SISTEM PENGAWASAN OBAT DALAM MELINDUNGI HAK KONSUMEN PADA KASUS PELANGGARAN STANDAR KEAMANAN DAN KUALITAS SIRUP OBAT DI INDONESIA.

This research investigates cases of acute kidney failure caused by contaminated syrup medicines from the perspective of administrative law. Using a normative legal research approach, analysis is conducted on primary legal sources related to the case, including laws, government regulations, presidential regulations, BPOM chief regulations, health ministry circulars, and administrative court decisions. These legal sources are considered as primary legal materials, which are authoritative and legally binding. The aim of this study is to provide a comprehensive understanding of the legal aspects related to the case and their implications within the framework of administrative law. The research shows that the Indonesian Food and Drug Monitoring Agency (BPOM) plays a crucial role in regulating the circulation of medicines in Indonesia in accordance with Presidential Regulation Number 80 of 2017. Although BPOM has conducted comprehensive monitoring, indications of propylene glycol raw material counterfeiting indicate shortcomings in monitoring. Nevertheless, BPOM continues to provide legal protection preventively and repressively to the public by tracing drug registrations, withdrawing problematic drugs from circulation, and imposing administrative sanctions on products that violate safety standards [ABSTRACT FROM AUTHOR]