India’s drugs regulator has banned the use of an anti-cold drug combination in children aged below four and ordered that drugs should be labelled accordingly, in the wake of the deaths of at least 141 children globally 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.
The order by the regulator on the fixed-drug combination (FDC), issued on December 18 and made public on Wednesday, requires drugmakers to label their products with the warning that the “FDC should not be used in children below 4 years of age”.
The fixed drug combination comprises chlorpheniramine maleate and phenylephrine — medication that is often used in syrups or tablets to treat common cold symptoms.
The World Health Organisation does not recommend the use of over-the-counter cough syrups or medicines for the treatment of coughs and cold symptoms in children younger than five years of age.