Definition of counterfeit medical product
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A drug or substance which is wholly or partly an imitation of a genuine drug; ... ampoule ????? 4,900 ampoules. ??????????????????? 600,000 ???. 18 ??????? 2550 ???. ...

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Definition of counterfeit medical product

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Definition of counterfeit medical product

Drug Act B.E. 2510 (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


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 90-110 % labeled amount

Sub-standard

Sub-standard

Counterfeit

Counterfeit

Standard

90 %

72%

110 %

132 %

> 20 %

> 20 %

maximum amount that declared in the registered formula

minimum amount that declared in the registered formula


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

1. Drug Act B.E. 2510 (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


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

  • 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


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

  • Email : complain@fda.moph.go.th.

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


Number of cases

How where these cases detected?


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.


8 2549 1 . . 22 Longer Viagra , Sex Drops , Woman Generau 110,350 10


  • 5 2549 3 .

  • 1. EPREX 4000 EPOEFIN ALFA 0.4 ml. 54 Syringes

  • 2. CELLCEPT MYCOPHENOLATE MOFETIL 250 ml. 8,000

  • 3. ZYPREXA 10 mg OLANZAPINE 980

  • DECA-DURABOLIN (NANDROLONE DECANOATE 100 mg) 1 ml. ampoule 4,900 ampoules

  • 600,000


18 2550 . Kamagar , Sandimmun Neoral, Zyloric-300 64,300


5 2550 3 . . 2,0 00 . 7


Smuggling ED Drugs (Sildenafil) groups from China and India


NUMBER OF PROSECUTION / CONVICTIONS / PENDING

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


PROPOSALS FOR ACTION


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