi. ; ~71 ..V .. ~~'f.i .~ or S Eswara Reddy M.Ph P:J.D. "rn COnalVOnS ofLlcence. .~ ~ .~ f.1<;-jt,.,/Assj!;Drugs Controller }i

1. A photocopy of licence~.a,.e e CdiScp'.ayed. in air nt p.lace ~~ ~r~~f'Et~r"ices '. \.2. r:~i~~~~~~~ ~~~gor~~a~~~~~~~:~~be acc~~;;~iee~r=fE~~,,~~~~~r~.-. "

I:: - __ ...,. .•.•••••••••

report and a batch release certificate, duly signed~.. d a~theRtiCil~ct","b,_"Ui§::. 'manufacturer with date of testing, date of release and 'tli aTe of forwarding suchreports. Tbe imported batch of each drug shaHbe sUbjected to examination and testingas 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.


Sr.No. Item1 Dr. Morepen Gluco One Blood

! I' Giucose Monitoring System TestStri s BG 03

12 Dr. Morepen GlucoOneBloodGlucose Monitoring System TestStrips BG 03i

Date: .- 9 AUG ZOl1

'HE tW}t ioL- 8 AUG 2014

Intended UseI Test strips for measurement ofGlucose of capillary whole Blood

Centrai Drugs Standard Control OrganisationDirectorate General of Health Services


Food and .DrugAdministration Bl:lawanKotla Road, New Delhi·110002

~ 9 AUG ZQ1t~/S. Accurex Biomedical pvt Ltd.,

GRFloor,Room No.1pt()t N().G·54~MJ.D.C,Boisar, Dist.Thane,Tarapur.

SUbject:lmportLicence 'underthe Dru9sandCo~metics AtL19AOAndRu!es·494S~~~~··-~~.~~=.~ ...~~~-~-tttTheP-1in:e~urr:nmder,;regard,"g.' " . .

1. VVith reference to y()qrapplicationJor import licence forwarded to this office with yourletter No.ABPUMeizhou Conrnley/2011l1mport dated 18.07.2011 received by thisoffice vide diary No. 34591 (FTS: 49539) dated 21.07.2011. I enclose licence(s) No._

~~~;~~:16~~g~a~~~~t~i~;'~~:~11~:~~~~~~~~~~r~ave been granted

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules1945are in addition to and not derogation of any other law for the time being in force and assuch the Iicence(s) issued under Drugs and Cosmetics Act and Rules will be in additionto and distinct from any licence(s) which m~e necessary under the Import TradeControl Regulations made of the Governl];l.e(1\~ India, Ministry of Commerce.

3. The import Iicence(s) mentioned in~a\ai'\1) above will not accordingly to itself Ithemselves be sufficient authority. Icf"litPort of Drugs covered by that / those Hcence(s)if under the Import Trade C~'~egu(ations of the Commerce Ministry separatelicense(s) are required for inO'lt ~f such drug(s).

4. i am therefore, to advise you to obtain, where necessary licence(s) for import of drugsin 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 (ObjectionableAdvertisement) Act.

5. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized toinl5pectth~pr~rt1i~esQf~importers~abljsn~ntsforthe-ptlrpoS'e of--Rule 25"Offfie Drugs' and Cosmetics Actand Rules thereunder.

7. Please acImo.wJe.dge-r.eceipt-Gf~tRj5ietter-and-itsencto'5ur~!5.-------~ ~..,---

~./6YOurs faithfUlly

(Dr. s. ~ddY)Asstt. Drugs Controller (I)

Copy forwarded for information to:1. Asstt. Drugs Controiler (India), Ahmedabad! Chen nail Cochinl Delhi! Hyderabadl

Kandia IKolkatal Mumbail Nhava Sheva.



Date: ~- 9 AUG lOllMls.Accurex Biomedical Pvt Ltd.,Gr.Floor,Room No.1,Plot No.G-54,M./.D.C., Boisar,Dist Thane, Tarapur is hereby licensed to import into India during the period for which thelicence is in force, the drugs sp ecified below, manufactured by Mis. Meizhou Comley Hi-Tech Co.Ltd, Nanshan Industrial Estate, BiogQng, Xiyang, Meizhou, GuangdongProvince, China and any otherdrugsmanufactured by the said manufacturer as mayfrom time to time be endorsed on this licence.

2. This licence shall be in force from - 9 AUfi~:::-_~_~ __Ml~l~!:t.- ----- --=~c~.~.-n~ it is sooner sllspemded or cancelled under thesai rules.

t:;trOlytes Analyzer~Qc~_

"(j.~....-

~~DSC., ._J&W»i'Qg ~tAemr· -" -

~ '~eTO ~ ~1~tW~.~.Q1.\~-". '<" ':,.:::;;t"" id !;J Dr. S. E:£WIl,o Reocy M.Pn Ph.D. i.

"/j":A ~ ~:;,~ f.'f<~";4i/AsSlt.r ~ugs Controilt;; \f..l'1 ~-if~ ~ ~I ~~-:::T~rP.~.f)- .' ~._ . . _ -'0 \ Ct•• Gelleral of Hea:~hServices I".

0A' Conditions 0.' Licence. ~ 'f. cosco {HQ~~FD~~~~~~'.'-. _ \

1. A photocopy of licence Sti.a.••~ ..•.••,<;Idii.ssP~la.y~~ J%1\\~. • mIn.e..t pl~'nP~a$a~ ~f 111e _ --.-Lpremises, and the.originallicenCe~p~~Ct, whene -' .

2, Each batch of drug imported into India shall be accompanied with a detailed batch testreport and a batch release certificate, dUly signed and authenticated by themanufacturer with dat~ of testillfl,ci~l~ofreJeaseand. tl'le; dateefforwar-cHng-sucnreports; The lniported batch of each drug shall be sUbjected to examination and testingas the licensing authority deems fit priQ!JQjts_maIketing~~~_~~__~----__~_- __---~ ~~_~~c_------~--

---- ---~; -The-iicensee-snalr be -fesponsciblefor the business activities of the manufacturer inIndia along with the registration holder and his authorised agent.




Food and Drug Administration BhawanKotla Road, New Delhi·110002

~ 9 AUG 2011./'"

vM/s. Accurex Biomedical pvt Ltd.,GRFloor,Room No.1 Plot No~G·54, .M.I.D.C, Boisar, DistThcme,farapur.

Subject: ImportUeence under the Drugs and Cosmetics Act 1940~nd Rtl!es"1-g45thereunder·regar:Qffig~ . ~--

==- =-> ---_.__._----_.--~~==-=~.~ .._-----

1. With reference to your application for import licence forwarded to this office withyour letter ..No. ABPLfTAfDbC/201111mport received by this office vide diary no34592 (FT,$ A4.. ~~A2)?n~~d 21.07.2011. I enclose Hcence(s) No. NCD·364/2008dated :-. ~ .U~ lUll. this / theselicence{ s} has / have been granted under theDrugs and Cosmetics Act 1940 and Rules 19~5 ~reunder.

2. I am to point out that the provisions of gs and Cosmetics Act 1940 andRules1945 are in addition to and not~cV n of any other law for the time beingin force and as such the IiCen~e(s' ed under Drugs and Cosmetics Act andRules will be in addition to and' from any licence(s) which may be necessaryunder the Import Trade C0nt!) egulations made of the Government of India,Ministry of Commerce.

3. The import licence(s) mentioned in para (1) above will not accordingly to itself Ithemselves be sufficient authority for import of Drugs covered by that I 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 Iicence(s) for import ofdrugs in question under the Import Trade Control Regulations.


6. The Assistant Drugs ControlJE:lLflmila).and T-ecnn1eal·Officerof1ne Cenfral DrugsGentf'oH:JrganlsatTonat the ports will be Officers authorized to inspect the pr~!l1i~E:l~_~- -~~--of importers establishments for JhE:lJ~urp.ose..of-RuIe-2G-of1:hei)mgsarurCosmetics

_...~-AGt~afld-RtltesjhereDnae~~---7. Please acknowledge receipt of this letter and its enclosures.

~~fUIlY

(Dr. S. Eswara Reddy)Asstt. Drugs Controller (I)

Copy forwarded for information to:1. Asstt. Drugs Controller (India), Ahmedabad/ Chennail Cachin/ Delhi! Hyderabad/

Kand!a /Kolkatal Mumbail Nhava Sheva.



Date: __ ~_9~AU--,",GZO_11_,MIs. Accurex Biomedical Pvt Ltd.,Gr.Ffoor,Room No.1,Pfot No.G-54,M.f.D.C.,Boisar,DistThane,Tarapur is hereby licensed to import into India during the period for which the licenceis in force, the diUgS specified be;ow, manufactured by M/sTaiDoc Technology Corp., 3F,5F, No.127, WUGONG Z'd Road, Wugu Township, Taipei Country, Taiwan, R.O.C. andany-otherdrugsmanufactured by the said manufacturer as may from time to time beendorsed on this licence.

2. This licence shall be in' force from,::' 9 AUG· 2011.,. to~~-~~ un!ess-jtts~sooner suspended or cance'Tiedunder the said rules.

- 8 AUG 2nl4

<J''-../~J.:::..<

i...WU

Place:N:wDelhi, Cpsco seaDate •. 9AUGiot ~

~ _ :f)'" Licmrslii§ m1mOrltV' , "70'-=

\1'>, . '::- Sp-al/St::lm ii.r1> *,!('\£l~t.ii ~ ~«' ~o ~ ~ ~ ~~.~. ~. ~. 11I- ,(\ ~ Dr. $. r::sw::r~j~addy M.Pt-,"h.D. i

OA' ,, . . • '.~~ ~j ~ ~ j;:':i~.:;.JP.t;st:2~~~s.controller \

tt~fi~rSOffJ~ 1 Dte, c:~::~t~f~~~ijl~;1~~rvices I·1. A photocopy of licence shall be disp1ijQd In a promiEnt PJ&cg:~~(~~~~~;~~002 \

premises, and the original licence shall be produced, whe ver requfMcra '~.d

2. Each batch of drug imported into India shall be accompan -witt1 a detaIled 6atch testce-POrtanda ,batch ~-elease ceftificate, duly signed 'ana ifufhenticated' by themanufacturer with date of testing, date of release and the date of forwarding such _

_____,__ ~r~eP_OrtsThejmp.oct~-tfg-shaH--be--subjectetlTo examinatIon ana-testing - ----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 of anychange in the constitution of the firm operating under the licence. Where any change inthe constitution of the firm takes place, the current licence shall be deemed to be validfor a maximum period of three months from the date on which the change takes placeunless, in the meantime, a fresh licence has been.taken from the licensing authority inthe name of the firm with the crlanged constitution.



Food and Drug Administration BhawanKotla Road, New De!hic110002

Dated:~ 9 AUG lOti

To // MIs. Sysmex ~ndia Pvt. Ltd.

;·v Viii. - Malpur,Baddi- Nalagarh Road,Distt .•.Solan (HP}

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 officewith your letter No. NIL dated 04/01/2011 receiv~dby this office vide diary no2554(FTS No,3947 ) datedJ8101l2011 and reply received vide diary

~~g~~~;/1~~:~e~0.48637)_d~eAUG IZ~]l..1 th~~~l~hs:seIlii~:~~:~~~h~soihave been granted under the Drugs and Eosmetics Act 1940 and Rules1945thereunder.

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 timebeing in force and as such the licence(s) is~d under Drugs and CosmeticsAct and Rules will be in addition to and ~ctfrom any licence(s) which maybe necessary under the Import .:r.r~"'t·ontrol Regulations made of theGovernment of India, Ministry~~~merce.

3. The import licence(s) me~~~~in para (1) above will not accordingly to itself1 themselves be sufficienNUthority for import of Drugs covered by that 1 thoseIicence(s) if under the Import Trade Control Regulations of the CommerceMinistry 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 importof drugs in question under the Import Trade Control Regulations.

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

6. The Assistant Df1.l9.sGontrollet (I.ndia)anct Technicat Officer of the Central..DrCigsCol1trol Organisation at the ports will be Officers authorized to inspectthe premises of importers~Ats-fer-the-purpo-se of Rule 26 of the

~~---Oru9s and Cosmetics Act and Rules thereunder.7. Please acknowledge receipt of this letter and its enclosures.c:;\ Yours faithfully

(Dr.~e~ddY)Asstt. Drugs Controller (I)

Copy forwarded for information to:1. Asstt. Drugs Controller '(lndia), Ahmedabadl Chennail Cochinl Delhil

Hyderabadl Kandla IKolkatal Mumbail Nhava .Sheva.



Date: fa 9 AUG ZOtlMis. Sysmex India Pvt. Ltd., Viii. - Malpur, Baddi- Nalagarh Road, Distt.- Solan(HP) is hereby licensed to import into India during the period for which the iicence isin force, the drugs specified beiow, manufactured by Mis. Siemens HealthcareDiagnostics Products GmbH. Emil-von-Behring Straf3e 76~35041Marburg(P;O.Box1149-350Q1 Marburg) Germany and any other drugsmanufactured by the. said manufacturer as· may from time to time be endorsed onthis licence.

tl,e~ _ ~~"'" ~ A IIi" ?n14

3. NamesOfdrUgstobeimported ..•..~AJ{{J~CO .. . ., nvO LVI

As per.attached .. Il~~~~g. Ilostic Ki . .. .Oye.d.by Licensing Authority<9EM(SlSIXTYSI. .• .. •... ~ 0Q~ ~G~'

.;;i ~c2 \P;....: -p,

Place: New Delhi :?: ~~ 0Date: - 9 AUG zon

CDSeO DSCQ""nsil'.!uthori~~ 7 ;$ ~-ea-i""'"'/~-G-m-·,.•p-----'1!.# r ~ 1ffl ~'<q;;1 ~ \tlf tli"14. lfl. \"1. . :<~\ ~ ~ Dr. S. Eswar.a Reddy M.Ph Ph.D.

~~.. .. ..{1~~?t •. ~ ... ~'~ &~ ~;:~~/~~~~cnlrOlle<§!!I'JditionsofLicence. . ..'-. Dte. Ganiual of :-iealth Services

1. A photocopy of licence shaH~,QiJ>.Qlayedin . ~ .•nt pl•• i~~~MFf€~~f~3,~ .. . Ipremises, and the original licence~p~ 0, w nev~(required. . _ .--..l

2. Each batch of drug imported into India shall be accompanied with a detailedbatch test report and a batch releasecerti~cClte.!dl.!ly§.ignedandauthel'lticatee..oythe mSl'lufactiJrerwithdateof testing,date of release and the date of forwardingsuch reports. The imported batch of each drug shall be subjected to examinatiorr-----·- --- - ----

__ -~a~n~dlestiAg_as-tAe-Heensillgaathority Beems fit prior to its marketing.3. The licensee shall be responsible for the business activities of 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 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 IicensiflQ authority in the name of the firm with the changed constitution.

VafidFromNames of drugs to be imported

List of Diagnostic Kits/Reagents to be imported vide Form-10 License NO.NCD-229/11

~. 9 AUG 20n to 'VfClA",~ca •...8 AUG 2014

.._-----------_~_--- -----_~.- ~ •••~ = - ,.

h ~o ~ ~ ;; 1Wf. 1ft. \;iI. ~.5 Dr. S. Eswara Reddy !'A.Ph Ph.D.~ ~ ~ ~/Asstt.Orugs ControllerI ~ ~ V,,,,I~ihll<.;14\ Ot~. 3enerel of Health Services

:\ CDSCO (HO), FDA Bhawani t(.!'Mw ~t).d: New Delhi-11 DOO?t...~..~,-_.....---_.-

S.No Product Name Intende Use1 THROMBOCLOTIN (cat No.281007) Reagent for the determination of !

• • t=i in 11f'V\ •••••:~ •••••••._..J

,' ~~~~~!n t!m_ ... hu ... an "'<JCI'CU i

1

2 Dade Ci-Troi 1 (cat No.291070) Ci-Trol® 1 was specially II developed as a control for the I

inormal range in coagulation testswith sodium citrate used as theanticoaaulant solution .

J3_.. Dade Ci-Trol 2 (cat N0.3~~.9?~1t ___ ~- ~_- -- .- .._- SJ:Jrol@_Z j§_y'~d_lDI _controLoLI~~~~_='.-~~_.·,~"o~-=,,-,--_~~"~~·c _~~_.~----~.,,-...-'~~~_~"~ coagulation tests in the middle to

upper therapeutic range of oralanticoaaulant theraov.

4 Dade Ci- Trol 3 (cat No.291 072) Ci-Trol® 3 is used for control ofI coagulation tests in the upper I

I therapeutic range of oralanticoaaulant theraov.

5 Dade Innovin (cat No. B4212-40, -50,~~O) For use in prothrombin time (PT)determinations and prothrombincO time-based assays in citrated

~\C~human plasma.

For use in prothrombin time (PT)O~ determinations and prothrombintime-based assays in citratedhuman olasma

6 Dade Actin Activated Cephaloplastin Reagent Liquid rabbit brain cephalin withplasma activator for use in the

(cat No.B4218-1, -2) determination of the activated

II partial thromboplastin time (APTT) I

and other coagulation procedures Irequtring an activated partialthromboplastin reagent. ILiquid rabbit brain cephalin withplasma activator for use in thedetermination of the activatedpartial thromboplastin time (APTT)

. al]dother coagulation proceduresrequiring an activated partialthromboplastin reaoent

---


Valid From ~ 9 AlJl:i lOnNames of drugs to be imported

- tH:~U§~J'-- 8 AUG 2014

I D(CaadteNAo.cBti4n2F1sa_A2oct,iV_1

8o

teO

d)·PTT Reagent liqUid purified soy phosphatides_ with plasma activator for use in the I

I determination of the activated,partialthrombopiastin time (APTT) I

I, and other coagulation procedures I

I, ::;::::: rn~:-::O:Ph:::~:I

with plasma activator for use in the I~_...--~-~.~ -'_··t---~-~.~.~- ._-~.---- ------ gf$i!~~~si~;EIDade Actin FSL Activated tJ I T Reagent Liquid purified soy and rabbit brain(cat No.B4219-1, -2) phosphatides with plasma

activator. An activated partialthromboplastin reagent withincreased sensitivity to lupus-likeinhibitors for use in thedetermination of the activatedpartial thromboplastin time (APTT)and related coagulationprocedures.

Dade Ci-Trol Heparin Control, Low(cat No.B4224-50)Dade Ci-Trol Heparin Control, High

1 (cat No.B4224-60)Dade Fibrinogen Determination Reagents(cat No.B4233-15SY)Dade Data-Fi Abnormal Fibrinogen Control·(CatNo. B4233-22)

For use as a control in heparinassay procedures.

For use as a control in heparin Iassay procedures.

For the quantitative determinationof fibrinogen in human plasma.

Dade® Data-Fi® AbnormalFibrinogen Control Plasma is acontrol derived from humanplasma. It is used to assessaccuracy and precision of Dade.®!=ibrirlogen DeterminationReaaents in the low ranoe.

~." ••••••••••. ~ •. ,-) IIIt4\;wIJOi:M'.·H:"l

6TO~~~'i;'1q;r4:n l'TT7?t •;Jr. S. Eswara Reddy M.Ph ~h.~.· v,.

~ 3tt~ ~/A5stt.brugs Controller~'<:".Al ~Rn """!"'i'~!I"Z1

Dte. G$nersf of ~-;ealth ServicesCDSCO (HO), FO.I\ Bl'1avv;,:,n

~.1;' K-~()ed. f'J~:,;"" D-'!:!"''-! <I {V ..•·~·2

IJ

I.j,~

~t.., •.... __ ._--'---

List of Diagnostic Kits/Reagents to be imported vide Form-10 License NO.NeD-229f11

Valid From . t: 9 AUtilOll to -vfO~~t'~rNames of drugs to be imported

- 8 AUG20J4Dade Thrombin Reagents(Cat No. 84233-25, =27)

For use in the quantttativedetermination of fibrinogen in Iplasma ..and to accelerate

, .",",cagUiation of anticoagulated I'

samples for immunohematologystudies.

Dade DlMERTEST Latex Assay(Cat No. 84233-60)

The Oade® OIMERTEST® LatexAssay. is intended for ..the rapidCjualitativeor semi-quantitative

. .~~--~~clrcura-Ing _-==~;ooO=-'-"_~~~

derivatives of cross-linked fibrindegradation products (XL-FOP) inhuman lasma.

.The Dade® DIMERTEST® Latex----~~:~t~~in~~:~~~~q-~:~ti;~f~~evaluatiarl\," of circulatingder.t!Pt~-ofcross~linked fibrin~~ation products (XL-FOP) in

uman lasma.Dilution buffer for coagulationtesting.

For photometric determination ofFactor VIII (antihemophilic factor)activity in human plasma.

For use as a heparin neutralizer inplasma to rule out heparin

I contamination in coagulation ItestinFor use in citrated coagulationsystems.

For use in citrated coagulationsystems

For use in citrated coagulationsystems.

Dade Dimert~st Latex Beads~CafNo. j34~3~:-e.1L)

Dade Owren's Veronal Buffer{Cat No. 84234-25

Factor VIII Chromogenic Assay(Cat No. 84238-40)

Dade C;-Troi Coagulation Control Level 1{Cat No. B4244-10Dade Ci- Trol Coagulation Control Level 2{CatNo .84244-20Dade Ci-Trol Coagulation Control Level 3{Cat NO.84244-30

.... ---------~---_._--~._-----------------~------------------------ ~<. . .

. _._. __ ,.c' •. b.·_.--,· ••.~_ ..,..._ ••~.....-'''': ..•.',.••.~.,'.>¥- '...••••.. ,I ....••. ," ..' !

~, mv ~ ~~<T' t.~"i~:In '.r:";~ ':';~ ~:-v ~i·,. ,

~. ~T~:~;·:&!:'~~~~~~~~~;~·0~"O,iM.pt~e~G~fl~:-.~: :.yo; ::::"~:-. ,?!:::",,·:C"';'S.


Valid From k 9AUG lDU to ,ieGAD9V2@r ~ .Names of drugs to be imported - 8~_UG2D14

The vWFAg* test kit is' intendedfor in-vitro diagnostic use with ISiemens Healthcare Diaanostics II or Sysmex® coagulation analyzers 'for the quantitative determinationof vWF Ag* -inhuman plasma byimmunoturbidimet .For the determination of thefunctional activity of protein S inhuman ' lasma.

tor~~r- forl:he" ,~airectcalibration of the prothrombin time(PI) in INR and % of norm. Forthe determination of a local IS! Ivalue.INNOVANGE® - O"Dimer -is 'aparticle-enhanced,immunoturbidimetric assay for thequantitative determination ofcross-linked fibrin degradationproducts (D-dimers) in humanplasma for use on coagulationanal zers.INNOVANCE* O-Dimer SampleDiluent is an in-vitro diagnosticproduct intended to be used inconjunction with the INNOVANCE*D-Dimer method, for themeasurement of samples outsidethe initial measurin ran e.INNOVANCE® D-Dimer Controi 1and INNOVANCE® D-DimerControl 2 are assayed controls forthe assessment of precision andanalytical bias in the normal andpathological range for thedetermination of D-dimer onSiemens and Sysmex® Systems.

INNOVANCE D-Dimer Sample Diluent(Cat No .OPBR)

IINNOVANCE D-Dimer Controls

(Cat No .OPDY)

-~--~-~~~~--

~6 't,,~c'~,:T"'~'.- 'I.. -~

'':,r-~i::; =-~:..:-. ...• 'fr,.

\~-L:>;~.'~'. < -:-'-:"

~J':'~....'-'-;;:'~Y."",

P3'\ r",.", ','. '. ','


Valid From ~ 9 AUG ZOI1 _Names of drugs to be imported

-"'iilC~ U3J;O.IJa --S_A UL; 2014

INNOVANCE® Antithrombin is achromogenic assay for the Iautomatic quantification of '

, 29funetionally active antithrombin Iin human citrated lasma.Imidazole Buffer Solution forcoa ulation test.Determination of the fibrinogenconcentration with Multifibren U onBFT II. __ ~ ~~~--~----~

L.A~L$c;@enlngRe.agEmts~Gat-Ne-~py-~~~~ creening Reagent and LA 2Confirmation Reagent aresimplified DRWT reagents fordetection of Lupus Anticoagulants

- (LATin one-sta-e cloWn tests.LA-t-ScreenihgReagent and LA 2Confirmation Reagent aresimplified DRWT reagents fordetection of Lupus AnticbagulantsLA in one-sta e clottin tests.

Reagent for the determination ofthe activated partialthromboplastin time (APTT) incitrated human lasma.Reagent for the determination ofthe activated partialthromboplastin time (APTT) incitrated human lasma.ProC® Global is a coagulation test I

for the determination of the Ianticoagulatory capacity of theProtein C system in humanplasma and is used to diagnosehereditary or acquired deficiencystates of the Protein C s stem.Fibrinogen Calibrators 1 to 6 areused to prepare reference curvesfor the assay of fibrinogen by themethQsLgfClauss1using-Siemens

- __Healthcare DiagnosticsMultifibren * U.

~-N-NOVANeEAntjthTom5rn-(Cat No .OPFH)

I

Pathromtin SL (Cat N""";. 0'


Valid From ~ 9 AU G ZOU __ to .1 IDlAB4il\icij;Names of drugs to be imported .•- 8 AVG. 2014

LA Control High is a high positivecontrol plasma for· use in·· Lupus ,Anticoagulant clotting test assays,specifically LA 1 Screening

.Reagent (DRVVT) . and LA 2Confirmation Reagent (DRVVT)from Siemens HealthcareDiagnostics on· automatedccia ulation anal zers.

~fOTtow isalow positivecontrol plasma for use in LupusAnticoagulant clotting test assays,specifically LA. 1 Screening IReagent ·-(DRVVT) and LA 2-Confirmation- Reagent (DRWT)from Siemens HealthcareDiagnostics on automatedcoa ulation anal zersProtein C Reagent ;5 acoagulation test for thequantitative determination ofprotein C activity in human

lasma.Calcium Chloride Solution is usedas Supplementary Reagent forvarious coa ulation assa sCONTROL N is an assayedcontrol used for the assessment ofprecision I

I and anal rtical deviation.Standard Human Plasma is usedfor the calibration of the followingtests:1. Prothrombin time (PT)2. Fibrino en Clauss methodIn .vitro diagnostic reagent for thedetermination of the activity ofcoagulation factor V. cmd forthe

-ai~J~clrol1-orfactor II Leiden inhuman lasma.-.------~:':~':·'l-

l.i D ,... -' '. ' .. , . ". I•.: r. '?- c~'(.'ura Redo·' fJ Ph Pt"1 1'1Ii Y1~~<lc;,~;tIT:; i~''.T,jq,/A$SIt..;,.)r~;''~C~~;r()!Ier fi -.. .·rcr;"*",::' -;.'?:n l'o;¢., ~~:id<1 t! U.!.,' L~,.;H..~;rEj; C".~~-1e.~:~h.Service:::

J rD5'~'--' ,:,.,.>, ~- ... -t! \d~ -.-' ..'" '\.~', rt~''\ ~';~!''Ho\J.c~,L_=::_~~:_:~~_:~:~'~~~i.::::'~.-J

LA Control Low (=C-,,""at-..N~()__O_Q_-W!i.~~~·r--'~..' .-~.Protein C Reagents (Cat Nb.O

~X,VCalcium Chloride Soli4J) (Cat No .ORHO)

Coagulation Factor V Deficient Plasma(Cat No .ORSM)

Ust of Diagnostic_Ki~RAT!fents to!.'e imported vide Form-10 License NO.NCD-229/11

Valid From L V G2011 to-tfct\ wn U _ .Names of drugs to be imported . - 8 AU G 2014

In vitro diagnostic reagents for thedetermination of the activity ofcoagulation factors Viii, IX, X! and,XII in human plasma by Icoa ulometric methods.

I Coagulation Factor XII Deficient Plasma In-vitrodiagnostic reageht~fbr the'1 (CatNo~OSDG) determination of the activity of

Icoagulation factors VIII, IX, XI and~II in human plasma bycoa ulometric methods.

46 Coagulation' FactorJJ J2e1i.cleoi;Plasma=~~-'4trvitrcrmagnostlcreagents for the

~=""~~-"'~'. '-1' ] <Cat No .OSGR) :~;::~;O~~!£(~rob;~~.a..in.ntcoagulation factor X in human

. plasma· ·by . coaguldiTiettlCmethods.In vitro diagnostic reagents for thedetermination of the activity ofcoagulation factor II (prothrombin),coagulation factor VII andcoagulation factor X in humanplasma by coagulometricmethods.In vitro diagnostic reagents for thedetermination of the activity ofcoagulation factors VIII, IX, XI andXII in human plasma bycoa ulometric methods.In vitro diagnostic reagents for the Idetermination of the activity ofcoagulation factors VIII, IX, XI andXII in human plasma bycoa ulometric methods.In vitro diagnostic reagents for the

determination of the activity ofcoagulation factor II (prothrombin),coagulation factor VII andcoagulation factor X.JI1_ .hlJt:nanplasm,:f oy'" coagulometricmethods.

Coagulation..f"actor XI Defieienl Plasma(CatNo.OSOF)

Coagulation Factor VII Deficient Plas(Cat No .OTXV) ~v

f<'V~

Coagulation Factor VIII D cient Plasma(Cat No .OTXW)

Coagulation Factor IX Deficient PlasmaI (Cat No .OTXX)

Coagulation Factor X Deficient Plasma(Cat No .OTXY)

~~---

~'~~-~"_."',"~-.~ ..r

~: ~ni) b5~,-t'?~....~ 1" ,;y~ ;., r,) ,;;, I;: ',-;.

J ~:rl.i:;~(\ .., ,~.:.,;+:~: I

~ ::,::,.~.~'~,.,.;.,'<.~-~:~.:"<h; I"..;~ •. ~.·-'d_ ,- ~; ••..,,~:?

L- -_..- _.....'"., -.., _


Valid From :- 9 AUr. ~q;i to . 1IClA 69 '/2(11;'Names of drugs to be impoe ' ,

- 8 AUG ~0I4Von Willebrand Reagent ...(Cat No .OU8D23) In-vitro diagnostic reagent for

determination of the ristocetin,

I cofactor activity of von Willebrandfactor inhuman plasma using the

I platelet agglutination method.

52 BC Von VViliebrand Reagent(Cat No ,008D37) tn-vitro diagnostic for the

determination of ristocetin cofactor." -of-vorr Wmebrand fadorin- ~~..~.."-"~

human plasma through plateletagglutination.

Berichrom a2-Antiplasmin(r.~t"I'" n'uiB'u"),_"""".,.v. __ I

For the quantitative determinationof biologically active 02-antiplasmin as an aid in ·thediagnosis of inherited or acquireddeficiencies and in managementof fibrinolytic therapy.

Berichrom Plasminogen(Cat No .OUCA) For the quantitative determination

of biological activity ofplasminogen as an aid in thediagnosis and monitoring offibrinolytic disorders.

l;l;I .-oJ

IThromborei S(Cat No ,OUHP)

I Thromborel® S Reagent is usedfor the determination of theprothrombin time (PT) accordingto Quick and, in conjunction withthe relevant deficient plasmas, forthe determination of the activity ofcoagulation factors II, V, VII and X,

Valid From - 9 AUG .2JW__ toNames of drugs to be import~d'''

jjQ-:?Jfl!! _no t'-----u.. (IS w.fi ~-_--

- 8 AUG 20.14 .56

Ii

BerichromC~1-lnhibitor(Cat No .QUIA)

59 Berichrom Protein C (Cat No

c1'I

60 Test Thrombin Reagent (Cat No .QWHM)

Determination .of. the functional, activity of Ci-inhibitor in piasma I'

for the rliagnosis of diminished C1-inhil:,)itor synthesis, increased Iconsumption and for monitoring Isubstitution therapy and steroidtherapy. I

"" .-f.or~~-efmillatiOlI'l:lf"the batroxobin time.

CONTROL P is an assayedcontrol used for the assessment ofprecision and. analytical deviationof the following analytes in thepathological range:1. Prothrombin time (PT)2. Activated partial thromboplastintime (APTT)3. Fibrinogen (Clauss method)

For the quantitative determinationof functionally active protein Cusing a chromogenic substrate asan aid in the diagnosis of inheritedand acquired deficiencies. I

Reagent for the determination ofthe thrombin time in humanplasma.

Berichrom®chromogenic


ValidFrom ~ 9 AUG 2011 to tl&ARn&Ji] __ .Names of drugs to be imported - 8 AUG 2014

Reagent for the quantitativedetermination of the thrombin time

I"!ncitfated 'hu'man pfasma.I

Determination of PAl activity inhuman plasma.

Photometric determination ofFactor XIII acfivityin plasmasal'liple~_,..~~~~~~~~m

Monitoring of substitution therapywith Factor XIII concentrate.

Berichrom Antithrombin III (A) ~~If"~'" Pt.1_ r'\'J\AA""" r~\VOl I'IV .vvvvvr()~,V

0«For the quantitative determinationof the fun~tiol'lal . activity of

-antithrombin III (AT III) in plasmausing automated analyzers fordiagnosing reduced AT III

.synthesis or increasedconsumption and for monitoringsubstitution therap .Quantitative determination offibrino en in lasma.

Multifibren U (Cat No .OWZG)

ITEM(S) SIXTY SIX ONLY

Place: New Delhi" 9" ur ?n'ilt:: M. u ",unDate: _




Dated: ~ 9 AUG 2011

To,~/S. :rrallsasiaBio-MedicalsUmited. . .'.. .

~~~~~~~n ••• __ ~A1l6FGeJwad Fa1ia, Opp--Som~8Y&$~~~~~~c~~~~~~~~~~~~~~"~~~-~'~c ~-~."~-~.-Nani Daman- 396210

Subject: Issue'Of an Eridofse,lJ-ei'ifNo. 01(0 Foil1'lJOL..ic;ense J'JQ. N~D ..t4011j ..dated30/05/20f1valid upto2910S12()1:/f ~regarding.

Sir . - ,Please refer to your application No. TBMNZ-1/A~~gn-01110-11/5687 dated

23/03/2011received by this office vide diary No. 1p90(~o.19563)dated 24/03/2011and reply received vide diary No.34503(FTS No.4 dated 21/07/2011regarding theabove cited sUbject. O<c~

Endorsement No. 01 to Form 10 License No. NCD-140/11 dated30/05/2011 valid upto 29/05/2014 for the import of drugs manufactured at Mis.VircellS.L.,Plaza Dominguez Ortiz,No.1,Poligono industrial Dos de Octubre, 18320,SantaFe,Granada,Spain enclosed hereby.

cO Yours faithfully. ~

fPr.S,J;$waraReddy)Asstt.Drugs-Controller(l)

Copy forwarded for information to:1. Asstt. Drugs Controller (India), Ahmedabad/ Chennai/ Cochin/ Delhi/ Hyderabad/

Kandla /Kolkata/ Mumbai/ Nhava Sheva,

FORM 10(Endorsement No.1)(See Ruies 23 and 27)

Licence to import drugs (excluding those specified inSchf?du/~ X) to the Drugs andCosmetics Rules, 1945

Date: ~9 AUG lOllMis. Transasia Bib-Medicals Limited., 47/6, Gelvyafl Falia, Qpp.SomnathBus Stop,Nani Daman..396210 is Iiere by licensed to import into India during the period for which thelicence is in force, the drugs specified below, manufactured by Mis. Vircell S.L., PlazaDominguez Ortiz,No.1, Poligono IndustriaslDos de Octubre, 18320,Santa Fe;Granada;Spain.

2. This Endorsement No. 01 shall be in force from ~ 9 AUG 2011to 29/05/2014unless it is sooner suspended or cancelled under the said rules.

. .t

3.. Names of drugs to be imported: .·-.··-·Qbi;;.'~· ~.... -As per attachedli~~~og{jC<tQ ~)1.9vedbyLicensingAuthority

. . . "" ~ \'ITEM(S)F~~ U(0 .. .~ ~ ~Q<) ~

~ ~Q:c U"Place: New Delhi ;........ ~---- <: -;::::.Date. ~ 9 AU~ ZOJl Z c:d ~

SC,.. HPfpUcensing Authority ==-7 ,Se1't'1S't'lmftlr'f)F""""----,."?' ~;;riiji ~~ il{:J 0 ~ ~C(q'(, ~ t!1f~, 1ft. ~ !'zr ~ ~\~:;,.Es~ar.a RerfdYM.PhPh:;·" j

1>;-Q" Cona'S:. o'IDk!JCIl- '\ 0L DIe: ~~£~:~~E:~;O""OI~'i1. A photocopy of Iicen.ce Sha~~~~.Y;din.a pr ' .. pl' ce. in<a..•.._..tRP..C:.¥fc.'~..C~M~imn~~vlces I

and the original licence shall be ••..•.. •. 11;; requir ..... _. 0002 I2. Each batch of drug imported into India f sna Ibe. a~compani~cjwith a C!~t§lil~cJ~bat9h test .._. ~.

reportandabatchrelease--cert:ifiG~te ,d uly signee and a Litnel'1tkafecfby theefnanufacturer--with date· aftesting, date of release and the date of forwarding such reports. The __ ~ _

-------nim-rt1ported ba-teh__of eacll dr ug---sha-n-be . subjected to examination and testing as thelicensing authority deems fit prior to its marketing.

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

4. The licensee shall inform the licensing authority forthwith in writing in the event of anychange in the constitution of the firm operating under the licence. Where any change inthe constitution of the firm takes place, the current licence shall be deemed to be validfor a maximum period of three months from the date on which the change takes placeunless., in the meantime, a fresh licence has been taken from the licensing authority inthe name of the firm with the changed constitution.

This licence shall be in force fromNamesof dru s to be importedS.No Product nam~._1 Dengue ELISA IgG

~ 9 AUG zon to

~ntendeduselndifectimmunoassay to testJgG antibodies against denguevirus inhuman serumTestlgM antloodiesagainstden uevirusin-hLHtiarlserumIndirect immunoassay to testIgGantib()dies againstTeponema paflidum in human Im~~~~~~·~~~~~~~~l· .".~..""~"-Indirect immunoassay to test

~:p:~ger:,:n~~~~~~: ~ng~~r:~n!Iserum-- . ... /

Date: - 9 AUG Zon



Food and Drug Administration BhawanKotlaRoad;N~w Delhi-11 0002

Dated: ~ 9 AUG lOll

~s. Transasia B!o-Medicals Limited,_ .47/6,·GelwadFaha,0pp. Somnath Bus Stop,Nani Daman 396210. .

SUbject: Import Licence under the Drugs and Cosmetics Act 1940 .a~BJ:ll~Jtt~§JL~~~~""..~~"~.~....~~~~~..~.~~~~~...~~~..t~~tfflder-regardtng:.~.~.-~.~...~~~~~~~~.~- ...~.~~~~~~.~~~~..

With ·referencefoyoiJrCil?pii~~tiQn..fQ.LimpprtJlcence Jorwarded-tothis office ·withYbUtlefterNo. TBMNZ-1/ADM/11-12/5677 dated 03/06/2011 received by this officevide diary no. 26544 (FTS No.36337) dated 03/06/2011 I enclose licence{s) No.

. NCD-231/11 dated ~ 9 AU-Gtl"M~1theselicence{s) .has I have been grantedunder the Drugs and Cosmetics Act '1~~O and Rules1~hereunder.

2. I am to point out that the provisions of Dru~ ~1! Cosmetics Act 1940 andRules1945 are in addition to and not der~ga '$_df'any other law for the time beingin force and as such the licence(s) iss .~er Drugs and Cosmetics Act andRules will be in addition to and distin~~ any Iicence(s) which may be necessaryunder the Import Trade Control Re~lations 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 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 A§§i§tanLQl"ugs Controller -(Jnma) ~nd::r.echnicalBfficer ofthe~Centra1 DrugsControl Organisation at the ports witibeOfficerS aUthorized to inspect the premisesof importers establishmentsJor.tbap~-tt-te-8rtlgs-ancteosrrn~1~s----Act and Rules thereunder.

7. Please acknowledge receipt of this letter and its enclosures.4 Yours faithfully

L/~~(Dr. S. swara Reddy)

Asstt. Drugs Controller (I)Copy forwarded for information to:

1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhi! HyderabadlKandla IKolkatal Mumbail Nhava Sheva.



Date:~l1

Mis. TransasiaBio-Medicals Limited, 47/6, Gelwad Falia, Opp. Somnath Bus Stop, NaniDaman 396210 is hereby licensed to import into India during the periodforwhich the licenceis in force, the drugs specified below, manufactured by Mis. Helena Laboratories (UK) Ltd.Trading as Helena Biosciences Europe, Queensway SoLitfl, T~?l-mValley TradingEstatei ···Gateshead, Tyne&Wear,_· NE11- OSo;' United Kingdom and any other drugsmanufactured by the said manufacturer as may from time to time be endorsed on thislicence.

c.c~~~ ~"~_.~~~~-~--~~---~2~-~~hfS-1jeence~tTaii-~b-e~~ifi-ro~rcerrom-·~~·9-AhJ{Tm·~--·to~'-~~--A1Jb-~11-·-unless it is sooner suspended or cancelled unde~e said rules.

3. Names ofdrugs.to.be.importe(ii";TH"\r;,;,- ...A~......- ·1\ It\l\LJU mY. . ...•'\1X~\.,;--- •.... -V-ff:/As per attached Iist~a9nosticKi .rov~{j)<p\kLicenSin9Authority

~\.:>lrEM{S) TWEN URONLYU",?t:'.

Q v;:::.'-./ ~

"\)'~

~'en~orit

.-:J' &. ... ,Sea tamp~. . ~O~~q ~ .-;;:--:. :' 'I. '.' ~"':,"j --q-51 ~ lNi. <ft. <!tl. m.

. ""7- ~ Dr, S. E::;WciC'! Reddy",. Ph -h D' .",,~> • 'Q<P .~. t':>. . ,. •• .•'71'\ ' ..••.~ " ,::,.", ,.q::v.r;/ASSfj.Dru"'s Cont- "v A f. " ,":..,.,..,-y ~""= .- ~ .o,er'"N •.. it ~ ~ ...•.''''''''':;''11 !'11:rA·""II~t.l~.J-. ConJJftiij;tOf·L"'tC.~nce r\Q Dte. ~<s;:..',:;-ai c:f He::llth S~rvices

1. A photocopy of ljceocP~l!.b"d .•.I$PlllYed10 a.f>~enl ~t:;,-;';'j,~JDG(,i1i.ae;~~OO?2. ~~c~i~~~~~~~~~;r;i~i~~~~~1f~~~~::7:~[~~~U~~~tailedbatC~~' ~~~

test report and a batch release certificate, duly signed and authenticated by themanufacturer with date of testing" -date·ofrelease .and:the date of forwarding siJchreports. The imported batch of each drug shall be SUbjected to examination and _

___ . te_s_t_in.g..aslheJicensiPg--autRGfity-deems-ftt-prior--toits-maTkeiing.3. The licensee shall be responsible for the business activities of 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 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)n the name of the firm with the changed constitution ..

Place: New Delhi <:Date: ~ 9 AUG @n

1/4

- 8 AUG 20;4This licence shall be in force from ~ 9 AUG 2011 to--------- ----------Names of drugs to be imported

. S:No.1 AA2 Hemo Control

I quantitative and lor qualitative controiJor theidentificationand/or·-quantitationof human hemoglobins byelectro horesis

5331 APSC· hemocontrol to be used as a~.~~.~~~.~.~..--.~-quam.j.f;-a~-aM~i1tative-controi·fC1 ~.~._._._...

the identification and/or quantitation ofhuman hemo lobins b electro horesisI.h~_YJt~~Iy.m.Erotein.6 ..band-Kit is .... ·1

.im~.D.Q~clJ.Qrthe .sepaIation..andquantitation of serum proteins byCa ilia ctro horesis CE).The Y4 munodisplacement Kit is'inte~B for the separation and

tification of monoclonalmmopathies by capillary zone

electrophoresis. This techniqueseparates proteins on the basis of theirnet charge in an alkaline buffer solutionin combination with their differinginteraction with the wall of the silicaca iliaThe VB Urine Preparation Buffer SP6Kit is intended to be used inconjunction with either desaltingcolumns or centrifugal concentratordevices to prepare urine samples forproteinanal sis on the VB instrument.

va Serum Protein 6-bandKit·

va Immunodisplacement.Kit

va Urine Preparation Buffer 800410SP6 Kit

=- 9 Au", lOll to

2/4

- 8 AUG 2014

The VB Urine Preparation Buffer SP6Zoom Kit is intended to be used inconjunction with either desalting columnor centrifuga"concen-tratordevices toprepare urine samples for protein

.analsis on the VB instrumentI The va Urine Preparation Buffer SPE I

.~tn~t~~f;g~~t~O~~~ia~~~'ting Icolumns or centrifugal concentratordevi~es to prepare urine samples-forprotein .~_.__~~~~~~_~~ __~~~"~-~

--~~-~-~~~-~. anal sis on the VB instrument.The VB Serum Protein SPE Kit isintended for the separation and

.-j-quantitation--ofserum-pro-teinsoyIGapillaryElectrophoreSi~f(CEr -

To accommodate variation in usageatterns

The VB Haemoglobin IEF Kit is intendefor the separation and quantitation of lhaemoglobins by CapillaryElectrophoresis (CE). Many analytes cabe separated in single runs with minimasam Ie and rea ent consum tionCEtrol Serum Control-Normal is to beused as a quantative and/or qualitativecontrol for serum protein electrophoresi0111lieVB CHnicarCapHIarY 'Electro horesis S stem,

"~'=~'~----r~. "5T:,; ,'f"'f s~·~-T.:,"',:~> ,,~ I·

\C •••• :' ."% .. ,'" t-. ,

"',,":.', . ~.:, •..

va Urine Preparation Buffer I 800411SP6 Zoom Kit

! V8UrimiPreparation BufferSPE Kit

+..- +-- --_.9 VB Serum Protein SPE Buffer 800501

sin Ie10 VB Serum Protein 6-band 800800

Zoom Kit

va Serum Protein 6-bandZoom Buffer sin Ieva Haemoglobin IEF Kit

To accommodate variation in usagepatternsThe VB'-s4 rotein 6-band ZoomKit i~n~ ed for the separation and

"il"litation of serum proteins bypillary Electrophoresis (CE).

This licence shall be in force from =- 9 AUG Z011 to--------- ---------

3/4

• - 8 AUG 2014

CEtrol Serum Control-Abnormal

802500I

VB Carbohydrate DeficientI-Transferrin Ki-t

820500 \f<VB Anti-free Kappa IAnti-free Lambda Kit

I CEtrol Serum Control-Abnormal is to bel. used as a quantative and/or qualitative 1

c...o...n.t..ro.I fo.r s~..~~m.pr.0. ~e..i.n electrophoresi·onthe V8 Cllnrcal CapJllary

Electro horesis S stem.TheV8 CDT kit is intended for the ,

I identification of CarbO....h..y..d.ra.te D. e.fi.'.cie.nt ITransferrin isoforms in human serum b~"Capilla" "zoneereCtro "hores"is.- -COT Control- Normal is to be used asquantative and/or qualitative control focarbohydrate deficient traFl.§lerdn~~~~ ...'~~~electrophoresis -analysis on the V8Clinical Electro horesis S stem.COT Control - Abnormal is to be used

"Eluantative-andt-or""-~~- ""qualitativecg,mrolfo-rCarb6IiydfateOefiTranSf~~ebtr. ophoresis analysis onCIi~~ctroPhoresiS System.

e V8 Anti-free Kappa / Anti-freeLambda Kit is intended for the separatiand identification of monoclonalgammopathies by capillary zoneelectrophoresis. This techniqueseparates proteins on the basis of theirnet charge in an alkaline buffer solutionin combination with their differing

I interaction with the wall of the silicaI capillary.

4/4

This licence shall be in force from _-_9_A_U_G_Z_O_'_'_to __ -_8_A_U_G_2_D_'_4_1821400I

I The V8 Anti-!gD / Anti-lgE Kit isintended for the separation and Iidentification of monoclonalgammopathiesbycapillary zone Ielectrophoresis, This technique

1_ separates proteins on the basisef thei~, net charge in an alkaline buffer SOlutio,

in combination with their differinainteraction with -the-wallbftne silica Icapillary.lmmunotyping of ~gamma~lobulins is achieved by testinaliqLiots of sample with a panel of

~n ---- ~-~~~~~~~ 11101 las~c1fic:antisera, on ----------~~------r~-830100 To be used when the V8 Clinical

Electr· oresis S stem is not in useJ~~J1200___ --10 n-the-V8GHAieal--Electrophoresl

~I VBAnti-IgD I Anti-lgE KitI I

II

21 _1"':~_~~!!1tef1_~_f1£E!_~uff~r

22 VBClinical Waste Drawer23 Urine Protein Desalting

Columns

830400GEHE17

()(;'VS200224 Urine Protein Spin

Concentrators

:To collect clinical wasteTo desalt urine in readiness for analysusing the VB Clinical ElectrophoresisS stemTo concentrate urine in readiness foranalysis using the VB ClinicalElectro horesis S stem

~~,--_.w~stn"g""A1.1ttttmtV-=-

:: mo ~ ~:td'i~~~qi. l;U. ~l.Dr._ ·S. ES'i{.:ua R~C!dy i\ti.P;"j Pil.D.

~ cfrerfe-'y P.·::-:)(f)/A~sr. :')ruQ£: C()~troHf::r~~'~~T -;-~~r~!f·;-:':--~~rrf(::-f7:

C~te.. Gh.$';'1~r~:of rtb~~':i'1-E'~er\';cesc!:.:~~;{~{HQ'),-P-D,A. -[Jr-fg:-W2;i'I.. ~ ~,,·,,"H. NlO<','( oeihi";OOO~~


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

Food and Drug Administration BhawanKatla R.oad,New Delhi-110002

To .L --~/s. Transasia Sio-Medicals Limited.

47/6, Gelwad Falia, Opp. SomnathBus Stop,NaniDaman- 3962tO .

SUbject: Issue of an Endorsement No. 01 to Form 10 License No. NCD-75/11 dated06/04/2011 vali~lJPJQ_Q5l0412014--regaTding.

~r ,Please refer to your application No. TBifN ~DM/1 0-11/5638 dated 28/12/2010

received by this office vide diary No. 60856 (FTS 45477) dated 28/12/2010 and replyreceived vide diary No.33403(FTS No.47738) . 14/07/2011regarding the above citedsubject. v<V

Endorsement No. 01J(t~~rm 10 License No. NCD-75/11 dated 06/04/2011valid upto 05/04/2014 for the impoft)Jf drugs manufactured at M/s.lMMCO DiagnosticsInc., 60 Pineview Drive Buffalo,NY 14228-2120 USA enclosed hereby.

~0i!b"Y(Dr. S. Eswara Reddy)

Asstt. Drugs Controller (I)

Copyfo.r\Nardedfor. information ..to:1. Asstt. Drugs Controller (India, Ahmedabad! Chennail CocJ:l.inl-geIffiI-Hyderab-ad~---·-_._.

-------I'ancUa /Kolkata, umbail Nhava Sheva.

FORM 10(Endorsement No.1)(See Rules 23 and 27)


Date: _. 9 AUGZOl1Mis. Tra/JsasiaB.iq-Nle.dicals Limited., 4716, Gelwad Falia, Opp. Somnath Bus Stop,Nani Daman- 396210 is heieby licensed to import into india during the period for which thelicence is in force, the drugs specified below, manufactured by Mis. IMMCO Diagnosticslnc;.,60Pineview Drive Buffalo;NY14228-2120USA. .' .

2. This Endorsement No. 01 shall be in force from:: 9 AUG lOti to 05/04/2014 .unless it is sooner suspended or·cancelledunder the said rules. . .. ~~.~.~.~~.~ ..~.~~~~~.~-~~~.~~~~~._~~ ..~_...,~~ ~ ..~ _~.~~~~.~~.~~ ..~~.~~_.~~ .•.............~.~ ~ ..~.~..••........ ~.~ "

3. Names of drugs to be imported: ~ ..As per..tla"h~~~\S)~_V~bY Licenslng Authority

Q~'J '!~.. V~~

~ ~r::i: v""Place: New Delhi I..::. ~

Date. ~ 9 AUG ~tt ~4~DSC. . Licensin.L~~""_Et~-".'r=·......-..· Seal/Stamp !

% , iJmo ~ ~ ~ ~ Q;llf. \fT. ~. ti. \1% ~i?f. Dr. S. Eswara Reddy M.Ph Ph.D.J~ .' ;" ~ atTtmt ~fA"'tt.Drug5 Controller""', ~~ ..q€i ~ ,.... ~.4 ~ 1Tl!':fo:,~'fIl&tQ

r,..... COnallibnsof l.icence. (.\,~; Dta. GwrwF*i of H~ailh Svrvices

::i{~~~a~F#~f~':~;p=~~~=:;~::~:O~~-~r~port and a batch release certificate, duly signed and authenticated by the manufacturerwith date of testing, date of release and the date of forwarding such reports. Theimported batch of each drug shall be subjected to examination and testing as theJicensingauthor~tydeemsfit priorto-its .marketing.

3. The licensee sliallbe responsible for the business aCtivities of the manufacturer in India__ .~_. __ ~a_lo~n_g~w~itb-t/::)e.regist+atiol+AGk:l~oo.ni5-a\;jtAer.ffied-aaent.


This licence shall be in force fromNames of drugs to be imported

~ 9 AUG ZOl1

S.No1

Enzyme linked immunosorbent assay (ELISA) for the detection of 19Gand I A class anti liadin antibodies in human serum.

~An..enz¥I.lW~liI:lked..jmm<tl'toossaYi~-tISP\'1<5nnEnre~Teclfon·andsemi:- jquantitation of 19G, IgA or IgM anticardiolipin antibodies, as an aid in Iassessing the risk of thrombosis in individuals with Systemic LupusE hematosus· SLE or lupus like disorders.

~f~ .An enZy~~ed immunoassay (ELISA) for the detection of IgG-, IgA-,19M aMnti-cardiolipin antibodies, as an aid in assessing the risk of

sis in individuals with anti-phospholi id s ndrome. .

An enzyme linked immunoassay (ELISA) for the detection and semi-quantitation of IgG, IgA or IgM anticardiolipin antibodies, as an aid inassessing the risk of thrombosis in individuals with Systemic LupusE hematosus (SLE or lu us like disorders.

An enzyme linked immunosorbent assay (ELISA) for the detection andsemi- uantitation of anti-histone antibodies in human serum.

-AnenzymelinkedimmunoassciY(~1...1S8). for theJ:letectionaAG semi--·quantitalTonoflgG anti6·odles to single stranded DNA (ssDNA) in human

serum. _

This licence shal! be in force from L 9 AUG 2011 to 05/04/2014-----------

Enzyme linked immunosorbent assay (ELISA) for the detection anduantitation of antibodiesto-Rieosomal Pin-human serUm.

- ARenzyme linked immunosorbant assay (ELISA) for the detection andquantitation of Rheumatoid Factor (RF) IgA or 19M isotype in humanserum.

COMVI Skin (fC/BMZ) (FA----1-10-- ---I----~-------

IAn indirect immunofluorescence antibody test for the detection andqu~ntit~io~ 0: anti-skin (anti-intercellular and anti-~~s_erT1:~t_m_efTlbrCl~)-antlbo9Les!Onuman-serum~----- --------

~uorescence (IFA) antibody test for the detection andof anti-neuronal (paraneoplastic) autoantibodies; anti-

C! anti-Ri in human serum_

,Gr5<An indirect immunofluorescence antibody test for the qualitative andsemi-quantitative detection of endomysial antibodies (EMA) in humanserum as an aid in the diagnosis of celiac disease and dermatitisher etiformis.

An indirect immunofluorescence antibody test for the detection andsemi uantitation of anti-reticulin antibodies _ARAin human serum.

An indirect immunofluorescence antibody test for the detection andsemi-quantitation of anti-neutrophil cytoplasmic antibodies (ANCA) inhuman serum.ANCA are found in the seraotpatientswithnecrotizingvascolitide~-ahcr1ience~-serv~.as_a.rLaidloJhecelinicakarir.Lother -

---laobf~lfo'-Tinaln-sTrlftle-dla nosls-of these disorders_

This licence shall be in force from ~ 9 AUG LOll to

114

1 l---. I Keratin IFA

Anjndirect-immunofluoreseence-antibody-tesl for-tile detection a"ouantitatiol'l-of-anti-keratin -antibodies\1\KA ··in--humanserum.

t-n im:fice.ctimrriunofiuorescencetestforthedetectiohahd semi-guantitationofisletcel! antibodies inhuman serum to aid in thedia nosis of insulin de endent diabetes mellitus IDDM.

Glomerular Basement membraneIFA

+~L I

I

An indirect immunofluorescence (IFA) antibody test for the detection andsemi-quantitation of anti-glomerular basement membrane (GBM)antibodies in human serum.

An indirect immunofluorescence antibody test for the detection andsemi- uantitatioA-ofth roid autoantibodies in humanserum.

~i'(jO~~rect immunofluorescence antibody test for the detection and

mi- uantitation ofth roid autoantibodies in human serum.

Myelin Associated GiycoproteinIFA

I For the screening and detection by indirect immunofluorescence (IF) ofprimarily anti-myelin associated glycoproteins (anti-MAG) and other

I coli id autoantibodies in human serum.

An indirect immunofluorescence test for the detection and semi-uantitation of exocrine ancreas antibodies io.human serum

-ITi:ff1\~~T!QNJ.)·-c

Date: E 9 AUG 2011

=: No.9671) dated - Central Drugs Standard Control ... · Mls.Standard Diagnostics Inc., ... Mls.SD...

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Transcript of =: No.9671) dated - Central Drugs Standard Control ... · Mls.Standard Diagnostics Inc., ... Mls.SD...