Could Falsified Medicines Be Slipping Through Your Supply Chain?
In today’s tightly regulated pharmaceutical environment, it’s tempting to think falsified medicines are someone else’s problem. But the reality? They’re closer than you think.
From spoofed supplier emails to diverted goods in transit, vulnerabilities exist throughout the pharmaceutical supply chain — even in fully licensed, GDP-compliant organisations.
🚨 What Are Falsified Medicines?
Falsified medicines aren’t limited to counterfeits. They also include genuine medicines that have been stolen, illegally obtained, or sold outside the legal supply chain. Diversion of medicine is a growing problem as criminal gangs seek new ways to fund their activity, the proceeds of which can often be linked to terrorism.
Examples include:
Stolen batches re-entering the market
Medicines traded outside licensing agreements or national boundaries
Products acquired from unlicensed suppliers
Batches manipulated or tampered with during import or transit
These threats compromise patient safety, brand trust, and regulatory compliance.
⚠️ Where Are the Weak Points?
Vulnerabilities can appear at multiple stages — not just at goods-in:
Fake supplier communications (cloned emails, spoofed domains)
Tempting pricing from unverified or insolvent businesses
Outdated regulatory databases listing non-compliant companies
Uncontrolled import channels, particularly across borders
Diversion during logistics: falsified recalls, driver fraud, or internal misconduct
🧰 Strengthen Your Defences with These Proven Controls:
✅ Vet every supplier thoroughly
Don’t rely solely on MHRA or EUDRA websites — they can be outdated and may list suppliers that are insolvent, suspended, or no longer trading. Always:
Contact the supplier’s Quality Department directly (not sales)
Request up-to-date WDA and GDP certificates, and verify their authenticity
Monitor business risk events (like bankruptcy) using tools such as Dun & Bradstreet
Where possible, perform a remote or on-site audit
If internal resource is limited, engage with us, we regularly audit suppliers across the UK and EU and can assist with fast, objective verification.
✅ Limit commercial influence — Procurement should work in partnership with Quality, not lead it alone.
✅ Only use GDP-accredited logistics providers, and conduct regular performance checks.
✅ Enforce strict goods-in checks — including expiry, tamper-evidence, and barcode scans.
✅ Train staff on phishing and fraud risks — especially in Buying and Quality.
✅ Use real-time tracking (e.g. telematics, scan-on-dispatch/delivery).
✅ Regularly test recall processes to detect falsified or manipulated notices.
✅ Access security and diversion opportunities within your direct supply chain - Are you doing enough?
📦 Use Lane-Level Risk Assessments for Transport
One powerful — and often overlooked — strategy is to use lane-based transport risk assessments.
Instead of relying solely on the credentials of your couriers, consider:
Specific origin–destination routes
Transit countries and locations
Day or time of transit
Product classification (e.g. temperature-sensitive, CDs)
By adjusting controls based on actual route-level risk, you can significantly improve transport security and GDP compliance.
❓Is Your Supply Chain Really Secure?
Having procedures on paper is one thing — but true protection lies in how well your controls are applied, tested, and evolved.
Ask yourself:
Are supplier records actively maintained and reverified, or simply assumed to be current?
Do we conduct ongoing due diligence on third-party logistics partners, not just during onboarding?
Could a falsified recall notice or unauthorised collection bypass our existing processes?
Do we truly know who we're selling to? Are our customers verified and risk-assessed?
Are we alert to unusual order patterns, such as sudden spikes in high-value medicines or controlled drugs that may signal diversion?
If any of these areas feel uncertain, now is the time to act. A robust supply chain isn’t just about compliance — it’s about control, visibility, and vigilance at every step.
If you'd like support assessing your supply chain, addressing specific concerns, or auditing your suppliers and logistics providers, get in touch — our team is here to help.