Indian pharm industry needs an effective strategy to combat counterfeiting

June 16, 2011 - PRLog -- Introduction
Counterfeit pharmaceuticals are an ongoing problem worldwide and the labelling industry has been heavily regulated as a result.  Different geographies can sometimes be at a higher risk than others, and in recent weeks, India has been cited as a source of counterfeits. The recent decision of Government of India of finalization of implementing bar code and to eliminate the apprehension of counterfeit drugs attracted the attention of the industry. This comes on the heels of a discovery of “Made in India” labels on fake pharmaceutical products produced in China. To combat this, all Indian pharmaceutical exports will carry a barcode as of July 1, 2011 on primary, secondary and tertiary packaging.

Missing Element - No Protection from fakes or tampering
The better-late-than-never rule will allow medicine to be traced and tracked to its source of origin. Bar code is a good solution for tracking and tracing of goods, but a problem will always remain if the product is counterfeit during the supply chain. As when the code is simply printed onto the packaging, it does not protect the pack against counterfeiting or tampering.
1.   Traceability features are not immune against foregery and require ad additional anti-counterfeiting feature to ensure their own authenticity as well as the authenticity of the product they are attached to.
2.   The codes can simply be copied and printed on to illegal produced packaging, or the original product can be removed from the original pack and replaced by fake.
3.   The consumer is obvious to this if the produce pack itself is not properly protected.

One needs to understand that product identification technologies such as barcode and DMS tracking should be used to facilitate the overt, covert and other forensic technology, not to compete with these proven technologies.

Example: European Federation of Pharmaceutical Industries and Association (EFPIA)
In May 2009, the EFPIA announced the pilot of its coding and identification solution in Sweden. The EFPIA solution does not provide for verification by the patient, as it is the Pharmacists who will check a unique identification code on each individual pack when it is dispensed to patient.

These codes are generated and applied by manufacturers using a simple 2D Data Matrix Barcode, which contain a unique serial number. The scan revealed any duplication of data on packs and triggers the system to immediately alert the pharmacist to the possibility of a counterfeit product. This solution presumes that all data collected in a central location in a timely fashion and can be queries against at anytime from almost anywhere. This opens up a list of question;
1.   Who is going to be responsible for storing and managing this data?
2.   Who will pay for it?
3.   Are pharmaceuticals firms willing to share their data with everyone else in the supply chain?
4.   Most pharmaceutical products pass through many hands along the supply chain before they reach their finial destination, which increases the chances of product counterfeiting, especially in European market, where distribution involves many countries and languages. The long supply chain increases the risk of products being repackaged or exchanged at the temporary storage facilities.

With this solution, a pharmaceutical company still loses, because you cannot tell which product is the counterfeit, so if the fake product was dispensed first, then you are going to end up holding back the genuine product when you get a duplicate hit.

EFPIA had himself acknowledges that the system check the code, not the product, so it does not necessarily authenticate that the medicines is genuine, but it will identify that the code is genuine. (see, Pharma Anti-counterfeiting news, Issue no1, August 2009)

Anti-Counterfeiting is a multi-layered approach
Counterfeiters can quickly identified and duplicate many drugs and drug safety measures. This is why a multi-layered approach to counterfeiting is essential for opting drug security. Printers should provide both overt and covert anti-counterfeiting solution.

EFPIA and OPPI (India) both have specified various safety elements for every drug unit. As per EFPIA,first, products should have a tamper-evident container closure system with overt and or covert authentication features, second, packaging should contain a randomized 2D barcode on each unit, and lastly, the supply chain should be transparent.

Further, the choice of technique should be depends on how the drug manufacturer intends to use security features, for example, a mandatory in favor of an individual technology, can backfire, once it fails.

Need of multi-layered security
In selecting a security feature, various tradeoffs are necessary between security and usability. It is possible to secure a document or product almost absolutely by applying layer after layer of complex security features, but to fully authenticate would require far more equipment and resources that is really practicable or necessary. The most effective brand protection is a multi-layered solution, with sufficient barriers to deter criminal activity, ideally combing both overt and covert approaches. This strategy will go a long way towards, protecting patient safety, as well as country reputation and revenues of pharma companies.


References
1.    How to select a security feature “ The Document Security Alliance (DSA) and The North American Security Products Organisation (NASPO)” www.documentsecurityalliance.org / www.naspo.org
2.   Solutions in the fight against drug counterfeiters “Schreiner MediPharm” www.schreiner-medipharm.com
3.   Anti-Counterfeiting – A multi layered approach “Eric Caro of Catalent Pharma Solutions” www.samedanltd.com / www.catalent.com
4.   DuPont anti-counterfeiting solutions / www.authentication.dupont.com
5.   www.pharmasia.com
6.   Technology advances anti-counterfeiting options “Pharmaceutical Product Security” eINFO
7.   US Immigration and Customers Enforcement, ‘ICE Efforts to Combat counterfeit Pharmaceuticals’ July 2006
8.   EFPIA, ‘Packaging Standard for Counterfeit Resistant Packaging and its Implementation into International Supply Chains in Europe’, May 2007
9.    MHRA, ‘Anticounterfeit Strategy 2007-2010’, November 2007
10.   European Federations of Pharmceutical Industries and Association (EFPIA) white paper “The Anti-Counterfeiting of Medicines”

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HOMAI the voice of the hologram industry is working for the promotion of Indian hologram industry as well as making it a unique one-stop source of authenticated, credible and reliable Brand Protection Solutions provider across India and world. Members of HOMAI are all involved in making solutions for brand protection, authentication, track & trace. Typically each solution requires Overt, covert and forensic features.