Centre Restricts Fixed-Dose Combination Cold Medicines for Children Under Four

New Delhi: The central government has restricted the manufacture, sale and distribution of fixed-dose combination (FDC) medicines containing chlorpheniramine maleate and phenylephrine hydrochloride for children below four years of age. The Union Health Ministry has issued a directive stating that these medicines should not be used in children under four.

The notification issued last year had restricted only certain medicines. The latest notification extends the restriction to all medicines containing this combination. The decision was taken based on recommendations from an expert committee and the Drugs Technical Advisory Board. Authorities said these medicines could pose risks to children below four, while safer alternatives are available. The notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940.

Manufacturers have also been directed to include a warning on the labels stating that the medicines should not be used for children below four years of age.

In June this year, the Centre had also prohibited the manufacture, sale and distribution of 16 fixed-dose combination medicines. The chlorpheniramine maleate and phenylephrine hydrochloride combination is primarily used in medicines for cold and allergies. Authorities said the restriction was imposed after it was found that the combination could cause more harm than benefit in young children.