According to the World Health Organisation, Diethylene Glycol (DEG) or ethylene glycol is toxic to humans when consumed and can prove fatal.
India’s drug regulator Central Drugs Standard Control Organisation (CDSCO) has initiated a probe after the World Health Organisation (WHO) issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to deaths of 66 children in The Gambia.
The WHO on Wednesday warned that four “contaminated” and “substandard” cough syrups allegedly produced by Maiden Pharmaceuticals Limited based in Haryana’s Sonepat could be the reason for the deaths in the West African nation.
News agency PTI quoted sources saying that the exact “one-to-one causal relation of death” has neither been provided by the United Nations Health Agency nor the details of labels and products been shared by it with the CDSCO, enabling it to confirm the identity or source of the manufacturing of the products.
The four cough syrups, Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, manufactured by Maiden Pharmaceuticals Limited, Haryana, failed the tests after they were found to have unacceptable amounts of Diethylene Glycol/Ethylene Glycol as contaminants.
According to the WHO, Diethylene Glycol (DEG) or ethylene glycol is toxic to humans when consumed and can prove fatal. It can cause neurological and kidney toxicity and has been associated with several cases of mass poisoning when consumed via drugs.
According to a paper in the National Library of Medicine under the National Center for Biotechnology Information, the chemical is used in antifreeze, brake fluids, cosmetics, and lubricants and causes renal insufficiency and failure and could even lead to coma and death.
The chemical tastes sweet and is water-insoluble. The toxic effects of the chemical include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state, and acute kidney injury. The NIH paper pointed to at least 10 mass poisoning events that have taken place due to the toxic chemical in the past.
From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products.
As per the tentative results received by WHO out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated. It has also been informed by WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India.
“At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products,” the official source stated.