I io j,. ~. T/:Mis. Becton Dickinson India Pvt Ltd,

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 Dated' :: 8 f.j. "n~."'"l ~..,., 1'.l011 j I io j,. ~. T/:Mis. Becton Dickinson India Pvt Ltd, " No-34, Assisi N~gar, West Thottam, Modhavaram, Chennai-51 Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1. With reference to your application for import Iillence forwarded to this office with your letter No. BDIURA-IU1 02/11 date~t3rl011 received by this office vide dj~ no dated 09/03/ en licence(s) NO. MD dated B". f-l,1--';-' 20n this 1 these Iicence(s) ave been granted under the Drugs and Gosmetics Act 1940 and Rules 19 reunder. 2. I am to point out that the... ions-of"orugs andgoslffetics -A-ct-1@40- anc}-- Rules1945 are in addition to 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 1 themselves be sufficient authority for import of Drugs covered by that 1 those Iicence(s) if under the Import Trade Control Regulations of the Commerce Ministry separate Iicense(s) are required for import of such drug(s). 4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import of drugs in question under the Import Trade Control Regulations. 5. Any literature or packing accompanying 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. Pleaseacknowleldgeneceiptof this letter and its enclosures. 4~1I: (Dr. S. EsWara Reddy) Asstt. Drugs Controller (I) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

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 Becton Dickinson India Pvt Ltd,No-34, Assisi Nagar, West Thottam, Modhavaram, Chennai-51 is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs Becton Dickinson and Company, BD Medical Diabetes Care, 1 Becton Drive, Franklin Lakes, New Jersey having factory premises at Mis BD Medical Diabetes Care, 1329 West Highway #6, Holdrege, Nebraska, 68949, USA and any other drugs manufactured by the said manufacturer as may from.time to time be endorsed on this licence. ~ 2. Thislicenceshallbe in forcefrom v,( 8 1-\([ unless it is sooner suspended otkcelled.. <;,,\J~ 3. Names of drugs to be i~lled:oj.\rd 1. Alcohol Swab. S'\~~ ITEM(S) ONE ONLY 0'-;, i5. c -_.Q c~._,~_~_. _ under the said rules. c~ G' "'.#f'? -_.-.~- - '% 'If' Date: ::- 8 0, 1m l11... j ii l a IJ ~ ō Dsc6dJi4 ~ Licensing Authority ~... Dr.~ESW!~j~P~Y.~h. ;.n.{) ~...> 0 o. ~stt. Drug:::.... (!.na;a) 1 A photocopyof Iicences~~d~i~PI:;~1n~"~rorrtihe~ <p)~ced~tl~~~~~;;ft!~" premises, and the original Iicenct S~lIbe. produced, wh~~t~r required. 2. Each batch of drug imported.into Jrid~hfiPlbr;r~cort\~'riled with a detailed batch test report and a batch release certificate, -daly-' ~tgned 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 ajongwiththe- registration -holder and his authorisedagent. 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) Food and Drug Administration Bhawan Kotla Road, New Delhi Dated:~ B,APR 2,on To /"..,/ MIs Multi Medics, Plot No.28, HPSIDC, Phase-III, Baddi, District- Solan (H.P) Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1.,With reference to your application for im~p:4:ence forwarded to this office with your letter No. NIL dated 21/ rec rd'by this offic~~ dj~nq.,~qq90 dated 03/03/ enclose licence(s) N<tI D datea (') l\r (, C,'flis 1 these Jicence(s) has 1 have been 9~d under the Drugs and Cosmetics Act 1940 and Rules1945 thereunder. G'X~ I am to point out that the(w~)visions of Drugs and Cosmetics Act 1940 and Rules1945 are in addition to 'A"'ndnot 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 licence(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 1 themselves be sufficient authority for import of Drugs covered by that 1 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). 4. I am therefore. to advise you to obtain, where necessary Iicence(s) for import of drugs in question under the Import Trade Control RegUlations. 5. Any literature or packing accompanying 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 AttandRules thereunder. 7. Please acknowledgereceipt of this letter and its enclosures. C;;;!OursfailhfuIlY (Dr. S.~ildY) Asstt. Drugs Controller (I). Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochin/. Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

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 Multi Medics, Plot No.28, HPSIDC, Phase-III, Baddi, District- Solan (H.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 Natec Medical Ltd., Maeva Centre Building, Business Park Ebene, Reduit, Mauritius and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence. 2 D 1.1 Z. This licence shall be in force from '- 8 t\:~:~!; unless it is sooner suspended or cancelled under the said rules. 3.. Na~:':~:U9sto~I~~~0P,R D 1.~~~~~~~~~~~IUe(NOn Sterile) Place: New Delhi 0«. >"v'v ~. I--::. <~..~... I..i.J U 8 f\pr?flbsco -:::. -'?... ~ Licensing Authority.~..& '. Seal/StamD ~.. ~"'Dr. S. E5WP."R"". REDDY (I/L!'h. Ph.D \.p. }..' '" A...<"N 1'\0', :r (India).""*'9/,4 ~';>D'-. G~~t~r: r o ~.v \ Kutla Roa(H~sw Delhi ~ ~onditions of Licenc~~,,....-~>)',:.iJil 1. A photocopy oflic~nceshall~ldi~pl~~dj~~j,rominent place in a part of the 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 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 IndiaalQogJlVithJbe.regi tri3tic)ilb()jcj~r al}d.llisaljthorisedagent. 4. The licensee shall inform the.licensing authority forthwifh Illwrifil'lgiri the'eveiifof ~fny 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.Contro~ 'Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division).t:..' To ~~ Evolutis India Pvt.Ltd, Office No.1, Bldg No.A, First Floor, MIs S.H Kelkar & Co. P. Ltd., L.B~SMarg, Mulund (W), Mumbai , Maharashtra Food and Drug Administration Bhawan Kotla Road, New Delhi Dated: :. o..-. I) t'ul 0 j',,' ;-. LV I SUbject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1. With reference to your application for import iemce forwarded to this office with your letter NO.NiI dated 11/03/2011 recembly this office vici..! c&arx:r'?" dated 14/03/ enclose Iice~c~\~. '1wrQ: dated Q /...;', Jtt:ff ~~e;~~~es~c;j;)t~:~e~.~~~~bo~a..under.the Drugs..~nd co~m~~cs. ~~t~=~~. 2. I am to point out...that the prbvi~r()ns 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 1 themselves be sufficient authority for import of Drugs covered by that 1 those Iicence(s) if under the Import Trade Control RegUlations of the Commerce Ministry separate Iicense(s) are required for import of such drug(s). 4. I am therefore, to advise you to obtain, where necessary licence(s) for import of drugs in question under the Import Trade Control RegUlations. 5. Any literature or packing accompanying 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. Please acknowledge receipt of this letter and its enclosures. 4~ourn failh:uiiy (Dr. s. ~ddy) Asstt. Drugs Controller (I) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

6 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 Evolutis India Pvt.Ltd, Office No.1,Bldg No A, First Floor, Mis S.H Kelkar & Co. P. Ltd., L.B.S Marg, Mulund (W), Mumbai , 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 Evolutis, Avenue De La Liberation , Briennon, France and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence. 8.'"'~I!". / This licence shall be in force from - ~ tu"!\ tu h unless it is sooner suspended 3. Names of drugs to beimported: n ARD 1. HIP JOINTS S,\~~\J.. 2. KNEE JOUNTS,. S or cancelled under the said rules. :: ~~~~ ;;:~:e:( r~i~ ANTI IIC) 5. ANCHOR:-l'i her 6. VANQUISH:. egradab 7. NAIL 0 F lasitic radia 8. TRAU 'L:J DUCTS: Pia... t ITE ) EI.GHTONlY. CDSC Place: New Delhi ~ If Date: _--_8_A_"P_R_2011 ~.. k~~ '9)-O,<'/i...~~~ 0 ~~:n:~:~!l~ PhD.~-4LTHGO\Jt\\~' As;tt. -D;,~\:~;;'::,~:~-"~ (India) Conditions orllcenc~ D.CHS, ;.~':.;\.~;h:,,"3n 1. A photocopy of licence shall be displayed in a prominent place inkl4iii~d-ot2\~lhj 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, dulysig neda nd authenticated_bytthe_ 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. 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

7 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 To / /M/s S.R International, 801, Manjusha,57, Nehru Place, New Delhi-19 Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1. With reference to your application for import licence forwarded to this office with your letter No Nil dated 28/02/2011 received by thi ffice ',ide;;fiar..no 9612 dated fi~le~~~:i~~~;~~;~~~lro 28/ enclose Iicence(s) NO. FF ted - 0 Al"'R ~tj~~:~;~ t~ nthese 2. 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 licence(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 1 themselves be sufficient authority for import of Drugs covered by that 1 those Iicence(s) if under the Import Trade Control Regulations of the Commerce Ministry separate Iicense(s) are required for import of such drug(s). 4. I am therefore, to advise you to obtain, where necessary Iicence(s) for import of drugs in question under the Import Trade Control Regulations. 5. Any literature or packing accompanying 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; Please acknowledge receipt of this letter and its enclosures; 47&-~fuIlY (Dr. S.Eswara Reddy) Asstt. Drugs Controller (I) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

8 FORM 10 (See Rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, ~ P. J\ i:=~ :~?~~:?'1 ~ ;.~ a \l" ~,_. ;c-- ~.; MIs S.R International, 801, Manjusha, 57, Nehru Place, New Delhi-19 is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs Arcadophta Sari, 11, rue Antoine Ricord, 311Q()Toul()se, France 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 forc~~~ :: 8 APR ZOU unless it is sooner suspend~~ cancelled under the said rules. o 3. Names of drugs to ~ i~orted:, ARD Cr'< 1. Arceole.SL~iDose I<ll\(rs.~;SFG, t:f2 6r~oPtraocular Gases) ITEM(S~ ONLY (:'? ",', (* o A'::;? ::{",z~ v "''I' Date: _- _8_A_P_R _Z_Ol1 c6r}ditions of Licence 1. A photocopy of licence shall be Jifi~~~Ef1,U:l ~ 'e,~~ent place in a part of the premises, and the original licence shall be pr(jdrl~a,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 manufacturer with date of testing, date of release and the date of forwarding such reports.- Theimported-batch-ofeachdrug shall be subjected to examrnatforrandtesting- - 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. 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 ctlailgetakes 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.

9 Centra! Drugs Standard'Control Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Organisation File NO MD/2009 DC Food and Drug Administration Bhawan Kotla Road, New Delhi Dated: -_ 8.1\ pf:\'?flll b.. f"', I il",v To / \./~!~~ ~axter (India) Pvt. Ltd, Plot NO-70, A-26, Rama Road, Industrial Area, New Delhi Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1. With reference to your application for import licence arded to this office with your letter No. Nil dated 11/03/2011 received by. 0 Ice vide!ary ne dated 14/03/ enclose licence(s} NO. MD- 1-4 dated - li AP}~ ~f ~~m~~f~:~)~~~e~~1~!e~;~~~~~~!~d; :~~g::::~i:m~~cs1~~ 2. 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 1 themselves be sufficient authority for import of Drugs covered by that 1 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). 4. I am therefore, to advise you to obtain, where necessary Iicence(s} for import of drugs in question under the Import Trade Control Regulations. 5. Any literature or packing accompanying 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. PleasEn~ckh(jWleageteCeiptofthis lettetanclits enclosures. ~:fuily (Dr. S."'ESWaraReddy) Asstt. Drugs Controller (I) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochin/ Delhil Hyderabadl Kandla /Kolkatal Mumbail Nhava Sheva.

10 FORM 10 (See Rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 M/s Baxter (India) Pvt. Ltd, Plot NO-70, A-26, Rama Road, Industrial Area, New Delhi is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by M/s Baxter Healthcare Corporation Armstrong Avenue Irvine, California, USA and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence 'I1')f'\ "ph - ;\rr\ LUll ~ 2. This licence shall be in force from unless it is sooner suspended or cancelled under the said rules. ~ 3. Names of drugs to be imjl~d: Floseal Endosc09tc""plic~~O ITEM(S) ONE &16~",~?~ ~«..~J (') () "v Place: New Delhi '" <: - 8 I'PP ZOlfJ.' H ~\ ~I~ ~ ~ censmg Authority Seal/Stamp SWP'=!!!,. "... 17=:1"'>.;->,/,..c~..." M. Ph Ph I..0 ':..DruG';. ~ ITi'd'a) \....I ~. 1. ~~i~~~o~~d ~~~i~~~~~,1t;!;ts~~r6e..~roducfcl~h~~:~~u'1e;;~;j~~ 2. Each batch of drug imported intet;f'~iashall be accomp~lft~ith a detailed batch test report and a batch release certifi~"f.d{uj~'\t~lm ; and authenticated by the manufacturer with date of testing, date of1t~~se 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 Iicenseeshall be responsible for the business activities of.themanufactur~eijn _~. 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 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.

11 Central Drugs Standard Control Org~nisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi To / / ~/s Boston Scientific International BV (C & FM/s Parekh Distributors), C-40, Okhla Industrial Area, Phase-II, New Delhi- 20. Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1. With reference to your application for import licence forwarded to this office with your letter No Nil date~ 01/03/2011 received by this office _vid~diat.wno9~57 dated. 01/03/ enclose hcence(s) NO. MD dated ~ ~t,ttthese ~~~~~~~5ht~~:e~~~:r~een g~anted under the Dru~s ~G~~tlCS _~~~~=~an~ 2. lam to point out that the provisions of Dr~~~ Cosmetics Act 1940 and RUles1945 are in addition to and not derogatio~fany 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 1 themselves be sufficient authority for import of Drugs covered by that 1 those Iicence(s) if under the Import Trade Control Regulations of the Commerce Ministry separate Iicense(s) are required for import of such drug(s). 4. I am therefore, to advise you to obtain, where necessary licence(s) for import of drugs in question under the Import Trade Control RegUlations. 5. Any literature or packing accompanying 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-andRulesthe[ellnc:f~r. 7. Please acknowledge receipt of this letter and its enclosures. (Dr. S. ra Reddy) Asstt. Drugs Controller (I) Copy forwarded for information to: ~, 2. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl De"1,1 Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

12 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 Boston Scientific International BV, (C & F MIs Parekh Distributors), C-40, Okhla Industrial Area, Phase-ll, New Delhi- 20 is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs. Boston Scientific Corporation, Boston Scientific Place, Natick, Massachusetts , USA having factory premises at MIs. Availmed S.A. de C.V. Av. Pasaeo Reforrna No Int. GIByG1 H, Col. Fraccionamiento Rubio, C.P , Le Mesa, Tijuana, Baja, California, Mexico 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 unless it is sooner suspended or cancelled under the said rules. ~ 3. Names of drugs to be irn-aed: n 1\ RD 1. Wiseguide Cathete(,V.<~Nvr.,"- ~: =~,~egam!!nlg,oc =;.~~.~J"'e\er Place: New Delhi ITEM(S) EONty' ~". ~ J...::. N - 8!\DR 1111$.. Date: - E'd I. i:., ~ : U..?1J~._~ :.r~ (j D..:> rr~~- L\LICensmg Authority Seal/Stamp % Dr~ Eswr.?Jl.,P7=.DD:(.. j'i.1;p~. ~~D ~ ~~. D:U!?::,:d:r;_,:,~~,;,!~,;'-;""1 \J"'..>: ~" D.G.H.,,).,,,.,.,". ;.c,,,,,,un -1Gonditionjl-~m~t-1\:e'1i8i 0 Kotla Road-Nevv Delhi..~ 1. A photocopy of licence shall. ~14~layed in a pro~ej1f place in a part of the premises, and the original licence shal~~]w:,oqucref~ftenever required. 2. Each batch of drug imported into India sharlbe-%dcompanied with a detailed batch test 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 thelicensing 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 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. ~

13 Centrai Drugs Standard Contro! 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 T~ MIs Veritas Bioventions Pvt.Ltd,.. G-8, Plot No.5305, Phase-IV, G.I.D.C, Vapi, Tal: Pardi (Valsad), Pin ~.~.~ :;.~...,'. ;-- oj i; ~ '.~ SUbject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regar~ing. -8~~i:l~~~~~1~:;~~fgz~ 1. With reference to your application for import licence forwarded to this office with ~~ffj11 re~;!~n~g~;;~ 2. I am to point out that the provisions of Dru~,,~ Cosmetics Act 1940 and Rules1945 are in addition to and not derogati~~rany other law for the time being in force and as such the Iicence(s) issued ulfder 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 Iicence(s) mentioned in para (1) above will not accordingiy to itself I themselves be sufficient authority for import of Drugs covered by that I those Iicence(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 Iicence(s) for import of drugs in question under the Import Trade Control Regulations. 5. Any literature or packing accompanying 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. Please acknowledge receipt of this letter and its enclosures. (Dr. S. Es dy) Asstt. Drugs Controller (I) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

14 FORM 10 (See Rules 23 and 27) Licence to import drugs (excluding those specified in Schedule X) to the Drugs and Cosmetics Rules, 1945 'Date: ~ ~ /s. :~'.~jr": :~.f,,:.~ '.. MIs Veritas Bioventions Pvt. Ltd, G-B, Plot No.5305, Phase-IV, G.I.D.C, Vapi, Tal: Pardi (Valsad), Pin is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs Natec Medical Ltd., Maeva Centre Building, Business Park Ebene, Reduit, Mauritius 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 :.. 8!\r;:~2ull to unless it is sooner suspe~ed or c~ncebed under the said rules. 3. Names of drugs to ~ported:. 'OARD rn. ' Catheter v....c.,.,\~~... '-UN,I?, 1. PTCAca~: Tamarl~jue (Non Sted.. le... ) O( () ITEM(~ ONLY ip-~:" J1Jr, 0«' <).' v~ _." '-~: V;.;;: v' ~,\ Place: New Delhi "6-8 t:, 1'1n,",,!"l1l1 c.~..7'7-a ~ Date:~ fiffi. L{Jh ~-=- Licensi;;g---A-ut-h-o-ri-ty ~ ;;::; Seal/Stamp ~.....,-E} S. ES\Nt:~C'l.':':::D~Y ~"'I'. d t ~... ~Assti:.<:=~..":,' M.pn. Ph.D ~onl Ion 'Htl!IG\?l _ ~ D.G.i-i r:' ;"::' ',:-: '-Her (India) 1. A ph~tocopy of Iic~n~es,hitf~~diSPlayea ina promine'\t<..~ac~ ink&bj>~ltd:j~qt~aw~n premises, and the orrglnalllcence"; Qa1lbe produced, wh~i1~ffi"required. New DeIhl 2. ~~~rt b~~~ o~d~;t~~pie~:~si~toc~~~~~~il{w5~~m~~:it:u~h~~~~~~t~~a~yh t~~ 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. The licen$ee~shall inform the-licensing-authority-forthwithin writing in the ~eventof-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

15 Central Drugs Standard Control Organisation Directorate General of Heaith Services' Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi Dated' - ~.~,..'? '!IH1. u!' '. '.~ t..,l ~ TO~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 Maharashtra Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1. With reference to your application~o import licence forwarded to this office with your letter No. Nil dated 25/02/201 eived by this office vide diary no 9387.dated 28/02/ enclose Iicence(s)~ dated-=: At p.:"'\ r.: "#1' 1 these Iic~I}c:~(~Lh~s 1 have been oca~d_ under the Drugs and C "'!etics _Ad ~Ig~~_a!1_~ Rules1945 thereunder. ~~ 2. I am to point outih ~'l provisions of Drugs and Cosmetics Act 1940 and Rules1945 are in a n to and not derogation of any other law for the time being in force and as suc the Iicence(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 Iicence(s) mentioned in para (1) above will not accordingly to itself 1 themselves be sufficient authority for import of Drugs covered by that 1 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). 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 accompanying 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.rtlles thereunder. 7. Please acknowledge receipt of this letter and its enclosures. ~fuily (Dr.s.ES~) Asstt. Drugs Controller (I) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

16 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. 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 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. Smith & Nephew Inc., Orthopaedic Division, 1450 Brooks Road, Memphis, TN 38116, USA 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 unless it is sooner suspended or cancelled under the said rules. 3. Names!i~~~~~~~?;~:~~V of drugs to be imported: n 5. VersaBond_and ml 6. Journey Kne 7. Legion Kne ~m 8. Tandem Hi y~~m 9. R3 Acetabular S~tem ITEM(S) NINE ONt'C DSC0 Place: New Delhi ~ ::r: Date: - 8 APR 2011 %1>, ~tcr o~ r0...~~ Licensin~rity '/:'lir- t,:~" 0.Seal/Stamp {~'4! -"., <,-t"~\\'4 r. s. ES\Jlj,I.\t:;;;'\ n1"'""dv ~, ",I H [0\1\;:'1"" Ac-tt <,.'.: : '-:';.', i.ph. Ph.D Conditions of li~ence "'= ~. ~~. :'j:,:< r;~(oj!c:.r (India) 1. A photocopy of licence shall be displayed in a prominent placed~ti~~~i;,,~~~~n premises, and the original licence shall be produced, whenever required. I 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 rnanyfaqturer witl}.g~!e9t te3$til1g,d~je3of JE3leClseandthedClte of forwarg.id9-. _U(~I}.. 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. 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

17 Central Drugs Standard Control Organisat~on Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi T/fMIs KMSMedisurgi Pvt. Ltd,.. 44, Mangladas Road, Bulakhidas Bldg, Shop No.7, MUl11bai400002, Maharashtra. Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1. ff:;~~:~li{~ii~~g~ With reference to your application for i~ licence forwarded to this office with ~E~~l:~b1::... 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 Iicence(s) mentioned in para (1) above will not accordingly to itself! 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). 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 accompanying 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. Please acknowledge receipt of this letter~anditsenclosures. 2. ~~~1~~~~ i~u~d~:~n~:~~~~~:;~~:~~g:f: ~fuily (Dr. S.E""swara Reddy) Asstt. Drugs Controller (I) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabad! Chennai! Cochin! Delhil Hyderabad! Kandla!Kolkatal Mumbai! Nhava Sheva.

18 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 KMS Medisurgi Pvt. Ltd, 44, Mangladas Road, Bulakhidas Bldg, Shop No.7, Murnbai, , 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 MASCIA BRUNELLI s.p.a Vie. Monza, 272, Milano -Italy 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 ~~ - 8 A DR ~"~l to unless it is sooner suspende(1"cancelled under the salcfh.ies. 3 Names of drugs to b~.rted:...rd.. 1. Haem ostati c_g~ SPDnge'(~lfttFOlVlf?O ITEM(S) ON~LY GS~.%, 0 Date :::' 8 a!=l lith 20n C'k'J r~ ()'- v ~~ :;.--'" V -- ~.. ---~-,.._._--~ o.. ~ ~... DSCO~ Licensing Authority ;:s Seal/Starnp i?s. ESWl.,PJ:.. REDCW ~U>h.Ph.D V'.ACOnditiO <c"'asstt. DrU~;s... '_.(India} 1. A photocopy of IiCenCeSh~f-~.diSPI~~4'n~rOmine~, <p1~cef?t~~~#~~i9.tjfl5~i~n ~~~~~~~1:~~~~~~J 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. 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 2. ~~;~~~~~~!

19 To 'Centra! Drugs Standard Control Organisation /' Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic ~~ Alpha and Omega Diagnostics (I) Ltd. Room No.1, 1st Floor, 13- Rajmahal, Bhuleshwar Road, Mumbai , Maharashtra. Division) Food and Drug Administration Bhawan Kotla Road, New Delhi f\i'"}d?;111 Dated: hi n :.,tn Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. 1. With reference to your' application for import Ii erlce forwarded to this office with your letter No. Nil dated 24/02/2011 receiv his office \lidecfiarx no 9195 dated 25/02/ enclose Iicence(s) NO. M - 83 dated. u t~t -';' ~~1~these ~~~~~~~~ ~b~:~~;~:r~een~r&\~ the Drugs and Cosmetics' Act 1'940 and 2. 1 am to point out -that th~~rsions of DrugsanaC()smetics,A;cr-lg-40~amt ' 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 1 themselves be sufficient authority for import of Drugs covered by that 1 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). 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 accompanying 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. Please acknowledge receipt of this letter and its enclosures. (Dr. S. EsWanr"Reddy) Asstt. Drugs Controller (I) Copy forwarded for information to:. 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva. ~IIY

20 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 Alpha and Omega Diagnostics (I) Ltd. Room No.1, 1st Floor, 13- Rajmahal, Bhuleshwar Road, Mumbai , 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 Labotect GmbH,.Labour- Technik- Gottingen Wille- Eicher Str. 25, Gottingen Germany and any other drugs manufactured by the said manufacturer as may from time to time be endorsed on this licence. - 8 i\ ;:;) ry n'11 i"\l I'. L';J~ 2. This licence shall be in force fro'll\. _. unless it is sooner suspende~cbncelled under the said rules. 3.~~~:b~~~~~~~... ~::\I'-~OiXRO Date:~ ITEM(S) ON~~( o.q~ Gc,? -----~--- O.r;) 'G' :cr.~. ~ DS C (ilicensing AtrffiOiity Seal/Stamp ~. /}IrS. ES\;~It.\R.l\, Rf'::-"v ".,Ph Ph 0 ~C()l1diti.?f.s.stt. D;~~~';; C(;~~':;~i;::; 1. A ph~tocopy of Iic~n~e ~Ji be displ ~wominent 8~~ i"o~t:r~:~)~:n premises, and the onglnal"ce~shall be pro uced, whenev~ f~qulred. 2. Each batch of drug imported int&~i~shall be accomp~~~ith a detailed batch test report and a batch.release certlfi(al~l;{dhiy)~m1\e\i and authenticated by the manufacturer with date of testing, date oftepe"ase and the date of forwarding such reports. The imported batch of each drug shall be SUbjectedto 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. The licensee shall inform the3licensing authority f()rthvvith in writing in theeventof any change!n 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. (l~dia)

21 To / Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) J~!.s Depuy Medical P.Ltd, Plot No.4, Survey No. 277/4, Demni Road, Village- Dadra-Dadra & Nagar Haveli (U.T.) Food and Drug Administration Bhawan Kotla Road, New Delhi Dated: - 8 APR 2011 Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunde~- regarding. 1. With reference to your application for import Ucence forwarded to this office with your letter No. No. DepUY/RAl2011/Fe~ru ~-01 dated 28/02/2011 received by this office vide diary no 9808 dated enclose licence(s) NO. MD dated-._dni~r:'~~ ~ ri~f.1 th Ii ce(s) has 1 have been granted under the Dr.ugs.andCo_.eJf(:;_~'.~ t.~j~_~o les1945 thereunder.. 2. ~~~S1t~4~~~~ i~u~d~:~nt~nd v~~~~:~o~~~~~g;f:~:~~~~~:~~~~~~-tj~:~~~~ 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 licence(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 1 themselves be sufficient authority for import of Drugs covered by that 1 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). 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 accompanying 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. Please acknowledge receipt of this letter and its enclosures. ~UIIY (Dr. S. Eswara Redd"y) Asstt. Drugs Controller (I) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

22 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 Depuy Medical P.Ltd, Plot No.4, Survey No. 277/4, Demni Road, Village- Dadra- Dadra & Nagar Haveli (U.T.) is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs Depuy Orthopaedics Inc. PO BOX 988, 700 Orthopaedics Drive, Warsaw, Indiana , USA having factory premises at MIs Johnson and Johnson Medical (Suzhou) Ltd, No.299, Chang Yang Street, Suzhou Industrial Park, Suzhou Jiangsu China 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 ~ 8 APR l011 to unless it is sooner suspended or cancelled under the said rules. 3. Names of drugs to be.imported:.... ~BD 1. PFC Tibial Tray~.-.ta. n.dltp~~b'dolar' ~: 2....~W~~~!i~::~.i" APe..x.. H.ole...E...um..,nato..~9~ <- 6. Global ~'il1;.~.ysterns> 7. screws\lorti~~,f~ j.~~~~ Place: New Delhi CDSCO q~... _-~_._ C... ~ /',... v alldpinnaclbcrews o z Date: - S APR 2011\ ~ ~)., ~Ecensi g uthority "9)- A 0 c:<:s~al!s~mj?,viu-i,'?.:... "..':Li0 ( p'l.ph. Ph.D o ~, Dr. S.,-... '/:'-".(r\ I\-~{~. "!,,.,.,u. :--"[""1"--"-'" ",,~,Jla) Con6i~9t~of Licen~~~ ~I\\~. ~O)~~'G~~;~t~:~:.;t~~~.~ 1. A photocopy of licence shall be dispfay~ GP~~rominent place in Ie:>tlWbcdNtM Delhi 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 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. 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.