Govt tightens rules on combinations containing 2 chemical compounds for young children

The government has imposed restrictions on the manufacture, sale and distribution of all fixed dose combinations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride whilst mandating a clear warning that these medicines shall not be used in children below four years of age.

The government had earlier restricted certain fixed-dose combinations (FDCs) containing the two chemical compounds, with the same age-specific warning.

However, the latest notification has included all formulations containing the two ingredients, which came about following the recommendations by an expert committee and the Drugs Technical Advisory Board (DTAB).


The government highlighted the risks posed by such combinations to children below four years of age and suggested safer alternatives.

The administration has ordered manufacturers 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.”