Drug Regulatory Authority — Kingdom of Bhutan
Bhutan DRA · Bhutan · asia pacific
Bhutan's national drug regulator — leech-specific authorisation pathway not independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Bhutan
- Leech status
- unregulated
- Last ASH review
- 2026-05-28
- Website
- https://www.dra.gov.bt
Relevant Regulation Codes
- Bhutan Medicines Act 2003 and amendments
- Bhutan Medicines Rules and Regulations 2012
Prescriber Requirements
- Bhutan Medical and Health Council–registered physician — order required for any biomedical device application
- Allied health professional application under physician supervision per institutional protocol
Supply Chain & GMP
Bhutan DRA registration as applicable; Dzongkha and English-language labelling. Standard cold-chain conditions, with logistical constraints typical of Himalayan distribution.
Import/Export Rules
Bhutan DRA and Bhutan Agriculture and Food Regulatory Authority (BAFRA) clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Bhutan's National Health Service (free at point of care) coverage depends on inpatient bundling under Gross National Happiness Index–aligned policy.
ASH Editorial Notes
Leech-specific authorisation pathway not independently verified by ASH; falls under general medical-device / Sowa-Rigpa traditional-medicine framework as appropriate. Bhutan integrates traditional Bhutanese medicine (gSo-ba Rig-pa) into its national health service — whether this captures medicinal leech application has not been independently mapped 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.