The government imposed restrictions on the manufacturing, sale and distribution of all fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age.
The Health Ministry, in a notification, mandated a clear warning that these medicines shall not be used in children below four years of age, in a significant step to safeguard the health and safety of young children.
The government directed 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 government said that the use of such combinations may pose risks to children below four years of age and that safer alternatives are available.
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.
