
Indian drug regulator Central Drugs Standard Control Organisation (CDSCO) has banned the use of an anti-cold drug combination in children below four years of age. It has ordered that drugs should be labelled should be labelled accordingly. The fixed drug combination comprises chlorpheniramine maleate and phenylephrine - medication that is often used in syrups or tablets to treat common cold symptoms.
The decision comes in the wake of the deaths of at least 141 children globally linked to cough syrups.
As per the regulator, concerns raised regarding promotion of an unapproved anti-cold drug formulation in infants lead to a discussion and thereafter, a resulting recommendation to not use the combination for that age group.
The matter was deliberated in the Subject Expert Committee (SEC- Pulmonary) meeting held in June.
Since 2019, a number of child deaths worldwide have been linked to toxic cough syrups made in the country. This includes at least 141 deaths in Gambia, Uzbekistan and Cameroon.
Meanwhile, in India, the death toll stands at 12 and four others were left with severe disabilities in 2019 after consuming domestically-made cough syrups.
The latest directive by the drug regulator on the fixed-drug combination (FDC), requires manufacturers to label their products with the warning that the "FDC should not be used in children below 4 years of age".
Earlier this year, the World Health Organization (WHO) released a call to action to countries to prevent, detect and respond to incidents of substandard and falsified medical products.
It also 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.
(With Reuters inputs)
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