India Bans Anti-Cold Drug Combination in Children Under 4 After Global Deaths Linked to Cough Syrups

In a significant move, the drugs regulator in India has prohibited the use of an anti-cold drug combination in children below the age of four, citing concerns about the promotion of an unapproved formulation. The decision comes in the wake of at least 141 child deaths globally linked to toxic cough syrups, with India itself reporting cases of child fatalities and severe disabilities due to domestically-made cough syrups.

The fixed-drug combination (FDC) targeted by the ban contains chlorpheniramine maleate and phenylephrine, commonly used to treat symptoms of the common cold. The regulatory order, issued on December 18 and disclosed on Wednesday, mandates drugmakers to label their products with a warning against using the FDC in children under four years old.

The move follows a series of child deaths since 2019, with authorities connecting fatalities to toxic cough syrups produced in India. The global toll includes 141 deaths in Gambia, Uzbekistan, and Cameroon, emphasizing the urgent need for regulatory action.

India, often referred to as the “world’s pharmacy,” has implemented mandatory testing for cough syrup exports since June and has heightened scrutiny of drug makers. Despite denial of wrongdoing by drug manufacturers whose products were associated with child deaths, the regulatory intervention aims to address potential risks associated with the use of cough syrups in young children.

The World Health Organization (WHO) does not recommend the use of over-the-counter cough syrups or medicines for the treatment of coughs and cold symptoms in children below the age of five. The Indian regulator’s decision reflects a commitment to safeguarding public health and addressing concerns surrounding the safety of certain drug formulations.

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