Why in news?
Recent news on the New Drugs and Clinical Trials (NDCT) Rules, 2019, highlights ongoing amendments by the Union Health Ministry as of 2025 to simplify and accelerate the drug testing and clinical trial processes in India.
 
The key updates include:

• The Ministry proposes reducing regulatory compliance by converting the current test license system into a notification/intimation system, where applicants no longer wait for licenses except in high-risk drug categories.
• This change is expected to reduce the number of license applications by about 50%, halving processing time for test licenses from 90 days to 45 days.
• Amendments also simplify submission procedures for Bioavailability (BA) and Bioequivalence (BE) study applications, allowing certain categories of BA/BE studies to start upon mere intimation to the Central Licensing Authority.
• These reforms aim to facilitate quicker initiation of studies, drug testing, and reduce delays in drug development and approval, enhancing India’s attractiveness as a global hub for pharmaceutical research.
• The amendments are part of the government’s broader efforts toward Ease of Doing Business and alignment with global best practices.
• Some experts have expressed concerns regarding reduced timelines and potential risks to public health related to BA/BE study requirements and regulatory rigor.

These developments reflect the government’s commitment to regulatory reform to promote clinical research and faster access to new drugs in India.

Download Pdf