New Delhi, Aug 22: The Government has restricted the manufacture, sale and distribution of fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age, citing safety concerns.

The Ministry of Health and Family Welfare, through a notification, has directed manufacturers to prominently display a warning on the product label, package insert and promotional material stating that the combination “shall not be used in children below four years of age.”
The government said the restriction was introduced in view of potential risks associated with the use of the combination in young children, particularly when safer alternatives are available for this age group.
The decision follows recommendations of an Expert Committee and the Drugs Technical Advisory Board (DTAB), which examined the safety of the formulations.
The latest measure is part of the government’s broader efforts to strengthen the safety of medicines used by children. It follows the Ministry’s decision in June to prohibit the manufacture, sale and distribution of 16 fixed-dose combination drugs for human use across the country.
The latest notification specifically applies to FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride when intended for children below four years.
The mandatory warning is aimed at ensuring that parents, caregivers and healthcare professionals are clearly informed about the age restriction and do not administer the formulations to children in the prohibited age group.
The move underscores the government’s emphasis on preventing potentially unsafe medication use among young children and ensuring that pharmaceutical products carry clear and prominent safety information.