Global drug serialization in pharma sector: Complete review

Abstract

The primary aim of this paper is to acquire an understanding of drug serialization within the pharmaceutical sector and explore its various dimensions. Presently, pharmaceutical counterfeiting poses a significant challenge in the industry. Various countries have established regulatory measures to combat counterfeit drugs, with drug serialization being one such regulatory compliance mechanism to address this issue. Over an extended period, counterfeit drugs have severely impacted the healthcare industry. Regulatory bodies across different nations are actively deliberating ways to alleviate the problem of counterfeit drugs and their adverse effects on consumers who unknowingly ingest fraudulent medications. Research indicates that in underdeveloped countries, as many as 4 out of 10 drugs are fake or have been adulterated through illicit means, contributing to a substantial problem. This situation has dire consequences for the healthcare industry, resulting in substantial financial losses due to the infiltration of counterfeit drugs into the supply chain. Additionally, consumers are put at risk when they unwittingly consume fake medicines, instead of the life-saving drugs they require. Regulatory authorities are responding by enacting new regulations to tackle this issue and prevent counterfeit or adulterated drugs from entering the supply chain. To ensure the safe and genuine delivery of drugs to patients, the pharmaceutical industry must implement robust traceability measures and adhere to stringent regulations. The tracking and tracing process of pharmaceutical drug serialization ensures the ability to trace individual drug packaging throughout the entire supply chain, encompassing manufacturers, distributors, wholesalers, pharmacies, and end consumers. Importantly, these serialization measures enhance the security of drugs within the supply chain without compromising drug quality, effectively reducing the infiltration of counterfeit drugs into the distribution network.