Brussels, 27/01/2015 (Agence Europe) - The European Medicines Agency (EMA) has recommended suspending the marketing of several hundred generic medicines in Europe, due to the lack of available data. The marketing of these products had been authorised, following positive conclusions in their favour after clinical trials had been carried out by the Indian company, GVK Biosciences, in Hyderabad.
The European Commission suspects that a certain amount of manipulation has occurred and called on the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) to examine over 1,000 pharmaceuticals that had been tested at the GVK site by the Indian company. For over 300 of them, sufficient supporting data from other sources were available to EMA and they will therefore remain on the market. On the other hand, for 700 other medicines, the CHMP recommended suspension unless they are of critical importance for patients because alternatives will not be able to meet patients' needs. There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences.
The French health authorities sounded the alarm last December, after having inspected the GVK site. In its press release, the national French medicines agency (ANSM) explained that its inspectors had evidence that personnel had manipulated data during a period of at least five years. It said that these anomalies “were characteristic of a lack of respect for good clinical practice concerning these bioequivalent studies”. ANSM therefore decided to suspend the marketing of 25 medicines in France. It then added a further eight medicines to its list on 23 January last. (IL)