An Overview of Track & Trace Regulations in Pharma Industry and its Impact on the Reverse Logistics of Medicines- Status in Regulated Countries and India

摘要

Drug counterfeiting is an important problem addressed by several countries. This requires multiple measures to protect the supply chain. The implementation of anti-counterfeit technologies is an important strategy taken up by several drug manufacturers and regulatory authorities. The track and trace system and serialization are given importance and are widely used among all anti- counterfeit technologies in different countries. Developed countries like the USA have implemented RFID while the European trend is towards 2D barcodes. The Indian government is getting sensitised about the extent of the problem and has formulated rules mandating barcodes. Reverse logistics is a combination of product returns of expiring or overstocked product, and recalls initiated by manufacturers themselves or by regulatory authority for product defects. Extensive government regulations and reporting requirements, along with an increased focus on pedigree, have increased the need for good tracking, visibility and control measurements which are all critical components for any reverse logistics process.