Indonesia prohibits cough syrup material linked to Gambian child deaths

INDONESIA — Indonesia banned cough syrup ingredients days after the World Health Organization (WHO) issued an alert about India-made cough and cold syrups linked to the deaths of 70 children in The Gambia.

Indonesia is also looking into the acute kidney damage that has killed over 20 children in Jakarta this year.

Indonesian National Agency of Drug and Food Control (BPOM), also stated that it was looking into the possibility that the ingredients, diethylene glycol and ethylene glycol, had contaminated other materials used as solvents.

The Gambia and India are investigating deaths from acute kidney injury in the West African country that are thought to be linked to cough syrups manufactured by Maiden Pharmaceuticals Ltd, based in New Delhi.

“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),” the regulator said in a statement.

The WHO issued a warning over four cough and cold syrups made by an Indian company, saying that they could be linked to the deaths of 70 children in The Gambia.

The WHO said that the cough and cold syrups, made by Maiden Pharmaceuticals in Haryana, could be the reason for serious kidney injuries. “Please do not use them,” the WHO said in its advisory.

The cold and cough syrups linked to the deaths of 70 children are: Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, Makoff Baby Cough Syrup, and Magrip N Cold Syrup, which the WHO said has “unacceptable” amount of diethylene glycol and ethylene glycol that can be toxic and cause acute kidney injury.

The deaths in The Gambia, the worst involving Indian-made drugs, are a setback for an industry whose exports have more than doubled in the last decade, reaching US$24.5 billion in the fiscal year ending March 31.

India, known as the “world pharmacy,” supplies 45 percent of all generic medicines used in Africa.

Indian health authorities have also announced production halt at the Maiden Pharmaceuticals factory located in Sonepat, northern India.

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.

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