India’s health ministry proposes amendments to streamline drug testing, BA/BE Study rules

Application processing timeline cut from 90 to 45 days.

India's Union Health Ministry has proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019 to cut red tape in drug testing and clinical research.

The draft rules, published in the Gazette of India on 28 August 2025, aim to streamline applications for test licences and Bioavailability/Bioequivalence (BA/BE) studies.

The proposed changes include replacing the current test licence system with a notification or intimation-based process. Except for a small category of high-risk drugs, applicants will no longer be required to wait for formal test licences, and the statutory processing time will be reduced from 90 days to 45 days.

For Bioavailability/Bioequivalence (BA/BE) study applications, the licence requirement for certain categories will be removed, allowing studies to commence upon submission of an intimation to the Central Licensing Authority.

The ministry expects the changes to reduce licence applications by about 50%, speed up research timelines, and ease workloads for the Central Drugs Standard Control Organization (CDSCO).

Officials said the reform supports the government’s push for “Ease of Doing Business” and strengthens India’s position as a global hub for pharmaceutical R&D.