Finalization of GSR 54(E) dated 21.02.2026 reg inclusion of Pregabalin under Schedule H1
The Gazette of India
CG-DL-E-21052026-272775
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 342] NEW DELHI, WEDNESDAY, MAY 20, 2026/VAISAKHA 30, 1948
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 13th May, 2026
G.S.R. 377(E).— Whereas a draft of certain rules further to amend the Drugs Rules, 1945 were 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 Wel
fare (Department of Health and Family Welfare) number G.S.R. 54 (E), dated the 21st January, 2026 published in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), dated the 27th January, 2026 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 Official Gazette containing the said notification were made available to the public;
And whereas, copies of the said Official Gazette were made available to the public on the 27th January, 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 (Second Amendment) Rules, 2026.
(2) They shall come into force after one eighty days from the date of publication of these rules in the Official Gazette.
2. In the Drugs Rules, 1945, in Schedule H1 after serial number 50 and entries relating thereto, the following
serial number and entry shall be inserted, namely: ―
“51. Pregabalin”.
[F. No. X.11014/14/2025-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 the December, 1945 and last amended vide notification number G.S.R 135(E), dated the 16 February, 2026.
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