Europe’s main pharmaceutical regulator recommended suspending the sale of hundreds of drug formulations that were approved for use based on “flawed” clinical studies conducted by GVK Biosciences, a clinical research organization in Hyderabad, India.
In a statement Friday, the European Medicines Agency said an inspection of GVK Biosciences raised concerns about the reliability of some studies conducted at the site between 2008 and 2014 on behalf of various drug makers. The inspection found “data manipulations” of electrocardiograms during the conduct of some studies of generic medicines, the EMA said.
The EMA said it has “no evidence of harm or lack of effectiveness with any of the medicines” studied by GVK Biosciences.
The EMA said it examined more than 1,000 doses and strengths of medicines that were studied at the GVK Biosciences site in India. For over 300 of them, there is enough supporting data from other sources to allow the drugs to remain on the market, the EMA said. The medicines lacking data from other sources should be suspended from the market unless they are of “critical importance” for patients because there are no suitable alternatives, the EMA said.
EU member states will have the authority to decide which medicines are critical for patients in their countries, the EMA said.(...)
On its website, the EMA provided a list of the drugs it is recommending for suspension. The medicines are sold by many different drug makers, including Mylan Inc . , Teva Pharmaceutical Industries Ltd . , Sanofi SA , Dr. Reddy’s Laboratories and the Sandoz unit of Novartis AG , as well as dozens of lesser known firms.(...)
India’s pharmaceutical industry has faced increasing scrutiny in recent years, including U.S. Food and Drug Administration concern over manufacturing problems at various Indian drug makers. (Más)
No olvidamos la "fervorosa" defensa que años atrás el presidente de Novartis en España y tambíen de la patronal/Farmaindustria hacía de esos "off-shoring" de países emergentes:
Del "off-shoring" en investigación clínica y/o el "deconstruir*" la "Doctrina Acebillo..."
Esta oferta altamente cualificada está en el origen de lo que se denomina "off-shoring" o "externalización global", es decir la externalización de un número de operaciones de alto valor añadido, a proveedores situados en los mercados emergentes, en condiciones más atractivas y competitivas que las que ofrecen los especialistas y proveedores occidentales. China, India, Singapur y el este de Europa entre otros, son ejemplos claros de países emergentes que han priorizado el desarrollo de "Clusters" biotecnológicos de alta competitividad, donde se ofrecen servicios de I+D del más alto nivel científico, con compromisos óptimos de tiempos de ejecución y a unos costos muy por debajo de los existentes en los países desarrollados.
La coincidencia en el espacio y en el tiempo de altos niveles tecnológicos, junto a bajos costes operativos es la causante de un desplazamiento histórico de riqueza y valor, desde el rico occidente al este emergente."
Entradas
No hay comentarios:
Publicar un comentario