The levels of two compounds in a cough syrup manufactured by an Indian pharmaceutical business have drawn the attention of the World Health Organisation, although the company asserted that the levels were within acceptable bounds.
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. Fourrts Lab, a company situated in Chennai, told the media that the syrup was not sold in India but was solely exported to Iraq. It also mentioned that the product was produced by a Puducherry-based company in January 2022 as per a contract.
"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, 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".
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 organisation said that samples of the paracetamol and chlorpheniramine combination syrup, which is used to treat symptoms of allergies and the common cold, had 2.1% ethylene glycol and 0.25% diethylene glycol as opposed to the recommended 0.1%.
