National Agency of Drug and Food Control (Indonesia)

The Indonesian Food and Drug Authority (Indonesian: Badan Pengawas Obat dan Makanan, lit. 'Agency for Drug and Food Control') or Badan POM/BPOM or Indonesian FDA, is a government agency of Indonesia, BPOM is responsible for protecting public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, dietary supplements, food safety, traditional medicine and cosmetics. The task and purposes of this agency is similar to USFDA.

Indonesian Food and Drug Authority
Badan Pengawas Obat dan Makanan
BPOM
Logo of Badan POM
Agency overview
Formed1936 (1936)
Preceding agency
  • Directorate General of Drug and Food Control of Ministry of Health
JurisdictionGovernment of Indonesia
HeadquartersJl. Percetakan Negara No.23, Central Jakarta 10520, Indonesia
Agency executive
  • Penny Lukito, Head of BPOM
Websitewww.pom.go.id/new/

History

Precursor of BPOM formed during Dutch east indies era by the name of de Dienst der Volksgezondheid (DVG) under the auspices of the Dutch pharmacy company. DVG itself acts as an institution in charge of producing chemical drugs as well as a pharmaceutical research center at that time. In 1964, DVG was nationalized during Guided democracy era and becomes the Pharmacy Inspectorate (Inspektorat Farmasi) of Ministry of Health. Three years later, it was renamed to be the Inspectorate of Pharmaceutical Affairs (Inspektorat Urusan Farmasi). In 1976, the name is changed to be Directorate General Drug and Food Control (Direktorat Jenderal Pengawasan Obat dan Makanan, Ditjen POM).[1]

Based on Presidential Decision No. 166/2000, Directorate General Drug and Food Control is officially separated from a directorate general within Ministry of Health to become independent agency and report directly to the president with coordination to the Minister of Health.[2][1] Since 2017, BPOM is regulated by Presidential Decree No. 80/2017.[3]

In 2020, Head of BPOM issued a decree on standardization of English nomenclature of BPOM, which provide official translation of the agency name in English.[4] The agency is previously known in English as 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]

  1. Drafting national policy in drug and food control;
  2. Execute national policy in drug and food control;
  3. Drafting and establish norms, standard, procedure, and criterion in supervision on before and after obtaining marketing authorisation;
  4. Execute supervision on before and after obtaining marketing authorisation;
  5. Coordinate execution of drug and food control within central and regional government;
  6. Provide technical assistance and supervision in drug and food control;
  7. Execute law enforcement di the field of drug and food control;
  8. Coordinate execution, supervision and administrative support to all entity within BPOM;
  9. Manage state assets within BPOM;
  10. Oversee task and functions execution within BPOM;
  11. Execute substantives support to all entity within BPOM.

Organization

Based on article 5 of Presidential Decree No. 80/2017, BPOM is organized into the following:[3]

  • 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 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:[3]

  • 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 Food and Drug Research and Studies

BPOM has several Technical Implementation Units (TIUs) which spread across Indonesia. TIUs in NAFDC are Bureau (Indonesian: Balai Besar) and Office (Indonesian: Balai).

References
  1. Chryshna, Mahatma (21 January 2021). "Badan Pengawas Obat dan Makanan (BPOM)". Kompas (in Indonesian). Retrieved 3 October 2021.
  2. "Keputusan Presiden RI Nomor 166 Tahun 2000 tentang Kedudukan, Tugas, Fungsi, Kewenangan, Susunan Organisasi, Dan Tata Kerja Lembaga Pemerintah Non Departemen". Presidential Decision No. 166 of 2000 (in Indonesian). President of Indonesia.
  3. "Peraturan Presiden RI Nomor 80 Tahun 2017 tentang Badan Pengawas Obat dan Makanan". Presidential Decree No. 80 of 2017 (in Indonesian). President of Indonesia.
  4. "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 No. HK.02.02.1.2.03.20.115. of 2020 (in Indonesian).


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