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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

Amendment to the Drugs Rules, 1945 for Small and Medium Manufacturers

11-Feb-2025 | G.S.R. 127(E)

Ministry Of Health and Family Welfare has issued a Notification regarding the amendment to the Drugs Rules, 1945, under the Drugs and Cosmetics Act, 1940. This amendment was published on 11th February 2025, following a public consultation process for the draft rules published on 4th January 2025.

By virtue of the notice, small and medium manufacturers with a turnover of less than 250 crores can apply for an extension to the timeline for implementing the Revised Good Manufacturing Practices (GMP) under Schedule-M. They must submit an application in Form ?A? to the Central Licence Approving Authority within three months from the publication date, along with a plan for upgrading their facilities. The deadline for compliance can be extended until 31st December 2025. The application must include details such as the manufacturer?s name, turnover, licence details, GMP certification, gap analysis, and a strategy for compliance.

Please refer the attached documents for more information

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