India proposes red label warning on cough syrups for children under four

India’s drug regulator is preparing to mandate a prominent red warning on cough-syrup containers, prohibiting use in children under four years old. The proposal, now before the Drugs Consultative Committee, also calls for a pictorial cue showing school-age children to reinforce the age restriction. The required wording would state: “WARNING: Cough syrup should not be used in children below 4 years of age,” and would amend Rule 96 of the Drugs Rules, 1945.

This step follows a 2025 advisory from the Directorate General of Health Services that urged judicious prescribing of cough and cold medicines, especially avoiding children under two. An April 2026 technical committee review highlighted the need for broader labeling, though the Indian Council of Medical Research declined to take up the issue. The move comes after the health ministry already barred certain fixed-dose combinations for the same age group, signalling a wider push to tighten pediatric medication safety.