Govt restricts fixed dose combinations containing 2 chemical compounds for children

• The government 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 shall not be used in children below four years of age.

• The decision followed recommendations by 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.

• Earlier, in a notification on April 15, 2025, the government had restricted certain fixed dose combinations 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 notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940.

• Manufacturers have been directed to clearly display the warning fixed dose combination shall not be used in children below four years of age on the label, package insert and promotional literature associated with these formulations.