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Faster drug trials in works as India eyes export gains
Mint New Delhi
|September 04, 2025
New drugs may reach chemists quicker and clinical trials kick off earlier, with the Union health ministry drafting rules to cut the time to process approvals by half and help India expand its footprint in the $1.55 billion global clinical trials industry.
The proposed changes will streamline the process for testing licences and certain studies by replacing the old licensing system with a faster online notification system, the health ministry said on Wednesday.
This will require an amendment to India's New Drugs and Clinical Trials Rules, 2019, potentially reducing the application processing time from 90 to 45 working days.
A key change proposed in the draft New Drugs and Clinical Trials (Amendment) Rules, 2025 allows firms to start studies on drugs meant for export with an online notification if the product's been approved in major markets such as the US, UK, EU, Japan, Australia and Canada. These studies will be limited to a maximum of 48 healthy adult volunteers.
The ministry said the changes aim to reduce licence applications by about 50%. The public has 30 days to submit comments.
This story is from the September 04, 2025 edition of Mint New Delhi.
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