The World Health Organisation on Monday raised an alert against an India-manufactured contaminated syrup sold in Iraq, following an investigation by an international news organisation. The alert, which follows a series of WHO alerts against contaminated Indian syrups , said the contamination was “reported to WHO on 10 July 2023 by a third party.” The paracetamol syrup Cold Out – manufactured by Chennai-headquartered Fourrts Laboratories – was found to contain 0.25% diethylene glycol (DG) and 2.1% ethylene glycol (EG), the WHO alert said. The acceptable limit for both contaminants in medical products is not more than 0.10 per cent. The alert warns people against consuming the syrup, healthcare officials to report any cases of adverse events, and national regulators to increase surveillance. Similar contaminated India-made syrups have been linked to the deaths of 70 children in Gambia, 18 children in Uzbekistan, and 6 children in Cameroon. Experts aware of drug regulations say that the most likely source of contaminants are solvents such as propylene glycol and glycerine used for syrups. “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 WHO alert said. The contaminants are known to cause abdominal pain, vomiting, diarrhoea, headache, altered mental status, inability to pass urine, acute kidney injury, and death. The intergovernmental organisation has thus far raised five alerts for syrups contaminated with DEG and EG since the first one issued last October. Of the five alerts, only one incident involved contamination in an Indonesia-manufactured syrup that led to deaths within the country. Besides these cases, Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC) also raised an alert against a syrup manufactured by a Mumbai-based company. Earlier this year, India mandated testing of cough syrups before exports to prevent such instances. There have also been reports of bacterial contaminants in eye drops and ointments from the United States and Sri Lanka. An official from India’s health ministry, in the know of the matter, said: “There have been 13 such incidents of contamination reported from other countries. However, we have received proper communication on the matter from Uzbekistan alone.”
