t./ Bldg. No. B, Gala No.1-10, Prerna Complex, Anjur Phata, Dapoda Road, At Val Village, Bhiwandi , Maharashtra

Transcription

1 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi File No MD/2010-DC Dated: L 7 DEe 20n To, ~/s B. Braun Medical (India) Private Limited t./ Bldg. No. B, Gala No.1-10, Prerna Complex, Anjur Phata, Dapoda Road, At Val Village, Bhiwandi , Maharashtra Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder - regarding. Sir, 1. With reference t~our applicatiq~ for imp-oitjicel"lce-wlwaf-geg-t-e-t-ais---efficenwith-youf' letter No. Nil dated and received by this office vide Diary No (FTS No ) dated I enclose licence(s) No. MD dated >- 7 ;\f~ :'~?!'j~1this / these licence(s) has / have been granted under the Drugs and CosmettCS A"er1 40 and Rules 1945 thereunder. 2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules1945 are in addition to and not derogation of any other law for the time being in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and Rules will be in addition to and distinct from any Iicence(s) which may be necessary under the Import Trade Control Regulations made of the Government of India, Ministry of Commerce. 3. The import Iicence(s) mentioned in para (1) above will not accordingly to itself / themselves be sufficient authority for import o~e;)rugs covered by that / those Iicence(s) if under the Import Trade Control Reg~~'lis of the Commerce Ministry separate license(s) are required for import of s~h Qlug(s). 4. I am therefore, to advise you to 9~r~~here necessary licence(s) for import of drugs in question under the Import T),:a(e\Cbntrol Regulations. 5. Any literature or packing aceompanying the drugs or any matter stated on the label should not contravene the provisions of the Drugs and Magic Remedies (Objectionable Advertisement) Act. 6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs Control Organisation at the ports will be Officers authorized to inspect the premises of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics Act and Rules thereunder. 7..gll:l~~E.'l.:C)c:kI1OV\lI~clge. re~e.iplotth isjetteranditsenclosures; ~~.~ (Dr. V. G. Somani) Drugs Controller General (India)

2 FORM 10 (See Rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 MIs B. Braun Medical (India) Private Limited, Bldg. No. B, Gala No.1-10, Prerna Complex, Anjur Phata, Dapoda Road, At Val Village, Bhiwandi , Maharashtra is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by I\IIls B. Braun Avitum AG, Schwarzenberger Weg 73-79, Melsungen, Germany having manufacturing premises at MIs B. Braun Avitum Italy S.p.A, via XXV Luglio 11, Mirandola (MO), Italy and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence. r-'.." f":;; (' l 011 L_ I v...v This licence shall be in force from ~_~~ ~~~-.l.inless-it-is-seefler---stlspende&orcancellec:flifiaenne -sa lorules. 2. Names of drugs to be imported: 1. Bloodlines (Lines for Plasma Treatment Bloodline Systems for'haemodialysis) ITEM(s) ONE ONLY ~ 7 f\,- (\? E1'l1 Date: _'~_"'_'_L_,i_:'_\_'J_L':,J I ", t f '('~. r~i"~, Licensing Authority...t:~~ ii, Seal/Stamp conditio~ml.;,lf~~ce"ii;. Dr. V. G. SOMANi, 1. A photocopy of licence shall 'be::displaye,ifj9"pmminentplace in a part~[t1le~~~~~~~t=~:! the original licence shall be pr6d4c:e~~freneverr"equir"ed:.'. Mi~!~~Y8~~~:;~i~o~ar~:~, ~~g~re 2. Each batch of drug imported intec~ia shall be accompanied with a detahedclilatc:h' <&st report and a batch release certificate, duly signed and au.th~nticated by the manufacturer with date of testing, date of release and'the date of forwarding such reports. The imported batch of each drug shall be subjected to e x?minajigniandtestingas_ the licensing authority ~deems-fifp-mjtt6 itsmarkefing...~ _.- 3. The licensee shall be respon.it:>~toltbabu.slness activities-o!~tl'le-manufagturer-ja--lndjaalong with the registration holder and his authorised agent. 4. The licensee shall inform the licensing authority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution

3 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) MIs B. L. Life Sciences Pvt. Ltd. 0-31, Site IV, Kasana, Surajpur Greater Noida (U.P.) Food and Drug Administration Bhawan Kotla Road, New Delhi Dated: f 7 DEe 2011 Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder - regarding. Sir, 1. With reference to your application for import licence forwarded to this office with your letter No. Nil dated and received by this office vide Diary NO (FTS No.!fZ7~(D._~aWR" I ebcj(lse_licence(-s)-----no.--m.g..82-2~1442 ~_dated ;;ut""',;i,,-t--f'--i=q-+ ; ~\.-,-:----+;yz1't'lu il this / these Iicence(s) has / 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 and Cosmetics Act 1940 and Rules1945 are in addition to and not derogation of any other law for the time being in force and as such the Iicence(s) issued under Drugs and Cosmetics Act and Rules will be in addition to and distinct from any Iicence(s) which may be necessary under the Import Trade Control 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 I themselves be sufficient authority for import of Drugs covered by that I those licence(s) if under the Import Trade Control Regulations of the Commerce Ministry separate Iicense(s) are required for import of such drug(s)..,.~i"~ 4. I am therefore, to advise you to obtain, where ne~~ Iicence(s) for import of drugs in question under the Import Trade Control Re~~iol'tS. 5. Any literature or packing accompanyin..~~ugs or any matter stated on the label should not contravene the provisions1'ofj/"r'e Drugs and Magic Remedies (Objectionable Advertisement) Act. " 6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs Control Organisation at the ports will be Officers authorized to inspect the premises of importers establishments for the purpose of Rule 26 of the Drugs and Cosmetics Act and Rules thereunder. 7. Please acknowledge receipt of this letter and its enclosur~s ~._ _.-- -~~.~. (Dr. V. G. Somani) Drugs Controller General (India)

4 FORM 10 (See Rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 Mis B. L. Life Sciences Pvt. ltd., 0-31, Site IV, Kasana, SurajpurGreater Noida (U.P.) is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs Foshan Nanhai Baihe Medical Technology Co., Ltd., having a factory premises at Technology Garden, Taoyuan West Road, Shishan Nanhai Foshan Guangdong Procvince P. R. China P.C and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence. 1. This licence shall be in force from P' 7 nfe 2D11-- unless it is sooner suspended or cancelled under the said rules. Names of drugs to be imported: 1. Central Venou_s_C~tbe-ter4Non-Ster~le} ~--(AII Sizes: Single Lumen, Double Lumen, Triple Lumen, Quadruple Lumen) 2. Hemodialysis Cathetef (Non Sterile) (All Sizes: Single Lumen, Double Triple Lumen)!TEM(S) TWO Date: r 7 DEe \j.~v- Licensing Authority ~'.:~;i Seal/Stamp c~9onditions6irli~~ce. D D!~~;o~~fSG~~~7~ilndia) 1. A photocopy of licence shall be disrlayedi'1"ef:~r~inent place in apart O~i~"\~~~~~;~~~re the original licence shall be produced; "vj;1enever required.. FDA Bhawan"Kotia Road,I.T.O. 2. Each batch of drug imported into J!1(te.:Shallbe accompanied with a detaile'lawea~61p ~~~ report and a batch release certificate\,duly signed and authenticated by the manufacturer with date of testing, date of release and the date of forwarding such reports. The imported batch of each drug shall be subjected to examination and testing as the licensing authority deems fit prior to its marketing..." ".'.. 3.3he:licensee-shalleeresponsible for ihebusiness -attivitiesof' fhe manufacturer in India along with the registration holder and his authorised agent _ ~-+Ae--lieensee---shal,--inform--tl'e"censTng-aUthority forthwith in writing in the event of any change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution

5 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) To.Mis. India Medtronic Pvt. Ltd. V p-i~t No.609, Survey/Shed-188 (Part), Chamunda Compo Kasheli Village, Dist. Thane, Bhiwandi , Maharashtra Food and Drug Administration Bhawan Kotla Road. New Delhi Date: r 7 D=.c. ZOl1 L Subject: Issue of an Endorsement No.2 to Form 10 License No. MD dated valid up to regarding. Please refer to your application No. VD/Sh/CV-End.02MD63-ILl0711 Dated received by this office vide dairy No (FTS-51509) dated and reply received vide diary no (FTS-69813) dated regarding the above cited SUbject. Endorsement NO.2 to Form 10 License No. MD dated valid up to for the import of drugs manuf~tqred by Mis Medtronic Inc, 710, Medtronic Park Way, NE Minneapolis, Mf\!;5{~~, USA having factory premises at Mis Medtronic Vascular, 37A, Cherry, tf~ O"rive, Danvers, MA 09123, USA is enclosed hereby. _"...,::,,-<;.V ~ The other conditions of the license will remain same. /,' >,,Jo - -\J- Lei,v-..,. _.~ Br_.-V-;-G; Somani)- Drugs Controller General (India)

6 FORM 10 (Endorsement (See Rules 23 and 27) No.2) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 MIs. India Medtronic Pvt. Ltd., Plot No.G09, Survey/Shed-188 (Part), Chamunda Compo Kasheli Village, Dist. Thane, Bhiwandi , Maharashtra is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs Medtronic Inc, 710, Medtronic Park Way, NE Minneapolis, MN , USA having factory premises at MIs Medtronic Vascular, 37A, Cherry Hill Drive, Danvers, MA 09123, USA is enclosed hereby. ~ -; r"\:- ~.-:,?r;~1 ~"'.i U'-J L ij I This Endorsement NO.2 shall be in force from =-... to unl~ss it is sooner suspended or cancelled under the said rules. 3. Names of dl'ugs-1oj>ejmported~~ ~--~----'------' ' Export AP Catheter ITEM ONE ONLY r 7 DEe 2Dll.,,; '~'/-' ~...::..", '"<>\ <;',. ". Licensing Authority r>~,;'-.~ Seal/Stamp " i ' - ~.. f" -"lv Dr. V. G. SOMANI ~ t-~f<;,,-- ~~ { """, --~C~riiJ/tlon~-_cjf,) nc(3i. g[~~~~~;i~?i~~r H~~~t~r~~~~:~ 1. A ph~tocopy of lice~c~: sh~1i be di~(' :~~IQ.";a'pF?minent Pla~e~~~~;;~~~!,:~~:~~~~re premises, and the o.ngrrl~1"c~nc~ ~_fp7zg[8(juce(j:; when.ever~equlr~tr.~elhl Each batch of drug Import7d 1!J.~~ia- ~~lib~-~ccompanredwlth a detailed batch test report and a batch re!~se'>certificate~ duly signed and. authenticated by the manufacturer with date of te~ng,. date of release and the date of forwarding such reports. The imported batch of each drug:sl]ahbe subjected to examination and testing as the licensing authority deemsfrt priorto 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 iicensee shall inform the licensing authority f"rthwith in writing intheeventgf any--cbange:irl-the-coflst+h./tionohheiirm-op-erc:rtln-g-uflae-t-tne-itce-nce. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution

7 Central Drugs Standard Control Organisation Directorate General of Health Services File No MD/2009-DC To, ~/s Termo Pen pol Ltd. Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Devi Prabha, T.C.9/1330 (15) Kattachal Bhagavathy Lane, Sasthamangalam, Thiruvanthapuram Bhawan Kotla Road, New Delhi Dated: r- 7 DEC ZDll Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder - regarding. Sir, 1. With reference to your application for import licence forwarded to this office with your letter No. Nil dated and received by this office vide Diary NO (FTS l'<no ) da1~<l-02j~20jj_ I edclosa-jlcence{s}----j'-jo.--mo--829~441- dated ~ii;;. J lj rl L J ii this I these licence(s) has I have been granted under the Drugs and Cosmetics Act 1940 and Rules1945 thereunder. 2. I am to point out that the provisions of Drugs and Cosmetics Act 1940 and Rules 1945 are in addition to and not derogation of any other law for the time being in force and as such the licence(s) issued under Drugs and Cosmetics Act and Rules will be in addition to and distinct from any licence(s) which may be necessary under the Import Trade Control 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 I themselves be sufficient authority for import of Drugs covered by that I those licence(s) if under the Import Trade Control Regulations of the Commerce Ministry separate license(s) are required for import of such drug(s). 4. I am therefore, to advise you to obtain, where necessary,licence(s) for import of drugs in question under the Import Trade Control Regulations. (,', 5. Any literature or packing accompanyingjl:1e"''cfrug's-o'-( any matter stated on the label should not contravene the provisions o(tt:!'e. Drugs and Magic Remedies (Objectionable Advertisement) Act. 6. The Assistant Drugs Controller (India) and Technical Officer of the Central Drugs Control Organisation at the ports will be Officers authorized to inspect the premises of importers estabiishments for the purpose of Rule 26 of the Drugs and Cosmetics Act and Rules thereunder. 7. Please acknowledge receipt of this letter and jts enclosures. ~.~~--~ -~ (Dr. V. G. Somani) Drugs Controller General (India)

8 FORM 10 (See Rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 [ 7 [; E(: 2011 MIs Termo Pen pol Ltd., Devi Prabha, T.C.9/1330 (15) Kattachal Bhagavathy Lane, Sasthamangalam, Thiruvanthapuram is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs Terumo Corporation, 44-1, 2-Chome, Hatagaya, Shibuya-ku, Tokyo , Japan having manufacturing premises at MIs Terumo Corporation, Kofu Factory , Tsuiji Arai, Showacho, Nakakoma-Gun, Yamanashi Perfecture, , Japan and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence. 2. This licence shall be in force from 7 DEe 2011 to unless it is sooner suspended or cancelled under the said rules. 3. Names 9f drugs to be_jmll-orted:.., ~ ~_~ ~_~ ~ ~ _ 1. Terufusion Blood Administration Set ITEM ONE ONLY Place: New Delhi I!i'F.., Date: ff:' IDe,...?n~l.- :J i ~.~.~ [7",+ Licensing Authority.. ""~;".~' ~ Se,allStamp. Conditions of. (;ence!.. Oi. V. G. SOMANI "''',''."'\"<(1'''', ::;,';::' -,.':':,' " Drugs Controller General (India) 1. ~~~~:~i~~ri~:~~:~~~i~~:lip~~d~~~~y~ls~jb~~~~i~ce in a part Of~~!Y~~!2~:~:;:~ 2. Each batch of drug importedin!9 I~~ ~h-all';;:b raccompanied with a detailed''bat'dh- t~2 report and a batch release certificclt~,.jduly signed and authenticated by the manufacturer with date of testing, date of release and the date of forwarding such reports. The imported batch of each drug shall be subjected to examination and testing as the licensing 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.-+f1e:-liceRsee~sflaIFii"lf0rm-tne-licensing-auth6rity forthwith --in--writing- iniheevent- of-any ~ change in the constitution of the firm operating under the licence. Where any change in the constitution of the firm takes place, the current licence shall be deemed to be valid for a maximum period of three months from the date on which the change takes place unless, in the meantime, a fresh licence has been taken from the licensing authority in the name of the firm with the changed constitution