Health Ministry to amend new drugs, clinical trials rules

New Delhi, Sep 03, 2025 : The Union Health Ministry will amend the New Drugs and Clinical Trials Rules, 2019, to simplify the requirements and procedures for obtaining test licenses and for submitting applications related to Bioavailability and Bioequivalence studies. The Ministry will amend the rule to reduce regulatory compliance and promote ease of doing business in the pharmaceutical and clinical research sectors. The proposed amendments have been published in the Gazette of India for public comments.

Under the proposed amendment, the present system of test licences has been converted to a notification and intimation system. Through this, the applicants need not wait for test licenses, but will need to just inform the Central Licensing Authority. Additionally, the overall statutory processing time for test license applications will be reduced from 90 to 45 days. These regulatory reforms are expected to benefit stakeholders by significantly reducing the timelines for processing applications.

These proposed amendments will reduce the number of license applications being submitted by approximately 50 per cent. The Ministry said that these steps are expected to increase the attractiveness of India for clinical research, thereby strengthening India’s position as a global hub for pharmaceutical research and development.