India, Sept. 3 -- image credit- shutterstock

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 is set to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019.

The proposed amendments were published in the Gazette of India on 28thAugust, 2025 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. Key highlights of the proposed amendments are as under:

1. Test Licence Applications:Under the proposed ame...