Centre restricts combination cold medicines for children under 4 over safety risks
NEW DELHI: Parents of children below four years will now have to exercise greater caution while giving them combination medicines for cold symptoms. The Centre has restricted the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride, citing potential risks to young children.
The government has said these combinations may pose risks to children below four and that safer alternatives are available. Manufacturers have been ordered to carry a prominent warning on the drug label, package insert and promotional material stating: “Fixed Dose Combination shall not be used in children below four years of age.”
Dr Rommel Tickoo, senior director of internal medicine at Max Hospital, said, “In children below four years, combination cold medicines containing chlorpheniramine and phenylephrine can cause excessive drowsiness or agitation, rapid heartbeat and, in some cases, serious adverse effects. Since these medicines offer limited benefit for a common cold, parents should prefer safer measures such as saline nasal drops, adequate fluids and honey for children above one year.”
The move is the latest step in a regulatory review that dates back to 2023, when concerns were raised over the use of the combination in young children. The issue was re-examined in 2024 with paediatricians, and the Drugs Technical Advisory Board (DTAB) recommended that the warning apply to all formulations.
The Centre subsequently imposed restrictions in April 2025, and DTAB revisited the matter in February 2026, agreeing to extend the restriction to all formulations. The latest notification now covers all such formulations, including those manufactured or imported and marketed in India.
The decision follows recommendations of an Expert Committee constituted by the Health Ministry and DTAB. At its February 16, 2026 meeting, DTAB agreed that the formulations should not be used in children below four.
Issued under Section 26A of the Drugs and Cosmetics Act, 1940, the notification came into force upon publication in the Official Gazette.
Health experts have welcomed the decision, noting that the potential harms of these combination medicines outweigh their benefits in young children. They have, however, emphasised that parents should consult a physician before giving any medicine to infants and toddlers, and should always follow the prescribed dosage and duration.
The restriction is part of a broader effort by the government to ensure the safe and rational use of drugs in vulnerable populations. Fixed-dose combinations are widely used in India, and regulators have been reviewing their safety and efficacy, particularly for children.
Parents are advised to read medicine labels carefully and avoid over-the-counter combination cold remedies for children below four. Simple home care, including steam inhalation (under adult supervision), saline nasal drops, and maintaining adequate hydration, is considered safe and effective for symptomatic relief.
The government has also asked state drug controllers to ensure strict compliance with the notification. Manufacturers and distributors who fail to comply may face action under the Drugs and Cosmetics Act.
