India bans anti-cold drug combination for kids below 4 in wake of deaths linked to cough syrups

Cough syrup deaths: In the wake of deaths of at least 141 children globally linked to cough syrups, Indian government  banned the use of an anti-cold drug combination in children aged below four. 

Concerns raised about the promotion of an unapproved anti-cold drug formulation in infants prompted a discussion and a recommendation to avoid using the combination in that age group, according to the regulator.

As per the order, "FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop/ml was declared as rational by Prof. Kokate committee and based on the recommendation of the committee, this office has issued NOC for continued manufacturing and marketing of subject FDC on July 17, 2015, under the 18 months policy decision."

"The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warning in this regard on label and package insert," the letter read.

The order follows a string of child deaths linked to toxic cough syrups made in the country since 2019, including at least 141 deaths in Gambia, Uzbekistan, and Cameroon since the middle of last year.

As per the reports, after 2019 at least 12 childrens died and other left with severe disabilities after consuming cold syrups. 

The Drugs general controller (India) wrote a letter on December 18, to all states and asked states and Union Territories to update the package insert of products made using a cocktail of two medicines chlorpheniramine maleate and phenylephrine.

The fixed drug combination comprises FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop/ml used in cold syrups. 

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