legal aspect of herbal medicine
TRANSCRIPT
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SUKRASNO SITI KUSMARDIYANI
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LEGAL ASPECT OF HERBAL MEDICINE
Definition, similarity and differences related to crude drug and their product.
Regulation of herbal medicine
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• Herbal Medicine• Phytomedicine• Phytopharmaca• Jamu• Kampo• Traditional Medicine• Natural Medicine• Native Medicine
TerminologyDefine and give examples of these terms:
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Read the next slides very carefully and state in your own words.
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Adverse effect/Toxicity of HM
o Intrinsic
or plant associated health risk due to active ingredients in plant.
o Extrinsic
or non plant associated which include:– Contamination
(heavy metals, pesticide, microorganism).
– Misidentification, substitution, and adulteration.
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Efficacy
o Scientific evidence of HM:– In vitro studies
– In vivo studies
– Clinical studies
o Efficacy Plant constituent
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Efficacy, Safety and Quality Control
o Efficacy and Safety Chemical constituents.o Quality control to assure the compliance
on quality standards.
Quality control essential prerequisite for ensuring safety and efficacy.
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Problems with HM QC
HM unique problems in quality standardization.
More factors affect the quality
The first steps is GAP (Good Agricultural Practices).
The second step is GMP (Good Manufacturing Process)
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HM QC
Analytical methods to assure authenticity and potency. Macroscopic, microscopic and organoleptic analyses,
DNA finger printing, analyses of marker or active component, chromatographic fingerprinting.
Marker and active component is commonly used to measure the quality.
Efficacy of HM multiple component. Chromatographic fingerprinting
More attractive Macro analytical approach Requirement proposed by FDA and European Agency for Evaluation HM.
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INDONESIAN HERBAL MEDICINE
Examples of products-slides-
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The Component of Herbal Medicine
Crude Drug (Simplisia): – part or the whole part of plant– exudate– dried
Galenical Preparation– extract– tincture
References : MMI, Pharmacopoeia
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Indonesian Herbal Medicine
o Jamu (Traditional Medicine)– Safety √– Efficacy is based on empirical data
o Standardized herbal extract– Safety √– Efficacy is based on pre-clinical data
o Phytopharmaca– Safety √– Efficacy is based on clinical data
---------------------------------------- Obat Bahan Alam Indonesia -----------------------------------------
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OBAT BAHAN ALAM INDONESIAObat bahan alam yang diproduksi di Indonesia
17 Mei 2004
JAMU
OBAT HERBAL TERSTANDAR
FITOFARMAKA
Berdasarkan cara pembuatan, jenis klaim penggunaan, dan tingkat pembuktian khasiat :
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Composition
• Phytopharmaca
– Crude drug
– Extract
– Fraction of extract
• Maximal 5 components
• Jamu
– Crude drug
– Herbal tea
– Extract
• Standardized Extract
– Extract
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Lampiran KepMenKes RINo: 761/Menkes/SK/IX/1992
Recommendation: each product contains 1 crude drug or galenical preparation.
Maximum 5 kinds of crude drugs or galenical preparations.
Pure chemical entity is forbidden.
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Pure Chemical Entity (BKO)Pure chemical entity/synthetic drug
• Jamu
• Standardized extract
• Phytopharmaca
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Prohibited (Pasal 39)
• Contains pharmacologically active pure chemical entity synthetic or isolated.
• Suppositoria, intra vaginal, eye drops and parentheral preparations.
• Contain ethanol > 1.0%
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Foreign Traditional Medicine
Foreign traditional medicine distributed in Indonesia must be registered in BPOM (Food and Drug Administration Agency)
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Other Similar Product
• Food Supplement
• The regulation is much different
• Synthetic drug is allowed– Coca cola
– Krating Daeng
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SE: 1464/DD-PR/VII/1983OT dengan Etanol
• Ethanol is allowed and the maximum is 15% as long as needed in the process
• If the content > 1% : must be printed in the label.
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The Industry of Herbal Medicine
IOT (Traditional Medicine Industry)
IKOT (Small Traditional Medicine Industry)
Industri Farmasi (Pharmaceutical Industry)
Registration of imported product can be conducted by pharmaceutical company in distribution sector.
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Powder
• Weight homogeneity• Weight of 5-10 g, 20 packs are weighted
– < 2 packs 10 %– < 1 pack 8%
• Total plate count < 106
• Fungal and yeast, pathogenic microorganism, and aflatoxin level as that of herbal tea.
• Additives– Preservative is not allowed in crude drug powder– Preservative may be added in extract powder if necessary
• Packaging and storage as standard
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Capsule
• Disintegration time < 15 minutes• Weight homogeneity
– Average weight 120 mg or smaller– < 2 deviates 10% (solid), 7,5% (liquid)– < 1 deviate 20% (solid), 7,5% (liquid)
• Water content of the content• Total plate count < 104
• Fungal and yeast number < 103
• Pathogenic microbe: negative• Aflatoxin < 30 ppm• Additives
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Tablet
• Weight homogeneity– < 25 mg 2 (15%) 1 (30%)– 26 – 150 mg 2 (10%) 1 (20%)– 151-300 mg 2 (7,5%) 1 (15%)– > 300 mg 2 (5%) 1 (10%)
• Disintegration time < 20 minutes• Water content• Total plate count• Yeast number• Pathogenic microbe• Aflatoxin• Additives
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Other Forms
• Pill• Taffy (Dodol atau jenang)• Lozenges (Pastiles)• Internal Liquid (Cairan Obat Dalam)• Jamu concentrate (Sari Jamu)• Parem, Pilis dan Tapel• Plaster (Koyok)• Topical Liquid• Ointment/Cream
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Kepmen No 659/Menkes/SK/X/1991Tentang CPOTB
IOT and IKOT have to implement CPOTB (GMP for traditional medicine).
Industry with asset < 50 million has to improve its capacity and by 1997 already implement CPOTB.
Certificate of CPOTB is issued by regional office (Kantor Wilayah) based on report by Head of Inspectorate Office.
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Good Manufacturing Practices
Peraturan BPOM No HK.00.05.4.1380Pedoman CPOTB
Did not refer to the previous legal document on CPOTB.
There is no clause on the necessity of pharmacist.
Coverage almost the same with the previous guideline
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Coverage
personnel, building, equipment, sanitation and hygiene, storage of raw materials, processing and packaging, quality control self inspection, documentation, handling of products already in the market
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LEGAL ASPECT OF HERBAL MEDICINE
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