Fighting Counterfeit Drugs

Counterfeit drugs have become a nuisance for pharma companies causing drug recalls, liability suits, and jeopardizing brand loyalty as consumers perceive added risks while using a company’s product. The biggest risk is for consumers as most of these fake medicines contain either adulterated active ingredients that can put the patient’s lives in danger or entirely inert materials such as 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 with ensuring patient safety, pharma manufacturers are coming up 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 fake drugs to facilitate their insertion into the legitimate drug supply chain. That is why a majority of the current anti-counterfeit measures are aimed at drug packaging. some of these are described here:

  • Tamper-evident/tamper-resistant packaging – It is used as an indicator to provide visible or audible proof to consumers that interference with the product has occurred.
  • Product Authentication – Unique features such as 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 features. A single hologram provides overt first-line authentication while covert features such as 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 in a product label, or a combination 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 mandatory requirement by several regulatory bodies across the world. It assigns a unique identification code to each stock unit during manufacturing which is maintained throughout the supply chain until its consumption and can be accessed easily on a secure database. This technology includes pedigree (paper document or electronic file that records the details of the distribution of a prescription drug 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 aid of these technologies, the drugs in the supply chain can be certified as legitimate by the government authorities.

 

A glimpse of the different 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 provide 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 is 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 medication with a simple text message. GSK in collaboration 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 guarantee 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 in the Canadian Consensus Statement, 2009, 2D bar codes on the primary package and 2D or linear barcodes on the secondary package, both including GTIN and the lot number were made mandatory. As of 2017, the bar 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 primary 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.

 

Country-wise details of measures undertaken to combat counterfeit products

Country Legal framework involved Border measures

(detention by customs)

Criminal prosecution

(duration of imprisonment and fine)

India ·    Trademarks Act 1999

·    Indian Penal Code 1860

·    Drugs & Cosmetics Act 1940

Not defined 6 months-3 years;

$765-$3,060

USA ·    Lanham Act (codified at 15 USC § 1051)

·    Trademark Counterfeiting Act 1984 (codified at 18 USC § 2320)

5-7 business days 10-20 years;

$2-$5 million

Canada ·    Trademarks Act (RSC 1985, c T-13)

·    Copyright Act (RSC 1985, c C-42, as amended)

·    Criminal Code (RSC 1985, c C-46)

10 working days 5 years;

C$1 million

UK ·    Trademarks Act 1994

·    The Frauds Act 2006 and the Proceeds of Crime Act 2002

10 days and 3 days for perishable goods Not defined
China ·    Civil code

·    Tort law

·    Criminal Law

·    Product Quality Law and the Anti-unfair Competition Law

3 working days $7250
France ·    EU Customs Regulation 608/2013 (amended by IP Code) 4 business days 3 years (or 7);

€300,000

Brazil ·    Industrial Property Law (9,279/96)

·    Copyright law (9,610/98)

·    Software law (9,609/98)

·    Internet law (12,965/14)

10 working days 3 months -1 year or 2-4 years + fine

 

Conclusion

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

References:
  1. Bansal, D., Malla, S., Gudala, K., & Tiwari, P. (2013). Anti-counterfeit technologies: A pharmaceutical industry perspective. Scientia Pharmaceutica, 81(1), 1–13. https://doi.org/10.3797/scipharm.1202-03
  2. Shah, R. Y., Prajapati, P. N., & Agrawal, Y. K. (2010). Anticounterfeit packaging technologies. Journal of Advanced Pharmaceutical Technology and Research, 1(4), 368–373. https://doi.org/10.4103/0110-5558.76434
  3. Global Anti-counterfeiting, Authentication and Verification Technologies Market 2020 – ResearchAndMarkets.com. (2020). https://www.businesswire.com/news/home/20200102005365/en/Global-Anti-counterfeiting-Authentication-Verification-Technologies-Market-2020
  4. SERIALISATION & TRACK AND TRACE DEADLINES : PRINTABLE WORLDMAP. (2019). https://www.laetus.com/wp-content/uploads/2016/08/Serialization_Map.pdf
  5. Khan, S., & Agrawal, S. (2020). Procedures and strategies for anti-counterfeiting: India. World Trademark Review. https://www.lexology.com/library/detail.aspx?g=3044c5a2-8329-4468-811c-649e523ee1e2
  6. Finnegan, & Henderson. (2018). Procedures and strategies for anti-counterfeiting: United States. World Trademark Review. https://www.lexology.com/library/detail.aspx?g=3495d584-f988-45ff-8add-7d83bcab50d2
  7. Lipkus, L. M., Danzig, G. S., & Lipkus, D. S. (2016). Procedures and strategies for anti-counterfeiting: Canada. World Trademark Review. https://www.lexology.com/library/detail.aspx?g=de7e14e9-65f1-4f32-9728-f5144c60c8a0
  8. McKenzie, B. (2019). Procedures and strategies for anti-counterfeiting: United Kingdom. World Trademark Review. https://www.worldtrademarkreview.com/anti-counterfeiting/procedures-and-strategies-anti-counterfeiting-united-kingdom-1
  9. Procedures and strategies for anti-counterfeiting: China. (2018). World Trademark Review. https://www.worldtrademarkreview.com/anti-counterfeiting/procedures-and-strategies-anti-counterfeiting-china-0
  10. Mikus, K. D. (2019). Procedures and strategies for anti-counterfeiting: France. World Trademark Review. https://www.worldtrademarkreview.com/anti-counterfeiting/procedures-and-strategies-anti-counterfeiting-france
  11. Fekete, E. K., Leonardos, G. F., & Amaral, R. L. (2020). Procedures and strategies for anti-counterfeiting: Brazil. World Trademark Review. https://www.worldtrademarkreview.com/anti-counterfeiting/procedures-and-strategies-anti-counterfeiting-brazil-3

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