Union Health Ministry to Amend NDCT Rules for Streamlining Applications
The Union Health Ministry is set to amend the New Drugs and Clinical Trials (NDCT) Rules, 2019, to simplify the process for obtaining test licenses and submitting Bioavailability/Bioequivalence (BA/BE) study applications. The amendments aim to reduce processing times from 90 to 45 days and eliminate certain licensing requirements, promoting ease of doing business in the pharmaceutical sector. This initiative is part of the government's commitment to regulatory reforms and enhancing India's position as a global hub for pharmaceutical research.
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