Central Government bans FDC of Chlorpheniramine + Phenylephrine for Children below four years
Ministry of Health and Family Welfare, Government of India, under Section 26A of Drugs and Cosmetics Act, 1940, has restricted the use of Fixed Dose Combination of Chlorpheniramine Maleate and Phenylephrine Hydrochloride in Children below Four Years vide SO 1717 (E) dated 15.04.2025, with immediate effect.
The concerns were raised about safety of the said FDC in children below four years by Subject Expert Committee (SEC – Pulmonary). In view of the same Drugs Controller General India had directed the manufacturers of said FDC through State Licensing Authorities to mention Warning accordingly on their label and package insert / promotional literature vide letter dated 18.12.2023.
Now, in view of the said notification, manufacturers, marketers will have to ensure that said FDC is not promoted to the Children below 4 years and shall mention “Warning: Fixed dose combination shall not be used in Children below four years of age” on the label, package insert or promotional literature of the said FDC.