Wed Sep 03 12:44:38 UTC 2025: **FOR IMMEDIATE RELEASE**

**India Streamlines Drug Testing Regulations to Boost Pharma Innovation**

**New Delhi, September 3, 2025** – The Union Health Ministry announced today significant amendments to the New Drugs and Clinical Trials Rules, 2019, aimed at easing the process for pharmaceutical and clinical research sectors in India. The reforms, published in The Gazette of India on August 28 and open for public comment, are designed to simplify requirements and procedures for obtaining test licenses and submitting applications for bioavailability/bioequivalence studies.

A key change is the shift from a license-based system to a notification and intimation system for test licenses. Except for high-risk drugs, applicants will no longer need to wait for formal licenses. Instead, they will simply notify the Central Licensing Authority. This move is expected to drastically reduce the statutory processing time for test license applications from 90 days to 45 days.

Furthermore, the existing license requirement for specific categories of bioavailability/bioequivalence studies will be removed. Studies can now commence upon notifying the Central Licensing Authority.

The Ministry anticipates these reforms will significantly benefit stakeholders by expediting application processing, potentially reducing the number of test license applications by 50%. This translates to faster initiation of bioavailability/bioequivalence studies, quicker drug testing and examination for research, and reduced delays in the overall drug development and approval pipeline.

“This will facilitate quicker initiation of bioavailability/bioequivalence studies, testing and examination of drugs for research, and reduce delays in the drug development and approval processes,” the Ministry stated in a release.

Beyond streamlining processes, the amendments are expected to enable the Central Drugs Standard Control Organisation to optimize its human resources, enhancing regulatory oversight efficiency and effectiveness.

The Health Ministry encourages the public to provide feedback on the proposed amendments, which are seen as a significant step towards promoting ease of doing business and fostering innovation within the Indian pharmaceutical and clinical research landscape.

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