The Global Counterfeit Drug Epidemic and the Computer System Validation Solution

October 10, 2022

In the wake of the 2020 pandemic, what was even more threatening than an unknown contagion, was the supply of counterfeit drugs. As Health and Life Sciences companies continue to grapple with the skewed demand and supply for pharmaceutical drugs, the number of preventable deaths due to counterfeit drugs, is staggering.

Christopher Vore, Managing Director, at Agile GxP Advisors, discusses the issue of fraudulent drugs and the ways to combat it through Computer System Validation. In his article, “The Global Counterfeit Drug Epidemic and the Computer System Validation Solution” , he gives insight into the root-causes for the rampant circulation of fraudulent drugs, its adverse impact on patients’ health and solutions using Computer System Validation Solution (CSV).

The article takes a dive deeper into the causative factors of counterfeit drug production. These include easy access to fake drugs; a growing market for less-expensive drug products, liberalization of drug trading routes, and online drug sales.

Streamlining the drug manufacturing process with regulatory compliance standards, the author underlines the need for a robust CSV. A CSV, with its pre-defined framework of FDA-identified guidelines, validates the system with GxP standards, during different stages of drug development. Working in tandem with serialization, CSV gives the double thrust to compliance. The combined effect of the two makes sure that vital digital data is traced and captured along the various points of the value chain. In this context, the author brings to the forefront, the rigorous serialization programs followed by many countries to fight the counterfeit drug trail.

With global health awareness on the rise, what is underscored in the article, is a regimented focus area for Health and Life Science companies. Primarily, to have their core systems integrated with regulatory compliance through CSV and serialization. The author reiterates that the CSV-serialization driver would not only be a panacea for the ‘counterfeit drugs epidemic’ but also an ‘immunized’ way forward towards the future – for patients and Health and Life Sciences companies alike.

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