Central Drugs Standard Control Organisation
CDSCO · India · asia pacific
India's central drug regulator — leech therapy (Jalaukavacharana / जलौकावचारण) integrated into the official AYUSH system as part of Ayurveda Panchakarma practice.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- India
- Leech status
- traditional medicine
- Last ASH review
- 2026-05-25
- Website
- https://cdsco.gov.in
Relevant Regulation Codes
- Drugs and Cosmetics Act, 1940 and Rules, 1945
- Medical Device Rules, 2017 (S.O. 78(E))
- Indian Medicine Central Council Act, 1970 (governs Ayurveda practice)
- National Commission for Indian System of Medicine Act, 2020
Prescriber Requirements
- Ayurveda physician (BAMS — Bachelor of Ayurvedic Medicine and Surgery) is the principal prescriber
- Allopathic physicians (MBBS) can prescribe but rarely do; cross-practice is restricted under the 2020 Act
- Hirudotherapy / Jalaukavacharana is taught at every BAMS curriculum nationally
Supply Chain & GMP
Ministry of AYUSH coordinates with CDSCO for traditional-medicine raw materials; leech farms (notably in Maharashtra and Karnataka) supply Ayurveda hospitals nationally. Cold-chain less standardised than Western markets.
Import/Export Rules
CITES paperwork for Hirudo medicinalis; Wildlife Protection Act, 1972 schedules certain leech species — Indian breeders typically use Hirudinaria granulosa (Indian medicinal leech) which is regulated separately.
Reimbursement Context
Ayushman Bharat — PM-JAY (national health insurance) covers Panchakarma including Jalaukavacharana in empanelled AYUSH hospitals; state-level Ayurveda hospitals are an additional public-sector channel.
Key Regulatory Documents
ASH Editorial Notes
India is the world's most institutionalised hirudotherapy jurisdiction — Jalaukavacharana is a recognised Panchakarma procedure with formal academic training. Hirudinaria granulosa is the principal Indian species; H. medicinalis used in research contexts.
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.
HSA — Singapore
Singapore's health sciences regulator — leech therapy supervised under the Health Products Act 2007 with separate licensing for TCM practitioners using leeches in clinical practice.