LEGAL PROTECTION FOR CONSUMERS AGAINST MEDICINAL PRODUCTS THAT POSE HEALTH RISKS: OPTIMIZING THE SUPERVISORY ROLE OF THE INDONESIAN FOOD AND DRUG AUTHORITY (BPOM) FROM THE PERSPECTIVE OF THE RULE OF LAW
Published:
2026-07-31Downloads
Abstract
“As a rule of law state that embraces the welfare state concept, Indonesia has an affirmative obligation to safeguard the safety of its citizens through the supervision of high-risk pharmaceutical products. The 2022 outbreak of Atypical Progressive Acute Kidney Injury (APAKI), caused by contamination with Ethylene Glycol (EG) and Diethylene Glycol (DEG) in syrup-based medicinal products, which resulted in the deaths of 324 children, underscores the urgent need to reconstruct the pharmaceutical regulatory oversight system. This study employs a normative juridical research method using statutory, case, and conceptual approaches. The findings indicate that the pre-market and post-market supervisory functions carried out by the Indonesian Food and Drug Authority (BPOM) have not been implemented optimally due to structural constraints, limited resources, and insufficient responsiveness to the evolving risks associated with modern pharmaceutical preparations. Grounded in the Responsive Law Theory and the concept of law as a tool of social engineering, the optimization of preventive and repressive legal protection for consumers must be achieved through the transformation of risk-based supervision, strengthening the accountability of state liability, digitalization of the pharmaceutical supply chain, and the integration of inter-institutional regulatory oversight.
Keywords:
Consumer Protection Indonesian Food and Drug Authority (BPOM) Optimization of Regulatory Oversight, Rule of Law High-Risk Medicinal Products.References
I. BOOKS
Asshiddiqie, J. (2021). Konstitusi dan Konstitusionalisme Indonesia. Jakarta: Sinar Grafika.
Hadjon, P. M., & Djatmiati, T. S. (2020). Argumentasi Hukum. Yogyakarta: Gadjah Mada University Press.
Ibrahim, J. (2019). Teori dan Metodologi Penelitian Hukum Normatif. Malang: Bayumedia.
Luhmann, Niklas. Social Systems. Stanford: Stanford University Press, 2021.
Marzuki, P. M. (2021). Penelitian Hukum. Jakarta: Kencana.
Nonet, Philippe, & Philip Selznick. (2017). Hukum Responsif. Terjemahan Rafael Edy Bosch. Jakarta: Nusa Media.
Pound, Roscoe. An Introduction to the Philosophy of Law. New Haven: Yale University Press, 2020.
Rini, I., & Idayanti, S. (2025). Strategi Penelitian Hukum: Teori, praktik, dan Inovasi. K-Media.
Soekanto, S., & Mamudji, S. (2021). Penelitian Hukum Normatif. Jakarta: RajaGrafindo Persada.
Stahl, Friedrich Julius. Philosophy of Law. Oxford: Oxford University Press, 2004.
Sunggono, B. (2020). Metodologi Penelitian Hukum. Jakarta: RajaGrafindo Persada.
Widiyastuti. Asas-Asas Pertanggungjawaban Perdata. Jakarta: (Penerbit), 2020.
Widjaja, G., Santoso, B., & Hidayat, M. (2022). Manajemen Risiko dalam Pengawasan Produk Farmasi. Jakarta: Prenada Media.
II. JOURNAL ARTICLES / SCHOLARLY WORKS
Agusta, M. “Pengaturan Mutu Produk Pangan.” DATIN Law Journal 1, no. 1 (2020)
Amalia, R. A., & Mulyanti, A. S. (2024). Peranan Badan Pengawas Obat dan Makanan (BPOM) dalam Mengawasi Peredaran Obat Tradisional yang Mengandung Bahan Kimia Obat. ALADALAH: Jurnal Politik, Sosial, Hukum dan Humaniora, 2(4).
Ardianti, L.. “Analisis Persepsi Orang Tua Terhadap Obat Sirup dan GGAPA.” Jurnal Kesehatan 3, no. 3 (2023)
Ardianti, R., Prasetyo, B., & Kurniawan, D. (2023). Risk-Based Supervision dalam Pengawasan Obat di Indonesia. Jurnal Hukum Kesehatan.
Aryawati, K. A. “Tanggung Gugat Farmasi Akibat Obat Sirup EG/DEG.” Indonesian Journal of Legal Justice 1, no. 4 (2024): 18–25. Bahmid, B. “Peranan BPOM dalam Perlindungan Konsumen.” De Lega Lata 5, no. 2 (2020)
Bahmid, A., Panjaitan, B., & Siregar, R. (2020). Peran BPOM dalam Sistem Perlindungan Konsumen di Indonesia. Jurnal Hukum dan Regulasi.
Bahmid, B., Martua, J., & Arbiah, A. (2020). Peranan Badan Pengawas Obat Dan Makanan Dalam Memberikan Perlindungan Studi Di Kantor Cabang Badan Pengawas Obat Dan Makanan Badan Pengawas Obat Makanan (BPOM) Tanjungbalai. De Lega Lata: Jurnal Ilmu Hukum, 5(2).
Lubis, Achmad Raihansyah, & Dwi Desi Yayi Tarina. (2023). Perlindungan hukum terhadap konsumen akibat mengkonsumsi obat sirup yang merusak kesehatan. Jurnal USM Law Review, 6(3)
Tampubolon, W. S. (2018). Peranan dan Tanggung Jawab Badan Pengawas Obat dan Makanan (BPOM) Terkait Kasus Albothyl Menurut Undang Undang Perlindungan Konsumen. Jurnal Ilmiah Advokasi, 6(1).
Umami, Allan Mustafa, et al. (2023). Tanggung gugat keperdataan Badan Pengawas Obat dan Makanan (BPOM) Indonesia dalam peredaran obat-obatan yang menyebabkan gagal ginjal akut pada anak. Jurnal Risalah Kenotariatan, 4(1).
Simanjuntak, H. (2024). Reformasi Kelembagaan BPOM dalam Meningkatkan Pengawasan Obat. Jurnal Kebijakan Publik.
Widjaja, G. “Pengawasan serta Pemberian Izin Edar Vaksin COVID-19.” ZAHRA Journal 2, no. 4 (2022)
Widodo, S. (2023). Negara Hukum dan Perlindungan Hak atas Kesehatan. Jurnal Konstitusi dan HAM.
Wirawan, A. F. “Tanggung Jawab BPOM Berdasarkan UU 17/2023.” Innovative Journal 4, no. 3 (2024)
Zein, Syafira. (2023). Aspek hukum perlindungan konsumen produk obat-obatan berdasarkan BPOM (Kasus obat sirup tercemar EG/DEG). Unnes Law Review, 6(2)
II. LEGISLATION
International Covenant on Economic, Social and Cultural Rights (ICESCR), 2022.
Kitab Undang-Undang Hukum Perdata (Burgelijk Wetboek).
Peraturan BPOM Nomor 21 Tahun 2020 tentang Organisasi dan Tata Kerja BPOM.
Peraturan Presiden Nomor 80 Tahun 2017 tentang Badan Pengawas Obat dan Makanan.
Undang-Undang Dasar Negara Republik Indonesia Tahun 1945.
Undang-Undang Nomor 8 Tahun 1999 tentang Perlindungan Konsumen.
Undang-Undang Nomor 17 Tahun 2023 tentang Kesehatan.
III. INTERNET SOURCES
Asatunews. “Panggil BPOM atas Kelalaian Mengawasi Obat Sirup.” 2022.
BBC Indonesia. “Gagal Ginjal Akut: Skandal Obat Sirop Belum Berakhir.” 2023.
BPOM. Laporan Pengawasan Obat dan Makanan 2021. Jakarta: BPOM, 2021.
BBC News Indonesia. (2024). Gagal Ginjal Akut: Skandal obat sirup belum berakhir. Diperoleh dari https://www.bbc.com/indonesia/articles/cx9v2z98ze8o
Salsabila, Rindi. (2024). Obat sirup berbahaya: 324 anak meninggal, BPOM digugat. CNBC Indonesia. Diperoleh dari https://www.cnbcindonesia.com/lifestyle/20221226174054-33-400254-meninggal-bpom-digugat
CNBC Indonesia. Salsabilla, R. “Obat Sirup Berbahaya: 324 Anak Meninggal.” 2022.
CNBC Indonesia. Salsabilla, R. “Update Kasus Obat Sirup.” 2022.
EMA – European Medicines Agency. Pharmacovigilance Systems Overview. 2021.
FDA – U.S. Food & Drug Administration. Drug Safety Communication Guidelines. 2020.
National Library of Medicine. “What Are Drug Substances?” 2024.
Ruff, K. “Global Pharmaceutical Supply Chains.” International Journal of Health Policy (2020)
License
Copyright (c) 2026 Aulia Jasmine Ayu Malika, Himawan Sugiharto, Soesi Idayanti
This work is licensed under a Creative Commons Attribution 4.0 International License.
