The Indonesian Food and Drug Authority (Indonesian: Badan Pengawas Obat dan Makanan, lit. 'Food and Drug Supervisory Agency'), Badan POM/BPOM, or Indonesian FDA is a government agency of Indonesia responsible for protecting public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medication), vaccines, biopharmaceuticals, dietary supplements, food safety, traditional medicine and cosmetics. The task and purposes of this agency is similar to the USFDA.
| Badan Pengawas Obat dan Makanan BPOM | |
 Logo of Badan POM | |
| Agency overview | |
|---|---|
| Formed | 1936 |
| Preceding agency |
|
| Jurisdiction | Government of Indonesia |
| Headquarters | Jl. Percetakan Negara No.23, Central Jakarta 10520, Indonesia |
| Agency executive |
|
| Website | www |
History
The predecessor of BPOM was formed during the colonial period and was named de Dienst der Volksgezondheid (DVG). Operating under the auspices of the Dutch pharmaceutical company, DVG itself was in charge of producing chemical drugs as well as operating a pharmaceutical research center. In 1964, during the Guided Democracy era, DVG was nationalized and became the Pharmacy Inspectorate (Inspektorat Farmasi) of the Indonesian Ministry of Health. Three years later, it was renamed the Inspectorate of Pharmaceutical Affairs (Inspektorat Urusan Farmasi). In 1976, it was again renamed the Directorate General Drug and Food Control (Direktorat Jenderal Pengawasan Obat dan Makanan, Ditjen POM).[1]
In accordance with Presidential Decree No. 166/2000, the Directorate-General of Drug and Food Control was officially divested from the Ministry of Health to become an independent agency which reports directly to the president, though it continues to coordinate with the Ministry.[2][1] Since 2017, BPOM has been regulated by Presidential Decree No. 80/2017.[3]
In 2020, the head of BPOM issued a decree regarding the standardization of English-language nomenclature used in reference to BPOM, which includes an official translation of the agency name in English.[4] The agency was previously known in English as the National Agency for Drug and Food Control.
Task and function
Task
As stipulated in article 2 of Presidential Decree No. 80/2017, BPOM was tasked to execute government role in the field of drug and food control.[3]
Function
According to article 3 of Presidential Decree No. 80/2017, BPOM has the following functions:[3]
- Drafting and executing national policy in drug and food control;
- Drafting and establish norms, standard, procedure, and criterion in supervision on before and after obtaining marketing authorisation;
- Executing supervision before and after obtaining marketing authorisation;
- Coordinating drug and food control within the central and regional governments;
- Providing technical assistance and supervision in drug and food control;
- Enforcing the law in regards to the field of drug and food control;
- Coordinating execution, supervision and administrative support for all entity within BPOM;
- Managing state assets within BPOM;
- Overseeing task and functions execution within BPOM.
Organization
Based on article 5 of Presidential Decree No. 80/2017,[3] and as expanded by BPOM Decrees No. 21/2020 and 13/2022, BPOM is organized into the following:
- Head of Indonesian Food and Drug Authority
- Secretariat General
- Deputy for Drug Control, Narcotics, Psychotropics, Precursors and Addictive Substances Supervision
- Directorate of Pharmaceutical, Narcotics, Precursors and Addictive Substances Standardization
- Directorate of Pharmaceutical Registration
- Directorate of Pharmaceutical, Narcotics, Psychotropics, and Precursors Production Supervision
- Directorate of Pharmaceutical, Narcotics, Psychotropics, and Precursors Distribution Supervision
- Directorate of Pharmaceutical, Narcotics, Psychotropics, Precursors, and Addictive Substances Safety, Quality, and Export-Import Supervision
- Deputy for Traditional Medicines, Health Supplements, and Cosmetics Supervision
- Directorate of Traditional Medicines, Health Supplements, and Cosmetics Standardization
- Directorate of Traditional Medicines, Health Supplements, and Cosmetics Registration
- Directorate of Traditional Medicines and Health Supplements Supervision
- Directorate of Cosmetics Supervision
- Directorate of Public and Business Empowerment in Traditional Medicines, Health Supplements, and Cosmetics
- Deputy for Processed Food Supervision
- Directorate of Processed Food Standardization
- Directorate of Processed Food Registration
- Directorate of Processed Food Production Supervision
- Directorate of Processed Food Distribution Supervision
- Directorate of Public and Business Empowerment in Processed Food
- Deputy for Law Enforcement
- Directorate of Prevention
- Directorate of Food and Drug Intelligence
- Directorate of Food and Drug Cyber
- Directorate of Food and Drug Investigation
- Inspectorate General
BPOM has four centers, those are:
- Center of Drug and Food Data and Information
- Center of Drug and Food Human Resource Development
- Center of National Drug and Food Testing Development
- Center of Drug and Food Policy Analysis
BPOM has several Technical Implementation Units (TIUs) which spread across Indonesia. TIUs in NAFDC are Bureau (Balai Besar) and Office (Balai).
References
- ^ a b Chryshna, Mahatma (21 January 2021). "Badan Pengawas Obat dan Makanan (BPOM)". Kompas (in Indonesian). Retrieved 3 October 2021.
- ^ Keputusan Presiden RI Nomor 166 Tahun 2000 tentang Kedudukan, Tugas, Fungsi, Kewenangan, Susunan Organisasi, Dan Tata Kerja Lembaga Pemerintah Non Departemen (Presidential Decision 166) (in Indonesian). President of Indonesia. 2000.
- ^ a b c d Peraturan Presiden RI Nomor 80 Tahun 2017 tentang Badan Pengawas Obat dan Makanan (Presidential Decree 80) (in Indonesian). President of Indonesia. 2017.
- ^ Keputusan Kepala Badan POM Tahun 2020 Nomor HK.02.02.1.2.03.20.115. Tentang Standardisasi Nomenklatur BPOM dalam Bahasa Inggris (Head of BPOM decree HK.02.02.1.2.03.20.115.) (in Indonesian). 2020.
