Medicinal Plant Database for International Trade · Demands of Herbal Medicine Market in Different...

Medicinal Plant Database for Medicinal Plant Database for

International TradeInternational Trade

Assoc.Prof.Dr.Surapote Wongyai

College of Oriental Medicine, Rangsit University

Pratumthani 12000, Thailand

[email protected]

CPhi (Convention on Pharmaceutical Ingredients) South East

Asia 2019

“Research and development on innovative herbal products”

12th March 2019, Queen Sirikit National Convention Center,

Bangkok, Thailand 1

Topics

• Global trends of herbal medicinal products

(HMPs)

• Trade and Regulation of HMPs

• Medicinal plants database for trade

• Suggestion for south east asia

• Conclusion

2

Topic 1

Global trends of herbal medicinal

products (HMPs)

3

WHO's forecast is that the global market for

naturall products:

$3,000 billion by year 2006

$5,000 billion by year 2050

Herbal remedies would become increasingly

relevant as people seek to avail natural

remedies.

Natural Products Trend

55www.strategyr.com/blog/blog-post.asp?bcode=MCP-1081

6

HMPs in Global Market (2017)

Group Value

(b$)

%

Herbal medicine 105.0 61.26

Herbal supplements 51.6 30.11

Phytocosmetics 14.8 8.63

Total 171.4 100.0

7

Herbal Medicine and Supplements

Drives Market Growth

USA

Japan

Canada

8

Globa l Marke t and Re la ted I ssues o f HMPsGloba l Marke t and Re la ted I ssues o f HMPs

HMPs inHMPs in

Global MarketGlobal Market

HERBAL DRUGSHERBAL DRUGS

HERBAL DRUG PREP.HERBAL DRUG PREP.

HERBAL MED. PREP.HERBAL MED. PREP.

HOUSE HOLD REM.HOUSE HOLD REM.

HERBAL BEVERAGEHERBAL BEVERAGE

NUTRACEUTICALSNUTRACEUTICALS

FUNCTIONAL FOODSFUNCTIONAL FOODS

ESSENTIAL OILSESSENTIAL OILS

AROMATIC WATERSAROMATIC WATERS

FLAVOURSFLAVOURS

FRAGANCESFRAGANCES

PERFUMESPERFUMES

EXTRACTSEXTRACTS

PHYTOPHARMACEUTICALSPHYTOPHARMACEUTICALS

MODERN DRUGSMODERN DRUGS

CHEMICALS ANDCHEMICALS AND

INTERMEDIATEINTERMEDIATE

NOVEL STRUCTURESNOVEL STRUCTURES

LEADS FOR NEW DRUGSLEADS FOR NEW DRUGS

METABOLOMICSMETABOLOMICS

PHARMACEUTICAL AIDSPHARMACEUTICAL AIDS

GUMS GUMS

MUCILAGESMUCILAGES

EDIBLE DYESEDIBLE DYES

INSECT REPELLANTSINSECT REPELLANTS

INSECTICIDESINSECTICIDES

PESTICIDESPESTICIDES

Medicinal and Aromatic Plants, MAPs

Topic 2

Trade and Regulation of HMPs

9

Status of Herbal Medicine

AfricaAfrica

EuropeEurope

AustraliaAustralia

AsiaAsia

South AmericaSouth America

North AmericaNorth America

Global Look of Herbal Medicine

Global Pharmaceutical Market, 2013 - 2017

1200 billion $

$105 billion(8.75%)

Herbal market

In terms of geography, the global herbal medicines market is divided among:

5% 10% 15%

Germany (28%)

Asia (19%)

Japan (17%)

France (13%)

Rest of Europe (12%)

North America (11%)

20% 25% 30%

2013

EU market covers 53%

Demands of Herbal Medicine Marketin Different Region

B JN, Shankar MB. Global market analysis of herbal drug formulations Int J Ayu Pharm Chem 2015:4 (1): 59-65.

Markets Projected Demand (for 2015)

Europe US$ 70 Billion (50%)

North America US$ 25 Billion (17.86%)

China US$ 12 Billion (8.57%)

India US$ 3 Billion (2.14%)

Others US$ 30 Billion (21.43%)

Total US$ 140 Billion (100%)

Thailand US$ 0.29 Billion in 2014 (0.21%)

(2010, 1.82% of pharmaceutical

market in Government Hospital)

2015

CHINA + INDIA = > 25% Total World Exports Value

15

www.strategyr.com/blog/blog-post.asp?bcode=MCP-1081

Europe

• Most elaborated and established regulation of

production and marketing of Herbal Medicinal

Products (HMPs)

• HMPs are classified as drugs

• HMPWG with in European Medicines Agency

(EMEA)

• Efforts to harmonize HMP in member states (MS)

• Over 180 elaborated monographs in EP

• Germany the leader

Asia

• Tremendous strength but weak

standards

• Strong traditions, Government

support and most variants

• From most developed and

elaborated to typical tribal use

North America

Canada• Herbal preparations are either classified as a drug or a food

under the federal Food and Drug Act

• Natural Health Products Directorate (NHPD) published by 2002.

• When implemented, all herb products will require the issuance of a product license

• Monographs will control the therapeutic claims

USA• Botanicals, dietary supplements controlled by DSHEA

• Drugs or supplement depending upon claim

• Inclusion of monographs in USP

• Office of Alternative Medicine, OAM (1992), now National Center for Complimentary and Alternative Medicine, NCCAM (1998) under NIH

United States Pharmacopoeia (USP)

Herbal Medicine Compendium

20

HMC-East Asia Expert Panel

https://hmc.usp.org/

Australia

• Near monopoly to allopathic physicians

• Drugs are governed by TG Act of 1998

• TG Administration (TGA) is responsible for

implementation of the act

• Office of complimentary medicines within TGA

• Complimentary Medicines Evaluation

Committee of experts for advisory affairs

South America

• Vast resources, few regulations

• TM are common but no regulations and standards

• Homeopathy

Africa

• Use of MAPs is very

popular

• No regulations and

standards for TM

• TMPs associations,

registration & training

programs exist in some

countries

24

PRESENTATION AND CONTENT OF THE REGISTRATION DOSSIER

MODULE 1

REGIONAL

ADMINISTRATIVE

INFORMATION

1.0

CTD TABLE OF CONTENTS

2.1

CTD INTRODUCTION

2.2

NON CLINICAL

OVERVIEW

2.4

CLINICAL

OVERVIEW

2.5

NONCLINICAL

SUMMARIES

2.6

CLINICAL

SUMMARY

2.7

QUALITY

OVERALL

SUMMARY

2.3

MODULE 3

QUALITY

3.0

MODULE 4

NONCLINICAL

STUDY REPORTS

4.0

MODULE 5

CLINICAL

STUDY REPORTS

5.0

DIAGRAMMATIC

REPRESENTATION

OF THE ORGANIZATION OF THE

CTD

MODULE 2

NOT PART OF THE CTD

CTD

COMMON TECHNICAL DOCUMENT

(CTD)

25

WHO traditional medicine strategy: 2014-2023.World Health Organization 2013, Geneva.

WHO Traditional Medicine Strategy

New Era of Traditional Medicine (TM)…2019 – new option for good health

Promotion, Utilization

& Enlarge Scale of

Production-raw materials, extracts

-products

Traditional Medicine in Asia-theory and principle, well documented

-authentication based on clinical practices in

modern time by TM doctors in conjunction

with modern medicine assessment

-selected practices and TM formulations for

further R & D

Academic Medicine-evidence based

-mono agent and target concept-rational approach

Alternative Medicine-experience based

-multi agent and target effects-no rational concept required

Standardization

2727

USA

20167.44 b$

Increase

7.7% 2015-2016

Herbalgram

115(2017)56-65.

2828

ขมิ้นชัน (Turmeric) ว่านหางจระเข้ (Aloe) น้้ามันมะพร้าว (Coconut Oil)

กระเทียม (Garlic)ส้มแขก (Garcinia)

หญ้าหวาน (Stevia)

อบเชย (Cinnamon)ขิง (Ginger)

1 4 13

14 19 32

3940

$47,654,008 (growth 32%)

2929

อิคินาเซีย (Echinacea) โสมจักรพรรดิ (Burdock, Gobo)

ใบมะกอก (Olive Leaf ) โสมอินเดีย (Ashwagandha)

9 35

28 8

$8,732,489 (growth 55.2%)

3030

( stress, male reprod.)

(Omega-3 fatty acids)

(constipation, IBS)

(decrease risk of prostate cancer)

(BPH, Prostate gland)

(hepatoprotective)

(UTI-E. coli, H. typhi)

(E. coli, P. aeruginosa)

(Detox, antioxidant)

(Anti-inflammation, Antioxidant)

(Obesity)

(Memory)

(Cholesterol)

(Anxiety)

(Medium chain fatty acid)

3131

(diabetes, loss of appetite)

(natural source of vitamins and Zn)

(Detox)

(Stress, Fatique)

(heart and blood vessels)

(Detox, Ca sources)(Decrease sugar level)

(Antiinflam., Nausea)

(beauty benefits)

(beauty benefits, HS)

(Anti-inflammation, Antioxidant)

(Sweetener)

(Anxiety)

(Hot flush)

32

USA 20167.44 b$,

Increase 7.7% 2015-2016

www.herbalgram.org

Retail Sales of Herbal Supplements in US

Increase by 8.5% in 2017, Topping $8

Billion

USA 20178.0 b$,

Increase 8.5% 2016-2017

US Herbal Supplements

Topic 3

Medicinal plants database for trade

33

Medicinal Plants Database for International Trade

A.General information

B.Scientific information

Medicinal Plants Database for Trade

A. General information:

1. Botanical name with authority and synonyms Family

2. Common characters and picture of plant and plant

part used

3. Common names in trade (local and foreign language)

4. HS code (Harmonized Commodity Description and

Coding System)

5. Use

6. Volume of production in the country

7. Volume of domestic consumption

8. Volume of export



• Average price

• Trade points and contact addresses in the country:

market, industry, association, cooperative, etc.

• Nature of plant material: wild, cultivated, organic

• Areas of production in the country

• Nature of plant products: crude, semi-processed and

processed

• Any special regulations pertaining to trade and web

links to enforcing agencies



• Cultivation including organic farming

• Pre- and post-harvest treatment

• Conservation Production of extracts: "ABI" (Active

botanical ingredient)

• Production of phyto-pharmaceuticals

• Production of herbal drugs


B. Scientific information:

1. Ethno-botanical information

2. Pharmacological studies

3. Quality control including chromatographic fingerprint

profiling

4. Chemical information including known chemo-types

5. DNA finger-printing

6. Safety data

7. Contraindications

8. Interactions with other drugs


B. Scientific information:

9. Dosage

10. Clinical trials

11. Registration status

12. People and projects and contact addresses

13. Monographs

14. Patents

15. Important publications

MEDICINAL PLANTS MONOGRAPHS ON DISEASES OF MEDICINAL PLANTS MONOGRAPHS ON DISEASES OF

PUBLIC HEALTH IMPORTANCEPUBLIC HEALTH IMPORTANCE

INTEGRATION OF KNOWLEDGE LEADSINTEGRATION OF KNOWLEDGE LEADS

MONOGRAPHS

MULTIDISCIPLINARY

RESEARCH DATADRUGSDISEASE

• PREVALENCE

• ETIOPATHOGENESIS

• SYMPTOMATOLOGY

• DIAGNOSIS

• PRINCIPLES OF TREATMENT/MANAGEMENT

• COMPLICATION IF

UNTREATED

• PROGNOSIS

• PRESENT STATUS &

LIMITATION

TRADILIONAL

MEDICINE

(TM)

DESCRIPTION

• PHARMACOLOGY

• TOXICOLOGY

• CLINICAL

• CHEMICAL

• PHARMACOGNOSY

• REFERENCES

• PHOTOGRAPHS

• INVESTIGATED, NOT MENTIONED IN TM

• MENTIONED IN TM - NOT INVESTIGATED

• FOLK LORE/ETHNOBOTANICAL TEXTS

Source Classification

CosIng lists numerous essential oils, although

CosIng: European Commission database with

these oils are not exclusively used in

aromatherapy. Essential oils for aromatherapy

information on the International Nomenclature

include:

of Cosmetic Ingredients (INCI) cosmetic

• Lavandula angustifolia herb oil (lavender)

substances and ingredients

• Pelargonium graveolens oil (rose geranium)

• Boswellia carterii gum oil (frankincense)

• 84776-65-8 (Lavender oil)

Chemical Abstract Service (CAS) Registry• 90082-51-2 and 8000-46-2 (Rose geranium oil)

Numbers• 89957-98-2 (Frankincense oil)

• 84787-70-2 and 8024-35-9 ( Sandalwood oil)

Classification of various essential oils for aromatherapy. These codes and

ingredient names are used to identify a product in documentation (as

listed in CosIng and with a CAS number) or in trade (through Harmonised

System codes, HS codes).

Sources Classification

Harmonised System codes

(trade), HS codes

Essential oils:

• 3301.12 – Sweet and bitter orange

• 3301.13 – Lemon

• 3301.19 – Citrus fruit oils not elsewhere

specified

• 3301.24 – Peppermint

• 3301.25 – Other mint oils

• 3301.29 – Other essential oils

• 3301.30 – Resinoids

• 3301.90 – Oleoresins

HS Codes of Essential Oils in Trade

Essential Oil Profile

Material Safety Data Sheet

Specification Requriments

43

Name of Oil

-Botanical

-Common

-Vendor

Extraction

-Method of Extraction

-Part of Plant Used

Safety Considerations Specific to This Oil

Significant properties

-Significant Chemical Constituents

-Actions


44

Application

-Method of Application

-Dosage

Smell

-Describe

-Combines with?


45

Phytochemistry and Standards

EO composition standards are described by a number of

bodies such as:

International Standards Organisation for Standardisation (ISO)

Research Institute for Fragrance Materials

International Fragrance Association

Association Francaise de Normalisation (AFNOR)

British Pharmacopoeia

The ISO and AFNOR standards are often accepted as

being the most reliable indicators of EO quality and

differentiate between the different grades of Eos.

46

Essential Oil–Medicine Interactions

It is difficult to determine the interaction between

conventional herbal medicine and essential oil. Only very

small amounts of EOs are absorbed from topical

applications, which makes interactions unlikely; however,

topical application of both the EO and the medicine to

the same area may enhance the absorption of medicine.

The potential for interactions increases with internal use

(see Table 1).

47


Essential oil Potential interaction/combined effect

Ylang ylang Increases dermal absorption of 5-fluorouracil

Eucalyptus globulus Enhances effects of streptomycin, isoniazid

Increases nicotine absorption

Roman chamomile Reduces the effects of phenobarbital when

administered subcutaneously (in rats) and inhaled.

Eucalyptol Reduces the effects of phenobarbital when

administered subcutaneously

(in rats) and inhaled.

Roman chamomile Products containing silver salts used in burns and

wound care.

Clove, fennel, coriander,

aniseed and EOs containing

cinnamaldehyde, trans-

anethole, estragole and

eugenol

Deplete liver glutathione in the presence of large doses

of paracetamol

Niaouli, ravensara, sweet

marjoram, geranium and oils

rich in terpineol

Increases absorption of topical prednisolone

48


Essenti al oil Potential interaction/combined effect

Limonene occurs in many EOs Increases absorption of indomethacin

Cedar wood Reduces effect of barbiturates,

May increase the risk of coagulation by reducing the

effectiveness of anti coagulants

Peppermint Affects 5-fluorouracil cancer treatment

Myristi cin (nutmeg) Inhibits monoamine oxidase inhibitor action

β-Asarone and d-pulegone Potentiate the toxic effect of medicines by depleting

liver P450 enzyme system

Eugenol, menthol, oil of

wintergreen and possibly white

birch especially if repeated

applicati ons are used during

the day.

Increases anti coagulant activity of anti coagulants and

aspirin, therefore, increases bleeding risk. When

applied in massage the force of the massage rather

than the essential oils may represent a risk of bruising

and bleeding.

Valerian Central nervous system depressant prolongs effects

and increases

the risk of prolonged sleep, drowsiness and falls. 49


Essenti al oil Potential interaction/combined effect

Primrose oil Interacts with promethazines, for example

chlorpromazine is

used to manage schizophrenia and can induce

seizures.

50

Conservation and Sustainable use for Health, Food

and Environment Security

Conservation and Sustainable use of Biological

diversity is of critical importance for meeting the

food, health and other needs of the growing

world population, for which purpose access to

and sharing of both genetic resources and

technologies are essential.

“UN Convention on

Biological diversity”

Material Safety Data Sheets

52

Analytical information is compiled into material safety data

sheets (MDSs), which can be obtained from reputable

EO suppliers. More recently, researchers have begun to

investigate the peroxide value (POV) (an indicator of

oxidation) of EOs and fixed vegetable oil carrier oils.

POV is an indicator of the possibility an EO could cause

skin irritation or sensitivity

Material Safety Data Sheets

Section I : Product Identification

Section II : Physical Data

Section III : Fire, Explosion and Reactivity

Section IV : Protection Information

Section V : Occupational Exposure Limit

Section VI : Health Hazard Information

Section VII : Emergency and First Aid Information

Section VIII: Spills, Leaks and Disposal Procedures

Section IX : Handling and Shipping Procedures

53

Topic 4

Suggestion for south east asia

54

MAPs - Global issues

• Standardization and quality control

• Cultivation and conservation

• Safety & efficacy assessment

• Trade regulation and harmonization

• Genuine interest to explore their potential

• Enlightenment of medical professionals to TM

• Public faith and medical bias: check

REGULATORY ISSUES

GOVT. POLICY/PLANS

ETHICAL CONSIDERATIONS

GGP, GHP, GMP, GLP, GCP

SAFETY ISSUES

STABILITY ISSUES CONTRAINDICATIONS

DRUG INTERACTIONS

REGISTRATION ISSUES

BIODIVERSITY ISSUES

SUSTAINABILITY

I.P.R. ISSUES

TRADE AND MARKETING

CONSUMPTION DATA

PRODUCTION DATA

R&D INVESTMENTS

TECHNOLOGICAL GAPS

LACK OF INFORMATION

NETWORK

MAPs Issues

HERBAL PRODUCTS

STANDARDIZATION

A CHALLENGE

VOLUME OF WORK

INVOLVED

1000 SINGLE PLANTS

635 FORMULATIONS

FLOODING OF

PROPRIETORY

PREPARATIONS

ABSENCE OF

RESEARCH DATA LACK OF INITIATIVES

BY MANUFACTURERS

COMPLEXITY AND INCONSISTANCY OF

FORMULATIONS

Regulatory

Aspects

Main Dependence on

Wild Sources Herbal

Pharmacopoeia?

Adulteration and

Substitution Constraints in

Quality Control

Lack of Public

Test – houses

No Certification of

Raw Material

Lack of safety

evaluation facility

Pharmacovigilance data

not collectedLack of Trained

Manpower

Poor investment in

R&D of Med. Plant

products

Constraints

“SWOT” ANALYSIS OF TRADE IN MAPS

IN SEA & PACIFIC REGIONS

Covers all agroclimatic zones, genetic and landscape diversity Land availability, both Farm as well as non-farm lands Traditional knowledge-long, well recognized, documented Low cost of labour, raw material, other inputs, trained manpower Good institutional infrastructure for R&D.

Lack of brand equity Lack of well developed, transparent market mechanism within the regions –

distribution and trade channels Lack of market intelligence, infrastructure for information collection Inadequate linkages between cultivators, collectors, users, institutional

buyers Inadequate incentives for cultivation of MAPs Poor facilities for value addition/processing Need to follow guidelines (WHO) for standardization, Q.C., process etc. Packaging standards not of international norms Govt support not in parity with other exportable crops Cost of cultivation of MAPs much higher than prices of collected plants

STRENGTHS

WEAKNESSES

OPPORTUNITIES

Global interest in NATURALS: Drugs, Dyes, Nutraceuticals, Cosmetics,

fragrances

MAPs – a focus at policy making level of Govts, large corporate houses,

financial institutions and donors

Business environment increasingly integrating global economy

South, SEA and Pacific region national is itself a huge market

Recognition of MAPs as income generating/poverty alleviation opportunities

Increasing demand for organically produced MAPs and broad use of MAPs

THREATS

Over exploitation of scarce resources

Unequal sharing of benefits for cultivators/collectors – thus increasing

chances of unsustainable collection is disincentive for cultivation of MAPs

Adulteration and other unethical practices by middle men resulting in

negative brand equity

Absence of traceability

Fluctuating prices of MAPs at commodity level

Stringent regularity environment in some large global markets

The pharmaceutical industry

AUTHENTICATIONAUTHENTICATION

TAXON. IDENTIFICATIONTAXON. IDENTIFICATION

ADULTERATIONADULTERATION

SUBSTITUTIONSUBSTITUTION

REGIONAL NAMESREGIONAL NAMES

QUALITY CONTROLQUALITY CONTROL

FOREIGN MATTERFOREIGN MATTER

ASH CONTENTASH CONTENT

EXTRACTIVE VALUESEXTRACTIVE VALUES

MICROBIAL LOADMICROBIAL LOAD

HEAVY METALSHEAVY METALS

PESTICIDE RESIDUEPESTICIDE RESIDUE

INDISCRIMINATE COLLECTIONINDISCRIMINATE COLLECTION

GATHERING PRACTICESGATHERING PRACTICES

MAPs PROBLEMS

CULTIVATIONCULTIVATION

AGROPRACTICESAGROPRACTICES

HARVESTING PRACTICESHARVESTING PRACTICES

DRYING PROCESSESDRYING PROCESSES

PULVERIZING PROCESSESPULVERIZING PROCESSES

STORAGE PRACTICESSTORAGE PRACTICES

PACKAGINGPACKAGING

INCONSISTENCYINCONSISTENCY

ECOTYPICECOTYPIC

CHEMOTYPICCHEMOTYPIC

GENOTYPICGENOTYPIC

DIURNAL DIURNAL

ONTOGENETICONTOGENETIC

MAPs TECHNOLOGIESMAPs TECHNOLOGIES

INFORMATION TECHNOLOGY

AGROTECHNOLOGY

POST-HARVEST TECHNOLOGY

GRINDING AND PULVERIZING TECHNOLOGY

EXTRACTION TECHNOLOGIES

SEPARATION AND ISOLATION TECHNIQUES

FORMULATION TECHNOLOGIES

PACKAGING AND LABELLING TECHNOLOGIES

BIOEVALUATION TECHNIQUES

DRUG DESIGN AND MOLECULAR MODELING TECHNIQUE

ANALYTICAL AND QUANTITATIVE TECHNIQUES

CHROMATOGRAPHIC TECHNIQUES

SPECTROSCOPIC TECHNIQUES

BUSINESS STRATEGY: HERBAL EXTRACTS

Focus on high market share and market value segments

Ensure availability of quality raw material, prefer organically

grown plants following GAP, GHP as per WHO norms

Adopt suitably advanced economical extraction technology

Produce extracts meeting international requirements of quality

Build-up repository of reference marker compounds

Develop qualitative and quantitative assay procedures

Develop well-resolved chromatographic finger print profile

Use GMP approved premises for production

Develop national and international markets

Topic 5

Conclusion

64

Opportunities for Developing and

Emerging Countries

• Rich bioresources and TM knowledge

• Capacity to control raw material production

• Benefit from the emerging demand

• Needs to improve quality of TM

• Conserve and introduce cultivations

• Incorporate use of TM in primary health care

• Medicinal plants big database for trade

Thank you

Medicinal Plant Database for International Trade · Demands of Herbal Medicine Market in Different...

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