Indian Drug Regulator Bans Anti-Cold Medication For Children Below 4 After Deaths Linked To Cough Syrups

India's drug regulatory authority has prohibited the use of a specific anti-cold medication mixture for children under the age of four, following the global deaths of at least 141 children associated with cough syrups. It has also mandated the appropriate labelling of these drugs.

The regulatory authority stated that the promotion of an unauthorised anti-cold medication for infants has sparked a debate, leading to a subsequent suggestion against using this combination for this particular age group, NDTV reported.

The directive was issued following a series of child fatalities since 2019, which officials attributed to poisonous cough syrups produced domestically. This includes a minimum of 141 deaths in Gambia, Uzbekistan, and Cameroon since the previous year's midpoint.

In 2019, officials in India reported that domestically-produced cough syrups resulted in the death of at least 12 children and left four others with serious disabilities.

The directive from the regulator regarding the fixed-drug combination (FDC), which was given on 18 December and disclosed on Wednesday, mandates pharmaceutical companies to mark their products with a caution stating that the "FDC is not suitable for use in children under 4 years old".

The combined medication, which includes chlorpheniramine maleate and phenylephrine, is typically found in syrup or tablet form and is commonly used to alleviate symptoms of the common cold.

The World Health Organization advises against the utilization of over-the-counter cough syrups or medications for managing coughs and cold symptoms in children who are under the age of five.

Since June, officials have implemented compulsory testing for exported cough syrups and have increased their examination of pharmaceutical companies. Those companies whose cough syrups have been associated with fatalities in children have refuted any allegations of misconduct.