Rules to Streamlining Test Licence and BA/BE Study Applications
New Delhi, Sep 03 Health Ministry is amending the New Drugs and Clinical Trials (NDCT) Rules, 2019, to reduce regulatory compliance and promote ease of doing business in the pharmaceutical and clinical research sectors, following Prime Minister Narendra Modi’s directives.
Published on August 28, 2025, for public comment, the amendments simplify test license and Bioavailability/Bioequivalence (BA/BE) study application procedures. Key changes include transitioning the test license system to a notification/intimation system, reducing processing time from 90 to 45 days, and eliminating existing license requirements for certain BA/BE studies, replacing them with intimation to the Central Licensing Authority.
These reforms are projected to reduce license applications by approximately 50%, expedite drug development, improve human resource deployment by the CDSCO, and enhance India’s attractiveness for clinical research, aligning with global best practices and strengthening its position as a pharmaceutical R&D hub.
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