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

ARYAWATI, KHOFIFAH AYU and Fitri, Icha Cahyaning (2024) TANGGUNG GUGATAN PERUSAHAAN FARMASIN TERHADAP KOINSUMEN MENGKOMSUMSI OBAT SIRUP YANG MENGANDUNG ETILEN GLIKOL (EG) DAN DIETILEN GLIKOL(DEG)(KASUS GAGAL GINJAL AKUT PADA ANAK). Undergraduate thesis, Universitas Muhammadiyah Jember.

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Abstract

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.

Item Type:

Thesis (Undergraduate)

Uncontrolled Keywords:

tanggung jawab, perusahaan farmasi, obat-obatan

Subjects:

300 Social Science > 340 Law > 346 Private Law

Divisions:

Faculty of Law > Department of Law Science (S1)

Department:

S1 Ilmu Hukum

Depositing User:

Khofifah Ayu Aryawati