Now Reading: Centre restricts two-ingredient cold medicines for children under four
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Centre restricts two-ingredient cold medicines for children under four
The Union health ministry has restricted the manufacture, sale and distribution of fixed-dose combinations containing chlorpheniramine maleate and phenylephrine hydrochloride for treating common cold symptoms in children below four years. Drugmakers must…
The Union health ministry has restricted the manufacture, sale and distribution of fixed-dose combinations containing chlorpheniramine maleate and phenylephrine hydrochloride for treating common cold symptoms in children below four years. Drugmakers must print a warning against use in this age group on labels, package inserts and promotional material.
The combination prevents separate adjustment of the two ingredients. Chlorpheniramine may cause lethargy, breathing problems, seizures and central nervous system depression, while phenylephrine can trigger high blood pressure, rapid heartbeat and arrhythmias. Accidental double-dosing may cause severe toxicity, hallucinations or loss of consciousness.
The action follows recommendations from an expert committee and the Drugs Technical Advisory Board. It affects a paediatric segment of India’s cough, cold and anti-allergic retail market, valued at over Rs 4,500 crore annually. For children under four, suggested alternatives include paracetamol for fever, saline nasal drops and oral hydration.
Indian Opinion Analysis
Fixed-dose combinations can simplify dispensing, but they also make it harder to alter one ingredient when a child’s symptoms, weight or response differs. Parents may also encounter the same active ingredients under different brand names, increasing the risk of duplicate dosing. A prescription or pharmacist’s check should therefore include the full ingredient list, not just the brand name. The practical signal to follow is the mandatory warning on every affected product label and package insert.
Source: livemint.com
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