Analisis Yuridis Kewenangan Pengawasan BPOM Terhadap Peredaran Obat Sirop Beracun

  • Irsyad Jelang Amirin Universitas Dr. Soetomo Surabaya
  • Nur Handayati Universitas Dr. Soetomo Surabaya
  • Subekti Subekti Universitas Dr. Soetomo Surabaya
  • M. Yustino Aribawa Universitas Dr. Soetomo Surabaya

Keywords

BPOM, Authority, Supervision, Toxic Syrup Medicines, Administrative Law

Abstract

The circulation of syrup medicines containing hazardous substances is a legal and public health issue that requires effective government oversight. The Food and Drug Supervisory Agency (Badan Pengawas Obat dan Makanan/BPOM), as the government institution authorized to supervise drugs and food, plays an important role in ensuring the safety, quality, and efficacy of medicines distributed to the public. This study aims to analyze the regulatory framework governing BPOM's supervisory authority based on applicable laws and regulations from the perspective of Administrative Law and to examine the forms of BPOM supervision over the circulation of toxic syrup medicines. The research employs a normative legal research method using a statutory approach and a conceptual approach. The legal materials consist of primary legal materials in the form of laws and regulations governing health, drugs and food, consumer protection, and the status and authority of BPOM, as well as secondary legal materials in the form of books, scientific journals, and legal scholars' opinions. The results show that BPOM's authority has a legal basis that legitimizes the supervision of medicines both before and after they are distributed to the public. From the perspective of Administrative Law, such authority constitutes governmental authority that must be exercised based on the principle of legality, legal certainty, and the general principles of good governance. BPOM's supervision of the circulation of toxic syrup medicines is conducted through pre-market and post-market surveillance, inspections of production and distribution facilities, sample collection and testing, product tracing, drug recalls, the imposition of administrative sanctions, and coordination with relevant agencies. Therefore, BPOM's authority and supervisory functions constitute important administrative law instruments for preventing the circulation of hazardous medicines and providing legal protection to the public

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2026-10-03