Govt restricts use of Chlorpheniramine and Phenylephrine combinations for children below 4

NEW DELHI, Aug 21: The government has restricted the manufacturing, sale and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age, citing potential health risks.

The Health Ministry, through a notification, directed manufacturers to prominently display a warning stating, “Fixed Dose Combination shall not be used in children below four years of age,” on the label, package insert and promotional literature of these formulations.

The government said the restriction was aimed at safeguarding young children, noting that the use of such combinations may pose risks to those below four years of age and that safer alternatives are available.

The move follows recommendations made by an Expert Committee and the Drug Technical Advisory Board regarding the safety of the medicines for young children.

The latest restriction comes after the Ministry of Health and Family Welfare in June prohibited the manufacturing, sale and distribution of 16 fixed-dose combination drugs for human use across the country.

The government’s decision forms part of measures to ensure the safety and appropriate use of medicines, particularly among vulnerable age groups. Manufacturers have been directed to ensure compliance with the prescribed warning across all relevant packaging and promotional material. (Agencies)