Trafficking in counterfeit medicine is not a victimless crime
Worldwide counterfeiting continues in epidemic proportions in the Pharmaceutical industry. A recent article about counterfeit antimalaria medication highlights the problem.
Malaria, a deadly infectious disease, is usually curable if treated early with appropriate drugs. Artesunate, developed by Chinese scientists in the 1970s, is a leading antimalaria drug. An article by Andrew Marshall in the October 2009 Smithsonian Magazine discusses fake artesunate pills which first appeared in Southeast Asia in the late 1990s and which have resulted in thousands of deaths annually.
In May of 2005, public health experts with INTERPOL attacked this problem through the study of spores and pollen grains in the drugs, palynology. They determined that nearly all of the counterfeits were manufactured in the same region of southern China. With this information, China's Ministry of Public Security were able to arrest two buyers and a seller for their roles in trafficking 240,000 blister packs of fake artesunate into Myanmar. The manufacturers of the counterfeit artesunate were never found.
In 2006, the World Health Organization (WHO) creating a global coalition of stakeholders called IMPACT (International Medical Products Anti-Counterfeiting Taskforce), to seek global solutions and increase awareness to the dangers of counterfeit medical products.
For 2007 WHO reported 1513 cases of counterfeit medicine. Many countries in Africa and parts of Asia and Latin America have areas where more than 30% of the medicines on sale can be counterfeit. The Chair IMPACT is Dr Carissa Etienne, Assistant Director-General, Health Systems and Services, WHO.
Over the last 12 months IMPACT has conducted several successful initiatives. Between September 29 and October 5, 2008 in East Africa, Operation Mamba, inspected 191 locations in Tanzania, including pharmacies, warehouses and illicit markets, resulted in the seizure of some 100 types of products. Police closed four pharmacies and 18 drug shops. In Uganda, a total of 38 shops and pharmacies were investigated. Unregistered medicines were confiscated and suspected counterfeit medicines were taken away for analysis.
On May 29 2009, IMPACT announced that in April and May, 2009, Egyptian police, customs and private sector investigators joined forces in Port Said, Cairo and the Suez Canal to seize 10 containers each holding hundreds of thousands of counterfeit medicines bound for the Middle East. Three of the containers were seized by Egyptian customs in the Suez Canal, and 3,300 bottles of counterfeit pharmaceuticals at Cairo airport.
Likewise, in Nigeria the National Agency for Food and Drug Administration and Control (NAFDAC), foiled an attempt to import a consignment of fake and adulterated antimalarial drugs Maloxine and Amalar tablets. Laboratory tests showed that the fake antimalarials which were produced in China but labelled "Made in India," contained only sulfadioxine and no pyrimethamine.
The U.S. Food and Drug Administration (FDA) formed a Counterfeit Drug Task Force in July 2003 and has a number of ongoing intiatives to combat this problem. On July 13, 2009,the FDA issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug. A PCID is a substance or combination of substances possessing a unique physical or chemical property used to identify and authenticate a drug product or dosage. In addition to inks, pigments, and flavors, specific chemicals may be used as molecular tags in a PCID. In some cases, the PCID may be easily detected by wholesalers or pharmacists to determine if they have authentic products. In other cases, special analytical instruments may be necessary to identify whether the PCID is present. For more information contact Christopher Kelly.
