Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare

Transcription

1 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (Medical Device & Diagnostics Division) Food & Drugs Administration Shawan, Kotla Road, New Delhi MIs J. Mitra & Co. Pvt. Ltd. A-180, 181, Okhla Industrial Area, Phase-I, New Delhi Please refer to your application no.jmpua-7/0/mkp/ii dated received by this office vide Diary NO (FTS 34365) aated and Diary NO (FTS 40979) dated on the subject cited above. The case has been examined in the light of the-documents submitted by you. This Directorate has no objection for the import of following raw material from different sources for the manufacturing of Diagnostic Test Kits under the drug manufacturing licence NO.1650 on form 26 issued by Licensing Authority (Delhi) valid up to Copy to: 4Z' (Dr. S. Eswara Reddy) Asstt. Drugs Controller (I) fie Asstt.' Drugs Controller (I) International Air Cargo Unit, Indira Gandhi International Airport, New Delhi- 37

2 Date:...1 ~ c.. JUL 2071 (a) Human IgM (b) Leptospira Biflexa Antigen (c) Leptospira Antigen (a) Alkaline Phosphatase (a) Polyclonal Anti human IgA (b) Monoclonal Anti human IgA (a) Biotin (b) Streptavidin HRPO Conjugate (c) Streptavidin Alkaline Phosphatas ConJugate (d) P. vivax Malaria Antigen (e) P. falciparum Malaria Antigen (f) P. malariae Malaria Antigen (g) P. ovale Malaria Antigen (h) Pan Malaria antibody (i) Malaria Pf PLDH antibody (j) Malaria Pf HRP2 antibody (k) Malaria P.v antibody (I) Polyc1onal anti Bovine antibody (a) Salmonella Typhi OMP antigen (b) Salmonella Typhi LPS antigen (c) Salmonella Paratyphi A OMP antigen (a) Monoclonal CD4 antibody (b) Polyclonal CD4 antibody (c) Polyclonal Anti Sheep IgG antibody (d) Polyclonal Anti Mouse IgG antibody (a) Polyclonal Anti Horse IgG antibody (b) Monoclonal COB antibody (c) Polyclonal COB antibody (d) Polyclonal Anti Rabbit IgG antibody (e) Polyclonal Anti Goat IgG antibody (f) Goat IgG (g) Horse IgG (a) Syphilis Antigen (a) Chikungunya Antigen (Dr. S. Eswara Reddy) Asstt. Drugs Controller (I)

3 Central Drugs Standard Control Organisation Directorate General of Health Services Ministry of Health & Family Welfare (_M""'e<WdLUoic_alLl.... De'l.~.e_and Diagnostic Division) _ Food and Drug Administration Bhawan Kotla Road, New Delhi To ~ Span Diagnostics Limited, Plot No. 336, 338, 340, Road No.3, G.I.D.C., Sachin , Surat, Gujarat, India. Dated:'1 3 JUL 2011 SUbject: Test License under the Drugs and Cosmetics Act 1940 and Rules 1945 there under-regarding. With reference to your letter No. SDUIMPNiro/11-12/00 dated 06/06/2011 received by this office vide diary No (FTS: 39404) dated 14/06/2011, I am to forward herewith Import License No. T-82/11 for the drugl drugs mentioned in your application. Copy forwarded for information to: 1.Asstt. Drugs Controller (India), Ahmedabadl Chennail Cochinl Delhi/ Hyderabadl Kandla IKolkatal Mumbail Nhava Sheva.

4 FORM-11 (SEE RULE - 33) LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINATION, TEST OR ANALYSIS Number of License T-82/11 Mis. Span-Biagnosties-ldmited,-J2IQt-NtJ.-338, 33~ 3~ Road No.3, G.I.D.C., Sachln , Surat, Gujarat, is hereby licensed to import from Mis. National Institute for Biological Standards and Control, Blanche Lane, South Mimms, Potters Bar, Hertfordshire EN6 3QG, U.K. the drugs specified below for purposes of examination, test or analysis at MIs. Span Diagnostics Limited, Plot No. 336, 338, 340, Road No.3, G.I.D.C., Sachin , Surat, Gujarat 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, 19~~Of\RDCONl: 3. This license shall unless ~r.;vi1usiysuspendedor~~'(5d, be in force for a period of one year fro~~te specified ;.pc;" Names of drugs to~ijtlporte f~ "f,f' 'Of As per attached Diagnosti by Licensing Bthority llj ITEM{ (:;1 {~ ) Z New Delhi Date 1 3 JUL loa ~-~,.~~m}t---- fg ~~it~~::~i1!r~in S~aV ~mj? "~-"I 'rl--niftl'l.. "L '... ::::..". ~o ~ ~ '~")~lff.~. t". \i1.'s....,j!!..,jtlonso.'.. Icen.se,~b.0- Dr. S.~~'inr -' "{ell',;" :"'. 1. The licensee shall use. the substancev}n)p.. prtedund...er.!b~~~ex~~lforf~o. $e:,~of;,.:~".:onc, examination, test or analysis and. shall caitf16r1'~et5@~jon,test or anal~"4n tm,1'iiac.e.,,.".. specifi~d in the license, or in such other places as'the licensing authority it\if; ~T":~~~ J? ';Pm~'3; ':: ~~~~~~~nsee shall allow any inspector authorized by the licensing aut1:llrit/frwiisrti;fi~lf {t;'::~~t~~i~'~~~~2 with or without prior notice, the premises where the substances are kept, /Qt;\6He111Spect the preml~,.. 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 a\jthority, 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 sudsequently 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 studiesltrials 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. '-'~., ;io

5 This license shall be in force from ~ to 1 2 j ~L ZOU- Names of drugs to be imported S.No Names of drugs Quantity which may be imported 1 Human C-Reactive Protein (85/506) 2 ampoule (each of 0.5 ml) 2 Rheumatoid Arthritis Serum (64/002) 2 ampoule (each of 2.0 ml) 3 Anti-Streptolysin-O Human ASO (97/662) 2 ampoule (each of 0.5 ml) 4 Human Syphilitic Plasma IgG & IgM 2 ampoule (each of 1.0 ml) (05/132) 5 Purified Protein Derivative (PPD) (PPDT) 2 ampoule (each of 2.0 ml) New Delhi 3 JUL l011 Date _1_. _ Not for Commercial Purpose. ITEM(S) FIVE ONLY

6 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 ~s. Microgene Diagnostics Systems Private Limited, 806, Vikram Towers, Rajendra Place, New Delhi Subject: Test License under the Drugs and Cosmetics Act 1940 and Rules 1945 there under-regarding. With reference to your letter No. MDS/Form 11(Biocan)/ dated 15106/2011 received by this office vide diary No (FTS: 39786) dated 15/06/2011, I am to forward herewith Import License No. T-83/11 for the drugl drugs mentioned in your application. (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..

7 FORM-11 (SEE RULE - 33) LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINATION, TEST OR ANALYSIS Number of License T-83/11 MIs. Microgene Diagnostic Systems Private Limited, 806, Vikram Tower, Rajendra Place, New Delhi is hereby licensed to import from MIs. Biocan Diagnostics Inc, the street East Suite 309, North Vancouver, BC Canada V7L2YB having factory premises at MIs. Artron Laboratories Inc, 3938 north Fraser Way Burnaby, BC Canada V5J5H6 the drugs specified below for purposes of examtilailon,test or analysls-armls--:-s"d.m:r~hosplfal~~esearch-centre,- Jaipur or in such other places as the licensing authority may from time to time authorize. 2 Dengue Test New De.~i Date.'1 3 JUL loll ~.. ~ ~'-' ; F"""::..;!..s'WL. _.-'w r' '.~~~Lice~~~ ~tho;i.a -L.~ \f't'r' \SIt) ~ ~A '-il.~.~. GO. \i~' ~.i Dr. S.EsWG a.,;r:rcry~..ph "'h.d. 1 ~ ~cr> ~ rrl;;~:oi:;./f..;:;tu::'.":;:;cor:;roi!er ' Conditions of Licence 'j ~W:U ~'i;::r"i~:;;r:,\;;..;q 1. The licensee shall use the substances imported under the lic$nce gtcrtl~~~~".l1!jlpa~~~,9.p:rvjce:> : examination, test or analysis and shall carry on such examinati;_ ' testkwme~:'i~~-!!i~~:;:tcoa2 '. specified in the licence, or in such other places as the licensing uthority may from time to time ' authorise. ;a..,.".., ~~.---:w-.._-,~~..~ 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 to the licensing authority, the substances imported under the licence, together with the quantities imported, the date of importation and the name ofthe manufacturer. 4. The licensee shall comply with such further requirements, if any, applicable to the holders of licences 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 licence shall not be used for clinical studies/trials unless specifically permitted so by licensing authority. 6. The tlrugs imported under this license shall not be directed to or for Commercial Marketing including export purposes.