Centre bans anti-cold drug combination for children aged under four

The Central Drugs Standard Control Organisation (CDSCO) has prohibited the use of an anti-cold drug combination in children aged below four, responding to global concerns after at least 141 deaths linked to cough syrups.

The regulator said concerns raised about the promotion of an unapproved anti-cold drug formulation in infants prompted a discussion and a resulting recommendation to not use the combination for that age group.

Rajeev Raghuvanshi, the Drugs Controller General of India (DCGI), has directed regulatory authorities in all states and Union territories to instruct manufacturers of the fixed drug combination (FDC) containing Chlorpheniramine Maleate IP 2mg and Phenylephrine HCL IP 5mg per ml drops to include a warning on the label, package insert, and promotional literature stating that the FDC should not be administered to children below the age of four.

"The committee recommended that the FDC should not be used in children below four years of age and accordingly the firms should mention warnings in this regard on label and package insert. The recommendation of the SEC has been considered by this office," the letter stated.

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