As per the proposed amendment, the unit of measurement for folic acid in Schedule V is to be changed from milligrams (mg) to micrograms (mcg). Accordingly, the specified limits will now be interpreted in micrograms. This means that for prophylactic use in adults, a patent or proprietary preparation should contain not less than 50 mcg and not more than 300 mcg of folic acid per daily dose. For therapeutic use in adults, the permitted range is 1,000 mcg to 1,500 mcg per day. In paediatric preparations, the daily dose for infants below one year should contain 25–100 mcg, while for children above one year up to adults, it should contain 100–500 mcg. Thus, the amendment does not change the numerical limits but corrects the unit to micrograms to align with standard dosing practice and prevent dosing errors.
These proposed draft rules have been issued 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 (DTAB). The draft has been published for the information of all persons likely to be affected, signaling a technical but clinically significant regulatory correction.
Schedule V deals with the standards for patent or proprietary medicines. The standards for patent or proprietary medicines shall be those laid down in Schedule V, and such medicines shall also comply with the standards laid down in the Second Schedule to the Act.
Schedule V under Rule 124B of the Drugs Rules, 1945 prescribes the standards for patent or proprietary medicines, particularly those containing vitamins and multiple active ingredients. It mandates that vitamin preparations intended for prophylactic (preventive), therapeutic, or paediatric use must contain each vitamin strictly within specified minimum and maximum quantities per daily dose, which may be administered as a single dose or in two divided doses, and are defined using standard units such as IU, mg, and mcg. The limits vary for adults, infants, and children. The Schedule further lays down general standards for combination formulations, requiring that selected active ingredients must not interact adversely, must not affect the safety or therapeutic efficacy of the product, and must not create difficulties in laboratory testing of individual ingredients. Any additives included must be harmless, must not interfere with the action of the active ingredients, and must not affect identity tests or assay results. Labels must clearly state whether the product is for prophylactic, therapeutic, or paediatric use, and in paediatric preparations, the intended age group must be specified. These standards do not apply to single-vitamin preparations or vitamin products for parenteral use; however, licensing authorities may permit deviations from the prescribed limits for disease-specific formulations when supported by adequate scientific justification.
The draft amendment states:
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, the unit mentioned against the Folic acid i.e. “mg.” shall be substituted with “mcg”.
The draft rules will be taken into consideration after the expiry of thirty days from the date on which copies of the Gazette of India containing the 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," the notification states.
"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", the gazette added.
To view the official notice, click the link below:
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