Data
Substandard and falsified medicines: the numbers, with sources
WHO's standing estimate is that at least 1 in 10 medical products circulating in low- and middle-income countries is substandard or falsified, an estimate first published in 2017, and that countries spend an estimated US$30.5 billion a year on such products. Both figures, their origins and their limits are set out below with their sources.
The 1-in-10 estimate
WHO's fact sheet states that at least 1 in 10 medicines in low- and middle-income countries are substandard or falsified, and records that the estimate was first published in 2017, when WHO estimated that 1 in 10 medicines in those countries failed quality control tests. The underlying analysis was published alongside WHO's 2017 report on its Global Surveillance and Monitoring System, which draws on reports gathered during the system's first four years of operation, to 30 June 2017.
Three limits worth respecting when quoting it. It is an estimate, not a census: it aggregates surveys of varying design. It applies to low- and middle-income countries, not to every market. And it says "at least": WHO presents it as a floor, not a midpoint.
Sources: WHO fact sheet, substandard and falsified medical products (last updated 3 December 2024) · WHO Global Surveillance and Monitoring System for substandard and falsified medical products (2017)
The US$30.5 billion annual spend
The same WHO fact sheet estimates that countries spend US$30.5 billion per year on substandard and falsified medical products. The figure describes money spent on products that are compromised: value lost to health systems and buyers, before counting the clinical consequences of treatment that does not work.
Source: WHO fact sheet, substandard and falsified medical products (last updated 3 December 2024)
What a certificate of analysis can and cannot do about this
A certificate of analysis is a document, and checking it cannot detect a counterfeit product or replace laboratory testing: a flawless certificate can accompany a bad product. What careful certificate checking does is close the document layer of the problem. Most compromised products travel with paperwork that nobody checked line by line, and a buyer who checks every certificate catches the incomplete, the internally contradictory and the quietly nonconforming before money and medicine change hands.
What that checking involves is set out in what a certificate of analysis must contain and, for buyers relying on supplier certificates in place of testing, the conditions that reliance rests on. For importers and trading companies, the commercial answer to the document layer is described on the importer page.
PharmaTrust supports qualified decision-making. It does not replace the responsible pharmaceutical or regulatory professional, does not certify compliance and does not grant regulatory approval.
Published 2026-08-27 · Last reviewed 2026-08-27 · Author: Dr. Majid Qaria
Spotted an error or a newer figure? Write to info@pharmatrust.tech; we correct within a week.