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Core Purpose

The Central Government, in consultation with the Drugs Technical Advisory Board, hereby makes the Drugs (Fifth 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. 477(E) on 9th June, 2026, promulgating the Drugs (Fifth Amendment) Rules, 2026. These rules, made by the Central Government in exercise of powers conferred by Sections 12 and 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, further amend the Drugs Rules, 1945. Specifically, in Schedule K of the Drugs Rules, 1945, under the heading "Class of Drugs," against serial number 13, in item number (7), the word "Syrups," shall be omitted. The draft rules were previously published as G.S.R. 927 (E), dated 29th December, 2025, inviting objections and suggestions, which were considered by the Central Government. The Drugs (Fifth Amendment) Rules, 2026, shall come into force on the date of their publication in the Official Gazette. The Drugs Rules, 1945, were originally published vide notification No. F. 28-10/45H(1), dated 21st December, 1945, and last amended vide G.S.R. 444(E), dated 1st June, 2026.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-15062026-273467 EXTRAORDINARY PART II—Section 3—Sub-section (i) PUBLISHED BY AUTHORITY No. 427] NEW DELHI, MONDAY, JUNE 15, 2026/JYAISTHA 25, 1948 THE GAZETTE OF INDIA : EXTRAORDINARY [PART II—SEC. 3(i)] MINISTRY OF HEALTH AND FAMILY WELFARE (Department of Health and Family Welfare) NOTIFICATION New Delhi, the 9th June, 2026 G.S.R. 477(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. 927 (E), dated the 29th December, 2025 published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated the 30th December, 2025 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 30th December, 2025; 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 (Fifth 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 Schedule K, in the column, under the heading Class of Drugs, against serial number 13, in item number (7), the word "Syrups," shall be omitted. [F. No. X.11014/11/2025-DR] 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. 444(E), dated.1st 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. SARVESH KUMAR

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