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Core Purpose

The Central Government notifies the Drugs (Ninth Amendment) Rules, 2026 to further amend the Drugs Rules, 1945.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) issued notification G.S.R. 561(E) on July 2, 2026, to publish the Drugs (Ninth Amendment) Rules, 2026. These rules, made by the Central Government under sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board, amend the Drugs Rules, 1945. Specifically, rule 43A of the Drugs Rules, 1945, is modified by substituting the words 'Cochin and Thiruvananthapuram' with 'Cochin, Thiruvananthapuram and Navi Mumbai'. A draft of these rules was previously published as G.S.R. 66(E) on January 28, 2026, inviting objections for thirty days, with no objections or suggestions received. The Drugs (Ninth Amendment) Rules, 2026, come into force on the date of their publication in the Official Gazette. The original Drugs Rules, 1945, were published on December 21, 1945, and last amended by G.S.R. 530(E) on June 29, 2026.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-07072026-274223 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY No. 503] NEW DELHI, FRIDAY, JULY 3, 2026/ASHADHA 12, 1948 MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 2nd July, 2026 G.S.R. 561(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 was 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. 66(E), dated the 28th January, 2026 published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i) dated the 28th 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 28th January, 2026; And whereas, no objections and suggestions were received from the public in respect of the said draft rules; Now, therefore, in exercise of the powers conferred by sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with 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 (Ninth Amendment) Rules, 2026. (2) They shall come into force on the date of their publication in the Official Gazette. 2. In the Drugs Rules, 1945, in rule 43A, for the words "Cochin and Thiruvananthapuram", the words, "Cochin, Thiruvananthapuram and Navi Mumbai" shall be substituted. [F. No. X.11035/131/2022-DR] HARSH MANGLA, Jt. Secy. Note: The Drugs Rules, 1945 were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated 21st December, 1945 and last amended vide notification number G.S.R. 530(E), dated 29th June, 2026 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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