Badan Pengawas Obat dan Makanan — National Agency of Drug and Food Control
BPOM · Indonesia · asia pacific
Indonesia's national agency for drug and food control — leech-specific regulatory pathway has not been independently verified by ASH; pengobatan tradisional has a separate framework under the Ministry of Health.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Indonesia
- Leech status
- traditional medicine
- Last ASH review
- 2026-05-25
- Website
- https://www.pom.go.id
Relevant Regulation Codes
- Undang-Undang Kesehatan (Indonesian Health Law)
- Indonesian Ministry of Health regulations on traditional medicine (pengobatan tradisional)
Prescriber Requirements
- Indonesian Medical Council (KKI)-registered physician for biomedical use
- Traditional medicine practitioners (battra / hattra) registered under the Ministry of Health may have separate scope; specific hirudotherapy authorisation not independently verified by ASH
Supply Chain & GMP
BPOM registration if classified as a medical device; Bahasa Indonesia labelling.
Import/Export Rules
BPOM import licence plus Quarantine Authority for live invertebrates; CITES Appendix II paperwork.
Reimbursement Context
BPJS Kesehatan (national health insurance) coverage for hirudotherapy not independently verified by ASH.
ASH Editorial Notes
Indonesia recognises three categories of traditional medicine practitioners (battra empiris, battra ramuan, battra ketrampilan) under Ministry of Health regulations. Whether leech therapy is regulated as a traditional medicine modality or as a medical device under BPOM has not been independently verified by ASH.
Related Jurisdictions
PMDA — Japan
Japan's medicines and devices regulator — leech therapy classified within the Kampo / traditional-medicine framework under MHLW oversight, with no PMDA-issued device approval to date.
NMPA — China
China's medical-products regulator — leeches (水蛭 / shui zhi) are codified in the Chinese Pharmacopoeia as Traditional Chinese Medicine (TCM) and regulated as a Chinese herbal medicine.
MFDS — South Korea
South Korea's drug-safety regulator (formerly KFDA) — leech therapy practised within the Korean Medicine (한의학 / Hanui) tradition; Hirudo medicinalis listed in the Korean Pharmacopoeia.
CDSCO — India
India's central drug regulator — leech therapy (Jalaukavacharana / जलौकावचारण) integrated into the official AYUSH system as part of Ayurveda Panchakarma practice.