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

New Delhi: India's drug regulator is considering mandatory labelling changes for cough syrups to discourage their use in children below four years of age. The proposal also calls for a pictorial depiction of school-age children on the label to reinforce that the medicine is intended for older children and not infants and toddlers.

The move comes amid continued concerns over the prescribing of cough syrups to infants and young children, despite a directorate general of health services (DGHS) advisory in October 2025 against the practice.

"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'," according to the proposal seen by ET. "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."


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The proposal has been placed before the drugs consultative committee (DCC) for deliberation and seeks an amendment to Rule 96 of the Drugs Rules, 1945.

The DGHS advisory last year called for judicious prescribing and dispensing of cough and cold medicines in paediatric care. It specifically advised that such medicines should not be prescribed or dispensed to children below two years of age.

Despite the advisory, a complaint was subsequently received regarding the continued prescribing of cough syrups to infants below two years of age. "The practice has continued even after the DGHS issued specific directions against it in October 2025," said a person familiar with the matter.

The complaint was deliberated by an internal technical committee of the Central Drugs Standard Control Organisation (CDSCO) in April 2026. The committee recommended discussing the matter with the Indian Council of Medical Research (ICMR) to ascertain whether the research body had any proposals concerning cough syrups in the paediatric population. It also recommended a stakeholder consultation on the regulatory and marketing feasibility of changes to the labelling.

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However, ICMR said it was not undertaking any work on cough syrup labelling.

"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," said another person familiar with the matter.