Indian authorities have ordered an investigation after four cough syrups manufactured by a local pharmaceutical company were linked to the deaths of 66 children in The Gambia.
The formulas contained “unacceptable” amounts of diethylene glycol and ethylene glycol, which caused acute kidney damage in the children, the World Health Organization (WHO) said in an alert issued this week.
The UN health agency advised regulators to halt sales of the products. It alerted India’s national drug regulator in September about the four syrups manufactured by Maiden Pharmaceuticals, based in the north Indian state of Haryana.
Preliminary inquiries by India’s Central Drugs Standard Control Organisation (CDSCO) revealed that the company exports four products: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup.
Initially, the WHO feared the formulas could have been distributed elsewhere through informal markets, but the CDSCO has confirmed exports were limited to The Gambia.
India’s Health Ministry has begun testing samples, it said in a statement, and added that Maiden Pharmaceuticals is not licensed to distribute the four products in India. The company has not responded to requests for comment.
The deaths in The Gambia are a blow to India’s image as a “pharmacy of the world” that supplies medicines to every continent, especially Africa.
Diethylene glycol and ethylene glycol are used in antifreeze and brake fluids and other industrial applications but also as a cheaper alternative in some pharmaceutical products.
India’s state health minister Anil Vij vowed there would be repercussions if the company’s products are proven to be behind the fatalities.
“We are trying to find out with the buyer exactly what has happened. We are not selling anything in India,” Naresh Kumar Goyal, a Maiden director, told Reuters.
WHO Director-General Tedros Adhanom Ghebreyesus said on Wednesday that the UN health agency was investigating the deaths of the 66 children from acute kidney injuries with India’s regulators and the drug maker.
