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Open Access October 03, 2023 Endnote/Zotero/Mendeley (RIS) BibTeX

Pharmaceutical Drug Serialization: A Comprehensive Review

Abstract A persistent problem in the pharmaceutical industry that has existed for centuries is the prevalence of counterfeit drugs, and the World Health Organization (WHO) estimates that millions of people are affected by this issue each year. In particular, 4 out of 10 drugs in poor or underdeveloped countries may be adulterated, which can lead to severe adverse events. To address this problem, many [...] Read more.
A persistent problem in the pharmaceutical industry that has existed for centuries is the prevalence of counterfeit drugs, and the World Health Organization (WHO) estimates that millions of people are affected by this issue each year. In particular, 4 out of 10 drugs in poor or underdeveloped countries may be adulterated, which can lead to severe adverse events. To address this problem, many countries have implemented regulatory compliance measures such as pharmaceutical drug serialization, which requires the unique identification of every drug package manufactured. This enables tracking and tracing of individual packages throughout the supply chain and helps to prevent counterfeit drugs from entering the market. In this paper, we conduct a systematic review of the serialization process evaluation and its impact on the pharmaceutical industry. We discuss the benefits of pharmaceutical drug serialization, including its ability to improve drug security and reduce adverse events and investigations. We also examine the challenges associated with implementing serialization processes and the regulatory requirements necessary for compliance. Finally, we explore the various tracking and tracing technologies used in serialization processes and their effectiveness in preventing the distribution of counterfeit drugs. Overall, this paper highlights the importance of pharmaceutical drug serialization in ensuring the safety and efficacy of drugs in the healthcare industry, particularly in poor or underdeveloped countries where the problem of adulterated drugs is especially prevalent.
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Keyword:  Aarav Gupta

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