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

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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 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 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.

The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, and is effective from the date of its publication in the official gazette.

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