Presentation on theme: "Definition of counterfeit medical product"— Presentation transcript:
1Definition 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
2Definition 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 amountSub-standardCounterfeitSub-standardStandardCounterfeit72 %90 %110 %132 %> 20 %> 20 %minimum amount that declared in the registered formulamaximum amount that declared in the registered formula
3Penalty 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.PresentManufacturer :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.FutureCompensationShall be justified and payable to those who posed risk from counterfeit medicine
4Penalty 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.
6National coordination Establish National Committee on Suppression and Anti-counterfeit since 2000Members :Royal Thai PoliceRoyal Thai CustomPReMATPMAOther relevant institution2. Establish Counterfeit Information Centerto discriminate / to publicise those counterfeit / illegal medicines via internetreceive suspected information of counterfeit medicines via internet and 24 hours hot line service number 1556
7Counterfeit Drug Information Center Provide data and pictures of illegal medicines founded in ThailandCounterfeit medicines found in Thailand (1998-present)Smuggling medicines (Unregistered in Thailand)Recalled medicinesDrugs whose formula registration has been ordered cancelled by the MinisterCounterfeit/ Unregistered veterinary medicinesSuspected counterfeit case report formCenter for Combating Counterfeit DrugWE provide data and pictures of illegal medicines founded in ThailandCounterfeit medicines (1998-present)Smuggling medicines (Non-register in Thailand)Banded medicinesCounterfeit medicines surveyed around the border line between Thailand and CambodiaSuspected counterfeit case report formLink to International Regulatory Agencies.
8Center 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.
9How where these cases detected? Number of casesSuspectedConfirmedImported / DomesticVital Medicines200788/0200633/0200522/0How where these cases detected?number of casesPatients complaints1Health professionals reportsEnforcement/investigation work2Routine checksReported by affected manufacturer/importer8Other
17Smuggling ED Drugs (Sildenafil) groups from China and India NameDosageLabelFound (mg)1. ZHONG MEI BAO JIAN (MIAOGE)Capsule (Green)China38.842. Wei Ge Wang Jiu Bian Li (JIUBIANLI WEIGEWANG)Tablet (Blue)68.772. Cap. (White)0.053. Cap. (Red)0.233. CP72.924. ZHONG MEI BAO JIAN (YE LANG)1. Tablet (Blue)77.62. Tablet (Brown)9.165. Bao WangTablet74.256. Lang Yi Hao (CHAONONGSUOPIAN)67.077. LONGBAO61.038. PERMANANCE (HAI KAK JIU JIU YAO YOU XIAN GOKG SI)50.729. HUGE (YIBAI)55.3210. ZANG ZHUAN SHEN BAO (CP)Capsule (White/Blue)38.0811. JINGZHUANGWEIGEWANG(ZHUANG YANG ZI YIN BAN LI JIAN XIAO)38.72. Tablet (Blue)32.5312. Nangen Zengzhangsu (LUQUAN)Capsule67.113. Bao Wang14. Power 1 SINGAPORE WalnutTablet (Pink)Singapore63.5615. EDEGRA 100India56.516. V TabletN/A36.68
18NUMBER OF PROSECUTION / CONVICTIONS / PENDING ManufacturerWholesaler / ImporterRetailerInformal sector200720062005The 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)
19PROPOSALS FOR ACTION Measures to be taken Who should do it? Critical factors to ensure successRealistic timeframeCost estimateI. Update Drug Act. B.E.2510Raising penalties for offendersEstablish and enforce compliance with GDP, GSP and GPP to assure the quality the drug supply chain.Thai FDAII. Establish field test method for :Anti-viral, anti-malaria and Infectious medicines for ACMECS member countries.NIRRefractrometerTLCColor test4.94 MB
20PROPOSALS FOR ACTION Measures to be taken Who should do it? Critical factors to ensure successRealistic timeframeCost estimateIII. EnforcementStudy on Anti-malarial Drugs Quality in Three Cambodian and 2 Thai Border ProvincesCambodia -Thailand joint action plan on combating counterfeit medicines along the borderInvestigators/teams in each country2008USAID & USP DQIIV. Risk communicationDevelop national database of cases including their starting point (first information received-FIR), progress and endPromote and encourage the understanding and importance of counterfeit drugs as a public health problem using the radio at FM.96.5 MHzThai FDA