The Central Government has announced restrictions on the manufacture, sale, and distribution of all fixed-dose combination (FDC) formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for use in children below four years of age. This decision, made under Section 26A of the Drugs and Cosmetics Act, 1940, comes into effect from April 15, 2025.
The government’s decision follows concerns that the use of this common cold drug combination poses a potential risk to children under the age of four, particularly as safer alternatives are readily available.
The matter was thoroughly examined by a Subject Expert Committee appointed by the Central Government. The committee recommended a clear warning be mandated on the label, package insert, and promotional materials of the drug, stating that the “fixed dose combination shall not be used in children below four years of age.”
The Drugs Technical Advisory Board (DTAB) also reviewed the FDC and further recommended its prohibition for use in children under four years under Section 26A of the Drugs and Cosmetics Act, 1940. The DTAB supported the condition that manufacturers must prominently display the warning about its unsuitability for this age group on all product-related materials.
Based on the recommendations of the DTAB, the Central Government has expressed its satisfaction that it is necessary and expedient in the public interest to regulate the manufacture for sale, sale, and distribution of this specific drug combination through restriction.
Mandatory Warning for Manufacturers
Consequently, the Central Government has now mandated that all manufacturers of fixed-dose combinations of Chlorpheniramine Maleate and Phenylephrine Hydrochloride must clearly and prominently mention the warning “fixed dose combination shall not be used in children below four years of age” on the label, package insert, and any promotional literature associated with the drug.
