New Drugs and Clinical Trials Rules amendments streamline research procedures
20 Jan, 2026

New Drugs and Clinical Trials Rules amendments streamline research procedures

Unit 2 — Research Aptitude Unit 9 — People, Development and Environment

What Happened?

The Ministry of Health and Family Welfare amended the 2019 Rules in January. For specified non-commercial research manufacturing, an online intimation can replace some licensing steps, while certain bioavailability and bioequivalence studies can begin after online intimation. Timelines for certain high-risk drug test licences were also reduced.

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