NEW DELHI, Aug. 22 -- In a significant step to safeguard the health and safety of young children, the Government has imposed restrictions on the manufacture, sale and distribution of all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, mandating a clear warning that these medicines shall not be used in children below four years of age.
Earlier, vide a notification dated April 15, 2025, the government had restricted certain fixed dose combinations (FDCs) containing the two chemical compounds, subject to the same age-specific warning.
The latest notification extends this requirement to all formulations containing these two ingredients.
The decision followed recommendations by an expert committee ...