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Los medicamentos genéricos y de marca tienen los mismos estándares de calidad
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Los medicamentos que se comercializan en Colombia, incluyendo los medicamentos genéricos y los medicamentos originales de marca, cumplen con los más altos estándares de calidad, aseguró el Director del Instituto Nacional de Vigilancia de Medicamentos y Alimentos (Invima), Javier Humberto Guzmán Cruz.
“La entidad verifica que todos los medicamentos que se comercializan en Colombia, incluyendo los medicamentos genéricos, cumplan con estándares internacionales de seguridad, eficacia y calidad antes de otorgar un registro sanitario. Esto incluye, por ejemplo, la certificación de la Buenas Prácticas de Manufactura (BPM) que garantiza el uso de materias primas de calidad, instalaciones apropiadas para la fabricación y pruebas adecuadas y suficientes para demostrar la calidad del producto”, explicó el Director al término del Foro Medicamentos Genéricos: Mitos y Verdades realizado este jueves en Bogotá con la Federación Médica Colombiana y Fedesalud.
En muchos casos, agregó, las compañías que fabrican medicamentos originales de marca, también fabrican genéricos, bajo los mismos parámetros de calidad.
“El Invima exige que se presenten estudios de bioequivalencia en algunos medicamentos con características especiales, como los medicamentos de estrecho margen terapéutico, para garantizar que se entregue la misma cantidad de ingrediente activo en el mismo tiempo que el producto de marca”, indicó el Director de la entidad.
Sobre la diferencia en los costos de los medicamentos genéricos y los originales de marca, el cual suscita muchas interrogantes sobre su calidad, el Director Javier Guzmán Cruz, explicó que, “los genéricos cuestan menos porque no incluyen los costos de investigación y desarrollo o los costos de las patentes, entre otros factores”
Finalmente, el Invima, que ha sido certificada por la Organización Panamericana de la Salud (OPS) como agencia de referencia de las Américas para medicamentos, ha realizado seguimiento a los productos que se comercializan en Colombia y no ha encontrado diferencias significativas entre los medicamentos originales de marca y los genéricos.
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