India GMP — Schedule M, Drugs and Cosmetics Rules
India's GMP requirements under the revised Schedule M of the Drugs and Cosmetics Rules, notified in December 2023. The revision introduces a formal pharmaceutical quality system, quality risk management, and computerised-system / data-integrity expectations, moving Indian GMP toward WHO/PIC-S norms.
Drug manufacturers in India. Implementation is phased — larger manufacturers first, with the MSME compliance deadline extended to 31 December 2025.
- 01Implement a documented pharmaceutical quality system
- 02Apply quality risk management
- 03Meet data-integrity and computerised-system expectations
- 04Comply within the applicable phased deadline
Revised Schedule M notified December 2023; large units required to comply in 2024, MSME deadline extended to 31 December 2025.
Revised Schedule M (2023): frequently asked questions
Quick answers to common questions about Revised Schedule M (2023).
What is Revised Schedule M (2023)?
Revised Schedule M (2023) — India GMP — Schedule M, Drugs and Cosmetics Rules — is a regulation issued by the Central Drugs Standard Control Organisation (India). India's GMP requirements under the revised Schedule M of the Drugs and Cosmetics Rules, notified in December 2023. The revision introduces a formal pharmaceutical quality system, quality risk management, and computerised-system / data-integrity expectations, moving Indian GMP toward WHO/PIC-S norms.
Who does Revised Schedule M (2023) apply to?
Drug manufacturers in India. Implementation is phased — larger manufacturers first, with the MSME compliance deadline extended to 31 December 2025.
What are the key requirements of Revised Schedule M (2023)?
CDSCO Revised Schedule M (2023) requires, among other things: Implement a documented pharmaceutical quality system; Apply quality risk management; Meet data-integrity and computerised-system expectations; Comply within the applicable phased deadline.
When was Revised Schedule M (2023) last updated?
The current version of Revised Schedule M (2023) dates from December 2023. Revised Schedule M notified December 2023; large units required to comply in 2024, MSME deadline extended to 31 December 2025.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
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