A large part of what we do at ASC Associates is supporting key stakeholders throughout the supply chain to maximise efficiency and compliance, in order to maintain product integrity and ensure the safety of the consumers. And a major aspect of this is recognising the threat of counterfeit drugs, and developing ways to secure the supply chain against this threat.
The sheer scale of the counterfeit drugs market was demonstrated recently when police in Poland shut down an illegal factory near the city of Bydgoszcz which was capable of producing millions of counterfeit medications. Within the raid, police found 100,000 counterfeit erectile dysfunction pills, alongside 430,000 vials of steroids, worth around $4.4million. However in a statement issued by the Central Bureau of Investigations in Poland (CBSP) it was recorded that the illegal unit was capable of producing much more than this.
The police managed to seize equipment that would create a whole pharma production line, including: mixers, tablet presses, blister packs, and screen printers, making it almost impossible to distinguish the counterfeit drugs from the real ones. A complex supply chain that included shipment to the UK was uncovered within the raid, and it is understood that the majority of these drugs would have been sold over the internet.
It is important to remember that the problem with counterfeit drugs goes beyond the financial implications of illegal reproductions. There are no regulations governing the production of counterfeit drugs, meaning that some may not contain even a trace of the active ingredient. And even when the medications produced do contain the active ingredient, it is often in an insufficient amount, making them ineffective and potentially dangerous as they can contribute to the development of drug-resistant strains of life-threatening diseases such as malaria and tuberculosis. People die every single day because of counterfeit drugs, and that is unacceptable.
So what can we do? Well, we need to be proactive in ensuring that we are doing everything we possibly can to ensure the integrity of the supply chain. By reducing the risk of counterfeit drugs entering the supply chain, we reduce the risk to the consumer. This can be done through a combination of a thorough audit of the entire supply chain, robust planning and quality managements systems, and adequate and appropriate training for every member of staff.
We also need to be aware of changes to regulations within the industry, such as the new Delegated Regulation (EU2016/161) published recently by the European Parliament and Council to supplement the Falsified Medicines Directive. This will come into effect by 2019 and aims to introduce two new safety features – a unique identifier that can be scanned at various points along the supply chain, and tamper evident features on the packaging.
Such safety features have already been introduced and trialled, thanks to tech start-ups, and these have shown real promise. However, as this article on the BBC shows, the tech start-ups cannot solve the problem alone – for these safety measures to have any real effect they have to be embraced by us all.
We offer Supply Chain Security Audits and can advise you on the best practices for Logistics and Supply Chain Security. If you would like to know more about our services, please contact us to discuss your requirements.