The World Health Organisation (WHO) has issued an alert over an Indian-made cough syrup that was sold in Iraq after it was found contaminated and deemed “not safe for use”.
The alert came after a sample of the common cold syrup, ‘Cold Out’, was obtained from a location in Iraq and submitted for laboratory analysis.
“The sample was found to contain unacceptable amounts of diethylene glycol (0.25%) and ethylene glycol (2.1%) as contaminants. The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%,” the health body said.
The WHO said that diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
The syrup was manufactured by Fourrts (India) Laboratories Pvt. Ltd, a Chennai-based plant, and the product is stated to be manufactured for Dabilife Pharma Pvt. Ltd. —India, the WHO said in a statement.
“To date, the stated manufacturer and the marketer have not provided guarantees to WHO on the safety and quality of the product,” the alert said.
It said that this syrup may have marketing authorisations in other countries or regions.
“The substandard batch of the product is unsafe and its use, especially in children, may result in serious injury or death,” the alert warned.
“Toxic effects can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death,” the WHO said.
The Iraqi officials have not yet found any deaths related to poisonous medications, but last week the Ministry of Health said that the medicine failed separate tests conducted by Iraqi authorities and that products circulating in the market were being confiscated.
This is the fifth time that contaminated syrups have been tied to an Indian manufacturer.
Cases of Indian-made tainted cold syrups have been reported in Indonesia, Gambia, Uzbekistan and Cameroon, and have killed about 300 children in the past year, reports Bloomberg.
The Indian manufacturer Marion Biotech, which had exported the syrups to Uzbekistan, had its drug license cancelled by the Uttar Pradesh government.
The company involved in Gambia, Maiden Pharmaceuticals, denied that its drugs were responsible for the deaths in the country. Later, tests by an Indian government laboratory found no toxins in the syrup.
According to Reuters, DCGI (Drugs Controller General of India) chief VG Somani wrote to WHO saying the samples of Maiden’s syrup had not been contaminated with ethylene glycol and diethylene glycol.
(With inputs from agencies)
