SUKRASNO SITI KUSMARDIYANI

LEGAL ASPECT OF HERBAL MEDICINE

Definition, similarity and differences related to crude drug and their product.

Regulation of herbal medicine

• Herbal Medicine• Phytomedicine• Phytopharmaca• Jamu• Kampo• Traditional Medicine• Natural Medicine• Native Medicine

TerminologyDefine and give examples of these terms:

Read the next slides very carefully and state in your own words.

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.

Efficacy

o Scientific evidence of HM:– In vitro studies

– In vivo studies

– Clinical studies

o Efficacy Plant constituent

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.

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)

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.

INDONESIAN HERBAL MEDICINE

Examples of products-slides-

The Component of Herbal Medicine

Crude Drug (Simplisia): – part or the whole part of plant– exudate– dried

Galenical Preparation– extract– tincture

References : MMI, Pharmacopoeia

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 -----------------------------------------

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 :

Composition

• Phytopharmaca

– Crude drug

– Extract

– Fraction of extract

• Maximal 5 components

• Jamu

– Crude drug

– Herbal tea

– Extract

• Standardized Extract

– Extract

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.

Pure Chemical Entity (BKO)Pure chemical entity/synthetic drug

• Jamu

• Standardized extract

• Phytopharmaca

Prohibited (Pasal 39)

• Contains pharmacologically active pure chemical entity synthetic or isolated.

• Suppositoria, intra vaginal, eye drops and parentheral preparations.

• Contain ethanol > 1.0%

Foreign Traditional Medicine

Foreign traditional medicine distributed in Indonesia must be registered in BPOM (Food and Drug Administration Agency)

Other Similar Product

• Food Supplement

• The regulation is much different

• Synthetic drug is allowed– Coca cola

– Krating Daeng

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.

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.

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

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

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

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

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.

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

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

LEGAL ASPECT OF HERBAL MEDICINE

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