DIRECTORATE OF RATIONAL DRUG USEDG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES

MINISTRY OF HEALTH, INDONESIA

NATIONAL POLICYNATIONAL POLICY

TRADITIONAL MEDICINES IS TRADITIONAL MEDICINES IS AN INTEGRAL PART OF HEALTH CARE AN INTEGRAL PART OF HEALTH CARE

ENSURING ITS SAFETY, EFFICACY & QUALITYENSURING ITS SAFETY, EFFICACY & QUALITY

SUPPORT FURTHER DEVELOPMENT AND IMPROVEMENT OF FORMS OF SUPPORT FURTHER DEVELOPMENT AND IMPROVEMENT OF FORMS OF TRADITIONAL MED. TRADITIONAL MED.

DEEMED SAFE & EFFICACIOUS DEEMED SAFE & EFFICACIOUS IN ORDER TO FULFIL THE GOAL OF IN ORDER TO FULFIL THE GOAL OF

OPTIMAL HEALTH FOR THE COMMUNITYOPTIMAL HEALTH FOR THE COMMUNITY

MoH DECREE No: 47/MENKES/SK/II/1983MoH DECREE No: 47/MENKES/SK/II/1983

POLICY

PROTECT THE COMMUNITY FROM DISADVANTAGE AND HAZARDS OF SUBSTANDARD PRODUCTS

CLINICAL PROVEN TRADITIONAL MEDICINES NEED TO BE DEVELOPED AND TO BE UTILIZED IN MEDICAL CARE FOR COMMNUNITY

MoH DECREE No: 47/MENKES/SK/II/1983MoH DECREE No: 47/MENKES/SK/II/1983

WHO

ENCOURAGES AND SUPPORTSTHE INTEGRATION OF TRADITIONAL AND COMPLEMENTARYMEDICINE INTO NATIONAL HEALTH CARE SYSTEMAND TO ENSURETHEIR RATIONAL USE

(LEGAL STATUS OF TCM, WHO 2001)

TRADITIONAL MEDICINES should comply

SAFE

EFECTIVE

QUALITY

RATIONAL USE

(WHO) (WHO) LEGAL STATUS OF TRADITIONAL MEDICINE LEGAL STATUS OF TRADITIONAL MEDICINE

AND COMPLEMENTARY/ ALTERNATIVE MEDICINE, 2002AND COMPLEMENTARY/ ALTERNATIVE MEDICINE, 2002

CLASSIFICATION

JAMU (HERBAL MEDICINES)

EKSTRAK TERSTANDAR (STANDARIZED EXTRACT)

FITOFARMAKA (PHYTOPHARMACY)

TOXYCITY TEST ACUTE (LD50)

SUBACUTE

CHRONIC

MUTAGENICITY

TERATOGENICITY

EMBRIOTOXICITY

CARSINOGENICITY

CLINICAL TEST (RCT) (MoH Decree No: 56 / 2000)

TM

SAFEEFECTIVEQUALITY

SAFEEFECTIVEQUALITY

GMP-TM

(Good Manufacturing Practice – Traditional Medicines) MoH Decree No: 659 / 1991

(KEPMENKES No: 650 Th 1991)

STEPS FOR DEVELOPMENTSTEP I:STEP I:

PRE-CLINICAL TESTPRE-CLINICAL TEST

TOXYICITY TESTTOXYICITY TEST PHARMACODYNAMICAL TESTPHARMACODYNAMICAL TEST

SAFETYSAFETY EFFICACYEFFICACY

SAFETY

TOXYCITYTOXYCITY:

GENERALGENERALTOXYCITYTOXYCITY

SPECIFICSPECIFICTOXYCITY TOXYCITY

ACUTE (LD50)ACUTE (LD50)SUB-ACUTESUB-ACUTE

CHRONICCHRONIC

TERATOGENICTERATOGENICMUTAGENICMUTAGENIC

CARCINOGENICCARCINOGENIC

STEP II

INITIAL STANDARDIZATIONINITIAL STANDARDIZATION

STEP IIISTEP III

PHARMACEUTICAL TECHNOLOGY PHARMACEUTICAL TECHNOLOGY WHICH DEFINE IDENTITY ACURATELYWHICH DEFINE IDENTITY ACURATELY

TO STANDARIZED PRODUCTTO STANDARIZED PRODUCT

STEP IV

EFFICACY: EFFICACY:

CLINICAL TEST CLINICAL TEST

ACCORDING TO ACCORDING TO GCPGCP

(GOOD CLINICAL PRACTICES)(GOOD CLINICAL PRACTICES)

RANDOMIZEDRANDOMIZED

DOUBLE BLIND CONTROLDOUBLE BLIND CONTROL

CLINICAL TEST

RESULTSRESULTS

AS A CONDITION FOR REGISTRATION AS A CONDITION FOR REGISTRATION

FURTHER UTILIZATION IN FORMAL HEALTH FURTHER UTILIZATION IN FORMAL HEALTH CARE EFFORTSCARE EFFORTS

KEPMENKES No: 56/MENKES/SK/I/2000

PHYTOPHARMACY

TRADITIONAL MEDICINES

WHICH HAVE BEEN PROVEN

SAFE, EFECTIVE

QUALITY

STANDARDIZED

MoH Decree No: 760 / 1992

PHYTOPHARMACY

EQUAL TO MODERN MEDICINES

ABLE TO PRESCRIBED BY PHYCISIANS

ABLE TO UTILIZED

IN A FORMAL HEALTH CARE FACILITIES

PHYTOPHARMACY

TENSIGARD

PHYTODIAR

RHEUMANEER

X GRA

STIMUNO

SP3TCENTRE OF

DEVELOPMENT & APPLICATION TRADITIONAL MEDICINES

PERFORM CLINICAL TESTING POTENTIAL ADVANCED TO

PHYTOPHARMACY

(MoH Decree No. 0584/MENKES/SK/VI/1995)

TRADITIONAL MEDICINES

PROHIBITED

MIXED/COMPOUNDED

WITH MODERN MEDICINES

MoH Decree 246/Menkes/Per/V/1990MoH Decree 246/Menkes/Per/V/1990

MoH Decree No 1147/D/SK/IV/81 23 JUNE 1977

PROHIBIT PROCUCTION & DISTRIBUTION SUPOSITORIA, INTRAVAGINAL & EYE DROPS OF TM

GUIDELINE OF TRADITIONAL MEDICINES

1985 LABELLING TM

1993 REGULATION TM

MoH Decree No 1516/A/81, 15 MAY 1981TM CONTAIN ETANOL

MEDICATION WITH TM

SHORT TERM

SAFETY PROVEN

LONG TERM

SAFETY & EFICACY PROVEN

DEVELOPMENT STRATEGY

DATA COLLECTION

DEVELOP MEDICATION GUIDELINES

DEVELOP PILOT PROJECT

MONITORING & EVALUATION

DEVELOP TO PHYTOPHARMACY

NOT YET PROVEN IN SAFETY AND EFICACY

ABLE TO UTILIZED OUTSIDE FORMAL MEDICAL CARE

BY MEDICAL STAFF

FOR RESEARCH PURPOSE

COMPLY WITH GOOD CLINICAL PRACTICE (GCP)

TM

TM