Notification/Circular No.: G.S.R. 444(E) | F. No. X.11014/14/2025-DR-Part(1) dated June 01, 2026
Applicable Act/Rule: Drugs and Cosmetics Act, 1940 (23 of 1940) / Drugs Rules, 1945
Applicable Section/Rule: Sections 12 and 33
Effective Date: December 05, 2026
Ministry of Health and Family Welfare (Department of Health and Family Welfare) has notified the Drugs (Fourth Amendment) Rules, 2026, published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i). A draft of the rules was previously published vide G.S.R. 53(E) dated January 21, 2026, and made available to the public on January 27, 2026. Objections and suggestions received from the public were considered by the Central Government. The amendment was made after consultation with the Drugs Technical Advisory Board.
In the Drugs Rules, 1945, in Schedule V, in paragraph 2, in the Table, in column (2) relating to unit, for the entry against “Folic acid”, the entry “mcg” shall be substituted.
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