✅ Regulation & quality · 6 min
Substandard and falsified medical products
Substandard products do not meet quality standards. Falsified products lie about what they are or where they come from. Both can fail to treat patients and can cause harm. Neither comes with a warning label.
General warning signs
- Spelling or printing errors on the carton, leaflet or label.
- Odd packaging: blurred print, wrong colours, poor-quality cartons, or a look that differs from the pack you know.
- A missing batch number or expiry date, a smudged one, or one that differs between the carton and the blister or bottle.
- Differences in the product itself: unusual smell, colour or texture, or tablets that crumble.
- An unusually low price, especially for a well-known product ('special price, today only').
- An unlicensed seller: no licence, no proper invoice, no address, or a seller who prefers cash and no paperwork.
One sign is a reason to look closer. Several signs together are a reason to stop.
Price is not a quality guide
A very low price can be a warning sign, but a high price proves nothing either. Criminals copy expensive products and can charge the real price. The best protection is the source: a licensed supplier, a proper invoice and a traceable batch.
What to do if you suspect a product
- Stop. Do not sell or dispense it.
- Quarantine it: separate it, label it 'Do not sell' and keep the pack and any paperwork.
- Record the product, batch, supplier and what looked wrong.
- Report it to the supplier and to the regulator (EFDA), following the current directives.
- Do not return it to the shelf or throw it away until you are told what to do.
Sources: WHO Global Surveillance and Monitoring System for substandard and falsified medical products · WHO guidance on substandard and falsified medical products (fact sheet) · EFDA directives (current)
Quick check
For licensed professionals and students. Educational information only: always follow current national guidelines (EFDA, Ministry of Health), the product label and your facility’s procedures.
