After at least 141 children have died worldwide from cough syrup overuse, India’s drug regulator has outlawed the use of anti-cold drug combinations in children under four and mandated that medications be labeled appropriately.
According to the regulator, discussions and a recommendation to avoid using the combination for that age group were sparked by concerns expressed about the promotion of an unapproved anti-cold drug formulation in infants.
The directive follows a wave of pediatric fatalities since 2019 that authorities have connected to the nation’s toxic cough syrup manufacturing, including at least 141 deaths in the Gambia, Uzbekistan, and Cameroon since the middle of the previous year.
According to Indian authorities, using cough syrups made in the country in 2019 resulted in at least 12 child deaths and four severely disabled children.
India is frequently referred to as the “world’s pharmacy” because of its abundance of inexpensive, life-saving medications.
The regulator’s order on fixed-drug combinations (FDCs), which was published on Wednesday, was issued on December 18 and mandates that manufacturers label their products with a warning that “FDCs should not be used in children below 4 years of age.”
The fixed drug combination includes phenylephrine and chlorpheniramine maleate, which are commonly found in syrups and tablets for the treatment of common cold symptoms.
When it comes to treating coughs and cold symptoms in children under five years old, the World Health Organization does not advise using over-the-counter cough syrups or medications.
Since June, authorities in this country have made testing for cough syrup exports mandatory and increased their investigation of pharmaceutical companies. The manufacturers of cough syrups that were connected to pediatric fatalities have refuted any misconduct.