India is considering mandatory warning labels on bottles to discourage their use in children below four years of age, months after a government advisory cautioned against prescribing such medicines to very young children.
The proposal calls for a prominent red warning stating that cough syrup should not be used in children below four. It also suggests adding a pictorial depiction of school-age children to make clear that the medicine is intended for older children.
The proposal was considered at a meeting chaired by (DCGI) on Friday, 18 September, according to two officials and a document reviewed by Mint.
The move follows repeated complaints about cough and cold formulations being administered to infants, despite an advisory issued by the Directorate General of Health Services (DGHS) in October 2025.
The DGHS advisory, issued on October 3, 2025, mentioned that cough and cold medicines should not be prescribed or dispensed to children below two years of age. It also said such medicines were generally not recommended for children below five years and that their use in older children should follow careful clinical evaluation, appropriate dosing and close supervision.
A subsequent complaint alleged that doctors continued to prescribe cough syrups to infants below two despite the DGHS directions.
The issue was discussed by the Internal Technical Committee of the Central Drugs Standard Control Organisation (CDSCO) on April 24, 2026. The committee recommended discussing the matter with the Indian Council of Medical Research (ICMR) and seeking information on any work related to cough syrups in children. It also called for consultation with stakeholders on the regulatory and marketing feasibility of changing the labels on cough syrup packs.
ICMR said it was not undertaking work on cough syrup labelling.
The drug regulator has now moved towards amending Rule 96 of the Drugs Rules, 1945, with the proposed warning specifically setting the age threshold at four years.
The proposal recommends a prominent red warning on cough syrup bottles stating: “WARNING: Cough syrup should not be used in children below 4 years of age.”
It also suggests using an image of school-age children on the packaging to reinforce that the product is intended for older children and discourage its use in infants and toddlers.
This proposed four-year warning sits alongside the existing DGHS guidance, which says cough and cold medicines should generally not be recommended for children below five years, while specifically prohibiting their prescription or dispensing to children below two.
The proposal comes amid wider concerns over the safety and use of paediatric cough syrups, including incidents involving products contaminated with toxic substances such as diethylene glycol (DEG) and ethylene glycol (EG).
According to reports, Indian-manufactured paediatric syrups were linked to the deaths of children in The Gambia in 2022 and Uzbekistan between 2022 and 2023.
In late 2025, contaminated Coldrif cough syrup manufactured by a Chennai-based drug maker was linked to the deaths of several children in Madhya Pradesh and Rajasthan after laboratory tests detected lethal levels of diethylene glycol.
