The Ministry of Health and Family Welfare has notified amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, reducing regulatory approval timelines from up to 90 working days to 45 working days for several processes related to clinical trials and drug development. The changes, issued as the NDCT (Amendment) Rules, 2026, will come into force 45 days after publication in the Official Gazette.
The amendments introduce a prior intimation mechanism for manufacturing new and investigational drugs intended for analytical and non-clinical testing. Under this system, manufacturers may begin production after online acknowledgment by the Central Licensing Authority, instead of waiting for formal permission. This provision does not apply to certain categories such as sex hormones, cytotoxic drugs, beta-lactams, biologics with live microorganisms, and narcotic or psychotropic substances.
Similar provisions have been extended to manufacturers of pharmaceutical formulations and active pharmaceutical ingredients. Drugs produced under these rules are restricted to use in clinical trials, bioavailability and bioequivalence studies, or testing and analysis, and cannot be sold commercially. Compliance with Good Manufacturing Practices, production in specified facilities, maintenance of detailed records, and proper labelling have been made mandatory.
The amended rules also specify conditions for suspension or cancellation of permissions or acknowledgments in cases of non-compliance, along with appeal mechanisms. Overall, the changes seek to improve procedural efficiency in drug research and clinical trials while retaining regulatory safeguards.esearch and drug development while maintaining safety, traceability, and regulatory control.
