Following the death of 66 children in Gambia, the World Health Organization (WHO) has raised an alert over four fever, cold and cough syrups made by an Indian company, urging people to not use them. All the four syrups — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup – are made by Haryana-based Maiden Pharmaceuticals.
Urgent investigation in the matter has been already taken up by CDSCO with the State Regulatory Authorities immediately after receiving communication from WHO based on the available information,” sources said.
One of the sources said that the exact one to one causal relation of death has not yet been provided by WHO, nor have the details of labels or products been shared by WHO with CDSCO enabling it to confirm the identity and the source of the manufacturing of the products.
“As per the tentative results received by WHO, out of the 23 samples tested, four have been found to contain Diethylene Glycol and Ethylene Glycol as indicated,” the source added.
“To date, the stated manufacturer has not provided guarantees to WHO on the safety and quality of these products,” the alert said, adding that laboratory analysis of samples of the products “confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants.”
Those substances are toxic to humans and can be fatal, it said, adding that the toxic effect “can include abdominal pain, vomiting, diarrhoea, inability to pass urine, headache, altered mental state and acute kidney injury which may lead to death.”
WHO Director-General Tedros Adhanom Ghebreyesus said, “The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited in India. WHO is conducting further investigation with the company and regulatory authorities in India,” he said, adding that the loss of young lives due to the products is “beyond heart-breaking for their families”.
“While the contaminated products have so far only been detected in The Gambia, they may have been distributed to other countries. WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients,” Ghebreyesus added.
In India, death of 17 children were reported from Jammu and Kashmir in 2020 after consuming another brand of cough syrup contaminated with the same diethylene glycol. In another incident, at least three children died in New Delhi last year after consuming a cough syrup with dextromethorphan, one of the components present in one of the four syrups flagged by WHO.