An Indian pharmaceutical company, which has come under the World Health Organisation scanner over the levels of two compounds in its cough syrup, claimed today that the chemicals were within permissible limits.
On Monday, the WHO had flagged a batch of contaminated syrup in Iraq and said it had higher-than-acceptable limits of diethylene glycol and ethylene glycol.
Chennai-based Fourrts Lab told NDTV today that the syrup was exported only to Iraq and is not sold in India. It added that, as part of a contract, the product was manufactured by a company based in Puducherry in January 2022.
"Our examination of the samples reveals that diethylene glycol was very much within the limits at 0.1%. Further investigation is on. We will respond to WHO once this is completed," Fourrts Lab's Vice-President Balasurendran said.
The company said officials from the Central Drugs Standard Control Organization had also taken samples of the syrup and the reports are awaited.
Asked whether the mandatory test of the finished product to check for ethylene glycol and diethylene glycol had been done, Mr Surendran said, "There was no such regulation in 2022, hence we did not do it. The regulation was put in place only in May 2023".
On Monday, the WHO had said, "The substandard batch of the product referenced in this Alert is unsafe and its use, especially in children, may result in serious injury or death".
The health body said that samples of the paracetamol and chlorpheniramine combination syrup, which is used to treat common cold and allergy symptoms, were found to contain 0.25 % diethylene glycol and 2.1% ethylene glycol against the accepted 0.1%.
This is the seventh Indian-made drug that has come under the WHO scanner since last year.
Global Pharma, which was ordered to suspend manufacturing of one kind of eye drop following adverse impact on patients in the US, was, however, given a clean chit by Indian authorities. Samples of the eye drop were taken from the firm's plant in Chennai after complaints of loss of vision and loss of life, but no contamination was found.
