Parents may soon see a prominent red warning on cough syrup bottles advising against their use in children below four years of age, as India considers tighter labelling requirements for these medicines.
The proposal has been placed before the Drugs Consultative Committee (DCC) and seeks an amendment to Rule 96 of the Drugs Rules, 1945. It also proposes a pictorial depiction of school-age children on the packaging to make it clearer that the medicines are intended for older children.
Why the warning is being considered
The proposed change follows continuing concerns over cough and cold medicines being prescribed or given to very young children despite earlier safety advice.
In October 2025, the Directorate General of Health Services (DGHS) advised that cough and cold medicines should be prescribed and dispensed judiciously in paediatric care. It specifically advised against prescribing or dispensing them to children below two years of age.
A subsequent complaint about cough syrups being prescribed to infants below two was examined by an internal technical committee of the Central Drugs Standard Control Organisation (CDSCO) in April 2026.
What parents should remember
The proposed label change has not yet become a final requirement. The DCC will deliberate on the proposal, followed by the regulatory process needed for any amendment to the Drugs Rules.
Parents should not give cough or cold medicines to babies and toddlers on their own. A child’s age, symptoms, medical history and the particular medicine all matter when deciding whether treatment is appropriate.
The proposed warning is intended to make age-related restrictions more visible and reduce the risk of inappropriate use among infants and young children.