India bans specific anti-cold drug combo for kids under 4

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INDIA, Dec 20: India’s drug regulatory authority has prohibited the use of a combination of anti-cold drugs in children under the age of four and mandated specific labeling for such drugs. This decision follows global reports of at least 141 children’s deaths linked to cough syrups. The regulator expressed concerns about the promotion of an unapproved anti-cold drug formulation for infants, prompting the recommendation to avoid this combination for that age group.

The move comes in response to a series of child deaths in India since 2019, associated with domestically-made toxic cough syrups. Globally, the deaths include at least 141 cases in Gambia, Uzbekistan, and Cameroon since the middle of last year. Domestically, Indian authorities reported at least 12 child deaths and four severe disabilities in 2019 linked to locally-produced cough syrups.

These incidents have raised questions about the quality of drug exports from India, known as the “world’s pharmacy” for its supply of affordable life-saving drugs. The recent order by the regulator, issued on December 18 and disclosed on Wednesday, mandates drug manufacturers to label their products with a warning against using the fixed-drug combination (FDC) in children under 4 years old.

The FDC consists of chlorpheniramine maleate and phenylephrine, commonly used in syrups or tablets to address symptoms of the common cold. The World Health Organization does not recommend the use of over-the-counter cough syrups or medications for treating coughs and cold symptoms in children under five.

Since June, India has implemented mandatory testing for cough syrup exports and intensified scrutiny of drug manufacturers. Companies whose cough syrups were associated with child deaths have denied any wrongdoing.

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