Law and Humanities
Quarterly Reviews
ISSN 2827-9735
Published: 25 December 2023
Responsibility of a Pharmaceutical Company on Medicine Safety (Case Study on Paracetamol Syrup)
Yuwono Prianto, Della Savelya
Tarumanagara University, Indonesia
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10.31014/aior.1996.02.04.96
Pages: 185-193
Keywords: Poisoning, Paracetamol, Ethylene Glycol, Diethylene Glycol
Abstract
Cases of medicine poisoning derived from paracetamol syrup that is currently rampant have caused acute kidney failure in children. This is known because of the content of harmful substances contained in the medicine. The dangerous substances contained in the medicine are Ethylene Glycol and Diethylene Glycol. Paracetamol syrup poisoning cases have claimed many victims. Up to now, 269 victims have experienced acute kidney failure and 157 of them are declared dead. This article analyses the responsibility of pharmaceutical companies in securing medicine in cases that occur and how legal steps are to protect the interests of victims and their families. The research methods employed normative legal methods sourced from secondary data in the form of legal materials and non-legal materials. The qualitative approach is descriptive and the data collection is qualitative. Qualitative data analysis using the Miles and Huberman model where the narrative and secondary data are examined with analysis content. This case is caused by intentional or negligence on the part of the pharmaceutical company producing the medicine in the production process and carelessness in the packaging and distribution of these medicines. The Ministry of Health and the Food and medicine Supervisory Agency (BPOM) are also recognized for being careless in supervising and issuing proper distribution permits for these medicines. There must be a responsibility from the parties concerned to the victims and their families. The parties involved in this medicine poisoning case have absolute legal responsibility (strict liability) for the losses suffered by the victims.
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