Key Points of the Notification: Issued by the Ministry of Health and Family Welfare under the Drugs and Cosmetics Act, 1940

KEY POINTS :

1. Authority and Context:

• Issued by the Ministry of Health and Family Welfare under the Drugs and Cosmetics Act, 1940.

• Refers to amendments in the Drugs Rules, 1945 made via notification G.S.R. 922(E) on 28th December 2023.

• Timeline for compliance with the revised Schedule M (Good Manufacturing Practices) is expiring for small and medium manufacturers.

2. Affected Entities:

• Small and medium manufacturers with a turnover of ₹250 crores or less.

3. Extension Provisions:

• The Government proposes to extend the compliance timeline for eligible manufacturers to 31st December 2025.

• Manufacturers must submit an application to seek this extension.

4. Application Process:

• Application must be submitted in Form A within three months of the notification's publication.

Form A requires:

• Manufacturer's details, turnover, and license information.

• WHO-GMP/CoPP certification details, if any.

• Gap analysis (plant, equipment, lab equipment, HVAC, utilities, staff, documentation).

• A compliance plan with a start date on or before 31st March 2025.

• Justification for the requested timeline.

5. Consultation and Feedback:

• Public objections and suggestions are invited within seven days of the Gazette's publication.

• Feedback to be sent to the Under Secretary (Drugs) at the Ministry or via email.

6. Conditions for Timeline Extension:

• Maximum timeline for compliance cannot exceed 1st January 2026.

Objective:

This notification aims to address concerns of small and medium-scale manufacturers regarding challenges in adhering to the revised Schedule M. It provides a framework to extend the compliance timeline, ensuring smoother transitions to upgraded GMP standards.

Download THE DOCUMENT FROM MINISTRY OF HEALTH AND FAMILY WELFARE: