The office of the US Trade Representative highlighted that India has a growing problem of counterfeit medicines, in its annual ‘Special 301 Report’ on intellectual property protection and review of ‘notorious markets’ for piracy and counterfeiting.
With third largest pharmaceutical market and one sixth of world population, India is one of the leading global producers of low-cost generic medicines due to its high domestic demand and inexpensive manufacturing costs. The reasons for it are numerous : limited access to medical care especially in rural areas, fragmented supply chain, lack of consumer awareness, prevalent practice of self-medication, high cost of genuine medicines, weak enforcement of legislation and corruption, prevalence of internet pharmacies and technology advancements in counterfeiting.
India’s status as a low cost manufacturing base has opened the gates for counterfeiters. Counterfeiters share none of the heavy research and development costs incurred by genuine manufacturers yet can earn high profits. Identifying counterfeit drugs is quite complex and costly. Consumers, and sometimes prescribing physicians themselves, cannot tell the difference between the legitimate product and a counterfeit one.
Across the world, many methods and platforms are tested to combat the menace. Some of them are: Global Surveillance and Monitoring System by WHO, tough penalty and full traceability mechanism by China, Handheld device developed by RxAII in Mayanamar, anti-counterfeit platform like mPedigree of Ghana, SMS service by Sproxil in Nigeria, UIMV (Unique Identification Mobile Verification) by PharmaSecure, Blockchain by FarmaTrust , SigmaLedger, Holograms , Tracers, taggants and inks, plastic tags, RFID tags, Serialization and many more like this . India has also taken some steps. NITI Ayog, in 2018 announced to partner with Oracle to deploy blockchain technology to advance the traceability of pharmaceutical products.
Among all these methods, barcoding is easiest and effective way to address this menace in a short span in a country like India. A two-dimensional (2D) barcode looks like a square and contains many small, individual dots. The two most popular types are Quick Response (QR) Code and DataMatrix, but there are other options available. QR code is mostly used to share link to the product’s digital information, whereas GS1 Datamatrix barcode is widely used for identifying healthcare products.
Its use on pharmaceutical products is already specified by regulators in Argentina, Egypt, Ethiopia, Jordan, Korea, Saudi Arabia, Turkey and the U.S., as well as being required as part of the European Commission’s regulation for medicines verification in Europe. It is also recommended for use on vaccines in Canada and is the recommendation on vaccines by WHO and requested by GAVI and UNICEF as well as other drug products in the area of Humanitarian Logistics.
According to GS1 India, “A single 2D datamatrix barcode can hold a significant amount of information and may remain legible even when printed at a small size or etched onto a product. 2D barcodes are used in a wide range of industries, from manufacturing and warehousing to logistics and healthcare.”
When drugs are scanned, they can immediately be identified. This improves the traceability of medicines, allowing fakes to be easily identifiable. Recently, mandatory barcoding of pharmaceutical products but anyhow its still not able to draw the required attention.
Barcoding on medical devices and exported medicines is compulsory, but domestically sold drugs are currently only voluntarily barcoded. The industry has been arguing over challenges in adopting the authentication techniques such as cost of equipment and infrastructure for adoption of barcoding. The government’s regulatory body for pharmaceutical and medical devices, the Drug and Technical Advisory Board (DTAB) suggested the change to combat false labelling as well, as manufacturers can quickly be identified.
It is comparatively easy to implement when many standard organizations like GS1 have extended their support to Govt. for the same. To make it more effective, it can be complimented with other mechanisms like SMS, QR code, Serialization, Blockchain or combination of these. However, this alone may not be enough without a strong legislation and penalty system at various levels from point of production to point of use. Intensive community awareness drives are required to supplement the efforts in long journey.
Approximately 78% of India’s 650 million mobile phone users have access to the internet, and online education about counterfeit and spurious medicine may be an effective way to tackle the issue quickly and efficiently. New possibilities through technology can be explored like use of forensic markers (chemical, biological and DNA taggants) and cloud-based supply chain data repositories to fight the menace of counterfeit drugs.
More we delay, more doubtful we will be about the authenticity of medicines, ability to monitor their ready availability, expiration, track and trace their recalls when needed. This is also one of the causes of avoidable medication errors, injuries or fatalities and proliferation of counterfeits.
In this race of being genuine, one should be alert, aware and technologically well-equipped to stay one step ahead. Even if we were to say that we have achieved 100 per cent anti-counterfeiting, one or two years later, counterfeiters will find some other ways to create menace. So, it’s a constant battle. We must constantly stay one step ahead. Moreover, a solution that worked 10 years ago might not work today. So, we must keep looking at the new advances and solutions in the market to stay alert.
By Dr Gajendra Singh, Public Health Expert
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