Pengawasan Terhadap Obat Tradisional China Impor Tanpa Izin Edar oleh Badan Pengawas Obat dan Makanan di Kota Surabaya

Supervision of Imported Traditional Chinese Medicines Without a Circulation Permit by the Food and Drug Adminiatration in Surabaya City

Obat tradisional China yang diedarkan wajib berizin edar, namun pada faktanya masih banyak pelaku usaha yang memperdagangkan obat tradisional China impor tanpa izin edar. Hal ini merupakan permasalahan pengawasan yang dilakukan oleh Balai Besar Pengawasan Obat dan Makanan Surabaya sebagai unit pelakasana teknis Badan Pengawas Obat dan Makanan di Provinsi Jawa Timur dalam pengawasan obat tradisional China impor tanpa izin edar di Surabaya. Kewajiban tentang izin edar obat tradisional China terdapat dalam Pasal 106 ayat (1) Undang-Undang Nomor 36 Tahun 2009 tentang Kesehatan. Dalam hal kewenangan pengawasan obat tradisional China dilakukan oleh kementerian yang selanjutnya diberikan kepada Kepala Badan yang tercantum pada Pasal 2 ayat (2) Peraturan Menteeri Kesehatan Republik Indonesia Nomor 007 Tahun 2012 tentang Registrasi Obat Tradisional. Kepala Badan adalah Kepala Badan yang memiliki tanggung jawab pada bidang pengawasan obat dan makanan. Hal tersebut sesuai dengan Peraturan Presiden Republik Indonesia Nomor 80 Tahun 2017 tentang Badan Pengawas Obat dan Makanan. Dalam hal mengedarkan obat tradisional impor tanpa izin edar Menteri memiliki kewenangan dalam memberikan tindakan administrasi kepada setiap pelaku usaha/ distributor/importir/pengecer yang tetap mengedarkan obat tradisional China impor yang  tercantum dalam UU Kesehatan Pasal 188 ayat (1) dan (3) . Metode penelitian yang digunakan adalah hukum empiris atau sosiologis dengan menggunakan penelitian dilapangan untuk mengkaji aturan hukum yang berlaku didalam masyarakat. Hasil penelitian menunjukan bahwa masih banyak importir yang masih mengedarkan obat tradisional China tanpa izin edar. Hal ini berdasarkan pada wawancara dan pengamatan yang dilakukan penulis terhadap pelaku usaha obat tradisional China. Faktor penghambat dalam pengawasan ini, adalah kurangnya Sumber Daya Manusia dari Balai Besar POM Surabaya, serta kurangnya kesadaran masyarakat untuk melaporkan produk obat tradisional China impor tanpa izin edar yang dapat menjadi ancaman bagi kesehatan masyarakat..

Kata Kunci: Pengawasan, Obat Tradisional China, Tanpa Izin Edar

Circulated Chinese traditional medicines must have a distribution license, but in fact there are still many business actors who trade imported traditional Chinese medicines without distribution permits. This is a problem of supervision carried out by the Surabaya Food and Drug Control Center as a technical unit for the Food and Drug Supervisory Agency in East Java Province in the supervision of imported traditional Chinese medicines without distribution permits in Surabaya. The obligation regarding the distribution permit of traditional Chinese medicine is contained in Article 106 paragraph (1) of Law Number 36 of 2009 concerning Health. In the event that the authority to supervise traditional Chinese medicine is exercised by the ministry which is then given to the Head of the Agency as stated in Article 2 paragraph (2) Regulation of the Minister of Health of the Republic of Indonesia Number 007 of 2012 concerning Registration of Traditional Medicines. Head of Agency is the Head of Agency who has responsibility in the field of drug and food control. This is in accordance with the Presidential Regulation of the Republic of Indonesia Number 80 of 2017 concerning the Food and Drug Supervisory Agency. In the case of circulating imported traditional medicines without a distribution permit, the Minister has the authority to provide administrative action to any business actor / distributor / importer / retailer who continues to circulate imported traditional Chinese medicines listed in the Health Law Article 188 paragraph (1) and (3). The research method used is empirical or sociological law by using field research to study the legal rules that apply in society. The results showed that there were still many importers circulating traditional Chinese medicines without distribution permits. This is based on interviews and observations made by the author of traditional Chinese medicine entrepreneurs. Inhibiting factors in this supervision are the lack of Human Resources from the Surabaya POM Center, as well as the lack of public awareness to report imported traditional Chinese medicinal products without distribution permits which can be a threat to public health.  

         Keywords: Supervision, Traditional Chinese Medicine, Without Distribution Permit