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 efficacious, if it meets specification(s) directly linked to a defined quality property/parameter. As, at present, a quality parameter for pharmaceutical products such as tablet and capsule, is undefined thus it is not possible to make valid claims in this regard.

Current regulatory and pharmacopeial approved products available on the market should only be considered as 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 is making or accepting such claims, and seek appropriate help in addressing the issue (link).

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