Definition of counterfeit medical product

Drug Act B.E. 2510 (1967)

Section 73 The following drug or substances are counterfeit drugs:

(1) A drug or substance which is wholly or partly an imitation of a genuine drug;

(2) A drug which shows the name of another medicine, or an expiration date

which is false;

(3) A drug which shows the name , or mark of a producer, or the location of the

manufacture, which is false;

(4) Drug which falsely shows registered number which is falsely;

(5) Product with active substances which quality or strength lower than the

minimum or higher than the maximum standards prescribed in the registered

formula under Section 79 by more than 20 %.

WH

O d

efin

ition

Medicine is categorized as sub-standard, if there is genuine packaging +

incorrect quantity of ingredient (not deliberate) with the amount of active

ingredient lower than the minimum or higher than the maximum amount that

declared in the registered formula but not more than 20 %.

Example :

minimum amount that declared in the registered formula

> 20 %

Counterfeit CounterfeitSub-standard Sub-standard

Definition of counterfeit medical product

90 % 110 %72 % 132 % > 20 %maximum amount that declared in the registered formula

The registered formula declared 90-110 % labeled amount

Standard

Manufacturer : Shall be liable imprisonment for a term from three years to life

and fine from ten thousand to fifty thousand Baht. Importer or Seller :

Shall be liable imprisonment for a term from one to twenty years and fine from two thousand to ten thousand Baht.

Manufacturer : Shall be liable imprisonment for a term from three years to life

and fine from three hundred thousand to five million Baht. Importer or Seller :

Shall be liable imprisonment for a term from one to twenty years and fine from one hundred thousand to two million Baht.

Presen

tF

utu

rePenalty for Manufacture, Import and Sell Counterfeit medicines (1)

1. Drug Act B.E. 2510 (1967)

Compensation

Shall be justified and payable to those who posed risk from counterfeit medicine

Penalty for Manufacture, Import and Sell Counterfeit medicines (2)

2. Trademark Act B.E. 2543 (2000)

Section 108 Any person who counterfeits a trademark, service mark,

certification mark or collective mark registered in Thailand by

another person shall be liable to imprisonment not exceeding four

years or a fine of not exceeding four hundred thousand baht or

both.

Section 110 Any person who:

(1) imports, distributes, offers for distribution…………………..

(2) gives or offers a service under a counterfeit service mark,

………………………………shall be liable to the penalties

provided in those Sections.

National coordination

1. Establish National Committee on Suppression and Anti-counterfeit since 2000

Members :

- Royal Thai Police

- Royal Thai Custom

- PReMA

- TPMA

- Other relevant institution

2. Establish Counterfeit Information Center

- to discriminate / to publicise those counterfeit / illegal medicines via

internet

- receive suspected information of counterfeit medicines via internet and

24 hours hot line service number 1556

Provide data and pictures of illegal medicines founded in Thailand

Counterfeit medicines found in Thailand (1998-present)

Smuggling medicines (Unregistered in Thailand)

Recalled medicines

Drugs whose formula registration has been ordered cancelled by

the Minister

Counterfeit/ Unregistered veterinary medicines

Suspected counterfeit case report form

Email : complain@fda.moph.go.th.

http://wwwapp1.fda.moph.go.th/drug/zone_counterfeit/fak001.asp

Counterfeit Drug Information Center

Number of casesSuspected Confirmed Imported / Domestic Vital Medicines

2007 0 8 8/0 0

2006 0 3 3/0 0

2005 0 2 2/0 0

How where these cases detected?number of cases

Patients complaints 1

Health professionals reports 0

Enforcement/investigation work 2

Routine checks 2

Reported by affected manufacturer/importer 8

Other 0

Number of cases 2005

Counterfeit = 2 cases = 31,100 tabs. (Imported) Viagra® = 1 case = 31,000 tabs. (Imported) Artesunate® = 1 case = 100 tabs. (Imported)

Vaccine H5N1 & H5N9 = 7 cases = 2,097 x 250 ml. (Parallel importation) Unregistered = 8 cases (Parallel importation )

2006 Counterfeit = 3 cases = 13,928 tabs. (Imported)

Viagra® = 13,178 tabs (Imported) Cialis ® = 750 tabs. (Imported)

Vaccine H5N1 & H5N9 = 2 cases = 450 x 250 ml. (Parallel importation ) Unregistered = 8 cases (Parallel importation )

ED medicines from China = 45,970 tabs. 2007

Counterfeit = 8 cases = 609 tabs. (Imported) Viagra® = 485 tabs (Imported) Cialis ® = 64 tabs. (Imported) Levitra® = 60 tabs (Imported)

Vaccine H5N1 & H5N9 = 1 cases = 1,800 x 250 ml. (Parallel importation ) Unregistered = 12 cases (Parallel importation)

ED medicines from China = 110,350 tabs.

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Name Dosage Label Found (mg)

1. ZHONG MEI BAO JIAN (MIAOGE) Capsule (Green) China 38.84

2. Wei Ge Wang Jiu Bian Li (JIUBIANLI WEIGEWANG)1. Tablet (Blue) China 68.77

2. Cap. (White) China 0.05

3. Cap. (Red) China 0.23

3. CP Tablet (Blue) China 72.92

4. ZHONG MEI BAO JIAN (YE LANG) 1. Tablet (Blue) China 77.6

2. Tablet (Brown) China 9.16

5. Bao Wang Tablet China 74.25

6. Lang Yi Hao (CHAONONGSUOPIAN) Tablet (Blue) China 67.07

7. LONGBAO Tablet (Blue) China 61.03

8. PERMANANCE (HAI KAK JIU JIU YAO YOU XIAN GOKG SI) Tablet (Blue) China 50.72

9. HUGE (YIBAI) Tablet (Blue) China 55.32

10. ZANG ZHUAN SHEN BAO (CP) Capsule (White/Blue) China 38.08

11. JINGZHUANGWEIGEWANG (ZHUANG YANG ZI YIN BAN LI JIAN XIAO)

1. Tablet (Blue) China 38.7

2. Tablet (Blue) China 32.53

12. Nangen Zengzhangsu (LUQUAN) Capsule China 67.1

13. Bao Wang Tablet China 74.25

14. Power 1 SINGAPORE Walnut Tablet (Pink) Singapore 63.56

15. EDEGRA 100 Tablet (Blue) India 56.5

16. V Tablet Tablet N/A 36.68

Smuggling ED Drugs (Sildenafil) groups from China and India

NUMBER OF PROSECUTION / CONVICTIONS / PENDING

Manufacturer Wholesaler / Importer Retailer Informal sector

2007

2006

2005

The legal process takes long time to get final decision.

March 20, 2002 : Mr.Gokhan Ozhek, a Turk hiring the Thai employees to do the

production of counterfeit Viagra has been arrested, and then all of the employees were

exterminated as well following : (final sentence on 28 March, 2005 : imprisonment for 10

years)

The employees living at the lodging in Bangkae District were captured along with

Viagra 100 mg (50,000 tablets approximately), raw materials, packaging materials

and production equipment. (imprisonment for 6 years and 8 months)

The employees , who sold or distributed counterfeit Viagra to the disguised police.

(imprisonment for 3 years)

PROPOSALS FOR ACTION

Measures to be taken Who should do it?

Critical factors to ensure success

Realistic timeframe

Cost estimate

I. Update Drug Act. B.E.2510

1. Raising penalties for offenders

2. Establish and enforce compliance with GDP, GSP and GPP to assure the quality the drug supply chain.

Thai FDA 2008-2009

II. Establish field test method for :

1. Anti-viral, anti-malaria and Infectious medicines for ACMECS member countries.

- NIR- Refractrometer- TLC- Color test

Thai FDA

2008-2009 4.94 MB

PROPOSALS FOR ACTION

Measures to be taken Who should do it?

Critical factors to ensure success

Realistic timeframe

Cost estimate

III. Enforcement

1. Study on Anti-malarial Drugs Quality in Three Cambodian and 2 Thai Border Provinces

2. Cambodia -Thailand joint action plan on combating counterfeit medicines along the border

Investigators/teams in each country

2008

2008-2010

USAID & USP DQI

IV. Risk communication

1. Develop national database of cases including their starting point (first information received-FIR), progress and end

2. Promote and encourage the understanding and importance of counterfeit drugs as a public health problem using the radio at FM.96.5 MHz

Thai FDA 2008

2007-2008