Pharma units likely to face action for Schedule M violations: Experts

The one-year grace period for MSME drug manufacturers to comply with revised Schedule M norms has ended, with the CDSCO instructing state regulators to initiate inspections & action against violators

Micro, small and medium-sized pharmaceutical companies may face regulatory action for non-compliance 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.

 

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