What happened: the Union Health Ministry expanded restrictions for paediatric cold medicines
The Union Health Ministry expanded restrictions on fixed-dose combination (FDC) cough-and-cold medicines that contain chlorpheniramine maleate and phenylephrine hydrochloride. The ministry’s notification requires manufacturers to clearly warn that these medicines should not be used in children below four years of age.
The notification applies across all formulations containing these two ingredients and requires the warning to appear on labels, package inserts, and promotional material. The notification is issued under the Drugs and Cosmetics Act, 1940 and becomes effective from the date of publication in the Official Gazette.
The Union Health Ministry links the restriction to child-specific risks. Chlorpheniramine maleate is described as an antihistamine for symptom relief such as runny nose and sneezing; the ministry cautions about possible marked drowsiness or sometimes excitability. Phenylephrine hydrochloride is described as a decongestant for nasal blockage; the ministry cautions about possible effects on heart rate and blood pressure.
The ministry states that evidence showing substantial improvement for uncomplicated colds in young children is limited. The ministry also places the decision within wider scrutiny of cough-and-cold medicines for young children.
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