Central Drugs Standard Control. Directorate General of Health Services / Ministry of Health & Family Welfare (Medical Device and Diagnostic

Transcription

1 Central Drugs Standard Control L Organisation Directorate General of Health Services / Ministry of Health & Family Welfare (Medical Device and Diagnostic Division) To ~!~. Microgene Diagnostics Systems Private Limited, 806, Vikram Towers, Rajendra Place, New Delhi Fo()d ~nd. Drug Administration Bhawan Kotla Road, New Delhi Dated: 1 9 JUL loll Subject: Test License under the Drugs and Cosmetics Act 1940 and Rules 1945 there under-regarding.. -Wifnreferencetoyoiii lelter No.-~nSlForm l17~pci2btf aa1ea 11Ib672br1- received by this office vide diary No (FTS: 40475) dated 17/06/2011, I am to forward herewith Import License No.~93/11 for thedrugl drugs mentioned in your application. 0~ 0«Kindly acknowi~~\~ipt V of Ihis letter and ils enclosures. Copy forwarded for information to: 1.Asstt. Drugs GontrolJer(lndia), Ahm~dabadl Chennail Cochinl Delhil Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

2 FORM-11 (SEE RULE- 33) LICENSE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINA TlON, TEST OR ANAL YSIS Number of License T -93/11 Mis. Microgene Diagnostic Systems Private Limited, B06, Vikram Tower, Rajendra Place, New Delhi-11000B is hereby licensed to import from Mis. DSI S.R.L. Via Volonterio, 361A21047-Soronno (VA) Italy manufacturing at Mis. RPC Diagnostics Systems Ltd., , Nizhniy Novgorod, ul, Kominterna 47 Russia the drugs specified below for purposes of examination, test or analysis at MIs. National Institute of Biologicals, Noida or in such other places as the licensing authority may from time to time authorize. New Del~i1 Date 2. The license is subject to the conditions prescribed in the Rules under the Drugs and Cosmetics Act, 19404',0 0<'(' 'i><\~"'4,l"~:'~ '", 3. This license shall unless,e~~\;;tiousiysuspended or'rev,ok.~d, be in force for a period of one year fro01,,:cl~tespecified b le~: '':c.", { "'~;" ":;1~" S.Ne PrQduct Name 1 DS-EIA-I::OV-AGAB-S'c 2 DS-I;J)\-HBsA EI)).-Anti-HCV NolferComm 9 JUL zgi(c~ O~'(~ SC l~~-.-' -,..- ~ '" c~ "(ffl ~Ja~~~~aJPlfuif. tri. ~ft. \Sl.," I:. Dr. ~. E~Vlara ~..;j,~.:m.?h Ph D CCih't;litionsof License. '0 "~<~""~ 0i'1l!f:,!, ~r-i<:;/a"htti~rt"jscf~r;;roller 1. The licensee shall use the substances'4rrrrbnt~d under Itl:tet.\ite,e exll!v.iiv~~~qa,~s~ ~f.~r,-~~. examination, test or analysis and shall carry on suth d examination' test or aricvmt;~~. ~~~~.~~vlces specified in the license, or in such other places as the licensing a hority ~fmoiltlrnl!l&oi tiol ;hi.,', 0002 authorize., 2. The licensee shall allow any inspector authorized by the licensing authority j-n-th-i-s -b-e-ha-i-f t-o-e'-n-te-r-, --_.-, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used to take samples thereof. 3. The licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the license, together with the quantities imported, the date of importation and the name of the manufacturer. 4. The licensee shall comply. with such further requirements, if any, applicable to the holders of licenses for examination, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice.. -5cThe drugs imported under this Iicel"lseshalll"lotbeusedforclinical studies/trials ul"lless specifically permitted so by licensing authority. 6. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.

3 Central Drugs Standard Control Organisation Directorate Ministry General of Health Services of Health & Family Welfare (Medical Device and Diagnostic Division) Food and Drug Administration Bhawan Kotla Road, New Delhi To ~19 JUL l011 ~s. BioMerieux India Pvt. Ltd. A-32- Mohan Co-operative Industrial Estate, New Delhi lndia. SUbject: Test License under the Drugs and Cosmetics Act 1940 and Rules 1945 there under-regarding. ---_._._.- Sir, With reference to your letter No. BMXl25/11 dated 24/05/2011 this office vide diary No (FTS:34770) dated 27/05/2011 this office vide diary No (FTS: 44670) dated 01/07/2011, received by and reply received by I am to forward herewith Import License No. T-9211b~i-\the drugl drugs mentioned in your application. ~ C,.<,\\J J'\ Kindly acknowledq) receipt of this letter and its enclosures. ~UIIY (Dr. S. E;Vara Reddy) Asstt. Drugs Controller (I) Copy forwarded for information to: 1. Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhil -Hyderabadf-K-andla 1Kolkatat MuftlcaiTNliavaShewa.

4 FORM-11 (SEE RULE - 33) LICENSE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINA TlON, TEST OR ANAL YSIS Number of License T -92/11 Mis. BioMerieux India Pvt. Ltd., A-32, Mohan Co-operative Industrial Estate, New Delhi is hereby licensed to import from Mis. BioMereiux S.A., 69280, Marcy-L-Etoile, France the drugs. specified. below. t()t_pyfpqsea of e<-amination,--test -or~ana1ysis-atm/s~-nriam-'s- Tiist,fiite -of -Medical Sciences, Punjagutta, Hyderabad , Andhra Pradesh, India or in such other places as the licensing authority may from time to time authorize. 2. The license is subject to the conditions prescribed in the Rules under the Drugs and Cosmetics Act, This license shall unless pr~~t~jt~1y'suspehg~d]qt revoked, be in force for a period of one year from P.~t~)s~ecified below:. '4",v' S.No Na~~$,'::t>f drugs 1. VIDAS ~ClitHBs Tota (P~fk size 60 tes '0t~TE,,#~T New Del'.li \;] Date II 9 JUL ztj1 ~,\, ~.."''/;.,. ~ bl(:eq$lng. ""(>?" t._<,0 Seal/Starn p 'J')onditions of License J:~~:;;' \6TO ~,,~.~ ~.l:fitlf. ~.~. ~. 1. The licensee shall use the substarlce's4rn12.9rtedund~):a~~:\\llliens~~wir~j~ltj!~~i:h.d. examination, test or analysis and shall carry JQ'n,s'Q,C!D'e'X'atrlrr,ati9n, test or ~~f~~~.~~t:..,: Controller specified in the license, or in such other places as the licensing.authc:lflty'.f1(li I"mo.mtifl1~~aW1'$ervices authorise. ~: cnsco nil). FD.A. Bn:!lwan ' 2. The licensee shall allow any inspector authorized by the licensi~ auth'saw'irfth~%~mfltep. ~r,' with or without prior notice, the premises where the substances ar~~..aj: l to inspect.tb.e R~.QJ_i$Jii,....,~ and investigate the manner in which the substances are being used to take samples thereof. 3. The licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the license, together with the quantities imported, the date of importation and the nameofthemanufacturer. 4. The licensee shall comply with such further requirements, if any, applicable to the holders of licenses for exainnation, test or analysis as may be specified in any rules subsequently made under Chapter,/I of the Act and of which the licensing authority has given to him not less than one month's notice. 5. Thifdrugs imported under this license shall not be used for clinical studies/trials unless specifically permitted so by licensing authority. 6. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.

5 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare To Food & Drugs Administration Bhawan, Kotla_!3{)Cl~,}"eVIIP~!bi:1JOQOf Date:!1 9 JUL ZOll ~. Vishat Diagnostic Pvt. Ltd , Gaurav Garden, Opp. Sai Petrol Pump, Mira-Bhayander Road, Mira Road East, Thane Subject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. With reference to your letter No. VDPU11-12/003 Dated received by this office vide diary no (FTS 35967) dated O~~06;2011I am to forward herewith Import Licence No. T-90/11 for the drug/ drugs ment~~n \your application. Kindly acknowledge receipt o~~tl:lfjetter and its enclosures. (". <!' ' ~ Yours faithfully (Dr.S.~dY) Asstt. Drugs Controller (I) Cop forwarded for informationto: 1. Asstt. Drugs Controller (India), Ahmedabad/ Chennai/ Cochin/ Delhi/ Hyderabad/ Kandla /Kolkata/ Mumbai/ Nhava Sheva.

6 FORM-11 (SEE RULE - 33) LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINA TION, TEST OR ANAL YS/S Number of Licence T-90/11 MIs. Vishat Diagnostic Pvt. Ltd., 23 24, Gaurav Garden, Opp. Sai Petrol Pump, Mira- Bhayander Road, Mira Road East, Thane is hereby licenced to import from MIs. NovaTec Immundiagnostica GmbH Technologie & Waldpark, Waldstr. 23 A6, , Dietzenbach,. Ger'!l~-']Y_tb~dIlJgs_sp_ecifiedbeJowJor--pbJ-rposes-ef-exam1nation, ----tesr-ofanalysrs--acm/s:-thyrocare Technologies Ltd., 0/37-1, MIDC, Turbhe, Opp. Sandoz, Navi Mumbai or in such other places as the Licensing Authority may from time to time authorize. 2. The licence is subject to the coqdi!iql"is::prescribed,inthe Rules under the Drugs and Cosmetics Act, , 3. This licence shall unle~s:previouslysusone year from date specified below:, ' -'0,.",' S. No. 1 2 Quantity 5 X 3~:;l5Kits 5 X 3=c15 Kits.:~ibJ.eEit t~-tmfrt- :1, -,~' 6TO ~~~~~~.~. ~. ~. \i. '-i J-, _ "-, '\ Dr. S. Eswa:-3 Reddy M.Ph Pil.D.,~, -Co'AQition1)f;Liee;ri~~' m;m; ~~f; l~:.~~i;::~~~.?i1.!~r; Controller r:, 1. The licensee shall use the substances imip~rt~cf iu~der the Iic~nsecft~CI~y~-i~;~~~o.fices \~, examination, test or analysis and shall carry on such examinatt\j.s1 ~..Jllm1b'j!l~_QQ2 ' ~~e~i~~~~~i;:~ license, or in such other places as the Iicen i~~_ ~~~~1~1~~y-:!~.~m, time to. ~_-.._:: 2. The licensee shall allow any inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used to take samples thereof;. 3. The licensee shall keep a record of, and shall report ot the licensing authority, the substances imported under the license, together with the quantities imported, the date of importation and the name of the manufacturer. 4. The licensee shall comply with such further requirements, if any, applicable to the holders of licenses for examination, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice. 5. The drugs imported under this license shall not be used for clinical studies/trials unless specifically permitted so by licensing authority. 6. The drugs imported under this license shall not be directed to or for Commercial Marketing including expgrt purposes..

7 Central Drugs Standard Control Organisation Directorate General of Health Services.- --wlrnlsfry-of-aealff1-&famlly~werf~rre Food & Drugs Administration Bhawan, Kotla Road, New Delhi To 1 9 JUL 2011 ~ Vishat Diagnostic Pvt. Ltd , Gaurav Garden, Opp. Sai Petrol Pump, Mira-Bhayander Road, Mira Road East, Thane SUbject: Import Licence under the Drugs and Cosmetics Act 1940 and Rules 1945 thereunder- regarding. With reference to your letter No. VDPL/:o~102 Dated received by this office vide diary no (FTS 35965) ~&) I am to forward herewith Import LicenceNo. T-89/11 for the drug/ ~~tioned in your application. Kindly 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), Ahmedabad! Chennai! Cochin! Delhi! Hyderabad! Kandla!Kolkata! Mumbai! Nhava Sheva.

8 FORM-11 (SEE RULE - 33) LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINA TlON, TEST OR ANAL YSIS Number of Licence T-89/11 MIs. Vishat Diagnostic Pvt. ltd., 23-24, Gaurav Garden, Opp. Sai Petrol Pump, Mira- Bhayander Road, Mira Road East, Thane is hereby licenced to import from Mis. SciMedx Corporation, 100 Ford Road, Denville, NJ 07834, USA the drugs specified below for purposes of examination, test or analysis at Mis. Metropolis --HeallncarEf-ttd:;-250,;D,lIdyog -Bhavan{Behind-GJax_oJ,Hind Circl~ Marg, Worli, Mumbai or in such other places as the Licensing Authority may from time fa time authorize. 2. The licence is subject to the conditions prescribed in the Rules under the Drugs and Cosmetics Act, This licence shall unless previously suspended orrevoked, be in force for a period of one year from date specified below:!:~c,,,,i (-<:' S. No. 1 2 bengue Dengue f!.(.oduct Narn~\: IgG,C:pdeNo~DEN~'_ IgM,iCbdeNo.DEN NO.tforCom t.".) ITE 'a OND New Delhi Date ~19 JUL ZaH;~1 (N l tr( ";1;'~,,",W '" l-~,-" ~if;::;} QullJltity 5 X 3==~~"5Kits 5 X 3= t~kits /~ -~. ";N~':h':tiM'li$'~"1ttftM1!'t~."- ~ ~ tf9 ~11~~~~. ~.~. ~ Dr.:. U.c.r:.l Red(i~M.Ph Ph.D. Condition of License ~~q; ~'Iii;f,;;;''T;~iq;i".~~:>Df\!;5 Controlh.- /i,~"«) ~~_ '"",_ ~'f/'~'''\;:',;",-~.1 '. ~j;=::?;... '.(;..~';-r ~~lj~~rrffu 1. The licensee shall use thesljlbstcf':'~~ 'lft\lptnted und~r thebuc~rex6tuse\mll~ Service! for purpose of examination, test or analysis anp shr!k~~ritfit9n.~~n~~~n()qol ~~~:i~i~~:' at:~~eo~ic:~li~~sa~~h~~~:~~; f~~~c~i~~ tlj,~~~%ir~i~~--~~ ~~ ~~--~ ~ 2. The licensee shall allow any inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the.substances are kept,and to inspect the premises, and investigate the manner in which the substances are being used to take samples thereof; 3. The licensee shall keep a record of, and shall report ot the licensing authority, the substances imported under the license, together with the quantities imported, the date of importation and the name of the manufacturer., 4. The licensee shall comply with such further requirements, if any, applicable to the holders of licenses for examination, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month's notice. The drugs imported under this license shall not be used for clinical studies/trials unless specifically permitted so by licensing authority. 6. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.