Health Ministry limits use of common cold meds for kids below four years

The Union Health Ministry hereby prohibits the use of cold FDC Chlorpheniramine Maleate 2 mg and Phenylephrine Hydrochloride 5 mg per ml drops in children below the age of this. The manufacturers must now put in their label, package insert, and promotional material a warning that reads, "FDC should not be used in children below 4 years of age".

This is in line with the advice given to restrict the FDC by the Subject Expert Committee (SEC) and the Drugs Technical Advisory Board (DTAB) on the assessment that the product is unsafe for children under four and safer alternatives are available. The restriction is powered under Section 26A of the Drugs and Cosmetics Act, which lays down that the Central Government may regulate the use of drugs in the public interest. Unless published in the Official Gazette, the directive is enforceable.

The Drugs Controller General of India (DCGI), Dr. Rajeev Singh Raghuvanshi, had directed state drug controllers and UT drug controllers to ensure compliance. Although in 2015 the Prof. Kokate Committee rationalized this FDC, it was recently reassessed due to new pediatric concerns. In June 2023, the SEC-Pulmonary, along with the input of pediatric experts, put forward the objection to its use in children under four, warranting the regulatory action.

"....on the basis of the recommendations of the said 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, sale and distribution for human use of the said drug in the country," said the Ministry.It added, "No, 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 drug manufacture, sale or distribution of all formulations of fixed dose combination of Chlorpheniramine Maleate + Phenylephrine Hydrochloride subject to the following condition, that the manufacturers 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".