--CentrarO'rugsStandarcrControIOrganisation 10 MD on 25.100001.… · --CentrarO'rugsStandarcrControIOrganisation Directorate General of Health Services ... The Assistant Drugs Controller

--CentrarO'rugsStandarcrControIOrganisationDirectorate General of Health Services

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

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

To,~/s. Metro Biosol Pvt. Ltd.,

26 Village Hauz Khas,New Delhi-11 0016

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

1. With reference to your application for import licence forwarded to this office with your letter No.31-924-MD/2011-DC ~ated 21/09/2011 received by this ejfice ~~9i!Ll..dalrXtLf'.J0.44.136dated21.09.2011. I enclose hcence(s) NO. MD-924-1402 dated'- ::; '1..,' \.; I £:3.( this 1 theseIicence(s) has 1 have been granted under the Drugs and Cosmetics Act 1940 and Rules1945thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules 1945 are inaddition to and not derogation of any other law for the time being in force and as such theIicence(s) issued under Drugs and Cosmetics Act and Rules will be in addition to and distinctfrom any licence(s) which may be necessary under the Import Trade Control Regulations madeof the Government of India, Ministry of Commerce. .

3. The import Iicence(s) mentioned in para (1) above will not accordingly to itself 1 themselves besufficient authority for import of Drugs covered by that 1 those licence(s) if under the ImportTrade Control Regulations of the Commerce Ministry separate license(s) are required for importof such drug(s). .'

4. I am therefore, to advise you to obtain, Wh.I~«()~cessary Iicence(s) for import of drugs inquestion under the Import Trade Control RefelWClns.

5. Any literature or packing accompanyj~:(~ lIrugs or any matter stated on the label should notcontravene the provisions of the I;,K.UQ's'-ahdMagic Remedies (Objectionable Advertisement) Act

6. The Assistant Drugs Controll'r~tlridia) and Technical Officer of the Central Drugs ControlOrganisation at the ports will be Officers authorized to inspect the premises of importersestablishments for the purpose of Rule' 26 of the Drugs and Cosmetics Act and Rulesthereunder.

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

~(Dr. S. Eswara Reddy)

Asstt. Drugs Controller (I)CopYforwafcfed for information-to:'-- -

8. Asstt Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl KandlaIKolkatal Mumbail Nhava Sheva

FORM 10(See Rules 23 and 27)

Licence to import drugs (excluding those specified in Schedule X) to the Drugs and

Licence Number: MD-963-1401 Cosmetics Rules, 1945 Date: 2. 5 c'r 2011

MIs. Metro Biosol Pvt. Ltd., 26 Village Hauz Khas, New Delhi-110016 is hereby licensed to importinto India during the period for which the licence is in force, the drugs specified below, manufactured byMIS VEXIM SAS 75, rue Saint Jean, 31130, Balma, France and any other drugs manufacturedby the said manufacturer as may from time to time be endorsed on this licence.

2. This licence shall be in force from 2 ,~ C ;,.T 201Lunless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported:Spine Jack System

1. Preparation kit ,G'?2. Expansion Kit $t':f3. Cohesion Bon~ement

~,,::3;/'~

f'""","~;~

Jl;::~iJ.j

Date: 2. 5 nn 20il Q>~.,"__~~~\ "TO (~ .'~=rii;""

~, ~'t.r;,~;>~~' , ;:-':;';~~~~';5.~rnp~ U~ Ytw ~_; .:-f!¥!'--- ::>-;;':!r~JHer

JJ- ConditioI'1S~Ol'1-icenc~ D1t~~~:_-,:,-c-_

1. A photocopy of licence shall be ~~eg irta p~.;.~el)~!~qe~W~ ~ait~bn-he,pr.em(s~~_.~~dthe .'

2. ~~~~~~~~hn~~~r~~1i~P~~:~~~~~~;;~e!~~~~~~~i~d with a 'd:tail~d'b~tch-t~~t'repo;and a batch release certificate, ~~d and authenticated by the manufacturer with date oftesting, date of release and ~'(d~te of forwarding such reports. The imported batch of eachdrug shall be subjected to exaftlination and testing as the licensing authority deems fit prior to itsmarketing.

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

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

--~------ ------ --constitution--~- ------ ------ --- --------~-- -- ---- - ------ --------------------------

4449823~09.2011

Central Drugs Standard Control OrganisationDirectorate General of Health Services



Dated: 2. 5 C C lOllTo,

~s HIS Surgicals,3/5, A.B., Ground Floor, Merwanji Bldg.,Chawl No.3, Opp., K.E.M Hospital, Parel,Tal: Dattaramlad Marg(Mumbai-Zone2)-400012

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

1. With reference to your application for import licence forwarded to this office with your letter No.Nil Dated 17/06/2011 received by this office vide dairy NO.33861 dated 18.07.2011 and replyreceived by this office vide diary no. 44498(Fts No. 65182) dated 23/09/2011. I encloselicence(s) NO. MD-402-634 dat~ ~ n'~';gl'"'tt-:- this r these licence(s) has 1 have beengranted under the Drugs and Co~ cSJAeti1 U md Rules 1945 thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules 1945 are inaddition to and not derogation of any other law,~' the time being in force and as such thelicence(s) issued under Drugs and Cosm••etir.~t'a~d Rules will be in addition to and distinctfrom any Iicence(s) which may be ~~~nder the Import Trade Control Regulations madeof the Government of India, M~py;o,e'ommerce.

3. The import.licence(s) mention~ in para (1) above will not accordingly to itself 1 themselves besufficient authority for import of Drugs covered by that 1 those licence(s) if under the ImportTrade Control Regulations of the Commerce Ministry separate Iicense(s) are required for importof such drug(s). .

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

5. Any literature or packing accompanying the drugs or any matter stated on the label should notcontravene the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act.

6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs ControlOrganisation at the ports will be Officers authorized to inspect the premises of importersestablishments for the purpose df Rule 26 of the Drugs and Cosmetics Act and Rulesthereunder.

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

_u~thfUIlY

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

Copy forwarded forJnformation to:8. Asstt. Drugs· Controller (India), Ahmedabadl Chennail Cochinl Delhi! Hyderabadl Kandla

IKolkatal Mumbail Nhava Sheva


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

M/s HIB Surgicals, 3/5, A.B., Ground Floor, Merwanji Bldg., Chawl No.3, Opp., K.E.MHospital, Parel, Tal: Dattaramlad Marg(Mumbai-Zone2)-400012 is hereby licensed to importinto India during the period for which the licence is in force, the drugs specified below, manufactured byMIS BioComposites Ltd., Keele Science Park, Keele Newcastle Under Lyme, Staffordshire, ST5 5NL England and any other drugs manufactured by the said manufacturer as may from time to time beendorsed on this licence.

2. This licence shall be in force fromunless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported: .' I' \:.\D/\R COl\}'h.

1. Genex-Bone viQIdlf~ler/Bone GraftJ$,tI~stitute2. Stimulan-lr8:l1'evoid filler/Bone GraffS~9~titute

----------~3~tlugT~~l£~tt-fi. . - -Gr~tUut=e---~--------~4. AllogrCfTltN-Bone vr

, '" ~aft su~tute'. ~f'1

'le' 'tJ'

. 7·:,...J\-oZ

Date: ---2. c; (!Q,fPlr'~'--_ -;; ~01 ;So s~r:'~~1':~c:~~8sing~uthority~ ~:c~'jJ.f',:! .. ::,~e~~.~p

.r f\ C d' ~_. :-:;:(;ih'rvA on It! Dt:"J~ _.

~)- ~f'!lqq j 10Q'<:::::> . , :._. . __..,;;;cs :

1. A p~oto~opy of licence shall be ~J?yed in a pro~inent P!~c~~a- p'artof-the:prerni$e;$~?!l~rre,:

2. ~~~~~~~~~n~~~r~~1i~P~~:~~~t~ ~~~6~J~p;~fiJ~~~~with-~'d~t~l~d batch test'rep'ort---·iand a batch release certificate, duly signed and authenticated by the manufacturer with date oftesting, date of release and the date of forwarding such reports. The imported batch of eachdrug shall be subjected to examination and testing as the licensing authority deems fit prior to itsmarketing.


4. The licensee shall inform the licensing authority forthwith in writing in the event of any change inthe constitution of the firm operating under the licence. Where any change in the constitution of

..!he firm takes place, the.current licence shall be deemed to be valid for a maximum period ofthree months fro'm the'dafe- on-whlcFiThe-cFii:l-ngelaKespface-umeSs;tfflhemeantime--;-a-freshlicence has been taken from the licensing authority in the name of the firm with the changedconstitution

4457423~09.201f




To,. -, ~ Fenwal (India) Pvt. Ltd., Kh-No.1220,l/i~t-~nd IInd Floor, Village Rithala, Delhi-110085

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

1. With reference to your application for import licence forwarded to this office with your letter No.------~~1__WJ..MQ/_2_G~__QG___9at_ed__2_31G91~-el'l_r_ec__eived__by__th-is---effiee---vfde--dairy-N0:-44-5-7--4--dated-

23.09.2011. I enclose licence(s) NO. MD-963-1401 dateti) - f~ ,.., .--- 9-R4fr- this I theselicence(s) has I have been granted under the Drugs and Cesmeties"Act l1Dm and Rules1945thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules 1945 are inaddition to and not derogation of any other law for the time being in force and as such thelicence(s) issued under Drugs and Cosmetics Act and, Rules will be in addition to and distinctfrom any licence(s) which may be necessary un~1ri'e~lmport Trade Control Regulations madeof the Government of India, Ministry of C~l1;lf!let¢jJ •

3. The import licence(s) mentioned i~~Sl1}"~bove will not accordingly to itself I themselves besufficient authority for import o~r(jgs ~covered by that I those licence(s) if under the ImportTrade Control Regulations of the Commerce Ministry separate Iicense(s) are required for importof such drug(s).

4. lam therefore, to advise you to obtain, where necessary Iicence(s) for import of drugs inquestion under the Import Trade Control Regulations.


6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs ControlOrganisation at the ports will be Officers authorized to inspect the premises of importersestablishments for the purpose of Rule 26 of the Drugs and Cosmetics Act and Rulesthereunder.

7. Please acknowledge receipt of this letter and its enclosures.\ . A YOU~ faithfully

e--u---~- ------- ----------- -- --- --- --- ------ - -------------------( D-r;-S~e_swa-ra-ReddYr-

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

8. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl KandlaIKolkatal Mumbail Nhava Sheva

FOJ~MtO(See Rules 23 and 27)


Date: ') ~. n r·T ZOlt--l,,; 0' ....r -" •

Mis. Fenwal (India) Pvt. Ltd., Kh-No.1220, 1stand IInd Floor, Village Rithala, Delhi-110085 is herebylicensed to import into India during the period for which the licence is in force, the drugs specified below,manufactured by MIS Fenwal Inc., Three Corporate Drive, lake Zurich, Illinois, 60047 USAhaving manufacturing premises at MIS Fenwal International Inc., Camino Real IndustrialPark, Road # 122, San German, Puerto Rico 00683, USA and 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 2 l r·c:! 2011-- to 31.07.2014unless it is sooner suspended or cancelled under the said rules.

-z;;::::>/I' C d"t:;::-- on I • ..'0-0 .•..

0'). '''. ..' "ct. '. "'~:;':;,",s

1. A photocopy of licence shalt ~tdisplayed fr'~~m~ place in,a~rt ofthe:premjse$;a~theoriginal licence shall be produceffl)V~enever required.t- ...<;.~~._.. ... _._l.

2. Each batch of drug imported into IntiiS'.Bball be accomR~\~'cI'/Witha detailed batch test reportand a batch release certificate, duly s1griJcTa""id(]@n~Fcatedby the manufacturer with date oftesting, date of release and the date of forwarding such reports. The imported batch of eachdrug shall be subjected to examination and testing as the licensing authority deems fit prior to itsmarketing.


4. The licensee shall inform the licensing authority forthwith in writing in the event of any change inthe constitution of the firm operating under the licence. Where any change in the constitution ofthe firm takes place, the current licence shall be deemed to be valid for a maximum period ofthree months from the date on which the change takes place unless, in the meantime, a freshlicence has been taken from the licensing authority in the name of the firm with the changed. -··----cori-stif·otron··--·-~-·--~-·--·-·------··~-·---.-~---._--~-_.__.-.._------,.---.-,'-------"..----,----------.-.--.,.--.-.-----.. ..'.,' --------.---.-....---------------.-'- ..-----.--.---~-.-.--..._------_....._._-

3. Names of drugs to be imported: '. NO1. Amicus Apheresis Kl!c;\~A"'.,2. Closed System A~~resis K~<t ~3. Open System A~lleresis K(!10 '''~'o-·

---------.--lIEM.{J"Jlr-ee}-ONL~,) #' ",~:J-;,;;."';(<, ...~,f'".,t ~

t~' '\ ...;J ~.;;;:U•.J

Z 5 OCTrO~ 5

4518727.09:2011




File No.31-383-MD/2007 -DC(Re-Reg.2011)

To,~ Amardeep Enterprise,No.5-G, 3rd Floor, Nr. Income Tax Building,Ashram Road, Ahmedabad, Pin-380009


1. With reference to your application for import licence forwarded to this office with your letterNo. 31-383MD/2007-DC(re-Reg.2011) Dated 19.08.2011 received by this office vide

.2.de}~-ttO ..45~~1.FTS ?6410) dat~d 27.09.2011 I enclose licence(s) NO. MD-383-876 datedv ...•.,J I LU I this I these hcence(s) has I have been granted under the Drugs and

Cosmetics Act 1940 andRules1945 thereunder.2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules1945 are

in addition to and not derogation of any other law for the time being in force and as suchthe licence(s) issued under Drugs and Cosmetics Act and Rules will be in addition to anddistinct from any Iicence(s) which may be necessary under the Import Trade ControlRegulations made of the Government of India, Ministry of Commerce.

3. The import Iicence(s) mentioned in para (1) abov~' will not accordingly to itself Ithemselves be sufficient authority for import of Dr~~o\tered by that I those Iicence(s) ifunder the Import Trade Control Regulations ¢ t~~mmerce Ministry separate license(s)are required for import of such drug(s). __\\,p'V

4. I am therefore, to advise you to ob~~.;~fVPlere necessary Iicence(s) for import of drugs inquestion under the Import Trade CdQJr'blRegUlations.

5. Any literature or packing accompanying the drugs or any matter stated on the label shouldnot contravene the provisions of the Drugs and Magic Remedies (ObjectionableAdvertisement) Act.

r--- 6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs ControlOrganisation at the ports will be Officers authorized to inspect the premises of importersestablishments for the purpose of Rule 26 of the Drugs and Cosmetics Act and Rulesthereunder.

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

~dY)Asstt. Drugs Controller (I)

Copy forwarded for information to:_ .fL8§~lLOJLJ9JLQ9nl(QI!~U1D9j~).L8hm~ga~~c:ILGbsmn~i! G.Q~bi.n!_R~lbj/tt~c:I~rapadIKandla

IKolkatal Mumbail Nhava Sheva

fORM __tQ(See Rules 23 and 27)

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

Mis Amardeep Enterprise, No.5-G, 3rd Floor, Nr. Income Tax Building, Ashram Road,Ahmedabad, Pin-380009 is hereby licensed to import into India during the period for which thelicence is in force, the drugs specified below, manufactured by MIS Solco Bio-Medical Co. Ltd.,34-6, Keuman-ri, Seotan-myeon, pyengtaek, Gyeonggi-do, 451-852, the Republic of Koreaand any other drugs manufactured by the said manufacturer as may from time to time be endorsedon this licence.

2. This licence shall be in force from 2. 5 0 CT 2011unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to ~.e ~~~~~~~S,pih~r~~iem~~h~St~rile)

-------------------0,~6~L~)-./---lTEM-+ON.E)..-ON-L~Y-·-"-~jl-,~C~f,-\---------.------<:~:::'.) ,-""'':''''-''''.''' . ")"~t:j--~,

-C),. '<"~~<~;t#tft

r:;:,,;~\)-17'';..J\

Place: New Delhi _eoA__A

Date: 2.5 OC;T lOll SE-<;~t~i;~~~L'-1'2 ;p-:- __'~T' SeallP:~IlflP:g'r.~.::1 ~;c:;:" -. --(:~,.,~ Conditio ~' .. - . ,;,fA D':::. , ~ " ,.

1. A photocopy of licence shall,*ft-~sPlaye~~~t Placewica~~ 'pnJ:l~_~pr~rnis~~1':and the original licence shall be pr~duced~ ~;~er requ.~~~~.~~,.' ""_ . ' ..-

2. Each batch of drug imported into Irfdl~,j~e acc~~~~~ied with a detailed batch test-'-'-~report and a batch release certificat~ttJ~l'~gr[d:}'liid::'~Uthenticated by the manufacturerwith date of testing, date of releasQi'td the date of forwarding such reports. The importedbatch of each drug shall be subjected to examination and testing as the licensing authoritydeems 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 in theconstitution of the firm takes place, the current licence shall be deemed to be valid for a

--'maximum -period ofthree months fr6-mthe date- onwhich'fhe'ch'ange-takesp'lace unle~ss,-i-nthe meantime, a fresh licence has been taken from the licensing authority in the name ofthe firm with the changed constitution

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

Date: 2 ~ (' {',", ~\'ur11oJ v'..: I t..'To,

As. Becton Dickinson India Private Limited,No.34, Assisi Nagar, West Thottam, MadhavaramChannai-51

Subject: Issue of an Endorsement No.1 to Form 10 License No.MD-03-765 dated28/04/2009valid upto 12/03/2012-regarding.

(Dr. S. Es eddy)Asstt. Drugs Controller (I)

Copy forwarded for information to:2. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl

Kandla IKolkatal Mumbail Nhava Sheva.

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


2011MIs. Becton Dickinson India Private Limited, No.34, Assisi Nagar, West Thottam,Madhavaram Channai-51 is hereby licensed to import into India during the period for whichthe licence is in force, the drugs specified below, manufactured by MIs. Becton DickinsonS.A. Ctra S ain Me uinenza sIn 22520. fra a. Heusca S ain.

2. This Endorsement NO.1 shall be in force from 5 0 C T 2a 11 to 12-03-2012unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported:-BD SoloshoeM MINI Syringes

ITEM(S) ONE ONLY

20n

..'..';:":.. :'}:~;

1. ~r:~~~~~~~dO~~C;~g~~af~~:~~e~~!~~:,~~~~~~~~;~~~:i~~~~~~:,_..-l2. Each batch of drug imported,~ 'hia~a shall be ac?ompanied with a ~etailed batch

test report and a batch re~se 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 be-deeme(Ho-be--valid-for-a--maximum-peFied-ef-thr€e--moRtRs--fr.om-the--d ate-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.

44205-_21.09.2011



Food and Drug Administration BhawanKotla Road, New Delhi-110002

To, .xC-v~~l/sCovidien Healthcare India Pvt Ltd.,

No-156, Doshi Towers, 6th Floor,Poonamall~e High Road, Kilpauk,Chennai-600010


1. With reference to your application for import licence forwarded to this office with your letter No.CHIUIRAlF-10/MD-624/2011 Dated 15/07/2011 received by this office vide dairy NO.33581dated 15.07.2011 and reply received by this office vide diary no. 44205(Fts No. 65721) dated~1/09/2011. I enclose licence(s) NO. MD-624-1400 date~ ~ .~,""7 4 this 1 theseIIcence(s) has 1 have .been granted under the Drugs and C&;rAetrcs·.J.\tt;!itfand Rules1945thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act .1940 and Rules1945 are inaddition to and not derogation of any other law for the time being in force and as such thelicence(s) issued under Drugs and Cosmetics Act and Rules will be in addition to and distinctfrom any Iicence(s) which may be necessary under the Import Trade Control Regulations madeof the Government of India, Ministry of Commerce.

3. The import Iicence(s) mentioned in para (1) above ~II not accordingly to itself 1 themselves besufficient authority for import of Drugs covere~~~ttlat 1 those Iicence(s) if under the ImportTrade Control Regulations of the comme~ee~try separate Iicense(s) are required for importof such drug(s). r~,~

4. I am therefore, to advise you to(tp~'Tt1, where necessary licence(s) for import of drugs inquestion under the Import Tradl.oontrol Regulations. .



7. Please acknowledge receipt of this letter and its enclosures.---------- . ~ ~ ~________~~Ully

,;;:::.x----(Dr. S. Eswara Reddy)

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

8. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl Kandla- IKolkatal Mumbail Nhava Sheva

FORM_tO(See Rules 23 and 27)


~ § f ... '" "i~1...~Vvl tUb

Mis Covidien Healthcare India Pvt. Ltd., No-156, Doshi Towers, 6th Floor, PoonamalleeHigh Road, Kilpauk, Chennai-600010 is hereby licensed to import into India during the period forwhich the licence is in force, the drugs specified below, manufactured by MIs ev3 Inc., 4600 NathenLane North, Plymouth, MN 55442, USA having manufacturing premises at MIs Micro TherapeuticsInc., d/b/a ev3 Neurovascular Inc. 9775 Toledo way, Irvine, CA 92618-USA and any other drugsmanufactured by the said manufacturer as may from time to time be endorsed on this licence.

2. This licence shall be in force from ~ '== n:T ~&'--unless it is sooner suspended or cancelleun"tlert~e'sa;r ,'es.

3. Names of drugs to be imported: ~n COAl'1. SilverHawk:j"1ltrlplieral Plaqoe €:'~sion

(:9 ITEM (One) ONLY <: 0<};;.0 if~'-"!"" , ;Y0

<) '~ ,-------------------------~,~!~-. ''A

X ~\".c- y~ -~<:' --

ZOl1Cf .,-~ .---l:J~~.".c S'Q;r:,,'; b~~~~9 t\,~!1Qlrity.f>.~:"Seal/Starn p

~ ~:::;;,;:<::i(' '::iOi;....-: ...,_.~..,

~, Condi ["'OJ. L:::if!' . . '; ..~'$

1. A p~oto~opy of licence Shall~~~Played fi\~W6~~ elace t~~~~:r1·bfth~·~)rerilises,~h~th~-,onglnal licence shall be producea.~henever reqUired.••. - ......r-:~'

2. Each batch of drug imported into IA~~fi9~1 be....?ffi.~~ltt~~with a detailed batch test reportand a batch release certificate, duly Sigri~lecf/ .~~t:fc'ated by the manufacturer with date oftesting, date of release and the date -p! "".. rding such reports. The imported batch of eachdrug shall be subjected to examin~ an testing as the licensing authority deems fit prior to itsmarketing.


4.. The licensee shall inform the licensing authority forthwith in writing in the event of any change inthe constitution of the firm operating under the licence. Where any change in the constitution ofthe firm takes place, the current licence shall be deemed to be valid for a maximum period ofthree months from the date on which the change takes place unless, in the meantime, a freshlicence has been taken from the licensing autho!l!.}t'!':l._the_I}§lEn_~.QUhefirm--'!'lth..1.l1JLQtLa_rm.ed_

-------------- ---c1Jrrs11totion-~---------- -.

4450823.09.2011




File No.31-844-MD/2010-DC

To,~ Teleflex Medical Private Limited,

Old No. 10, No: 19, 1st Floor & Ground Floor,Harrington Road, Chetpet, Chennai-600031


1. With reference to your application for import licence forwarded to this office with your letter No.TFX/RAllmport license/Arrow/Asheboro Dated 06/07/2011 received by this office vide dairyNo.32885 dated 11.07.2011 and reply received by this office vide ~rycn9\4~50~W;f ~o.65190) dated 23/09/2011. I enclose hcence(s) NO.MD-844-1399 dated t.. ..) v'...' • ..:..vl this 1these Iicence(s) has 1 have been granted under the Drugs and Cosmetics Act 1940 andRules1945 thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules1945 are inaddition to and not derogation of any other law for the time being in force and as such theIicence(s) issued under Drugs and Cosmetics Act and Rules will be in addition to and distinctfrom any licence(s) which may be necessary under the Import Trade Control Regulations madeof the Government of India, Ministry of Commerce. ~,'

3. The.i~port Iicen?e(s) ":Ientioned in para (1) above ~~-hdt accord!ngly to its~lf 1 themselves besuffiCient authonty for Import of Drugs cover~ ~\tf1at 1 those hcence(s) If under the ImportTrade Control Regulations of the Comm~~istry separate Iicense(s) are required for importof such drug(s). ,(_0,\"': \

4. I am therefore, to advise you to o'bla1n,where necessary Iicence(s) for import of drugs inquestion under the Import Trade Control Regulations.



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

<-zJ~~(Dr. S. Eswara Reddy)


8. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl KandlaIKolkatal Mumbail Nhava Sheva



MIs MIs Teleflex Medical Private Limited, Old No. 10, No: 19, 1st Floor & Ground Floor,Harrington Road, Chetpet, Chennai-G00031 is hereby licensed to import into India during theperiod for which the licence is in force, the drugs specified below, manufactured by MIS ArrowInternational Inc.,(Subsidiary of Teleflex Inc.} 2400 Bern Ville Road Reading Pennsylvania 19605,USA having manufacturing premises at MIS Arrow International Inc., 312 Commerce Palace,Asheboro, North Carolina 27203, USA and any other drugs manufactured by the said manufacturer asmay from time to time be endorsed on this licence.

2. This licence shall be in force from 2. 5 C (. 'r' Z011--unless it is sooner suspended or cancelled under the said rules.

3. Names of drugs to be imported: \'.lOARD COl\l1. Central veno~e:atl1eters( Sm-glbea~uble, Multi Lumen, Uncoated

and ARR~~+ard Blue(coated), ancr~~sure injectable)2. Peripher~~ly Inserted c catheters iihd accessories, including

pressu@ injectab,03. Acute~ Hemodi .,. (Uncoat~~ & ARROWg+ard

Blu~~oated) and rile?,.;,4. EpiClnral Catheters ies -5. Sti~Lcath Periphe and accesso1!esG. Central Vencws cath ories-Introducer Needle7. Centra(~s€@ , 3(~W Raulerson Syringe

Assembly8. Mult~umen Acce1-.<r

~J-O,t:'

IttJiLTHI

25 ("".,r·.....,~~

UG ~ 2011

Conditions of Licence, '. '''';1. A photocopy of licence shall be displayed in a prominent place in a part aHbe .pl'€.mises;and tt)e

original licence shall be produced, whenever required. '. KO~I'~-·'~:::::~'".•...•....... \:;:~2. Each batch of drug imported into India shall be accompanie~ with a 'aetaUeClb'a1Ch'test'rep()rt~

and a batch release certificate, duly signed and authenticated by the manufacturer with dateoL.testing, date of release and the date of forwarding such reports. The imported batch of eachdrug shall be subjected to examination and testing as the licensing authority deems fit prior to itsmarketing.


4. The licensee shall inform the licensing authority forthwith in writing in the event of any change inthe constitution of the firm operating under the licence. Where any change in the constitution ofthe firm takes place, the current licence shall be deemed to be valid for a maximum period ofthree months from the date on which the change takes place unless, in the meantime, a freshlicence has been taken from the licensing authority in the name of the firm with the changedconstitution

4450723.09.2011 ..




To,~ Teleflex Medical Private Limited,\ Old No. 10, No: 19, 1st Floor & Ground Floor,

Harrington Road, Chetpet, Chennai-600031

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

1. With reference to your application for import licence forwarded to this office with your letter No.TFXlRAllmport license/Arrow/New Jersey Dated 0770772011 recelvecoy tnis offlc-e vide~---dairy NO.32886 dated 11.07.2011 and reply received by this office vide"eiia,ry PO", 4A~~(lits No.65185) dated 23/09/2011. I enclose Iicence(s) NO. MD-843-1403 dated~ :L I,J \J j LU II!this 1these licence(s) has .f have been granted under the Drugs and' Cosmetics Act 1940 andRules1945 thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules 1945 are inaddition to and not derogation of any other law for the time being in force and as such thelicence(s) issued under Drugs and Cosmetics Act and Rules will be in addition to and distinctfrom any licence(s) which may be necessary under the Imfr\ Trade Control Regulations madeof the Government of India, Ministry of Commerce. (y.•

3. The import licence(s) mentioned in para (1) abov~w£riot accordingly to itself 1 themselves besufficient authority for import of Drugs cove~'fthat 1 those Iicence(s) if under the ImportTrade Control Regulations of the comme..t.~ ~i~istry separate license(s) are required for importof such drug(s). \) ~

4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import of drugs inquestion under the Import Trade Control Regulations.



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

~ithfUIIY

~(Dr. S. Eswara Reddy)


8. Asstt.DruQsControllel' (India), Ahmedabadl ChennaiL Cochinl Delhi! Hyderabadl KandlaIKolkatal Mumbail Nhava Sheva


Licence to import drugs (excluding those specified in Schedule X) to the Drugs andCosmetics Rules, 1945 2. 5 OCT 20\1

Mis Teleflex Medical Private Limited, Old No. 10, No: 19, 1st Floor & Ground Floor,Harrington Road, Chetpet, Chennai-600031 is hereby licensed to import into India during theperiod for which the licence is in force, the drugs specified below, manufactured by MIS ArrowInternationallnc.,(Subsidiary of Teleflex Inc.) 2400 Bern Ville Road Reading Pennsylvania 19605,USA having manufacturing premises at MIS Arrow International Inc., 2, Berry Drive, Mount Holly,New Jersey, 08048, USA 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 2. 5 (I CT 2011unless it is sooner suspended or cancelled under the said rules.

_______ 3_. _N_a_mesof drugs.to ?e imported: .. ', \:..'OA.RQ CQf\j);,~.1~ihermo"difutmrrecrtheter-a:rfdM~ones,-st-en~2. Wedge Pressure Catheter ~nd Accessories, Sterlit, r"",3. Bermen Angiograpbi'C)Balloon Cath ;:lnd access~j~, Sterile4. Pacing Cathetersaj'ti Accesso~i,. \~J1

!~,,( 'trPlace: New Delhi /0." 'if,

Date: 2 c; OCT 2011 , ;;;_,ol9.\:;r;.~~,t:.;':."I'l;~;.;"4.'II':·~:;;::"::.':_,·,'··_:;;';'···

~. ""ty~fO c;::cr '(T'~~::"2::fJeell$m". ,,,,.q~r>.;' , .....,.....,.' 'Sea'1I8tamp

. CCrt D~C()..•'•...•......•". .. . .;::,..;:tro;:.:;r~~ ~~. '.' . "0:;,""

1. A photocopy of licence &hall be dis~ .ace iJJr,~P~ft:6f.·'fh_~,J?r~n;il~es.,;~p',~the '•...original licence shall be ~duced, ~n ".-'" '-~ .d. ~,,', Iv'__w2 •

2. Each batch of drug impo~~f! into India niedwith~taHed1Jatch tesrrepbii'-~""and a batch release certificate duly sign icated by t~ manufacturer with date oftesting, date of release and 1l5a date of ~ng s .h reports, CDne imported batch of eachdrug shall be subjected to exam~ion and testing as the Iiceos#\g authority deems fit prior to its

f j. ~x..."3. ~~;~7~~~~ee shall be responsible f~:~14Tu'sIpe§~aBr.~~~~f the manufacturer in India along

with the registration holder and his authorised agent.4. The licensee shall inform the licensing authority forthwith in writing in the event of any change in

the constitution of the firm operating under the licence. Where any change in the constitution ofthe firm takes place, the current licence shall be deemed to be valid for a maximum period ofthree months from the date on which the change takes place unless, in the meantime, a freshlicence has been taken from the licensing authority in the name of the firm with the changed

-~GORstitbltj.QR··~~-~~~.- -. ~-.... . - .~. - -._~ __

Documents

--CentrarO'rugsStandarcrControIOrganisation 10 MD on 25.100001.… · --CentrarO'rugsStandarcrControIOrganisation Directorate General of Health Services ... The Assistant Drugs Controller