Indonesian Food and Drug Authority

Indonesian government agency

Directorate General of Drug and Food Control of Ministry of Health

JurisdictionGovernment of IndonesiaHeadquartersJl. Percetakan Negara No.23, Central Jakarta 10520, IndonesiaAgency executive

Penny Lukito, Head of BPOM

Websitewww.pom.go.id

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.

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.

External links

National Agency for Drug and Food Control of Indonesia (in English)

Government of Indonesia

Executive Branch

Central
Government

Elected officials	President of Indonesia list Vice President of Indonesia list
Cabinet (List) and Ministries	Coordinating Minister for Economic Affairs Coordinating Minister for Human Development and Cultural Affairs Coordinating Minister for Maritime Affairs Coordinating Minister for Political, Legal, and Security Affairs Agriculture State Apparatus Utilization and Bureaucratic Reform Communication and Information Technology Cooperatives and Small & Medium Enterprises Defense Energy and Mineral Resources Environment and Forestry Women Empowerment and Child Protection Finance Foreign Affairs Health Home Affairs Industry Investment Agrarian Affairs and Spatial Planning Law and Human Rights Manpower Maritime Affairs and Fisheries National Development Planning Public Works and People's Housing Religious Affairs Education, Culture, Research, and Technology Social Affairs State Owned Enterprises Ministry of State Secretariat Tourism and Creative Economy Trade Transportation Villages, Development of Disadvantaged Regions, and Transmigration Youth and Sports Affairs
Non-Ministerial Government Agency	Maritime Security Agency National Armed Forces National Counter Terrorism Agency National Cyber and Crypto Agency National Food Agency National Disaster Management Authority National Narcotics Board National Police National Resilience Institute National Search and Rescue Agency Public Prosecution Service State Intelligence Agency Quarantine Agency Bank Indonesia Government Goods and Services Procurement Policy Institute Finance and Development Supervisory Agency Central Agency on Statistics Indonesian Migrant Workers Protection Agency National Population and Family Planning Board Geospatial Information Agency Meteorology, Climatology, and Geophysical Agency National Agency of Drug and Food Control National Archives of Indonesia National Library of Indonesia National Research and Innovation Agency National Standardization Agency Nuclear Energy Regulatory Agency Cabinet Secretariat National Administration Institute National Civil Service Agency Radio of the Republic of Indonesia Television of the Republic of Indonesia
Non-Structural Agency	Acceleration of Housing Enforcement Acceleration of Infrastructure Provision Policy Committee Anti Dumping Committee Attorney Commission Broadcasting Commission Business Competition Supervisory Commission Central Information Commission Child Protection Commission Civil Service Advisory Agency Commission for Assessment of Analysis of Environmental Impacts Commission on Biological Safety of Genetically Engineered Products Company Privatization Committee Cooperative Council Corruption Eradication Commission Council of Engineers Council of Health Workers Counterfeited Rupiah Eradication Coordinating Board Defense Industry Policy Committee Deposit Insurance Agency Executive Office of the President Film Agency Film Censorship Institution Financing Policy Committee for Micro, Small and Medium Enterprises Financial Services Authority Financial Transaction Reports and Analysis Centre General Elections Commission General Elections Organiser Ethics Council General Elections Supervisory Agency Government Accounting Standards Committee Hajj Financial Management Agency Health Workers Disciplinary Board Hospital Oversight Agency Indonesian Academy of Sciences Institute for the Prevention and Eradication of Forest Damage Istiqlal Mosque Management Executive Board Lake Toba Authority Agency Medical Counci National Accreditation Committee National Amil Zakat Agency National Aviation Security Committee National Border Management Agency National Commission on Violence against Women National Commission on Human Rights National Committee on Sharia Economics and Finance National Consumer Protection Agency National Council for Special Economic Zones National Defense Council National Disability Commission National Energy Council National Film Advisory Agency National Health Advisory Agency National Industry Committee National Information and Communication Technology Council National Police Commission National Productivity Institute National Professional Certification Board National Social Security Board National Sports Committee of Indonesia National Team for the Acceleration of Poverty Reduction National Transportation Safety Committee National Wages Council National Water Resources Council Nuclear Energy Advisory Council Nusantara Capital City Authority Oil and Gas Downstream Regulatory Agency Ombudsman of the Republic of Indonesia Pancasila Ideology Development Agency Patent Appeal Commission Peace Maintenance Mission Coordination Team Peat and Mangrove Restoration Agency Presidential Advisory Council Press Council Public Accountants Professional Committee Public Housing Savings Committee Public Housing Savings Management Agency Regional Autonomy Advisory Council Regional Border Management Agency Social Security Administrator Special Task Force for Upstream Oil and Gas Business Activities State Civil Service Commission State Civil Service Advisory Board Titles, Decorations and Honours Council Tourism Promotion Board Trade Security Committee Trademark Appeal Commission Tripartite Cooperation Institute Waqf Agency Witness and Victim Protection Agency

Regional
Government

Legislative Branch

Central Government	People's Consultative Assembly House of Representatives List Regional Representative Council List
Regional Government	Regional House of Representatives