India, Oct. 1 -- image credit- shutterstock

On August 28, 2025, in accordance with the directions of Prime Minister Narendra Modi towards reducing the regulatory compliance and towards promoting ease of doing business in the pharmaceutical and clinical research sectors, the Union Health Ministry published the proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, in the Gazette of India, seeking public comments. The amendments aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to Bioavailability/Bioequivalence (BA/BE) studies.

The key highlights of the proposed amendments include significant changes to the licensing process. For test licence applicati...