Transcript Hanafi Indonesia

INDONESIAN COUNTRY REPORT
ON TRADITIONAL MEDICINE
M. Hanafi, A. Darmawan, H. Kresnadi, T. Basuki, N. Artanti, I.D. Dewiyanti,
Leonardus B. S. Kardono
Research Center for Chemistry
-Indonesian Institute of Sciences
(RCChem-LIPI)
INTRODUCTION
TRADITIONAL MEDICINES
• 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.
Indonesia is known as a country with
a megadiversity of biological species
as well as the megacenter for world biodiversity
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Indonesia possess:
10% of world’s flowering plant species
12% of world’s mammal species
16% of world’s reptile and amphibian species
17% of world’s bird species
25% of world’s fish species
15% of world’s insect species
Indonesia forest and marine content
a huge of biodiversity:
Almost 30,000 plants of herbal medicinal
Appr. 7,000 species known and have been
used for medical purposes
About 250 species used in the traditional
herbal medicine, Jamu, industries
In 2003 a total of 9,737 items of herbal medicines has
been registered, which include 1,093 items imported
products
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Trend of Herbal Medicines in
Indonesia
Year
2003
Modern
Medicines
US $ (billion)
17.0
Herbal
Medicines
US $ (billion
2.0
Contribution
Herbal Med.
%
10.5
2005
21.3
2.9
12.0
2010
Est
37.3
7.2
16.0
Source: BPPT 2005
Jamu SidoMuncul Products
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.
Indonesian herbal medicines are used
based on empirical practice: diseases
preventive (48.9%), health promotion (22.47
%), diseases curative (21.78%) and the rests
are for cosmetics
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•According to Indonesian Medical Association
(IDI) statements, herbal medicines will be
accepted formally by the conventional (Western)
medical doctors if its safety and efficacy has
been proved scientifically (current trend
application, especially for degenerative
diseases, certain viral infection, and cancer).
The National Agency for Food and Drug Control
Program on Natural Products Drug Development:
•
Assurance on Quality-Safety-Efficacy,
•
Supply-Demand Balance,
•
Sustainable Development of Upstream,
Intermediate and Downstream Industries,
•
Market Development which includes Health Care
Services
•
Research
Standard And Regulation
Classification of Herbal Products in Indonesia
National Agency of Drug and Food Control, Indonesia:
SK Ka Badan POM – RI No HK. 00.05.4.2411
1. Traditional medicine
2. Standardized
Herbal Products
3. Phytopharmaceuticals
Level of Data in the Experimental,
preclinical, and clinical Evaluation
The categories based on their processing
development:
Herbal product falls into traditional medicine
(jamu) when the process is simple and toxicity
evaluation is recommended (not compulsory).
Standardized extract preparation when the
process is more complex than jamu, has been
controlled chemically, and has a preclinical
(toxicology, pharmacology) evaluation.
Phytopharmaceutical when it has a complex
process, preclinical and clinical evaluation for
safety and efficacy insurance is a must
Other Regulation related to traditional
medicine in Indonesia:
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SK Ka Badan POM – RI No HK.00.05.41.1384
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PERATURAN MENTERI KESEHATAN REPUBLIK INDONESIA
Nomor: 246/Menkes/Per/V/1990
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About Permits for Traditonal medicine industry and
traditional medicine registration
SK Ka Badan POM – RI No HK.00.05.4.1380
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About traditional medicine registration
About Guideline for good manufacturing practice for
traditional medicine
Etc.
Research and Systematization of
Indonesian Traditional Medicines
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Modern research on Indonesian herbal medicines included as a necessary
prerequisite, the comprehensive understanding of their :
• Origin,
• Process,
• Distribution, • Resources, • Therapeutic usage,
• Quality,
• Safety,
• Efficacy
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Many research institutions such as, Universities, Indonesian Institute of
Sciences, National Agency for Drug and Food Control , etc. have been
actively conducting research based on Indonesian traditional medicine as
well as conducting scientific meeting and research collaboration among
research institutions in Indonesia and overseas and also with traditional
medicine industries.
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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 and Drug Control, Prosea (Plant Resources of South East
Asia), Indonesian Institute of Sciences
All of these efforts are dedicated to the development of Indonesian
medicinal plants to be able to compete globally
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International requirements such as on GMP, GAP, GLP, ICH-GCP (The
International Conference on Harmonization-Good Clinical Practice), Research
Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines, HACCP,
etc., should be followed
Stelecocarphus burahol
> 300 sp.
Indonesian Journals
Nine medicinal plants of first priority for
phytopharmaceuticals
No.
Plant
Medicinal Uses
Bio-marker
Leaves:
immunomodulator
Astringent
Traditional, Most
famous preparation
for dengue treatment
1
OH
OH
HO
O
ORha
OH
O
Quercitrin
Psidium guajava
Fruit: Antihypertension
Leaves: Antidiabetic
OGlc(1-6)-Glc
O
OH
HO
O
Morindin
2
O
OH
OH
Morindone
Morinda citrifolia
O
No.
Plant
Medicinal Uses
Bio-marker
OH
OH
HO
O
Leaves:
Antidiabetic
3
ORha
OH
Quercitrin
O
Sizygium polyanthum
OH
Catechin and Friedelin
OH
HO
Leaves:
Antiobesity
4
O
OH
Guazuma ulmifolia
OH
Rhizomes:
Carminative
Stomachic
Stimulants
5
Zingiber officinale
Gingerol
O
OH
MeO
(CH2)nCH 3
HO
No.
Plant
6
Curcuma domestica
Medicinal Uses
Rhizomes:
Antilipedemic
Anti-bacteria,
cholagogum
Immunostimulants
Bio-marker
O
O
MeO
OMe
HO
OH
Curcuminoid
O
O
MeO
Rhizomes:
Hepatoprotector,
Choleretic,
antiinflammation
7
OMe
HO
OH
Curcuminoid,
OH
Xanthorhizol
Curcuma xanthorrhiza
Andrographolide (1),
Neoandrographolide(2)
8
Andrographis paniculata
Leaves:
Antipyretic, antiulcer,
antidiabetic
O
OH
O
O
OH
(2)
O
OH
O
O
(1)
OH
HO
HO
OH
No.
Plant
Medicinal
Uses
Bio-marker
OH
HO
OH
OH
HO
Aerial part:
Vasodilator,
Immunostimulants
9
O
HO
O
OH
O
HO
O
O
HO
O
OH
O
HO
Centella asiatica
OH
Asiaticoside and Madecasol
Development of Process Technology for Industrial Uses
of Medicinal Plants
♪ The medicines for internal use prepared in the traditional manner
involve simple methods, such as:
• 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
♪ The range of products that could be obtained from medicinal plants
Growth of Herbal Medicine
Manufacturers in Indonesia
2001 2002 2003
Small scale ind.
903
933
Big scale ind.
113
139
938
149
Source: NDA, 2004
Big Scale Ind. : Jamu Sidomuncul, Jago,Air Mancur,
Borobudur, Nyonya Meneer,
Kimia Farma, Kalbe Farma, Dexa, Soho, etc
Intelectual Property
Right Protection
LIPI
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Convention on Biological Diversity
(CBD)
Signed in 1992.
Indonesia ratified it through Law No
5/1994.
States have sovereign rights over their own
biological resources.
States are responsible for conserving their
biological diversity and for using their
biological resources in a sustainable
manner.
LIPI
CBD
Article 8 j : Tradisional Knowledge
Subject 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
LIPI
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RELATED LAWS AND RULES
Law No. 5/1990 regarding Conservation of Natural
Resources and Its Ecosystems.
Law No.5/1994 regarding the Ratification of the
United Nations Convention on Biological Diversity
Law No. 7/1994 regarding the Ratification of TRIPs.
Law No. 18/2002 regarding National System on
Research, Development, and Application of Science
and Technology.
All Indonesian IPR Laws.
CONCLUSION
Indonesia is a rich country biodiversity and traditional
knowledge including the trational medicine.
However, in the global era, the richness of
biodiversity is not the determining factor for
prosperity of the people. Knowledge how to develop
its biodiversity and traditional knowledge is
important. The key factor is how Indonesia ability to
convert knowledge into wealth and social good
through the process of innovation. It is a must for
Indonesia to work collaboratively also with other
contries in traditional medicine improvement.
Thank you.