The Central Drugs Standard Control Organisation (CDSCO), the country’s apex health regulatory agency, has decided to ban the use of a popular anti-cold cocktail medicine combination among children below four years of age.
In a letter to various States and UTs, the apex health regulatory agency said concerns have been raised over the use of a fixed drug combination of Chlorpheniramine Maleate IP 2mg and Phenylephrine HCI IP 5mg drops. The formulation, it said, was an unapproved one for infants.
The matter was taken up for discussion by an expert committee in June and it had then recommended that this FDC should not be used for children below ‘4 years of age’ and accordingly firms should mention warning in this regard on labels and package insert.
The combination is used to treat cold and flu-like symptoms, which include coughing, sneezing, watery eyes, among others.
Some popular brands that use this formulation are reportedly T-Minic Oral Drops, Ascoril Flu Syrup and Solvin Cold Syrup, among others. Makers of these medicines have been asked to insert a ‘warning’.