Reporting a Suspected Falsified Product to an African Regulator
Four regulators, four published routes, and one shared problem: a report is only as useful as the evidence behind it. A channel map for Kenya, Nigeria, South Africa and Ghana, with the record a buyer should keep.
Which channel does each regulator publish for reporting a suspect product, what information does the form ask for, and what should the buyer keep?
Each of the four regulators covered here publishes at least one route for reporting a suspect product, but the routes are not alike: Kenya's Pharmacy and Poisons Board runs an electronic pharmacovigilance portal, Nigeria's NAFDAC points to a Med Safety reporting portal, South Africa's SAHPRA accepts verbal or written reports and feeds a rapid alert system, and Ghana's Food and Drugs Authority operates a Safety Watch system and asks the public to report to its offices [1][3][4][5].
These systems are built for medicines. A research buyer who holds a suspect item may find that the form does not fit and that the regulator has no jurisdiction over a research reagent. The channel map below says what each regulator publishes. The sections on evidence apply whatever the outcome. All pages were read on 10 October 2026; contact details change, so read them from the live page.
When a report is warranted
A discrepancy is not automatically a falsification. A label with a printing error, a lot number that differs from the certificate, or a damaged carton may all be ordinary supplier faults. Those are matters for a written query to the supplier, with photographs, and a request for a corrected document or replacement.
A report to a regulator becomes appropriate when the evidence points beyond an ordinary fault: a lot number that does not exist at the manufacturer, packaging that differs from a verified specimen, a product matching a published alert, or a supplier that cannot be identified. The buyer does not need to prove falsification. The regulator investigates; the buyer describes what was received.
Kenya: the PPB
The Pharmacy and Poisons Board runs a Pharmacovigilance Electronic Reporting System. The site has a Report link in its menu and lists a telephone number and two email addresses, pv@ppb.go.ke and regulatory@pharmacyboardkenya.org [1]. The page does not say which channel suits a quality complaint, and it does not describe a USSD code or hotline, so none is given here.
The Board also publishes a Submit a complaint page on its main website [2]. When read, the page content could not be extracted automatically, so what it asks for should be read from the live form. Contact the Board by the listed email if it is unclear which route applies to a research reagent.
Nigeria: NAFDAC
NAFDAC's reporting for substandard or falsified medicines is on a Med Safety portal [3]. The portal could not be read by automated means when this article was prepared, so the fields it requests, and any hotline or complaints email shown on it, should be read directly. Do not rely on a number copied from a social media post. Take contact details from the portal or from NAFDAC's own website.
South Africa: SAHPRA
SAHPRA describes its Rapid Alert System as the way it shares and receives alerts about falsified and substandard medicines with WHO and other regulators [4]. Its page says quality concerns can come from inspectors, public complaints, manufacturers or other stakeholders, that reports can be verbal or written, and that they are registered as health-product quality investigations.
The page gives no hotline. It lists a general enquiries email address, but states that this is for general, non-product-specific enquiries only. Its menu links to a Report Health Products page, which is the better starting point for a product-specific report.
Ghana: the FDA
The Food and Drugs Authority operates a Safety Watch system at adr.fdaghana.gov.gh [5]. The page reached by that address is a login page with a registration link, and it does not state whether it accepts reports of suspect products. Separately, the Authority's public alerts ask people to report suspected falsified products to the nearest health facility or to its offices.
An older press page that earlier guidance pointed to for Ghana's reporting form is no longer available, so it is not cited. Confirm the current phone line, email address and form on the Authority's website, or by calling its offices.
| Regulator | Route published | What to confirm on the live page |
|---|---|---|
| Kenya, PPB | Electronic pharmacovigilance portal; listed phone and two emails; separate complaint page | Which route handles a quality complaint |
| Nigeria, NAFDAC | Med Safety portal | Fields requested; any hotline or complaints email |
| South Africa, SAHPRA | Verbal or written reports under the Rapid Alert System; Report Health Products page | Product-specific reporting contact |
| Ghana, FDA | Safety Watch system; reports to FDA offices or health facilities | Whether the portal accepts suspect-product reports; current contacts |
What to keep
Every route above will ask, in some form, for the same facts. Collect them before reporting, and before anything is opened, moved or returned.
- The item and all packaging, in the condition received. Do not discard outer cartons or inserts.
- Photographs of the carton, label, seals and any code, taken before the item is moved.
- The lot or batch number and expiry. If you need a refresher on what a batch number is, the information site explains it plainly.
- The invoice, the order confirmation and the supplier's contact details.
- The courier waybill and tracking history, with the delivery time and signatory.
- A written note of how the item has been stored since receipt and who has handled it.
Writing the report itself
Keep the narrative short and chronological. State what was ordered, from whom and when; when it arrived and in what condition; what was noticed; and what you have done since. Separate observation from inference. "The lot number on the label differs from the lot number on the certificate" is an observation. "The product is falsified" is a conclusion that belongs to the regulator.
Attach photographs with file names that show the order they were taken. Give your institution, your role and a direct contact. If you are reporting on behalf of a laboratory, say so, and say who else holds the same lot, because the regulator may want to trace it. Keep a copy of exactly what was submitted, with the date and time, and a screenshot of any confirmation page.
If a portal rejects the report because the product does not fit its categories, do not abandon it. Send the same information by email to the regulator's published address and note that the portal could not accept it. The point of the exercise is that the information reaches a person who can act on it.
What happens after a report
The regulator will usually acknowledge a report, may ask for the item or for further documents, and may take no visible action. A report is a notification, not a complaint with a guaranteed remedy. Do not expect a ruling on a research reagent, and do not tell others that a regulator has confirmed a problem unless it has said so.
If the regulator asks for the item, ask for a written receipt and a reference number. Note the date and the name of the officer. Add all correspondence to the file, in order.
What to do next
Add a one-page incident sheet to your quality system: a list of the six items above, a space for the date each was collected, and the contact details of the regulator for your country, copied from the live page and dated. Having it ready means that the first time a suspect item arrives, the evidence is gathered in the right order.
References
- Pharmacovigilance Electronic Reporting System (report adverse events and poor quality medicines)Pharmacy and Poisons Board (Kenya)
- Submit a complaintPharmacy and Poisons Board (Kenya)
- Report substandard or falsified medicines (Med Safety)National Agency for Food and Drug Administration and Control (Nigeria)
- Rapid Alert SystemSouth African Health Products Regulatory Authority
- Safety Watch System (adverse reaction portal)Food and Drugs Authority (Ghana)