The Indian pharmaceutical industry is facing major challenges in the area of traceability and security of its supply chain. The entire process of sourcing high-quality raw materials to sustaining the cold chain integrity of drug manufacturing to safety announcements and drug recalls – every stage is a cause of concern in the Indian context.
On the other hand, counterfeit drugs are hurting the pharmaceutical manufacturing sector while also endangering the unsuspecting patients. Fake and Counterfeit Drugs in India – Booming Biz, a 2014 report published by ASSOCHAM, revealed that counterfeit drugs occupy a staggering 25% of the domestic medicine market of India.
The industry has attempted to address concerns regarding track and traceability for drug pharmaceutical counterfeiting through global positioning system (GPS), RFID (Radio-Frequency Identification) tags, electronic data interchange (EDI), barcodes and QR codes, near-field communication (NFC) and other such technologies.
However, these tools failed to take off due to the following reasons:
Blockchain introduces a distributed, decentralized ledger that is collectively managed by a set of stakeholders. These stakeholders operate a blockchain node, which is a reflection of the real-time transactions.
Every entry recorded into the ledger is cryptographically encrypted and secured. As a result, none of the entries can be erased or manipulated. These entries are made further immutable through cryptographic hash linkages to the previous entry.
Therefore, blockchain technology just might be the prescription for the counterfeit drug and track and traceability through the supply chain issues. It can primarily grant the following advantages:
The pharmaceutical supply chain can be mapped as a blockchain node, which will be overseen by a governmental regulatory body. All the stakeholders and parties involved in the drug manufacturing to distribution will log their data in the node.
For instance, the pharmaceutical manufacturing company will record the production data and time for every batch and unit produced. The loading docks will capture when the batch is loaded onto the trucks. The temperature sensors present in the trucks will log the real-time weather conditions, and so on.
Regulatory bodies can immediately detect and address any issues due to granular monitoring and auditing at every level. Most importantly, this data is available in real-time and immune to tampering!
Moving beyond the domestic landscape, the Directorate General of Foreign Trade (DGFT) has made it mandatory for drug manufacturing companies to realize serialized tracking of exported goods. This action is in response to the Drug Supply Chain Security Act of the US and similar laws imposed by other nations. Thus, the adoption of blockchain technology ensures compliance with these global regulations.
From the above, it becomes clear that blockchain technology adds value and efficiency to the drugs and pharmaceutical industry.It will positively help combat the various issues, from supply chain gaps to drug counterfeiting that are currently plaguing the pharmaceutical industry.