Lestari, Lutfiah
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ANALISA KEPUTUSAN INDUSTRI TERHADAP PRODUK HASIL INDUSTRI YANG BEREDAR DI MASYARAKAT MENYEBABKAN KERUGIAN : STUDI KASUS SIRUP ANAK PENYEBAB GAGAL GINJAL Putri, Risma Syntia; Lestari, Lutfiah; Raihan, Muhammad; Damanik, Fioren Christiovani; Antoni, Herli
Jurnal Dialektika Hukum Vol 5 No 2 (2023): Jurnal Dialektika Hukum
Publisher : Law Department Jenderal Achmad Yani University

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.36859/jdh.v5i2.1498

Abstract

The actions of the pharmaceutical industry in Children's syrup containing ethylene glycol (EG) and diethylene glycol (DEG) which cause kidney failure in children need to be more deeply examined in relation to decision-making and responsibility. This study aims to analyze the industry's decision-making on industrial products that circulate in society and cause losses, with a case study of children's syrup causing kidney failure. The research used a normative juridical method with a case study approach. The results show that the syrup medicine could circulate in society due to negligence in the production, supervision, and distribution that does not meet the established standards. BPOM, as the responsible agency for drugs and food in Indonesia, has taken law enforcement measures against industrial perpetrators who violate regulations, such as revocation of circulation permits, product seizures, and criminal prosecution. In addition, BPOM also provides socialization and education to the public about how to choose and use safe and high-quality drugs. This study recommends that the pharmaceutical industry improve product quality and compliance with applicable regulations, as well as collaborate with relevant parties to prevent similar cases in the future. This study also refers to Presidential Regulation No. 12 of 2021 on the Security of Drugs and Food as a legal basis for handling cases of children's syrup causing kidney failure.