BPOM Supervision Negligence Review Results in Child Victims of Acute Kidney Failure
DOI:
https://doi.org/10.38035/jlph.v5i2.1070Keywords:
BPOM, Negligence, SupervisionAbstract
In 2022, the Indonesian Pediatrician Association (IDAI) through the Ministry of Health conveyed to the public that there were 324 cases of atypical progressive acute kidney failure of unknown cause in children spread across 27 provinces in Indonesia. The method used in this study is the normative research method by collecting secondary data which is then analyzed qualitatively to obtain conclusions about the circulation of syrup drugs that cause acute kidney failure in children, which is certainly not in accordance with the provisions in the Health Law and also violates the guidelines for Good Manufacturing Practices. The form of legal responsibility that can be carried out by BPOM is to strengthen the pre-market and post-market supervision function of drugs in circulation and conduct independent drug tests. In addition, it is hoped that the government will immediately ratify the Drug and Food Supervision Bill to strengthen the supervisory function, authority and sanctions that can be imposed on BPOM if they are negligent.
References
“Perizinan BPOM (Badan Pengawasan Obat dan Makanan)”, di akses melalui https://bisnisukm.com/perizinan-bpom-badan-pengawasan-obat-dan-makanan.html pada tanggal 10 Maret 2024.
“Perizinan BPOM (Badan Pengawasan Obat dan Makanan)”, terdapat disitus https://bisnisukm.com/perizinan-bpom-badan-pengawasan-obat-dan-makanan.html, diakses pada tanggal 10 Maret 2024.
Badan POM, “ Penjelasan BPOM RI Nomor HM.01.1.2.11.22.179 Tanggal 17 November 2022 Tentang Informasi Kesembilan Perkembangan Hasil Pengawasan Dan Penindakan Terkait Sirup Obat yang Mengandung Cemaran Etilin Glikol/ Dietilen Glikol”, https://www.pom.go.id, dikunjungi pada tanggal 10 Maret 2024.
Muhammad Abdulkadir, Hukum dan Penelitian Hukum, (Bandung: PT. Citra Aditya Bakti, 2004), hlm. 43.
BPOM, “Penjelasan BPOM RI tentang Isu Obat Sirup yang Beresiko Mengandung Cemaran Etilen dan Dietilen Glikol", terdapat disitus https://www.pom.go.id/penjelasan-publik/penjelasan-bpom-ri-tentang-isu-obat-sirup-yang-berisiko-mengandung-cemaran-etilen-glikol-eg-dan-dietilen-glikol-deg, diakses pada tanggal 18 Oktober 2024.
Roberto Ranto, “Tinjauan Yuridis Perlindungan Hukum Terhadap Konsumen Dalam Transaksi Jual Beli Melalui Media Elektronik,” Jurnal Ilmu Hukum Alethea 2, no. 2 (2019): 148.
Phlipus M. Hadjon, Perlindungan Hukum Bagi Rakyat Indonesia, (Surabaya: PT Bina Ilmu, 1997), hlm. 2.
Hans Kalsen, Teori Umum Tentang Hukum Dan Negara (Bandung: PT. Raja Grafindo Persada Bandung, 2006). Hal.81
Rofiq Hidayat, “Memperkuat Kewenangan BPOM Lewat RUU Pengawasan Obat Dan Makanan,” 9 November, 2022, https://www.hukumonline.com/berita/a/memperkuat-kewenangan-bpom-lewat-ruu-pengawasan-obat-dan-makanan-lt636b915f70a95/.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2024 Harry Sunyoto, Amad Sudiro
This work is licensed under a Creative Commons Attribution 4.0 International License.
Authors who publish their manuscripts in this journal agree to the following conditions:
- The copyright on each article belongs to the author(s).
- The author acknowledges that the Journal of Law, Poliitic and Humanities (JLPH) has the right to be the first to publish with a Creative Commons Attribution 4.0 International license (Attribution 4.0 International (CC BY 4.0).
- Authors can submit articles separately, arrange for the non-exclusive distribution of manuscripts that have been published in this journal into other versions (e.g., sent to the author's institutional repository, publication into books, etc.), by acknowledging that the manuscript has been published for the first time in the Journal of Law, Poliitic and Humanities (JLPH).