India Bans Anti-Cold Drug for Children Under 4 After Global Deaths

(CTN News) – At least 141 children have died around the world from complications related to cough syrups, prompting India’s medicines authority to ban the use of anti-cold drug combinations in children younger than four and to require appropriate labeling of drugs.

According to the agency, the recommendation to not use the combination for that age range was based on discussions spurred by concerns about marketing an unapproved anti-cold medication formulation in infants.

At least 141 children have died in Gambia, Uzbekistan, and Cameroon since the middle of last year, and officials have connected the deaths to poisonous cough syrups manufactured in India. This order comes as the nation draws lessons from this tragedy.

In 2019, at least 12 children in India died, and 4 others were severely disabled after ingesting cough syrups prepared in the country.

India is known as the “world’s pharmacy” because of its abundant supply of affordable, life-saving pharmaceuticals; nevertheless, the recent deaths have damaged the country’s export reputation.

Medicinal product labels must include the following statement: “FDC should not be used in children below 4 years of age” by a regulatory directive regarding fixed-drug combinations (FDCs) that was published on December 18 and made public on Wednesday.

Chlorpheniramine maleate and phenylephrine, two medications commonly found in cold syrups and pills, make up the fixed drug combination.

The World Health Organization does not advise using over-the-counter cough syrups or medications to alleviate cold and cough symptoms for children under five.

India has increased its monitoring of pharmaceutical companies and instituted testing as a condition for exporting cough syrup as of June. Pharmaceutical companies have denied any wrongdoing by the children whose cough syrups were associated with fatalities.