Union Health Ministry Moves to Amend NDCT Rules 2019, Simplifying Drug Test Licences & BA/BE Study Applications

New Delhi- In line with the vision of Prime Minister Narendra Modi to reduce regulatory burden and promote Ease of Doing Business in the pharmaceutical and clinical research sectors, the Union Ministry of Health & Family Welfare has proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019. The draft notification was published in the Gazette of India on 28th August 2025, inviting public comments.

Key Features of the Proposed Amendments

1. Simplified Test Licence Applications

   • Conversion of the current licensing system into a notification/intimation model.

   • Applicants (except for a limited category of high-risk drugs) will no longer need prior approval; only intimation to the Central Licensing Authority (CLA) will be required.

   • Statutory processing timelines cut down from 90 days to 45 days.

2. Eased BA/BE Study Procedures

   • Certain Bioavailability/Bioequivalence (BA/BE) studies will be exempt from licensing requirements.

   • These can now be initiated through simple notification to CLA, eliminating delays.

Expected Benefits

• 50% reduction in licence applications, easing the compliance load.

• Faster commencement of BA/BE studies, testing, and drug development.

• Reduced delays in research and approval processes.

• Optimised workforce utilisation within the CDSCO, improving regulatory oversight.

The Health Ministry highlighted that these reforms are part of broader efforts to align India’s regulatory ecosystem with global best practices. By enhancing efficiency, transparency, and timelines, the move is expected to make India a more attractive destination for clinical research and pharmaceutical innovation, bolstering its position as a global pharma hub.