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HEALTH & FAMILY WELFARE

Introduction of Drugs Without Clinical Trial

New Delhi: December 11,2012

The Department Related Parliamentary Standing Committee on Health & Family Welfare in its 59th Report on the Functioning of the Central Drugs Standard Control Organisation (CDSCO) has raised various issues pertaining to the functioning of the organisation, including alleged approval of drugs without clinical trials.

New drugs are approved by the CDSCO based on non-clinical data, clinical data of safety and efficacy of drug, regulatory status in other countries etc. as per the Guidelines and requirements specified in Rule 122A, 122B, 122D and Schedule-Y of the Drugs and Cosmetics Rules, 1945. However, as per Rule 122 A (2) and Rule 122 B (3), the requirement of clinical trial may not be necessary if the drug is of such a nature that the Licensing Authority may, in public interest, decide to grant permission to import / manufacture the new drug on the basis of data available from other countries. Further, as per clause 1 (3) of Schedule Y, for drugs indicated in life threatening / serious diseases or diseases of special relevance to the Indian health scenario, clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Licensing Authority. For grant of permission to import / manufacture of the Fixed Dose Combinations (FDC), the requirements are prescribed under Appendix-VI of Schedule-Y. As per these requirements, clinical trial on Indian patients is required in certain category of FDCs

Government had constituted a three member expert committee to examine the issues raised by the Parliamentary Committee comprising Dr. V.M. Katoch, Secretary (Department of Health Research) and Director General, ICMR, Dr. P.N. Tandon, President, National Brain Research Centre, Department of Biotechnology, Manesar and Dr. S.S. Aggarwal, former Director, Sanjay Gandhi Post-graduate Institute of Medical Sciences, Lucknow to inter alia examine the validity of the scientific and statutory basis adopted for approval of new drugs without Phase-III clinical trials on Indian population. The Report of the Expert Committee has been received and the same is under consideration.

This information was given by Minister for Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha today.

BN/HB/AS
(Release ID :90351)

 
PIB Release/DL/1191

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