COMBATING COUNTERFEIT DRUGS IN INDONESIA

COMBATING
COUNTERFEIT
DRUGS IN
INDONESIA
National Agency of Drug and Food Control
Indonesia
First ASEAN-China Conference on Combating
Counterfeit Medical Products
Jakarta, 13-15 November 2007
BACKGROUND
INDONESIA
located between two continents and two
oceans, which is easily accessible by land, sea,
or air.
some problems are still being faced, including in
the field of drug control.
problems may arise from borderline areas,
which are susceptible to smuggled, counterfeit
medicines.
Regarding counterfeit medicines they may be
Illegally imported or
Distributed
Locally manufactured by
to illegal
illegal manufacturer
market
NUMBER OF INTERNATIONAL PORT
 SEAPORT : 141
 AIRPORT : 10
FREE TRADE ZONE
 Free Trade Zone BATAM, including Batam Island, Tonton
Island, Setotok Island, Nipah Island, Rempang Island,
Galang Island and Galang Baru Island.
 Free Trade Zone BINTAN, including Galang Batang
Industrial Estate, Maritim Industrial Estate, and Loban
Island, Senggarang Industrial Estate and Dompak Barat
Industrial Estate
 Free Trade Zone KARIMUN, including number of
Karimun Island, Karimun Anak Island
 Free Trade Zone SABANG.
LEGISLATIVE
INFRASTRUCTURE
BORDER POST
 Efforts have been taken by establishing Border Posts in some areas,
i.e :
 SKOU (Papua New Guinea)
 MOTA AIN, NAPAN & META MAUK (Timor Leste)
 MARORE & MIANGAS (Philipine)
 ENTIKONG & JAGOI BABANG (East Malaysia Land)
 NUNUKAN (East Malaysia Ocean)
 SUNGAI GUNTUNG (West Malaysia Ocean)
 SAMBU BELAKANG, PADANG & TAREMPA (West Malaysia
Ocean)
 Objective :
To control imported goods
To minimize illegal & counterfeit drugs entering the
country
Definition
Counterfeit Drugs (CD’s) definition in
Indonesia based on Indonesian MoH
Decree No. 949/2000 :
A medicinal product which is manufactured
by illegal manufacturer or deliberately
mislabeled with respect to identity of
registered product.
Basic Law and Regulation related drug
counterfeiting
1.
2.
3.
4.
5.
Law No. 1/1946 on Criminal Act
Law No. 23/1992 on Health
Law No. 8/1999 on Consumer Protection
Law No. 14/2001 on Patent
Law No. 15/2001 on Mark
NUMBER OF CASES
ILLEGAL SECTOR OPERATION RESULT
(NADFC DATA)
PERIODE 2005 - October 2007
Number of Cases
60
51
50
40
37
Total
28
30
20
14
13 15
Illegal Imported
products
21 19
Counterfeit drugs
10
2
0
2005
2006
Year
2007
COUNTERFEIT DRUGS (55 ITEMS)
PERIODE 2005 - October 2007
9%
15%
4%
7%
28%
2%
4%
11%
7%
4%
9%
analgetic
antiinfection
antihistamine
antidiabetic
antihipertensi
afrodisiak
antiinflamasi
transquilizer
hormon
others
vitamin
FINDINGS ON CASE I (2007)
13%
counterfeit drugs
22%
IIlegal imported drugs
Not confirmed yet
65%
FINDINGS ON CASE II (2007)
27%
29%
counterfeit drugs
IIlegal imported drugs
original
10%
Not confirmed yet
34%
COUNTERFEIT DRUGS FINDING FREQUENCIES
PERIOD 2001-2007 (October)
Ponstan 500 mg
Fansidar tablet
obat palsu
drugs
Counterfeit
Dextamine tablet
Daonil tablet
Ponstan 250 mg kapsul
Lasix tablet
Incidal kapsul
Supertetra soft cap
Fulcin 500 mg tablet
Broadced inj 1 g
Amoxsan 500 kapsul
0
1
2
3
4
5
frekuensifrequency
temuan per 7 tahun terakhir
* The data is made from finding frequencies > 3 times
6
7
NUMBER OF CASES
SUSPECTED CONFIRMED IMPORTED /
DOSMETIC
VITAL
MEDICAL
2007 2 *
2
Import and
Domestic
Yes
2006 1
1
Domestic
No
2005 3
3
Domestic
Yes (injectable)
* a result of joint operation whereby an illegal warehouse was found filled with
thousand of boxes of 26 items of counterfeit medicines, with an estimated
value of up to 25 billion rupiahs
HOW WHERE THESE CASES DETECTED
% or number of cases
Patients complaints
NO DATA AVAILABLE
Health professionals reports
NO DATA AVAILABLE
Enforcement/investigation work
NO DATA AVAILABLE
Routine checks
NO DATA AVAILABLE
Reported by affected manufacturer
28,6% (2005), 20 % (2006),
4,16% (2007)
NUMBER OF PROSECUTIONS / CONVICTIONS/PENDING
NADFC DATA
MANUFACTUR
ER
WHOLESALER /
IMPORTER
RETAILER
INFORM
AL
SECTOR
2007 1( in
process)
1 (in process)
2006 -
-
1 (in
process)
2005 -
-
3 (2
Sentence
penalty, 1
Wanted List)
-
NATIONAL
COORDINATION
Mechanism of national coordination
Combating Counterfeit Drugs requires joint effort
Government
Drug/National Regulatory
Authority
Drug
medicines
manufacturers
importers &
wholesalers
Healthcare &
medicine
providers
medicines
Civil societies
Patient Interest Groups
Ministries, police,
customs,
Prosecutors
Patients /
consumers
BENEFITS & LIMITATIONS OF COORDINATION
 BENEFITS
 Technical support such as laboratory test, expert witness statement
will be provided by NADFC if needed
 If facing difficulties, force effort will be provided by the Police
 Provided information of import-registered products for the custom
 Several Laws and regulation as basic legal process to combat
Counterfeit Drugs are available
• LIMITATIONS
 Lack of the reference standard available in NQCL
 Lack of coordination among law enforcement agencies at all level
(National-provincial-district)
 On-line system is not in place
 Weakness of Implementation of some Laws, such as need appeal
from the manufacturing authorization holder of authentic drugs
STRATEGIC ACTION ON COMBATING COUNTERFEIT
DRUGS (CDs) in INDONESIA
ILEGAL MANUFACTURER
ILLEGAL MARKET
CONSUMER
National Program ;
ILEGAL DISTRIBUTOR
FACTS :
•
CDs are found, mostly
in illegal market
•
Difficult to
differenciate with
the genuine one
•
Lack of public
awareness
(consumers buy drugs
in the illegal market)
STRATEGIES :
• Breaking up the
Illegal chain
• Sustainable law
enforcement with
deterrent
penalties
• Reveal modus
operandi, identify
the intellectual
actors and their
network
•
•
•
•
•
•
Comprehensive investigation and
mopping-up what is already in
circulation
National Joint Operation and
joint investigatin with police (in
ilegal market)
Strenghtening the
infrastructure
Improvement collaboration and
coordination with other law
enforcement agencies
Increasing comprehensive drug
distribution control
Increasing public awareness and
law enforcement agencies
REGIONAL LEVEL
GAPS
IMPLICATIONS
STRATEGY
 Inter-sectoral coordination
is not based on written
procedure which are clearly
defined roles, adequate
resources and effective
administrative and
operational tools.
 Lack of awareness about
the severity of the problem
among stakeholder.
 No comprehensive
program on
combating
counterfeit drugs
 Develop national tskforce on intersectoral coordination base on written
procedures, clearly defined roles,
adequate resources, and effective
administrative and operational tools.
 No deterrent
sanctions
 No specific law on
Counterfeit Drugs.
 Limitation of reference
standard on NQCL
 No deterrent
sanctions
 The time line of lab
result is not on
schedule
 Increasing awareness on the
harmful/impact of counterfeit drugs
through seminar for the specific target
groups such as Pharmaceutical
Manufacturer, Health professionals,
patients, training for Law enforcement
Agencies, and DRA
 Assist national authorities to develop
risk communication and advocacy
materials
 Develop draft on counterfeit drugs Law
 Need collaboration to get reference
atandard assist by WHO
REGIONAL LEVEL
GAPS
IMPLICATIONS
STRATEGY
 Lack of Information
difficulties on
Promote networking and
Exchange among
contacting the
collaboration among ASEAN DRA
countries, no designated
person in charge
on counterfeit drugs
person in charge at DRA
 Different definition of
Different follow
Develop TOR which are include
Counterfeit Drugs
up action
discussion among ASEAN
among Countries
countries on :
 Lack of networking on
 the definition of counterfeit
Counterfeit drugs
difficulty to know
drugs.
problem among ASEAN
the genuity of
 Survey existing national and
DRAs
the suspected
international legislation &
drug
requirements
Difficulty to trace
 Assess existing national best
practices and develop model
the suspect if
best practices
they escape to
Promote secure exchange of
other countries
information and alerts among
ASEAN DRA
Proposed Project against Counterfeit Drugs
ASEAN Project on Strengthening Collaboration on Combating
Counterfeit Drugs
 Development of common definition of counterfeit drug
within ASEAN Countries
Development ASEAN Scheme on tackling of counterfeit drugs
Development a Regional Strategy and Systematic Program
OUTPUT
Exchange of information by designated unit of DRA
Develop data base of counterfeit drugs
Develop Alert System
CONCLUSION
 No adequate data on “how where the cases
detected” showed that reported mechanism is
not in place as well as awareness of severity of
the cases
 Weaknesses on inter sectoral coordination due
to some factor i.e : no written standardized
procedure, no specific law on counterfeit
medical product.
 Lack of networking on combating counterfeit
medical product in regional, i.e : among ASEAN
countries.
EXPECTATION
Establish national and regional taskforce
on combating counterfeit drugs
Combating counterfeit drugs need
international support
still a long way to go!
ENTIKONG
NUNUKAN
SKOU
JAGAOI BABANG
back
MIANGAS
& MARORE
SUNGAI
GUNTUNG
TAREMPA, SAMBU
BELAKANG PADANG
back
MOTA AIN, NAPAN,
META MAUK