Banjul, Gambia; 7 Oct 2022 (UMMN): 66 children are suspected to have died after taking Indian made cough syrup in Gambia, the World Health Organization said on Wednesday.
Their death, caused by kidney injuries, may be linked to contaminated cough and cold syrups made by an Indian drug manufacturer Maiden Pharma.
The WHO has issued a medical product alert asking regulators to remove Maiden Pharma goods from the market.
WHO Director-General Tedros Adhanom Ghebreyesus told reporters that the UN agency was conducting an investigation along with Indian regulators and the drugmaker, New Delhi-based Maiden Pharmaceuticals Ltd.
Maiden Pharma declined to comment on the alert, while calls and Reuters messages to the Drugs Controller General of India went unanswered.
According to Al Jazeera, the alert covers four products – Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup.
Lab analysis confirmed “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic when consumed, the WHO said.
Maiden Pharmaceuticals manufactures medicines at its facilities in India, which it then sells domestically, as well as exporting it to countries in Asia, Africa and Latin America, according to its website, reported Al Jazeera.
WHO said that information received from India's Central Drugs Standard Control Organisation indicated that the manufacturer had only supplied the contaminated medications to The Gambia.
"However, the supply of these products through informal or unregulated markets to other countries in Africa, cannot be ruled out," the UN agency said in an email.
"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."
"In addition, the manufacturer may have used the same contaminated material in other products and distributed them locally or exported," it warned.
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."
Tedros urged caution, calling on all countries to work to "detect and remove these products from circulation to prevent further harm to patients."
