ANALISIS PERTANGGUNGJAWABAN HUKUM BADAN PENGAWAS OBAT DAN MAKANAN TERKAIT PEREDARAN OBAT YANG MENYEBABKAN GANGGUAN GINJAL AKUT

Muhamad Reyhan Yudha Kurniawan, . (2025) ANALISIS PERTANGGUNGJAWABAN HUKUM BADAN PENGAWAS OBAT DAN MAKANAN TERKAIT PEREDARAN OBAT YANG MENYEBABKAN GANGGUAN GINJAL AKUT. Skripsi thesis, Universitas Pembangunan Nasional Veteran Jakarta.

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Abstract

Objective The acute kidney injury cases that occurred at the end of 2022 have shocked various parties. This phenomenon is suspected to be closely related to the use of drugs that allegedly contain contaminants from liquid drug solvents, namely Ethylene Glycol (EG) and Diethylene Glycol (DEG). This research aims to analyze the legal liability of the Food and Drug Supervisory Agency regarding the circulation of drugs that cause acute kidney injury. Method This research uses the normative legal research method. The type of normative legal research that will be conducted in this study is research on legal principles. The primary legal sources used come from relevant legislation and are analyzed using descriptive qualitative data analysis methods. Result Legal liability must be borne by the Food and Drug Supervisory Agency (BPOM) in relation to the circulation of drugs causing acute kidney injury because BPOM is a public institution responsible for drug supervision. Generally, legal liability as a public body can be carried out administratively and civilly. According to UU No. 30 of 2014, BPOM can be sued through administrative efforts at the State Administrative Court (PTUN). Civilly, KUH Perdata 1365 of the Civil Code explain that any unlawful act that causes harm to another party obliges the party causing the harm to compensate. From a criminal perspective, the KUHP explains that public bodies cannot be directly prosecuted. However, if there is a mistake or error in policy-making, officials related to the case can be prosecuted through the general court system. Conclusion Based on the research results, BPOM can be held administratively, civilly, and criminally liable for negligence in supervising the circulation of drugs containing hazardous substances such as ethylene glycol (EG) and diethylene glycol (DEG)

Item Type: Thesis (Skripsi)
Additional Information: [No.Panggil : 2110211025] [Pembimbing 1 : Abdul Kolib] [Pembimbing 2 : Boenga NurCita] [Penguji : Ria Maria Theresa]
Uncontrolled Keywords: Legal Liability, Food and Drug Supervisory Agency, Drug Circulation, Acute Kidney Injury.
Subjects: R Medicine > R Medicine (General)
R Medicine > RZ Other systems of medicine
Divisions: Fakultas Kedokteran > Program Studi Kedokteran (S1)
Depositing User: MUHAMAD REYHAN YUDHA KURNIAWAN
Date Deposited: 12 Mar 2025 01:41
Last Modified: 12 Mar 2025 01:41
URI: http://repository.upnvj.ac.id/id/eprint/34480

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