Emerging markets are expected to contribute majorly in the global Pharma business. Plans have been made by pharma giants to tap this promising market. A major challenge faced by pharma companies is the need to address drug counterfeiting and recalls across the global supply chain, while focusing on this business .Drug counterfeiting poses a major challenge for patient safety and compromises on revenues, brand image and supply chain logistics.
Pharma companies need to address this important issue by taking a holistic view and framing a comprehensive global anti-counterfeiting strategy.
The key aspect of the strategy should emphasize ownership of the drug across the supply chain, till it reaches the patient and Complying with country or region specific regulatory mandate should not be the only criteria of this strategy. Identification of products and markets that are vulnerable for counterfeiting and devising mechanisms is an essential requirement for a strong strategy.
The anti-counterfeiting strategy has to align with the corporate supply chain strategy, and should spell out a roadmap for implementing anti-counterfeiting measures. The best approach for addressing anti-counterfeiting measures is a phase wise implementation of Track and Trace solution from plant to patient, using Serialization process.
Serialization refers to the placement of unique marking, one or two dimensional bar-codes with or without human-readable letter / number using variable data printers on various levels of packaging materials to register the parent-child relationship which are generated by a serialization manager and is then read by vision system to update the record of commissioned and decommissioned serials. As a result of parent-child aggregation, when the barcode on the highest pack level is read then it will track the information regarding all shipping containers. The serials repository database will be authenticated by the regulatory bodies once the product is shipped and will provide the ability to track-and-trace products from the point of manufacturing to the point of dispensing.
The information printed as serialization is mainly dependent on various regulatory standards. An ePedigree system shall maintain the complete ownership of the supply chain whilean electronic and automated system shall be capable of authentication and certification of each owner of the drug from the current owner back to the original manufacturer as part of serialization. Beyond compliance to a regulatory requirement, serialization solution implementation shall be considered as a strategy of supply chain, safety, security and efficiency.
The best known regulatory mandate is that of California’s ePedigree law, which has been recently extended from 2011 to 2015. EU has mandated serialization for at least one product line by end of 2011 and complete pedigree systems to be implemented for all products by 2014. Turkey and France have mandated Serialization using 2D barcode as per GS1 standards. From January 1st, 2011, France mandated all distributed Pharmaceutical products should have ECC200 Data Matrix barcode made up of GS1 code. It constitutes of a batch number and the medicine expiry date and human readable text which shall be printed on the production line as a replacement of the current French pre-printed CIP 7 standards to Code CIP 13 but no serial number is required on the external packaging.
Turkey mandated that all Pharmaceutical companies to provide track and trace with the help of a secondary identifier and report the information to the system operated by Ministry of Health. The system provides traceability of products and data collection for assessment. The secondary identifier shall be 2D barcode on all product packaging till unit-level items.
India’s DGFT has mandated Serialization for Life Sciences companies to incorporate, 1D Data Matrix, Unique product identification code (GTIN), Batch No., Expiry Date and Unique Serial No on Tertiary packaging by 1st October, 2011. 1D or 2D Data matrix, Unique product identification code (GTIN), Batch No., Expiry Date and Unique Serial No. on Secondary Packaging by 1st January, 2012. 2D Data matrix, unique product identification code (GTIN) and Unique serial Number on primary packaging by 1st July, 2012. All these features shall use bar coding technology as per GS1 global standards. Also the DGFT has suggested that, in case the importing country has mandated a specific requirement, the exporter can adhere to the same.
The crucial element of any serialization strategy is to employ a holistic approach: deploying an end-to-end IT-enabled business process across not only manufacturing, distribution, and logistics arenas, but also encompassing product safety and compliance with industry standards, to track and trace drugs across the supply chain.