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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-20082025-265531
EXTRAORDINARY
PART II-Section 3-Sub-section (i)
PUBLISHED BY AUTHORITY
No. 510]
NEW DELHI, MONDAY, AUGUST 18, 2025/SHRAVANA 27, 1947
5493GI/2025
(1)
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 18th August, 2025
G.S.R. 554(E).—Whereas a draft of certain rules further to amend the Drugs Rules, 1945 was
published, as required under sub-section (1) of sections 12 and sub-section (1) of 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. 391 (E), dated the 12th July, 2024, 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 12thJuly, 2024;
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 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 (2nd Amendment) Rules, 2025.
(2) They shall come into force from 1st March, 2026.
2. In the Drugs Rules, 1945, in rule 96, in sub-rule (7), —
(a) In clause (vii), for the words "date of expiry; and", the word "date of expiry" shall be substituted;
(b) After clause (viii), the following clause shall be inserted, namely:-
"(ix) qualitative details of excipients."
[F. No. X.11035/44/2024-DRS]
NIKHIL GAJRAJ, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated the
21st December, 1945 and last amended vide notification number G.S.R. 127(E), dated 11th February, 2025.
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.
GORAKHA NATH YADAVA
Digitally signed by GORAKHA NATH
Date: 2025.08.20 11:40:44 +05°30'