Draft Drugs (Amendment) Rules, 2026

Notification / Circular No. : G.S.R. 52(E) dated January 22, 2026

Applicable Act / Rule : Drugs and Cosmetics Act, 1940 (Act 23 of 1940)

Applicable Section / Rule : Sections 12 and 33

The Drugs Rules, 1945 prescribe testing and analysis fees payable to Central Drugs Laboratories, State Drugs Laboratories, and the Pharmacopoeial Laboratory for Indian Medicine. The Central Government has proposed amendments to rationalise and update the fee structure prescribed under Schedule B and Schedule B(1). Accordingly, draft rules have been published inviting objections and suggestions from stakeholders within thirty days from the date the Gazette is made available to the public.

The draft rules shall come into force on the date of their final publication in the Official Gazette.

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