SUKRASNO

SITI KUSMARDIYANI
 LEGAL ASPECT
OF HERBAL MEDICINE

Definition, similarity and differences related to

crude drug and their product.

Regulation of herbal medicine

Terminology
Define and give examples of these terms:

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

Illustration of commercial products.

Find other examples and criticize.
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 INDONESIA
Obat bahan alam yang diproduksi di Indonesia

Berdasarkan cara pembuatan, jenis klaim penggunaan,

dan tingkat pembuktian khasiat :

JAMU

OBAT HERBAL TERSTANDAR

FITOFARMAKA
17 Mei 2004
 Composition

• Jamu • Standardized • Phytopharmaca

– Crude drug Extract – Crude drug
– Herbal tea – Extract – Extract
– Extract – Fraction of extract
• Maximal 5 components
 Lampiran KepMenKes RI
No: 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/1983
OT 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/1991
Tentang 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.00.05.4.1380
Pedoman 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
Get more related information and summarize:

LEGAL ASPECT
OF HERBAL MEDICINE