New Delhi, 22 August (H.S.):

The central government has imposed fresh restrictions on the manufacture, sale and distribution of all fixed-dose combination (FDC) medicines containing chlorpheniramine maleate and phenylephrine hydrochloride, commonly used for cough and cold, with a clear directive that these medicines must not be administered to children below four years of age.

According to a notification issued on Saturday, it will be mandatory for the labels, package inserts and promotional materials of these medicines to carry a warning stating that they should not be used in children under four. The government had earlier imposed a similar restriction on certain FDC medicines on April 15, 2025. The scope of the regulation has now been expanded to cover all FDC medicines containing chlorpheniramine maleate and phenylephrine hydrochloride.

The government said the decision was taken based on recommendations from an expert committee and the Drugs Technical Advisory Board. According to the government, the use of these medicines in children below four years of age may pose health risks, while safer alternatives are available for this age group.

The order has been issued in the public interest under Section 26A of the Drugs and Cosmetics Act, 1940, with the objective of safeguarding the health and safety of young children.

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Hindusthan Samachar / Jun Sarkar