NEW DELHI, Aug 22: Government of India 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 to safeguard the health and safety of young children.
Earlier, vide a notification dated April 15, 2025, the government had restricted certain fixed dose combinations containing the two chemical compounds, subject to the same age-specific warning.
Said notification extends this requirement to all formulations containing these two ingredients.
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.
In June this year, the Ministry of Health and Family Welfare prohibited the manufacturing, sale and distribution of 16 fixed-dose combination (FDC) drugs for human use across the country.
This decision has been taken following the recommendations of an Expert Committee and the Drug Technical Advisory Board.
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