India’s top drug controller has banned an anti-cold drug combination for use in children below the age of four.
The ban comes after a spate of child deaths in The Gambia and Uzbekistan were linked to Indian-made cough syrups last year.
In India, at least 12 children died between 2019 and 2020 allegedly after consuming a similar medication
Manufacturers of these drugs, however, have denied any wrongdoing and say their products are safe for use.
The banned combination includes three drugs – chlorpheniramine maleate and phenylephrin – and was approved in 2015. It is used in cough syrups and tablets to treat symptoms of common cold.
The order, which was made public on Wednesday, makes it compulsory for drugmakers selling the combination to label their products with the warning that it should not be used by children below the age of four.
Indian cough syrups came under scrutiny last year after the WHO put out a global warning over four India-made cough syrups allegedly linked to the deaths of 66 children in The Gambia.
Lab analysis of the samples of a syrup confirmed the presence of “unacceptable amounts” of diethylene glycol and another toxic alcohol called ethylene glycol.
Similar deaths were reported in Uzbekistan, where 18 children had died till 2022 allegedly after consuming an Indian manufactured cough syrup, according to the country’s health ministry.
In India’s Jammu region, at least 12 children between the age of two months and six years died in 2019 after drinking an allegedly toxic cough syrup.
Indian regulators have said in the past that the deaths reported in the country were one-off instances.
It has also said that the four cough syrups linked to child deaths in The Gambia complied with specifications when tested at home – a claim the WHO has contested.
It did, however, cancel the manufacturing licence of the firm whose products allegedly led to fatalities in Uzbekistan.
The country has also stepped up its scrutiny of drugs – in June, the government made it mandatory for companies to get their cough syrups tested before exporting it to other parts of the world.
