1. Definition of counterfeit medical product
Drug Act B.E (1967)
Section 73 The following drug or substances are counterfeit drugs:
A drug or substance which is wholly or partly an imitation of a genuine drug;
A drug which shows the name of another medicine, or an expiration date which is false;
A drug which shows the name , or mark of a producer, or the location of the manufacture, which is false;
Drug which falsely shows registered number which is falsely;
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 %.
WHO definition

2. Definition of counterfeit medical product
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 :
The registered formula declared % labeled amount
Sub-standard
Counterfeit
Sub-standard
Standard
Counterfeit
72 %
90 %
110 %
132 %
> 20 %
> 20 %
minimum amount that declared in the registered formula
maximum amount that declared in the registered formula

3. Penalty for Manufacture, Import and Sell Counterfeit medicines (1)
1. Drug Act B.E (1967)
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.
Present
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.
Future
Compensation
Shall be justified and payable to those who posed risk from counterfeit medicine

4. Penalty for Manufacture, Import and Sell Counterfeit medicines (2)
2. Trademark Act B.E (2000)
Section 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 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.

6. National coordination
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

7. Counterfeit Drug Information Center
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
Center for Combating Counterfeit Drug
WE provide data and pictures of illegal medicines founded in Thailand
Counterfeit medicines (1998-present)
Smuggling medicines (Non-register in Thailand)
Banded medicines
Counterfeit medicines surveyed around the border line between Thailand and Cambodia
Suspected counterfeit case report form
Link to International Regulatory Agencies.

8. Center for Combating Counterfeit Drug (1)
This web site is one of a feasible strategy for combating Counterfeit Drug problem.
We have both Thai and English version.
The data in this site provide some important information for combating purpose.
The information will be shared within the country and region to solve the problem.

9. How where these cases detected?
Number of cases
Suspected
Confirmed
Imported / Domestic
Vital Medicines
2007 8
8/0
2006 3
3/0
2005 2
2/0
How where these cases detected?
number of cases
Patients complaints 1
Health professionals reports
Enforcement/investigation work 2
Routine checks
Reported by affected manufacturer/importer 8
Other

10. Number of cases 2005 Counterfeit = 2 cases = 31,100 tabs. (Imported)
Viagra® = 1 case = 31,000 tabs. (Imported)
Artesunate® = 1 case = 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 ® = tabs. (Imported)
Vaccine H5N1 & H5N9 = 2 cases = 450 x 250 ml. (Parallel importation )
ED medicines from China = 45,970 tabs.
2007
Counterfeit = 8 cases = 609 tabs. (Imported)
Viagra® = 485 tabs (Imported)
Cialis ® = tabs. (Imported)
Levitra® = 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.

13. 8 มกราคม 2549 ส่วนสืบสวนปราบปราม 1 สสป. ร่วมกับ สกท
8 มกราคม 2549 ส่วนสืบสวนปราบปราม 1 สสป. ร่วมกับ สกท. จับยากระตุ้นทางเพศทั้งชายและหญิง ซุกซ่อนมากับสินค้าที่สำแดง จำนวนมากกว่า 22 รายการ อาทิเช่น ยา Longer Viagra , ยา Sex Drops , ยา Woman Generau ฯลฯ จำนวนรวม 110,350 เม็ด รวมมูลค่ามากกว่า 10 ล้านบาท

14. มูลค่าของกลางประมาณ 600,000 บาท
5 กันยายน ส่วนสืบสวนปราบปราม 3 สสป จับกุมยาอันตรายที่ไม่มีการขึ้นทะเบียนยาไว้ชนิดต่างๆ ที่ท่าอากาศยานกรุงเทพ ดังนี้
1. ยาฉีด “EPREX 4000” EPOEFIN ALFA 0.4 ml. จำนวน 54 Syringes
2. ยา “CELLCEPT” MYCOPHENOLATE MOFETIL 250 ml. จำนวน 8,000 แคปซูล
3. ยา “ZYPREXA” 10 mg OLANZAPINE จำนวน 980 เม็ด
ยาฉีด “DECA-DURABOLIN” (NANDROLONE DECANOATE 100 mg) ขนาด ml. ampoule จำนวน 4,900 ampoules
มูลค่าของกลางประมาณ 600,000 บาท

15. 18 สิงหาคม สผภ. ยาเม็ดบรรจุแผง ชนิดต่าง ๆ จำนวนมาก อาทิ ยา Kamagar , ยา Sandimmun Neoral, ยา Zyloric-300 ฯลฯ รวมประมาณ 64,300 เม็ด

16. 5 กันยายน 2550 ส่วนสืบสวนปราบปราม 3 สสป. ร่วมกับ สสภ
5 กันยายน ส่วนสืบสวนปราบปราม 3 สสป. ร่วมกับ สสภ. จับกุมเภสัชเคมีภัณฑ์ที่จัดเป็นยาปฏิชีวนะ ใช้สำหรับรักษาและฆ่าเชื้อแบคทีเรีย สามารถใช้ได้ทั้งคนและสัตว์ น้ำหนักรวม 2,0 00 กก. มูลค่ากว่า 7 ล้านบาท

17. Smuggling ED Drugs (Sildenafil) groups from China and India
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)
Tablet (Blue)
68.77
2. Cap. (White)
0.05
3. Cap. (Red)
0.23
3. CP
72.92
4. ZHONG MEI BAO JIAN (YE LANG)
1. Tablet (Blue)
77.6
2. Tablet (Brown)
9.16
5. Bao Wang
Tablet
74.25
6. Lang Yi Hao (CHAONONGSUOPIAN)
67.07
7. LONGBAO
61.03
8. PERMANANCE (HAI KAK JIU JIU YAO YOU XIAN GOKG SI)
50.72
9. HUGE (YIBAI)
55.32
10. ZANG ZHUAN SHEN BAO (CP)
Capsule (White/Blue)
38.08
11. JINGZHUANGWEIGEWANG
(ZHUANG YANG ZI YIN BAN LI JIAN XIAO)
38.7
2. Tablet (Blue)
32.53
12. Nangen Zengzhangsu (LUQUAN)
Capsule
67.1
13. Bao Wang
14. Power 1 SINGAPORE Walnut
Tablet (Pink)
Singapore
63.56
15. EDEGRA 100
India
56.5
16. V Tablet
N/A
36.68

18. 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)

19. 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
Raising penalties for offenders
Establish and enforce compliance with GDP, GSP and GPP to assure the quality the drug supply chain.
Thai FDA
II. Establish field test method for :
Anti-viral, anti-malaria and Infectious medicines for ACMECS member countries.
NIR
Refractrometer
TLC
Color test
4.94 MB

20. PROPOSALS FOR ACTION Measures to be taken Who should do it?
Critical factors to ensure success
Realistic timeframe
Cost estimate
III. Enforcement
Study on Anti-malarial Drugs Quality in Three Cambodian and 2 Thai Border Provinces
Cambodia -Thailand joint action plan on combating counterfeit medicines along the border
Investigators/teams in each country
2008
USAID & USP DQI
IV. Risk communication
Develop national database of cases including their starting point (first information received-FIR), progress and end
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