Final Notification reg Amendment in unit of measurement of Folic Acid under the Drugs Rules 1945
The Gazette of India
CG-DL-E-05062026-273185
EXTRAORDINARY
PART II—Section 3—Sub-section (i)
PUBLISHED BY AUTHORITY
No. 397] NEW DELHI, FRIDAY, JUNE 5, 2026/JYAISTHA 15, 1948
MINISTRY OF HEALTH AND FAMILY WELFARE
(Department of Health and Family Welfare)
NOTIFICATION
New Delhi, the 1st June, 2026
G.S.R. 444(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 Welfare
(Department of Health and Family Welfare) number G.S.R. 53 (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 (Fourth Amendment) Rules, 2026.
(2) They shall come into force after six months from the date of their publication in the Official
Gazette.
2. In the Drugs Rules, 1945, in Schedule V, in paragraph 2, in the Table, in column (2) relating to unit, for the
entry against “Folic acid”, the entry “mcg” shall be substituted.
[F. No. X.11014/14/2025-DR-Part(1)]
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. 407(E), dated the 22nd May, 2026.
Final Notification reg
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