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POLICY OF TRADITIONAL MEDICINES. DIRECTORATE OF RATIONAL DRUG USE DG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES MINISTRY OF HEALTH, INDONESIA. NATIONAL POLICY. TRADITIONAL MEDICINES IS AN INTEGRAL PART OF HEALTH CARE ENSURING ITS SAFETY, EFFICACY & QUALITY

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POLICY OF

TRADITIONAL MEDICINES

DIRECTORATE OF RATIONAL DRUG USE

DG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES

MINISTRY OF HEALTH, INDONESIA


National policy
NATIONAL POLICY

TRADITIONAL MEDICINES IS

AN INTEGRAL PART OF HEALTH CARE

ENSURING ITS SAFETY, EFFICACY & QUALITY

SUPPORT FURTHER DEVELOPMENT AND IMPROVEMENT OF FORMS OF TRADITIONAL MED.

DEEMED SAFE & EFFICACIOUS

IN ORDER TO FULFIL THE GOAL OF

OPTIMAL HEALTH FOR THE COMMUNITY

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


Policy
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/1983


WHO

ENCOURAGES AND SUPPORTS

THE INTEGRATION OF

TRADITIONAL AND COMPLEMENTARY

MEDICINE

INTO

NATIONAL HEALTH CARE SYSTEM

AND TO ENSURE

THEIR RATIONAL USE

(LEGAL STATUS OF TCM, WHO 2001)


Traditional medicines should comply
TRADITIONAL MEDICINES should comply

SAFE

EFECTIVE

QUALITY

RATIONAL USE

(WHO) LEGAL STATUS OF TRADITIONAL MEDICINE

AND COMPLEMENTARY/ ALTERNATIVE MEDICINE, 2002


Classification
CLASSIFICATION

JAMU (HERBAL MEDICINES)

EKSTRAK TERSTANDAR

(STANDARIZED EXTRACT)

FITOFARMAKA (PHYTOPHARMACY)


TM

  • TOXYCITY TESTACUTE (LD50)

    • SUBACUTE

    • CHRONIC

    • MUTAGENICITY

    • TERATOGENICITY

    • EMBRIOTOXICITY

    • CARSINOGENICITY

    • CLINICAL TEST (RCT)

    • (MoH Decree No: 56 / 2000)

(KEPMENKES No: 650 Th 1991)

SAFE

EFECTIVE

QUALITY

  • GMP-TM

  • (Good Manufacturing Practice – Traditional Medicines)

  • MoH Decree No: 659 / 1991


Steps for development
STEPS FOR DEVELOPMENT

STEP I:

PRE-CLINICAL TEST

TOXYICITY TEST

PHARMACODYNAMICAL TEST

EFFICACY

SAFETY


Safety
SAFETY

TOXYCITY:

GENERAL

TOXYCITY

SPECIFIC

TOXYCITY

ACUTE (LD50)

SUB-ACUTE

CHRONIC

TERATOGENIC

MUTAGENIC

CARCINOGENIC


Step ii
STEP II

INITIAL STANDARDIZATION

STEP III

PHARMACEUTICAL TECHNOLOGY

WHICH DEFINE IDENTITY ACURATELY

TO STANDARIZED PRODUCT


Step iv
STEP IV

EFFICACY:

CLINICAL TEST

ACCORDING TO GCP

(GOOD CLINICAL PRACTICES)

RANDOMIZED

DOUBLE BLIND CONTROL


Clinical test
CLINICAL TEST

RESULTS

AS A CONDITION FOR REGISTRATION

FURTHER UTILIZATION IN FORMAL HEALTH CARE EFFORTS

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


Phytopharmacy
PHYTOPHARMACY

TRADITIONAL MEDICINES

WHICH HAVE BEEN PROVEN

SAFE, EFECTIVE

QUALITY

STANDARDIZED

MoH Decree No: 760 / 1992


Phytopharmacy1
PHYTOPHARMACY

EQUAL TO MODERN MEDICINES

ABLE TO PRESCRIBED BY PHYCISIANS

ABLE TO UTILIZED

IN A FORMAL HEALTH CARE FACILITIES


Phytopharmacy2
PHYTOPHARMACY

TENSIGARD

PHYTODIAR

RHEUMANEER

X GRA

STIMUNO


SP3T

CENTRE OF

DEVELOPMENT & APPLICATION TRADITIONAL MEDICINES

PERFORM CLINICAL TESTING POTENTIAL ADVANCED TO PHYTOPHARMACY

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


Traditional medicines
TRADITIONAL MEDICINES

PROHIBITED

MIXED/COMPOUNDED

WITH MODERN MEDICINES

MoH Decree 246/Menkes/Per/V/1990


MoH Decree No 1147/D/SK/IV/81 23 JUNE 1977PROHIBIT PROCUCTION & DISTRIBUTIONSUPOSITORIA,INTRAVAGINAL & EYE DROPS OF TM

GUIDELINE OF TRADITIONAL MEDICINES

1985 LABELLING TM

1993 REGULATION TM

MoH Decree No 1516/A/81, 15 MAY 1981

TM CONTAIN ETANOL


Medication with tm
MEDICATION WITH TM

SHORT TERM

SAFETY PROVEN

LONG TERM

SAFETY & EFICACY PROVEN


Development strategy
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

THANK YOU

TERIMA KASIH


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