Regulatory System on Herbal Drug :

Indonesia Perspective

Deputy For Traditional Medicine, Cosmetic and

Complementary Product Control
NADFC of The Republic of Indonesia
South Korea, 4th September 2013
Indonesia is the 2nd richest of biological diversity
in the world, if marine organisms are accounted,
Indonesia becomes the richest in the world
Many of them have been used over generations for
human welfare in the promotion of health,
prevention and treatment of diseases as well as for
rehabilitation.
In Indonesia, herbal drug or natural sources used
for medication is officially named as Traditional
Medicines

Prior marketing, Traditional Medicines should be

registered to NADFC for quality, safety and
efficacy assessment
 NADFC
National Agency of Drug and Food Control of
The Republic of Indonesia
VISION
TO BE AN INOVATIVE, CREDIBLE AND INTERNATIONALLY RECOGNIZED
INSTITUTION OF CONTROL OF DRUG AND FOOD IN ORDER TO PROTECT
PUBLIC

MISSION
• Performing control of pre-market and post-market
using international standard
• Implementing quality management system
consistently
• Optimizing partnership with stakeholder in the
various lines
• Empowering public to be able to protect themselves
from the Drug and Food that have risk to health
• Building a learning organization
 MAIN FUNCTIONS
• Legislation, regulation and standardization;
• Licensing and certification of pharmaceutical industries based
on Good Manufacturing Practices;
• Pre-market evaluation of products;
• Post-marketing vigilance including product sampling and
laboratory testing, inspection of production and distribution
facilities, investigation and law enforcement;
• Pre-audit and post-audit of product advertisement and
promotion;
• Research on drug and food policies implementation;
• Public communication, information and education including
public warning
 COMMODITIES
Under NA-DFC Control

• Pharmaceuticals
• Biologicals, including vaccines
• Narcotic and Psychotropics
• Traditional Medicines
• Food Supplements
• Processed Foods
• Cosmetics
• Hazardous Substances
CATCHMENT AREAS
 Three layers of Control Sub-System
•Enhanced knowledge and
Consumer
Protection increased awareness on
Act products quality and safety
Consumer •Self control by the consumer

•Pre-market registration and

post-market control
Government •Communication, information
and education of consumers

•Producer should have an internal

control system for complying with
Producer the requirements of the GMP
•By law, the producer is responsible
for product quality and safety.

Optimal consumer protection

 HEAD OF NADFC

Inspectorate PERMANENT SECRETARY

• Bureau of Planning and Financing

• Bureau of International Cooperation
• Bureau of Legislation & Public Relation
• Bureau of General Affairs

TM National
Laboratory of
Centre of Drug Centre of Centre of
& Food Drug & Food Drug & Food
Drug & Food
Investigation Research Information
Control

DEPUTY FOR THERAPEUTIC DEPUTY FOR TRADITIONAL

DEPUTY FOR FOOD SAFETY AND
PRODUCTS AND NARCOTICS, MEDICINES, COSMETIC AND
HAZARDOUS SUBSTANCES
PSYCHOTROPIC AND ADDICTIVE COMPLEMENTARY PRODUCT
CONTROL
SUBSTANCES CONTROL CONTROL

Directorate for: Directorate for: Directorate for:

• Drug and Biological Products Evaluation
• Therapeutic Products Standardization
• Therapeutic Product and Consumer Goods
Production Control
• Therapeutic Product and Consumer Goods
Distribution Control
• Narcotics, Psychotropic and Addictive
Substance Control
• Traditional Medicines, Food Supplemen
and Cosmetic Evaluation
• Traditional Medicines, Cosmetic and
Complementary Product Inspection and
Certification
• Traditional Medicines, Cosmetic and
Complementary Product Standardization
• Indonesia Indigenous Medicines
• Food Safety Evaluation
• Food Products Standardization
• Food Products Inspection and Certification
• Surveilance and Food Safety Extension
• Product and Hazardous Substances Control

31 Regional Offices
 TRADITIONAL MEDICINE
DEFINITION
(Decree of Minister of Health No. 007 year 2012)
Substances or mixture of substances forming from herbs, plants,
animal parts and/or mineral raw materials, galenic preparation
which has been used for generations for medication and can be
applied in accordance with community norms

1. Decree of Minister of Health No. 006 year 2012

Regulation regarding License of Traditional Medicine
Manufacturer
2. Decree of Minister of Health No. 007 year 2012
regarding Registration of Traditional Medicine
3. Decree of the Head of NADFC No. HK.00.05.41.1384
year 2005 regarding Criteria and Procedure of
Traditional Medicine Procedure Registration
4. Decree of the Head of NADFC No. HK.00.05.4.2411
year 2004 regarding TM Classification and Labelling
5. Decree of the Head of NADFC No. HK.00.05.4.1380
year 2005 regarding GMP Guideline for TM
 POLICY ON TM 2010-2014

ü Revitalizaton of jamu position in the contex of

health maintaining
ü Improvement of safety, efficacy and quality
aspects as well as quality assurance
ü Improvement Jamu industries regarding to
Standard and quality requirements
ü Prevention of drug adulteration in Jamu
qCLASSIFICATION AND LABELLING OF JAMU
qENCOURAGE JAMU RESEARCH BY EXPLORING THE POTENCY
OF INDONESIAN HERBAL THROUGH GOOD CLINICAL
PRACTICE
qDEVELOPMENT OF GUIDELINE ON JAMU, INDONESIA
HERBAL PHARMACOPEIA, AND HERBAL PLANT EXTRACT
MONOGRAPH
qENCOURAGE GOOD MANUFACTURING PRACTICE FOR JAMU
WITH GRADUAL IMPLEMENTATION
qSTRENGTHENING LAW ENFORCEMENT OF DRUG
ADULTRATION IN JAMU
qPROMOTING THE USE OF JAMU IN HEALTH MAINTENANCE
qSYNERGISTIC COLLABORATION BETWEEN RELEVANT
PARTIES FOR JAMU DEVELOPMENT
qEDUCATION FOR TM SME’s TO FULFILL HYGIENE,
SANITATION AND DOCUMENTATION REQUIREMENTS BY
NEW INITIATIVE PROGRAMME IN 2013
 Development Stages and Classification
Of Indonesian Traditional Medicine

Empirical
Jamu
Quality Test
Self Medication

•Pre Clinical Study (Toxicity , Efficacy)

Standardized Herbal •Standardized Raw Material
Medicines
Quality Test

•Clinical Study
•Standardized Raw Material and
Finished Product
Quality Test
 NADFC ROLES
IN TRADITIONAL MEDICINES CONTROL
Pre-Market
Evaluation
• Before sold or distributed
throughout Indonesia, traditional
medicine products should be
registered to Indonesia FDA;
except products which are produced
by home industries or Jamu peddler
that is freshly prepared and
marketed in a very limited area.
Post-Market
Control
• Inspection of manufacturer and
distribution facilities
• Product sampling and
laboratory testing
• Monitoring of advertisement,
promotion and labeling
• Monitoring adverse reaction
• Consumer education and public
warning
• Sanction and law enforcement
There are two steps of Registration as follows :
1. Pre evaluation step :
To determine evaluation path,
completeness and validity of registration
documents, registration fee.

2. Evaluation step:
Submission of registration documents and
evaluation process.
FLOW OF EVALUATION STEP
APPLICANTS
COMPLETTE
DOC

NATIONAL
Ad Hoc COMMITTEE
Committee On ON EVALUATION
Evaluation Of TM OF TRAD. MEDICINE
NADFC
Safety, EVALUATION
OF CLINICAL TRIAL
Efficacy,
Quality,
Labeling

REJECTION APPROVAL ADD DATA

Certif.Of Registration
Approval
 REGISTRATION REQUIREMENTS
1. ADMINISTRATION REQUIREMENTS

Certificate of manufacturer licensed for

TMs or Certificate of impoter for TMs
Trade Bussiness License, General Importer
Number and Registered Importer Certificate for
the Importer

Letter of Authorization

Good Manufacturing Practices (GMP)

Certificate

Certificate of Free Sale (CFS) or Certificate of

Pharmaceutical Products issued by Government
2. TECHNICAL 1. Microbial contaminant test result
2. Heavy Metal Test : Hg, Pb, Cd, As
REQUIREMENTS SAFETY 3. Quantitative: Preservative Test,
alcohol content
4. Mold and Yeast count test/Total
Plate Count
5. Prohibited Substance Test, such
as chemical substances, narcotic,
QUALITY psychotropic
EFFICACY
6. Toxicity (Acute, Sub acute, Special
Toxicity) if needed
1. Qualitative Test:
Identification
2. Quantitative: Water
Content, disintegration Labeling/ Product
Time Test Result Information
3. Manufacturing Process Levels of the Active
Substances
4. CoA of Raw Material
5. CoA of finish product Empiric
1. Indication or claim
6. Stability Study: 30 ± 2 Pharmacodynamic
oC / RH 75 ± 5 % 2. Direction of use Clinical Trial
7. Finished Product 3. Packaged Size
Specification
4. Composition
8. Formula: active and
excipient 5. Expired date
6. Etc.
LABELING OF TRADITIONAL MEDICINES
n Product name
n Dosage form
n Net weight or net content
n Manufacturer and importer name and address
n Indication/usage
n Direction of use and serving dosage
n List/Strength of active ingredients (AI)
n Contraindication, warning, side effect (if any)
n Alcohol content (if any)
n Registration No.
n Batch/Lot No.
n Manufacturing date
n Expiry date
n Storage condition

All of information above should be mentioned in Indonesian

language
 PROHIBITION FOR TM
1. Containing any chemical substances include
pharmaceutical substances, narcotic, psychotropic
2. Containing of any banned ingredients (30 simplicia
in a negative list) and endangered species.
3. Dosage form: parenteral, eye drop, intra vaginal
preparation and suppository (except for hemorrhoid)
4. Ethanol more than 1% (except for tincture, which is
used by dilution)
 Products Withdrawal
Decree of the Head of NADFC No. HK.00.05.41.1384 year 2005

The marketed product can be cancelled or withdrawn due to :

a. The obligation as referred in Article 4 is not met, such as :

uncompliance of raw material safety and quality, or
uncompliance of GMP;
b. Labeling and promotion deviated from marketing
authorization or ;
c. The obligation as referred in Article 31 is not met, such as :
the particular product should be imported at the latest 1
year after the approval is issued;
d. Within 24 consecutive months the particular TM is not
manufactured nor imported nor marketed;
e. The industry license of applicant, manufacturer or marketer
of product is revoked;
f. Marketing authorization holder violates the provisions on
the manufacturing and/or marketing of the TM.
INDONESIA MARKET SHARE
FOR HERBAL DRUG

YEAR VALUE
(Billion)
2006 US$ 0.5
2007 US$ 0.6
2008 US$ 0.72
2012 US$ 1.3
•IMPORTERS : 346

•INDUSTRIES : 948
 Registered TM Products
2008 – June 2013

Category Total
Jamu 8522

Standardized Herbal 41
Medicine
Phytopharmaca 6
 Registered TM Products From
South Korea
2008 – June 2013

Category Traditional Medicine

Total Number of Korean Products 16

Total Number of Imported Products 1338

% Total Number of Registered Korean 1.19%

Products compared to Total Imported
Products
 Claim 2012
General health 20%
Immune system 11%
Women’s health 11%
Joint health 10%
Others 48%
 Claim 2008 – June 2013

General health 37.5%

Digestion health 19%
Blood circulation 12.5%
Stamina 12.5%
Others 18.5%