Full Text
REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-18102025-267030
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 676]
NEW DELHI, THURSDAY, OCTOBER 16, 2025/ASVINA 24, 1947
6930 GI/2025
(1)
THE GAZETTE OF INDIA : EXTRAORDINARY
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 16th October, 2025
G.S.R. 760(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 Director (Drugs regulation), Ministry of Health and Family Welfare, Government of India, Room No. 407, A Wing, Nirman Bhavan, New Delhi - 110011 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 final publication in the Official Gazette.
2. (i) In the Drugs Rules, 1945, in Schedule K against the serial no. 10, under Extent and Conditions of Exemptions the words "All provisions of Chapter IV of the Act and rules thereunder" shall be substituted with the words as under:
"All provisions of Chapter IV of the Act and rules thereunder except for all oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters."
(ii) In the Drugs Rules, 1945, under Schedule H1, after the last entry, following entry shall be inserted, namely: -
"51. All oral formulations containing more than 12% alcohol v/v (Ethyl Alcohol) packed and sold in packings or bottles of more than 30 milliliters.
[F. No. X.11014/07/2025-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.....
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