COMBATING COUNTERFEIT DRUGS IN INDONESIA First ASEAN-China Conference on Combating Counterfeit Medical Products Jakarta, 13-15 November 2007 National Agency.

COMBATING COUNTERFEIT

DRUGS IN INDONESIA

First ASEAN-China Conference on Combating Counterfeit Medical Products

Jakarta, 13-15 November 2007

National Agency of Drug and Food Control

Indonesia

BACKGROUND

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 Illegally imported or Locally manufactured by Locally manufactured by illegal manufacturerillegal manufacturer

INDONESIA

Distributed to illegal market

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.

NUMBER OF INTERNATIONAL PORT

SEAPORT : 141 AIRPORT : 10

LEGISLATIVE LEGISLATIVE INFRASTRUCTUREINFRASTRUCTURE

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 Ocea

n)

Objective :

To control imported goodsTo 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. 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

NUMBER OF CASES

ILLEGAL SECTOR OPERATION RESULT (NADFC DATA)

PERIODE 2005 - October 2007

51

28

21

37

1319

14 15

2

0

10

20

30

40

50

60

2005 2006 2007

Year

Nu

mb

er o

f C

ases

Total

Illegal Importedproducts

Counterfeit drugs

COUNTERFEIT DRUGS (55 ITEMS)PERIODE 2005 - October 2007

9%

28%

9%4%7%11%

7%4%

15%

2%

4%

analgetic antiinfection antihistamine antidiabetic antihipertensi vitamin

afrodisiak antiinf lamasi transquilizer hormon others

14

12

3

15

1 0

0

2

4

6

8

10

12

14

16

2005 2006

Year

FOLLOW UP OF FINDINGS ON CRIMINAL JUSTICE SYSTEM (NADFC DATA)

2005 - 2006

Number of Cases Investigated Penalty

FINDINGS ON CASE I (2007)

65%

22%

13%counterfeit drugs

IIlegal imported drugs

Not confirmed yet

FINDINGS ON CASE II (2007)

27%

34%10%

29% counterfeit drugs

IIlegal imported drugs

original

Not confirmed yet

COUNTERFEIT DRUGS FINDING FREQUENCIESPERIOD 2001-2007 (October)

0 1 2 3 4 5 6 7

Amoxsan 500 kapsul

Broadced inj 1 g

Fulcin 500 mg tablet

Supertetra soft cap

Incidal kapsul

Lasix tablet

Ponstan 250 mg kapsul

Daonil tablet

Dextamine tablet

Fansidar tablet

Ponstan 500 mg

ob

at

pa

lsu

frekuensi temuan per 7 tahun terakhirfrequency

* The data is made from finding frequencies > 3 times

Co

un

terf

eit

dru

gs

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

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)

-

NADFC DATA

NATIONAL COORDINATION

Mechanism of national coordinationCombating Counterfeit Drugs requires joint effort

Drug/National Regulatory Authority

Healthcare & medicine

providers

Civil societiesPatient Interest Groups

Patients /consumers

Drug manufacturers importers &wholesalers

medicines

Ministries, police, customs,

Prosecutors

Government

medicines

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 STRATEGIC ACTION ON COMBATING COUNTERFEIT DRUGS (CDs) in INDONESIADRUGS (CDs) in INDONESIA

ILEGAL MANUFACTURER ILLEGAL MARKET

ILEGAL DISTRIBUTOR

CONSUMER

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

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

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

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

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

Proposed Project against Counterfeit Drugs

OUTPUTExchange of information by designated unit of DRADevelop data base of counterfeit drugsDevelop Alert System

ASEAN Project on Strengthening Collaboration on Combating Counterfeit Drugs

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!

NUNUKANENTIKONG

JAGAOI BABANG

SKOU

back

MIANGAS & MARORE

SUNGAI GUNTUNG

TAREMPA, SAMBU BELAKANG PADANG

MOTA AIN, NAPAN, META MAUK

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