The Delhi High Court has asked pharmaceutical companies to provide stringent warnings against the use of fixed-dose combination (FDC) cough syrups among children under the age of four. The direction came in response to a government notification issued on April 15 regarding safety concerns linked to such formulations.

Key Highlights:Mandatory Warning On Labels And Marketing Material
The court directed firms to put a clear warning on all labels and marketing material:
"Fixed combination not to be used for children under four years."Public Notices in National Newspapers

• Manufacturers are required to issue notices in two national newspapers (one English and one Hindi) to inform the public about the ban.

• These notices need to be placed prominently and command attention but will not be classified as advertisements according to drug license rules.

Court Affirms April 15 Government Directive
Despite the fact that companies Glenmark and Zuventus Healthcare objected to the directive, the court held that the ban has to extend to all drugs produced after April 15, 2025.

Background on Government Action
The Central Government had prohibited the sale of some FDC cough syrups for children under four years old due to serious safety concerns that were detected during regulatory scrutiny.

Quotes from Officials or Leaders
Delhi High Court Bench (headed by Chief Justice DK Upadhaya):
"Though retrospective application is questionable, producers are bound by duty to obey the notification for all production post-April 15. Public safety comes first."This legal order gives teeth to the Union Health Ministry's safety protocols to safeguard children from unsafe drugs. With drug companies now legally required to give warnings and public notices, the step is likely to create much-needed awareness among doctors, retailers, and parents.