Pharmaceutical Serialization : A Challenge for Small Manufacturers

Abstract

The purpose of this paper is to focus on the Challenges faced by Small Manufacturers due to the Serialization compliance. Pharmaceutical serialization is the process of assigning unique serial number to each saleable product pack. Each product pack contains information about product source, Global Trade Identification Number (GTIN), Batch number, Expiry date and unique serial number. Pharmaceutical serialization is not new compliance, and it was initially introduced by Turkey in 2010, and other market such as the China and South Korea. Since many years China made compulsory for all supply chain partners to record drug distribution information of individuals drugs units in a traceability system. As we are approaching to 2023, It will be final phase of 10 yearlong implementation of Drug Supply Chain Security Act (DSCSA) since compliance enacted in 2013. Verification router services (Saleable Return) is another compliance which was scheduled to enforce on 2020 but it is now push back to 2023 due to Covid-19 impact. Under 2023 DSCSA Act, manufacturers need to provide product tracing information in secure and interoperable manner electronically to distributors and wholesaler in supply chain. Wholesaler must transfer product tracing information to dispensers and pharmacy and verify saleable returns receive from supply chain stakeholders. Dispenser/Pharmacy should be able to receive Electronic Product Code Information Services (EPCIS) and product tracing information electronically and to be able to reconcile physical product unique identifier with electronic records. Finally, everyone in supply chain must be connected electronically through interoperable network which will allow regulatory bodies to track and trace the information’s. The importance of drug traceability has been increasingly emphasized and mandated by several countries across the world. The Drug Supply Chain Security Act (DSCSA) has been working on a pilot project with big pharmaceutical companies, wholesalers and distributors to design and test interoperable network to trace pharmaceutical prescribed drug electronically at package level. This will help supply chain stakeholders to verify the authenticity of drug in United States.