Drug Regulatory Authority of Pakistan
DRAP · Pakistan · asia pacific
Pakistan's Drug Regulatory Authority — federal authority over therapeutic goods; leech-specific regulatory pathway has not been independently verified by ASH.
Regulatory Profile
- Agency type
- national regulator
- Region
- asia pacific
- Country
- Pakistan
- Leech status
- unregulated
- Last ASH review
- 2026-05-25
- Website
- https://www.dra.gov.pk
Relevant Regulation Codes
- Drug Regulatory Authority of Pakistan Act, 2012
- Pakistani national medical-device regulatory framework
Prescriber Requirements
- PMC (Pakistan Medical Commission)-registered MD prescription required
- Traditional medicine (Tibb) and complementary medicine practitioner scope under the National Council for Tibb / National Council for Homoeopathy for hirudotherapy not independently verified by ASH
Supply Chain & GMP
DRAP product registration if classified as a medical device; English and Urdu-language labelling.
Import/Export Rules
DRAP import licence plus Department of Plant Protection / animal quarantine clearance for live invertebrates; CITES Appendix II paperwork.
Reimbursement Context
Sehat Sahulat Programme and provincial social health insurance coverage for hirudotherapy not independently verified by ASH.
ASH Editorial Notes
Pakistan has a long-standing Tibb (Unani) traditional medicine tradition with statutory recognition via the National Council for Tibb; whether leech therapy is regulated as a Tibb modality or as a medical device under DRAP 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.