Cdsco Schedule M Gmp
CDSCO Schedule M, prescribed under the Drugs and Cosmetics Rules 1945, sets mandatory Good Manufacturing Practice (GMP) requirements for all licensed pharmaceutical manufacturers in India. The April 2023 revision aligns Indian GMP with WHO TRS 986 and EU GMP standards. Non-compliance exposes manufacturers to licence suspension, import alerts, and prosecution under the Drugs and Cosmetics Act 1940.
Key regulatory references: Drugs and Cosmetics Act 1940; Drugs and Cosmetics Rules 1945 Schedule M (revised April 2023); CDSCO GMP Guidelines; WHO Technical Report Series 986 (TRS 986) Annex 2 Good Manufacturing Practices for pharmaceutical products.
Frequently Asked Questions
What is CDSCO Schedule M GMP?
Schedule M is Part I of the Second Schedule to the Drugs and Cosmetics Rules 1945. It prescribes the Good Manufacturing Practice requirements that all pharmaceutical manufacturers licensed under the Drugs and Cosmetics Act 1940 must meet, covering premises, equipment, personnel qualifications, documentation, quality control laboratories, and sterile product manufacturing operations.
When did the revised Schedule M come into force?
The revised Schedule M was notified in December 2022 and came into force on April 1, 2023 for large manufacturers. MSME manufacturers received a phased timeline: Category B (turnover Rs 10 to 250 crore) by August 1, 2023 and Category C (turnover below Rs 10 crore) by December 31, 2023.
Who must comply with Schedule M GMP requirements?
All manufacturers holding a licence to manufacture drugs for sale in India under the Drugs and Cosmetics Act 1940 must comply. This includes allopathic drug manufacturers, API manufacturers, contract manufacturing organisations (CMOs), and any facility manufacturing drugs for export from India.
What are the most significant changes in the 2023 Schedule M revision?
Key changes include mandatory ISO 5/7/8 cleanroom classification aligned with EU GMP Grade A/B/C/D, enhanced water system design requirements for WFI and purified water, formal change control and deviation management procedures, computerised system validation requirements equivalent to FDA 21 CFR Part 11, and expanded CAPA programme documentation obligations.
What are the penalties for Schedule M non-compliance?
Under section 27 of the Drugs and Cosmetics Act 1940, manufacturing drugs in contravention of GMP licence conditions is a cognisable offence carrying imprisonment and fines. Regulatory consequences also include suspension or cancellation of the manufacturing licence and, for export-oriented manufacturers, FDA import alerts and WHO pre-qualification suspension.