Cases of Acute Kidney Failure, House of Representatives Reminds of 10 Years in Imprisonment for Pharmaceutical Companies

JAKARTA - Chair of Commission IX of the House of Representatives (DPR), Felly Estelita Runtuwene, reminded pharmaceutical companies about the potential for violations that could lead to criminal sanctions and fines for their negligence, causing cases of atypical progressive acute kidney disorder (GGAPA) in children.

Felly said that if a pharmaceutical company is proven negligent, there is a threat of 10 years in prison and a fine of IDR 10 billion.

"Based on Article 188 in conjunction with Article 196 of the Health Law, it is stated that anyone who intentionally produces and distributes pharmaceuticals and/or medical devices that do not meet the safety requirements, shall be sentenced to a maximum of 10 years and a fine of 1 billion rupiahs", said Felly in a working meeting with the Minister of Health, Budi Gunadi Sadikin, and the Food and Drug Supervisory Agency (BPOM) at the DPR building, Senayan, Jakarta, Wednesday, November 2.

Felly also warned of potential violations in Law Number 8 of 1999 concerning Consumer Protection in cases of acute kidney failure. Especially Article 8 and Article 62 of the Law.

"Regarding the liability of pharmaceutical companies for material and immaterial losses for the losses, the maximum penalty is 5 years and a maximum fine of 2 billion rupiahs", said Felly.

Previously, the National Police Headquarters had raised the status of cases of acute kidney failure from investigation to investigation which allegedly involved the pharmaceutical company PT Afi Farma Pharmaceutical Industries (Afifarma).

"Regarding the handling of cases of acute kidney failure in children, today the National Police Criminal Investigation Unit has filed a case to improve the status of the investigation so that it is an investigation into the findings of PT AF's drug products", said Head of the Public Relations Division of the National Police Public Relations Division, Commissioner Nurul Azizah, to reporters, Tuesday, November 1.

The Joint Criminal Investigation Team of the National Police has targeted a pharmaceutical company, PT AFI Pharma, which is suspected of producing paracetamol syrup containing Ethylene Glycol (EG) and Diethylene Glycol (DEG) exceeding the threshold causing death in children.

The head of the Joint Investigation Team for the Criminal Investigation Unit of the National Police, Brigadier General Pipit Rismanto, explained that the status of the investigation was increased after the case, together with the Food and Drug Supervisory Agency (BPOM), Tuesday, November 1.

"Based on the results of the trial this afternoon, they agreed to increase from an investigation to an investigation into PT AFI Pharma", explained Pipit via a short message to reporters in Jakarta, Tuesday, November 1.