A pharmacy can follow every dispensing rule and still hand over a poor-quality medicine if the product was compromised before it arrived. That is the practical problem with counterfeit, substandard and falsified medicines. The World Health Organization (WHO) estimates that at least 1 in 10 medicines in low- and middle-income countries is substandard or falsified, and antimalarials and antibiotics are among the products most often reported.
In Tanzania, the Tanzania Medicines and Medical Devices Authority (TMDA) tests, inspects and removes such products from the market. It relies on pharmacists, dispensers and facility staff to spot and report them. This article explains the terms, summarises what the local evidence shows, sets out the checks worth making at the counter and describes what to do when a product looks wrong.
What counterfeit, substandard, falsified and unregistered mean
The World Health Assembly agreed shared WHO definitions in May 2017. They replaced the older “substandard/spurious/falsely labelled/falsified/counterfeit” label, which had mixed quality failures with trademark disputes.
That is why “counterfeit” needs care. In everyday Tanzanian usage, and in TMDA warnings and press reports, it still means a fake medicine, and it appears in the country’s medicines legislation. A TMDA presentation summarising the legal definition describes a counterfeit as a medicine made under another medicine’s name, or as an imitation of or substitute for another medicine. WHO now reserves the term for intellectual property infringement and uses “falsified” when the concern is deception about identity, composition or source. In practice, a product reported as counterfeit in Tanzania usually belongs under falsified. Articles and reports should say which sense they mean.
A substandard product is authorised for sale but fails its quality standards or specifications, or both. It is usually a genuine product that was made or kept badly. Poor manufacturing and weak quality control are common causes, and heat and humidity during storage and distribution can degrade a medicine that left the factory in good condition.
A falsified product deliberately misrepresents its identity, composition or source. It may contain no active ingredient, the wrong one or the wrong amount. An unregistered or unlicensed product has not been evaluated or approved by the national regulator for the market where it is sold. It may be perfectly good, but TMDA has not assessed it.
The distinction changes the response. A substandard batch usually calls for a recall and an investigation by the manufacturer. Falsification is deliberate fraud, so the police may need to be involved alongside the regulator.
What the Tanzanian evidence shows
The picture is mixed, and the figures measure different things. TMDA has said that an average of about 97 per cent of the samples it tests meet quality standards, from roughly 1,372 samples a year. WHO’s estimate of 1 in 10 covers low- and middle-income countries as a group. Neither describes every product at every outlet. Surveillance samples are often chosen by risk: a 2022 survey of veterinary medicines in Tanzania, for example, targeted products with earlier quality problems. A result from one survey cannot simply be read as a market-wide rate.
Labelling is a recurring weak point. In a surveillance study of 777 anti-tuberculosis medicine samples collected between 2012 and 2018, 176 of 247 samples taken from distribution outlets, or 71.3 per cent, did not meet TMDA labelling and product information requirements. Poor labelling alone is weaker evidence of falsification than a failed laboratory test, yet it removes one of the main tools a pharmacist uses to tell a genuine product from a doubtful one.
Enforcement continues. In September 2026, TMDA reported intercepting unregistered medicines and medical equipment worth TZS 360 million that had been abandoned at Julius Nyerere International Airport. Preliminary laboratory tests found that several of the products contained strong active ingredients for conditions including diabetes, hypertension, epilepsy and cancer. In remarks reported on 21 October, Health Minister Mohamed Mchengerwa directed TMDA to expand its regional offices, strengthen post-market surveillance, use technology to track products from manufacturer to patient and link its systems to the National Health Insurance Fund (NHIF), so that insurance does not pay for medicines TMDA has not registered.
Checks that take a minute at the counter
No single check proves a product is genuine. Together they catch the obvious problems early.
- Confirm the source. Accept stock only from licensed suppliers, and keep invoices that link every batch to a supplier. WHO notes that substandard and falsified products are often sold online or in informal markets.
- Look for the TMDA registration number on the label, and check the product against TMDA’s list of registered products.
- Examine the packaging. Spelling mistakes, blurred printing, uneven labels and a leaflet that does not match the product are all warning signs.
- Compare the batch number, manufacturing date and expiry date on the outer carton with those on the inner pack. In an earlier warning about fake Duo-cotecxin tablets, issued when the regulator was still the Tanzania Food and Drugs Authority, the inner pack carried a different delivery number from the outer carton. On genuine packs, the two matched.
- Inspect the product. Compare its colour, shape, markings and smell with a batch you know is genuine, and treat a price far below the usual wholesale rate as a reason to ask questions.
Why looking is not enough
Some falsified products are visually almost identical to the genuine item, and WHO warns that some have contained toxic chemicals or the wrong active ingredient at dangerous levels. A tablet that looks right can still fail an assay, and finding that out takes laboratory testing. That is the purpose of post-marketing surveillance, and it is why TMDA’s quality control laboratory in Dar es Salaam, which is prequalified by WHO, matters to every dispensing outlet.
Technology can narrow the gap. WHO lists handheld spectrometers, mobile apps and track-and-trace systems among the tools that improve detection when they sit on top of strong regulation. The minister’s call for product tracking points in the same direction, though the reported directive did not include a timetable.
When a product looks wrong
The World Health Professions Alliance toolkit for pharmacists sets out a sequence. Tell your manager if you work in a facility. Keep samples of the suspect medicine, including its packaging and leaflet. Check how much of the product you hold. Stop dispensing it and secure the stock until analysis is complete. Then submit a report to the relevant authority. The toolkit’s sample form asks for the brand name, active ingredient, strength, dosage form, pack size, batch number, expiry date and likely source, so have those details to hand.
In Tanzania, that authority is TMDA. It has published a toll-free number, 0800110084, for reports of suspected harmful medicines, and has urged people to report to its offices or to police stations.
Reporting is where practice lags. A survey of 773 Tanzanian healthcare providers, described in a preprint by Muhimbili University researchers, found that 81.9 per cent had good knowledge of substandard and falsified products, and pharmacists scored best. Yet 53.8 per cent did not know which reporting tools to use, and only 5.9 per cent had used the correct form. Only 13.2 per cent said they had learned about the subject at university, which raises a question for pharmacy curricula.
Building verification into routine practice
The checks above will not catch every falsified product, and nobody should expect them to. They catch the obvious ones early, and they give TMDA a batch number and a sample to test when a doubtful product turns up. Pharmacies, ADDOs and hospital stores that make verification routine, and that know the reporting route before they need it, are the ones who can supply both.
This article is for professional education. It does not replace TMDA guidance or the advice of a qualified pharmacist.
