Government restricts fixed dose combinations containing 2 chemical compounds for young children

The Indian government has taken measures to protect young children by restricting the production, sale, and distribution of fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. These two chemical compounds, found in various medications, will not be used in children under the age of four, according to a recent warning.

Previously, certain fixed dose combinations containing the two compounds were already subject to the same age-specific restriction, effective from April 15, 2025. The updated regulation now applies to all formulations containing these ingredients. The decision was made following advice from an expert committee and the Drugs Technical Advisory Board (DTAB).

The government emphasized that the use of such combinations in young children may pose risks and that safer alternatives exist. Manufacturers are required to clearly display the warning on the label, package insert, and promotional materials. This regulation, issued under Section 26A of the Drugs and Cosmetics Act, 1940, will be enforced from the date of its publication in the official gazette.