Indonesian National Police Names Two Pharmaceutical Companies as Suspects on Acute Kidney Failure Case

JAKARTADAILY.ID – Indonesian National Police's Criminal Investigation Agency (Bareskrim Polri) has named two companies, PT Afi Farma and CV Samudera Chemical, as suspects in acute kidney failure cases in Indonesia. The two companies have different but interrelated roles.

PT Afi Farma is a manufacturer of syrup drugs that contain levels of Ethylene Glycol (EG) and Diethylene Glycol (DEG) that exceed the threshold. Meanwhile, CV Samudra Chemical is a supplier of raw materials for PT Afi Farma.

Also Read: Indonesia's FDA Recalls Five Syrup-Based Medicine that Allegedly Caused Acute Kidney Injury in Children

EG and DEG are strongly suspected of being the cause of many deaths in children with kidney failure.

This was stated by the National Police Public Relations through a press release published on Thursday, November 17, 2022.

In the press release, it was revealed that the determination of suspects against the two companies was carried out after the joint team of Bareskrim Polri held a case title on Wednesday, November 16, 2022, as well as examined 41 witnesses.

Also Read: Indonesian Ministry of Health Detected Three Chemicals in that Caused Acute Kidney Injuries in Children

"These two corporations are suspected of committing the crime of producing drugs or distributing pharmaceutical preparations that do not meet standards and or requirements for safety, efficacy or benefits and quality," said National Police Spokesperson, Police Inspector General Dedi Prasetyo.

Dedi explained, PT Afi Farma had deliberately not tested the additive propylene glycol which turned out to contain EG and DEG exceeding the threshold. The additional material is supplied by CV Samudera Chemical.

"PT A only copies the data provided by the supplier without testing and quality control to ensure that the material can be used for production," he explained.

Also Read: MoH Orders Pharmacies to Stop Selling Syrup-Based Medicine Due to String of Acute Kidney Injury Among Children

Dedi added, as a result of his actions, PT Afi Farma was charged with Article 196 in conjunction with Article 98 paragraph (2) and paragraph (3) in conjunction with Article 201 paragraph (1) and/or paragraph (2) of RI Law No. 36 of 2009 concerning Health, and Article 62 paragraph (1) in conjunction with Article 8 paragraph (3) of Republic of Indonesia Law No. 8 of 1999 concerning Consumer Protection.

Meanwhile, CV Samudra Chemical was charged with Article 196 in conjunction with Article 98 paragraph (2) and paragraph (3) and/or Article 60 number 4 of Law Number 11 of 2020 concerning Job Creation Changes to Article 197 Jo Article 106 Jo Article 201 paragraph (1) and/or paragraph (2) of Law Number 36 of 2009 concerning Health and Article 62 in conjunction with Article 8 Paragraph (3) of Law Number 8 of 1999 concerning Consumer Protection Jo article 55 and/or article 56 of the Criminal Code.