Union Health Ministry Proposes Key Amendments to Streamline Drug Test Licences and BA/BE Study Applications

New Delhi, September 3, 2025: The Union Health Ministry has announced that it has proposed new amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019. The new amendments are aimed at simplifying procedures for obtaining test licences and filing applications related to Bioavailability and Bioequivalence (BA/BE) studies. The amendments are a part of the Indian government’s bigger strategy to promote ease of doing business in the pharmaceutical and clinical research sectors by reducing the required regulatory compliance.

Key Amendments To Streamline Drug Testing And Approval Process

As per current provisions, test licences are required before proceeding. In the proposed amendment, this is proposed to be shifted to a notification/intimation system, except for high-risk drugs. This will allow for faster initiation of drug testing, and applicants will only have to inform the Central Licensing Authority.

The processing time has also been proposed for a reduction. Currently, it takes around 90 days to process a test licence application, which is proposed to be reduced to 45 days, allowing for faster approvals.

Lastly, for quicker licence initiation for certain BA/BE studies, it is proposed that the licence requirement should be dispensed with, and the studies can begin after the notification.

Facilitation of Faster Initiation of BA/BE Studies and Improving India’s Pharmaceutical Position

The amendments proposed by the Union Health Ministry will help in faster initiation of BA/BE studies and help strengthen India’s global position as a global hub for pharmaceutical research and development. Furthermore, if approved, the amendments will help the Central Drugs Standard Control Organization (CDSCO) to utilise its human resources in a better way.

Th͏e propo͏sed a͏mend͏ments to the͏ ͏NDCT Rules, 201͏9, ai͏m to simplify te͏s͏t lice͏n͏ce proc͏edures and reduce ͏processi͏n͏g timelines from 90 to 45 days. By allowing certain BA/BE ͏studies to͏ begin aft͏er n͏otification, the changes are expect͏ed ͏to acceler͏ate clin͏ical research workfl͏ows and o͏ptimis͏e regulator͏y ope͏ra͏tions͏ within Indi͏a’s ͏phar͏maceu͏tical secto͏r.

REF: https://www.pib.gov.in/PressReleaseIframePage.aspx?PRID=2163255

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