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FDA Pune asks manufacturers to carry warnings on anti-cold drugs for children below 4 years
The directions come after the FDA headquarters issued orders on Wednesday to all regional offices following the Drugs Controller General of India directions
The Food and Drug Administration (FDA), Pune region, on Thursday, issued a letter to all manufacturing units in its jurisdiction directing to update package insert warning prohibition over the use of anti-cold fixed drug combination in children below four years of age.
All manufacturers of fixed drug combination (FDC) of Chlorpheniramine Maleate IP 2mg + Phenylephrine HCL IP 5mg drop/ml are asked to insert a warning that “FDC should not be used in children below four years of age” on the label and package insert/promotional literature of the drug.
The directions come after the FDA headquarters issued orders on Wednesday to all regional offices following the Drugs Controller General of India directions.
SV Pratapwar, joint commissioner of FDA, Pune region, said, the letter has been issued to all manufacturersin the Pune region.
“After a few months, all manufacturing units, retailers and wholesalers will be inspected to check if the changes have been made. In case of violation strict action will be taken on the manufacturer and the retailer,” he said.
Dr Pradeep Suryawanshi, director, neonatology and paediatrics, Sahyadri Super-Speciality Hospitals, said, the acute problem in the country is the availability of medicines over the counter. Many people even use old prescriptions to take the drugs without a doctor’s prescription.
“Taking cough syrup without a doctor’s prescription can lead to adverse effects and complications like sedation, nausea, vomiting, giddiness, vomiting amongst others. There are different categories of cough like, dry cough, wet cough, chronic cough and active cough and different components of the cough syrup have different effects,” he said.
Dr Suryawanshi, appreciated the decision taken by the government and asked people to refrain from taking over-the-counter cough syrups without doctors’ advice.
“Not all children will develop symptoms but a few will develop symptoms and sometimes there could even be serious adverse effects that would need hospitalisation. It is better to avoid it by following the doctor’s advice,” he said.
