The reported development is recorded under the focus phrase India chlorpheniramine phenylephrine restriction. India has restricted the manufacture, sale and distribution of fixed-dose formulations containing chlorpheniramine maleate and phenylephrine hydrochloride for children below four years of age. The restriction was announced under the Drugs and Cosmetics Act through a government notification.

The government directed that labels on the affected formulations carry a warning that the combination must not be used in children below four. The action followed recommendations from expert bodies that reviewed the safety and use of the combination in young children.

The restriction applies to the specified fixed-dose combination rather than every cold medicine or every product containing either ingredient separately. The exact product and label should therefore be checked against the official notification and advice from a qualified clinician.

The Press Information Bureau and the published gazette notice provide the government’s legal basis and wording. This report describes the regulatory action and is not a substitute for medical advice or a prescription.

The current coverage gave the event a specific date and location, or identified the named organisation behind it. Where the reports described a proposal, estimate, scheduled launch or ongoing investigation, those limits remain part of the confirmed account and are not treated as a completed outcome.