India has notified two draft amendments to the New Drugs and Clinical Trials Rules, proposing a structured framework for post-approval manufacturing quality-related changes and the removal of provisional registration for Ethics Committees conducting biomedical and health research.

The first notification [G.S.R. 97(E)] introduces a lifecycle-based, risk-proportionate framework for post-approval manufacturing changes. Manufacturers would have to notify the Central Licensing Authority in writing of any modifications to manufacturing processes, excipients, packaging, shelf life, specifications, testing methods, documentation, or related aspects, with regulatory scrutiny determined by the potential impact on the drug’s identity, strength, quality, purity, or potency.

Major (Level I) and moderate (Level II) changes require prior approval before implementation, while minor changes (Level III) may be implemented without prior approval but must be reported annually in the first quarter of each calendar year. However, changes to the shelf life of the drug substance or drug product continue to require prior approval even if otherwise considered minor.

The second notification [G.S.R. 98(E)] proposes to remove the earlier system under which Ethics Committees were granted automatic provisional registration for two years upon receipt of an application in Form CT-01, allowing them to function even when a detailed scrutiny was pending by the designated authority. Under the proposed amendment, applications would instead be directly evaluated, with final registration granted only upon full compliance or rejected with recorded reasons, ensuring that only duly compliant Ethics Committees are permitted to review biomedical and health research.

 Taken together, these draft measures indicate a shift toward risk-proportionate regulation, enhanced quality governance across the drug lifecycle and stronger safeguards for human research participants, while seeking to maintain procedural efficiency and regulatory predictability.