India's drug regulator prohibits usage of combination anti-cold drug

Global reports linked cough syrups to deaths of minimum of 141 children

WHO does not endorse the use of over-the-counter cough syrups

India’s drug regulator has prohibited the usage of a combination anti-cold drug for children under the age of four, emphasizing the need for appropriate labeling of such medications.

This decision follows global reports linking cough syrups to the deaths of a minimum of 141 children.

The regulatory authority responded to worries about the endorsement of an unapproved formulation of an anti-cold drug for infants. This prompted discussions and ultimately a recommendation against utilizing the combination for that specific age group.

This instruction comes in the aftermath of a string of child fatalities in India since 2019, connected to domestically manufactured toxic cough syrups. These occurrences, encompassing a minimum of 141 deaths in Gambia, Uzbekistan, and Cameroon since the middle of the previous year, have sparked inquiries into the standard of pharmaceutical exports from India. The country, often recognized as the “world’s pharmacy” for supplying life-saving drugs at reasonable prices, now faces scrutiny.

The regulatory body issued a directive requiring drug manufacturers to include a warning on their products, specifying that the fixed-drug combination (FDC) should not be used in children below 4 years of age.

This FDC contains chlorpheniramine maleate and phenylephrine, commonly found in syrups or tablets to alleviate common cold symptoms. It’s noteworthy that the World Health Organization does not endorse the use of over-the-counter cough syrups or medications for treating coughs and cold symptoms in children under the age of five.