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September 18

India is witnessing a treacherously increasing problem of counterfeit medicines. The United States Trade Representative (USTR) office releases an annual report on intellectual property protection and markets that are notorious for counterfeiting. This ‘Special 301 Report’ mentions that 20% of all pharmaceutical goods sold in the Indian market are counterfeit.

There are a number of reasons for this. India is one of the leading global producers of low-cost generic medicines, with the third largest pharmaceutical market in the world. This is largely due to its high domestic demand and comparatively lower manufacturing costs. In addition, there are many other factors which fuel the rampant proliferation of counterfeit medicines – limited access to medical care in rural areas, haphazard supply chains, lack of consumer awareness, higher cost of genuine medicines and technology advancements in counterfeiting are only to name a few.

Counterfeiters earn very high profits, since there are no research and development costs or testing & approval processes involved in producing fake medicines. Agencies all over the world are doing their best in contesting this menace. The WHO has its Global Tracing & Monitoring System, while China has severely tough penalties and a full traceability mechanism. Lesser economically developed countries like Nigeria and Ghana also have anti-counterfeiting systems in place like Sproxil & mPedigree. In India, NITI Ayog was announced in 2018 to partner with Oracle and deploy block chain technology for successful traceability of pharmaceutical products.

In a vast and diverse country like India, as of date, Quick Response Coding (QR) has been established as the easiest and most effective way to address the issue of counterfeiting in a relatively short span of time. A two-dimensional (2D) QR code looks like a square and contains many small, individual dots. While QR codes are mostly used to share a link to the product’s digital information, there is also another type of code known as the GS1 Datamatrix barcode, which is widely used for the identification of genuine pharmaceutical products. These systems have already been implemented in most parts of the world, and are even a part of the European Union’s regulation for pharmaceutical verification. They are also recommended by WHO and UNICEF for use on vaccines.

Roadblocks in implementation

It has been made mandatory for pharmaceutical products to have QR or barcodes in India, but it is yet to gain the necessary importance it requires. Though it is compulsory for export of medicines and medical devices, the domestic market is still based on the manufacturers’ discretion.

 Citing challenges such as infrastructure and equipment cost, the small and medium sized manufacturers of the Pharma industry have been in a constant argument with regulatory bodies. The Drug and Technical Advisory Board (DTAB) has also suggested QR coding to combat label counterfeiting.

A QR code or 2D datamatrix can hold a significant amount of information related to the product, and can be easily read by handheld mobile devices even when printed in a very small size. This enables their usage in a wide range of industry segments, from manufacturing to warehousing and logistics, and of course healthcare. QR technology streamlines the traceability of medicines, allowing fakes to be easily and immediately identifiable.

A constant battle

Effectively speaking, this technology is not as difficult to implement as it seems. With many standard organizations like GS1 extending their support to the government, other mechanisms like SMS verification, serialization, block chain or even a combination of these can be implemented throughout supply chains irrespective of the scale.

Fighting counterfeits is a constant battle, and we need to stay a step ahead of counterfeiters who are always thinking up new ways to dupe unsuspecting consumers. We need to be technologically well-equipped in all aspects and keep abreast with the rapidly evolving solutions in the market. Combined with strict legislation, severe penalties and consumer awareness initiatives, QR coding systems will definitely prove to be an effective and fool proof method to tackle the pressing issue of counterfeit medicines.