The Food and Drug Administration (FDA) in Pune has issued a directive to pharmaceutical manufacturers within its jurisdiction to update warning labels on specific anti-cold medications. The new regulation prohibits the use of a fixed drug combination (FDC) in children below four years of age. The order follows directions from the Drugs Controller General of India and was disseminated to regional FDA offices.
Manufacturers producing the fixed drug combination of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg drop/ml have been instructed to incorporate a warning stating, “FDC should not be used in children below four years of age,” on both the label and package insert/promotional literature of the drug.
SV Pratapwar, joint commissioner of FDA in Pune, confirmed the issuance of the directive to all manufacturers under their jurisdiction. He emphasized forthcoming inspections at manufacturing units, retailers, and wholesalers to ensure compliance. Any violations will be met with stringent actions against the manufacturers and retailers involved.
Dr. Pradeep Suryawanshi, director of neonatology and pediatrics at Sahyadri Super-Speciality Hospitals, underscored a critical issue concerning the over-the-counter availability of medicines. He cautioned against the unsupervised use of cough syrups, highlighting potential adverse effects such as sedation, nausea, vomiting, and dizziness. Dr. Suryawanshi stressed the importance of differentiating between types of cough and understanding the diverse effects of various components within cough syrups.
Applauding the government’s decision, Dr. Suryawanshi urged the public to refrain from self-medicating with over-the-counter cough syrups without professional medical advice. He emphasized the varying reactions different individuals, particularly children, might have to such medications, even leading to severe adverse effects necessitating hospitalization.
The directive by the FDA in Pune aligns with efforts to regulate medication use, particularly concerning vulnerable demographics like young children. It underscores the importance of seeking medical guidance before administering medications, especially to children, to ensure their safety and well-being.
Sources By Agencies
