SRINAGAR: The Government has restricted the manufacturing, sale and distribution of fixed-dose combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride for children below four years of age, citing concerns over their safety.
The Ministry of Health and Family Welfare, through a notification, directed manufacturers to carry a clear warning stating that the combination “shall not be used in children below four years of age”.
The warning must be prominently displayed on the product label, package insert and promotional material associated with the formulations.
The government said the use of such combinations may pose risks to children under four, while safer alternatives are available for this age group.
The restriction follows recommendations of an Expert Committee and the Drug Technical Advisory Board (DTAB).
The move comes after the Ministry of Health and Family Welfare in June prohibited the manufacture, sale and distribution of 16 fixed-dose combination drugs for human use across the country.
The latest restriction specifically covers FDCs containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride intended for use in children below four years of age.
