The World Health Organisation on Wednesday raised an alert against four India-made cough and cold syrups whose consumption may have led to the death of more than 60 children in The Gambia, a country in west Africa.
“The WHO has today issued a medical product alert for four contaminated medicines identified in The Gambia that have been potentially linked with acute kidney injuries and 66 deaths among children. The four medicines are cough and cold syrups produced by Maiden Pharmaceuticals Limited in Haryana, India,” WHO director general Tedros Adhanom Ghebreyesus said at a press conference in Geneva.
He said the UN health body was conducting further investigation with the company and regulatory authorities in India. “The loss of these young lives is beyond heartbreaking for their families,” Ghebreyesus added.
While the contaminated products have so far only been detected in The Gambia, the WHO asked other nations to be on alert as they may have been distributed to other countries. The four products are Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
According to the UN health body’s medical product alert, laboratory analysis of samples of each of the four products confirms that they contain unacceptable amounts of diethylene glycol and ethylene glycol as contaminants. The manufacturer has not provided guarantees to WHO on the safety and quality of these products.
Diethylene glycol and ethylene glycol are toxic to humans when consumed and can prove fatal
The 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.
Health Ministry sources told DH that the company manufactured and exported these products only to The Gambia so far. “It is a practice that the importing country tests these products on quality parameters, and satisfies itself as to the quality of the products before their release for usage in the country,” sources said.
As per the tentative results received by WHO out of the 23 samples tested, four were 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 WHO 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 and products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products,” sources said, adding that the Central Drug Standards Control Organisation too launched an investigation.
“WHO recommends all countries detect and remove these products from circulation to prevent further harm to patients,” Ghebreyesus advised.
Medical officers in Gambia raised the alarm in July, after children began falling ill with kidney problems three to five days after taking a locally-sold paracetamol syrup. By August, 28 had died, but health authorities said the toll would likely rise.