In December 2008, International Medical Products Anti-counterfeiting Taskforce (a WHO body founded in 2006) dropped the word ‘history’ from the proposed definition of counterfeit drugs, which has worsened the problem of counterfeiting. According to the WHO definition, a counterfeit is “a medicine which is deliberately and fraudulently mislabelled with respect to identity and/or source.
Counterfeiting can happen in both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging." A marginal phenomenon just a few years ago, counterfeit has now become a global problem affecting all countries in the world.
The WHO estimates that up to 15 per cent of the $500 billion world pharmaceutical market is counterfeit (up to 25 per cent in some countries). The research shows that [the problem of] counterfeiting of medicines is on the increase, and it's a substantial one. It is estimated that the business is more than $35 billion a year and at a growth rate of between 12-16 per cent. In 2010 counterfeit medicines may possibly become a $75 billion criminal activity.
Medicine counterfeiting is much more of a threat to public health than to company revenues. The problem is getting worse, especially in developing countries where the regulatory structure is weak and measurement and oversight is difficult. With the estimated percentage of spurious drugs between 25-35 per cent of the total spurious drugs, India is a major hub of spurious drug activities. This has lead to significant negative publicity around the world.
This increasing menace is a worry to Indian pharma companies and government officials. However, it is important to note that pharma industry is ramping up the fight and it involves technological innovations that use packaging as an essential substrate and biggest rescuer.
Packaging is a unique discipline that blends science and technology, design, marketing and business principles. Packaging is one of the largest industry sectors in the world, worth $280 billion. The basic goal for packaging has always been to protect a product during distribution. The demand for pharmaceutical packaging is increasing and will continue to increase as companies rely more on packaging and labelling as media to protect and promote their products, increase patient compliance, and meet new regulations.
Innovations in packaging technology have come to play an important role in helping the consumer identify the authentic products and to ward off counterfeiters. But still the packaging industry has not succeeded much as on date in making drug packing tamper proof. There are a lot of anti-counterfeit features that have been developed. A lot of companies specialize in anti-counterfeit business but still there is scope for improvement. The pharma companies have started using security labels, holographic products and innovative packaging with attractive and unique colour combinations as a means to confront counterfeiting. Though these protective measures have enjoyed some success but have not escaped the counterfeiter’s gambit.
Pharmaceutical packaging is the vector for three integrated elements of an effective anti-counterfeit strategy. First an optimum tamper evident container closure system, overt &/or covert authentication features such as machine-readable inks and optically variable devices. Second, a randomized barcoding with two dimensional barcodes on itemized packaging level and finally, a transparent supply chain with active participation of all stakeholders. 100 per cent tamper proof packagings is the goal, and in some way challenge for packaging industry experts.
According to Henry Lobo, Chairman, Preema Packaging “The idea of 100 per cent tamper proof packaging is an unrealistic demand because technology has advanced so much giving good chance for identical copying. When currency can be faked so can this. It is just about educating the people.” Although 100 per cent counterfeiting packaging material may not be possible for pharma industry, packaging can be made difficult to copy by using special features and special printing inks.
In several products of Pfizer including Viagra, Lipitor, Zoloft, Norvasc and Celebrex a unique logo is introduced onto their packaging that uses colour-shift ink- a technology which is difficult to fake but easy to verify and is similar to the ink used on bank notes.
The changes in pharmaceutical packaging and distribution over the next decade should include more tracking and verification technology to combat counterfeiting. The track and trace method has not gained much popularity inspite of being seen as one of the strongest anti-counterfeiting weapons. Radio Frequency Identification (RFID) tracking technology is an option where the package contains a small electronic device and antenna which can be set up to contain a variety of information (including product codes and expiry dates) and be tracked and interrogated remotely as products pass in and out of a warehouse and also into the pharmacy.
However such a system requires major investment by the pharmaceutical companies in an increasingly difficult economic context. But it is definitely affordable if complete cost v/s benefit perspective is looked at. Apart from cost also there are certain other issues which require attention. In cities and big outlet traceability and tracking is possible but it is unrealistic to imagine a rural town or village in India to have a RFID scanner at the outlet.
Also the victims are generally targeted in areas having lower traceability. However, prior to adoption of RFID, a harmonized 2D data matrix coding system (a barcode system) is believed to be one of the best bets for introducing security into the supply chain in the near future. The system provides the same track and product authentication data as RFID through a central database, but it does not require access to a harmonized radio frequency and reader to fulfill these functions. The process involves physically scanning the pack as it leaves a location and can carry all of the data required by industry, retailers and the regulatory authorities to authenticate medicine packs. Such a system could also be migrated to RFID technology in the future if required.
Addressing this threat requires a sophisticated, co-coordinated and united response. The government, industry experts, players in the supply chain and professional association should pool their efforts to combat the scourge of counterfeit. “Information on fake drug identity and distribution needs to be shared nationally and internationally between government drug regulatory authorities, customs and police organizations, pharmaceutical companies, non-governmental organizations, and consumer groups," says Peter Pitts, Director of the Center for Medicine in the Public Interest. In future we should thus routinely expect that the packaging of drug product will incorporate the best security technology backed by secure verification for the protection of society as a whole.
Mrunali R. Patel is faculty Indukaka Ipcowala College of Pharmacy, Sardar Patel University, New Vallabh Vidyanagar. Rashmin B. Patel& Bharat G. Patel are faculty.A. R. College of Pharmacy and G. H. Patel Institute of Pharmacy, Sardar Patel University, Vallabh Vidyanagar