New Delhi: The Central Drugs Standard Control Organisation (CDSCO) has opted to prohibit the use of a popular anti-cold cocktail medicine combination for infants and children below four years of age. This decision impacts pharmaceutical companies manufacturing prominent products like GlaxoSmithKline’s T-Minic Oral Drops, Glenmark’s Ascoril Flu Syrup, and IPCA Laboratories’ Solvin Cold Syrup, among others.
According to a report by News18, the CDSCO has instructed these pharmaceutical firms to include a ‘warning’ regarding the use of this combination in their products. Paediatricians quoted in the report expressed concerns about the widespread use of this combination among children, often due to self-medication and self-prescription by parents.
The regulatory body’s decision, communicated through a letter dated December 18, urges states and Union Territories to update the package insert of products containing a cocktail of two medicines — chlorpheniramine maleate and phenylephrine. This combination is commonly used to alleviate cold and flu symptoms, including watery eyes, runny nose, sneezing, and nasal or throat itching. While chlorpheniramine maleate acts as an anti-allergic, phenylephrine serves as a decongestant, narrowing small blood vessels to relieve nasal congestion.
The fixed-dose combination (FDC) had previously faced scrutiny for being deemed “irrational,” but a government committee approved it based on reasonable evidence. In a letter, the CDSCO acknowledged the approval of the FDC of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCI IP 5mg drop per ml on July 17, 2015. However, concerns were later raised regarding its use among infants and children.
The matter was deliberated in the Subject Expert Committee (Pulmonary) on June 6, leading to the recommendation that the FDC should not be used in children below four years of age. Consequently, pharmaceutical companies are required to incorporate a warning to this effect on labels and package inserts.
Paediatricians cited in the report highlighted that developed nations, including the United States and the European Union, had banned such products for infants and children nearly a decade ago. The CDSCO’s decision aligns with growing global awareness and caution regarding the use of certain medications in pediatric populations.
