© IJARCSMS (www.ijarcsms.com), All Rights Reserved 21 | P age e-ISJN: A4372-3114 ISSN: 2321-7782 (Online) p-ISJN: A4372-3115 ISSN: 2347-1778 (Print) Impact Factor: 7.529 Volume 10, Issue 3, March 2022 International Journal of Advance Research in Computer Science and Management Studies Research Article / Survey Paper / Case Study Available online at: www.ijarcsms.com Pharmaceutical serialization: Impact on drug packaging Shambhu Sarkar Master of Commerce, Micro-master’s in healthcare administration USA Abstract: The purpose of this paper is to focus on the serialization regulation impacts on drug packaging. Pharmaceutical serialization is a regulatory compliance in many countries for drug traceability. It leverages the traceability of pharmaceutical drugs and improves the visibility throughout the pharmaceutical supply chain. Serialization compliance requires advanced levels of packaging including unique identifiers in individual units and tamper proof seals with holograms. The main objective of governments and regulatory bodies for implementing serialization with advanced level packaging is to secure the supply chain and mitigate the risk of counterfeit [1]. Counterfeit drugs are products deliberately and fraudulently produced and/or mislabeled with respect to identity and/or source to make it appear to be a genuine product [2] [3]. The World Health Organization (WHO) has estimated that 1 in 10 drugs in low to middle income countries (particularly Southeast Asia and Africa) is falsified or substandard during market circulation.[4] Serialization has been proving a very productive regulation in combating counterfeiting drugs. New secure technologies bring new methods to identify and ensure the safety of drugs by implementing advanced tamper proof packaging methods which have been very successful for minimizing counterfeit drugs in the supply chain. Objective: This study intends to empirically examine the impacts on packaging by regulating drug serialization compliance. Keywords: Serialization, drug traceability, pharmaceutical packaging, tamper evident, barcodes, counterfeit drugs, falsified, pharmaceutical industry. I. INTRODUCTION Pharma Serialization is assigning a unique code to the packaging of each drug and printing this code on the packaging by any method. There are two main points in this definition. The first is the unique code and the second is the drug packaging. According to Jose A. Alfaro [6], traceability is a mechanism to ensure safety. Traceability is defined by The British Standards Institution as: ―The ability to trace the history, application, or location of an object. The object is defined by this same standard as being any perceivable or conceivable thing. Objects can be material (i.e., an engine, a sheet of paper, a diamond), non- material (i.e., a conversion rate, a design plan) or imagined (i.e., the future state of the organization)‖. The tracing of pharmaceutical drugs to improve the visibility throughout the pharmaceutical supply chain. Turkey introduced serialization requirements in 2010 with unique identifier printing on individual drug units, other markets such as China, South Korea have regulations in place. Since last decade, China has required all the supply chain partners involved in the drugs distribution to record information of individual drug units in a traceability system. The importance of drug traceability has been increasingly emphasized and mandated by several countries across the world. The US regulatory body Drug Supply Chain Security Act (DSCSA) has outlined steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. [7].