India raises onus on cough syrup manufacturers; bans anti-cold drug combination for kids under four

India's drugregulator on Wednesday (Dec 20) prohibited the use of an anti-cold drug combination in children aged below four. The regulatory body has mandated that drug labels should clearly reflect this restriction.

The move follows concerns raised about the promotion of an unapproved anti-cold drug formulation for infants.

A letter issued to the states and the Union Territories by the Drugs General Controller (India) stated that the concern has been recognised after the promotion of unapproved anti-cold drug formulation for infants.

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"The committee recommended that the FDC should not be used in children below 4 years of age and accordingly the firms should mention warning in this regard on label and package insert," it read further.

The cough syrups manufactured in India have been linked with a series of deaths of children aged less than four in parts of the world.

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These incidents have raised concerns about the quality of pharmaceutical exports from India, often referred to as the "world's pharmacy"due to its widespread supply of life-saving drugs at affordable prices.

In response to the global outcry, the World Health Organization (WHO) has underscored its recommendation against the use of over-the-counter cough syrups or medicines for treating coughs and cold symptoms in children under five years of age.

India implemented mandatory testing for cough syrup exports in June and has intensified scrutiny of drug manufacturers.

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The regulatory directive now obliges drugmakers to prominently label their products with a warning against the use of the specified FDC in children below four years of age.

(With inputs from agencies)