187 Requirement of approval of Review Committee on Generic Manipulation (RCGM) under Department of Biotechnology for r-DNA derived drugs like Insulin, Monoclonal antibody, etc 2015-Nov-10 242kb

"Dated 10.11.2015

File No. 12-01/14-DC (Pt. 47) Central Drugs Standard Control Organization . Directorate General of Health Services Ministry of Health and Family Welfare FDA Bhawan, Kotla Road, New Delhi 110002

CIRCULAR

Subject:- Requirement of approval of Review Committee on Genetic Manipulation (RCGM) under Department of Biotechnology for r-DNA derived drugs like Insulin, Monoclonal antibody, etc. — regarding.

To deliberate stakeholders concerns and the way forward relating to some issues on conduct of , Clinical trials in India, two,meetings were held on 20.08.2015 and 06.10.2015 under the Chairmanship of Secretary, Ministry of Health and Family Welfare in which experts including Secretary, D/o Health Research & Director General, ICMR and Director General Health Services were present. under As regards requirement of approval of Review Committee on Genetic Manipulation (RCGM) was Department of Biotechnology for r-DNA derived drugs like Insulin, Monoclonal antibody, etc., it decided in the meeting that the applicant may submit parallel application to RCGM and DCG (I) seeking approval to conduct clinical trial. However, DCG (I) shall complete the scrutiny of application and issue permission, only after RCGM clearance was received. This is communicated for information and necessary compliance by all concerned.

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(Dr. /G. N. Singh) Drugs Controller Géneral (India)

To:i) All stakeholders through website of DCG (I). ii) Zonal and Sub-zonal offices of CDSCO/ all officers of CDSCO (HQ). Copy to:i) PS to Secretary, Ministry of Health and Family Welfare | ii) PPS to DGHS, iii) PPS to JS(R).