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BPOM: Cost-cutting by pharma firms to blame for AKI spike
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An employee collects medicinal syrups that contain paracetamol at a minimarket in South Tangerang, Banten, on Oct. 19, 2022. The Health Ministry has banned the sale of all medicinal syrups following the deaths of over 100 children across the country from unexplained acute kidney failure. (Antara/Sulthony Hasanuddin )
T
he Food and Drug Monitoring Agency (BPOM) has alleged that cost-cutting measures by drug manufacturers are to blame for toxic medicines that have caused a recent spike in acute kidney injury (AKI) cases, which has left dozens of children dead this year.
Following weeks of investigation, health authorities have linked these deaths to the circulation of medicine containing dangerous levels of ethylene glycol (EG) and diethylene glycol (DEG), which are commonly found as contaminants in the solvents of syrup-based medicines.
Speaking at a press briefing on Thursday, BPOM head Penny Lukito said that there was “a big chance” that this happened as a result of drug manufacturers purposefully resorting to importing non-pharmaceutical grade raw materials as a way to cut production costs.
The BPOM has previously singled out two unnamed pharmaceutical companies thought to be guilty of producing these toxic medicines and is now pursuing a potential criminal investigation against these manufacturers.
Read also: Govt may take legal action as child AKI deaths rise“[We have found] the usage of improper raw materials that fail to meet existing requirements. This could be [due to] the source of the raw materials themselves,” Penny said. “Pharmaceutical grade [raw materials] with a high purity should not contain these contaminants."
Another possibility, Penny said, was that EG and DEG were instead used as solvents in the toxic medicine. This goes against BPOM regulations, which only allows EG and DEG contaminants to amount to less than 0.1 percent in solvents for syrup-based medicines.
“Possibly, what are supposed to be contaminants were instead used as the solvents, [...] since there were shocking levels of [EG and DEG] found in the products. This is what we are investigating [...] along with what other industries have these [EG and DEG] solvents been circulated to,” she added.
