India's Advanced Schedule M Platform

Everything About Revised Schedule M

The definitive intelligence platform for GMP compliance. Navigate the 1945 Drugs & Cosmetics Act with AI-powered gap analysis, instant clause search, and automated audit checks.

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248
Mandatory Clauses
Fully indexed & searchable
50+
Expert FAQs
Answers to complex compliance edge-cases
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Mar 2025
Intelligence Date
Synced with Revised Schedule M
Multilingual Support

Know what Schedule M is, in your own language

A brief overview of the Good Manufacturing Practices (GMP) natively broken down to ease understanding across regions.

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What's New in Revised Schedule M

The 2025 revision introduces stricter documentation requirements, enhanced HVAC standards, new QA independence clauses, personnel training records, equipment qualification norms (IQ/OQ/PQ), mandatory cleaning validation, and a formal CAPA system.

CDSCO Intelligence Feed

Mar 2025

Revised Schedule M notified in Gazette

Comprehensive GMP overhaul bringing India closer to WHO standards.

Jan 2025

Draft circulated for public comments

60-day window for industry feedback on proposed changes.

Nov 2024

Expert Committee finalizes draft

CDSCO committee recommends WHO GMP baseline with India-specific modifications.

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