Ministry of Health and Family Welfare

Removal of Syrup exemption under schedule K

Issue Date: 30 December 2025 Published: 30 December 2025

Gazette ID: CG-DL-E-30122025-268923 Download PDF

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Core Purpose

This notification publishes draft rules to amend the Drugs Rules, 1945, for public information and invites objections and suggestions.

Detailed Summary

The Ministry of Health and Family Welfare (Department of Health and Family Welfare) published G.S.R. 927(E) on December 29, 2025, presenting draft rules to further amend the Drugs Rules, 1945. These draft rules, proposed by the Central Government, are made in exercise of 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 proposed amendment specifically involves the omission of the word 'Syrup,' from Entry No. 7, under the column 'Class of Drugs,' in Serial No. 13 of Schedule K of the Drugs Rules, 1945. The draft rules, titled the Drugs (...... Amendment) Rules, 2025, are set to come into force on their publication date in the Official Gazette. All persons likely to be affected are invited to submit objections and suggestions to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, at U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or via email at drugsdiv-mohfw@gov.in, within thirty days from the date of the Gazette's availability to the public. The principal Drugs Rules, 1945, were originally published on December 21, 1945.

Full Text

REGD. No. D. L.-33004/99 The Gazette of India CG-DL-E-30122025-268923 EXTRAORDINARY PART II-Section 3-Sub-section (i) PUBLISHED BY AUTHORITY NEW DELHI, TUESDAY, DECEMBER 30, 2025/PAUSHA 9, 1947 No. 841] 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 29th December, 2025 G.S.R. 927(E). -The following draft of certain rules further 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 sub- section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation with the Drugs Technical Advisory Board is hereby published 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), Ministry of Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1, New Delhi, 110001 or emailed at drugsdiv-mohfw@gov.in. DRAFT RULES 1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025. (ii) 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 Serial No. 13, under the column "Class of Drugs", in the Entry No. 7, the word "Syrup," shall be omitted. [F. No. X.11014/11/2025-DR] HARSH MANGLA, 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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