India is the third-largest drug producer globally by volume and 14th by value, with an estimated 5,000 production lines. This is an impressive record, but it is being over-shadowed by the growth of the fake drug market in the country. Even globally, counterfeit drugs form a growing problem. The World Health Organisation (WHO) estimates that counterfeit drug prevalence rates fall between 10% and 30% in the developing world, as compared to 1% or less in developed countries.
A recent report shows the extent of the prevalence of counterfeit drugs in the Indian market. Maharashtra is the worst affected, with 23% of the medicines in the state found to be not of standard quality. For Tamil Nadu, this number is 13%, Kerala 9.2%, Gujarat 8.5%, Karnataka 7.2%, UP 6.9%, J&K 6.08% and Rajasthan 5.8%. Spurious drugs, which can take the benign form of simple sugar pills, also have huge destructive capabilities. A large portion of fake drugs seized by the government were found to contain toxic chemicals like mercury, not to mention heavy metals. These chemicals, when ingested normally, are hugely dangerous. When taken as a substitute for genuine medicines, however, spurious drugs can be fatal. The government, thus, has started a campaign to implement bar codes on drugs, so as to distinguish them from the fakes. The global anti-counterfeit packaging market is expected to be worth $79.3 billion by 2014, growing at an estimated CAGR of 8.6% from 2009 to 2014. This opens up a significant market potential for track-and-trace management (barcoding) product authentication solutions for the pharmaceuticals industry.
According to India Barcode Scanners & Printers Market Forecast & Opportunities, 2017, the revenues of the barcode industry in India are likely to grow at a whopping CAGR of around 30% during the period 2011-2017. Cashing in on this potential, Goose Technologies, a provider of pharmaceuticals industry-focused business re-engineering software products and solutions, has launched its new-generation online and offline 2D serialisation bar coding solution, for the drug industry. Goose Tracker is a simple and easy-to-configure track and trace solution for achieving bar coding on drug packaging as per the recent Directorate of Foreign Trade (DGFT) regulation, says Deb Pattnaik, founder and chief executive of Goose. The solution creates, manages and tracks unique serial numbers printed on the tertiary, primary and secondary packages.
Goose Tracker integrates with existing applications to securely meet data management and printing needs for packaging and shipping labels. We are working with several governments and non-government entities to include changes as and when they are announced, Pattnaik adds. The company is engaged in discussions with quite a few pharmaceuticals manufacturing organisations in the country who are in the process of complying with the barcoding requirements for secondary packages, which came into effect on January 1, 2013, and subsequently primary packaging serialisation which will become mandatory for exports this year.
Globally, governments and drug companies are implementing various methods to tackle the problem of spurious drugs. From July 2010, the National Agency for Food and Drug Administration and Control (NAFDAC) has been using a mobile authentication service and an RFID system.
Similarly, US-based PharmaSecure has demonstrated that its platform can cover the last mile of the pharmaceuticals industry by engaging consumers in a low cost, two-way communication about their drug utilisation and related behaviours. PharmaSecure has developed an SMS/Mobile solution for drug authentication, by which a randomly generated, unique nine-digit alpha-numeric code is printed on a medicine pack along with an SMS number9901099010. If the drug purchaser sends the unique code to the number, he will get a confirmation within 10 seconds of whether the drug is genuine or not.
With the growing ubiquity of mobile phones in India, this can have a tremendous impact in the country. According to Nakul Pasricha, vice-president, operations, at PharmaSecure, the recent announcement from the government has sped up the process of implementation which was already underway with some of our clients, and validated the decision of some other clients to ensure installation, implementation and commissioning of the solution by December 31. PharmaSecure has tied up with the top-10 pharmaceutical companies in India, according to Kishore Kar, vice president, sales and marketing, PharmaSecure. Due to confidentiality reasons, he couldnt reveal the names of these companies, though.
Since launching its India operations in 2009, PharmaSecure has printed over 250 million pharmaceutical packages with unique ID codes that allow consumer authentication by SMS, and now by using their free app. Using the new app, consumers can either enter the code on imprinted pharmaceutical packages or simply scan a bar code on the packages. It has coded over 20 crore packages of medicine for consumers to verify by SMS.
Although there are several different programmes running globally, there is still a need to do a lot more with a proper anti-counterfeiting strategy comprising government, legislation, drug companies, solutions providers and consumers. Manoj Kochar, president, Hologram Manufacturers Association of India (HOMAI) says, First of all, we need to understand that serialisation technologies such as barcode will never provide authentication of a product. Serialised numbers are a visible feature and therefore may be altered, distorted or deleted by the fraudsters. He says that the track-and-trace technologies have to work in tandem with a dedicated anti-counterfeiting technology like security hologram to fight the counterfeiters effectively.
Secondly, pharmaceutical packaging require multiple levels of authentication. Currently, pharmaceutical brand owners are facing problem of counterfeiting in forms of pilfering, tampering, diversion, sub-standards drugs, and look-alikes. Hence, bar-coding alone will not solve all these problems, he adds.
These objections are not valid, though, according to PharmaSecures Kar. Its a randomly generated code, and so cannot be duplicated, he says. Another method of duplication could be where the counterfeiter provides an alternate phone number to send the messages to. While in theory that could work, in practice it will not. The phone number can be traced. This method of counterfeiting is like setting up a formal system to conduct informal and illegal activities. It will not work, he adds.
The value of each technology can be enhanced by using several different complementing technologies. Every authentication solution would involve the use of a multi-level technology which need to have overt (verification by human eye), covert (verification by specified tool/ device) and forensic (verification by expert with advanced tools in a laboratory) technology.