#StopFakeMeds #ThinkSmart
When a familiar medicine becomes unavailable, fake medicines may try to take its place. This is a serious risk to our health. Drug shortages create gaps—and criminals are quick to fill them.
So, why are these shortages happening, and why are they not going away? – Two recent cases help explain part of the problem.
1. Suspicious clinical trials in India : In May 2024, the European Commission recommended suspending the marketing authorization of nearly 400 generic medicines. The reason: irregularities in studies meant to prove these drugs were equivalent to existing ones. These trials were conducted by an Indian subcontractor, Synapse Labs.
In France, 41 out of the 72 affected medicines were granted a two-year delay in suspension to avoid immediate shortages of essential treatments. This decision—although risky—was made to protect supply.
2. Fines for lack of safety stock in France
In September 2024, after a year of inspections, France’s national drug safety agency (ANSM) imposed nearly €8 million in fines on 11 pharmaceutical companies for failing to maintain mandatory safety stocks of medicines of major therapeutic interest (MITMs)—a requirement since 2021. Here are a few examples:
- Biogaran: €4.5 million fines for 7 breaches, including the anti-hypertensive irbesartan
- Sandoz: €1.4 million for 9 breaches, covering drugs like zonisamide (anti-epileptic) and sertraline (antidepressant)
- Viatris: €800,000
- Sanofi: €551,000
- Zentiva: €170,000
- Other companies fined include GSK, Leo Pharma, Teva, Arrow, Provepharm, and Medac
Some of these pharmaceutical companies argue the sanctions could weaken their finances and force them to withdraw essential medicines from the market.
What’s going on and why won’t it change soon ?
In the first case, irregular or falsified clinical studies amount to fraud or at least gross negligence. They mislead public authorities and patients about a drug’s safety and effectiveness. Such practices could allow fake medicines to enter legal distribution chains. Yet because of shortages, governments must choose: fakes, or nothing at all.
In the second case, companies say building up stocks is too expensive. Expiry dates of the products are short. Margins are tight. In a competitive market, some prefer to optimize cash flow rather than tie up money in inventory—even if it risks leaving shelves empty. And sometimes, the fines cost less than the savings made by cutting stock and selling the same products in countries where prices are higher. For example, some drugs are two to six times more expensive in Germany than in France.
Shortages create a dangerous opportunity for fake medicines
The longer these shortages last, the more we risk fake medicines entering supply chains—especially through illegal imports and unverified online pharmacies.
Around 50% of drugs sold online are estimated to be fake. Patients facing stockouts often turn to unfamiliar websites, social media offers, or unofficial sellers. The wave of falsified Ozempic—a diabetes medication used off-label for weight loss—is a recent example.
Out of habit, necessity, or lack of awareness, we may end up using fake medicines, thinking they’re safe and effective.
#StopFakeMeds #ThinkSmart – and protect ourselves :
- Only buy medicines from legal sources and websites approved by your country’s health authorities
- If in doubt, ask your doctor or pharmacist
- Report suspicious products or side effects to your national drug safety agency
