4 th . World Ayurveda Congress 4 . World Ayurveda Congress Bangalore, India Dec 11-13, 2010 Tirtha R. Sakya Gorkha B. DC Gorkha B. DC Ram H. Subedi Back ANSAB
4th. World Ayurveda Congress4 . World Ayurveda CongressBangalore, IndiaDec 11-13, 2010
Tirtha R. SakyaGorkha B. DCGorkha B. DC
Ram H. Subedi
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1. Drug Act & Regulations
2. Regulatory requirements for product registrationproduct registration
3. Trade 3. Trade
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1. Drug Act 1978
2. Regulation2.1 Drug registration Regulation2.1 Drug registration Regulation2.2 Drug Standardization Regulation2.3 Drug Investigation and Inspection 2.3 Drug Investigation and Inspection
Regulation.
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3. Codes3. Codes3.1 Manufacturing 3.2 Advertisement3.2 Advertisement3.3 Dispensing
www.dda.gov.np
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Two main agencies to implement drug act1. Dept. of Drug Administration1. Dept. of Drug Administration2. National Medicine LaboratoryNML is responsible for:
Testing Testing PreregistrationPost registrationMarket surveillanceMarket surveillanceInvestigation
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1. Company/ Industry registration2. Product Registration2. Product Registration
1.1 WHO GMP Certificate1.1 WHO GMP Certificate1.2 On-site Audit of the factory
( audit fee $1500)( audit fee $1500)
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2. Product Registration2.1 COPP of each products
2.2 Manufacturing license2.2 Manufacturing license2.3 Product specification2.4 Analysis Report2.4 Analysis Report2.5 Samples and labelsValidity of license: a. Company registration forever
with the payment of INR 50,000 with the payment of INR 50,000 Product Validity: Initially 2 yrs, renewal every yr, Rs.
1600 each products, renewal fee INR. 200
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Forests (39.6%), shrub land, meadows - over Forests (39.6%), shrub land, meadows - over 50% of Nepal s land area Himalayan ecosystem a biodiversity global Himalayan ecosystem a biodiversity global hotspot> 10,000 plant species recorded, over 1000 for economic uses: 700 MAPs, 440 wild food, 238 economic uses: 700 MAPs, 440 wild food, 238 essential oils, 71 fiber Unique and high value products Unique and high value products
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> 160 species in tradeVast majority (90%) harvested from Vast majority (90%) harvested from wild by the poor in remotest mountainsNepal s export estimated over $35 Nepal s export estimated over $35 million per annum.
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Market Channels for MAPs in Domestic Market
MAPs
Market Channels for MAPs in Domestic Market
Individual Collectors (90%) FUGs (10%)
Village Traders
Road Head/Airport Traders
Local Processors
Terai Wholesalers/Regional Traders
Export of Crude Herbs (India, Overseas) approx. 90% of total
Processing Units (public & private) approx 10% of total Overseas) approx. 90% of total
volume of tradeprivate) approx 10% of total
volume of trade
Export of Processed Products (essential oil, resinoids etc.)
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(essential oil, resinoids etc.)
Sustainable resource Sustainable resource management potential
Over 14,000 FUGs, representing more than a third representing more than a third population (23m)
Nearly 1 million ha (> 18% of forest area) under community forest area) under community management
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Sustainable resource Sustainable resource management potential
60% of total forest land potential for community potential for community forestry
Extensive support and priority from government, donors and from government, donors and civil society
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Traditional knowledge and skillsTraditional knowledge and skills
Local knowledge and Local knowledge and practices on resource harvesting and post harvesting and post harvest activities
Indigenous knowledge Indigenous knowledge on use of medicinal plants (Amchi, Baidya)plants (Amchi, Baidya)
BackANSAB 13Opportunities
ProductionProductionDomestication- high altitude sppsMarketing- Branding, PositioningMarketing- Branding, PositioningCertification- Organic, fair tradeProduct standardizationProduct standardizationR & D Economy of scaleEconomy of scale
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Amount in
Export of Herbs & Essential Oil
2009 Qty(kg)Amount in US$
Herbal Products Export(Raw materials, essential oil)
383258 25 M 383258 25 M
2008 Qty(kg)Amount in US$2008 Qty(kg) US$
Herbal Products Export(Raw materials,
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essential oil) 117796 19 M
Products Value in 000 Rs
Export value of major Products
Products Value in 000 Rs
Large cardamom 1,160,000 (46%)Large cardamom 1,160,000 (46%)
Herbs in crude form ( 43 major species) 892,519 (35%)
Lokta handmade papers and its products 275,375 (11%)Lokta handmade papers and its products 275,375 (11%)
Pine resin 108,000 (4%)
Essential oils 50,559 (2%)
Allo and hemp products 43,675 (2%)Allo and hemp products 43,675 (2%)
Incense 16,503 (1%)
Total 2,546,631 (100%)
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Total 2,546,631 (100%)Source: Subedi 2004
List of FSC Certified ProductsList of FSC Certified Products
SN Scientific Name English Name Local name/parts Type
1 Daphne spp. Dry Lokta Bark F
2 Edgeworthia gardnerii Argeli whiteskin F
3Gaultheria fragrantissima Wintergreen Machhino leaves F,O
Himalayan 4 Girardinia diversifolia
Himalayan Nettle Dry Allo fiber F
5 Parmelia spp Lichen Jhyau F
6 Rubia manjith Maddar Majitho F6 Rubia manjith Maddar Majitho F
7 Berginia ciliata Pakhanved F
8 Swertia chiraiyita Dry Chiraito F
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8 Swertia chiraiyita Dry Chiraito F
9 Paris polyphylla Satuwa F
10 Rheum australe Rhubarb Padamchal F
List of FSC Certified ProductsList of FSC Certified ProductsEnglish Local
SN Scientific Name Name name/parts Type
11 Silenium cadollei Bhutkesh F
12 Morchela spsMorel Mushroom
Guchchhi chyau F12 Morchela sps Mushroom chyau F
13 Valeriana jatamansi Valerian Sugandhwal F,O
14Pichrorhizascrophulariflora Gentian Kutki F14 scrophulariflora Gentian Kutki F
15 Nardostachys grandiflora Spikenard Jatamansi F,O
16 Aconitium heterophyllum Atis FRhododendrun Anthopogo
17Rhododendrun anthopogon
Anthopogon Sunpati F, O
18 Juniperus indica Juniper Dhupi F, O
19 Juniperus spp Juniper Lahare dhupi F, O
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19 Juniperus spp Juniper Lahare dhupi F, O
20 Abies spectabilis Fir Gobresalla F, O
21 Taxus baccata Taxus/Yew Lauth salla F
List of FSC Certified ProductsList of FSC Certified Products
SN Scientific Name English Name
Local name/parts Type
22 Pinus wallichiana PineSalla Simta (Cone) F22 Pinus wallichiana Pine (Cone) F
23 Artemisia vulgarisArtemisia/Armoise Titepati O
Zanthoxylum 24
Zanthoxylum armatum Timur O
25 Acorus calamus Swet fleg Bojho O
26Cymbopogon flaxuosus Lemongrass O26 flaxuosus Lemongrass O
27Cymbopogonwinterianus Citronella O
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