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Govt may take legal action against pharma companies as child AKI deaths rise
Changes in raw ingredients of medicines are likely to blame for child acute kidney injury (AKI) case spike in Indonesia, minister says.
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Police officers visit a drug store to inspect syrup formulas for children, following numerous child deaths from kidney injuries attributed to harmful substances in medicinal syrups, in Banda Aceh on October 24, 2022.
(AFP/Chaideer Mahyudin)
T
he government has attributed the recent spike in acute kidney injury (AKI) cases to toxic levels of chemical compounds in medicinal syrups, as it considers a potential criminal investigation against drug manufacturers whose products have been linked to 141 child deaths this year.
Food and Drug Monitoring Agency (BPOM) chief Penny Lukito revealed on Monday that the agency had singled out two pharmaceutical companies that produced medicines with unacceptable levels of ethylene glycol (EG) and diethylene glycol (DEG).
Commonly found as contaminants in the solvents of syrup-based medicines, EG and DEG are thought to be the cause of Indonesia’s spike in AKI cases and deaths.
To this end, Penny said the BPOM would work with the police to build a criminal case against the two companies over the composition of ingredients used in their products. She did not identify the two firms in question.
“There is indication that EG and DEG levels found in these companies’ products more than exceeds [safe levels of] contaminants,” she told reporters after a meeting with President Joko “Jokowi” Widodo at the Bogor Palace in West Java.
Previously, the BPOM was under pressure to explain how it managed to greenlight a number of products for market that scientists have found to be linked to kidney failure in over 100 cases involving children under the age of six.
But Penny said the agency had fulfilled its mandate and observed all prevailing regulations in inspecting products circulating in the market; she insisted it was the responsibility of pharmaceutical companies – and not the BPOM – to check the level of contaminants found in their own products.
