The World Health Organisation (WHO) on Monday issued a substandard medicine alert from Iraq for a cough syrup manufactured by an Indian firm, making it fifth such warning for India-made drugs in the past 10 months.
“A sample of the ‘Cold Out’ Syrup was obtained from one 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,” WHO said in a statement. “The acceptable safety limit for both ethylene glycol and diethylene glycol is no more than 0.10%.”
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal.
The affected batch of the syrup, branded Cold Out, was manufactured by Tamil Nadu-based Fourrts (India) Laboratories Pvt Ltd for Maharashtra-based Dabilife Pharma Pvt Ltd.
“This WHO medical product alert refers to one batch of substandard (contaminated) Cold Out syrup (Paracetamol and Chlorpheniramine Maleate) identified in Iraq and reported to the World Health Organization on 10 July 2023 by a third party,” the United Nations body’s statement read.
