Central Drugs Standard Control Organisationcdsco.nic.in/medical_div/form_10_md/form 10 final md 29...Central Drugs Standard Control Organisation Directorate General of Health Services

194813.01.2012

Central Drugs Standard Control OrganisationDirectorate General of Health Services

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

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

To,~fS. Trivitron Healthcare Pvt. Ltd.. Ground Floor, Door No.-15 [Old No.-25]

IV Street, Abiramapuram, Chennai-18

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. THPl/P/0007 dated 22.12.2011 and received by this office f/Jd@D1iflrY. Nat~~~1948 dated 13.01.2012 I enclose Iicence(s) No. MD-946-1502 dated t-~,; c_ • """

this I these Iicence(s) has I have been granted under the Drugs and Cosmetics Act 1940and Rules 1945 thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules1945are in addition to and not derogation of ~ni'~ law for the time being in force and assuch the Iicence(s) issued under Drugs ~sr:net,ics Act and Rules will be in additionto and distinct from any Iicence(~~i~ may be necessary under the Import TradeControl Regulations made of ~'Mernment of India, Ministry of Commerce.

3. The import Iicence(s) m~)ined in para (1) above will not accordingly to itself /themselves be sufficient authority for import of Drugs covered by that I those licence(s) ifunder the Import Trade Control Regulations of the Commerce Ministry separateIicense(s) are required for import of 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 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 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 Rules

___~1b~@under_. ~ ~ ~_ __ _ _ _ __ _7. Please acknowledge receipt of this letter and its enclosures.

~(Dr. G N Singh)

Drugs Controller General (India) Ilc

FORM--tO- -(See Rules 23 and 27)

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

MIs. Trivitron Healthcare Pvt. Ltd., Ground Floor, Door No.-15 [Old No.-25], IV Street,Abiramapuram, Chennai-18 is hereby licensed to import into India during the period for which thelicence is in force, the drugs specified below, manufactured by MIs Boston ScientificCorporation, One Boston Scientific Place, Natick, MA 01760, USA having manufacturing atMIs Techdevice Corporation, 650 Pleasant St. Watertown, MA 02472, USA and any otherdevice manufactured by the said manufacturer as may from time to time be endorsed on thislicence.

1. This licence shall be in force fromunless it is sooner suspended ,orcancelled under the said rules.

~~~1~.,,-' \..,•. , '.,.;.; ~ ht<:.

2. Names of drugs to be imported: .. ~\o~RDCnf','1. Rigifiex Ii Achalasia Balloon D~a,fc)ftatheter(M6cYe~ 30mm, 35mm, 40mm).

For Single Use Only. ~( .•;' . '( 0ITEM(S)ON§PllLY '~A

Q v~~ .~.

~ \J't- ~< -~"C 0

Place: New Delhi U. I;'" ~~,M Z

Date: 2.:;" ;:Jl C~Co. DSC~~~. Li~s,ng Authority

~ .. ~ J Seal/Stamp\1'> .. '. ... •...•..........'.. .'.'.''.' .'. .. i ......•~o • Dr. G. N. SINGH···••.19pnditionStQf4L1~utWhi •...•..•....•......0«... P.~~~;~:~~~~~:~~r;,(I~dia)

1. A photocopy of licence shallbedi~~'yedinaprominent place in~arto_~~~1:re

2. ~:c~rig~~~li~~n~f~J~~lp~~~dt)rrif6~~:ri~~~=~\'~~~with ••••••••~.·•••·'d~t~il~ig~;~H~~~t I.TO.

report and a batch release certificate, duly signeCJ'ana authenticated by the manufacturerwith date of testing, date of release and 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._TbeJicensee-shall--be--r-eSJ30nsible~f-orthe-business-activttie-s-oftnemanufi:fcturerin Inaiaalong 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 amaximum period of three months from the date on which the change takes place unless, inthe meantime, a fresh licence has been taken from the licensing authority in the name of thefirm with the changed constitution


Ministry of Health & Family Welfare(Medical Device & Diagnostics Division)

Food and Drug Administration Bhawan,Kotla Road, New Delhi-110002

To/M/S. St. Jude Medical India Private Limited,

A & B, 2nd Floor, Brij Tarang, Greenlands,Begumpet, Hyderabad-500016, India

SUB:- Amendment in Registration Certificate No. MD-26 (End.2) dated05.10.2011 valid up to 30.06.2012 and Form 10 No.MD-26-950 (End.2)dated 04.01.2012 valid up to 30.06.2012 -reg.

Please refer to your letter No. Nil dat~,0t~~~ 0.2011 received by this office vidediary no. 48283 (FTS 70982) dated 14. ~.20"\ind reply received vide diary no. 57959(FTS 86355) dated 19.12.2011, 20~ IiG~970) dated 16.01.2012 on the subject matter.'f~~

This is with reference Q 'he Registration Certificate No. MD-26 (End.2) dated05.10.2011 valid up to 30.06.2012 and Form 10 NO.MD-26-950 (End.2) dated 04.01.2012valid up to 30.06.2012 issued by this office. The name of the Product is hereby amendedas follows:-

In place of:''Trifecta™ Valve Aortic (19mm- 27mm)".

Read as:''Trifecta™ Valve Aortic (19mm- 29mm)".

~

'

. (Dr. G Singh)Drugs Controller General (I dial IIc

253318.01.2012




Dated: 2 S

To~B. Braun Medical (India) Pvt. Ltd.

Bldg No. B, Gala No 1-10, Prerna Complex,Anjur Phata, Dapoda Road, At Val VillageBhiwandic421302, Maharashtra.

SUbject: Issue of an Endorsement No.3 to Form 10 License No. FF-432-11026 dated27.12.2010 valid up to 31.07.2013 regarding.

;;•. :'1\

Please refer to your applic@oo'\ No. BBRNIMP-432-FF/01-2012 dated17.01.2012 and received by thi$Qffrgft'.r-VideDiary No.2533 (FTS 4408) dated 18.01.2012regarding the above citeg~'~~fJj~&t~

~Endorsement NO.1 to Form 10 License No. FF-432-11026 dated 27.12.2010

valid up to 31.07.2013 for the import of drugs manufactured by MIs B. BraunMelsungen AG, Germany having manufacturing premises at MIs B. BraunMedical KFT, Deli-Kulhatr UT 2-4, 3200 Gyongyos Hungary is enclosed hereby.

Yours faithfully

.. (Dr. G~9h)............ __._.__. .Drugs_Co_ntroUe.r_Genexal(India)JLc '.

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

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

Date: 2 r; ~._ to, r.:?_: ' ~~

MIs B. Braun Medical (India) Pvt. Ltd., Bldg No. B, Gala No 1-10, Prerna Complex, Anjur Phata,Dapoda Road, At Val Village, Bhiwandi-421302, Maharashtra is hereby licensed to import intoIndia during the period for which the licence is in force, the drugs specified below, manufactured byMIs B. Braun Melsungen AG, Germany having manufacturing premises at MIs B. Braun MedicalKFT, Deli-Kulhatr UT 2-4,3200 Gyongyos Hungary.

? 'T'lThis Endorsement shall be in force from e- ~.O' ,.., to 31.07.2013unless it is sooner suspended or cancelled under the said rules.

Names of drugs to be imported:As per Annexure-IITEM(S) ONE ONLY

.." C'·Date: __ L._""'_' _; __

Lice;'st~~~~o Dr. G. N. SINGH

.. rugs Controller General (India).J . •. .' .. Ote General of Health Service

Conditipns of Licence. . 1v~~~:~~;:ae:l~o~:~~V;~I;re1. A photocopy of licence shall be displayed in. a prominent place in ~;P~I;'I;h1&btl2' ·.I.V.

premises, and the original licence shall be produced, whenever required .. 2. Each batch of drug imported into India shall be accompanied with a detailed batch

test report and a batch release certificate, duly signed and authenticated by the" -maA-ufacturer--wjthdate-otiesting;-uate--\)f,el~ra-5eand--tlle- d'ate-orforwaFafritfsDch"

reports. The imported batch of each drug shall be subjected to examination andtesting as the licensing authority deems fit prior to its marketing.

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

4. The .licensee shall inform the licensing authority forthwith in writing in the event ofany change in the constitution of the firm operating under the licence. Where anychange in the constitution of the firm takes place, the current licence shall bedeemed to be va Iidfor-a 'maximum- period-ofihree m onthsfromthed ate- orfWlilchthe 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.

C' ''''or;~,("., <.; utb

r'I -Form 10 Licenses No. FF-432-11026 Dated t..:r,

IV administration sets with air vent forgravity infusions.

IV administration sets with air vent forpressure and gravity infusions

- IVa.~·jt)i~b'h ;ets with air vent for(\,~~~~tt9'Tnfusions ..

IV administration sets with air vent forpressure and gravity infusions

LicensintorilYsei~~~~pDr. G. N. SINGH

Drugs Controller General (India)Dte. General of Hea::h Services

Ministry of Health & Famllv WelfareFDABhawan. Kolla Road. I.T.O.

New Delhi-110002

149211.01.2012




F'- ""'r .:x;..

l...;., ~_... :.- .~W".

To, ~~ MIs. Nibso Metals (P) ltd.,

5-A, Harish Mukherjee Road,(Ground Floor) Kolkata-700025


1. With reference to your application for import licence forwarded to this office with yourletter No. NIL dated 0~.01.2012 and received by this offic~ ~.ide~OlarY~R~~~92 dated11.01.2012 I enclose hcence(s) No. MD-604-1500 dated t, -..<~, :df,IS / theseIicence(s) has / have been granted under the Drugs and Cosmetics Act 1940 andRules 1945 thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules 1945are in addition to and not derogation of an.y ~~~~tor the time being in force and assuch the licence(s) issued under Drugs ao:d ~ics Act and Rules will be in additionto and distinct from any licenc~~_\~ay be necessary under the Import TradeControl Regulations made of th~r;.,ment of India, Ministry of Commerce.

3. The import licence(s) mentionea in para (1) above will not accordingly to itself /themselves be sufficient authority for import of Drugs covered by that / those licence(s) ifunder the Import Trade Control Regulations of the Commerce Ministry separatelicense(s) are required for import of such drug(s).



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.

~(Dr. G Singh)

Dru~I._Controlier General ,India) lie

FORM 10(See f3ules 23 and 27)

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

2, ~- ,...",~'~ ~-'~'-';7~_, •.. ~ ·c,.:o.c,

MIs. Nibso Metals (P) Ltd., 5-A, Harish Mukherjee Road, Ground Floor) Kolkata-700025 ishereby licensed to import into India during the period for which the licence is in force, the drugsspecified below, manufactured by MIs Terumo Europe NV, Researchpark Zone, 2-Haasrode,Interleuvenlaan, 40, B-3001, Leuven, Belgium and any other device manufactured by the saidmanufacturer as may from time to time be endorsed on this licence.

/!,!. r· ~-:-,~.,''''-,--,-~",.N.

1. ~~li:~~C~~~~~~~~rb:u~p~~:~r~~cancelle'iU~~~~~id;UI~~

\C\\·C~2. Names of drugs to be import~ ~ \\

1. Nobori Drug Eluting Stent~ES)SystemITEM(S) ONE ONLY

~

LiCEmS~g AuthoritySeal/StampDr. G. N. SINGH

Drugs Controller General (India)Dte General of Heal:h Services

Ministry of Health & Family WelfareFDA Shawan, Kotla Road, !.T.O.

New Delhi-110002Conditions of Licence

1. A photocopy of licence shall be displayed in a prominent place in a part of the premises, andthe original licence shall be produced, whenever required.

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 the manufacturerwith'dateoftesti ng,' date 'arrete'ase ana-tile' CIate' oT f6RrVardinffs'uclirep'6rts: The'i mpoIiedbatch 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 shaH be deemed to be valid for a-maxi mumperiodofthree months fromthe'date on'whichthech angetakes -placeu nless ,-inthe meantime, a fresh licence has been taken from the licensing authority in the name of thefirm with the changed-constitution

149311.01.2012




Dated:"" ~,i~~

To, .L~~s.Dashmesh Sonail Healthcare Pvt. Ltd.

42, Kamlesh, Shere Punjab Society,Plot No. 36814, Andheri (East),Mumbai-400093, Maharashtra.



letter No. NIL dated 26.12.2011 and received by this office vide Diary No. 1493 dated11.01.2012 I enclose Iicence(s) No. MD-293-1504 dated , C r cf":. "C"tthis / theseIicence(s) has / have been granted under the Drugs and Cosmetics Act 1940 andRules 1945 thereunder.

2. I am to point out that the provisions of Drugs and ~q~metics Act 1940 and Rules1945are in add.ition to a~d not derogation of anx o~~,~ fur the time being. in fo~ce an? assuch the hcence(s) Issued under Dr:,u~~~'¢:,Co.-smetlcs Act and Rules Will be In additionto and distinct from any licenc~)~\Yhl~ may be necessary under the Import TradeControl Regulations made of the'~overnment of India, Ministry of Commerce.

3. The import licence(s) mentioned in para (1) above will not accordingly to itself /themselves be sufficient authority for import of Drugs covered by that / those Iicence(s) ifunder the Import Trade Control Regulations of the Commerce Ministry separatelicense(s) are required for import of such drug(s).



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 importers

_~§t~J:>li~tmlelJt~_fQLth_e_pU[pDse.otRule 26-of-the-blfHgs- -anEl-GesmeticsAct· and,Rulesthereunder.

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

· FORM 10---.--(See Rules 23 and 27)

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

Mis Dashmesh Sonail Healthcare Pvt. Ltd. 42, Kamlesh, Shere Punjab Society, Plot No.36814, Andheri (East), Mumbai-400093, Maharashtra is hereby licensed to import into Indiaduring the period for which the licence is in force, the drugs specified below, manufactured by MisZhanjiang Star Enterprise Co. Ltd., having manufacturing site at No. 49 Jinchuan Road 524094Zhanjiang, People's Republic of China and any other device manufactured by the saidmanufactureras may from time to time be endorsed on this licence.

1. This licence shall be in force from 2. S7 , '''' :,,;.unless it is sooner suspended or cancelled under the said rules.

2. Names of drugs to1. Foley Catheter

;:r. ~~nsin Authority

&-..:::. eallStampO· Dr. G. N. SINGH..--.0.. .. . Drugs Controller General (India)

1.A photocopy of licence ~I"part ()H~~J~;~~;;ifye~~C::re"tF[ffi gWwan."koti'a Koad. LT.G.the original licence shall New Delhi-11 0002

2. Each batch of drug imported shall be accompanied with a detailed batch testreport ana a batch release certificate, duly signed and authentic'ated by the manufacturerwith date aftesting, date of relea~e and the date of forwarding such reports. The importedbaTch-of-each drug-shaH be sUbJecfecffo examlnati'o'n-a-!lcn-esting i:\-sthe licensing authoritydeems fit prior to its marketing.

3. The ficensee 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 amaximum period of three months from the date on which the change takes place unless, inthemeantirrre,afresh Iicenceha-s-oeenlakenrromthelicenSingaufhorityWfthe name of thefirm with the changed constitution


Ministry of Health & Family Welfare

Food and Drug Administration Shawan,Kotla Road, New Delhi-11 0002

To,~/s. Leading Health Technologies Pvt. Ltd.

Shop No. A-24, Local Shopping Centre,A-Block, Naraina Vihar, New Delhi-110028

SUB:-Amendment in Registration Certificate No. MD-241 issued on27.12.2011 valid from 01.12.2011 up to 30.11.2014 -reg.

Please refer to your letter No. LHTPLl1 OlfOt~,)d'ated 29.12.2011 and received bythis office vide Diary N059582 (FTS N~:~~~\~~~t~d 29.12.2011 on the subject matter.

. 'no( \\This is with reference to M Registration Certificate No. MD-241 issued on

27.12.2011 valid from 01.12.2011 up to 30.11-.2014 issued by this office. The name of theproduct is hereby amended as follows: -

In place of:"Lifeport Infustion Sets (Catalogue NO.LPS3004, LPS3005, LPS3006, LPS3007,LPS3009, LPS3017, LPS3023, LPS3025)".

Read as:"Lifeport Infustion Sets (Catalogue No.LPS3004, LPS3005, LPS3006,LPS3007, LPS3009, LPS3017, LPS3023, LPS3025, LPS3008)".

~(Dr. G. N. Singh)

__~rl.lg_~_~ontroller Gen~ra! (!ncHa) lIe

5735914.12.2011


Ministry of Health & Family Welfare(Medical Device andOiagnosHcDivision)

Food and Drug Administration BhawanKotla Road, New Delhi-110002

To,~/s Galaxy Surgitech

New No.7, Old No.36, 1st Floor,AB-Block (Facing 5th Street), Anna Nagar,Chennai-600040



letter No. GS/DCGI/3792/2011 dated 05.12.2011 and received by this office vide DiaryNO-,-57359(FT$ .85151) dated 14.12.2011 I enclose licence(s) No. MD-569-1476 dated2 ,) ;-;-:- ::mZthis / these Iicence(s) has / have been granted under the Drugs andCosmetics Act 1940 and Rules 1945 thereunder.

2. I am to point out that the provisions of Drugs ~t4smetics Act 1940 and Rules1945are in addition to and not derOgation. O~fa, ~~ 1'1wfor the time being in force and assuch the licence(s) issued under gJ~ + Cosmetics Act and Rules will be in additionto and distinct from any Iicen~~\w1 ich may be necessary under the Import TradeControl Regulations made of th~"tovernment of India, Ministry of Commerce.

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



6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs Control-Organisation BtiheportswiH--be-OfficeTs·aothorized-toinspectthe-premise-s·of -jmpbrters

establishments for the purpose of Rule 26 of the Drugs and Cosmetics Act and Rulesthereunder.

7. Please acknowledge receiptofthis letter and its enclosures.

(Dr. G. . Singh)Drugs Controller General India) lie

FORM 10(See Rules 23 and 27)


~"~,?~r~'·r!}. -;

~acE.,..

Mis Galaxy Surgitech, New No.7, Old No.36, 1st Floor, AB-Block (Facing 5th Street), AnnaNagar, Chennai-600040 is hereby licensed to import into India during the period for which thelicence is in force, the drugs specified below, manufactured by Mis Surgical Specialities, USAhaving manufacturing Premises at Surgical Specialities Corporation-dba Angiotech, 100Dennis Drive, Reading Pennsylvania 19606, USA and any other drugs manufactured by the saidmanufacturer as may from time to time be endorsed on this licence.

,2 .,,,,~,-~':.-This licence shall be in force fromunless it is sooner suspended or cancelled under the said rules.

2. Names of drugs to beirnported:1. Synthetic Ab$()rb~:tJl~

Suture (Quit2. Synthetic A

(Quill Mono3. Non-absorba'4. Non-absorb'

PolypropylewU

~"Retaining System Barded

stem Barded Suture

Baf'ded ,ture (Quill Nylon)gSystem 'rded Suture (Quill

"6Z

5(" ~I~

o¢i~si Authority" SeallStamp

"..~ Dr. G. N. SINGH

1. A photocopy of licence sballbedi$[$ ".>. ". ... ~fa part Ofth~Q~~~~I~,r~~~r~le~:~the original licence shallbeproducedwhe 'F MinistryofHealth& FamilyWelfa~e

2. Each batch of drug imported into I~dia sh'all be accompanied with a det~~&r~§~~~~t,g~' LT.O.reR-QIt ..~md.a__batchrelease_certiflcate~-dul¥sjghed-and-alJthel'lticated-by--tl1e--manufacturerwith date of testing, date of release and 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.


4. The licensee shall inform the licensing authoiity forthwith in writing in the event of anychange in the constitution of the firm operating under the licence. Where any change in thecOI1~tituti()".l_()f Jh.f3J.!!:!'r1J§.~~§J?ta(;~tr~_~lJ.rreJ::lLH~~D~~§b~lLbe._dee.m~.~:Uo_be..\fa lid .for amaximum period of three months from the date on which the change takes place unless, inthe meantime, a fresh licence has been taken from the. licensing authority in the name ofthefirm with the changed constitution

"" ,~

O t/ .....a e : ,_-__"'_"__

129410.01.2012




~s. Smiths Medical India Pvt. Ltd.Unit No. 501, 5th Floor, Western Edge-1,Western Express Highway, Tah: Borivali East,(Mumbai -Zone 7) 400066



letter No. Nil dated 10.01.2012 and received by this office vide Diary No. 1294 (FTS2N.9.24~~}d~t;e.o ~0.01.2012. I enclose Iicence(s) No. MD.;809-1494 dated

" ,-.~ b-",'~" thiS I these hcence(s} has I have been granted under the Drugs andCosmetics Act 1940 and Rules1945 thereunder.~,,}q

2. I am to point out that the provisions of Drugs.~~~osmetics Act 1940 and Rules 1945are in addition to and not derogation of .AA~o~~iaw for the time being in force and assuch the Iicence(s} issued under Q~I~<r'Cosmetics Act and Rules will be in additionto and distinct from any licenc(~r which may be necessary under the Import TradeControl Regulations 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 those Iicence(s} ifunder the Import Trade Control Regulations of the Commerce Ministry separateIicense(s} are required for import of 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 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 Drugs Control_QJ9?Dj§~jQ~aJ tb~_pprtswjILb_e~Qfficers--8.u1h01:izedJQjnspecUbe-premisesof--im portersestablishments for the purpose of Rule 26 of the Drugs and Cosmetics Act and Rulesthereunder.


~l1/- ..---- -t'-_.~...-(Dr. G IN Singh)

Drugs Controller General (India) lIe


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

Mis. Smiths Medical India Pvt. Ltd., Unit No. 501, 5th Floor, Western Edge-1, WesternExpress Highway, Tah: Borivali East, (Mumbai -Zone 7) 400066 is hereby licensed to importinto India during the period for which the licence is in force, the drugs specified below,manufactured by Mis Smiths Medical ASD Inc, 201 West Queen Street, Southington,Connecticut 06489, USA and any other drugs manufactured by the said manufacturer as mayfrom time to time be endorsed on this licence.

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

2. Names of drugs to be imported: , ;, \..:.1. LV. Cahteters . '" ':;;,'.1:" .

Protect IV® Plus SafetY,,1~W.Catheter. (,(Product COdes-30~O:~$"662, 3063, 3Q.6.5f.~p66,3068, 3b8V.~.3083, 3085, 3086, 3088)

.::;',~ ITEM(SkQt{ ; ';":'.:7~'''''''<'>d;'f ",,_~:'

A':-"~"

(~ ;1'1::.?-?-:~J:;;~

Licensi g Authority.~~ :;,~'::; Seal/Stamp

1.•.< ..••. Conditi . . ..~.: Dr. G, N. SINGH1. A photocopy of licence shall B~>eisplaye . ce. in a pa~txift~~~~~~~~e~~a;

the original licence shall be prbqft:j. uTI"... . .c;;·' MinistryofHealth& FamilyWelfare2. Each batch of drug imported ilit .~.'l.,dia shall beaccompanieg,y{lth- a dl&h~~B(~a1~' !.T.o,

report and a batch release certificatel~.!cjuly signed and aUJQ~Rticated by the manuta'clurerwith date of testing, date of release and':trl~p,atefQt\oJ'&~r.ahig such reports. The importedbatch of each drug shall be subjected to examinatTon and testing as the licensing authoritydeems fit prior to its marketing. _.__...,_,,_ __"

3.-The-licensee- shan-De -leSI:Y6nsi6Ie -f6flne'l:)usi'r18ss -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 amaximum period of three months from the date onwhich the change takes place unless, inthe meantime, a fresh licence has been taken from the licensing authority in the name of thefirm with the changed constitution



Food and Drug Administration Bhawan,Kotla Road, New Delhi-11 0002

, :(~;t·;,f~t- 4:" if;;.....•.•..k~~

To~ Becton Dickinson India Pvt. Ltd.

Plot No.34, Assisi Nagar, West Thottam,Madhavaram, Chennai-51

SUB:- Amendment in Form 10 License No. MD-623-1462 dated 27.12.2011valid up to 31.03.2015 -reg.

Sir,", ~

Please refer to your letter No. BDIPL/RAI~~'W0'1 dated 06.01.2012 received bythis office vide diary no. 921 (FTS 179~\~6:&1.2012 on the subject matter.

This is with reference to thD~~ 10 License No. MD-623-1462 dated 27.12.2011valid up to 31.03.2015 issued by this office. The name of the Form 10 License No. ishereby amended as follows:-

In place of:"Form 10 License No. MD-623-1462".

Read as:_Ufol"m·:'I_O- License-NG.M9-623-811".

(i;lr.~ngh)Drugs Controller General (India) lie

202316.01.2012



Food and Drug Administration BhawanKotla Road, New Delhi·110002

To~ Atrium Medical India Pvt. Ltd.

Old No. 54, New No. 11, NRD Tower, 3rd Floor,First Avenue Jawaharlal Nehru Road, Ashok Nagar, Chennai-83

Subject: Issue of an Endorsement No.1 to Form 10 License No. MD-524-1454 dated19.12.2011 valid up to 30.11.2014-regarding.

Please refer to your application No. Nil dated .U.01.2012 and received by thisoffic.e vide Diary No.2023 (FTS 4000) dated 19~~12} regarding the above citedsubject. r"~ ~,,?

.t'))'(,!yEndorsement NO.1 to For~1!O'''Ucense No. MD-524-1454 dated 19.12.2011

valid up to 30.11.2014 for the import of drugs manufactured by Mis Atrium MedicalCorporation, 5, Wentworth Drive Hudson, New Hampshire 03051, USA is enclosedhereby.

Yours faithfully

(Dr. ~ghJDrugsController Genera1(~~ii~)lIe



MIs Atrium Medical India Pvt. Ltd. Old No. 54, New No. 11, NRD Tower, 3rd Floor, FirstAvenue Jawaharlal Nehru Road, Ashok Nagar, Chennai-83 is hereby licensed to importinto India during the period for which the licence is in force, the drugs specified below,manufactured by MIs Atrium Medical Corporation, 5, Wentworth Drive Hudson, NewHampshire 03051, USA.

~1. This Endorsement shall be in force from tL,.- < :';0;

unless it is sooner suspended or cancelled under the said rules.

2. Names of drugs to be imported:1. Family of C-Qur Mesh (Comprising ofG-Our FX.Mesh).

ITEM(S) ONE ONLY

.t""':', -"•

./'<-~ ~.,; ~ •..• -

Licgnsin ~ority~:a~~~amp

o Dr. G. N, SiN!'"rugs Controlll>r GF "H

Ole, G"q"'~1 of H -neral (1M;",. ••• Ministry ~fH' 0", 8alt'S£:rvif'l>-;

. . Cog~/tIO?S ofLlc~nc:~q.:, . FDA Bhav,a~1~'~~~F~:I:;W:!fare1. A photocopy of licence shall bedlsplaye~r->I~PJlOmlnent place In a pa'fltD0~dlrie,~~'/,/'0.

premises, and the original licence sh~~~'ffi)ced, whenever required.2. Each batch of drug imported .JP'~t~fap~all be accompanied with a detailed batch

test report and a batch rele~ certificate, duly signed and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchrepgFts~-+·he-import~El·t3at.ch··gf-ea.ch-E!rug"sha IIbesubjectedtG-exam inatiGRanE!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 theregistrationhQlder and his authorised agent.

4. The licensee shall inform the licensing authority forthwith in writing in the event ofany change inJheconstitutionof 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 whichthechangetakesplaGeuniess,in tf1e-meantime, afresh ··licence~hasbeen ·takenfrom the licensing authority in the name of the firm with the changed constitution,

· ··2334··17.01.2012




Dated: ,ilII!I'<;) ="

7t':,,~?LUU ••

To,~s. Teleflex Medical Pvt. Ltd.,

Old No.1 0, No. 19,1st Floor & Ground Floor,Harrington Road, Chetpet,Chennai-600031.



letter No. NIL dated 13.01.2012 and received by this office vide Diary No. 2334 dated17.01.2012 I enclose licence(s) No. MD-882-1506 dated? C r. .. ····'''>.c;?this I theselicence(s) has I have been granted under the Drugs arld - CosrTleticsAct 1940 andRules 1945 thereunder.

2. I am to point out that the provisions of Drugs and Co~tn,etics Act 1940 and Rules 1945are in addition to and not derogation of any other.,1,1"W\~r,the time being in force and assuch the licence(s) issued under Drugs an\;t ~osme'tfts Act and Rules will be in additionto and distiflct from any licence(s) WJ\\~~ be necessary under the Import TradeControl Regulations made of the G:0~,J{ffient 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 those licence(s) ifunder the Import Trade Control Regulations of the Commerce Ministry separatelicense(s) are required for import of such drug(s).


5. Any literature or packing accornpanying 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 ControJler (India) and Technical Officer of the Central Drugs ControlOrganisation at the ports will be Officers authorized to inspect the premises of importers

·estab·lisFHnentsfor ..ttlepurposeofHLlle26dltle.Dwgs cmg.Q.9?rn~tif~ Act and Rulesthereunder.


IDr.~ghlDrugsC()l1trolferGe~eral (India{'lIc

FORM 10(See Rl}les 23 and 27)

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

MIs. Johnson & Johnson Ltd., J-1, Shree Arihant Complex, Viii. Kalher, Thane-BhiwandiRoad, Dist. Thane, Bhiwandi is hereby licensed to import into India during the period for whichthe licence is in force, the drugs specified below, manufactured by MIs Cordis Cashel, CahirRoad, Cashel Co., Tipperary Ireland having factory premises at MIs. Cordis de Mexico, S.A.,de C.V., Calle Circuito Interior Norte # 1820, Parque Industrial Salvarcar, Ciudad Juarez,Chihuahua, Mexico 32575 and any other drugs manufactured by the said manufacturer as mayfrom time to time be endorsed on this licence.

This licence shall be in force from 2S '~-' ~~1~2unless it is sooner suspended or cancelled under the said rules.

2. Names of drugs to be imported:As per Annexure-IITEM(S) THIRTEEN ONLY

c1) r .;'~ ";';-'1"Date: __ L_',_:._.. _" _".'_.'-_ •.. '., , .•.•

Lic.~hsig AuthoritySeallStampDr. G. N. SINGH

:.~~:~g~~:f~;~~~~~;~~~~i;~!~~:a:~~1~~~o/~~with date of testing, date of release and the date of forwarding such reports. The importedbatch of each drug shall be subjected to examination and testing as the licensing authority

. deemsfifpn6flo-ltSrrfafRetilig:- -.--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 any change in theconstitution of the firm takes place, the current licence shall be deemed to be valid for amaximum period of three months from the date on which the change takes place unless, inthe meantime, a fresh licence has been taken from the licensing authority in the name of thefirm withthech angedconstitution

Form 10 License No. MD-881-1482 Da~ed....•£z-;'-;~.-. ~~···_--~.....,.Z.",..,:_Valid Up to 14.04.2014

1. Cordis Palmaz Blue 0.014 Peripheral Stent System2. Cordis Palmaz Genesis Periphe'ral Stent on OPTA PRO 0.035" Delivery

System3. Cordis Palmaz Genesis Peripheral Stent on SLALOM .018" Delivery System4. Cordis Palmaz Blue ,018" Peripheral Stent System5, Opta*Pro Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation

Catheter6. Cordis Sialom* Percutaneous Transluminal Angioplasty (PTA) Balloon

Dilatation Catheter7. P?wer!lex* P3 Percutaneous Transluminal~~gioplasty (PTA) Balloon

Dilatation Catheter ,r.,"\\('( \\8. Cordis Powerflex* Extreme Percut9-,t1~1ransluminal Angioplasty (PTA)

Balloon Dilatation catheter ~~C~·9. Maxi LD* Percutaneous Tr~l1minal Angioplasty (PTA) Balloon Dilatation

Catheter \0~'10.Cordis Aviator Plus Percutaneous Transluminal Angioplasty (PTA) Balloon

Dilatation Catheter11.SAVVY Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation

Catheter12.Cordis DURA Star RX PlCA Dilatation Catheter13.Cordis Fire Star RX PTCA Dilatation Catheter

ITEM(S) THIRTEEN ONLY

Licens~thoritYi~;aI/Stamp

Dr. G. N. SINGHDrugs Controller General (India)D~e.General of Hea!'h Services

Mint~ti)' of Health & Family WelfareFDABh~wan, Kotla R!':xJ, I.TO.

New Deihi··j 1!.):";2

137610.01.2012

Central Drugs Stand~rd Control OrganisationDirectorate General of Health Services



tp-,. ,-,:,To,

~/S Meril Life Sciences India Pvt. Ltd.512-513, "MIDAS" Sahar Plaza Complex,J.B. Nagar, Andheri (East) MumbaiTal: Andheri East (Mumbai-Zone6)-400059

~.. . (Dr; GIN -Singh)

Drugs Controller General~lndia) lie



MIs. Meril Life Sciences India Pvt. Ltd., 512-513, "MIDAS" Sahar Plaza Complex, J.B. Nagar,Andheri (East) Mumbai, Tal: Andheri East (Mumbai-Zone6)-400059 is hereby licensed to importinto India during the period for which the licence is in force, the drugs specified below,manufactured by MIs. Evolutis having manufacturing premises at Avenue de la Liberation-42720Briennon, France. Manufactured by the said manufacturer as may from time to time be endorsedon this licence.

P-b ~.,I' -, r', " ": ?

This licence shall be in force from L _..J L "'Co>

unless it is sooner suspended or cancelled under the said rules.

ff'", ,~t::-!-

2. Names of drugs to1. Freedom Total

• H73 Freedo• H29 FREED• H51 FREED• H14 Alumin• H10 Cobalt• H35 FREED

n

i~horitySeal/Stamp

Dr. G. N. SIN13HDrugs Controller General (India)

Conditions of Licen~f:~ Dte General of Health Services

1. A photocopy of licence shall be displayed in a,prCfTl,Qnt place in a part of t~~~W~t~rm~~,~~~~~ethe original licence shall be produced, w~~ required. New Delhi-110002 .

2. '~~~rtba~~~aO~a~~~~r~~~~~~ge~:~J&~ti1Y'-s:g~:a~~~~mat~~ke~i~i~a~6~~~~le~a~~~~~t6~~;with date of testing, date of release and 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;


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 ofthe-firm'takes place; the current licence shall-be deemed to be valid for amaximum period of three months from the date on which the change takes place unless, in

. the meantime, afresh licence has been taken from the licensing authority in the name of thefirm with the changed constitution

194913.01.2012




To,~. Meditech Devices,

8, Devam, Second Floor,Indranil Society, NR. Jivraj Cross Road,Vejalpur, Ahmedabad-380051



letter No. NIL dated 09.01.2012 and received by this offic~, vide-Diary No".j848 dated13.01.20121 enclose licence(s) No. MD-744-1505 dated L -" ~ . c-:J2!this /theselicence(s) has / have been granted under the Drugs and Cosmetics Act 1940 andRules 1945 thereunder.

2. I am to point out that the provisions of Drugs and CosfTl~tics Act 1940 and Rules 1945are in addition to and not derogation of any ott1erIw'A(:J6rthe time being in force and assuch the Iicence(s) issued under Drugs and ~sm"'~~s Act and Rules will be in additionto and distinct from any Iicence(s) wNph-J~r be necessary under the Import TradeControl Regulations made of the G9~W'Di~nt of India, Ministry of Commerce.

3. The import licence(s) mentioned ·trf para (1) above will not accordingly to itself /themselves be sufficient authority for import of Drugs covered by that / those licence(s) ifunder the Import Trade Control Regulations of the Commerce Ministry separatelicense(s) are required for import of such drug(s).



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 importers

-estat3lisl:ll'l1entsfor -tl:le purpose of-Rule 26 of the Drugs and Cosmetics Act and Rulesthereunder.


~__ .....(Dr. NSingh)

Drugs Controller Genera· (India) lie


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

MIs. Meditech Device's, 8, Devam, Second Floor, Indranil Society, NR. Jivraj Cross Road,Vejalpur, Ahmedabad-380051 is hereby licensed to import into India during the period for whichthe licence is in force, the drugs specified below, manufactured by MIs. Medcomp Inc., havingfactory premises at 1499, Delp Drive Harleysville, Pa19438, USA and any other devicemanufactured by the said manufacturer as may from time to time be endorsed on this licence.

1. This licence shall be in force from 2: r C"t1unless it is sooner suspended or cancelled under the said rules~'

2. Names of drugs to be imported:As per Annexure-IITEM(S) TWO ONLY

Licensin AuthorityeallStamp

r. G. N. SINGH

C d't' fL" .. ' Drugs Controller General (India)..on I 10~SQ •... Ic~ncE1f)~:{" . .' Ole. General. of Healt!1~ervices

1. A pho~o.cop~of licence shall bedlsp'layed In a P,~,O~I~t\place mapart 0tt~~e~f~~\~~i~~ethe onglnallicence shall be produced, Wh~e~ellred. "... > .. - N0V,1 ,;pihi~1i[,C!r;2' ..

2. ~apCohrtb:~~haO~a~~hgr~:Pa~~ege~:~al~t~~~g~~l~~8m~~g~~i~i~d ab~~~~le~a~~~~~t~~:~with date of testing, date of release and 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 amaximum period of three months from the date on which the change takes place unless, inthe meantime, a fresh licence has been taken from the licensing authority in the name of thefirm with the changed constitution

., (',

Date: __ 1-_. _-_. _

Product Article No.

1. Hemodialysis XTP94CTI XTP94MTI XTP96CTI XTP96MTI XTP114CTICatherter & XTP116CTI XTP118CTI XTP119CTI XTP114MTIAccessories XTP116MTI XTP119MTI XTP1141JC-21 XTP1161JC-21

XTP1181JC-21 XTP1141JS-21 XTP1161JS-21 XTP1181JS-21XTP941JCI XTP961JCI XTP981JCI XTP941JSI XTP961JSIXTP981JSI XTP1141JCI XTP1161JCI XTP1181JCIXTP1141JSI XTP1161JSI XTP1181JSI T74MI T94CI T96CIT98C/T94M/T96M/T98M/T114C/T116C/T118C/T119CIT114MI T116MI T118MI T119MI T1141JC-21 T1161JC-21T1181JC-21 T114IJS-21 T1161JS-21 T1181JS-21 SL 12PI

I

SL 15CI SL20CI SL24CI S~~L?OI SL241 XTP3114CTI, XTP3116CTI XTP3118C"f~ 114MTI XTP3116MTI

XTP3118MT/I\Il~$'McF101 MCF551 SL281 SL321SL24PI ASIRS,SS:i3TLEIASPC-36-3WOEI ASPC-28-3WOE

2. Peritoneal MDC31S1 MDC32S1 MDC37S1 MDC42S1 MDC47S1Dialysis MPD2421 MDC57CI MDC63CI MPD2571 MPD2631Catheter & MSC31S/MSC37S1 MSC42S1 MSC46S1 MPD-146SIAccessories MPP41S1 MPP46S1 MPD1411 MPD1461 MPP40CI MPP57CI

MPP60CI MPD1601MC200301/M C200302/M C20040 11MC2004021MC2001 01/MC2001 021 MC200201/MC200202/MTCI

Lices~~~:Drugs Controller General (India)Dte. General of Heal:~ Services

Ministry of Health &. Famiiy Vv'cifC)reFDA8hawan, l<ot!2 Ro"d, I.T.O.

New Deirl;-"H)C~2



Food and Drug Administration Bhawan,Kotla Road, New Delhi-11 0002

Dated 2 : ~~:!~:lTo

/1'JI/s Smith & Nephew Healthcare Pvt. Ltd.,(C&F Elian Trading Co)Bldg No 2-3 & 15-17,Rajlaxmi Complex, Opp. Hanuman Bus Stop,Kalher, Thane Bhiwandi Road, Dist- Thane 421302Maharashtra

SUB:- Amendment in Registration Certificate No. MD-431 dated 25.11.2011valid from 01.01.2012 up to 31.12.2014 -reg.

",p'.;.Please refer to your letter No. SN1/5:312o'D(~ted 28.11.2011 and received by this

office vide diary no. 55243 dated 30:J);~~~~nd reply received vide diary no. 777 (FTS1811) dated 06.01.2012 on the sUbi~matter.

\~~

This is with reference to the Registration Certificate No. MD-431 dated 25.11.2011valid from 01.01.2012 up to 31.12.2014 issued by this office. The name of the Product ishereby amended as follows:-

In place of:"Enobutton" .

Read as:"Endobutton".

Yours faithfully,

. (Dr~SinghlDrugs Controller General (India) lie

51304.01.2012




Dated: 2 c' '-

ToA/s. Depuy Medical P. Ltd.

Plot No.4, Survery No. 277/4, Demni Road,Viliage-Dadra-Dadra & Nagar Haveli, (U.T).

Subject: Issue of an Endorsement No.1 to Form 10 License No. MD-128-127 dated09.06.2010 valid up to 14.04.2013-regarding.

Please refer to your application No. DePuy/RA/2012/Jan/lL-01dated04.01.2012and receivedby this office vide DiaryNO.513(FTS No.114~)dated 04.01.2012regardingthe above cited subject. .~ (('\~?

. .f ~:~d

Endorsement NO.1 to Form.~~~e 'No. MD-128-127 dated 09.06.2010valid up to 14.04.2013 for the(~ckt of drugs manufactured by MIs DePuyOrthopaedics, Inc., PO Box 988, 700 Orthopaedics Drive Warsaw, Indiana46581-0988, USA having manufacturing premises at MIs DePuy Orthopedics,Inc., 325 Paramount Drives, Raynham, MA 02767, USA is enclosed hereby.

Yours faithfully

(Dr.-~ngh)Drugs Controller General (India) lie



Mis. Depuy Medical P. Ltd., Plot No.4, Survery No. 277/4, Demni Road, Village-Dadra-Dadra & Nagar Haveli, (U.T). is hereby licensed to import into India during the period forwhich the licence is in force, the drugs specified below, manufactured by M/s DePuyOrthopaedics, Inc., PO Box 988, 700 Orthopaedics Drive Warsaw, Indiana 46581-0988,USA having manufacturing premises at M/s DePuy Orthopedics, Inc., 325 ParamountDrives, Raynham, MA 02767, USA.

1. This Endorsement shall be in force from -" ,>:1 ;,2 to 14.04.2013unless it is sooner suspended or cancelled under the said rules.

2. Names of drugs to be imported:1. Sigma High Performance (HP) Partial Knee System

ITEM(S) ONE ONLY

Lice.$;-:AuthoritySeal/Stamp

Dr. G. N. SINGH

C . . f .. '>-,', Drugs Contreller Generai (india)ond/tlons 0 .LiFf¢lJC~' D~e. General of Health Services

1. A photocopy of licence shall be dis..play~J4h~ a prominent PlaceM~~U·~PUK~1'~ffl¥!r.w~lhre\1"\... <'" ~.ll ,b'tl" "Odd I I U

premises, and the originallicens~ ~~~Iwe produced, whenever requirec:NewDelhi.1w,,,?· ...

2. Each batch of drug importeo\j:~(i:'I~aia shall be accompanied with a detailed batchtest report and a batch relMse 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 and,testing as the licensing authorfty deems fit prior to its marketing.

3. ThelicenseeshaJlbe responsible fnrthe busil"less activities-of the manufacturer inIndia along- with the registration holder and hisauthorised 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.

179713.01.2012




~/s. Smith & Nephew Healthcare Pvt. Ltd.(C & F Elian Trading Co.), Bldg No.2-3 & 15-17,Rajlaxmi Complex, Opp. Hanuman Bus Stop, Kalher,Thane Bhiwandi Road, Dist-Thane 421302, Maharashtra



letter No. SNII59/2012 dated 11.01.2012 and received by this office vide Diary NO.1797"'](GTSN9.33?~~ da~ed 13.01.~012 I enclose Iicence(s) No. MD-1012-1493 datedb""" ..' '" '. .. ".i il this / these Iicence(s) has I have been granted under the Drugs and

Cosmetics Act 1940 and Rules 1945 thereunder. "2. I.am to point out that the provisions of Drugs",~c.\Cosmetics Act 1940 and Rules1945

are in addition to and not derogation of any/'{)fu'e'r law for the time being in force and assuch the licence(s) issued under Dru~'~<f'tosmetics Act and Rules will be in additionto and distinct !rom any licen~~(s~~cl1 may be. nec~~sary under the Import TradeControl Regulations made of t~)~avernment of India, MInistry of Commerce.

3. The import Iicence(s) mentio~d in para (1) above will not accordingly to itself /themselves be sufficient authority for import of Drugs covered by that / those Iicence(s) ifunder the Import Trade Control Regulations of the Commerce Ministry separateIicense(s) are required for import of such drug(s).

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


6. Tbe,L\??L§tclOtQW9s.CQntroUer(lndia)andTechnical Offioer oHheC-entral Drugs ControiOrganisation 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(Ok)

Drugs Controller General (India) Uc <


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

MIs. Smith & Nephew Healthcare Pvt. Ltd., (C & F Elian Trading Co.), 81dg No.2-3 & 15-17,Rajlaxmi Complex, Opp. Hanuman Bus Stop, Kalher, Thane Bhiwandi Road, Dist-Thane421302, Maharashtra is hereby licensed to import into India during the period for which the licenceis in force, the drugs specified below, manufactured by MIs Smith & Nephew, Inc., 1450 EBrooks Road, Memphis, Tennesse 38116 USA having manufacturing premises at MIs Q-MedAS, Seminariegatan 21, SE-752 28, Uppsala, Sweden and any other drugs manufactured by thesaid manufacturer as may from time to time be endorsed on this licence.

r-.This licence shall be in force from ~.~. runless it is sooner suspended or cancelled under the said rules:"'

2. Names of drugs to be imported:1. Durolane - (Hyaluronic Acid, Stabilized Single Injection 20mg/ml)

ITEM(S) ONE ONLY

~, Licensi ~ I~uth~rity~{H vi~~~mp

conditi9-n~gibence . Dr. G.N. SINGH

1. A pho~ocopy of licence shall be displ?y~:~ a promin~nt place in a part of tg~~~~~~Ir~le~~a~the onglnal licence shall be pro9..u~<t \~enever required. MinistryofHealth& FamilyWelfare

2. Each batch of drug imported ~ "India shall be accompanied with a dEffl{N~\~~a~, !.T.O.report and a batch release certificate, duly signed and authenticated by the m~rhu'f~t1liF~~with date of testing, date of release and 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_Indiaalo r:lg w~tl'1-the-fegistraHon-001derand-hts-C3 c.'thoris-euagenl.

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 amaximum period of three months from the date on which the change takes place unless, inthe meantime, a fresh licence bas been taken fromthe licensing authority in the name of thefirm with the changed constitution

~ r"': ..••...., ._ ..

t:'

151711.01.2012

Central Drugs Standard Control OrganisationDirectorate General' of Health Services



?\' ,.~ i.'-".

L _":

To,A Smiths Medical India Pvt. Ltd.Unit No. 501, 5th Floor, Western EDGE-1Western Express Highway, Borivali EastMumbai-400066



letter No. NIL dated 10.01.2011 and received by this office vide Diary No. 1517 dated11.01.2012 I enclose licence(s) No. MD-830-1501 dated ';;'" ; :·'jthis I theselicence(s) has I have been granted under the Drugs arm Cosmetics AG'r 1940 andRules 1945 thereunder.

2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules 1945are in addition to and not derogation of any othef,la;yv for the time being in force and assuch the Iicence(s) issued under Drugs anqFC~tfietics Act and Rules will be in additionto and distinct from any licence(s) vy,J;1te \m~y be necessary under the Import TradeControl Regulations made of the 9~~ent of India, Ministry of Commerce.

3. The import licence(s) mention~(f \tn para (1) above will not accordingly to itself Ithemselves be sufficient authoritP for import of Drugs covered by that I those licence(s) ifunder the Import Trade Control Regulations of the Commerce Ministry separateIicense(s) are required for import of such drug(s).

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


6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs ControlOrganisation a't the ports will be Officers authorized to inspect the premises of importersestablishments for the pl.!q?Q~e_QLRul~_~6.QLthe~Drugs--andCosmetiGs-AGt ami-Rules.·-tnefeunaer~-----.- .... -

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

~(Dr.G NSingh)

Drugs Controller General India) lIe


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

MIs Smiths Medical India Pvt. Ltd. Unit No. 501, 5th Floor, Western EDGE-1, WesternExpress Highway, Borivali East, Mumbai-400066 is hereby licensed to import into India duringthe period for which the licence is in force, the drugs specified below, manufactured by MIs.Smiths Medical ASD Inc., 10, Bowman Drive, Keene, NH 03431 0724, USA having amanufacturing at MIs. Smiths Medical International Ltd. St. Crispin Way, Haslingden,Rossendale, Lancashire, BB4 4PW, UK. manufactured by the said manufacturer as may fromtime to time be endorsed on this licence.

t_":'

1. This licence shall be in force from L ._.;!unless it is sooner suspended or cancelled under the said rules.

2. Names of drugs to be imported:As per Annexure-IiTEM(S) ONE ONLY

Licen~uthorily,~_~ Seal/Stamp<-,*<J."...... Dr. G. N. SINGH. . ,~~?~~:.-,<. Drugs Controller General (India)

1. A photocopy of licence shall be)dT$~~:;:;t~~~t place in..a poft Of~i;;H~~:~~~~~iv;o:rethe original licence shall be produc~~tre~;ver required. . FDA'B~~:;tie~~i~I~1~g~2'.I. .

2. Each batch of drug imported into'Mdia shall be accompanied with a detailed batch testreport 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. The importedbatch oreach drug shall be subjected to examination and testing as the licensing authoritydeems fit prior tQit§marketlng~

3: -Th-eTicensee 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 amaximum period of three months from the date on which the change takes place unless, inthe meantime, a fresh licence has been taken from the licensing authority in the name of thefirm with the changed.constitution

Annexure-I

Form 10 Licenses No. MD-830-1501 Dated 2 S [,:=,:,) ,=--J~Z Valid Up to 14.04.2014

100/382/116 Portex ®Epidural Catheter100/382/118 Portex ®Epidural Catheter100/391/019 Portex ®Epidural Minipack System 1100/391/116 Portex ®Epidural Minipack System 1100/391/118 Portex ®Epidural Minipack System 1100/391/518 Portex ® Epidural Minipack System 1100/392/116 Portex ® Epidural Minipack System 2100/392/118 Portex ® Epidural Minipack System 2100/393/116 Portex ®Epidural Minipack System 3 .100/393/118 Portex ® Epidural Minipack System 3100/394/116 Portex ® Epidural Minipack System 4100/394/118 Portex ®Epidural Minipack System 4100/491/115 RapiD Portex®Spinal I Epidural MiniPack, Lancet Point Needie.100/491/318 CSEcure Portex ®Combined Spinal 1 Epidural MiniPack with LockLancet Tip Spinal Needle. .'".,{;)'~,100/491/618 RapiD Portex® Spinal 1 Epid~[JlfiniPack, Pencil Point Needle

.• <~ ,\ 11-

100/491/716 CSEure Portex ®C~t'\~~ Spinal 1 Epidural MiniPack with LockPencil Point Spinal Needle.{_~,:~\\f"~~·100/491/718 CSEcure Porte~) Combined Spinal 1 Epidural MiniPack with Loc'kPencil Point Spinal Needle.100/491/816 RapiD Portex® Spinal 1 Epidural MiniPack, Pencil Point Needle.100/491/818 RapiD Portex® Spinal 1 Epidural MiniPack, Pencil Point Needle.100/491/916 CSE cure Portex ®Combined Spinal 1 Epidural MiniPack with LockPencil Point Spinal Needle.

$"c,

Date: L. ,.

Licens;G~uthoritys~~;~mp

Dr. G. N. SINGHDrugs Controller General (India)_ ~t:.Ge~le;aLof HealthSentices

fI!':~ru;:,l?:.O' health & Family WelfarerDA!::>~~wan, f~otl2 Road, LTO.

!'l7';'v"! De!h~-I-: 0002

264018.01.2012


Ministry QfHealth& Family Welfare(Medical Device and Diagnostic Division)


To~/s 3M India Limited,

No-60/16, Huskor road,Electronic City, Bangalore-560100

SUbject: Issue of an Endorsement No.3 to Form 10 License No. MD-874-1472 dated10.01.2012 valid up to 15.11.2014 regarding.

Please refer to your application No. 31-874-MD/201o-DCdated 17.01.2012andreceived by this office vide Diary NO.2460(FTS 4~~~ated 18.01.2012regarding theabove cited subject. c' i\ ((~ \'dJ

._;'f: '.\~ .,'--...:::!J,. \,.;P', \\

Endorsement NO.3to Form (~'ti~ense No. MD-874-1472 dated 10.01.2011valid up to 15.11.2014 for the import of drugs manufactured by MIs. 3M HealthCare, St. Paul Minnesota 55144-1000, USA having manufacturing premises atMIs 3M HealthCare, 3M Brookings, 601, 22nd Ave, South Brookings, SouthDakota 57006, USA is enclosed hereby.

Yours faithfully

(Dr.~ingh)....l:>rlJ9~J:~.QIJj;(QllerGenera~\~~ia)lIC



MIs 3M India Limited, No-60/16, Huskor road, Electronic City, Bangalore-560100 ishereby licensed to import into India during the period for which the licence is in force, thedrugs specified below, manufactured by Mis. 3M Health Care, St. Paul Minnesota 55144-1000, USA having manufacturing premises at Mis 3M Health Care, 3M Brookings, 601,22nd Ave, South Brookings, South Dakota 57006, USA.

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

. -' ~". , .,.. <.-:.n {.,

2. Names of drugs to be imported:1. 3M ™ Tegaderm™ Diamond Film Diamond Pattern Film Dressing

iITEM(S) ONE ONLY

Lic~nsintritYSeal/StampDr. G. N. SINGH

Drugs Controller General (India)Dte. General of Health Serl/ices

Ministry of Health & Family WelfareFQABhawan, Kalla f1l'ad, 1.1.0.

1. A photocopy of licence shall place In 3l~m;,ooet/iilepremises, and the original licence required.

2. Each batch of drug imported be accompanied with a detailed batchtest report and a batch duly signed and authenti.cated by themanufacturer with date of testing, date of release and the date of forwarding suchreports...The. imported ..I:>§!~b_oJ_~~ch.Qlli9-..~h.aJLbesubjecte.dto.exarninatjOr:l·and .

. . -tes1ing-as·the'llcenslng authority deems 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 unles~" in. tbemE3.Qo1ime,.afre.shJicence.has,been takenfrom file licensTrlgal..lthoritYinthe name ofthe firm with the changed constitution.

Documents

Central Drugs Standard Control Organisationcdsco.nic.in/medical_div/form_10_md/form 10 final md 29...Central Drugs Standard Control Organisation Directorate General of Health Services