The Drugs Amendment Rules, 2025 were introduced to modify certain provisions of the Drugs (Amendment) Rules, 2023, under the Drugs and Cosmetics Act, 1940. A key change is the extension of the compliance timeline for small and medium manufacturers with a turnover of less than 250 crores. These manufacturers can apply for an extension, submitting an upgradation plan within three months from the publication of the notification. If approved, the deadline for compliance is extended to December 31, 2025. This amendment aims to provide these manufacturers with additional time to meet regulatory requirements.
The notification G.S.R. 127(E) relates to an amendment in the Drugs Rules, 1945, under the Drugs and Cosmetics Act, 1940. The draft of these amended rules was published on January 4, 2025, inviting objections and suggestions from the public, with a deadline of seven days after the notification was made available.
After considering the feedback, the Central Government introduced changes in the Drugs (Amendment) Rules, 2023. Specifically, in Rule 6, the entry for "Small and Medium manufacturers" now includes a proviso.
This proviso allows manufacturers with a turnover of less than 250 crores to request an extension for compliance. These manufacturers can apply to the Central Licence Approving Authority within three months from the publication of the notification, providing an upgradation plan.
If granted, the compliance deadline for these manufacturers will be extended to December 31, 2025