Delhi HC Says Ban On Certain Cold Medicines For Kids Below 4 To Apply Prospectively

In a relief for Glenmark Pharmaceuticals Ltd and other drug manufacturers, the Delhi High Court on Thursday ruled that the Centre's restriction on fixed-dose combinations of chlorpheniramine maleate and phenylephrine hydrochloride for children below four years of age will be applied prospectively.

The government notification, issued on April 15 asked manufacturers to include a warning stating, “fixed-dose combination shall not be used in children below four years of age” on the label, package insert, and promotional material of affected drugs. These combinations are found in widely used syrups for colds and allergies, including Glenmark’s Ascoril Flu Drops and certain Alex variants.

The court directed pharmaceutical companies to “compulsorily comply” with the labelling requirements for all stocks made or circulated after April 15. It also ordered the firms to publish a clear notice in national newspapers and issue advisories to doctors, chemists, and retailers that the drug combinations must not be prescribed for children under four.

The petitioners, including Glenmark and Zuventus Healthcare Ltd, had challenged the notification, arguing they were not given a chance to be heard before the restriction was imposed, and that retrospective application was unlawful.

The court said no coercive steps would be taken against the companies if they complied with the labelling and communication requirements and submitted affidavits detailing stocks made or in circulation before April15. It also clarified that the notices would not be considered as advertisements and therefore would not violate licensing norms. The next hearing for the case is on May 15.