Presentation on theme: "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."— Presentation transcript:
Definition of counterfeit medical product Drug Act B.E (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 %. WHO definition
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 Sub-standard Definition of counterfeit medical product 90 % 110 %72 % 132 % > 20 % maximum amount that declared in the registered formula The registered formula declared % 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. Present Future Penalty for Manufacture, Import and Sell Counterfeit medicines (1) 1. Drug Act B.E (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 (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 Counterfeit Drug Information Center
Number of cases SuspectedConfirmedImported / DomesticVital Medicines / / /00 How where these cases detected? number of cases Patients complaints1 Health professionals reports0 Enforcement/investigation work2 Routine checks2 Reported by affected manufacturer/importer8 Other0
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 H 5 N 1 & H 5 N 9 = 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 H 5 N 1 & H 5 N 9 = 2 cases = 450 x 250 ml. (Parallel importation ) Unregistered = 8 cases (Parallel importation ) ED medicines from China = 45,970 tabs Counterfeit = 8 cases = 609 tabs. (Imported) Viagra ® = 485 tabs (Imported) Cialis ® = 64 tabs. (Imported) Levitra ® = 60 tabs (Imported) Vaccine H 5 N 1 & H 5 N 9 = 1 cases = 1,800 x 250 ml. (Parallel importation ) Unregistered = 12 cases (Parallel importation) ED medicines from China = 110,350 tabs.
Longer Viagra, Sex Drops, Woman Generau 110,350 10
NameDosageLabelFound (mg) 1. ZHONG MEI BAO JIAN (MIAOGE)Capsule (Green)China Wei Ge Wang Jiu Bian Li (JIUBIANLI WEIGEWANG) 1.Tablet (Blue)China Cap. (White)China Cap. (Red)China CPTablet (Blue)China ZHONG MEI BAO JIAN (YE LANG)1. Tablet (Blue)China Tablet (Brown)China Bao WangTabletChina Lang Yi Hao (CHAONONGSUOPIAN)Tablet (Blue)China LONGBAOTablet (Blue)China PERMANANCE (HAI KAK JIU JIU YAO YOU XIAN GOKG SI)Tablet (Blue)China HUGE (YIBAI)Tablet (Blue)China ZANG ZHUAN SHEN BAO (CP)Capsule (White/Blue)China JINGZHUANGWEIGEWANG (ZHUANG YANG ZI YIN BAN LI JIAN XIAO) 1. Tablet (Blue)China Tablet (Blue)China Nangen Zengzhangsu (LUQUAN)CapsuleChina Bao WangTabletChina Power 1 SINGAPORE WalnutTablet (Pink)Singapore EDEGRA 100Tablet (Blue)India V TabletTabletN/A36.68 Smuggling ED Drugs (Sildenafil) groups from China and India
NUMBER OF PROSECUTION / CONVICTIONS / PENDING ManufacturerWholesaler / ImporterRetailerInformal sector 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 takenWho should do it? Critical factors to ensure success Realistic timeframe Cost estimate I. Update Drug Act. B.E Raising penalties for offenders 2.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 : 1.Anti-viral, anti-malaria and Infectious medicines for ACMECS member countries. -NIR -Refractrometer -TLC -Color test Thai FDA MB
PROPOSALS FOR ACTION Measures to be takenWho 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 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