In response to global concerns and reported child deaths linked to Indian-made cough syrups, India’s top drug controller has banned an anti-cold drug combination for use in children below the age of four. The ban follows a spate of child deaths in The Gambia and Uzbekistan, which were associated with Indian-made cough syrups in the previous year.
The banned combination includes – chlorpheniramine maleate and phenylephrin – and was approved in 2015 for use in cough syrups and tablets to treat symptoms of the common cold. At least 12 children in India reportedly died between 2019 and 2020 after consuming a similar medication, leading to increased scrutiny.
Manufacturers of the drugs have denied any wrongdoing, asserting that their products are safe for use. The order, made public on Wednesday, mandates drugmakers selling the combination to label their products with a warning against use in children below the age of four.
Last year, the World Health Organization (WHO) issued a global warning about four India-made cough syrups allegedly linked to the deaths of 66 children in The Gambia. Lab analysis confirmed the presence of “unacceptable amounts” of diethylene glycol and another toxic alcohol called ethylene glycol in the samples.
Similar deaths were reported in Uzbekistan, where 18 children died till 2022 allegedly after consuming an Indian-manufactured cough syrup. In India’s Jammu region, at least 12 children between the ages of two months and six years died in 2019 after drinking an allegedly toxic cough syrup.
Indian regulators have maintained that the deaths reported in the country were isolated instances. While they claim that the four cough syrups linked to child deaths in The Gambia complied with specifications when tested at home, the WHO has contested this. The manufacturing license of the firm whose products allegedly led to fatalities in Uzbekistan was canceled.