Pharma units likely to face action for Schedule M violations

Micro, small and medium-sized pharmaceutical companies may face regulatory action for noncompliance with norms under the revised Schedule M, with the Central Drugs Standard Control Organisation (CDSCO) directing states to conduct inspections at drug manufacturing units, said industry experts.

- SANKET KOUL

The move indicated the end of the one-year grace period granted to Micro, Small, and Medium Enterprises (MSME) pharma units — those with an annual turnover of up to ₹250 crore — for complying with the revised Schedule M norms.

The revised Schedule M, which prescribes quality standards and good manufacturing practices (GMP) for drugmakers, was notified by the Union Health Ministry in December 2023 and became effective from January 1, 2025.