The Union Ministry of Health and Family Welfare has announced a ban on Fixed Dose Combinations (FDCs) that include chlorpheniramine maleate and phenylephrine hydrochloride for children under four years old. This decision was made on Saturday, emphasizing the need to protect young children from potential health risks associated with these medications.
“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 (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 health ministry said in a statement on Saturday.
The latest notification extends this requirement to all formulations containing these two ingredients. The decision has been taken following the recommendations of an expert committee and the Drugs Technical Advisory Board (DTAB). The Drugs Technical Advisory Board (DTAB), which advises the ministry’s drugs regulatory authority—the Central Drugs Standard Control Organisation (CDSCO)—constitutes an expert committee to examine various FDCs and identify those that are “irrational, lack therapeutic justification or may pose risks to human health. Based on the scientific assessment and recommendations of the expert committee, the government then takes action.
“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,” read the health ministry statement. “The notification has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, in the interest of public health and is effective from the date of its publication in the Official Gazette,” it added.
Earlier, the Centre had restricted certain FDCs containing chlorpheniramine maleate and phenylephrine hydrochloride, subject to the same age-specific warning.
