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According to the World Health Organization (WHO)(2006), a counterfeit drug can be defined as one that is deliberately and fraudulently mislabeled with respect to identity and/or source. Such pharmaceutical products either have wrong ingredients or may have correct ingredients but in the wrong quantity. Penetration of such counterfeit drugs in the authentic pharmaceutical supply chain is evaluated by Mackey et al. (2015) and they observed that no single entity alone is able to combat this menace.
Counterfeiting is one of the major concerns faced by the pharmaceutical industry. According to the Center for Medicine in the Public Interest, sales of counterfeit drugs are increasing globally at about 13 per cent annually, nearly twice the pace of legitimate pharmaceuticals, as examined by Pfizer’s Global security(2017). This has prompted regulators and pharmaceutical firms across the globe to take the requisite measures to tackle the increasing trade in counterfeit drugs. For example, product serialization continues to be a driving force for reform in the segment of pharmaceutical packaging in the battle against, duplication, fraud, deviation and misleading returns to manufacturers. Serialization requires a robust program to monitor and control the flow of prescription medications across the entire supply chain in order to reduce the supply of counterfeit drugs. The process of serialization and labelling involves printing 2D barcodes directly onto the medicines, packets and boxes. It allows the manufacturers, pharmacies and hospitals to track their pharmaceutical products. With the use of Automatic Identification, a customer can verify whether a product is genuine or not, via labels. Vision identification is also implemented for the real-time validation of barcodes that can be printed on products in compliance with the Specific Product Recognition specifications of the FDA. Radiofrequency Identification (RFID) is another sophisticated serialization technology used, as studied by Kumar(2019).
The growing threat of spurious drugs has forced the US Food and Drug Administration(FDA) to drift their focus to the Indian pharmaceutical industry. The measures taken by the Indian government such as ‘Make in India’ and ‘Skill India’ are binding together with the healthcare firms at a global level to provide comprehensive packaging solutions and improve the quality of drugs manufactured. A government portal called Drug Authentication and Verification Application (DAVA) based on GS1 standards has been developed for authentication and traceability. Its objective is to boost India's status as a world leader in production. But there are some loopholes in the system like it is not necessary that each transaction is transparent to all the stakeholders in the supply chain. Furthermore, it is not able to locate and regulate the product in the entire supply chain, as mentioned in niti.gov.in (2020). Banerjee and Bali, (2019) has Designed a Bioinformatics Feature Based DNA Sequence Data Compression Algorithm for enhancing the security of the algorithm.
At present, around 1.9 million of the total world’s population has been affected by the Novel Coronavirus (COVID-19). The coronavirus pandemic has resulted in the increasing demands of a wide variety of products that aren’t readily available to the general public, like the self-testing kits at home. To avoid the growing gaps in the market, selling of fake drugs in developing countries like Africa became more profound. Falsified claims have been made for the treatment and prevention of COVID-19, essential healthcare products like face masks, hand sanitizers have been counterfeited in the supply chain. Selling of substandard drugs as well as the medical devices is a matter of grave concern, which needs to be addressed in this time of crisis, as studied by Newton et al. (2020).
The issue of counterfeiting is more prevalent in developing countries, like India and China due to the limited use of track and trace technology. Therefore, there is an urgent need for transparency and intervention in drug data provenance and how they have been managed throughout the entire course of the supply chain, as studied by Kumar(2019).