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Govt looks to reduce drug development, approval timelines
Business Standard
|September 04, 2025
The Union health ministry is planning to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, to reduce delays in drug development and approval timelines in the country, with the overall statutory processing time for test licence applications expected to be reduced from 90 to 45 days.
In a notification dated September 3, the ministry has sought public comments on the proposed amendments that aim to simplify the requirements and procedures for obtaining test licences and for submitting applications related to bioavailability/bioequivalence (BA/BE) studies.
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