NEW DELHI, AUG 23 (AGENCIES): Parents of children below four years will now have to be more cautious about giving them combination medicines for cold symptoms, with the Centre restricting the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride, a TOI report stated.
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 4 years of age.” Dr Rommel Tickoo, senior director, internal medicine, Max hospital, said, “In children below 4 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 1 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 children. The issue was re-examined in 2024 with paediatricians, with DTAB recommending that the warning apply to all formulations. 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 Health ministry and Drugs Technical Advisory Board. DTAB, at its February 16, 2026 meeting, 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.
