Counterfeited Medical Products: What changed with the new Decree-Law N38 of 2024 in the UAE?
In comparison with the Federal Decree-Law n8 of 2019, distribution reporting is being reinforced, with notable expansions of scopes, responsibilities and introduction of strict timelines. A national database for reporting counterfeit has been also introduced in an effort to fight such illegal activities. But why?
With the increasing demand for medical products worldwide, the market is subject to counterfeited drugs more than ever before. Regulatory bodies all over the world have tightened their requirements over the recent years, however, counterfeit continues to find its way into supply chains till this day. The Middle East -being the point of transit between Asia, Africa and the Americas- is a sensitive pole for these harmful activities. In 2023, reports indicate that Dubai serves as a significant global hub for trafficking various counterfeit goods, including pharmaceuticals. In 2024, the Department of Health in Abu Dhabi (DoH) has detected 116 counterfeit pharmaceutical products since the beginning of the year.
Incidents like this do not only present a critical health risk to patients, but also a significant financial and reputational threat to pharmaceutical establishments involved in the distribution activities.
What should you do to minimize risks?
- Check your partners’ credentials through an independent verification.
- Verify your partners’ certifications and Wholesaler’s licenses for handling medicines.
- Check for an unusual trading activities or appearances of the products being handled.
What should you do when you suspect a product is counterfeited?
1) If you suspect that you identified a counterfeited product, the first thing to do is to ENGAGE EXPERIENCED AND QUALIFIED PERSONNEL. This is important to assess the situation correctly.
2) The quantity in question should be immediately physically segregated from all other products and labelled as counterfeit.
3) Thorough documentation should be performed (Exp: Date of receipt, quantity, visual description, product information in detail, photos, notes)
4) Promptly notifying the regulatory authority, in the UAE’s case it would be the EDE starting from January 2nd 2025 through the national database.
Now as a pharmaceutical establishment, you are legally required to report these incidents, but how can you ensure that you have the right strategy to identify a counterfeit when you see one?
We need to understand that there is no fix all solution. Counterfeiters have adapted more and more underhanded tactics over the years; however, companies often rely on their previous experiences to identify a suspicious product. Training your distribution personnel can avoid the strict penalties up to AED 1M.
At Inglasia Pharma Solutions, we have a highly experienced team with decades of experience in good distribution practices. We help companies in multiple continents secure their supply chain and assess their risks. We can help you tailor strategies fit for your business activities and needs, and turn quality processes into business growth opportunities.
Don’t let regulatory changes catch you off guard. Contact us today for expert guidance in counterfeit detecting strategy!
Written by Ghada Amami