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Definition of counterfeit medical product

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;

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Definition of counterfeit medical product

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  1. 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

  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 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. Number of cases How where these cases detected?

  8. 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.

  9. 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

  10. 5 กันยายน 2549 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 1 ml. ampoule จำนวน 4,900 ampoules • มูลค่าของกลางประมาณ 600,000 บาท

  11. 18 สิงหาคม 2550 สผภ. ยาเม็ดบรรจุแผง ชนิดต่าง ๆ จำนวนมาก อาทิ ยา Kamagar , ยา Sandimmun Neoral, ยา Zyloric-300 ฯลฯ รวมประมาณ 64,300 เม็ด

  12. 5 กันยายน 2550 ส่วนสืบสวนปราบปราม 3 สสป. ร่วมกับ สสภ. จับกุมเภสัชเคมีภัณฑ์ที่จัดเป็นยาปฏิชีวนะ ใช้สำหรับรักษาและฆ่าเชื้อแบคทีเรีย สามารถใช้ได้ทั้งคนและสัตว์ น้ำหนักรวม 2,0 00 กก. มูลค่ากว่า 7 ล้านบาท

  13. Smuggling ED Drugs (Sildenafil) groups from China and India

  14. 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)

  15. PROPOSALS FOR ACTION

  16. PROPOSALS FOR ACTION

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