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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

New Drugs and Clinical Trials (Amendment) Rules, 2026

20-Jan-2026 | 46(E)

This circular issued by the Central Government, after consultation with the Drugs Technical Advisory Board, notifies the New Drugs and Clinical Trials (Amendment) Rules, 2026, which amend the New Drugs and Clinical Trials Rules, 2019. These amendments introduce and operationalise the concept of permission or prior intimation for the manufacture of new drugs and investigational new drugs for purposes such as clinical trials, bioavailability and bioequivalence studies, and examination, test, and analysis. Manufacturers shall ensure that applications are submitted in the prescribed forms (CT-10, CT-12, CT-13, CT-14, and CT-15, as applicable) either for obtaining prior permission or for giving prior intimation to the Central Licensing Authority, in accordance with the revised provisions. Institutions shall comply with the revised timelines, noting that the processing period has been reduced from ninety working days to forty-five working days under the relevant rules.

Manufacturers shall strictly restrict the use of drugs manufactured under permission or prior intimation to approved purposes only, shall not sell or supply such drugs in the market, and shall maintain complete records of manufacture, use, supply, disposal, and destruction in accordance with Good Manufacturing Practices. Further, institutions shall adhere to the revised provisions relating to inspection, labelling, suspension or cancellation of permission or acknowledgement of prior intimation, and appellate remedies as prescribed under the amended rules. Compliance with these amendments shall be mandatory upon their coming into force, i.e., forty-five days from the date of publication in the Official Gazette.

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