Central Drugs Standard Control OrganisationDirectorate General of Health ServicesMinistry of Health & Family Welfare

(Medical Device and Diagnostic Division)

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

Date:2, 0 /;PR Z011To /

~/s Terumo corporation Chennai Branch,Alaxander Square, 34 &35, 4th Floor, Sardar Patel Road,Guindy,.Chennai-32. ~

SUbject: Issue of an Endorsement No.1 t~m 10 License No.MD-141-1142 dated26/08/2010 valid upto 14/06/201Cdlgarding.

Sir, ~~ .Please refer to your ~ication No. Nil dated 25/03/2011 received by this

office vide diary No.1575.~ 04/04/2011 regarding the above cited sUbject.

Endorsement NO.1 to Form 10 License NO.MD-141- 1142 dated 26/08/2010valid upto 14/06/2013 for the import of drugs manufactured by MIs. TerumoCorporation, 44-1,2-Chome, Hatagaya, Shibuya-Ku, Tokyo, 151-0072, havingfactory premises at MIs. Terumo Corporation,150, Maimaigi- cho, Fujiomiya-shi,Shizuoka, 418-0015, Japan is enclosed hereby.

~ithfUIlY

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

Copy forwarded for information to:1.Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil HyderabadlKandla IKolkatal Mumbail Nhava Sheva.

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: Z. 0 APR LOllMIs Terumo corporation Chennai Branch, Alaxander Square, 34 &35, 4th Floor, SardarPatel Road, GUindy, Chennai-32 is hereby licensed to import into India during the period forwhich the licence is in force, the drugs specified below, manufactured by MIs. TerumoCorporation, 44-1,2-Chome, Hatagaya, Shibuya-Ku, Tokyo, 151-0072, having factorypremises at MIs. Terumo Corporation,150, Maimaigi- cho, Fujiomiya-shi, Shizuoka, 418-0015, Japan is ~nclosed hereby.

2. This Endorsement No.1 shall be in force from 2 0 APR l011 to 14-06-2013unless it is sooner suspended or ~ncelled under the said rules.

3. Names of drugs to be. Impn~. • .•.ahlD... A.RD CO1. Hiryu PTCA Ditil aL~P~~tet· . N1RIl"2. F.INECR.ass ..O&drYMicro-.GuideCatnGfeJ:.

ITEM(S) TW~.... •.••~. U1>G'O~~~ 1',*

<c. iJI

Place: New Delhi fi ~Date: Z 0 APR l011 tJ DS<::~r,ty

Seal/Stamp

.o{.rl

. rJj.itionsofLicence... . ';!: ..::,\L 'i.·,:.i;.~:i~';~)S

1. A photocopy of licence shaIl6e4liAAlayed. in. ""ro~'1ItiP!i"Cl\in, ",paril ,ol"t.iiJao:premises, and the originallicence.·~JtD~p(9(J)lt~\}"heneverJequired.

2. Each batch of drug imported into India shall be accompanied with a detailed batchtest report and a batch release certificate, dUly signed and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchreports. The imported batch of each drug shall be subjected to examination 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 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.

Central Drugs Standard Control OrganisationDirectorate General of Health Services

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

Food and Drug Administration BhawanKotla Road, New Delhi-110002

Dated: 2. 0 APR l011To

.~ Nipro India Corporation P. Ltd,New No.167, Old No 137,YE~DEE House,1stFloor Valluvarkottam High Road,Nungambakkam, Chennai- 600034

Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945thereunc;ter- regarding.

1. With reference to your application for import !"cence forwarded to this office withyour letter No Nil dated 01/04/2011 receiv y this office vide diary no 15367dated 01/04/2011. I enclose licence(s) NO. ·565-1288 dated ~ ~ A D~ tfij¥l'lthese licence(s) has 1 have been grante oer the Drugs and Com tids 'A 1~.\tJand Rules1945 thereunder. ~~

2. I am to point out that the pro' s of Drugs and Cosmetics Act 1940 andRules1945 are in addition to d t derogation of any other law for the time beingin force and as such the Iic~e(s) issued under Drugs and Cosmetics Act andRules will be in addition to and distinct from any Iicence(s) which may be necessaryunder 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 1themselves be sufficient authority for import of Drugs covered by that 1 thoseIicence(s) if under the Import Trade Control Regulations of the Commerce Ministryseparate license(s) are required for import of such drug(s).

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

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

6. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

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

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

Kandla IKolkatal Mumbail Nhava Sheva.

FORM 10(See Rules 23 and 27)

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

2. 0 APR 2011MIs. Nipro India Corporation P. Ltd, New No.167, Old No 137, YES DEE House, 1st FloorValluvarkottam High Road, Nungambakkam, Chennai- 600034 is hereby licensed toimport into India during the period for which the licence is in force, the drugs specified below,manufactured by MIs Nipro Corporation Odata Factory, 8-7, Hanukiyachi, Niida, Odate-Shi, Akita 018- 5794, Japan and any other drugs manufactured by the said manufacturer asmay from time to time be endorsed on this licence.

2. This licence shall be in force from 2 0 APR lfllL to 31-10-2011unless it is sooner suspended or ca~lIed under the said rules.

. ~

3. Narf.~rfa:~:~5~:I~~~~~~ITEM(S) TW~~~'s . .••• .~

O.<:::;Q,:..;s~'V

~Place: New Delhi f!::-

Date: 2 0 APUOn§C

%'J.):. . .

1. ~r:~~~~O~~d~~~i:~~a{~~t~~:;~J~ro.~)~~~:~~;~:'p.;>l>&;;ih~:;~:::2. Each batch qf drug imported into India shttb~~anied with a detailed batch test

report and a batch release certificate, duly signed and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchreports. The imported batch of each drug shall be subjected to examination and testingas the licensing authority deems fit prior to its marketing.

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

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

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

Dated: 2. 0 APR l011

*NiPro India Corporation P. Ltd.,New No.167, Old No 137, YES DEE House,1st Floor Valluvarkottam High Road,Nungambakkam, Chennai- 600034

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

1. With reference to your application for import licen rwarded to this office withyour letter No Nil dated 01/04/2011 received b . office vid~ d,43ryno..15366dated 01/04/2011. I enclose licence(s) NO.M . -1289 dated (. U hi 1\ ~BI1these Iicence(s) has 1 have been granted he Drugs and Cosmetics Act 1940and Rules1945 thereunder. <(i

2. I am to point out that the proVisiO~) Drugs and Cosmetics Act 1940 andRules1945 are in addition to and not d'efogation of any other law for the time beingin force and as such the Iicence(s) issued under Drugs and Cosmetics Act andRules will be in addition to and distinct from any Iicence(s) which may be necessaryunder 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 Ithemselves be sufficient authority for import of Drugs covered by that 1 thoselicence(s) if under the Import Trade Control Regulations of the Commerce Ministryseparate license(s) are required for import of such drug(s).

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

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

6. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

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

(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. .

FORM 10(See Rules 23 and 27)

Licence to imporl drugs (excluding those specified in Schedule X) to the Drugs andCosmetics Rules, 1945 z 0 APR l011

M/s. Nipro India Corporation P. Ltd, New No.167, Old No 131, YES DEE House, 1st FloorValluvarkottam High Road, Nungambakkam,Chennai- 600034 is hereby licensed toimport into India during the period for which the licence is in force, the drugs specified below,manufactured by M/s Nipro Medical Industries Ltd., 2-19-64, Matsubara, Tetebayashi,Gunma, Japan-374-8518 and any other drugs manufactured by the said manufacturer asmay from time to time be endorsed on this licence.

2. This licence shall be in force fro~ 2. 0 APR 2011unless it is sooner suspended ~ancelled under the said rules.

3. Na~.esGC::i~:~~et(N~~:~~.~~eWif5t\l<;D (ONITEM(S) O~LY S'\N~ "11(0. ,,«. s :<0

'V ~Q~~

~

.~DSC~ensmg AuthoritySeal/Stamp

~10 ,\~(:;, '-:;"':-"'"'.;-,.!,'.';

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"'Z.""" '"

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1. A photocopy of licence &Pfa8~'iih,,:.~:."artv' 6f;~,tti;ri~~JOG2

2. ~~~i~~~~~~~ ~~~gO~~~d~~d~rit61~dia~htft~ paniede:r~q~i~ee~~i1ed batch testreport and a batch release certificate, dUly signed and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchreports. The imported batch of each drug shall be subjected to examination and testingas the licen~ing authority deems fit prior to its marketing.

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

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

Date: 2. 0 APR Z0118

Central Drugs Standard Control Organisation; Directorate General of Health Services

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

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

Dated: 2 0 APR 2011

~ India Medtronic Pvt. Ltd,Plot No.609,Survey/Shed-188{Part),Chamunda Comp, Kasheli Village,Dist. -Thane Bhiwandi, 421301 Maharashtra.

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

Sir, ~

1. With refer,ence to your apPlicat,,$ror import licence forwarded to this office withyour letter No VD/SH/CV-M~RR-ILl0311 and VD/SH/CV-MD381-RR-ILl0311dated 21/03/2011 and 28/031. 11 respectively received by this office vide diary no's13083 and 149J.p da~~~ 21 2011 and 29/03/11.1 enclose licence(s) NO. MD-381-1285 dated t. U ~'i\ ~ these Iicence(s) has 1 have been granted under theDrugs and Cosmetics 1940 and Rules1945 thereunder.

2. I am to point out tH the provisions of Drugs and Cosmetics Act 1940 andRules1945 are in addition to and not derogation of any other law for the time beingin force and as such the Iicence(s) issued under Drugs and Cosmetics Act andRules will be in addition to and distinct from any licence(s) which may be necessaryunder 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 1themselves be sufficient authority for import of Drugs covered by that 1 thoselicence(s) if under the Import Trade Control Regulations of the Commerce Ministryseparate license(s) are required for import of such drug(s).

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

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

6. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

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

~hfUIlY

(Dr. S.-e5Wara 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.

FORM 10(See Rules 23 and 27)

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

MIs. India Medtronic Pvt. Ltd, Plot No.609,Survey/Shed-188{Part), Chamunda Comp,Kasheli Village, Dist. Thane, Bhiwandi 421301 Maharashtra is hereby licensed to importinto India during the period for which the licence is in force, the drugs specified below,manufactured by Mis. Medtronic Inc, 710 Medtronic Park Way, N.E. Minneapolis, MN-55432, USA having factory premises at Mis Medtronic Mexico, S.de R.L de C.V., AvenidaPaseo del Cucapah 10510, Parque Industrial El Lago, Tijuana, B.C 22570, Mexico andany other drugs manufactured by the said manufacturer as may from time to time beendorsed on this licence.

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

3. Namesof drugs to be Impo~1. Sprinter Rapi~Exch •..•• all@M~ttj\\ip,nCat ..h.e.ter2. Sprinter Legertci;B ..... 'l!itlatatlorrb'llYIl'~ ..3. Melody Transca .. IrnonaryValve/ •~O

ITEM{S) T~. LY ..•.....•. . '/pG;'J

Q ~'t:~ .~t::l:::" ''Q

I.",,~ ~~ -Place : New Delhi t?J 0

Date: l 0 APR 2011~C

2. 0 APH LOll

~ Li~nsing uthority% .. Seal/Stamp

~~~. .•. ' 6[0 ~ff .. ·+:;I""IY~~I,r'Fl!.n;ii.~~fl"2 ... ' . ../ ~. Q~Dr, ... HC'~';"h. nf'll PhD' ,"

~ditionSoicence •. , ~ '~i'~;:j!:';i/:J:,::,/,~,;:,,;i);>:';,~~nirO/ier

1.~r:~~~:'~~d~~eli~~~~lI!h~~l~.I~~:ro·=L~~~;:?~~!'~~~;:~V;C~~2. Each batch of drug imported into India shall 5e accompanied with a-der~i1~d'6§td~C;ts~f10002

report and a batch release certificate, duly signed and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchreports. The 'imported batch of each drug shall be subjected to examination and testingas the licensing authority deems fit prior to its marketing.

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

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

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 OO(}2

Dated:Z 0 APR lOll

w( Nobel Blocare India Pvt. Ltd,103-A & 103-B, First Floor, "C" Wing Fortune 2000,Bandra Kurla Complex, Bandra (E), Mumbai .•400051, Maharashtra

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

1. With reference to your application for import~lice· orwarded to this office withyour letter No Nil dated 31/03/2011 receive is office vid~ diary no 15243 .dated 31/03/2011. I enclose licence(s) NO.MJ; 8-1291 dated l. 0 APR t"'Ulthese Iicence(s) has 1 have been gran1P~wVer the Drugs and Cosmetics Act 1'9~dand Rules1945 thereunder. "'~

2. I am to point out that the provQ\s of Drugs and Cosmetics Act 1940 andRules1945 are in addition to and not derogation of any other law for the time beingin force and as such the licence(s) issued under Drugs and Cosmetics Act andRules will be in addition to and distinct from any licence(s) which may be necessaryunder 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 1themselves be sufficient authority for import of Drugs covered by that 1 thoselicence(s) if under the Import Trade Control RegUlations of the Commerce Ministryseparate 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 ofdrugs in question under the Import Trade Control RegUlations.

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

6. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

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

~hfUIlY

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

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

Kandla IKolkatal Mumbail Nhava Sheva.

FORM 10(See Rules 23 and 27)

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

2. 0 I,PR l011

MIs. Nobel Biocare India Pvt. Ltd, 103-A & 103-B, First Floor, "C" Wing Fortune 2000,Bandra Kurla Complex, Bandra (E), Mumbai-400051, Maharashtra is hereby licensed toimport into India during the period for which the licence is in force, the drugs specified below,manufactured by MIs. Nobel Biocare USA LLC, 22715 Savi Ranch Parkway Yorba Linda,CA 92887and any other drugs manufactured by the said manufacturer as may from time totime be endorsed on this licence. 2. 0 APH lOll

2. This licence shall be in force from to 28-02-2014unless it is sooner suspended or cancelled under the said rules.

Date: 2 0 APR 2011/; ~. censing Authority1'}. ~0 SeallStamp

OJ::'Itp . ..~\~<O~ ,sm '"~AL7ll!GO\lt:~\'< 'Hi,:TC,i

Conditions of Licence i)te.. I:.

1. A photocopy of licence shall be displayed in a prominent plaK%),t1,9.:J?,arJ:i8.fithe.;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 testreport and a batch release certificate, duly signed and authenticated by themanufacturer with date of testing, date of release and the date of forwarding suchreports. The imported batch of each drug shall be sUbjected to examination and testingas the licensing authority deems fit prior to its marketing.

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

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

Central Drugs Standard Control Organisat\ionDirectorate General of Health Services !

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

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

Dated: 2. 0 APR lOll

~s Hansraj Nayyar Medical India,1416, Maker Chambers V,14th Floor, Nariman Point,Mumbai - 400 021, Maharashtra.

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

Sir, ~

1. With reference to your application for import licence forwar~~ this office withyour letter No Nil dated 29/03/201 received by this offi~e . ~ial no 14624 dated29/03/2011. I enclose Iicence(s) NO.MD-809-1293 da f1rtMtheselicence(s) has 1 have been granted under the Dru~~ Cosmetics Act 19'4'0andRules1945 thereunder. 0

2. I am to point out that the provIsions of Drugs and Cosmetics Act 1940 andRules1945 are in addition to and not derogation of any other law for the time beingin force and as such the Iicence(s) issued under Drugs and Cosmetics Act andRules will be in addition to and distinct from any Iicence(s) which may be necessaryunder 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 1themselves be sufficient authority for import of Drugs covered by that 1 thoseIicence{s) if under the Import Trade Control Regulations of the Commerce Ministryseparate license(s) are required for import of such drug(s).

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

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

6. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

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

(Dr. S. swara 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.

FORM 10(See Rules 23 and 27)

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

2. 0 t~PR 2011

Mis. Hansraj Nayyar Medical India, 1416, Maker Chambers V, 14th Floor, Nariman Point,Mumbai • 400 021, Maharashtra. is hereby licensed to import into India during the period forwhich the licence is in force, the drugs specified below, manufactured by Mis. SmithsMedical ASO Inc., 201 West Queen Street, Southington, Connecticut 06489,USA andany other drugs manufactured by the said manufacturer as may from time to time beendorsed on this licence.

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

3. Names of drugs to be im~d:

~::~~~~~~~~~~~~~;~3060' 3062, 3063,3065,

o <) ~~~ ~~;:;r ?J..,

Place: New Delhi ./ff!.... .,~Date: 2 0 APR 201~ ~

'z 0 APH 201'

,,,: ';;, ,,:,~""'. .,. ' r;,;r:;'.:'I:i&r

1. minen<~&e,.iIn"~··;.~p.'art:()f•.tb~:;;;ii'Yitj;I~·premises, and the originallicen. . . .duced,.w .r.(:e~~,:;;.;;:,/i'~i;,;~~::':!;!;"Niln "

2. ~~~rt b~~~ o~d~~~~P~~:~~=toc~rtif~1~ef~6~ i' 'ed an:i~u~h~~~~~~~~a~;'t~~~'1'1 OP0~

manufacturer 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 testingas the licensing authority deems fit prior to its marketing.

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

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

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

Date: 2. 0 APR lOll

.~ J.Mitra and Bros,Shop No. 20, Double Storey Market,New Rajinder Nagar, New Delhi-110060.

Subject: Issue of an Endorsement No.1 to Form 10 License No.MD-141-1156 dated17/09/2010 valid upto 14/06/2013-regarding.

Please refer to your application No. Nil dated 29/03~2011 received by this 'office vide diary NO.15113date 31/03/2011 regarding t~~ove cited subject.. . c::.~

Endorsement NO.1 to Forrn 10 Licenie· ~D-141- 1156 dated 17109/2010valid upto 14/06/2013 for the import of manufactured by MIs. TerumoCorporation, 44-1,2-Chome, Hatagaya ~ uya-Ku, Tokyo, 151-0072, havingfactory premises at MIs. Terumo Cor~""bon,150, Maimaigi- cho, Fujiomiya-shi,Shizuoka, 418-0015, Japan is enclose~;eby.

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

Copy forwarded for information to:1.Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil HyderabadlKandla IKolkatal Mumbail Nhava Sheva.

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

2. 0 APR ZOll

MIs J.Mitra and Bros,Shop No. 20, Double Storey Market, New Rajinder Nagar, NewDelhi-110060.is hereby licensed to import into India during the period for which the licence isin force, the drugs specified below, manufactured by MIs. Terumo Corporation, 44-1,2-Chome, Hatagaya, Shibuya-Ku, Tokyo, 151-0072, having factory premises at MIs. TerumoCorporation,150, Maimaigi- cho, FUjiomiya-shi, Shizuoka, 418-0015, Japan is enclosedhereby.

2. This Endorsement No.1 shall be ~orce from 2. 0 I\PH 2011 to 14-06-2013unless it is sooner suspendeddl:ancelled under the said rules.

3. Nam~~c;rl~~~~~~~.i~~~t'~D CONtRA.2. FINECROS~jlarYlVlic.ro-GuideCatl'l8feJ"

IrEM(S} N' .•... .•••... .•.••....•.....•....•...... ..•. V"9Q~t,u-.

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Date: 2. 0 APR 2011 sc$; .....'1;,- . . r~~~~,r~, ft."'" -'&;1

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1. ~r:~~~~~~~d~~~"o"~:~~~:n~;~~¢~~=~~~~:P~;(;tltie;C.~~~;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 themanufacturer with date of testing, date of release and the date of forwarding suchreports. The imported batch of each drug shall be sUbjected to examination andtesting as the licensing authority deems fit prior to its marketing.

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

4. The licensee shall inform the licensing authority forthwith in writing in the event ofany change in the constitution of the firm operating under the licence. Where anychange in the constitution of the firm takes place, the current licence shall 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.

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 Delhl-11 0002

Dated: 2 0 APR 2011To ./

\/MIs Faith Biotech Pvt. Ltd,E-107, Lajpat Nagar-I, New Delhi-24.

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

Sir, ~

1. With reference to your application for import licence ~~ded to this office withyour letter No Nil dated 28/03/201 received by this iMide diWY~o 1. ~QQ49.qt~~31/03/2011. I enclose Iicence(s} NO. MD-804 dated L U AI-'K LlWl'these licence(s) has 1 have been granted un Drugs and Cosmetics Act 1940and Rules1945 thereunder. ()

2. I am to· point out that the provisions of .Drugs and Cosmetics Act 1940 andRules1945 are in addition to and not derogation of any other law for the time beingin force and as such the Iicence(s) issued under Drugs and Cosmetics Act andRules will be in addition to and distinct from any licence(s) which may be necessaryunder 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 1themselves be sufficient authority for import of Drugs covered by that 1 thoselicence(s) if under the Import Trade Control Regulations of the Commerce Ministryseparate license(s) are required for import of such drug(s).

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

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

6. The Assistant Drugs Controller (India) and Technical Officer of the Central DrugsControl Organisation at the ports will be Officers authorized to inspect the premisesof importers establishments for the purpose of Rule 26 of the Drugs and CosmeticsAct and Rules thereunder.

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

(Dr. S. Es ara 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.

FORJ\<110(See Rules 23 and 27)

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

MIs. Faith Biotech Pvt. Ltd, E-107, Lajpat Nagar-I, New Delhi-24 is hereby licensed toimport into India during the period for which the licence is in force, the drugs specified below,manufactured by MIs Micro Vention Inc., 1311 Valencia Avenue, Tustin, CA, USA, 92780and any other drugs manufactured by the said manufacturer as may from time to time beendorsed on this licence.

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

3. Names of drugs to b~ im ~:

~: ~~~rc:;~e~lcOii~eSl~~~~DITEM(S ONLY.>' ./i?<J

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2 0 APR l011

2. 0 APRDSC@)censing uthority

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rp~il~!.~ri~~~fc.;~~~~~~t:;"';d"",':{;.,.::#;;;;;1. ~r:~~~~o:~d ~~eli~~~~eal~~:~c~estMt~£Q\l, ene~~r ~~~~lr~d.a part of the2. 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 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 testingas the licensing authority deems fit prior to its marketing.

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

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