Fighting against counterfeit pharmaceuticals
Issued by Mitas Corporation - Jun 26th 2018, 13:36
Counterfeit pharmaceuticals are a major problem for the proprietary pharmaceutical industry causing loss of revenues, damage reputations, and pose significant health risks to consumers, with the WHO estimating one million people die every year from counterfeit drugs. They also pose indirect costs to society as counterfeiting often supports organised crime.
Various factors including the high cost of proprietary drugs, the ease of producing counterfeits, the lack of risk in counterfeiting relative to other illegal activities, and the increased use of the Internet as a source for marketing pharmaceuticals have encouraged counterfeit proliferation.
In 2011 it was estimated that the counterfeit drug manufacturers generate over $75 billion a year in revenue with more recent reports estimating that the EU pharmaceutical sector loses 20.2 billion Euro a year to counterfeit medicine and that 10 - 15% of the global drug supply is fake, in Africa fake medicines may account for up to 30% of medicines in circulation. Much of the counterfeit market exists in third world countries where traceability is limited and price sensitivity is high. In these markets, counterfeiters purposely target lifesaving drugs such as anti-malarial pills due to their high prices.
Counterfeiting in developed markets is much less prevalent but still, poses a significant threat due to the higher consumption of drugs and the increasing use of the internet as a source in these markets. The WHO estimates that 1 in 10 medical products circulating in low and middle-income countries is either sub-standard or falsified, this means that people are taking medicines that fail to treat or prevent disease. It is estimated that fake malaria drugs killed more than 100 000 children in Africa each year and fake emergency contraception has led to a rise in dangerous abortions in East Africa.
Our range of solutions available currently to help identify if the medicine is genuine range from the Pharmatrack Labeling system which enables you to code and label pharmaceutical packets on the upper surface of the product, using tamper evident labels in order to guarantee the “secure conditions” imposed by the directive 2011/62 EU.
Our Pharmatij aqueous ink cartridge is suitable for security coding in high output industrial printing applications designed for porous substrates such as cardboard and paper. When exposed to 365nm blacklight the Pharmatij ink changes from black to either blue, green or red depending on the ink type, as a result, the ink is ideal for security applications for customers seeking a low cost-effective option, the Pharmatij solvent ink is ideal for the pharmaceutical applications, offering dark, sharp text and barcode printing on substrates such as blister foil, aluminium, OPP and PET film and nylon and UV laminated papers. Methanol-free, the ink uses absorption for adhesion and has a throw distance of 2mm which limits applications to flat surfaces.
Tracers/taggants are unique micro-sized particles that are added onto or within the proprietary products they are trying to protect as a means of differentiating them from counterfeits or generics. Our tracers consist of a food and pharmaceutical grade polymer with embedded iron powder and food dye. Each particle is 100-200 microns or smaller in size with micro-engraved lettering 10-20 microns in size. All materials used to make are GRAS (generally regarded as safe) and relatively chemically inactive. The particles can be included in/on pills, capsules, packaging and labels.
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While most fakes and counterfeits have typically been manufactured in China, other regions like India are also a common place for counterfeits to originate from. These days, it’s becoming more common to see counterfeiters working in countries where they operate.
Inspection is part of the overall drug quality assurance system. The objective of inspecting pharmaceutical manufacturing facilities is either to enforce Good Manufacturing Practice (GMP) compliance or to provide authorization for the manufacture of specific pharmaceutical products, usually in relation to an application for marketing authorization.
In the pharmaceutical manufacturing environment, it is absolutely critical to managing environmental conditions. Currently, this is done either manually or with bespoke solutions that have been very expensive and intrusive. Additionally, the mechanical equipment that is currently used, requires annual maintenance and calibration. This process is very expensive and resource intensive.
Counterfeiting has become a multi-billion-dollar criminal activity affecting almost every industry and South Africa is feeling the impact of these activities in the illicit economy as a large portion of its GDP is being lost every year. This includes the smuggling of tobacco products, counterfeit textiles, and drug manufacturing and smuggling.