Drugs and Clinical Trial (Amendment) Rules, 2023
The Union Government passed an amendment to the New Drugs and Clinical Trial Rules (2023).
- It is aimed at promoting clinical research in India and ensuring the conduct of ethical trials.
- Approval time for drugs discovered or developed in India is reduced to 30 days, while for drugs developed outside it is set at 90 days.
- Ethics Committees will monitor trials and determine compensation for adverse events.
- Orphan drugs, treating conditions affecting up to five lakh persons, are defined for the first time.
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Clinical Trials
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