Gazette Tracker
Gazette Tracker

Core Purpose

The Central Government promulgates the Drugs (Fourth Amendment) Rules, 2026, to further amend the Drugs Rules, 1945, after consultation with the Drugs Technical Advisory Board.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued notification G.S.R. 444(E) on 1st June, 2026, introducing the Drugs (Fourth Amendment) Rules, 2026. These rules are enacted under the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), following consultation with the Drugs Technical Advisory Board. A draft of these amendments was previously published as G.S.R. 53(E) on 21st January, 2026, in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated 27th January, 2026, for public objections and suggestions, which were subsequently considered by the Central Government. The Drugs (Fourth Amendment) Rules, 2026, will come into force six months from their publication date in the Official Gazette. The specific amendment involves replacing the existing unit entry with "mcg" for "Folic acid" in column (2) of the Table, located within paragraph 2 of Schedule V of the Drugs Rules, 1945. The Drugs Rules, 1945, were originally published vide notification No. F. 28-10/45H(1) dated 21st December, 1945, and were last amended by notification number G.S.R. 407(E) dated 22nd May, 2026.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-05062026-273185 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 397] NEW DELHI, FRIDAY, JUNE 5, 2026/JYAISTHA 15, 1948 4040 GI/2026 (1) MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 1st June, 2026 G.S.R. 444(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 were published as required under sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) vide notification of the Government of India in the Ministry of Health and Family Welfare (Department of Health and Family Welfare) number G.S.R. 53 (E), dated the 21st January, 2026 published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated the 27th January, 2026 inviting objections and suggestions from persons likely to be affected thereby, before the expiry of a period of thirty days from the date on which the copies of the Official Gazette containing the said notification were made available to the public; And whereas, copies of the said Official Gazette were made available to the public on the 27th January, 2026; And whereas, objections and suggestions received from the public on the said draft rules have been considered by the Central Government; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the said Act, the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the following rules further to amend the Drugs Rules, 1945, namely:— 1. (1) These rules may be called the Drugs (Fourth Amendment) Rules, 2026. (2) They shall come into force after six months from the date of their publication in the Official Gazette. 2. 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. [F. No. X.11014/14/2025-DR-Part(1)] HARSH MANGLA, Jt. Secy. Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45H(1), dated the 21st the December, 1945 and last amended vide notification number G.S.R. 407(E), dated the 22nd May, 2026.

Never miss important gazettes

Create a free account to save gazettes, add notes, and get email alerts for keywords you care about.

Sign Up Free