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

Back 11Opportunities

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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