Should claims of quality of approved and marketed drug products be considered valid – not necessarily? Theranos’ style regulatory and pharmacopeial claims!

A product can only be considered of quality and, by extension, safe and effective if it meets specification(s) directly linked to a defined quality property/parameter. Currently, a quality parameter for pharmaceutical products, such as tablets and capsules, is undefined; thus, making valid claims in this regard is impossible.

Current regulatory and pharmacopeial-approved products available on the market should only be considered compliant to arbitrary standards/specifications, mostly invalid and irrelevant for quality. Claims are unsupported – a similar scenario as observed in the case of Theranos (link). Please use caution when making or accepting such claims, and seek appropriate help addressing the issue (link).

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