India Says No to Cold Medicine for Kids Under 4

Labels Required After Regulatory Move

India's drug regulator has prohibited the usage of a combination anti-cold drug for children under four years old, instructing that medications be appropriately labeled, as per Reuters.

The decision was prompted by the deaths of at least 141 children worldwide, which were associated with cough syrups.

The regulatory body raised concerns about the promotion of an unapproved anti-cold drug formulation for infants. This led to discussions and a subsequent recommendation against using the combination for that age group.

This directive comes in the wake of a series of child deaths in India since 2019, attributed to toxic cough syrups produced domestically. These incidents, involving at least 141 deaths in Gambia, Uzbekistan, and Cameroon since the middle of last year, have raised concerns about the quality of pharmaceutical exports from India, often known as the "world's pharmacy" for providing life-saving drugs at affordable prices.

On December 18, the regulator issued a public order, disclosed on Wednesday, instructing drug manufacturers to label their products with a warning that the fixed-drug combination (FDC) "should not be used in children below 4 years of age." This FDC includes chlorpheniramine maleate and phenylephrine, commonly used in syrups or tablets for common cold symptoms. Notably, the World Health Organization does not recommend the use of over-the-counter cough syrups or medicines for treating coughs and cold symptoms in children under five years old.

Since June, India has enforced mandatory testing for cough syrup exports and increased scrutiny of drug manufacturers. Despite these measures, companies linked to child deaths related to cough syrups have consistently denied any wrongdoing.