Health Ministry Notifies Change in Folic Acid Measurement Unit from Milligrams (mg) to Micrograms (mcg)
New Delhi: In a move aimed at ensuring dosing accuracy and aligning regulatory standards with established clinical practice, the Ministry of Health and Family Welfare (MoHFW) has notified an amendment to the Drugs Rules, 1945, replacing the unit of measurement for folic acid under Schedule V from "mg" (milligrams) to "mcg" (micrograms).
The amendment has been brought into effect through the Drugs (Fourth Amendment) Rules, 2026, notified vide Gazette Notification G.S.R. 444(E) dated June 1, 2026. The change follows the publication of draft rules in January 2026 and consideration of objections and suggestions received from stakeholders.
As per the notification, in Schedule V of the Drugs Rules, 1945, under paragraph 2 relating to standards for patent or proprietary medicines, the entry against "Folic acid" in the unit column has been amended. The earlier unit "mg" has now been substituted with "mcg". The amendment is intended to correct the unit of measurement and bring it in line with internationally accepted dosing standards for folic acid, which is routinely prescribed and labeled in micrograms.
Although the numerical limits prescribed for folic acid preparations remain unchanged, the correction is significant from a regulatory and patient-safety perspective. Folic acid requirements for prophylactic and therapeutic use are generally measured in micrograms, and the use of milligrams in the Schedule had the potential to create confusion regarding dosage interpretation. The amendment is therefore expected to improve clarity for manufacturers, regulators, healthcare professionals, and consumers.
The Ministry stated that the amendment has been made after consultation with the Drugs Technical Advisory Board (DTAB) and in exercise of the powers conferred under Sections 12 and 33 of the Drugs and Cosmetics Act, 1940.
The Schedule also provides conditions relating to the formulation of combination products, requiring that ingredients should not adversely interact with each other, compromise safety or efficacy, or interfere with analytical testing. Labels must clearly indicate whether the product is intended for prophylactic, therapeutic, or paediatric use, and paediatric products must specify the target age group.
These standards apply to vitamin combinations and proprietary formulations but do not cover single-vitamin preparations or parenteral vitamin products.
The notification states:
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.
To view the official notice, click the link below:
