Regulatory Updates
Stay informed with a chronological timeline of official CDSCO notifications, draft circulations, committee reports, and implementation guidelines regarding Revised Schedule M.
March 2025
Revised Schedule M Notified in Official Gazette
The Ministry of Health and Family Welfare has officially notified the Revised Schedule M under the Drugs and Cosmetics Act, 1945. This comprehensive update brings India's GMP standards in line with WHO GMP guidelines and introduces significant new requirements for documentation, equipment qualification, and quality systems.
January 2025
Draft Revised Schedule M Circulated for Public Comments
CDSCO circulated the draft Revised Schedule M for industry feedback. The draft included proposed changes to self-inspection frequency, equipment qualification requirements, and documentation standards. Industry stakeholders were given 60 days to submit their comments.
November 2024
CDSCO Expert Committee Finalizes Draft Schedule M Revisions
The expert committee constituted by CDSCO completed its review of proposed Schedule M amendments. The committee recommended adoption of WHO GMP guidelines as the baseline, with India-specific modifications to address local manufacturing conditions.
August 2024
Stakeholder Consultation on Schedule M Revision
CDSCO held a multi-stakeholder consultation meeting with representation from pharmaceutical industry associations, academic institutions, and regulatory bodies. Key discussion points included transition timelines, validation requirements, and support for MSME manufacturers.
May 2024
CDSCO Circular on GMP Inspection Harmonization
CDSCO issued a circular to all State Drug Controllers regarding harmonization of GMP inspections across states. The circular emphasized the need for standardized inspection checklists and uniform compliance assessment criteria.
February 2024
Training Program for Drug Inspectors on Revised GMP Standards
CDSCO in collaboration with NIPER launched a training program for Drug Inspectors on the proposed revised GMP standards. The program covers inspection methodologies, documentation review, and assessment of validation activities.
September 2023
WHO GMP Pre-qualification Alignment Initiative
Government of India announced an initiative to align Schedule M with WHO GMP pre-qualification requirements. This would enable more Indian manufacturers to achieve WHO GMP certification for international market access.
June 2018
Previous Schedule M Amendment
The previous significant amendment to Schedule M was notified, addressing basic GMP requirements. This version served as the baseline for many Indian manufacturers until the comprehensive 2025 revision.
June 2005
Original Schedule M Notification
The original Schedule M was notified under the Drugs and Cosmetics Act, establishing the first comprehensive GMP framework for pharmaceutical manufacturing in India.
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