IPT: What are some of the major challenges in combating counterfeit medicine?
EC: The main challenge when it comes to combating counterfeit medicine is the fact that counterfeiters are becoming smarter. In today’s technologically-advanced world, we believe there is a need for innovative and effective solutions when it comes to product authentication, track & trace and supply chain integrity.
Increasingly, internet pharmacies are helping the counterfeit industry to reach the customer, directly. This, coupled with a lack of consumer awareness about counterfeit medicines, is helping them to fuel the industry's expansion.
The pharmaceutical industry is looking towards putting anti-counterfeit solutions into practice to safeguard its products. But the process of implementing track & trace is complex, affecting the whole ecosystem and causing financial implications and overheads for the manufacturers.
Furthermore, the different and ever-changing regulations between countries make it even more difficult for manufacturers to implement and maintain them. If manufacturers want to safeguard their products against counterfeiters, they need to implement comprehensive solutions, integrated at each level starting from manufacturers planning down to the stakeholder supply chain and the end users.
IPT: How does ACGI feel the European Union (EU) Falsified Medicines Directive (FMD) will address these and can more be done beyond these regulations?
EC: The EU regulations facilitate not only the pharmaceutical industry against counterfeit medicines, but they also empower consumers through the authentication process. The EU FMD approach of a centralised repository with localised verification data centres is a well thought-through deployment scenario.
ACGI expects the regulation to extend its scope to include serialization at all packaging levels in the future, with verification across the entire supply chain. This will enable governments to have complete visibility of the pharma supply chain. The information received through these implementations will be used for controlling medicine stock and prices throughout the supply chain.
IPT: How is ACGI looking towards the future of securing the safety of drug supply?
EC: The track & trace industry is going through a complete overhaul, in light of the technological revolution. We foresee technologies like cryptography printing, blockchain, the internet of things (IoT) and machine learning playing key roles in securing the pharmaceutical supply chain from counterfeited goods. And, we aim to be at the forefront of this revolution.
IPT: How do you think future global regulation, in regard to securing the supply chain, will change over the coming years?
EC: We expect that, in the future, all countries will come together to standardise track & trace implementation and information exchange.
The overall data captured throughout the pharma manufacturing process to the supply chain will be used for predictive quality improvement using traceability. We, therefore, foresee that track & trace will become an essential and integrated part of the business quality process. It will move from a ‘need to have’ technology to a ‘must have’ technology in the complete pharmaceutical production. Here the pharmaceutical manufacturer will need to monitor and track products at each point in the supply chain, 24/7. We also foresee track & trace expanding its reach downstream and upstream, accommodating the tracking of the complete pharma process from an active pharmaceutical ingredient (API)/molecular level through to the actual consumption of the product and the incorporation of consumer feedback.
Ettore Cucchetti is the CEO of ACG Inspection Systems Pvt. Ltd., which includes ACG ValueLinks LLP and ACG Pharma Agents LLP.
