Extension of Timeline for Compliance with Revised Schedule M for Small and Medium Drug Manufacturers

 The Ministry of Health and Family Welfare has proposed an extension for small and medium drug manufacturers to comply with the revised Schedule M under the Drugs Rules, 1945. Eligible manufacturers with a turnover of ₹250 crores or less can apply for an extension until 31st December 2025. Applications must be submitted within three months from the notification date, along with an upgrade plan.

The Ministry of Health and Family Welfare has issued a draft notification (G.S.R. 10(E)) on 4th January 2025, proposing an extension for small and medium drug manufacturers to comply with the revised Schedule M under the Drugs Rules, 1945, framed under the Drugs and Cosmetics Act, 1940 (23 of 1940).

Key Points:

• The original notification G.S.R. 922(E) was issued on 28th December 2023, granting 12 months for compliance.
• The deadline is expiring soon, and industry associations have requested an extension.
• Manufacturers with a turnover of ₹250 crores or less can seek an extension by applying to the Central Licence Approving Authority in Form A within three months of this notification.
• Approved applicants will have a new compliance deadline of 31st December 2025.
• Final enforcement date: 1st January 2026 for those granted an extension.
• Objections or suggestions can be submitted to the Under Secretary (Drugs), Ministry of Health and Family Welfare, at drugsdiv-mohfw@nic.in.