DIRECTORATE OF RATIONAL DRUG USE DG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES MINISTRY OF HEALTH, INDONESIA.

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Presentation transcript:

DIRECTORATE OF RATIONAL DRUG USE DG OF PHARMACEUTICAL SERVICE & MEDICAL DEVICES MINISTRY OF HEALTH, INDONESIA

NATIONAL POLICY TRADITIONAL MEDICINES IS 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 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 SAFE EFECTIVE QUALITY RATIONAL USE (WHO) LEGAL STATUS OF TRADITIONAL MEDICINE AND 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 SAFE EFECTIVE QUALITY SAFE EFECTIVE QUALITY GMP-TM (Good Manufacturing Practice – Traditional Medicines) MoH Decree No: 659 / 1991 (KEPMENKES No: 650 Th 1991)

STEPS FOR DEVELOPMENT STEP I: PRE-CLINICAL TEST TOXYICITY TEST PHARMACODYNAMICAL TEST SAFETY EFFICACY

SAFETY TOXYCITY TOXYCITY: GENERALTOXYCITY SPECIFICTOXYCITY ACUTE (LD50) SUB-ACUTECHRONICTERATOGENICMUTAGENICCARCINOGENIC

STEP II INITIAL STANDARDIZATION STEP III PHARMACEUTICAL TECHNOLOGY WHICH DEFINE IDENTITY ACURATELY TO STANDARIZED PRODUCT

STEP IV EFFICACY: CLINICAL TEST ACCORDING TO GCP (GOOD CLINICAL PRACTICES) RANDOMIZED DOUBLE BLIND CONTROL DOUBLE BLIND CONTROL

CLINICAL TEST RESULTS AS A CONDITION FOR REGISTRATION FURTHER UTILIZATION IN FORMAL HEALTH CARE 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

SP3T CENTRE 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/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 1981 TM 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