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REGD. No. D. L.-33004/99
The Gazette of India
CG-DL-E-27012026-269588
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 53]
NEW DELHI, THURSDAY, JANUARY 22, 2026/MAGHA 2, 1947
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, 21st January, 2026
G.S.R. 53(E).— The following draft of certain rules further to amend the Drugs Rules, 1945, which
the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section
12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), after consultation
with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be
affected thereby, and notice is hereby given that the said draft rules shall be taken into consideration on or
after the expiry of a period of thirty days from the date on which the copies of the Gazette of India containing
these draft rules are made available to the public.
Objections and suggestions which may be received from any person within the period specified above
will be considered by the Central Government.
Objections and suggestions, if any, may be addressed to the Under Secretary (Drugs), Ministry of
Health and Family Welfare, Government of India, U-6, Work Hall- C Wing, first floor, Kartavya Bhawan-1,
New Delhi, 110001 or emailed at drugsdiv-mohfw@gov.in.
DRAFT RULES
1. (i) These rules may be called the Drugs (...... Amendment) Rules, 2025.
(ii) They shall come into force on the date of their final publication in the Official Gazette.
2. In the Drugs Rules, 1945, under the Table of Schedule V, unit mentioned against the Folic acid
i.e. "mg." shall be substituted with "mcg".
[F. No. X.11014/14/2025-DR]
HARSH MANGLA, Jt. Secy.
Note: The principal rules were published in the Official Gazette vide notification No. F. 28-10/45-H(1) dated
21st the December, 1945 and last amended vide notification number G.S.R......(E), dated.......