GLOBAL THREAT

• national commerce was first mentioned as a problem at WHO Conference of Experts on rational Drug Use in Nairobi, Kenya 1985
• Globally, counterfeit medicines are one of the fastest growing grey economies after prostitution, narcotics, terrorism and arm trade
• According to WHO estimates, counterfeit medicines are up to 10% of pharmaceutical trade of which 25% is consumed in developing countries
• The US based Centre for Medicines in the Public Interest predicted that, counterfeit drug sales will reach USS 75 billion globally in 2010, which is a 90% increase from 2005
• Reports of 771 cases of substandard medicines were entered into the WHO database on counterfeits in April 1999, of which, 77% were from developing countries
• Analysis of the data showed that 60% of the 325 cases had no active ingredient in the product
• Up to 40% of artesunate products (anti-malarial medicines) contain no active ingredients which result in no therapeutic benefits
• GlaxoSmithKline in the United States discovered counterfeiting of medicines used for HIV/AIDS treatment in 2002 in which bottles containing Ziagen® (abacavir sulphate) were mislabeled Combivir® (WHO, 2003b)
• There were 46 confidential reports relating to counterfeit medicines from 20 countries that were received by WHO between January 1990-Oct 2000 of which about 60 % are from developing countries while 40 % from industrialized countries
• Vast majority of counterfeit medicines are thought to be produced in China, India and Russia, though significant numbers of illegal factories have been reported in Nigeria and Philippines
• Fake medicines are estimated to represent 13-30 % of pharmaceutical market in India and about 75 % cases of counterfeit medicines originate from India being a major exporter of counterfeit medicines to developing countries including ARVs
• In 2006, Peru's counterfeit drug sales have risen from an estimate of US$ 40 million in 2002 to US$ 66 million
• Russia's Federal Service for Health Sphere Supervision reported that 10 % of all drugs on the Russian market were counterfeit
• In 2006, 50 % of the pharmacies in Dominican Republic operated illegally while 10% of the medicines that arrived in the country were fake and the commercialization of counterfeit medicines generated economic losses of around $40 million to the pharmaceutical industry of El Salvador
• Counterfeit pharmaceutical products account for approximately $130 million annual sales in Kenya while pirated drugs constituted 25 % of Indonesia's $2 billion pharmaceutical market
• Approximately 70 % of medicines used by the Angolan population were forgeries; an estimate of US$60 million or 5 % of the total annual market of medicines sold in Colombia were contraband, counterfeit or adulterated; 35 % of pharmaceuticals available in the Lebanese market were counterfeit while illegal products represented about 10 % of the pharmaceutical market in Mexico
• 30 % of drug store outlets visited by food and drug deregulation officers carry and sell counterfeit drugs in 2003
• 13 % of the drugs on Cambodia domestic market were counterfeit or substandard in 2002; an estimation of about 8 % of over-the-counter drugs sold in China are counterfeit; an estimated illegal drugs growth in India was estimated to be from 10 % to 20 % of the total market while the countries' pharmaceutical companies claimed a loss in revenue of between 4 % and 5 % annually
• In Nigeria, an estimate of 70 % of drugs in circulation was either fake or adulterated in 2002 while 48 % of goods and drugs imported into the country in 2004 were substandard or counterfeit
• Internet-based sales of pharmaceuticals are a major source of counterfeit medicines
• Illegal Internet pharmacies are operated internationally, sell products that have an unknown or vague origin and sell medications without prescriptions
• In Nigeria, 109 children died after the use of paracetamol syrup in 1990, 14 children died after the administration of chloroquine phosphate injection in 1994, 2,500 deaths after vaccination with 88,000 Pasteur Merieux and SmithKline Beecham meningitis vaccines to Niger in 1995, and 84 children were reported dead between late 2008 and early 2009 due to diethylene glycol-contaminated My Pikin Baby Teething Mixture
• There were cases of counterfeit artesunate-amodiaquine in Nigeria
• 89 people died in Haiti after using cough syrup containing di-ethylene glycol 1995 and 30 people died in Cambodia after taking counterfeit antimalarial medicine in 1999
• 38% of 104 antimalarial drugs for sale in pharmacies in Southeast Asia did not contain any active ingredients, causing a number of preventable deaths from the disease according to a study in 2001
• In 2004, a trail of death was caused by fake medicine
• Types of counterfeit medicines

  • Products without active ingredients, 32.1%
  • Products with incorrect quantities of active ingredients, 20.2%
  • Products with wrong ingredients, 21.4%
  • Products with correct quantities of active ingredients but with fake packaging, 15.6%
  • Copies of an original product, 1%
  • Products with high levels of impurities and contaminants, 8.5%
• Specific examples of counterfeit medicines

  • Avastin (for cancer treatment) in the USA in 2012, lacking active ingredient
  • Viagra and Cialis (for erectile dysfunction) smuggled into the UK in 2012, contained undeclared active ingredients
  • Truvada and Viread (for HIV/AIDS) seized in the UK in 2011, diverted authentic product in falsified packaging
  • Zidolam-N (for HIV/AIDS) in Kenya in 2011, falsified batch affecting nearly 3,000 patients
  • Alli (weight-loss medicines) smuggled into the USA in 2010, contained undeclared active ingredients
  • Anti-diabetic traditional medicine in China in 2009, contained six times the normal dose of glibenclamide, two people died and nine people were hospitalized
  • Metakelfin (antimalarial) in the United Republic of Tanzania in 2009, lacked sufficient active ingredient
• Counterfeit Medicine is a drug with containers or labeling of which, without authorization, bears the trademark, trade name, or other identifying mark, imprint, or any likeness thereof, of a drug manufacturer, processor, packer, or distributor other than the person or persons who in fact manufactured, processed, packed, or distributed such drugs, thereby, falsely purports or is represented to be the product of, or to have been packed or distributed by, such other drug manufacturer, processor, packer, or distributor
• Factors encouraging counterfeiting of medicines

  • Lack of or weak enforcement of existing laws on the quality, safety and efficacy of both imported and locally manufactured medicines
  • Weak penal actions
  • Absence of or weak drug regulation
  • Corruption and conflict of interest
  • High remunerative trade
  • Lack of cooperation between stakeholders
  • Lack of control by exporting countries and within free trade zones
  • Availability/accessibility of advanced technology
  • Poverty
  • Low-availability of testing facilities
• Counterfeiters evade legitimate taxation (Finlay 2011)
• Intellectual Property (IP) Rights

  Counterfeiting of medicines violates IP Rights as a result of unlawfully bearing a registered trademark, which affects the trademark owners
• The breach of IP may include patency and industrial design
• Anti-Counterfeit Measures in Pharmaceutical Industry

  • Tamper-evident/tamper-resistant packing
  • Holograms
  • mPedigree
• Tamper-evident/tamper-resistant packing


  1. Product packing has an indicator or entry barrier which provides visible or audible evidence to the consumers that the product has been tempered with, if breached or missing

  2. Examples include blister packs, tape seals, shrinkable seals, film wrappers and breakable caps
• Holograms


  1. Combination of three layered security features: Overt features, Covert features such as micro-text, scrambled images UV-sensitive or specialized, Serialization of hologram

  2. Authentication is combined with traceability
• mPedigree


  1. Offshore data centre tracks the codes which are randomly generated by the pharmaceutical manufacturer

  2. Medicine pack has a distinctive panel that reveals a ten-digit code when scratched

  3. Code is sent to a central number through a short message service (SMS) and a response to the SMS is received indicating whether the medicine is genuine or counterfeit
• In Nigeria, mPedigree has been incorporated into the national quality assurance standards for pharmaceuticals by the Nigeria Government
• Using mPedigree in Nigeria

  1. Scratch the distinctive panel (card) to reveal the PIN

  2. Text PIN to 38353

  3. Wait for a response

  4. Text PIN only ONCE
• Analytical methods used to authenticate pharmaceutical products

  • Chromatography (High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC) coupled with optical, electrochemical or mass detectors)
  • Thin-Layer Chromatography (TLC)
  • Colorimetry
  • Optical spectroscopy
  • Isotopic characterization
  • Near Infra-Red (NIR) and Raman spectroscopies