GRI

New Drugs and Clinical Trials Rules 2019

Law Healthcare & Pharma English Drugs and Cosmetics
Date: 4th Oct, 2024 Source: Central Drugs Standard Control Organization Country: India Original Source

Brief

The New Drugs and Clinical Trials Rules, 2019 aim to standardize drug approvals and clinical trials in India, emphasizing safety, transparency, and efficiency. Key provisions include mandatory ethics committee approval, fast-track approval for critical drugs, and clear guidelines for participant compensation. The Rules enhance India’s role in global clinical research.

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Central Drugs Standard Control Organization

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