INDONESIAN COUNTRY REPORT INDONESIAN COUNTRY REPORT ON TRADITIONAL MEDICINEON TRADITIONAL MEDICINE

M. Hanafi, A. Darmawan, H. Kresnadi, T. Basuki, N. Artanti, I.D. Dewiyanti, M. Hanafi, A. Darmawan, H. Kresnadi, T. Basuki, N. Artanti, I.D. Dewiyanti, Leonardus B. S. KardonoLeonardus B. S. Kardono

Research Center for Chemistry -Indonesian Institute of Sciences

(RCChem-LIPI)

• The traditional herbal system of medicine has been used since ancient times

• Most of the developing countries and in particular those situated in the tropical belt such as Indonesia constitute richest store house of medicinal plants

• Only a few of these countries have been able to organize proper system of research and development for exploitation, conservation or industrial use of these plants.

• The indiscriminate export and exploitation by private traders of valuable raw materials also creates ecological imbalance

• Indonesian government has in view of its importance, identified medicinal plants as a priority area of the country’s program.

TRADITIONAL MEDICINES

INTRODUCTIONINTRODUCTION

Indonesia is known as a country with a megadiversity of biological species

as well as the megacenter for world biodiversity

Indonesia possess:Indonesia possess: 10%10% of world’s of world’s flowering plant speciesflowering plant species 12% of world’s mammal species12% of world’s mammal species 16% of world’s reptile and amphibian species16% of world’s reptile and amphibian species 17% of world’s bird species17% of world’s bird species 25% of world’s fish species25% of world’s fish species 15% of world’s insect species15% of world’s insect species

Almost 30,000 plants of herbal medicinal Almost 30,000 plants of herbal medicinal Appr. 7,000 species known and have beenAppr. 7,000 species known and have been used for medical purposesused for medical purposes About 250 species used in the traditionalAbout 250 species used in the traditional herbal medicine, herbal medicine, JamuJamu, industries, industries In 2003 a total of 9,737 items of herbal medicines has In 2003 a total of 9,737 items of herbal medicines has

been registered, which include 1,093 items imported been registered, which include 1,093 items imported productsproducts

Indonesia forest and marine content a huge of biodiversity:

Trend of Herbal Medicines in Trend of Herbal Medicines in IndonesiaIndonesia

YearYear Modern Modern MedicinesMedicines

US $ (billion)US $ (billion)

Herbal Herbal MedicinesMedicines

US $ (billionUS $ (billion

Contribution Contribution Herbal Med.Herbal Med.

%%

20032003 17.017.0 2.02.0 10.510.5

20052005 21.321.3 2.92.9 12.012.0

2010 2010 EstEst

37.337.3 7.27.2 16.016.0

Source: BPPT 2005

By trial-and-error for centuries, Indonesian people have learned how to distinguish useful plants with beneficial effects from those which were toxic or non-active, and which plant combinations or plant processing methods had to be used to gain optimal results.

Jamu SidoMuncul Products

Indonesian herbal medicines are used Indonesian herbal medicines are used based on empirical practice: diseases based on empirical practice: diseases preventive (48.9%), health promotion (22.47 preventive (48.9%), health promotion (22.47 %), diseases curative (21.78%) and the rests %), diseases curative (21.78%) and the rests are for cosmeticsare for cosmetics

•According to Indonesian Medical Association According to Indonesian Medical Association (IDI) statements, herbal medicines will be (IDI) statements, herbal medicines will be

accepted formally by the conventional (Western) accepted formally by the conventional (Western) medical doctors if its safety and efficacy has medical doctors if its safety and efficacy has

been proved scientifically (current trend been proved scientifically (current trend application, especially for degenerative application, especially for degenerative

diseases, certain viral infection, and cancer).diseases, certain viral infection, and cancer).

The National Agency for Food and Drug Control The National Agency for Food and Drug Control Program on Natural Products Drug Development:Program on Natural Products Drug Development:

• Assurance on Quality-Safety-Efficacy, Assurance on Quality-Safety-Efficacy,

• Supply-Demand Balance, Supply-Demand Balance,

• Sustainable Development of Upstream, Sustainable Development of Upstream, Intermediate and Downstream Industries, Intermediate and Downstream Industries,

• Market Development which includes Health Care Market Development which includes Health Care Services Services

• Research Research

Classification of Herbal Products in IndonesiaClassification of Herbal Products in IndonesiaNational Agency of Drug and Food Control, Indonesia:National Agency of Drug and Food Control, Indonesia:

SK Ka Badan POM – RI No HK. 00.05.4.2411SK Ka Badan POM – RI No HK. 00.05.4.2411

1.1.TraditionalTraditional medicinemedicine

2. Standardized 2. Standardized Herbal Products Herbal Products

3. Phytopharmaceuticals3. Phytopharmaceuticals

Level of Data in the Level of Data in the Experimental, preclinical, and Experimental, preclinical, and

clinical Evaluationclinical Evaluation

Standard And RegulationStandard And Regulation

The categories based on their The categories based on their processing development:processing development:

Herbal product falls into traditional Herbal product falls into traditional medicinemedicine ( (jamujamu) ) when the when the process is process is simple and toxicity evaluation is simple and toxicity evaluation is recommended (not compulsory)recommended (not compulsory). .

Standardized extract preparationStandardized extract preparation when when the the process is more complexprocess is more complex than than jamujamu, , has been controlled chemically, and has a has been controlled chemically, and has a preclinical (toxicology, pharmacology) preclinical (toxicology, pharmacology) evaluationevaluation. .

PhytopharmaceuticalPhytopharmaceutical when it has a when it has a complex process, preclinical and clinical complex process, preclinical and clinical evaluation for safety and efficacy insurance evaluation for safety and efficacy insurance is a mustis a must

Other Regulation related to traditional Other Regulation related to traditional medicine in Indonesia:medicine in Indonesia:

SK Ka Badan POM – RI No HSK Ka Badan POM – RI No HK.00.05.41.1384 About traditional medicine registration

PERATURAN MENTERI KESEHATAN REPUBLIK INDONESIA Nomor: 246/Menkes/Per/V/1990 About Permits for Traditonal medicine industry and

traditional medicine registration

SK Ka Badan POM – RI No SK Ka Badan POM – RI No HK.00.05.4.1380 About Guideline for good manufacturing practice for

traditional medicine

Etc.Etc.

Research and Systematization of Research and Systematization of Indonesian Traditional MedicinesIndonesian Traditional Medicines

Modern research on Indonesian herbal medicines included as a Modern research on Indonesian herbal medicines included as a necessary necessary prerequisiteprerequisite, the , the comprehensive understandingcomprehensive understanding of their : of their :

Many research institutions such as, Universities, Indonesian Institute of Sciences, Many research institutions such as, Universities, Indonesian Institute of Sciences, National Agency for Drug and Food Control , etc. have been actively conducting National Agency for Drug and Food Control , etc. have been actively conducting research based on Indonesian traditional medicine as well as conducting scientific research based on Indonesian traditional medicine as well as conducting scientific meeting and research collaboration among research institutions in Indonesia and meeting and research collaboration among research institutions in Indonesia and overseas and also with traditional medicine industries. overseas and also with traditional medicine industries.

This knowledge paved the way for the publication of several hard copies either This knowledge paved the way for the publication of several hard copies either from Directorate General of Food and Drug Control, or National agency for Food from Directorate General of Food and Drug Control, or National agency for Food and Drug Control, and Drug Control, ProseaProsea (Plant Resources of South East Asia), Indonesian (Plant Resources of South East Asia), Indonesian Institute of SciencesInstitute of Sciences

All of these efforts are All of these efforts are dedicated to the development of Indonesian medicinal dedicated to the development of Indonesian medicinal plantsplants to be able to compete globally to be able to compete globally

International requirements such as on International requirements such as on GMP, GAP, GLP, ICH-GCPGMP, GAP, GLP, ICH-GCP (The International (The International Conference on Harmonization-Good Clinical Practice), Conference on Harmonization-Good Clinical Practice), Research Guidelines for Evaluating Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, HACCPthe Safety and Efficacy of Herbal Medicines, HACCP, etc., should be followed , etc., should be followed

• Origin, • Distribution, • Resources, • Therapeutic usage,• Process, • Quality, • Safety, • Efficacy

> 300 sp.

Stelecocarphus burahol

Indonesian Journals

Nine medicinal plants of first priority for Nine medicinal plants of first priority for phytopharmaceuticals phytopharmaceuticals

No.No. PlantPlant Medicinal UsesMedicinal Uses Bio-markerBio-marker

11

Psidium guajavaPsidium guajava

Leaves: Leaves: immunomodulatorimmunomodulator

AstringentAstringent

Traditional, Most Traditional, Most famous famous

preparation for preparation for dengue treatmentdengue treatment

22

Morinda citrifoliaMorinda citrifolia

Fruit: Anti-Fruit: Anti-hypertensionhypertension

Leaves: Leaves: Antidiabetic Antidiabetic

MorindoneMorindone

O

O

OH

OH

O

O

OH

HO

OGlc(1-6)-Glc

Morindin

OH

O

ORha

HO

OH O

OH

Quercitrin

No.No. PlantPlant Medicinal Medicinal UsesUses Bio-markerBio-marker

33

Sizygium Sizygium polyanthumpolyanthum

Leaves: Leaves: AntidiabeticAntidiabetic

44

Guazuma ulmifoliaGuazuma ulmifolia

Leaves: Leaves: AntiobesityAntiobesity

Catechin and FriedelinCatechin and Friedelin

55

Zingiber officinaleZingiber officinale

Rhizomes: Rhizomes: CarminativeCarminative

StomachicStomachic

StimulantsStimulants

GingerolGingerol

(CH2)nCH3

MeO

HO

O OH

OH

OH

HO O

OH

OH

OH

O

ORha

HO

OH O

OH

Quercitrin

No.No. PlantPlant Medicinal UsesMedicinal Uses Bio-markerBio-marker

66

Curcuma domesticaCurcuma domestica

Rhizomes: Rhizomes: AntilipedemicAntilipedemic

Anti-bacteria, Anti-bacteria, cholagogumcholagogum

Immuno- Immuno- stimulantsstimulants

CurcuminoidCurcuminoid

77

Curcuma xanthorrhizaCurcuma xanthorrhiza

Rhizomes: Rhizomes: HepatoprotectHepatoprotector, Choleretic, or, Choleretic, antiinflammatiantiinflammati

onon

Curcuminoid, Curcuminoid,

XanthorhizolXanthorhizol

88

Andrographis paniculataAndrographis paniculata

Leaves: Leaves: Antipyretic, Antipyretic, anti-ulcer, anti-ulcer,

antidiabeticantidiabetic

Andrographolide (1), Andrographolide (1),

Neoandrographolide(2)Neoandrographolide(2)

O O

OMe

OH

MeO

HO

O

OH

O

OH

OH

(1)

O

O O

O

HO

HO OH

OH

(2)

OH

O O

OMe

OH

MeO

HO

No.No. PlantPlant Medicinal Medicinal UsesUses Bio-markerBio-marker

99

Centella asiaticaCentella asiatica

Aerial Aerial part:part:

VasodilatoVasodilator,r,

Immuno-Immuno-stimulantsstimulants

Asiaticoside and MadecasolAsiaticoside and Madecasol

O

OH

HO

HO

O

O

HO

OH

HO

O

O

HO OH

OH

O

O

OH

OH

HO

Development of Process Technology for Industrial Development of Process Technology for Industrial Uses of Medicinal PlantsUses of Medicinal Plants

♪ The medicines for internal use prepared in the traditional manner involve simple methods, such as:

♪ The range of products that could be obtained from medicinal plants

• Hot and cold water extraction,

• Expression of juice after crushing,

• Powdered of dried material,

• Formulation of powder into pastes via such a vehicle as water, oil or honey, and even fermentation after adding a sugar source

Growth of Herbal Medicine Growth of Herbal Medicine Manufacturers in IndonesiaManufacturers in Indonesia

2001 2002 20032001 2002 2003

Small scale ind. 903 933 938Small scale ind. 903 933 938

Big scale ind. 113 139 149Big scale ind. 113 139 149

Source: NDA, 2004Source: NDA, 2004

Big Scale Ind. : Jamu Sidomuncul, Jago,Air Mancur, Borobudur, Nyonya Meneer,

Kimia Farma, Kalbe Farma, Dexa, Soho, etc

Intelectual Property Intelectual Property Right Protection Right Protection

Convention on Biological DiversityConvention on Biological Diversity(CBD)(CBD)

Signed in 1992.Signed in 1992. Indonesia ratified it through Law No Indonesia ratified it through Law No

5/1994.5/1994. States have States have sovereign rightssovereign rights over their over their

own biological resources.own biological resources. States are responsible for States are responsible for conservingconserving their their

biological diversity and for using their biological diversity and for using their biological resources in a sustainable biological resources in a sustainable manner.manner.

LIPI

CBDCBD

Article 8 j : Tradisional KnowledgeArticle 8 j : Tradisional KnowledgeSubject to its national legislation, respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and sustainable use of biological diversity and promote their wider application with the approval and involvement of the holders of such knowledge, innovations and practices and encourage the equitable sharing of the benefits arising from the utilization of such knowledge, innovations and practices;

LIPI

RELATED LAWS AND RULESRELATED LAWS AND RULES

Law No. 5/1990 regarding Conservation of Natural Law No. 5/1990 regarding Conservation of Natural Resources and Its Ecosystems.Resources and Its Ecosystems.

Law No.5/1994 regarding the Ratification of the Law No.5/1994 regarding the Ratification of the United Nations Convention on Biological DiversityUnited Nations Convention on Biological Diversity

Law No. 7/1994 regarding the Ratification of TRIPs.Law No. 7/1994 regarding the Ratification of TRIPs. Law No. 18/2002 regarding National System on Law No. 18/2002 regarding National System on

Research, Development, and Application of Science Research, Development, and Application of Science and Technology.and Technology.

All Indonesian IPR Laws.All Indonesian IPR Laws.

LIPI

CONCLUSIONCONCLUSION

Indonesia is a rich country biodiversity and traditional Indonesia is a rich country biodiversity and traditional knowledge including the trational medicine. knowledge including the trational medicine. However, in the global era, the richness of However, in the global era, the richness of biodiversity is not the determining factor for biodiversity is not the determining factor for prosperity of the people. Knowledge how to develop prosperity of the people. Knowledge how to develop its biodiversity and traditional knowledge is its biodiversity and traditional knowledge is important. The key factor is how Indonesia ability to important. The key factor is how Indonesia ability to convert knowledge into wealth and social good convert knowledge into wealth and social good through the process of innovation. It is a must for through the process of innovation. It is a must for Indonesia to work collaboratively also with other Indonesia to work collaboratively also with other contries in traditional medicine improvement. contries in traditional medicine improvement.

Thank you.