Acute Kidney Injury; BPOM Finds EG, DEG Contaminants 702 Times Safe Limit
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18 November 2022 11:23 WIB
TEMPO.CO, Jakarta - The Indonesian Food and Drug Monitoring Agency (BPOM) head Penny K Lukito revealed the investigation results on five pharmaceutical companies following the rising cases of acute kidney injury among children. It is found that their syrup drugs contain ethylene glycol (EG) and diethylene glycol (DEG) at 433 to 702 times the safe limit.
"The five pharmaceutical firms have been given administrative sanctions,” said Penny in a press conference on Thursday, November 17, 2022.
They are PT Yarindo Farmatama, PT Universal Pharmaceutical Industries, PT Samco Farma, PT Ciubros Farma, and PT Afi Farma. The investigation into the last three companies is still afoot.
Administrative sanctions given are in the form of revocation of certificates of Good Manufacturing Practices (GMP), revocation of distribution permits for medicinal syrup products, termination of production activities, withdrawal of all medicinal syrups from circulation, and destruction of all supplies or stocks of medicinal syrups.
The agency also revoked the Certificates of Good Drug Distribution Practices (CDOB) to two pharmaceutical wholesalers (PBF) involved in the distribution of the raw materials of Propylene Glycol that did not meet the requirements. They are PT Afi Farma and CV Samudra Chemical.
To date, PT Yarindo Farmatama and PT Universal Pharmaceutical Industries have been named as suspects in cases of acute kidney injury in children. Meanwhile, PT Ciubros Farma and PT Samco Farma are still being examined to determine the suspect's status.
Meanwhile, PT Afi Farma and CV Samudra Chemical are also being processed as suspects by the BPOM and National Police's Criminal Investigation Agency (Bareskrim).
RIANI SANUSI PUTRI
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