}"'ileno. CT/25/2011-DCG (I) Directorate General of Health Services Office of Drugs Controller General (India)

Transcription

1 }"'ileno. CT/25/2011-DCG (I) To, Mis VCB India Pvt. Ltd. 504, Peninsula Towers, Peninsula Corporate Park, Ganpatrao Kadam Marg, Lower Parol (W) Mumbai FDA Bhawan, New Delhi Dated Kotla Road, Subject: Export of biological samples by Mis VCB India Pvt. Ltd Mumbai to VK for testing purpose. Protocol No. - SLOOIO Ref: Letter No. PISPLlUCB /0 1, dated 1/4/2011 Sir, This directorate has no objection to your export of following quantity of samples for testl analysis at Mis Millipore BioPharma Services, 91 Milton Park, Abingdon, Oxon, OX14 4RY, UK. Yours Faithfully (Dr. K. B ngar rajan) Dy. Drugs Controller (I)

2 To, F. No. CT/25/2011-DCGI (I) (Biological Division) Mis. DCB India Private Limited #504, Peninsula Towers, Peninsula Corporate Park Ganpatrao Kadam Marg, Lower Parel (W), Mum bai M/s. FDA Bhawan New Delhi Dated: ~'8 AUG loll Subject: " A Phase 3, randomized, double blind, Placebo controlled, Multicenter study of the efficacy and safety of four 12-week treatment cycles (48 weeks total) of Epratuzumab in systemic lupus Erythematosus Subjects with moderate to severe disease (Embody 2) ( Protocol No. SLOOI0) - regarding Reference: Your letter No. PISPLlUCB /2011/01, dated 1 April, 2011 (Dy. No , dated ) Sir, This Directorate has no objection to your conducting clinical trials with the said drug under the supervision of the investigators mentioned in your letter and as per the protocol forwarded to this Directorate. At the time of submitting clinical trials reports to this Directorate for evaluation you are required to comply with the following requirements:- I. Submit complete repoli of clinical trials as per the approved protocol from the individual investigator duly signed by him along with his observations/remarks on the drug. 2. Indicating the date of commencement and conclusion of the clinical trial at each center (in case the study is multi-centric). 3. Approval of the Ethical Committee of the concerned centrelinstitution for conducting the clinical trial with the said drug. You are requested to submit to this Directorate an annual status report on each clinical trial viz. ongoing, completed or terminated. Tn case the trial is terminated the reasons for the same should be communicated to this Directorate. In case any unexpected serious adverse reaction is observed during trial, the same should be immediately communicated. It may kindly be noted that merely granting permission to conduct clinical trials with the drug does not conveyor imply that based on the clinical trial data generated with the drug, permission to market this drug in the country will automatically be granted to you. You are also requested to follow Ethical aspects of the clinical trial as described in the booklet "Ethical Guidelines for Biomedical Research on Human Subjects" published by Indian Council of Medical Research (ICMR), New Delhi, and 'GCP' guideline issued by this Department and to obtain Ethical Committee clearance of the Institute before initiation of the study. Ethical Committee clearance should be obtained before initiation of the study. It is mandatory to register this clinical trial at ICMR clinical trial registry at before enrolling first patient in the study. In future correspondence, you may intimate this Directorate that you have registered the study as mentioned above and also mention the registration number in all your correspondences. In case of study related injury or death, you will provide complete medical care as well as compensation for the injury or death and statement to this effect should be incorporated in the Informed Consent Form. Further in case of such injuries or deaths the details of compensation provided should be intimated to this Directorate. You are also directed to submit details of all six sites proposed in India, as you have submitted details of only four Indian sites before initiation of study. (Dr.Surinder Singh) DrugsController General (India)

3 F.No CT125/2011 DCGI (Biological Division) To, FDA Bhawan KotIa Road, New Delhi, Dated:~, Mis. UCB India Private Limited #504, Peninsula Towers, Peninsula Corporate Park Ganpatrao Kadam Marg, Lower Parel (W), Mumbai Dear Sir I Sirs,. With reference to your letter no. PISPLlUCB / , dated 1 April, 2011 (Dy. No , dated ), please find enclosed herewith the license for "examination, and analysis" bearing Nos. T III for the drug I drugs mentioned in your application(s). test Kindly acknowledge receipt of this letter and its enclosures. Yours faithfully,. ~~ DEPUTY DRUGS CONtROLLER (INDIA) Copy together with a copy of licence Nos T Ill, dated----!i !y--,g..:. Forwarded for information to:- 1. The Asstt. Drugs Controller, India, New Customs House, Mumbai 2. The Asstt. Drugs Controller, India, Custom House, Calcutta. 3. The Asstt. Drugs Controller, India, Custom House, Chennai 4. The Asstt. Drugs Controller, India, IGI Airport, Air Cargo Unit, New Delhi

4 THE DRUGS AND COSMETICS RULES, 1945 FORM-11 (SEE RULE - 33) LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINATION, Number of Licence T /11 TEST OR ANALYSIS M/s. UCB India Pvt. Ltd.# 504, peninsula Towers, Peninsula Corporate Park, Ganpatrao Kadam Marg, Lower Parel (W), Mumbai is hereby licensed to import from Singapore depot: 21 Bukit Batok Cresent #12-71/72 WCEGA Building Singapore , the drugs specified below for purposes of examination, test or analysis in India or in such other places as the licensing authority may from time to time authorize. (3) The licence is subject to the conditions prescribed in the Rules under the Drugs and Cosmetics Act, (4) This licence shall unless previously suspended or revoked, be in force for period of one year from date specified below: S.No. Name of the Drug 1. Nutrimix (em ty TPN mixing bag) (Item One (01) only) Not for any Commercial Purposes Condition of License (Dr. Bangarurajan) Deputy Drugs Controller (India) 1. The licensee shall use the substances imported under the license exclusively for purpose of examination, test or analysis and shall carryon such examination, test or analysis in the place specified in the license, or in such other places as the licensing authority may from time to time authorize. 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 license, together with the quantities imported, the date of importation and the name of the man ufactu rer. 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 export purposes. 7. The firm shall obtain No Objection Certificate from the Narcotics Commissioner of India, 19, The Mall Morar, Gwalior for the import of drugs under Narcotic Drugs and Psychotropic Substances Act and Rules, 1985.

5 F.No CT125/2011 DCGI Direct.orate General of Health Services. (Biological Division) To, FDA Bhawan Kotla Road, New Delhi, Dated:~l1 MIs. UCB India Private Limited #504, Peninsula Towers, Peninsula Corporate Park Ganpatrao Kadam Marg, Lower Parel (W), Mumbai Dear Sir I Sirs, With reference to your letter no. PISPLlUCB /2011/01, dated 1 April, 2011 (Dy. No , dated ), please find enclosed herewith the license for "examination, and analysis" bearing Nos. T III for the drug I drugs mentioned in your application(s). test Kindly acknowledge receipt of this letter and its enclosures. Yours faithfully, Copy together with a copy of licence Nos Forwarded for information to:- 1. The Asstt. Drugs Controller, India, New Customs House, Mumbai 2. The Asstt. Drugs Controller, India, Custom House, Calcutta 3. The Asstt. Drugs Controller, India, Custom House, Chennai 4. The Asstt. Drugs Controller, India, IGI Airport, Air Cargo Unit, New Delhi

6 THE DRUGS AND COSMETICS RULES, FORM-II (SEE RULE - 33) LICENCE TO IMPORT DRUGS FOR THE PURPOSE OF EXAMINATION, TEST OR ANALYSIS Number of Licence T- 4774/11 Mis. UCB India Pvt. Ltd.# 504, peninsula Towers, Peninsula Corporate Park, Ganpatrao Kadam Marg, Lower Parel (W), Mumbai is hereby licensed toimport from UCB Pharma S.A. Clinical trial supplies Operations Chemin du foriest B1420 Braine 1'alleud Belgium, the drugs specified below for purposes of examination, test or analysis in India or in such other places as the licensing authority may from time to time authorize. (1) The licence is subject to the conditions prescribed in the Rules under the Drugs and Cosmetics Act, (2) This licence shall unless previously suspended or revoked, be in force for period of one year from date specified below: S.No. I. Quantity 3994 vials (Item One (01) only) New Delhi Date~O" Not for any Commercial Purposes (D'.K~ Deputy Drugs Controller (India) Cond ition of License The licensee shall use the substances imported under the license exclusively for purpose of examination, test or analysis and shall carryon such examination, test or analysis in the place specified in the license, or in such other places as the licensing authority may from time to time authorize. 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; 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. 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. The drugs imported under this license shall not be directed to or for Commercial Marketing including export purposes. The firm shall obtain No Objection Certificate from the Narcotics Commissioner of India, 19, The Mall Morar, Gwalior for the import of drugs under Narcotic Drugs and Psychotropic Substances Act and Rules, 1985.