Centre Restricts All Cold Combination Drugs for Children Under Four
The Government of India has imposed restrictions on the manufacture, sale and distribution of all fixed-dose combinations (FDCs) containing chlorpheniramine maleate and phenylephrine hydrochloride, mandating a clear warning that these medicines should not be used in children below four years of age.
According to the health ministry, the latest notification extends the requirement to all formulations containing the two ingredients. Earlier, via a notification dated April 15, 2025, the government had restricted certain FDCs containing these compounds, subject to the same age-specific warning.
The decision follows recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB), the government noted that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available.
Manufacturers have been directed to prominently display the warning “Fixed Dose Combination shall not be used in children below four years of age” on product labels, package inserts and promotional literature associated with these formulations.
The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, and takes effect from the date of its publication in the Official Gazette.
Medical experts have supported the move. Dr Rommel Tickoo, senior director, internal medicine, Max hospital, said that 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,” Dr Tickoo advised.
The regulatory review 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, with DTAB recommending 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.