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

Drugs (Amendment) Rules, 2026

16-Feb-2026 | G.S.R. 135(E)

Pursuant to the circular G.S.R. 135(E) issued by the Ministry of Health and Family Welfare, Government of India, dated 28th May 2025, and in exercise of the powers under the Drugs and Cosmetics Act, 1940, the Drugs (Amendment) Rules, 2026 have been notified and come into force from the date of their publication in the Official Gazette.

All solutions of substances intended for parenteral administration, including water or other aqueous solvents supplied along with such substances, must comply with a test for bacterial endotoxins or, where justified, with the test for pyrogens. These tests must be carried out as per the current edition of the Indian Pharmacopeia (I.P).

For licenses under Form 20B, Form 20G, and Form 21B, the sale of drugs must be under the personal supervision of a competent person, whose name must be recorded in the license.

The licensee must report any change in the competent person to the licensing authority within one month of such change. All conditions as specified in the relevant Forms (20B, 20G, 21B) must be adhered to, including supervision, reporting changes, and compliance with drug testing protocols.

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