Drug panel rejects child images on cough syrup labels, proposes age warning for use below 4 years

New Delhi: An expert committee has rejected a proposal to allow pictures of infants, toddlers, toys or similar child-oriented imagery on cough syrup labels, saying such depictions could suggest that the medicines are meant for use in young children. Instead, it proposed to carry a prominent warning in red on cough syrup bottles, stating that they should not be used in children below four years of age, according to documents seen by ET.

The government is considering the recommendation and may soon amend the drugs rules to give effect to the labelling requirement proposed by the drugs consultative committee.

Also read: Cough syrup bottles may soon carry a warning label in 'red'


The DCC recently deliberated on the proposal that came from within the committee. It agreed in principle to introduce the statutory warning on age restriction under Rule 96 of the Drugs Rules, 1945, amid continued concerns over the prescription of cough syrups to infants and young children.

The warning proposed by the committee will read: "WARNING: Cough syrup shall not be used in children below 4 years of age." The warning must be displayed prominently in red and in an appropriately large font size on the label, it said.

The original proposal was that a pictorial depiction of school-age children could be included on the bottle labels to reinforce that the product was intended for older children and discourage its use below the specified age. The committee said such depictions could create confusion and proposed inclusion of the red warning instead. ET reported about the proposal in September.

The move comes amid continued concerns over the use of cough and cold medicines in paediatric care. A directorate general of health services (DGHS) advisory issued in October 2025 called for judicious prescription and dispensation of such medicines. It specifically advised against prescribing those drugs for children below two years of age.

Also read: Drug regulator cracks down hard on non-compliant cough syrup makers

A complaint it received subsequently alleged continued prescription of cough syrups to infants below two years of age.

The internal technical committee of the Central Drugs Standard Control Organisation considered the plaint in April 2026. It recommended discussing the matter with the Indian Council of Medical Research to ascertain whether the research body had any proposals concerning cough syrups in the paediatric population.