JAKARTA: Indonesia has banned ingredients linked to the deaths of 70 children in The Gambia from cough syrups as it investigates acute kidney damage that has killed more than 20 children in Jakarta this year.
The food and drug regulator BPOM also said it was investigating the possibility that the ingredients, diethylene glycol and ethylene glycol, had contaminated other materials that are used as solvents.
The Gambia and India are investigating the deaths from acute kidney injury in the west African country thought to be linked to cough syrups made by New Delhi-based Maiden Pharmaceuticals Ltd.
The World Health Organization has said that laboratory analysis of four Maiden products — Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup and Magrip N Cold Syrup — had “unacceptable” amounts of diethylene glycol and ethylene glycol, which can be toxic and cause acute kidney injury.
Indian health authorities announced a production halt at the Maiden Pharmaceuticals factory in Sonepat in northern India on Wednesday.
The matter “is being seriously investigated by appropriate authorities,” Indian foreign minister S Jaishankar said.
The deaths in The Gambia, the worst involving drugs made in India, are a blow to an industry whose exports more than doubled in the last decade to hit $24.5 billion in the fiscal year through March.
Known as the “pharmacy of the world”, India supplies 45% of all generic medicines used in Africa.
The Indonesian regulator on Saturday announced curbs on the two ingredients under suspicion.
“To provide protection to the public, BPOM has set a requirement at the time of registration that all medicinal syrup products for children and adults are not allowed to use diethylene glycol (DEG) and ethylene glycol (EG),” it said in a statement.
The BPOM reiterated that the four products linked to the deaths in The Gambia are not registered in Indonesia, nor are any other Maiden products.
