Cough Syrup Bottles May Carry Red Warning Against Use in Children Under Four
New Delhi: India's drug regulator is considering a mandatory warning on cough syrup bottles and an image of school-age children to discourage use in children below four years of age and show that the product is intended for older children.
According to a recent media report in The Economic Times, the proposal has been placed before the Drugs Consultative Committee for deliberation and would require an amendment to Rule 96 of the Drugs Rules, 1945.
It states:"The following warning may be prominently displayed in red on the bottle label: 'WARNING: Cough syrup should not be used in children below 4 years of age'," and adds, "Additionally, a pictorial depiction of school-age children may be included on the bottle label to reinforce that the product is intended for older children and to discourage its use in children below the specified age."
The proposal follows an October 2025 advisory from the Directorate General of Health Services urging careful prescribing and dispensing of cough and cold medicines for children. That advisory specifically said the medicines should not be prescribed or dispensed to children below two years of age.
A complaint received after the advisory alleged that cough syrups were still being prescribed to infants below two years of age. “The practice has continued even after the DGHS issued specific directions against it in October 2025,” a person familiar with the matter told ET.
A CDSCO internal technical committee discussed the complaint in April 2026 and recommended consulting the Indian Council of Medical Research about any proposals for paediatric cough syrup use. It also recommended consulting stakeholders on whether labelling changes would be feasible from regulatory and marketing perspectives. ICMR said it was not working on cough syrup labelling.
Another person familiar with the matter told ET, "Cough syrups are among the most commonly prescribed and over-the-counter purchased medicines in India, and their use in very young children has long been a concern among health experts."
