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Acute Kidney Injury: BPOM to Penalize Pharmaceutical Companies
TheIndonesia.id - The Indonesian Drug and Food Control Agency (BPOM) said it will penalize two pharmaceutical companies after ethylene glycol (EG) and diethylene glycol (DEG) were detected in their syrups, as the number of child deaths from acute kidney injury (AKI) in the country hits 141.
Despite announcing the next step that the agency is seeking to take, head of BPOM Penny Lukito didn’t reveal the names of the two companies.
“We already know the two pharmaceutical industry that we will penalize,” Lukito said on Monday, October 24, as reported by Antara.
She further explained that she had assigned a unit in the agency to work together with the National Police to investigate the two companies and their penalization.
“I can’t reveal the names now because the process is still ongoing, [but] we will certainly inform the public soon,” Lukito said.
The agency’s leader said the penalization is based on finding that EG and DEG content in the companies’ syrup products couldn’t be considered as mere contaminants because the level was high.
"There’s indication that EG and DEG in the product were not only as contaminants but were very high—and of course, very toxic. [Therefore] it can be suspected to be the cause of acute kidney injury," he said.
Previously, on Thursday, October 20, BPOM announced that five brands of medicinal syrup distributed in Indonesia contained EG which exceeded the safety threshold.
The first one was Termorex Sirup 60 ml, produced by PT Konimex with permit number DBL781300353A7A1. The next one was Flurin DMP Sirup 60 ml, distributed by PT Yarindo Farmatama with permit number DTL0332708637A1.
Meanwhile, the remaining three products were syrups produced by Universal Pharmaceutical Industries, and they were were Unibebi Cough Sirup 60 ml (DTL7226303037A1), Unibebi Demam Sirup 60 ml (DBL8726301237A1), and Unibebi Demam Drops 15 ml (DBL1926303336A1).
On the same occasion, Minister of Health Budi Gunadi Sadikin revealed that there have been 245 cases of AKI in 26 provinces, with 141 deaths reported (57.6 percent).