TANGGUNG GUGATAN PERUSAHAAN FARMASIN TERHADAP KOINSUMEN MENGKOMSUMSI OBAT SIRUP YANG MENGANDUNG ETILEN GLIKOL (EG) DAN DIETILEN GLIKOL(DEG)(KASUS GAGAL GINJAL AKUT PADA ANAK)

In August 2022 in Indonesia through the Indonesian Ministry of Health (MOH) and
the Indonesian Pediatric Association (IDAI) received reports of a sharp increase in cases of
Atypical Progressive Acute Kidney Injury (AKI). The Minister of Health (Menkes) announced
that the syrup containing Ethylene Glycol (EG) and Diethylene Glycol (DEG) has a
concentration of ceramaran 400 times more than the 0.5 mg/kg that should be used. This
research examines how the Liability of Pharmaceutical Companies for Consumers
Consuming Syrup Drugs Containing Ethylene Glycol and Diethylene Glycol (Cases of Acute
Kidney Failure in Children) using case, conceptual, and statutory approaches. Article 1 point
(5) of the Food and Drug Supervisory Agency Regulation Number 34 of 2018 concerning
Guidelines for Good Manufacturing Practices and in Article 19 of Law No. 8 of 1999
concerning Consumer Protection in this article can be civil sanctions in the form of
compensation to consumers who have consumed drugs that are not in accordance with
BPOM standards.