Notification regarding restriction of sale of drug products containing

Notification regarding restriction of sale of drug products containing alcohol content under the Drugs Rules, 1945

The Gazette of India

CG-DL-E-09072026-274311

EXTRAORDINARY

PART II—Section 3—Sub-section (i)

PUBLISHED BY AUTHORITY

No. 549] NEW DELHI, THURSDAY, JULY 9, 2026/ASHADHA 18, 1948

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 8th July, 2026

G.S.R. 607(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. 760 (E), dated the 16th October, 2025, in the Gazette of India, Extraordinary,
Part II, section 3, sub-section (i), 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 Gazette containing the said notification
were made available to the public;

And whereas, copies of the said Gazette were made available to the public on the 18th October, 2025;
And whereas, no objections and suggestions received from the public on the said draft rules;

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. (i) These rules may be called the Drugs (Tenth Amendment) Rules, 2026.
(ii) They shall come into force after the 6 months of publication of these rules in the Official Gazette.

2. In the Drugs Rules, 1945, ─

(i) in Schedule K, under the heading Extent and Conditions of Exemptions, against the serial no. 10, after the
words “Act and rules thereunder”, the words, figures, symbols, letters and brackets “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.”, shall be inserted;

(ii) in Schedule H1, after the entry “51. Pregabalin”, the following entry shall be inserted, namely: ─
“52. 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-Part(3)]
HARSH MANGLA, Jt. Secy.

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