Notification/Circular No. G.S.R. 127(E)
Document Date February 11, 2025
Applicable Act/Rule Drugs and Cosmetics Act, 1940
Effective Date February 11, 2025
The Ministry of Health and Family Welfare has amended the Drugs (Amendment) Rules, 2023, to allow small and medium pharmaceutical manufacturers more time to comply with the revised Good Manufacturing Practices (GMP)* under Schedule M of the Drugs Rules, 1945.
Small and Medium Manufacturers with an annual turnover of less than ₹250 crores can apply for an extension by submitting Form ‘A’ to the Central Licence Approving Authority within three months from the notification’s publication. This application must include details of the existing gaps, an upgrade plan, and justification for the requested extension.
If approved, the deadline for compliance will be extended until December 31, 2025. This amendment helps smaller manufacturers align with the revised GMP requirements without facing immediate operational disruptions.
*Good Manufacturing Practices (GMP) is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
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