201l Food and Drug Administration Bhawan Kotla Road, New Delhi

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 To, ~ ~"~.~riends Consolidation Limited, D. No /82/AJ281-0, Road No. 10 B, Gayathri Hills, Jubilee Hills, MCH Circle-5 Mandai, Hyderabad Dist. 201l 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 thi~-.9fficevide Diary No dated I enclose Iicence(s) No. ~l~$it~iled r. ":r f11isi these Iicence(s) has I have been gr.an~,9.~ ~. -rugs and cb~rrl~iics cah\""1940 and Rules1945 thereunder. O~\'f. 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 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 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 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. Drugs Controller (Dr. Gen

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 Friends Consolidation Limited, D. No /A/281-0, Road No. 10 B, Gayathri Hills, Jubilee Hills, MCH Circle-5 Mandai, Hyderabad Dlst. is hereby licensed to import into India during the period for which the licence is in force, the drugs specified below, manufactured by MIs Livedo Corporation having a manufacturing at 45-2 Handaotsu, Kanada-cho, Shikoku chuo-shi, Ehime-Ken , Japan manufactured by the said manufacturer as may from time to time be endorsed on this licence. 1. This licence shall be in force from.:. v,',r' ; ill unless it is sooner suspended or cancelled under the said rules. 2. Names of drugs to be imported: ~OARD C 1. Haemostatic PadAiT SS'"\~ '.. ~(j 11:1;, ~C(»P Date: _""'_' _ "1' ;.. l " 1. A photocopy of licence SI'1~lJi(p~ the original licence shall ip'. 2. Each batch of drug imr~rt~ I ~horlty ~~~~tamp Cr. G. N. SINGH Controller General (India) or H:aalth Services 8, Family VVelfare LTD.,,;-'11C002 I9remis6Slaa):uli:l, report and a batch release certificate, duly signe and au en Ica eye 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

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 , / MIs Cure Surglcals, 5-12, 1 st Floor, Green Park Extn., New Delhi 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 dated and reply received vide diary No dated , diary No dated , dairy No dated and. 7 diary No.J~"9700 dated ~ I enclose licence(s) No. MD-945-1i~etJ."::,,;; i "": ~..,.. ;i(his / these IIcence(s) has / have been granted unom;~hmgs and Cosmetics Act 1940 and 2. ~~~St~9~~i~~e~~~~~~rtheprovisidtlit1~~~~""" 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 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 / 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 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. Drugs Controller (Dr. G~ingh) Gen~~1 ~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 Cure Surgicals, S-12, r t Floor, Green Park Extn., 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 MIs GS Medical Co. Ltd., 12-F, Kolon Digital Tower Aston, , Gasandong, Geumcheon-gu, Seoul, , Korea having Manufacturing premises at Mis GS Medical Co. Ltd., # 636, Yeonje-ri, Gangoe-myeon, Cheongwon-gun, Chungb uk, Korea and any other device manufactured by the said manufacturer as may from time to time be endorsed on this licence. '} 1. This licence shall be in force from... ; ; \,. ok, unless it is sooner suspended or cancelled under the said rules. 2. Names of drugs to beimport~d: ~\)ARD C0tVt, ",,c, 1]E.M~Sl(!)N E.()NI...Y'.0 Q<;; 1. GSS Pedicle Screw System S~\~ '.> >... ~Ol Date:,",,'1! '.._ in~;;t rugs Controller General (India) G,enercl of Hec:JUl Services of Health & Family \f\felf3fs \(0,101 Roed, 1.1.0, ;::I:',1-1'10U02 1. A photocopy of licence sl1ahbeqi~p!.~ and the original licence shallpeproduced, 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

5 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 MIs Vee Care Incorporation, No. 36, Block No.7, Vijay Nagar, New Delhi-11 0,009 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 dated and reply received vide=,di~~y,no." 1~ 15 dated I enclose Iicence(s) No. MD dated- 's f ",,'n:1 this I these Iicence(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 un~e Import Trade Control Regulations made of the Government of India, Ministry of C. erce. 3. The import licence(s) mentioned in para (1) above will nqb~ ordingly to itself / themselves be sufficient authority for import of Drugs covek~ byqhat / those Iicence(s) if under the Import Trade Control Regulations of th~.. \~rnmerce Ministry separate license(s) are required for import of such drug(s). ((~~~ 4. I am therefore, to advise you to obtain, where nec~ary 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. Drugs Controller (Dr.G~gh) General (India)

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,~,,,. v, :pis ~, :'..~~,) i~4.;;'~';. Mis Vee Care Incorporation, No. 36, Block No.7, Vijay Nagar, 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 Mis Medcomp Inc., having manufacturing premises at 1499, Delp Drive Harleysville, Pa19438, USA and any other device manufactured by the said manufacturer as may from time to time be endorsed on this licence. '''''' This licence shall be in force from -J,." {~Oil unless it is sooner suspended 2. Names of drugs to be imported: As per Annexure-I or cancelled under the said rules. Date: ':_'... '_,,,', G. N, S\NC,]-i C~rlcHt,iQnsof Licence Drugs Controller Gener~\ (\i:~i2!.' I.. /51 } """,'... "".,' c,. Dte, General of Health Ser\ilc8,o 1. A photocopy of licence shall be displayed 1I1' a'prol11jo.eat':placein a part of t~ipr~li'hies,&a11lclk!\j\!:.i;~)f; the original licence shall be produced, whenever required. FOP, 8113W8n, I~Otl3r(?,~5i,i. 1.(; l~"w, L;lnl-110(;v!. 2. Each batch of drug imported into India shall be accompanied with a detailed Daren 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

7 Product 1. Hemodialysis Catheter & Accessories Article No. XTP94CTI XTP94MTI XTP96CTI XTP96MTI XTP114CTI XTP116CTI XTP118CTI XTP119CTI XTP114MTI XTP116MT/XTP118MTI XTP119MTI XTP1141JC-21 XTP1161JC-21 XTP1181JC-21 XTP1141JS-21 XTP1161JS-21 XTP1181JS-21 XTP941JCI XTP961JCI XTP981JCI XTP941JSI XTP961JSI XTP981JSI XTP1141JCI XTP1161JCI XTP1181JCI XT~~j1f\IJ,Sr;),(TtP;l,~1rijIJSI XTP1181JSI T74MI T94CI T9f?OI,Tg'aCI T94MI t9j6ivijli~~~mi T114CI T116CI T118CI,:rJ19CI T114MI T116MI T118M/1!:t,19MI T1141JC-21 T1161~C~21T118IJC-21,~:t,1)1IJS-21T116f.:J, -21T1181JS-21 SL:t~~I'! SL15CJ-,~p..",.':, 'L3;~.21 SL15(~~201 SL241,x.~'S1t4CT/,~~~~,!~3118CTI ~P3114MTI..,,\~~~~P3116MTI XTP~1C~~",/,,"41 MCF101 Mc;B651SL281,:,,<f\~\~~.r,,:S,L321SL24PI AS~~,~;$~:;~'B'i",;~SPC-36-3WOE/(~SPC-28- \:d \~ "3WOE ' ""r' : ',." ",. ~<i't',;"':,~" ;' 2. Peritoneal Dialysis Catheter & Accessories, MD~3~SJ; "'~D~C~2~/i( 'MO:C3;~~1 MI:;>C4~S~ MDC47S1 MpD24.21 Mbc"5~C/' ':"U:~C,63CI MPD2571 MPD2631 MSC31S1 Msc.srSI MS:042SI MSC46S/MPD-146SI MPP41S1MPP4~~I:MPD1,~~I'~RJ;)1461MPP~901 MPP57CI MPP60CI,., MPD1'60/MC2<Y0301/MC200302/MC «"',':,'';'~~:'T\~,'(~->',":~;(~':~'~t:~ g >lo. MC200~021 MC200101/MC MC MC200202,/MTCI