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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.
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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 • 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
Trend of Herbal Medicines in Indonesia 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 • 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 • 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 preparationwhen 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: • SK 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 HK.00.05.4.1380 • About Guideline for good manufacturing practice for traditional medicine • Etc.
Research and Systematization of Indonesian Traditional Medicines
• Origin, • Distribution, • Resources, • Therapeutic usage, • Process, • Quality, • Safety, • Efficacy • Modern research on Indonesian herbal medicines included as a necessary prerequisite, the comprehensive understanding of their : • 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. • 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 • 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.
Nine medicinal plants of first priority for phytopharmaceuticals
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: • 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 Manufacturers in Indonesia 2001 2002 2003 Small scale ind. 903 933 938 Big scale ind. 113 139 149 Source: NDA, 2004 Big Scale Ind. : Jamu Sidomuncul, Jago,Air Mancur, Borobudur, Nyonya Meneer, Kimia Farma, Kalbe Farma, Dexa, Soho, etc
LIPI 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 utilization of such knowledge, innovations and practices;
LIPI 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.