MOHFW Extends Mandatory Warning Requirement to All Chlorpheniramine Maleate and Phenylephrine Hydrochloride Fixed Dose Combinations

The Ministry of Health and Family Welfare has issued a Notification dated 18 August 2026 under Section 26A of the Drugs and Cosmetics Act, 1940, to regulate the manufacture, sale and distribution of all formulations of fixed dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for human use. The Notification follows an earlier Notification dated 15 April 2025, which required certain FDCs to carry a warning that they should not be used in children below four years of age. Based on the recommendations of the Expert Committee constituted by the Ministry of Health and Family Welfare and the Drugs Technical Advisory Board (DTAB), the Central Government has now extended this requirement to all such FDC formulations. The DTAB, in its meeting held on 16 February 2026, concluded that these formulations may pose a risk to children below four years of age and that safer alternatives are available. Accordingly, in the interest of public health, the Government has decided to restrict the manufacture, sale and distribution of these drugs across India.

Under the Notification dated 18^th August 2026, the manufacture, sale and distribution of all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride are permitted only subject to the condition that manufacturers prominently display the warning “Fixed dose combination shall not be used in children below four years of age” on the drug’s label, package insert and promotional literature.

The Notification has come into force on its publication in the Official Gazette.

Source: Official Gazette