The Union Health Ministry has proposed amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aiming to streamline regulatory processes for the pharmaceutical and clinical research sectors. The move follows Prime Minister Narendra Modi’s directive to reduce compliance burdens and enhance ease of doing business, the ministry said in an official release.
The draft amendments, published in the Gazette of India on August 28, 2025, are now open for public comments. They primarily focus on simplifying requirements for test licences and Bioavailability/Bioequivalence (BA/BE) study applications.
Key highlights include:
- Test Licence Applications: The current licensing system will be replaced by a notification/intimation model. Except for certain high-risk drugs, applicants will no longer need prior approval and can proceed after informing the Central Licensing Authority. Processing timelines will also be reduced from 90 days to 45 days.
- BA/BE Study Applications: Licence requirements for certain categories of BA/BE studies will be removed. Such studies can be initiated upon simple notification to the authority.
According to the ministry, these reforms could reduce licence applications by nearly 50%, enabling faster initiation of studies, drug testing, and examination, while minimising delays in the drug development and approval pipeline.
The changes will also allow the Central Drugs Standard Control Organisation (CDSCO) to optimise human resources, improving regulatory efficiency and oversight.
Framed as part of India’s broader regulatory reform agenda, the amendments are expected to make the country more attractive for clinical research and strengthen its position as a global hub for pharmaceutical innovation and development.
