Frequently Asked Questions

Revised Schedule M is the updated set of Good Manufacturing Practice (GMP) requirements under the Drugs and Cosmetics Act, 1945. It was notified in the official Gazette in March 2025, replacing the older Schedule M. The revision brings India's GMP standards closer to WHO GMP guidelines and introduces stricter requirements for documentation, equipment qualification, validation, and quality systems.

The Revised Schedule M was notified in March 2025. Manufacturers have been given a transition period to comply with the new requirements. Large manufacturers typically have 12 months, while small and medium enterprises may have an extended timeline. Check the official CDSCO notification for specific compliance deadlines.

All manufacturers holding a drug manufacturing license under the Drugs and Cosmetics Act must comply. This includes manufacturers of APIs, finished pharmaceutical products, intermediates, and biological products. Both domestic manufacturers and those exporting from India are covered.

Key changes include: self-inspection frequency increased from annual to semi-annual, new requirements for equipment qualification (IQ/OQ/PQ), mandatory cleaning validation, formal CAPA system, 30-day OOS investigation timeline, stricter HVAC requirements, enhanced personnel training records, QA independence requirements, mandated process validation with three consecutive batches, and comprehensive gowning validation.

Schedule M primarily applies to allopathic (modern) medicines including APIs, FPPs, biologicals, and intermediates. Ayurvedic, Siddha, and Unani medicines have separate GMP requirements under Schedule T of the Drugs and Cosmetics Act. Homeopathic medicines have their own set of standards. However, the principles of GMP are universal.