Ministry of Health and Family Welfare Department of Health and Family Welfare Not Applicable

Proposal to correct the strength of Folic Acid wrt Unit of measurement under the Schedule V of Drugs Rules 1945

Published: 27 January 2026 Download PDF

Gazette ID: CG-DL-E-27012026-269588

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Core Purpose

This notification publishes the draft of rules to further amend the Drugs Rules, 1945, specifically proposing to change the unit for Folic acid in Schedule V from "mg." to "mcg.".

Detailed Summary

This notification, G.S.R. 53(E) dated 21st January, 2026, issued by the Ministry of Health and Family Welfare (Department of Health and Family Welfare), publishes a draft of rules intended to further amend the Drugs Rules, 1945. The Central Government proposes these amendments in exercise of 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), following consultation with the Drugs Technical Advisory Board. The primary proposed change is to substitute "mg." with "mcg" as the unit for Folic acid in the Table of Schedule V of the Drugs Rules, 1945. These draft rules are named the Drugs (...... Amendment) Rules, 2025, and are slated to come into force on the date of their final publication in the Official Gazette. The notification invites objections and suggestions from all persons likely to be affected, to be submitted within thirty days from the date of public availability of the Gazette containing these draft rules. Submissions should 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 to drugsdiv-mohfw@gov.in. The principal Drugs Rules, 1945, were originally published vide notification No. F. 28-10/45-H(1) dated 21st December, 1945.

Full Text

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.......

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