National Medicines Regulatory Authority
NMRA · Sri Lanka · asia pacific
Sri Lanka's National Medicines Regulatory Authority — leech-specific regulatory pathway has not been independently verified by ASH; medicinal leeches fall under the general medical device framework or indigenous medicine (Ayurveda) pathways as appropriate.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Sri Lanka
- Leech status
- unregulated
- Last ASH review
- 2026-05-26
- Website
- https://nmra.gov.lk
Relevant Regulation Codes
- National Medicines Regulatory Authority Act (Sri Lanka)
- Sri Lankan framework for Ayurveda and indigenous medicine as appropriate
Prescriber Requirements
- Sri Lanka Medical Council–registered physician — order required for any biomedical device application
- Ayurvedic practitioners registered under the Ayurvedic Medical Council may have separate scope; specific hirudotherapy authorisation not independently verified by ASH
Supply Chain & GMP
NMRA registration as applicable; Sinhala, Tamil, and English-language labelling. Standard cold-chain conditions.
Import/Export Rules
NMRA import licence requirements; Department of Animal Production and Health clearance for live invertebrates; CITES Appendix II paperwork for Hirudo medicinalis / verbana.
Reimbursement Context
Not covered under public insurance schemes for leech therapy specifically.
ASH Editorial Notes
Leech-specific pathway not independently verified by ASH; falls under general medical device / traditional medicine framework as appropriate. Sri Lanka has a parallel Department of Ayurveda; leech therapy (jalauka avacharana) is part of classical Ayurvedic practice, but its regulatory status as a clinical modality 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.