Fighting the dangers of counterfeit medicines: a way forward

Counterfeiting is a global problem of enormous magnitude, which has a negative impact on many industries around the world. Counterfeit, falsified or adulterated medicines pose one of the major threats to pharmaceutical companies as they damage their reputation and overall business. Counterfeit drugs seriously harm the health of consumers. India is no exception. Furthermore, counterfeits damage the nation’s reputation, given that India is a major exporter of pharmaceuticals to more than 150 countries.

A recent report from the Association of Authentication Solution Providers Association (ASPA), a non-profit organization specializing in the area of ​​counterfeit awareness, highlights that the COVID-19 pandemic has fueled drug incidents of substandard and falsified (SF) and other medicines produced by almost 47% in just one year – from 2020 to 2021. The pandemic and subsequent lockdown has resulted in an imbalance between demand and supply for authentic products or ingredients leading to the rise of online pharmacies. Although online pharmacies are a necessity, we need clear regulations to ensure the sale of quality medicines through this channel. Unregulated websites filled with misleading information allow people to buy drugs without a prescription, leading to a growing demand for fake drugs around the world. Poor practices throughout the supply chain, unsatisfactory quality control at the manufacturing site, lack of vigilance measures, existing gaps in the regulatory framework and lack of consumer awareness of counterfeit or inaccurate medicines are some of the reasons that require immediate intervention. the attention of government and the pharmaceutical industry.

In a bid to eradicate the threat of counterfeit drugs, the Indian government is taking several steps in this direction. APIs are used as the main raw materials when manufacturing tablets, capsules, syrups and intermediates. From January 2023, QR codes on the packaging of active pharmaceutical ingredients (APIs) will be mandatory. From May 2023, the imposition of a barcode/QR code will be mandatory on the packaging of the top 300 pharmaceutical brands sold in the domestic market, according to the recent draft notification issued by the Ministry of Health and Labor. Family well-being. However, the most important part is still to ensure uniformity in the whole process as well as strict enforcement so that there are no loopholes that can be misused by fraudsters. The pharmaceutical industry should proactively come forward and work with the government to ensure that the vigilance process is properly supported – from manufacturing units to when a vendor sells the drug.

Some of the digital technologies can play a central role in providing transparency in identifying fake medicines. Pharmaceutical players in India are in a constant process of implementing procedures like coding and serialization which cover components like barcode, data matrix and radio frequency identification (RFID). Track-and-trace digital technologies can help manufacturers identify unauthorized sellers on the Internet. It is also capable of remotely authenticating a product anywhere and anytime by scanning a product label through a smartphone or inserting a code into a web-based platform. Pharmaceutical players, especially those with a large market share for a particular drug, need to come up with a unique packaging design that is difficult to copy.

Currently, the difficult part is that there is no established mechanism to distinguish between NSQs (not standard quality) and fake drugs. The problem of counterfeit drugs must be tackled and dealt with appropriately around the world because it tarnishes the brand image and creates a huge loss for the genuine manufacturer. The need of the hour is to strengthen testing technologies so that there is clear identification of NSQ and fake drugs as two separate categories so that pharmaceutical companies can take necessary action against the drug identified as counterfeit. A collaborative approach between government and the private sector is the only way to win the battle against counterfeit medicines.



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The opinions expressed above are those of the author.



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