FMD compliant solution powered by IoT, blockchain and AI for providing end-to-end traceability
Bosch PharmaTrace is an interoperable IT solution powered by IoT, Blockchain and AI, built to equip its customers with strict compliance to the FMD.
The solution is of great importance for the pharmaceutical industry due to the growing problem of counterfeiting- affecting both patient lives and revenue losses to the pharmaceutical companies along with the mandate to comply with the Falsified Medicines Directive.
The solution focuses on the following key applications:
• Track and trace of prescription medicines:
The use case uses the unique serialization number of each package to track it along the entire supply chain, across the stakeholders using the PharmaTrace solution. Counterfeits are detected by alert flags raised by the system on scanning of the fake drug barcode. . A real time verification and validation of registered assets with the regulator’s database thereby ensures robust leakage detection and control mechanism
• Saleable Returns / EMVS Verification: The verification of serialisation data at one or more stops along the supply chain is the next step in the EU FMD. After the manufacturers have generated the serialisation data, they must report the product master and production data to a centralised hub, known as the European Medicines Verification System (EMVS) and forwards all data to the respective National Systems. Channel partners have 10 days before they can add drugs back into the EMVS for reselling. PharmaTrace provides real time, secure verification of the product returned by the pharmacy to the distributor/wholesaler. PharmaTrace provides interoperability so that wholesalers and distributors can easily verify barcodes with the database and flags as well as logs transactions that are suspicious.
• Condition monitoring: The PharmaTrace blockchain platform is capable of interacting with the condition monitoring IoT device placed in the cold storage containers- large cold storages, refrigerators, vehicles, etc. This use case is relevant for drugs that need to be stored under prescribed temperature, pressure, humidity, etc. E.g. Vaccines, photosensitive drugs. In case of any breaches, PharmaTrace’s autonomous agents raise flags, log into the system and reports it to the relevant stakeholders. The in-built track and trace mechanism then allows removal of spoiled medicines from the supply chain system.
• Certificate management: The use case ensures digitization of compliance certificates and supply chain documents like invoices, e-bill of lading, title of ownership, customs clearances, bank letters of credit etc., along with selective sharing of digital assets with relevant stakeholders like Pharma Company, distributors wholesalers and dispensers for compliance and completeness of the process. The benefits are seamless process optimization and faster payment cycles solves the problem of inefficiencies, forgery and large account receivables.