Health Ministry Restricts Chlorpheniramine-Phenylephrine FDCs for Children Below 4, Mandates Warning Labels
New Delhi: In a move aimed at strengthening drug safety and protecting young children from potential risks associated with certain cough and cold formulations, the Ministry of Health and Family Welfare (MoHFW) has restricted the manufacture, sale and distribution of all formulations of fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, making it mandatory for manufacturers to carry the warning "fixed dose combination shall not be used in children below four years of age" on the drug label, package insert or promotional literature.
The restriction has been notified through S.O. 4595(E) dated August 18, 2026, issued under Section 26A of the Drugs and Cosmetics Act, 1940. The notification follows an earlier government notification, S.O. 1717(E) dated April 15, 2025, which had imposed a similar restriction on formulations of the same FDC.
According to the Ministry, the Central Government is satisfied that the use of other drug fixed-dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride is likely to involve risk to children below four years of age.
The Expert Committee constituted by the Ministry of Health and Family Welfare, Government of India examined the fixed dose combinations of other drugs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, and the said Expert Committee further recommended that the same warning should be applicable on all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride manufactured or imported and marketed in India.
Further, the Drugs Technical Advisory Board also examined the proposal in its meeting held on the 16th February, 2026 to restrict the manufacture for sale or for distribution of all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, in addition to the said notification S.O. No. 1717 (E), dated the 15th April, 2025, and after detailed deliberation, the Drugs Technical Advisory Board agreed that such formulations shall not be used in children below four years of age.
On the basis of the said recommendations of the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of restriction the manufacture for sale or for distribution for human use of such drug in the country.
In view of the foregoing, the Gazette notification states:
"Therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government hereby restricts the manufacture, sale or distribution of all formulations of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, subject to the condition that the manufacturers of such drugs shall mention the warning “fixed dose combination shall not be used in children below four years of age” on the label and package insert or the promotional literature of the drug."
The notification further states that it shall come into force on the date of its publication in the Official Gazette.
To view the official notice, click the link below:
