Day 40
Science & TechnologySkim2025-02-24
CDSCO Issues Directive on Category D FDCs
What Happened
The Central Drugs Standard Control Organization (CDSCO) has ordered manufacturers of Category D Fixed Dose Combinations (FDCs) licensed before October 2012 to submit Phase IV clinical trial protocols. Companies must apply for these safety studies by May 24, 2025, to remain compliant with regulatory standards.
Why It Matters
This move ensures that older combination drugs in the Indian market meet modern safety and efficacy benchmarks, preventing the circulation of potentially irrational or harmful medical formulations.
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