Blockchaintechnology may be the prescription to the problems faced by the Pharmaceutical industry. One of the biggest challenges faced by the industry is the traceability of its supply chain from the manufacturing unit on to the customer. From the tracing of the quality of raw materials to maintaining the cold chain integrity of finished products in transit-these are only some of the supply chain concerns of the industry.There is also a huge global industry of counterfeit medicines. The percentage of counterfeit drugs in India alone stood at 25 percent.
The industry has developed tracking solutions with radio frequency identification tags and barcodes, but the same is insufficient for syncing the data across different suppliers. Since data is not available in real time, the systems are susceptible to fraud and manipulation.
Blockchain could be the solution to the problems. The distributed and decentralized ledger is managed by a set of stakeholders who do not trust one another. Every entry in the ledger is secured and made immutable by linking it to the previous entry using cryptographic hashes. Every stakeholder runs a blockchain node which instantly mirrors the transactions taking place in the network and in turn, keeping the ledger in sync.
The blockchain in pharmaceutical industry could be a private blockchain, overseen by a government regulator. Those involved in the supply chain can log their data into a common blockchain. The production factory can log the date and time of production of each batch and unit and the loading dock can log when the batch is loaded into the truck. Further, the temperature sensors on the truck can report the real time temperatures in the blockchain. This real time visibility for all the stakeholders means the problems can be detected and resolved immediately. The data is immune from tempering. Every time a consumer purchases a medicine, they can also scan the barcode on the packet and instantly verify the authenticity of the medicine from the blockchain.
The Directorate General of Foreign Trade in India has mandated the serialized tracking of exported pharmaceutical products down to the strip or vial, in addition to sharing and archiving the data. The USA already has compliance mandates for the supply chain security. A trace and track system enabled by a blockchain can make it easier for manufacturers to comply with such regulations globally and also provide the regulatory with a high integrity audit trail visible in real time. Apart from supply chain, blockchain technology could positively impact clinical trials. According to a report, 50% of the clinical trials do not report a result and industry sponsored trials are four times more likely to declare positive results as compared to others. These trials can suffer from incorrect consent reporting, selective inclusion and data fudging.
Blockchain is a superior way to ensure integrity and accuracy of the outcome. Blockchain would mitigate any risk consent fraud. The biggest hurdles to the adoption of blockchain are regulatory issues and data privacy. These can be considered as short term hurdles since regulators are reviewing how blockchain can help the industry and the entire blockchain community is adding data privacy on the platforms.