India bans anti-cold drug combination after 141 deaths in Africa, Asia
The regulator said concerns raised about the promotion of an unapproved anti-cold drug formulation in infants prompted the recommendation.
Indian authorities have banned an anti-cold drug combination for children under four years after it was linked to the deaths of at least 141 kids in Africa and Asia.
India's drugs regulator also decreed that manufacturers must label their products with the warning that the “FDC (fixed-drug combination) should not be used in children below four years of age”, a report on Reuters said.
The order was issued on December 18 and made public on Wednesday (December 20).
The regulator said concerns raised about the promotion of an unapproved anti-cold drug formulation in infants prompted a discussion and a recommendation to not use it for that age group.
Child deaths since 2019 have been linked to toxic cough syrups made in India. At least 141 deaths have been reported from Gambia, Uzbekistan and Cameroon since the middle of last year.
In India, authorities have said at least 12 children died and four others were left with severe disabilities in 2019 after consuming the domestically-made cough syrups.
Indian drugs
The deaths have cast a shadow over the quality of exports from India, which produces life-saving drugs at low prices and whose medicines are widely consumed in developing countries.
The FDC comprises chlorpheniramine maleate and phenylephrine – medication that is often used in syrups or tablets to treat common cold symptoms.
The World Health Organization (WHO) does not recommend the use of over-the-counter cough syrups or medicines for the treatment of coughs and cold symptoms in children younger than five years of age.
India has introduced mandatory testing for cough syrup exports since June and stepped up scrutiny of drug makers. Drug makers whose cough syrups were linked to child deaths have denied any wrongdoing.
