In a significant move, the Central Drugs Standard Control Organisation (CDSCO) is poised to enforce a prohibition on a widely used cold medication combination for infants and children under four years old. The decision, based on recommendations from the Subject Expert Committee (SEC) specializing in pulmonary treatments, comes as a cautionary step regarding the use of certain drug compositions.
The SEC emphasized the unsuitability of a specified combination—chlorpheniramine maleate IP 2mg with phenylephrine HCL IP 5 mg per ml drops—for children below the age of four. This directive, set forth on June 6, 2023, by the committee triggered action from the Drug Controller General of India (DCGI) chief, Dr. Rajeev Singh Raghuvanshi. A letter issued on December 18 mandated all manufacturers producing this common cold fixed-dose combination (FDC) to include a warning on labels and package inserts, explicitly cautioning against usage in children under four years old.
The DCGI further extended this requirement to State and Union Territory drug controllers, urging them to ensure the prominent display of the warning, “FDC should not be used in children below 4 years of age,” not only on the drug’s packaging but also on any promotional materials associated with it.
This particular combination, primarily used to alleviate cold and flu symptoms like runny nose, watery eyes, sneezing, and throat or nasal itching, includes chlorpheniramine maleate as an antiallergic drug and phenylephrine as a decongestant.
Several pharmaceutical companies, including Glaxo SmithKline Pharmaceuticals Ltd, Glenmark Pharmaceuticals Ltd, Alembic Pharmaceuticals Ltd, Wanbury Ltd, and Ipca Laboratories Ltd, manufacture variations of this combination, which includes brands like T-Minic, Ascoril Flu, Wikoryl AF, Coriminic, Coriminic QR, and Solvin Cold AF.
This regulatory action follows an earlier declaration in 2015, approving the combination under certain policies, citing recommendations from Prof. Kokate’s committee. However, the recent cautionary steps stress the need for heightened vigilance and adherence to safety guidelines, especially in pediatric medication usage.
The emphasis on warning labels and communications underscores a proactive approach to safeguarding young children from potential risks associated with the specific composition, marking a critical step in ensuring pharmaceutical safety and adherence to stringent regulatory standards.
Sources By Agencies
