Govt puts curbs on cold meds that may harm kids under 4
The Indian government has restricted the sale and distribution of cold medicines containing chlorpheniramine maleate and phenylephrine for children under four. Manufacturers are now required to include prominent warning labels on these products.
Why it matters
This regulatory change aims to protect pediatric health by preventing the use of potentially harmful combination drugs in young children.
NEW DELHI: Parents of children below four years will now have to be more cautious about giving them combination medicines for cold symptoms, with the Centre restricting the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride.The government has said these combinations may pose risks to children below four and that safer alternatives are available. Manufacturers have been ordered to carry a prominent warning on the drug label, package insert and promotional material stating: “Fixed Dose Combination shall not be used in children below four years of age.”Dr Rommel Tickoo, senior director, internal medicine, Max hospital, said, “In children below four years, combination cold medicines containing chlorpheniramine and phenylephrine can cause excessive drowsiness or agitation, rapid heartbeat and, in some cases, serious adverse effects.
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