Daijiworld Media Network - New Delhi

New Delhi, Sep 19: Cough syrup bottles in India may soon carry a prominent warning against their use in children below four years of age, with the country's drug regulator considering changes to labelling requirements for such medicines, according to a report.

The proposal has been placed before the Drugs Consultative Committee (DCC) and calls for the warning to be displayed in red on cough syrup labels. It also proposes a pictorial representation of school-age children to indicate that the medicines are intended for older children and discourage their use in infants and toddlers.

The proposed warning reads: “WARNING: Cough syrup should not be used in children below 4 years of age.”

The proposal seeks an amendment to Rule 96 of the Drugs Rules, 1945. Any change will be subject to deliberation by the DCC and the subsequent regulatory process.

The move comes amid continued concerns over the use of cough and cold medicines among young children. In October 2025, the Directorate General of Health Services (DGHS) advised that such medicines should be prescribed and dispensed judiciously in paediatric care and specifically advised against prescribing or dispensing them to children below two years of age.

A complaint regarding the continued prescription of cough syrups to infants below two years was subsequently examined by an internal technical committee of the Central Drugs Standard Control Organisation (CDSCO) in April 2026.

The committee recommended consulting the Indian Council of Medical Research (ICMR) on whether it had any proposals concerning cough syrups for children. It also recommended consultations with stakeholders on the regulatory and marketing feasibility of changes to cough-syrup labelling.

According to the report, the ICMR said it was not undertaking any work on cough-syrup labelling.

The proposed broader labelling change comes shortly after the government imposed restrictions on fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride for use in children below four years.

In an August 22 notification, the Union Health Ministry directed manufacturers of these FDCs to display a warning on the label, package insert and promotional literature stating that they should not be used in children below four years of age.

The restriction followed recommendations from an expert committee and the Drugs Technical Advisory Board.

If approved, the proposed cough-syrup labelling requirement would apply more broadly and would require a separate amendment to the Drugs Rules, 1945.