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New Delhi, February 13, 2025: In a significant move, the Ministry of Health & Family Welfare has granted a conditional extension for small and medium pharmaceutical manufacturers to comply with the revised Schedule M regulations. The new deadline for implementation has been extended to December 31, 2025, for manufacturers with an annual turnover of Rs. 250 crores or less.
The revised Schedule M notification, first announced on December 28, 2023, introduced upgraded “good manufacturing practices and requirements of plant and equipment for pharmaceutical products.” Under this regulation, pharmaceutical manufacturers were categorized into two groups:
- Large manufacturers (turnover exceeding Rs. 250 crores) – Required to comply within six months, with the deadline set for June 28, 2024.
- Small and medium manufacturers (turnover of Rs. 250 crores or less) – Initially given 12 months, with a compliance deadline of December 28, 2024.
While large manufacturers have already adhered to the revised regulations, small and medium pharmaceutical companies sought additional time to improve their infrastructure, train personnel, and secure financial resources. Considering their representations, the government has conditionally extended the compliance timeline.
Conditional Extension and Compliance Requirements
Small and medium manufacturers now have until February 11, 2025, to submit their upgradation plan in Form A to the Central License Approving Authority. Manufacturers who meet this requirement will be granted the extended compliance deadline of December 31, 2025.
Ensuring Quality and Global Competitiveness
The revised Schedule M regulations are aimed at enhancing the quality and safety of pharmaceutical products in India. By adopting these improved manufacturing practices, Indian pharma companies will not only strengthen their domestic position but also boost their competitiveness in the global market.
Disclaimer: The above information is based on official government notifications. Stakeholders are advised to refer to the Ministry of Health & Family Welfare for further details and clarifications regarding compliance requirements.
