Allegations of counterfeit drugs have haunted the Indian pharmaceutical industry for quite a few years now. You can never be sure whether the tablet actually has an API or just white chalk. An E.U. Report last year pointed out that India was the largest source for the 2.7 million counterfeit drugs that were seized at the E.U. borders in 2006. For its part the WHO claims that India is the source of 35% of all counterfeit drugs in the world while the OECD pegs the figure at 75%. Our very own DCGI is in the midst of a study to assess the true scale of the problem. The fear over counterfeit drugs reached such epic proportions a few years ago that the Central Government proposed the death penalty for all those people convicted of peddling counterfeit drugs. That was 5 years ago and nothing has happened so far. Regardless of this proposal the fact of the matter remains that the government machinery is simply too incompetent to rein in such a serious threat to public health. It was therefore up to the market forces to innovate on effective anti-counterfeiting strategies in a bid to save the consumer from fake drugs apart from protecting themsleves from product liability lawsuits.
There are several forms of anti-counterfeiting technologies which I will not deal with since Sai has already done a brilliant post covering these various technologies. I’ll restrict myself to the latest.
The latest, most cost-effective anti-countereiting technology is ‘mass serialization‘ and it has been brought to our notice that Roche India has sucessfully implemented this technology for most of its products being sold in India. Roche had entered into an agreement with Norway based M/s Kezzler for this unique anti-counterfeiting technology sometime ago. Most of Roche’s products from now onwards will have a unique 16 digit alpha-numeric, human readable, computer generated code on the packaging. Any consumer who now buys a Roche product will be able to confirm the authenticity of the product by emailing/SMSing the 16 digit alpha-numeric security code to Roche’s database which will then either confirm or deny the authenticity of the product in question. The main advantage of this technology lies in the fact that it is relatively cost-effective when compared to other anti-counterfeiting technologies such as RFID. Also it is one of the most secure technologies since it maintains a real time link between the consumer and the manufacturer. The U.S. FDA has lauded the ‘mass serialization’ technology as the ‘single most powerful tool’ in the fight against counterfeit drugs. It is expected to become the most widely used anti-counterfeiting technology in the world.
So does that mean that the problem of counterfeiting drugs, being shipped to the E.U., will be resolved? If Big Pharma is to be believed these anti-counterfeiting measures will not help unless and until a re-packaging ban is enforced in Europe. ‘Re-packaging’ refers to the practice of importing low-cost drugs being sold in developing countries and re-packaging them to be sold in the E.U. Some members of Big Pharma (not Roche) have been reluctant to invest resources in credible anti-counterfeiting technologies such as mass serialization until the E.U. imposes a ban on repackaging since they claim that re-packaging is the weakest link in the drug supply chain. They claim that the re-packaging industry is the entry point for counterfeit drugs into the system. Any such ban on repackaging would kill the practice of parallel imports thereby increasing medical costs across the E.U. Ironically such a ban would lower costs for Indian consumers since Big Pharma will now be able to sell more of its products in India at a lower price without having to worry that the product in question would be re-packaged and sold in the E.U. The parallel traders are obviously up in arms against the ban claiming that the re-packaging industry is subject to high standards of regulation by the E.U. and that in the last 35 years only one counterfeiter has been caught introducing fake drugs through the re-packaging industry.