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.

Quick reference — brief coverage only.

Up next

What Happened

Why It Matters

Rajasthan Atomic Power Project Unit-7 Commences Operation