Tiurma Tobing, Elsa (2023) KEWENANGAN BALAI BESAR PENGAWAS OBAT DAN MAKANAN SERANG TERHADAP PENGAWASAN PEREDARAN PRODUK OBAT SIRUP YANG TERKONTAMINASI ETILEN GLIKOL DAN DIETILEN GLIKOL PADA BEBERAPA PRODUK OBAT SIRUP DI PROVINSI BANTEN DALAM MEWUJUDKAN KEAMANAN OBAT-OBATAN BERDASARKAN PERATURAN PRESIDEN NOMOR 80 TAHUN 2017 TENTANG BADAN PENGAWAS OBAT DAN MAKANAN. S1 thesis, UNIVERSITAS SULTAS AGENG TIRTAYASA.
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Abstract
The Ministry of Health (Kemenkes) has halted the circulation of cough and fever syrup for children due to numerous cases. One of the factories in Serang, namely PT. Yarindo, which produces kidney-failure-inducing syrup, has been closed by the Food and Drug Supervisory Agency and the Indonesian National Police. The first identified problem is the implementation of the authority of the Serang Big Office for Drug and Food Supervision in monitoring the distribution of syrup products contaminated with ethylene glycol and diethylene glycol in several syrup products in the Banten Province to ensure drug safety based on Presidential Regulation Number 80 of 2017 concerning the Food and Drug Supervisory Agency. The second issue is the obstacles faced by the Serang Big Office for Drug and Food Supervision in monitoring the distribution of syrup products contaminated with ethylene glycol and diethylene glycol in several syrup products in the Banten Province to ensure drug safety based on Presidential Regulation Number 80 of 2017 concerning the Food and Drug Supervisory Agency. The theories used are the authority theory and the supervision theory. The research method used is empirical juridical with analytical data through a qualitative approach using primary data in the form of interviews with the Serang Big Office for Drug and Food Supervision and secondary data in the form of literature. The research results show that the Serang Big Office for Drug and Food Supervision only plays a role in enforcement, intelligence, and imposing administrative sanctions according to applicable regulations. The authority obstacle is the limited authority of the Food and Drug Supervisory Agency's Law Enforcement and Supervision Officers in Serang.In conclusion, the delegation authority theory is implemented, and the Serang Big Office for Drug and Food Supervision is hindered in carrying out repressive supervision. Evaluation is needed to expedite the handling of the Serang Big Office for Drug and Food Supervision towards contaminated drug products, and the optimization of the performance of the Serang Big Office for Drug and Food Supervision needs to be done
| Item Type: | Thesis (S1) | |||||||||
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| Additional Information: | Kementerian Kesehatan (Kemenkes) telah menghentikan peredaran obat batuk dan demam dalam bentuk sirup bagi anak-anak akibat banyaknya Kasus. Salah satu Pabrik di Serang yaitu PT. Yarindo yang membuat obat sirup gagal ginjal yang ditutup oleh Badan Pengawas Obat dan Makanan serta Kepolisian RI. Adapun identifikasi masalah yang pertama yaitu bagaimana implementasi kewenangan Balai Besar Pengawas Obat dan Makanan Serang terhadap pengawasan peredaran produk obat sirup yang terkontaminasi etilen glikol dan dietilen glikol pada beberapa produk obat sirup di Provinsi Banten dalam mewujudkan keamanan obat-obatan berdasarkan Peraturan Presiden Nomor 80 Tahun 2017 Tentang Badan Pengawas Obat Dan Makanan? dan yang kedua yaitu bagaimana hambatan Balai Besar Pengawas Obat dan Makanan Serang terhadap pengawasan peredaran produk obat sirup yang terkontaminasi etilen glikol dan dietilen glikol pada beberapa produk obat sirup di Provinsi Banten dalam mewujudkan keamanan obat-obatan berdasarkan Peraturan Presiden Nomor 80 Tahun 2017 Tentang Badan Pengawas Obat Dan Makanan?Teori yang digunakan ialah teori kewenangan dan teori pengawasan. Metode penelitian yang digunakan yaitu yuridis empiris dengan analitis data melalui pendekatan kualitatif menggunakan data primer berupa wawancara kepada Balai Besar Pengawas Obat dan Makanan Serang dan data sekunder berupa pustaka. Hasil penelitian yaitu Balai Besar POM Serang hanya berperan dalam penindakan, intelijen, dan memberikan sanksi administratif sesuai aturan yang berlaku, hambatan kewenangan yaitu keterbatasan kewenangan PPNS Badan POM Serang memperlambat penindakan karena harus berkoordinasi dengan Badan Pengawas Obat dan Makanan serta Kepolisian RI. Kesimpulannya ialah teori kewenangan delegasi yang dijalankan dan Balai Besar POM Serang terhambat dalam melakukan pengawasan represif terutama dalam mencabut izin produksi yang menjadi kewenangan Badan Pengawas Obat dan Makanan. Adapun saran dari penulis yaitu evaluasi diperlukan untuk mempercepat penanganan Balai Besar POM Serang terhadap produk obat yang terkontaminasi dan optimalisasi kinerja Balai Besar Pengawasan Obat dan Makanan Serang perlu dilakukan. | |||||||||
| Uncontrolled Keywords: | Serang Main Office of Food and Drug Monitoring Agency, Authority, Supervision, Presidential Regulation No. 80 of 2017. Balai Besar Pengawas Obat Makanan Serang, Kewenangan, Pengawasan, Peraturan Presiden Nomor 80 Tahun 2017. | |||||||||
| Subjects: | K Law > K Law (General) | |||||||||
| Divisions: | 01-Fakultas Hukum 01-Fakultas Hukum > 74201-Program Studi Ilmu Hukum |
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| Depositing User: | Mrs Elsa Tiurma Tobing | |||||||||
| Date Deposited: | 22 Feb 2024 12:15 | |||||||||
| Last Modified: | 22 Feb 2024 12:15 | |||||||||
| URI: | http://eprints.untirta.ac.id/id/eprint/33015 |
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