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Core Purpose

This notification publishes the draft of the Drugs (Amendment) Rules, 2026, proposing specific amendments to rule 43A of the Drugs Rules, 1945.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued notification G.S.R. 66(E) on January 28, 2026, publishing the draft of the Drugs (Amendment) Rules, 2026. These proposed rules aim to amend the Drugs Rules, 1945, exercising powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), following consultation with the Drugs Technical Advisory Board. The draft rules are set to come into force upon their final publication in the Official Gazette. Specifically, the amendment proposes to substitute the words “Cochin and Thiruvananthapuram” in rule 43A of the Drugs Rules, 1945, with “Cochin, Thiruvananthapuram and Navi Mumbai International Airport (NMIA) in Raigad, Maharashtra”. Public objections and suggestions are invited within thirty days from the date the Gazette of India containing these draft rules is made available and should be sent to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, Kartavya Bhawan, C Wing, New Delhi - 110011, or emailed at drugsdiv-mohfw@gov.in. The principal Drugs Rules, 1945, were originally published vide notification No. F. 28-10/45-H(1) dated 21st December, 1945.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-29012026-269655 EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 65] NEW DELHI, WEDNESDAY, JANUARY 28, 2026/MAGHA 8, 1947 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 28th January, 2026 G.S.R. 66(E).— The following draft of certain rules to amend the Drugs Rules, 1945, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and subsection (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), is hereby published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing these draft rules are made available to the public. Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government; Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs Regulation), Ministry of Health and Family Welfare, Government of India, Kartavya Bhawan, C Wing, New Delhi - 110011 or emailed at drugsdiv-mohfw@gov.in. DRAFT RULES (1) These rules may be called the Drugs (........Amendment) Rules, 2026. (2) They shall come into force on the date of their final publication in the Official Gazette. In the Drugs Rules, 1945, in rule 43A, for the words “Cochin and Thiruvananthapuram”, the words, "Cochin, Thiruvananthapuram and Navi Mumbai International Airport (NMIA) in Raigad, Maharashtra" shall be substituted. [F. No. X. 11035/131/2022 -DR] NIKHIL GAJRAJ, Jt. Secy. Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21st the December, 1945 and last amended vide notification number G.S.R......(E), dated....... Uploaded by Dte. of Printing at Government of India Press, Ring Road, Mayapuri, New Delhi-110064 and Published by the Controller of Publications, Delhi-110054.

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