A substandard medicine is an authorized medical product that fails to meet established quality standards or specifications.
Substandard medicines are genuine products that have not met the required specifications for quality. Problems may arise during manufacturing, storage, transportation, or other parts of the supply chain.
For example, a medicine may contain the wrong amount of an active ingredient, fail to dissolve properly, become degraded because of poor storage conditions, or otherwise fall outside the required quality limits.
Unlike a falsified medicine, a substandard medicine is not necessarily produced with the intention to deceive. The distinction is important because both can potentially cause treatment failure or harm, but they represent different underlying problems.
QUICK FACT
A medicine can be substandard without being deliberately fake.
COMMONLY CONFUSED WITH
- Falsified medicine — Deliberately misrepresents its identity, composition, or source.
- Expired medicine — A medicine used beyond its stated expiration date; this is not automatically the same as a substandard medicine.
- Poorly stored medicine — A medicine exposed to inappropriate conditions such as excessive heat or moisture may lose quality, although storage problems do not automatically establish that the product is substandard.
SEE ALSO
- Falsified medicine
- Quality-assured medicine
- Medicine authentication
- Medicine storage
