Counterfeit drugs became a nuisance for pharma companies causing drug recalls, liability suits, and jeopardizing brand loyalty as consumers perceive added risks while employing a company’s product. the most important risk is for consumers as most of those fake medicines contain either adulterated active ingredients which will put the patient’s lives in peril or entirely inert materials like chalk or cornstarch rendering the medicines completely inactive. Further, these fake drugs are reprocessed in an unhygienic environment and stored at temperatures without considering the drug’s stability which again threatens the well-being of patients.

To circumvent the risks along side ensuring patient safety, pharma manufacturers are arising with numerous proficient anti-counterfeit strategies. The contemporary methods to combat counterfeiting include legal actions on illicit traders, countermeasures using technologies, consumer education and awareness, private investigations, and cooperation with enforcement agencies.

Current global approaches for tackling counterfeit drugs
Counterfeiters pay special attention to the packaging of faux drugs to facilitate their insertion into the legitimate drug supply chain. that's why a majority of the present anti-counterfeit measures are aimed toward drug packaging. a number of these are described here:
• Tamper-evident/tamper-resistant packaging – it's used as an indicator to supply visible or audible proof to consumers that interference with the merchandise has occurred.
• Product Authentication – Unique features like overt (holograms, colour-shift inks) or covert (embedded images, digital watermarks, invisible printing), or forensic (chemical and biological tag, micro-taggants) are embedded either on the dose or on the packaging of the medicines. Holograms can combine 3-layer security measures . one hologram provides overt first-line authentication while covert features like scrambled images, microtext, UV-sensitive, or other specialised inks provide second-line authentication. The serialisation of holograms (e.g. binary encrypted holograms, light diffraction hologram elements during a product label, or a mixture of a hologram, 2D data-matrix, and thermal monitoring) offers authentication with traceability.
• Track & Trace (T&T) technology – T&T is currently leading the battle against the rising menace of the counterfeit drug market and has been made a compulsory requirement by several regulatory bodies across the planet . It assigns a singular identification code to every stock unit during manufacturing which is maintained throughout the availability chain until its consumption and may be accessed easily on a secure database. This technology includes pedigree (paper document or electronic file that records the small print of the distribution of a prescription from its manufacture through wholesale transactions), mass serialisation (uniquely identifies every entity and ensures the absence of counterfeits), Global Trade Item Number (GTIN), serialised Global Trade Item Number (sGTIN) and data carriers. With the help of those technologies, the drugs within the supply chain are often certified as legitimate by the govt authorities.

A glimpse of the various anti-counterfeit initiatives worldwide
• Following 2016, signature DNA marker packaging materials are to be adopted over digital coding, to deliver efficient anti-counterfeiting for pharmaceutical tablets as they supply more encryption. Four years post-enactment, the USA Drug Supply Chain Security Act (DSCSA) imposes that the drugs must be serialised by manufacturers at the sealable unit and case level.
• Mobile Authentication Service may be a NAFDAC (National Agency for Food, Drug, Administration, and Control) program in Nigeria supported by BIOFEM pharmaceuticals where Sproxil technology enables any consumer to verify the authenticity of a medicine with an easy text message. GSK together with NAFDAC applies this service for the authentication of antibiotic Ampiclox™.
• The Malaysian Ministry of Health introduced the “Meditag” holographic authentication sticker in 2005 to ensure the authenticity of registered medicines.
• The French Health Products Safety Agency notified the distributors mandating replacement of ‘13 character CIP (Club Inter Pharmaceutique) code with the batch number, expiry date, and Simplex linear barcode’ with 2D data matrix marking.
• As archived within the Canadian Consensus Statement, 2009, 2D bar codes on the first package and 2D or linear barcodes on the secondary package, both including GTIN and therefore the lot number were made mandatory. As of 2017, the Universal Product Code project is in Phase 4 of development.
• The Directorate General of Foreign Trade, India issued a public notice in 2011, stating that exported pharmaceutical products must be equipped with T&T capability using barcode technology as per GS1 global standards. A 2D barcode must be maintained at the first level packaging, 1D or 2D on the secondary level and 1D at the tertiary level encoding the GTIN code, batch number, expiry date, and serial number of respective packaging.

As the technologies are becoming smarter, counterfeiters also are devising new ways to beat the anti-counterfeit techniques employed by the regulatory bodies and therefore the pharma companies. However, with the increasing use of T&T and serialisation systems along side the implementation of other counterfeit detection methods, we will certainly hope to curb the threat of faux medicines.

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Pharmaceutical Solutions