Agriculture Nkea_herbs Subsector

8/6/2019 Agriculture Nkea_herbs Subsector

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AGRICULTURE NKEA: HERBS SUB-SECTOR

ENTRY POINT PROJECT (EPP)

HIGH VALUE HERBAL PRODUCTS

February2011

(LIMITEDCIRCULATION)



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INTRODUCTION

Globaltradeofnaturalproducts,whichamountedtoRM777billionin2009,isprojected

to tripleby2020.Theshift inhealthcare,denotedbyglobalgrowth innutraceuticals,

towardsapreferencefornaturalproductswiththerapeuticvalueprovidesopportunities

forMalaysiatobecomeasignificantglobalplayer,givenourrichbiodiversity.However,

currentlythemajorityoflocalproductsarelargelyinthelow-endmarketsegment,such

as fortified beverages. Diversification towards high-end herbal products based on

standardized extracts and validated byclinical studies remainsweakdue to lack of

industrychampions,weaknesses in local R&D, large investment required forclinical

studiesanddifficultyinpenetratinginternationalmarkets.

OBJECTIVES

Giventhevastpotentialinmarketopportunities,andinsupportofprovidingalternative

andcomplementarymedicinestothemassesforbetterhealthcareandhealthyliving,

theEntryPointProjectforherbalproductstowardsnutraceuticalswithclaimsandhigh

value botanical drugshas been identified.ThisEPP isaprivatesector-led initiative,

aimedasacoordinatednationalprojectwiththefollowingobjectives:

Toincreasethegrossnationalincome(GNI)amountingtoUSD1.016billionor

RM3.25billionby2020;

Toproducequality,safeandefficacioushigh-endherbalproductsespeciallyfor

theexportmarkets;

Tostrengthenthesuppliesacrossthevaluechain;and

ToenhanceR&Dinherbsandsecuretheintellectualpropertyrightsfromlocal

herbs.

GNI CONTRIBUTION

Thisinitiativeisprojectedtoprovideanincreaseingrossnationalincometothecountry

amounting toUSD1.016billion orRM3.25 billion by2020with contribution from the

EntryPoint Project of high value herbal products and spin-offs fromotherbusiness

opportunities.



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GNI Contribution : USD1.016billion(RM3.25billion)

EPPHighvalue

Herbalproducts :USD692million(RM2.21billion)

Businessopportunities :USD324million(1.04billion)

COMPONENTS OF THE PROJECT OF HIGH VALUE HERBAL PRODUCTS

I. R&Dgrantswillbeestablishedtosupport:

Upstream research activities (discovery and crop production & agronomy).

Grants will be given to research institutions based on research requirements

requestedbytheparticipatingcompanies.

Downstream research activities (standardization& product development, and

pre-clinical and clinicalstudies) tobe given to research institutions based on

researchrequirementsasrequestedbytheparticipatingcompanies.

Private sector manufacturing companies will invest in other capital expenditure

(CAPEX)andoperationsexpenditure(OPEX).

Theherbalfundismeanttobeaseedgrant.Oncefullydisbursed,theprivatesector

is expected to make further investment contribution to the development,

commercializationofherbalproductsandfinallytogeneratereturnstoincreasethe

grossnationalincometothecountrywithintheagricultureNKEAherbalsub-sector.

II. Clusters of R&D Centre of Excellence (CoEs).These clusters will coordinate

researchamongstpublicR&Dorganizations.Theclustersare:

discovery;

cropproduction&agronomy;

standardization&productdevelopment;

pre-clinicalsandclinicals;and

processingtechnology



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ThemainroleoftheR&Dclustersistoaccelerateandcoordinatesustainable

R&D activities for the NKEA projects. As such, research capabilities and

infrastructurewillbeimproved.

III. Rawmaterialsupply

Toensureadequateandconsistent supplyofrawmaterials,HerbalCultivation

Parks willbedeveloped incorridorareaswheretheherbswillbeplantedona

largecommercialscalebasedonacontractfarmingmodel.Anchorcompanies

willbeselectedtomanagesmallerfarmers(out-growers)andensurecompliance

withinternationalstandardsonGAPandorganiccertifications.TheGovernment

willprovidethebasicinfrastructurei.e.basicutilities,andacollection,processing

andpackagingcenter.Inreturn,anchorcompanieswillinvestinequipmentand

machineries,aswellasmanageandruntheoperations.

IV. StandardizedextractsupplyExtractionfacilities inthecountrywillbeexpanded.Therearecurrentlylimited

commercial-scalefacilities.Mostaresmalloratpilotscaleandnotdesignedto

operate commercially. New facilities will be built, each with a capacity of1,000kgperextraction cycle tosupply the industrywithreliableandpremium

qualityextractsatcompetitivecost.

V. NationalBranding Governmentwill facilitate an integratedmarketing approach to promotea

nationalbrand

Herbalproductsdevelopedundertheprojectwillcarrythenationalbrand

PRIVATE SECTOR LED

TheGovernmentencouragesgreaterparticipationfromtheprivatesectorindrivingthe

developmentofthesehighvalueherbalproductsNKEAinitiativeasanewgrowtharea.

The Government will facilitate and support this project through the set-up of aMalaysianHerbalCouncil.



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PARTICIPATION

Malaysianherbalcompaniesareinvitedtoparticipateinthisnationalprogram.Several

popularMalaysianherbshavebeenidentifiedasthefocus,includingtongkatali,kacip

fatimah,misaikucing,hempedubumianddukunganak.

Thetargetforeachparticipatingcompanyistodevelopandlaunch:

Newnutraceuticalsproductsby2012and2013

Newbotanicaldrugsby2016

Companiesareexpectedtosellproductsoverseasandhenceneedtocomplywiththe

requirementsofforeignregulators.

APPLICATION PROCEDURES

Thefollowingareproceduresthatcompaniesneedtocomplywith:

1. Submitaletterofintent,signedbythecompanymanagementandattachedwith

thecompanyprofile,totheHerbalDevelopmentOffice.

2. Signthenon-disclosureagreement(NDA)withtheHerbalDevelopmentOffice.

3. Submit the company’s business plan (including the brief proposal for R&D

areas) as an appendix and present to the Herbal Development Office for

evaluationandapproval.

4. Onceapproved,signacontractagreementwiththeHerbalDevelopmentOffice.

5. Works on the details of the R&D areas with the chosen COE/s for onward

submissiontotheHerbalDevelopmentOffice.

Companieswishingtoparticipatewillneedtofillinthenecessarydocumentsas

intheapplicationprocedures,andtosatisfyrequirements.



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FAQs

1. What is defined as nutraceutical product and what is a botanical drug?

Nutraceuticals are beneficial foods, currently classified as ‘foods’ and not

‘drugs’.Therefore,anymedicalclaimstoprevent,treatorcurediseasecannotbe made for nutraceutical products. However, both dietary supplements and

functionalfoodsarepermittedtomakehealthclaims.

Source:Nutraceuticals,AGlobalStrategicBusinessReport,GlobalIndustryAnalysts,Inc,March

2008 A botanical drug product consists of plant materials, which may include

vegetables, algae, macroscopic fungi, or combinations thereof, which is

intendedfor use in the diagnosis,cure,mitigation, treatment orpreventionof

diseaseinhumans.

Source:FDA,US

2. Can companies participate in both nutraceuticals and botanical drugs?

Yes,qualifiedcompaniescanparticipateinbothaslongasthecompaniesfulfill

the-requirements.

3. Can companies submit more than one product proposal for nutraceuticals and

/ or botanical drugs?

Yes,butthisissubjecttoapprovalfromtheHerbalDevelopmentOffice.

4. Are the herbs confined to selected few?

Thelistedherbsarethe focusherbs (tongkatali,kacip fatimah,misai kucing,

hempedubumianddukunganak)identifiedforEPP.However,ifcompaniescan

justifyfocusingonherbsoutsidethesefiveinordertogeneratehighreturnsfor

GNI, they are welcome to present these business opportunities in their

proposal.



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5. Can companies choose their own research institutions?

Yes,companiesmayengagewithanyresearchinstitutionsundertheparticular

clusters.

6. Can non-Bionexus companies participate in this program?

Yes, non-Bionexus companies can participate in this programas longas the

companiesfulfillthepre-requirementsoftheevaluationcriteria.

7. What are the procedures or guidelines that companies need to adhere to in

relation to the pre-clinical and clinical compliance by the Ministry of Health?

Companies or individuals interested in venturing into upgrading the value of

theirherbalproductsareadvisedtocomplywiththeguidelinesdeterminedby

theMinistryofHealthMalaysia(MOH),whichwerepreparedaccordingtothe

respective international standards and requirements. These includeproduct’s

manufacturing as in Good Manufacturing Practice (GMP), Good Laboratory

Practices(GLP)forpre-clinicaltoxicology/safetytestingaswellasGoodClinical

Practice(GCP) forclinical trials. Further informationaremade available from

thefollowingwebsites:

i. GMPandGLPpractices:TheNationalPharmaceuticalControlBureau

(BPFK)websitehttp://portal.bpfk.gov.my/

ii. Ethicalapproval:TheNationalInstituteofhealth(NIH),MOHResearchand

EthicalCommittee(MREC),http://nih.gov.my/

iii. GuidelinesforResearchinHerbalMedicineincludingPreclinicalsafetyevaluation:NationalResearchandDevelopmentonHerbalMedicine

Committee(NRDHM)http://www.globinmed.com/

iv. Clinicalevaluationandclinicaltrial:ClinicalResearchCentre(CRC)http://www.crc.gov.my/

http://portal.bpfk.gov.my/



http://nih.gov.my/

http://nih.gov.my/

http://nih.gov.my/

http://www.globinmed.com/



http://www.crc.gov.my/




http://nih.gov.my/




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-------------------------------------------------------------

Address all enquiries and forms to

HeadHerbalDevelopmentOffice

Level10,WismaTani

KementerianPertaniandanIndustriAsasTani

No28,PersiaranPerdana,Presint4

62624Putrajaya

Tel:03-88701000

Faks:03-88886901e-mail:[email protected]/[email protected]

mailto:[email protected]










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GUIDELINES FOR APPLICANTS

ELIGIBILITY CRITERIA

1. EVALUATIONOFCOMPANIES

1.1 COMMERCIALIZATIONCAPABILITYFORNUTRACEUTICALwithCLAIMS

andBOTANICALDRUGS

1.1.1 marketknowledge

1.1.2 regulatoryknowledge

1.1.3 branding

1.1.4

productsdistributionlocallyandinternational1.1.5 manufacturing

1.2 SCIENTIFICANDTECHNOLOGYCAPABILITIES(whereapplicable)

1.2.1 discovery

1.2.2 cropproduction&agronomy

1.2.3 pre-clinicalandclinical

1.2.4

standardization&productdevelopment

1.3 FINANCIALSTRENGTHINCOMERCIALIZINGHERBALPRODUCTS

LOCALLY&OVERSEAS

1.4 PREFERABLYCOMPANIESARETOSOURCETHEIRRAWMATERIALS

ANDEXTRACTIONFACILITIESLOCALLY

1.5 CORPORATESTRENGTHS/PROJECTMANAGEMENT

1.5.1 Allcategoriesofcompaniesmusthaveaminimumof51%equity heldby

Malaysians. Company applicant mustprovide the attested latest Form49

CompaniesAct1965togetherwiththeauditedthreeyearsAnnualReport;

1.5.2 Company entity must have minimum paid-up capital of RM 1 million.

CompanyapplicantmustprovidetheattestedlatestForm24CompaniesAct



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1965,andForms9,24and49CompaniesAct1965shouldbecertifiedby

theCompaniesCommissionofMalaysia(SSM)priortosubmission;

1.5.3 None of the company directors have been convicted for any fraudulent

activities, nor has the company ever been into bankruptcy, liquidation orreceivership.

1.6PROJECT&APPLICATIONDURATION

Themaximumprojectdurationallowedisupto10yearswithgoodperformanceinline

withtheNKEAEPP.Thetargetforparticipatingcompaniesistodevelopandlauncha

minimumof:

Tennutraceuticalsproductsby2012and2013

Fivebotanicaldrugsby2016

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