Drug Regulator Says Anti-Cold Drug Mix Not to Be Used For Children Below Four
The Wire Staff
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New Delhi: India's drug regulator has decided that an anti-cold drug mixture “should be not used in children below four years of age” and ordered that manufacturers apply a warning label to this effect.
The Central Drugs Standard Control Organisation (CDSCO) asked state drug controllers on Monday (December 18) to direct manufacturers in their respective jurisdictions to apply the label to the drug mixture.
Dr Rajeev Singh Raghuvanshi, India's drug controller general and head of the CDSCO, said that the decision was taken based on the recommendations of an expert committee that met in June.
The mixture in question is a ‘fixed-dose combination’ (FDC) of chlorpheniramine maleate and phenylephrine hydrochloride.
According to Reuters, the FDC is used in syrups and tablets to treat common cold symptoms.
Cough syrups manufactured in India have come under scrutiny after the deaths of children both at home and abroad were linked to their consumption.
The World Health Organisation said that cough syrups made in India were linked to the deaths of 141 children in the Gambia, Uzbekistan and Cameroon over 2022, Reuters reported.
The news agency also reported that in June this year, India announced plans to mandate the testing of cough syrups before they are exported.
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