Counterfeit or fake medicines are drugs which are previously expired, fraudulently diluted, adulterated, substituted, completely misrepresented, or sold with a false brand name. They constitute 10% of the global drug market and mostly originate in the developing world, where regulatory and enforcement measures are weakest. Lack of expected clinical benefit, direct harm and emergence of drug resistance can occur due to counterfeit medicines. WHO, along with national and international organizations are taking legislative, regulatory, enforcement, technological and quality assurance initiatives to prevent and detect counterfeit medicines, besides raising awareness about the issue. However, despite making good progress, the threat looms large for the consumer as long as he is not empowered to differentiate between genuine and counterfeit medicines. © 2013 Elsevier B.V., All rights reserved.