A significant directive impacting the production and marketing of common cold fixed dosage combinations (FDC) including chlorpheniramine maleate IP 2 mg and phenylephrine HCL IP 5 mg per millilitre drops has been issued by the Drugs Controller General of India (DCGI) in a recent development. Prompted by suggestions from a Subject Expert Committee (SEC) focused on pulmonary issues, the directive requires manufacturers to advise against using this combination in children younger than four years old on the label, package insert, and promotional materials.
