Health Ministry to ease test licence, BA/BE study rules; pharma sector set to gain

In a major regulatory reform aimed at promoting ease of doing business in the pharma and clinical research sectors, the Union Health Ministry is planning top amend the New Drugs and Clinical Trials (NDCT) Rules, 2019.

The most significant change proposed is the replacement of the current licensing system for test licences, with a simplified intimation and notification mechanism.

Under the new framework proposed, companies will no longer need to wait for approvals in most cases; instead, they can begin work after intimating the Central Licensing Authority.

Only a small set of high-risk category drugs will continue to require prior clearances.

Moreover, the statutory processing time for such applications will be halved, from the existing 90 days to 45 days. This gives drug developers faster access to testing permissions.

The amendments, notified in the Gazette of India on August 28 and now open for public comments, are expected to streamline procedures for test licences and applications related to Bioavailability/Bioequivalence (BA/BE) studies.

BA/BE study applications

The amendments also address regulatory requirements for BA/BE studies, which are critical in establishing therapeutic equivalence of generic drugs with their innovator counterparts.

For certain categories of studies, the existing licence requirement will be dispensed with.

These studies can now be initiated simply through intimation to the Central Licensing Authority, cutting down delays in study initiation.

Sources said, faster initiation of clinical research and streamlined compliance are expected to make India a more attractive destination for global drug developers. This will further strengthen the country’s position as a hub for pharmaceutical research and development.

Once implemented, the reforms are expected to give a fillip to India’s ₹4.5-lakh-crore pharma industry, which has been seeking faster approval mechanisms to reduce time-to-market for new drugs and generics.

Published on September 3, 2025