The Ministry of Health and Family Welfare, Government of India, has issued a notification restricting the manufacture, sale and distribution of all formulations of the fixed dose combination (FDC) of Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age.
The notification, dated 15 April 2025, was issued under Section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), citing the potential risk of using the said FDC in children under four and the availability of safer alternatives.
According to the ministry, the matter was first examined by a Subject Expert Committee constituted by the Central Government. The committee recommended that the combination should not be used in children below the age of four years and advised that manufacturers must include the warning: “fixed dose combination shall not be used in children below four years of age” on the product label, package insert, and any promotional literature.
Subsequently, the Drugs Technical Advisory Board (DTAB) also reviewed the safety of the combination. The board endorsed the recommendation that use of the FDC be prohibited for children under four years of age and that the required warning must be displayed clearly on all related product material.
The Central Government stated it is satisfied that it is necessary and expedient in public interest to restrict the manufacture for sale, sale and distribution of the FDC for human use in India, based on DTAB’s recommendations.
The notification takes effect from the date of its publication in the Official Gazette.