A sample of cold syrup manufactured by Chennai-based Fourrts (India) Pvt Ltd and sold in Iraq was tainted with toxic chemicals, Bloomberg News reported, citing a test commissioned by it. The company, however, said its products are safe for consumption and have “zero contamination”.
On Friday, Bloomberg reported that a bottle of Cold Out label syrup purchased at a pharmacy in Baghdad in March contains 2.1 per cent ethylene glycol, according to Valisure LLC, an independent US laboratory. The report said the ethylene glycol content is about 21 times higher than the widely accepted limit. “The compound is lethal to humans in small amounts and played a role in mass child deaths caused by Indian-made cough syrups in Gambia and Uzbekistan last year,” it noted.
Bloomberg further said it has shared the test results with the World Health Organization (WHO) as well as Iraqi and Indian officials on July 8, and that the WHO found Valisure’s test results to be “acceptable”.
“We have not manufactured the product directly. We have subcontracted the manufacture of Cold Out to Puducherry-based Sharun Pharmaceuticals Pvt Ltd,” a senior official told businessline.
He also added that tests were based on products sent to Iraq one-and-half years ago, but the test limits were introduced only in May 2023. “We had some returned samples. After the Bloomberg news report, we again tested the samples and found it 100 per cent safe. This is our stand,” he added.
The Bloomberg report said Valisure tested the Cold Out sample five times and found, on average, ethylene glycol content of 2.1 per cent and diethylene glycol content of 0.25 per cent. “The diethylene glycol content is more than twice the limit. None of the other syrups with contaminants exceeded the 0.1 per cent level,” it added.
However, the Fourrts official said, nowhere in the world such limit tests are conducted on finished products. He added that since the issue has now raked up, the Iraqi government might come out with new specifications going forward.
Bloomberg said WHO will issue an alert if the Iraqi government confirms the product was sold there. No public alert or recall has been announced yet.
Founded by SV Veeramani in 1977, Fourrts is into manufacture and exports of generic formulations, cardiovascular, anti-diabetic, nutraceuticals and anti-malarials. Its products are exported to more than 50 countries including the UK, Germany and Canada. The company has two manufacturing facilities in Chennai, a WHO-GMP approved plant in Kelambakkam near Chennai for manufacturing coated and uncoated tablets, capsules, liquid orals/suspensions, and Ointments. Another EU GMP approved site for supplies to Australia, Canada and Ethiopia. It also does contract manufacturing majorly for its export customers.
The latest developments come just months after another Chennai-based company, Global Pharma Healthcare, made headlines due to contamination of its eye drops in the US market in April. The company was forced to recall 50,000 tubes of eye drops in the US market after the US Food and Drug Administration (USFDA) found Global Pharma’s eye lubricant for artificial tears which have been linked to vision loss in the US.