E-drug: Concept of generic drugs (cont'd)
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Although the definition of "generics" is less important
than the concept, the key question here is: Is there
enough competition in the market to lower prices? If
products are marketed at various prices (as brands or
generics), generic policies should be oriented towards
guaranteeing their quality, by requiring Good
Manufacturing Practices (GMP) and additional well defined
quality requirements for some products.
On the other hand, equivalence has another important
aspect: the induction of demand by interchangeability. If
bioequivalence studies are required for a product,
countries should clearly define for which products such
studies are required and which products are the reference,
which product is a "multi-source" one, which is an
innovator drug, etc. This should all be defined in a
generics policy.
In other words, trust in the quality of various competing
products should be guaranteed by a GMP requirement and
bioavailability and bioequivalence studies (when really
necessary). Interchangeability is a commercial issue which
producers manage to induce demand for his product.
Health authorities should only worry about defining the
criteria for GMP requirements, the products for which
bioequivalence studies are needed, and the reference
products for those. All else is only a grammatical problem.
I hope these definitions would stimulate further debate.
Claudia Vacca Gonzalez
Pharmacist
Instituto Nacional de Vigilancia de Medicamentos y
Alimentos (INVIMA)
Colombia
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