New Delhi, February 12 (HS): The Central Government has given time till 31 December this year to small pharmaceutical companies to comply with the revised Schedule M. This decision will benefit more than 8500 companies. An order was issued in this regard on Wednesday.

The Ministry of Health and Family Welfare in its order has conditionally extended the due date for implementation of 'Revised Schedule M' (Good Manufacturing Practice Provisions) in respect of small and medium pharmaceutical manufacturers with a turnover of Rs 250 crore or less to 31 December 2025.

Earlier, the ministry had notified the 'Revised Schedule M' requirements on 28 December 2023.

According to the notification, the category of manufacturers has been divided into two parts, in which the first category was of large manufacturers with a turnover of more than 250 crores. Such manufacturers were given a timeline of 6 months for compliance and the second category of small and medium manufacturers with turnover less than or equal to ₹250 crore were given a timeline of 12 months for compliance. The 'Revised Schedule M' requirements have been made applicable from June 28, 2024 for large manufacturers.

Small and medium pharmaceutical manufacturers had made representations for extension of the timeline to improve infrastructure, training of personnel and arrange for financial resources. This has been considered and small and medium manufacturers have been given 3 months from February 11, 2025 to submit their plan for upgradation to Form A to the Central License Approval Authority. For such manufacturers who submit these details, the implementation timeline will be extended to December 31, 2025. According to the ministry, the new rules will enable pharma companies to not only strengthen their domestic position but also become more competitive globally.

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Hindusthan Samachar / Jun Sarkar