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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-05022024-251806
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 86]
NEW DELHI, MONDAY, FEBRUARY 5, 2024/MAGHA 16, 1945
740 GI/2024
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi the 5th February, 2024
G.S.R. 95(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 Ministry of Health and Family Welfare, Government of India, number
G.S.R. 686 (E) dated 25th September, 2023 published in the Gazette of India, Extraordinary, Part II, Section 3, Sub-
section (i), inviting objections and suggestions from the persons likely to be affected thereby before the expiry of a
period of thirty days from the date on which the copies of the Official Gazette containing the said notification were
made available to the public;
And, whereas, copies of the Gazette were made available to the public on 25.09.2023;
And, whereas, objections and suggestions received from the public on the said rules have been considered by
the Central Government;
Now, therefore, in exercise of the powers conferred by section 12 read with section 33 of the Drugs and
Cosmetics Act, 1940 (23 of 1940), 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 (Amendment) Rules, 2024.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs Rules, 1945, in Schedule H1, after serial number 48 and entries relating thereto, the following
serial number and entry shall be inserted, namely:-
"49. Oseltamivir
50. Zanamivir".
[F. No. X.11014/10/2016-DRS]
RAJIV WADHAWAN, Advisor (Cost).
Note: The principal rules were published in the Gazette of India vide notification number F.28-10/45-H(1), dated the
21st December, 1945 and last amended vide notification number G.S.R. 922(E), dated the
28th December, 2023.
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.
MANOJ KUMAR VERMA
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