Counterfeit pharmaceuticals are a major problem for the proprietary pharmaceutical industry. Counterfeits cause loss of revenues, damage reputations, and pose significant health risks to consumers. 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.

Over the last year, counterfeit pharmaceuticals generated $75 billion in revenue and caused over 1,000,000 preventable deaths a year. 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 found 50% of online pharmacies that conceal their physical address were found to be providing counterfeits.

Federal regulators, international task forces, NGOs, and pharmaceutical manufacturers have attempted to stem the tide of counterfeits through regulations, tracking systems, tamper-proof bottles, holographic labelling, unique inks, quick tests, and random assays, all have their faults. Tracking systems are expensive, adding as much as 8-10% to manufacturing cost, and drugs purchased over the internet are difficult to trace via these means.

Assays for active drug components take time and can be confounded when counterfeiters add diluted doses of the active ingredients. Visible mechanisms of identifying products can be duplicated; in some cases, the holograms of counterfeits were found to be more complex and detailed than the holograms of a legitimate product. Moreover, counterfeiters often recycle legitimate packaging and replace its contents with counterfeit products.

SECUR Micro-Engraved Tracers

SECUR belong to a class of anti-counterfeiting products known as “tracers” or “taggants”. 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. What makes SECUR Tracers unique, however, is the fact that they are comprised of food/pharmaceutical grade materials and don’t require the use of an expensive and proprietary reader.

SECUR 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 SECUR Tracers are GRAS (generally regarded as safe) and relatively chemically inactive. The particles can be included in/on pills, capsules, packaging and labels.

Instant identification of the tracer is possible using a black light, as this will cause the embedded food dye to fluoresce. To confirm the authenticity of the product, the pills are then read under an inexpensive 120x power microscope. This process takes about 30 seconds. Each particle may include a company name and/or other identifying information (i.e. lot number, production date, expiration information). The SECUR Tracers can be formulated into the coating of a pill. To confirm the pill’s authenticity, the tracers are located using a black light and then read under a microscope.

Advantages of SECUR Tracers

SECUR is an acronym standing for “safe”, “easy”, “customizable”, “useful”, and “reliable”. They have numerous advantages over alternate anti-counterfeiting technologies:

SAFE FOR HUMAN CONSUMPTION
All the materials formulated in the tracers are GRAS (generally regarded as safe) and permitted in foods/pharmaceuticals. They consist of relatively inactive compounds unlikely to affect the active components of the pills they are included in or on. They can be included in the pills themselves, in the coating of pills, and/or outside the container on the labelling/packaging.

EASY TO IDENTIFY
SECUR Tracers are magnetically retrievable and simple to read. They are detected by shining a Black UV light on the coating of pills containing the tracer and read using a simple handheld microscope. The test can be completed within 30 seconds.

CUSTOMISABLE MESSAGE
SECUR Tracers can be engraved with almost any letter, number, or symbol. Templates for characters on the tracers can be changed regularly and at a low cost. Moreover, the size of SECUR Tracers can be customised to fit a client’s needs. The particles can be as small as 50 microns in size (to maximise the number of tracer particles per gram of tracer) or as large as 300 microns in size (to increase the amount of information engraved on each particle).

USEFUL FOR VARIETY OF PURPOSES
In addition to their application as an anti-counterfeiting mechanism, SECUR Tracers can be used to differentiate proprietary products from generics, identify “gray market sales” (i.e. product purchased in lower priced markets and resold into higher priced markets), validate returned products, verify batch/lot information, and determine medication non-adherence (since tracers are not digestible).

RELIABLE AND PROTECTED
Manufacturing of SECUR tracers requires specialised semiconductor equipment and a variety of technical skills. These pose high barriers to entry for potential counterfeiters. Additionally, Micro-Tracers can embed ‘secret’ coding materials into the matrix of the tracers that would be virtually impossible for counterfeiters to identify and replicate.

Regulatory Compliance

Food And Drug Administration (FDA) issued a document “Guidance for Industry: Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting” (2009). In the document, the FDA provides recommendations for which “identifiers” to use and guidance regarding regulations of such identifiers.

They recommend that the identifiers be comprised of “food substances that are generally recognised as safe (GRAS)”, “be pharmacologically inactive”, and “not adversely affect the identity, strength, quality, purity, potency, of bioavailability of ”. If a PCID meets these criteria, as SECUR Tracers are designed to do, drug manufacturers would not need prior approval from the FDA for inclusion of the PCID.

In addition, manufacturers are to be given discretion as to whether they want to label products as containing identifiers or keep their use covert. Companies will have to document the identifier’s chemical composition, how it will be incorporated into the medicine, at what concentration, and show the identifier does not alter the product’s biological behaviour in any way.

Click here to download the SECUR Microtracers flyer.

This article was orginally published on fastmoving.co.za