sboa obat herbal
TRANSCRIPT
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MENGAPA STANDARISASI
BAHAN OBAT ALAM HARUSDILAKUKAN?
80% PENDUDUKDUNIA
MENGGUNAKANOBAT HERBAL
SECARA EMPIRIS
BERAGAM JENIS
SENYAWAMETABOLIT
DALAM OBATHERBAL
TIDAK MENJUALSECARA EKONOMIS
FITOFARMA
KA
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A• sediaan obat bahan alamyang telah dibuktikan
keamanan dan khasiatnyasecara ilmiah dengan ujipraklinik dan uji klinik,
bahan baku dan produk jadinya telah di standarisasi.
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Botani farmasi
Farmakognositokimiakimiakimia
farmaceutikafarmaceutika
AD A AP A D E ! A " #
??
f f armakologiarmakologi
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BA$AA%A"
SEDIAANSEDIAAN
GALENIKGALENIK
OBAT HERBALOBAT HERBAL
TERSTANDARTERSTANDAR
F & ' ( F A) " A* A
??
OBAOBAT TRADT TRAD
JAMJAM
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• Diduni !"#d$! 0&000 '$"'i"' !n(n) *0&000+"#d di Ind,n"'i) -&.00 +"#/'i! ,+! dn '"/i!#00 '$"'i"' di(n1!/n '"+2i ,+! !#di'i,n3
• S! ini $"(n1!n 'u(+"# d4 4!i !"#+"'#d3 d3( ("($#,du/'i O+!
• WHO 56007 9 :7;80% $"ndudu/ duni ("n22un/n
"#+3) dn d * /"3,($,/9<& T"#in!"2#'i9 Ti,n2/,/) K,#") J"$n26& F,#(39 In22#i'9 J"#(n) B"3nd*& T,3"#n9 Ind,n"'i dn n"2# +"#/"(+n2
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• P"n2,+!n dn $"n2"!un ,+! !#di'i,n3diInd,n"'i di!u#un/n '"=# 3i'n d#i '!u2"n"#'i /" 2"n"#'i dn >u2 !"#!u3i' d#i dun
3,n!# dn /"$u'!/n K"#!,n&
• Min! ('4#/! d3( ("n22un/n "#+3!"#u' ("nin2/! +"#d'#/n /,n'"$ +=/ !,n!u#"
• P'# ,+! 3(i Ind,n"'i !"#u' ("nin2/!5600* R$& 6)7T 6007 R$& T 60<0di$"#/i#/nR$& 8T
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• P"#!"n2n +d @@) RRC ("n2"(+n2/n 'i'!i($"n2,+!n +#u !i$" RRC 9 $"n2,+!n !#di'i,n35TCM !"#in!"2#'i d"n2n /"d,/!"#n /,n"n'i,n3&
• Ind,n"'i 9 ("n"3i!i "#+3 d"n2n ("n22un/n("!,d" i3(i un!u/ di/"!ui "1"/!i!' dn/"(nnn4 dn >u2 ("33ui 'in!i/'i >(uun!u/ diin!"2#'i/n /" d3( 'i'!i( /"'"!n1,#(3) d3( u$4 $#,(,!i1;$#""n!i1) /u#!i1;
#"+i3i!!i1 dn $3i!i1) 2# di$"#,3" 'i3 4n2,$!i(3
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•B"#d'#/n d! "($i#i' !"n!n2 (n1!$"n2,+!n "#+3 /3'i/) un!u/ $"n2,+!n4n2 ,$!i(3 d$! di$"#!i(+n2/n!"#in!"2#'i /" d3( $"34nn /"d,/!"#n
/,n"n'i,n3&
• Un!u/ !u>un !"#'"+u! di$"#3u/n />in '"=#i3(i !"n!n2 1#(/,3,2i "1"/!i!' dn
/"(nn $"n2,+!n dn ,+! !#di'i,n3
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+ources of atural Products
• Plants -/,/// di0erent plant species inthe 1orld2
• &nsects 3/ million species2
• Fungi 4, million2• Algae 4, million2• (ther Prokaryotics 4, million2Data From ). 5erpoorte, DD' 46672, 3, -3-8-372
Endogenous "icroorganism 99992• "arine (rganism 9992• 5ertebrates and &n:ertebrates 992
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4. (bat tradisional adalah bahan atau ramuan bahan yang berupa
bahan tumbuhan, bahan he1an, bahan mineral, sediaan sariangalenik2 atau campuran dari bahan tersebut, yang secara turun8temurun telah digunakan untuk pengobatan berdasarkanpengalaman.
-. ;amu adalah obat tradisional &ndonesia.
3. (bat herbal terstandar adalah sediaan obat bahan alam yangtelah dibuktikan keamanan dan khasiatnya secara ilmiah denganuji praklinik dan bahan bakunya telah di standarisasi.
<. Fitofarmaka adalah sediaan obat bahan alam yang telahdibuktikan keamanan dan khasiatnya secara ilmiah dengan uji
praklinik dan uji klinik, bahan baku dan produk jadinya telah distandarisasi.
. +ediaan galenik adalah hasil ekstraksi simplisia yang berasal daritumbuh8tumbuhan atau he1an.
BADA PE!A=A+ (BA' DA "A*AA PE)A'#)A ("() > $*.//./.<4.437< , - "aret -// 2
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&++#E +')A'E;&* P)(B%E" BA!+ADA%A" B&DA! (BA' BA$A A%A"
4. +#"BE) BA$A BA*#-. &%"# PE!E'A$#A DA 'E*(%(!&3. PED&D&*A
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PE!A=A+A
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BA$A(BA'
P)(D#* (BA'
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PA)AD&!"A >4.Cuality-.+afety3.Ecacy<.Acceptable
Pengembangan (bat "odernFDA
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4.)A'&(A%&'-.$AE
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P$A)"AE#'&+ , "A BE BA+ED ( (EP'+ >4.5A%&D "A'E)&A% $E"&A%
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STANDARDI#ED
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$H"TO$HARMA%ETI%ALS
(BA' BA$A A%A"
&+(%A'ED+#B+'AEEG')A'() F)A'&(
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+&!%E("P(#D
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(bat "odern+ingle ompound2
and cosmetic
;amu 8(bat $erbal 8Fitofarmaka 8
"ulti omponents2
8 Food8 utrition
$EA%'$ KC#A%&'
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L C#A%&' +AFE' L
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+&!%E("P(#D
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E*+')A* F)A*+& 2
ROAD MA$
) $HARMA%ETI% A$$ROA%H*
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$ELANGBA$A(BA'
P)(D#* (BA'
&P#'&P#'
PROSES OUTPUT(#'("E+
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"A+A)A*A'
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BA$A(BA'
"A+A)A*
T"$E O+ THERA$" ,&- $re.e/ti.e
'- %au0al
(- S1mtomatic
2- Su33orti.e4- Re5a6ilitati.e
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9- %a/cer T5era31
TANTANGAN
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(bat "odern+ingle ompound2
and cosmetic
;amu 8(bat $erbal 8Fitofarmaka 8
"ulti omponents2
8 Food8 utrisi
!)E
A)EA
(BA' L ;A"# ;A"# L (BA'
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PE)%# )E!#%A+& BE)BA+&+ &%"&A$
$ealth Food
Food +upplements
RIM$ANG KEN%R
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%ONTOH
$ELANG :
TANTANGAN
O
O
O
RIM$ANG KEN%R
&(5A'&5E )A'&(A% $AE 8 (+' 8 P)&E
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*(+"E'&* 'AB&) +#)A
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&
' (
2
4
7
A
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A
PEGEMBANGANOBAT
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Ad"#'" ""=!T,i=i!4 ,1 HM
o In!#in'i= ,# $3n! '',=i!"d "3! #i'/du" !, =!i" in2#"di"n!' in $3n!&
o E!#in'i= ,# n,n $3n! '',=i!"di= in=3ud"9
– C,n!(in!i,n
5"4 ("!3') $"'!i=id") (i=#,,#2ni'(& – Mi'id"n!i=!i,n) 'u+'!i!u!i,n) nd du3!"#!i,n&
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Safety, efficacy and quality
• Lack of research methodology• Inadequate evidence-base for TM/CM
thera!ies and !roducts
• Lack of international and national standardsfor ensuring safety, efficacy and quality
control of TM/CM thera!ies and !roducts
• Lack of adequate regulation and registrationof herbal medicines
• Lack of registration of TM/CM !roviders
• Inadequate su!!ort for research
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CC"SS
• Lack of data measuring access levels andaffordability
• #eed to identify safe and effective
thera!ies and !roducts
• Lack of official recognition of role of
TM/CM !roviders
• Lack of coo!eration bet$een TM/CM!roviders and allo!athic !ractitioners
• %nsustainable use of medicinal !lant
resources
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E==4
o S=i"n!i= "id"n=" ,1 HM9
– In vitro studies
– In vivo studies
– C3ini=3 '!udi"'
o E==4
$3n! =,n'!i!u"n!
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E==4) S1"!4 nd u3i!4 C,n!#
o E==4 nd S1"!4 C"(i=3 =,n'!i!u"n!'&
o u3i!4 =,n!#,3 !, ''u#" !" =,($3in=" ,n u3i!4 '!nd#d'&
o u3i!4 =,n!#,3 "''"n!i3 $#"#"ui'i!"1,# "n'u#in2 '1"!4 nd "==4&
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P#,+3"(' i! HM C
o HM uniu" $#,+3"('in u3i!4 '!nd#di!i,n&
o M,#" 1=!,#' "=! !" u3i!4
o T" #'! '!"$' i' GAP52,,d 2#i=u3!u#3 $#=!i="'&
o T" '"=,nd '!"$ i' GMP52,,d (nu1=!u#in2 $#,="''
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HM C
• An34!i=3 ("!,d' !, ''u#" u!"n!i=i!4 nd $,!"n=4&
• M=#,'=,$i=) (i=#,'=,$i= nd ,#2n,3"$!i= n34'"') DNA$#in!in2) n34'"' ,1 (#/"# ,# =!i" =,($,n"n!)
=#,(!,2#$i= n2"#$#in!in2&• M#/"# nd =!i" =,($,n"n! i' =,((,n34 u'"d !, ("'
u3i!4&• E==4 ,1 HM (u3!i$3" =,($,n"n!&
• C#,(!,2#$i= n2"#$#in!in2
– M,#" !!#=!i" – M=#, n34!i=3 $$#,=
– R"ui#"("n! $#,$,'"d +4 FDA nd Eu#,$"n A2"n=4 1,# E3u!i,n
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• Si'!"( P"#undn2n K"'"!n• B"3u( +n4/ in1,#('i K'i! dn /"(nn 4n2
("33ui U>i K3ini'• B"3u( d /,($"!"n'i $d D,/!"#• Ku#n2n4 $"#3indun2n ('4#/! !"#d$ "1"/
$3'"+, i/3n ,+! +"#+n 3(• B"3u( !"#i($unn4 d! ("n2"ni ,+! +n 3(
Ind,n"'i +"#d'#/n $d"id"n=" +'"d• Ku#n2n4 /,,#din'i n!# in'!i!u'i d3( $"n"3i!in ,+!
+n 3( Ind,n"'i
• B"3u( d ,#2ni''i $#,1"'i /"d,/!"#n 4n2 /u'u'("nd3(i "#+3 Ind,n"'i
&'(
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&'(
)uidelines
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)uidelines for the regulation of herbal
medicines in the South-"ast sia *egion
These guidelines aim to !ro!ose to member states a frame$ork for
facilitating the regulation of herbal medicines/ !roducts used in
traditional medicine
They cover the follo$ing issues+
• Classification of herbal medicines• Minimum requirements for assessment of safety of herbal
medicine
• Minimum requirements for assessment of the efficacy of herbal
medicines
• uality assurance of herbal medicinal !roducts
• harmacovigilance of herbal medicinal !roducts
• Control of advertisements of herbal medicinal !roducts
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uality Control Methods for Medicinal
lant Materials
This manual describes a series of tests for assessing thequality of medicinal !lant materials. These tests aredesigned !rimarily for use in national drug qualitycontrol laboratories in develo!ing countries and
com!lement those described in The International Pharmacopeia.
It !ertains to the follo$ing
• o$der fineness and sieve si0e
• Macrosco!ic and microsco!ic !ro!erties
• 1etermination of ash, e2tractable matter, volatile oils,bitterness value, hemolytic activity, tannins, !esticideresidues, radioactive contamination etc.
&'( ) id li f t it i f
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&'( )uidelines on safety monitoring of
herbal medicines in !harmacovigilance
systems
Safety of herbal medicine is an im!ortant !ublic healthissue. The guidelines stresses u!on+
•The im!ortance and !rocess of monitoring the safety of
herbal medicine $ithin the !harmacoivigilance system
•Standard definitions of terms related to!harmacovigilance and safety monitoring of herbalmedicine
•Challenges in monitoring the safety of herbal medicine
•Need for good communication for ensuring successfulsafety monitoring
&'( ) id li d i lt l d
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&'( )uidelines on good agricultural and
collection !ractices 3)C4 for medicinal !lants
These guidelines are intended to !rovide technical
kno$ledge on obtaining medicinal !lant materials of goodquality for the sustainable !roduction of herbal !roducts
classified as medicines.
They a!!ly to the follo$ing +
• Identification, authentication, cultivation and harvest of medicinal !lants
• )ood collection !ractices for medicinal !lants
• Common technical as!ects of good agricultural !racticesfor medicinal !lants in terms of !ersonnel, !ackaging,
storage and trans!ortation.
• *elevant issues of ethical/ legal considerations and
research
)eneral g idelines for methodologies on
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)eneral guidelines for methodologies on
research and evaluation of traditional
medicine
These guidelines have been develo!ed to !romote the
!ro!er use and develo!ment of traditional medicine
and relate to s!ecific issues of methodologies for+
• research and evaluation of herbal medicines
• research and evaluation of traditional !rocedure 5
based thera!ies
• Clinical research norms• (ther issues and considerations of ethics, education/
training and surveillance systems.
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&'( )lobal
Strategic
1irections
&'( Traditional Medicine Strategy+
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•
&'( Traditional Medicine Strategy+
(b6ectives, Com!onents and "2!ected (utcomes
(b6ectives Com!onents "2!ected outcomes
(LIC7+
Integrate
TM/CM $ith
national health
care systems,as a!!ro!riate,
by develo!ing
and
im!lementing
*ecognition of TM/CM •
'el! countries to develo!
national !olicies and
!rogrammes on
TM/CM
Increased government
su!!ort for TM/CM,
through com!rehensive
national !olicies on
TM/CM*elevant TM/CM
integrated into national
health care system
services
nationalTM/CM
!olicies8 and
!rogrammes
rotection and !reservationof indigenous TM
kno$ledge relating to health
'el! countries to develo!
strategies to !rotect their
indigenous TM kno$ledge
Increased recording and
!reservation of indigenous
kno$ledge of TM, including
develo!ment of digital TM
libraries
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•
•
•
&'( Traditional Medicine Strategy+
(b6ectives, Com!onents and "2!ected (utcomes
(b6ectives Com!onents "2!ected outcomes
S9"T7, "vidence-base for Increased access to and e2tent of
"99ICC7 #1 TM/CM Increase kno$ledge of TM/CM through
%LIT7+ access to and e2tent of net$orking and e2change of
romote the kno$ledge of the safety, accurate information
safety, efficacy efficacy and quality of Technical revie$s of research onand quality of TM/CM, $ith an use of TM/CM for !revention,TM/CM by em!hasis on !riority treatment and management of e2!anding the health !roblems such common diseases and conditionskno$ledge-base
on TM/CM, and
by !rovidingguidance on
regulatory and
quality assurance
as malaria and
'I:/I1SSelective su!!ort for clinical
research into use of TM/CM for
!riority health !roblems such as
malaria and 'I:/I1S, and
common diseases
standards
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•
•
&'( Traditional Medicine Strategy +
(b6ectives, Com!onents and "2!ected (utcomes
(b6ectives Com!onents "2!ected outcomes*TI(#L %S"+ ro!er use of TM/CM ;asic training in
romote by !roviders Increase commonly used TM/CM
thera!eutically ca!acity of TM/CM thera!ies !ractitioners
sound use of !roviders to make
a!!ro!riate
TM/CM by
!roviders and
consumers
!ro!er use of TM/CM
!roducts and thera!ies ;asic training in !rimaryhealth care for TM
ractitioners
ro!er use of TM/CM
by consumers
Increase ca!acity of consumers to make
informed decisions
about use of TM/CM
!roducts and
thera!ies
•Reliable information for
consumers on !ro!er use of
TM/CM thera!ies
•Improved communication
bet$een allo!athic !ractitioners
and their !atients concerning
use of TM/CM
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quality control of herbal
quality of TM/CM
&'( Traditional Medicine Strategy+
(b6ectives, Com!onents and "2!ected (utcomes
(b6ectives Com!onents "2!ected outcomes
S9"T7, *egulation of herbal medicines • #ational regulation of herbal
"99ICC7 #1 Su!!ort countries to establish medicines, including
%LIT7+ effective regulatory systems for registration, established and
romote the registration and quality im!lemented
safety, efficacy assurance of herbal medicines • Safety monitoring of herbaland quality of medicines and otherTM/CM by TM/CM !roducts ande2!anding the thera!ieskno$ledge-base
on TM/CM,and by !roviding
guidance on
regulatory and
quality assurance
standards
)uidelines on safety, efficacy • Technical guidelines and
and quality 1evelo! and methodology for evaluatingsu!!ort im!lementation of safety, efficacy and quality of
technical guidelines for TM/CM
ensuring the safety, efficacy and • Criteria for evidence-based
data on safety, efficacy andmedicines and other TM/CM
!roducts and thera!ies thera!ies
&'( Traditional Medicine Strategy+
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•
•
•
&'( Traditional Medicine Strategy+
(b6ectives, Com!onents and "2!ected (utcomes
(b6ectives Com!onents "2!ected outcomes
CC"SS+ *ecognition of role of Criteria and indicators, $here
Increase the TM/CM !ractitioners in !ossible, to measure cost-
availability and health care romote effectiveness and equitable access
affordability of recognition of role of to TM/CM
TM/CM, as
a!!ro!riate,$ith an
em!hasis on
TM/CM !ractitioners in
health care by encouraginginteraction and dialogue
bet$een TM/CM
Increased !rovision of
a!!ro!riate TM/CM through
national health services
access for !oor !ractitioners and allo!athic Increased number of national
!o!ulations !ractitioners organi0ations of TM/CM
!roviders
rotection of medicinal
!lants romote
sustainable use and
cultivation of medicinal
!lants
•Guidelines for good agriculture
!ractice in relation to medicinal !lants
•Sustainable use of medicinal !lant
resources
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INDONESIA
HERBAL
MEDICINE
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T" C,($,n"n! ,1 H"#+3 M"di=in
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– "ud!"
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o G3"ni=3 $#"$#!i,n
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o R"1 9 MMI) P#(=,$,"i
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o
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L($i#n K"$M"nK"' RIN,9 :.<M"n/"'SKI@<--6
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Pu#" C"(i=3 En!i!4 5BKOPu#" ="(i=3 "n!i!4'4n!"!i= d#u2
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P#,i+i!"d 5P'3 *-
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O!"# Si(i3# P#,du=!
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• S4n!"!i= d#u2 i' 33,"d
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SE9 <.DDPRII<-8*
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PARADIGMA SAAT
INI
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PARADIGMA SEHARUSNYA
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STRATEGI
PEMERINTA
H
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S!#!"2i P"("#in!
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BPOM
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D"$&P"#!nin
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• BALITRO 5B3i P"n"3i!in Tn(n
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BPPT
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• PB IDI +"#'( PDUI) PDHMI dnBALITBANG D"$K"' RI ("n4u'un
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T" Indu'!#4 ,1 H"#+3 M"di=in"
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• R"2i'!#!i,n ,1 i($,#!"d $#,du=! =n +"
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P,d"#
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– Q 6 $=/' <0 % – Q < $=/ 8%
• T,!3 $3!" =,un! Q <0.
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• P=/2in2 nd '!,#2" ' '!nd#d
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– – – –
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P#"() Pi3i' dn T$"3
P3'!"# 5K,4,/
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K"$("n N, .7-M"n/"'SK@<--< T"n!n2 CPOTB
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i($#," i!' =$=i!4 nd +4 <--: 3#"d4i($3"("n! CPOTB&
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G,,d Mnu1=!u#in2 P#=!i="'
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I($3"("n!'in4
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• I(un,(,du3!,#) 4i!u9 "#+3 4n2 d$!("nin2/!/n /"/"+3n !u+u) n!# 3inM"ni#n) Lid +u4) S(+i3,!,) T"(u3/
• An!i In('i) n!# 3in 9 T"(u3/)
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dn J(+u Bi>i
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• An!i+i,!i/9 B"#/'i! !"#d$ >(u# Cndid3+i=n') T#i=,$4!,n ("n!2,$4!"')S!$43,=,==u' u#"u')P'"ud,(,n' "#u2in,' dn Mi=#,'$,# =ni'&B"+"#$ H"#+3 4n2 +"#/'i! n!# 3in 9
M"ni#n)B"3un!') L"n2/u' dn T+! B#i!,&• An!i Hi$"#=,3"'!"#"(i9 L+u Si() T"(u3/)
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Bn2 Pu!i) Bu L"un=) K4u Mni'&• An!i O/'idn 9 T"(u3/) C+i) Bu
M"n2/udu) L"n2/u') Dun S3() T") LdHi!(
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• An!i Kn/"#9 Si#i M"#) T"(u $u!i)Ru($u! Mu!i#) K"3di Ti/u') Jin!"n
Hi!() Bu M"n2/udu) Bn2 Pu!i• K,'("!i/9 B"n2/,n2) /"n=u#) /u3i!
(n22i') ("3!i) dun >(+u ("d"&
• Nu!#i'i dn Minu(n9 T"(u3/)Kun4i! A'() P"22n) S#i P=")Mdu) B"#' K"n=u#) $"#("n "#+3
;road %se and !!eal
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;road %se and !!eal
In many develo!ing
and develo!ed
countries as often
stated in government
re!orts the ma6ority
of the !o!ulation
continues to use TM
to meet its !rimaryhealth care needs.
ercentage of o!ulation used CM
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ercentage of o!ulation used CM
tleast (nce
Sources: Fisher P !ard "# $%%%& 'ealth Canada# ())$# !orld 'ealth *rgani+ation# $%%,-.#,#/
Commonly used TM/CM thera!ies
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Commonly used TM/CM thera!ies
and thera!eutic techniques
More and More Countries are
7/25/2019 SBOA Obat Herbal
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*egulating 'erbal Medicines
Source: !orld 'ealth *rgani+ation# $%%,0$ and data collected b1 !orld 'ealth *rgani+ation during period $%%%–())$-
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Thank 7ou
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