The Government has imposed restrictions on the manufacture, sale, and distribution of certain medicines containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride, citing potential risks to children under four years of age.
In a move aimed at safeguarding the health and safety of young children, the Government has issued a notification restricting the manufacture, sale, and distribution of all Fixed Dose Combinations (FDCs) containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride. These medicines are now forbidden for use in children below four years of age due to potential risks associated with their use. The decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB).
Previously, certain FDCs containing these ingredients were restricted, subject to a warning not to use them on children under four years of age. With this latest notification, this requirement has been extended to all formulations containing Chlorpheniramine Maleate and Phenylephrine Hydrochloride.
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. 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.
Source:
Press Information Bureau
