Notification for amendment under Rule 89 of Drugs Rules,

Notification for amendment under Rule 89 of Drugs Rules, 1945, for obtaining licence under Form 29 for different categories falling under Form 25A,25F,28A,28B, 28D, 28DA, 28E, 28F.

The Gazette of India

CG-DL-E-08082026-275299

EXTRAORDINARY

PART II—Section 3—Sub-section (ii)

PUBLISHED BY AUTHORITY

No. 649] NEW DELHI, FRIDAY, AUGUST 7, 2026/SHRAVAN 16, 1948

MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 6th August, 2026

G.S.R. 713(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. 299(E), dated the 21st April, 2026, 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 22nd April, 2026;
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 (Twelfth Amendment) Rules, 2026.
(2) They shall come into force from the date of their publication in the Official Gazette.
2. In the Drugs Rules, 1945, in rule 89, for the words and figures “Form 25 or Form 28” the words, figures and letters
“Form 25 or Form 25A or Form 25F or Form 28 or Form 28A or Form 28B or Form 28D or Form 28DA or 28E or
Form 28F” shall be substituted.

[F. No. X.11014/03/2026-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 December, 1945 and last amended vide notification number G.S.R. 706 (E), dated the 30th July, 2026.

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