. 2022 Jun 15;106(6):1778–1790. doi: 10.4269/ajtmh.21-1123

Table 2.

Suggested guidelines for reporting poor-quality medicines as substandard or falsified medicines

Medicine quality	WHO definition	Operational characterizations of medicine quality	Suggested guidelines for medicine quality reporting
Falsified	Medical products that deliberately/fraudulently misrepresent their identity, composition or source	If at least one of the following is true: - Contains 0% - Contains an incorrect API - Manufacturer credibly confirms the packaging misrepresents the identity of the medicine - Analysis of the packaging gives conclusive evidence for falsification (e.g., the stated manufacturer does not exist)	Report numerical values of % API for every medicine tested, denoting the medicine, country, and region it was obtained from, sampled location (e.g., entry ports, warehouses, district hospitals, health centers, pharmacies, informal outlets), and method obtained (e.g., overt, mystery client). Visual inspection of packaging should be accompanied by findings from chemical testing to assess % API and results of communication with the manufacturer to confirm the source. Report if evidence for degradation exists (e.g., exhibiting multiple peaks in HPLC chromatogram) for samples containing < 80% API. Performance tests such as dissolution or disintegration test results should be reported for tablets alongside information on % API (e.g., results of Minilab tablet disintegration procedure).
Likely Falsified	Contains < 50% API and there is no evidence of decomposition
Likely Substandard	Authorized medical products that fail to meet either their quality standards, specifications, or both	Extreme deviation¹³ - The content of API deviates by more than 20% from the declared content and/or - For tablets, an average dissolution value of tested units below pharmacopoeial Q value minus 25% Other deviations

Medicine quality

WHO definition

Operational characterizations of medicine quality

Suggested guidelines for medicine quality reporting

Falsified

Medical products that deliberately/fraudulently misrepresent their identity, composition or source

If at least one of the following is true:

- Contains 0%
- Contains an incorrect API
- Manufacturer credibly confirms the packaging misrepresents the identity of the medicine
- Analysis of the packaging gives conclusive evidence for falsification (e.g., the stated manufacturer does not exist)

Report numerical values of % API for every medicine tested, denoting the medicine, country, and region it was obtained from, sampled location (e.g., entry ports, warehouses, district hospitals, health centers, pharmacies, informal outlets), and method obtained (e.g., overt, mystery client).
Visual inspection of packaging should be accompanied by findings from chemical testing to assess % API and results of communication with the manufacturer to confirm the source.
Report if evidence for degradation exists (e.g., exhibiting multiple peaks in HPLC chromatogram) for samples containing < 80% API.
Performance tests such as dissolution or disintegration test results should be reported for tablets alongside information on % API (e.g., results of Minilab tablet disintegration procedure).

Likely Falsified

Contains < 50% API and there is no evidence of decomposition

Likely Substandard

Authorized medical products that fail to meet either their quality standards, specifications, or both

Extreme deviation¹³

- The content of API deviates by more than 20% from the declared content

and/or

- For tablets, an average dissolution value of tested units below pharmacopoeial Q value minus 25%

Other deviations

API = active pharmaceutical ingredient; HPLC = high-performance liquid chromatography.