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The Union Ministry of Health and Family Welfare notified on 19 March 2019 the new Drugs and Clinical Trials Rules 2019 (the ' Rules ') aimed at promoting clinical research in the country through a consistent and faster approval process.

The new rule extends to all new drugs, new ethics committee and new research products for human use, clinical trials and bioequivalence studies

Download - New Drugs and Clinical Trials Rules 2019 - PDF
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