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COMBATING COUNTERFEIT DRUGS IN INDONESIA

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COMBATING COUNTERFEIT DRUGS IN INDONESIA National Agency of Drug and Food Control Indonesia First ASEAN-China Conference on Combating Counterfeit Medical Products – PowerPoint PPT presentation

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Title: COMBATING COUNTERFEIT DRUGS IN INDONESIA


1
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

2
BACKGROUND
3
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
  • Locally manufactured by
  • illegal manufacturer

4
FREE TRADE ZONE
NUMBER OF INTERNATIONAL PORT
  • SEAPORT 141
  • AIRPORT 10
  • 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.

5
LEGISLATIVE INFRASTRUCTURE
6
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

7
Definition
  • Counterfeit Drugs (CDs) 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.

8
Basic Law and Regulation related drug
counterfeiting
  1. Law No. 1/1946 on Criminal Act
  2. Law No. 23/1992 on Health
  3. Law No. 8/1999 on Consumer Protection
  4. Law No. 14/2001 on Patent
  5. Law No. 15/2001 on Mark

9
NUMBER OF CASES
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14
COUNTERFEIT DRUGS FINDING FREQUENCIESPERIOD
2001-2007 (October)
Counterfeit drugs
frequency
The data is made from finding frequencies gt 3
times
15
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
16
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)
17
NUMBER OF PROSECUTIONS / CONVICTIONS/PENDING
NADFC DATA
MANUFACTURER WHOLESALER / IMPORTER RETAILER INFORMAL SECTOR
2007 1( in process) 1 (in process)
2006 - - 1 (in process) -
2005 - - 3 (2 Sentence penalty, 1 Wanted List) -
18
NATIONAL COORDINATION
19
Mechanism of national coordinationCombating
Counterfeit Drugs requires joint effort
medicines
20
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-distric
    t)
  • 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

21
STRATEGIC ACTION ON COMBATING COUNTERFEIT DRUGS
(CDs) in INDONESIA
CONSUMER
ILEGAL MANUFACTURER
ILLEGAL MARKET
  • National Program
  • 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

ILEGAL DISTRIBUTOR
  • STRATEGIES
  • Breaking up the Illegal chain
  • Sustainable law enforcement with deterrent
    penalties
  • Reveal modus operandi, identify the intellectual
    actors and their network
  • 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)

22
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 specific law on Counterfeit Drugs. Limitation of reference standard on NQCL No comprehensive program on combating counterfeit drugs No deterrent sanctions No deterrent sanctions The time line of lab result is not on schedule Develop national tskforce on inter-sectoral coordination base on written procedures, clearly defined roles, adequate resources, and effective administrative and operational tools. 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
23
REGIONAL LEVEL
GAPS IMPLICATIONS STRATEGY
Lack of Information Exchange among countries, no designated person in charge at DRA Different definition of Counterfeit Drugs among Countries Lack of networking on Counterfeit drugs problem among ASEAN DRAs difficulties on contacting the person in charge Different follow up action difficulty to know the genuity of the suspected drug Difficulty to trace the suspect if they escape to other countries Promote networking and collaboration among ASEAN DRA on counterfeit drugs Develop TOR which are include discussion among ASEAN countries on the definition of counterfeit drugs. Survey existing national and international legislation requirements Assess existing national best practices and develop model best practices Promote secure exchange of information and alerts among ASEAN DRA
24
Proposed Project against 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

ASEAN Project on Strengthening Collaboration on
Combating Counterfeit Drugs
  • OUTPUT
  • Exchange of information by designated unit of DRA
  • Develop data base of counterfeit drugs
  • Develop Alert System

25
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.

26
EXPECTATION
  • Establish national and regional taskforce on
    combating counterfeit drugs
  • Combating counterfeit drugs need international
    support

27
still a long way to go!
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30
ENTIKONG
NUNUKAN
SKOU
JAGAOI BABANG
back
31
MIANGAS MARORE
SUNGAI GUNTUNG
MOTA AIN, NAPAN, META MAUK
TAREMPA, SAMBU BELAKANG PADANG
back
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