BERAGAM
JENIS
SENYAWA
METABOLIT
DALAM OBAT
HERBAL
80% PENDUDUK
DUNIA
MENGGUNAKAN
OBAT HERBAL
SECARA EMPIRIS
FITOFARMA
KA
FITOFARMAK
A
Botani farmasi
Farmakognosi
fitokimia
farmakologi
kimia
?
ADA
APA
DEN
GAN
MU
farmaceutika
BAHAN
ALAM
OBAT TRAD
JAMU
SEDIAAN
GALENIK
?
FITO
FARM
AKA
OBAT HERBAL
TERSTANDAR
BAHAN
OBAT
PARADIGMA :
1.Quality
2.Safety
3.Efficacy
4.Acceptable
PRODUK
OBAT
MASYARAKAT
1.RATIONALITY
2.CHANCE
QUALITY AND
STANDARDIZED
PHARMACEUTICS ,
MAY BE BASED ON CONCEPTS :
1.VALID MATERIAL (CHEMICAL /
BIOLOGICAL)
2.RATIONAL FORMULATION DESIGN
3.DRUGS TARGET (MOLECULAR
CELLULAR) BASED DELIVERY
SYSTEM DESIGN
4.ACCEPTABLE DOSAGE FORM
DESIGN FOR OPTIMAL
BIOAVAILABILITY OR
BIOEQUIVALENCY
HUMAN
PLANTS
STRATEGIC THINKING
MENGANDUNG
TRADITIONAL MENGANDUNG
MISTERI ETNISBANYAK KOMPONEN KOMPONEN UTAMA
JUMLAH BESAR ( > 2
CAM THERAPYDENGAN JUMLAH KECIL
EXTRACT
SIMPLISIA
FORMULATION OR FRACTION
PHYTOPHARMACEUTICALS
3
ISOLATED
SUBSTANCE
ROAD MAP
(THERAPY APPROACH)
SINGLE
COMPOUND
MULTI
COMPONENTS
SINGLE BIOLOGICAL
RESPONSE AND
SOME SIDE EFFECTS
+ QUALITY SAFETY +
EFFICACY
Obat Modern
(Single Compound)
and cosmetic
ADEQUACY
HEALTH &
QUALITY
OF LIFE
BIOACTIVITY
- Food
(Multi Components)
- Nutrition
ROAD MAP
( PHARMACEUTIC APPROACH)
SINGLE
COMPOUND
MULTI
COMPONENTS
PENGEMBANGAN
OBAT MODERN
PENGEMBANGAN OBAT
(BADAN POM) :
1. OBAT TRADISIONAL
2. SEDIAAN GALENIK
3. OBAT HERBAL TERSTANDAR
4. FITOFARMAKA
(EKSTRAK / FRAKSI )
BAHAN
OBAT
PELUANG
PROSES
INPUT
OUTPUT
OUTCOMES
IMPACT
PRODUK
OBAT
MASYARAKAT
ISOLATED LEAD COMPOUND
BAHAN
OBAT
INPUT
TANTANGAN
PROSES
TYPE OF THERAPY :
1.
2.
3.
4.
5.
6.
7.
Preventive
Causal
Symtomatic
Supportive
Rehabilitative
Immunomodulative
Cancer Therapy
OUTCOMES
OUTPUT IMPACT
PRODUK
OBAT
IMPROVE :
1.HEALTH STATUS MASYARAKA
2.QUALITY OF LIVE
Obat Modern
OBAT + NUTRISI
NUTRISI + OBAT
Health Food
Food Supplements
(Single Compound)
OBAT + JAMU
JAMU + OBAT
and cosmetic
GREY
AREA
- Food
- Nutrisi (Multi Components)
NUTRISI + JAMU
JAMU + NUTRISI
RIMPANG KENCUR
CONTOH
PELUANG &
TANTANGAN
1
2
Minyak Kencur
OBAT HERBAL
(EKSTRAK TOTAL)
TERSTANDAR
FITOFARMAKA
6
OBAT MODERN
Analgesik
Antipiretik
A
PEGEMBANGA
N
OBAT
Adverseeffect/ToxicityofHM
o Intrinsic orplantassociatedhealthrisk
duetoactiveingredientsinplant.
o Extrinsic ornonplantassociated
whichinclude:
Contamination
(heavymetals,pesticide,microorganism).
Misidentification,substitution,andadulteration.
ACCESS
Lack of data measuring access levels and
affordability
Need to identify safe and effective
therapies and products
Lack of official recognition of role of
TM/CAM providers
Lack of cooperation between TM/CAM
providers and allopathic practitioners
Unsustainable use of medicinal plant
resources
Efficacy
o ScientificevidenceofHM:
Invitrostudies
Invivostudies
Clinicalstudies
o Efficacy
plantconstitue
nt
Efficacy,SafetyandQualityContro
o EfficacyandSafety
Chemicalconstituents.
o Qualitycontroltoassurethecompliance
onqualitystandards.
o Qualitycontrol essentialprerequisite
forensuringsafetyandefficacy.
ProblemswithHMQC
o HM uniqueproblems
inqualitystandardization.
o Morefactorsaffectthequality
o ThefirststepsisGAP
(goodagriculturalpractices).
o ThesecondstepisGMP
(goodmanufacturingprocess)
HMQC
Analyticalmethodstoassureauthenticityandpotency.
Macroscopic,microscopicandorganolepticanalyses,DNA
printing,analysesofmarkeroractivecomponent,
chromatographicfingerprinting.
Markerandactivecomponentiscommonlyusedtomeasu
quality.
EfficacyofHM
multiplecomponent.
Chromatographicfingerprinting
Moreattractive
Macroanalyticalapproach
RequirementproposedbyFDAandEuropeanAgencyforEvaluation
WHO
Guidelines
WHO Global
Strategic
Directions
Components
Expected outcomes
Recognition of TM/CAM
Help countries to develop
national policies and
programmes on
TM/CAM
Increased government
support for TM/CAM,
through comprehensive
national policies on
TM/CAM
Relevant TM/CAM
integrated into national
health care system
services
Components
Expected outcomes
Evidence-base for
TM/CAM Increase
access to and extent of
knowledge of the safety,
efficacy and quality of
TM/CAM, with an
emphasis on priority
health problems such
as malaria and
HIV/AIDS
Components
Expected outcomes
RATIONAL USE:
Promote
therapeutically
sound use of
appropriate
TM/CAM by
providers and
consumers
Basic training in
commonly used TM/CAM
therapies practitioners
Components
Regulation of herbal medicines
Support countries to establish
effective regulatory systems for
registration and quality
assurance of herbal medicines
Expected outcomes
National regulation of herbal
medicines, including
registration, established and
implemented
Safety monitoring of herbal
medicines and other
TM/CAM products and
therapies
Components
Expected outcomes
ACCESS:
Increase the
availability and
affordability of
TM/CAM, as
appropriate,
with an
emphasis on
access for poor
populations
Recognition of role of
TM/CAM practitioners in
health care Promote
recognition of role of
TM/CAM practitioners in
health care by encouraging
interaction and dialogue
between TM/CAM
practitioners and allopathic
practitioners
Increased provision of
appropriate TM/CAM through
national health services
Protection of medicinal
plants Promote
sustainable use and
cultivation of medicinal
plants
INDONESIAN
HERBAL
MEDICINE
TheComponentofHerbalMedicine
o CrudeDrug(simplisia):
partorthewholepartofplant
exudate
dried
Notyetprocessed
o Galenical preparation
Extract
tincture
o Ref:MMI,Pharmacopoeia
IndonesianHerbalMedicine
o
Jamu(TraditionalMedicine)
Safety
Efficacyisbasedonempiricaldata
Standardizedherbalextract
Safety
Efficacyisbasedonpreclinicaldata
Phytopharmaca
Safety
Efficacyisbasedonclinicaldata
Composition
Jamu
Crudedrug
Herbaltea
Extract
Standardized
Extract
Extract
Phytopharmaca
Crudedrug
Extract
Fractionofextract
Maximal5components
LampiranKepMenKesRI
No:761/Menkes/SK/IX/1992
Recommendation:eachproductcontains
1crudedrugorgalenicalpreparation.
Maximum5kindsofcrudedrugsorgalenica
preparations.
Purechemicalentityisforbidden.
PureChemicalEntity(BKO)
Purechemicalentity/syntheticdrug
Jamu
Standardizedextract
Phytopharmaca
Prohibited(Pasal39)
Containspharmacologicallyactivepure
chemicalentitysyntheticorisolated.
Suppositoria,intravaginal,eyedropsand
parentheral preparations.
Containethanol>1.0%
ForeignTraditionalMedicine
Foreigntraditionalmedicinedistributed
inIndonesiamustberegisteredinBPOM
(FoodandDrugAdministrationAgency)
OtherSimilarProduct
FoodSupplement
Theregulationismuchdifferent
Syntheticdrugisallowed
Cocacola
KratingDaeng
SE:1464/DDPR/VII/1983
OTdenganEtanol
Ethanolisallowedandthemaximumis15%
longasneededintheprocess
Ifthecontent>1% :mustbeprintedinthel
PARADIGMA SAAT
INI
PARADIGMA SEHARUSNYA
STRATEGI
PEMERINTA
H
Strategi Pemerintah
Pendekatan : A-B-G
A = Academic
B = Bussiness
G = Government
BPOM
Membagi obat bahan alam
berdasarkan
tingkat pengujiannya :
1. Jamu (empiris)
2. Herbal terstandar (bhn baku
terstandar, uji preklinis)
3. Fitofarmaka (bhn baku terstandar,
uji
klinis)
Dep.Pertanian
Membuat road map tanaman obat di
seluruh Indonesia
BALITRO (Balai Penelitian Tanaman
Rempah dan Obat)
Mendapatkan bibit unggul tanaman
obat
BPPT
Menjadikan pengembangan obat
bahan
alam sebagai salah satu prioritas
program
BPPT sampai tahun 2025
TheIndustryofHerbalMedicine
IOT(TraditionalMedicineIndustry)
IKOT(SmallTraditionalMedicineIndustry
Industrifarmasi(PharmaceuticalIndustry)
Registrationofimportedproductcanbe
conductedbypharmaceuticalcompanyin
distributionsector.
Powder
Weighthomogeneity
Weightof510g,20packsareweighted
< 2packs
< 1pack
10%
8%
Totalplatecount<106
Fungalandyeast,pathogenicmicroorganism,and
aflatoxinlevelasthatofherbaltea.
Additives
Preservativeisnotallowedincrudedrugpowder
Preservativemaybeaddedinextractpowderifneces
Packagingandstorageasstandard
Capsule
Disintegrationtime< 15minutes
Weighthomogeneity
Averageweight120mgorsmaller
< 2deviates10%(solid),7,5%(liquid)
< 1deviate20%(solid),7,5%(liquid)
Watercontentofthecontent
Totalplatecount< 104
Fungalandyeastnumber< 103
Pathogenicmicrobe:negative
Aflatoxin < 30ppm
Additives
Tablet
Weighthomogeneity
< 25mg
2(15%)
26 150mg 2(10%)
151300mg 2(7,5%)
>300mg
2(5%)
1(30%)
1(20%)
1(15%)
1(10%)
Disintegrationtime< 20minutes
Watercontent
Totalplatecount
Yeastnumber
Pathogenicmicrobe
Aflatoxin
Additives
OtherForms
Pill
Taffy(Dodolataujenang)
Lozenges(Pastiles)
InternalLiquid(CairanObatDalam)
Jamuconcentrate(SariJamu)
Parem,PilisdanTapel
Plaster(Koyok)
TopicalLiquid
Ointment/Cream
KepmenNo659/Menkes/SK/X/1991
TentangCPOTB
IOTandIKOThavetoimplementCPOTB(GM
fortraditionalmedicine)
Industrywithasset<50millionhasto
improveitscapacityandby1997already
implementCPOTB.
CertificateofCPOTBisissuedbyregional
office(KantorWilayah)basedonreportby
HeadofInspectorateOffice.
GoodManufacturingPractices
Peraturan BPOMNoHK.00.05.4.1380
Pedoman CPOTB
Didnotrefertothepreviouslegaldocumen
onCPOTB.
Thereisnoclauseonthenecessityof
pharmacist.
Coveragealmostthesamewiththepreviou
guideline.
Coverage
personnel,
building,
equipment,
sanitationandhygiene,
storageofrawmaterials,
processingandpackaging,qualitycontrol
selfinspection,
documentation,
handlingofproductsalreadyinthemarket
Terminology
o
o
o
o
o
o
o
o
HerbalMedicine
Phytomedicine
Phytopharmaca
Jamu
Kampo
TraditionalMedicine
NaturalMedicine
NativeMedicine
Implementasinya
Herbal yang dapat digunakan dalam
sistim
pelayanan konvensional adalah :
- fitofarmaka
- herbal terstandar (pelayanan
penelitian)
- jamu (usul : Badan Litbangkes)
Sources: Fisher P & Ward A, 1999; Health Canada, 2001, World Health Organization, 1998.7,8,6
Source: World Health Organization, 199841 and data collected by World Health Organization during period 19992001.
Thank You