Counterfeit Medicines - The Global Hazard
A counterfeit medicine is a product, which is deliberately and fraudulently mislabeled with respect to identity and/or source, ingredients or the packaging while substandard medicines are genuine medicines produced by legitimate manufacturers that do not meet the quality specifications that the producer says they meet.
Even countries with advanced regulatory systems are seriously challenged by this deceptive practice. An analysis conducted by International Medical Product Anti-Counterfeiting Taskforce (IMPACT) shows that counterfeiting is greater in those areas where regulatory and legal oversight is weaker. This easy and lucrative business has attracted organized crime and in most of the countries, the punishment is not sufficiently strong to deter criminals. The fight against counterfeit medicines requires collaboration at national, regional and international levels. The absence of deterrent legislation, non implementation of Good Manufacturing Practices (GMPs), lapses in the product supply chain and unauthorized internet based sales of pharmaceuticals remain the major reasons of the proliferation of this crime. To deal with this problem strict measures are to be taken by the governments,complementing the legislation with effective law enforcement. RFID (Radio frequency identification technology) and OVDs (optically variable devices) can help track and authenticate the drugs.
Introduction
Counterfeiting is deceptive and immoral in any field. But in healthcare, it is criminal and simply unacceptable. According to World Health Organization the definition of counterfeit medicines is “A counterfeit medicine is a product which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging”. It is important to make a distinction between counterfeit medicines and other kinds of substandard medicines. All counterfeit medicines are substandard because they are manufactured and distributed outside of regulatory control and their composition is unpredictable. On the other hand, not all substandard medicines are counterfeit because not all of them have been ‘deliberately and fraudulently mislabeled’. According to WHO, Substandard medicines are genuine medicines produced by legitimate manufacturers that do not meet the quality specifications that the producer says they meet. For example, they may contain less (or more) active ingredient than written on the package. This may not be an intention to cheat, but may be due to problems with the manufacturing process Many cases of counterfeiting have been uncovered while investigating therapeutic failure or adverse events observed in patients. Such cases lead to a serious consequence i.e. the erosion of confidence in health-care systems. Counterfeit drugs particularly affect the most disadvantaged people in poor countries.
One of the most worrying implication of counterfeit medicines is the emergence of drug resistant pathogens, bacteria, viruses, parasites. Substandard or counterfeit drugs increase the risk of spreading the resistance. Such a situation will lead to therapeutic failure and a need for discovery and development of new drugs will arise. The counterfeit medicines could also cause adverse effects through excessive dose or due to the presence of potentially toxic active ingredients or pathogenic contaminants. Loss of confidence and faith in the medicines and in the health care system is also a very serious damaging consequence of the counterfeit medicines. Not only the patient but also the health professional, pharmaceutical manufacturers, distributors, suppliers, retailers etc. loose confidence in the medicine that they rely upon. The pharmaceutical companies may loose the interest to invest in research and development and future innovation because the counterfeit product deprives the pharmaceutical companies of significant amount of revenues.
Some facts highlighting the presence of counterfeit medicines globally
The problem is truly global. Counterfeit medicines are increasingly detected not only in developing countries but also in European and North-American countries. This suggests that even countries with advanced regulatory systems are seriously challenged by this menace. Rough estimates suggest that up to 10% of the medicines circulating in the world could be counterfeit.
Read the rest of this article on counterfeit medicines.
