Dalam rangka kemudahan berusaha dan percepatan proses perizinan, pemerintah telah melakukan simplifikasi regulasi terkait perizinan berusaha termasuk dalam bidang distribusi obat dengan menerbitkan PP No. 5 Tahun 2021 dan PerBPOM No. 10 Tahun 2021. Berdasarkan regulasi tersebut, terdapat perubahan persyaratan dalam proses sertifikasi CDOB diantaranya pemangkasan timeline proses sertifikasi CDOB baik dari pihak BPOM maupun pelaku usaha, serta simplifikasi jenis sertifikat CDOB. Tujuan penelitian untuk mengetahui implementasi kebijakan sertifikasi CDOB sebagai standar perizinan berusaha di Indonesia. Penelitian menggunakan pendekatan kualitatif dengan wawancara mendalam dan telaah dokumen. Penelitian menggunakan teori analisis kebijakan Van Meter dan Van Horn dengan variabel ukuran dan tujuan kebijakan, sumber daya, karakteristik badan pelaksana, komunikasi, disposisi pelaksana, serta lingkungan ekonomi, sosial dan politik yang mempengaruhi implementasi kebijakan. Hasil penelitian adalah ukuran dan tujuan kebijakan serta disposisi pelaksana telah jelas dan dipahami namun masih terkendala pada aspek sumber daya (anggaran), komunikasi, dan karakteristik badan pelaksana dalam hal keterbatasan SDM dan fasilitas khususnya di instansi pemerintah, serta lingkungan ekonomi, sosial dan politik turut berpengaruh pada implementasi kebijakan sertifikasi CDOB sebagai standar perizinan berusaha. Kesimpulan: implementasi kebijakan sertifikasi CDOB sebagai standar perizinan berusaha belum berjalan secara optimal karena masih terdapat perubahan kebijakan yang belum diimplementasikan terkait simplifikasi jenis sertifikat CDOB.

In the context of facilitating doing business and accelerating the licensing process, the government has simplified regulations related to business licensing, including in the field of drug distribution by issuing Government Regulation Number 5 of 2021 and BPOM Regulation Number 10 of 2021. Based on these regulations, there are changes to the requirements in the GDP certification process included trimming the timeline for the GDP certification process both from the BPOM and business actors, as well as simplification of the types of GDP certificates. The research objective is to determine the implementation of the CDOB certification policy as a business licensing standard in Indonesia. The research uses a qualitative approach with in-depth interviews and document review. This study uses the theory of policy analysis by Van Meter and Van Horn with the variables of policy size and objectives, resources, characteristics of implementing agencies, communication, disposition of implementers, as well as the economic, social and political environment that influences policy implementation. The results of the research are that the size and objectives of the policy as well as the disposition of the executors are clear and understood but are still constrained in the aspects of resources (budget), communication, and the characteristics of the implementing agency in terms of limited human resources and facilities, especially in government agencies, as well as the economic, social and political environment. influence on the implementation of the GDP certification policy as a business licensing standard. Conclusion: the implementation of the GDP certification policy as a business licensing standard has not run optimally because there are still policy changes that have not been implemented regarding the simplification of the GDP certificate type.

Fenomena gunung es di Indonesia, yaitu terkait penyalahgunaan obat sudah dalam tahap mengkhawatirkan. Dampak peredaran penyalahgunaan obat-obat Tramadol tidak hanya pada sisi kesehatan saja melainkan pada aspek sosial ekonomi masyarakat serta keamanan dan ketertiban. Badan POM telah mengeluarkan Peraturan Kepala Badan POM No.10 Tahun 2019 tentang Pedoman Pengelolaan Obat-obat Tertentu yang sering disalahgunakan yang tujuannya adalah melindungi masyarakat dari penyalahgunaan dan penggunaan yang salah atas obat-obat tertentu. Penelitian ini bertujuan mengetahui implementasi kebijakan pengelolaan obat-obat tertentu yang sering disalahgunakan di Jakara khususnya penyaluran obat Tramadol oleh PBF. Penelitian dilakukan secara kualitatif, melalui wawancara mendalam dan telaah dokumen. Kerangka konsep mengacu pada teori Van Metter Van Horn. Ada 6 Pedagang Besar Farmasi (PBF) di 5 wilayah kotamadya propinsi DKI Jakarta yang menjadi lokasi penelitian. Hasil penelitian menunjukkan bahwa kinerja implementasi kebijakan Pengelolaan Obat-obat tertentu yang sering disalahgunakan di Jakarta belum optimal. Faktor ukuran dan tujuan kebijakan telah jelas namun masih terkendala pada sumber daya manusia yang belum optimal, belum ada anggaran khusus, fasilitas sudah cukup baik, komunikasi antar organisasi yang terdiri dari transmisi, konsistensi dan kejelasan sudah optimal karena sosialisasi perka sudah baik, karakteristik badan pelaksana belum optimal dalam hal hubungan antar organisasi karena terkendala pada koordinasi lintas sektoral, fragmentasi sudah optimal, disposisi pelaksana yang terdiri dari pemahaman, arah penerimaan dan intensitas sudah optimal, serta lingkungan ekonomi, sosial dan politik yang cukup mendukung implementasi kebijakan. Kesimpulan dari penelitian ini adalah implementasi belum berjalan dengan optimal dengan kendala pada variabel yang cukup berpengaruh yaitu sumber daya manusia, anggaran dan hubungan antar organisasi. Penelitian ini merekomendasikan dibentuknya tim evaluasi dan monitoring kebijakan bersama antara BBPOM di Jakarta dan Dinas Kesehatan Propinsi DKI Jakarta sehingga hambatan-hambatan yang terjadi di wilayah Jakarta terkait Pengelolaan Obat-obat Tertentu yang sering disalahgunakan berjalan lebih efektif dan terintegrasi.

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Background: The tip of iceberg phenomenon in Indonesia, which is related to drug abuse, is already at an alarming stage. The effects of Tramadol drug abuse are not only on the health side but on the socio-economic aspects of society as well as security and order. The POM Agency has issued Head of POM Agency Regulation No.10 Year 2019 regarding Guidelines for the Management of Certain Drugs which are often misused with the aim of protecting the public from misuse and misuse of certain drugs. PBF is a distribution company for certain drugs which is suspected to still be a gap for the distribution of certain drugs such as Tramadol. This study aims  to determine the implementation of the policy of managing certain drugs which are often abused in Jakarta specifically the distribution of tramadol drugs by PBF. Subjects and Methods: This study used a qualitative approach by means of interviews and document review, this research was conducted in March to June 2020. The main informants in this study were BPOM officials, BBPOM in Jakarta, Jakarta Provincial Health Office and 6 PBF. The variables studied were the size and objectives of the policy, resources, characteristics of the implementing agency, communication between organizations, disposition of implementers, and the social, economic, political environment. Data were collected by interview and document review. Data were analyzed descriptively. Result: the implementation of policies on the management of certain drugs which are often abused in Jakarta, especially the distribution of Tramadol drugs by PBF has not been optimal. The size and objectives of the implementation policy are optimal. Resources in the form of budgets have not been allocated specifically, facilities are good, HR is not optimal in terms of numbers, Characteristics of implementing agencies in the form of relationships between organizations are not optimal and fragmentation is good, Communication between organizations namely transmission, consistency and clarity is optimal, Implementing disposition in the form of understanding , the direction of acceptance and intensity is good, and social, economic and political environmental factors have supported the implementation of the policy. Conclusion: The performance of the implementation of policies on the management of certain drugs which are often abused in the Jakarta area, in particular the distribution of Tramadol Medicines in the Regulation of the Head of POM RI Number 10 of 2019 based on the theoretical variable Van meter and Van horn approach in general has not been optimally implemented.