Kolkata: Doctors in the city have cautioned parents not to buy fixed drug combinations (FDC) over the counter after the Central Drugs Standard Control Organization (CDSCO) of India issued a mandate of clear labelling that such drugs should not be used in children below four years. The West Bengal Chemists and Druggists Association is issuing a notice to its members not to sell this cough syrup for children below four years.
The seemingly harmless FDC cough syrup is a cocktail of two drugs — chlorpheniramine maleate and phenylephrine. While the first one is an anti-allgery drug, the second one is a decongestant. Sold commonly as Maxtra, many parents tend to buy it over the counter. There has been reports of children under two years being rushed to hospital due to reactions like convulsion and rapid heart rate.
“Medicating young children requires a delicate balance between alleviating discomfort and ensuring safety. The recent decision is a prudent measure in safeguarding our youngest and most vulnerable patients from adverse effects. As clinicians and pharmacologists, we must continuously weigh the benefits against the risks. Don’t take over the counter cough syrup, it may be harmful for your child,” said clinical pharmacologist Shamo S Samajdar.
The directive also requires all manufacturers include a warning, stating: “FDC should not be used in kids below four years of age,” ensuring that the risks associated with these medications are communicated clearly to the public.
The pharmacy body in West Bengal, the Bengal Chemists’ and Druggists’ Association (BCDA), is issuing a notification to all of its 40,000 members not to sell the combination drug for kids below four years. “For the specific medicine, we will issue a restricted sale notice to our members. However, we have already warned our members not to sell any cough syrup without a prescription. There are a total of 14 pharmaceutical companies in India who manufacture cough syrups with the same formulation. We are specifying each product so that there is no confusion among the pharmacy owners,” said Sajal Ganguly, general secretary of BCDA.
According to Rajendra Khandelwal of Dhanwantary Pharma, the specific formulation is prescribed by a handful of physicians, so there is less chance of indiscriminate sale of the product. “Specialised doctors have been prescribing the formulation, especially when there is an emergency. Not many doctors prescribe the formulation. Therefore, chances of the medicine being sold as an OTC product are very low,” he said.
Metro Pharma sells an average of 20 bottles of the combination syrup each day from each of the stores. “We have stopped selling the medicine despite queries from patients. However, we are yet to get any notification,’ said Somnath Ghosh of Metro Pharma.