The sale of hundreds of medicines for which authorization was given on the basis of clinical studies conducted at GVK Biosciences in Hyderabad was recommended suspension by the European Medicines Agency (EMA).
The French medicines agency (ANSM) carried out an inspection, which revealed data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines.
Advertisement"These manipulations appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site," said a statement issued by EMA.
EMA's Committee for Medicinal Products for Human Use (CHMP) looked at over 1,000 pharmaceutical forms and strengths of medicines studied at the GVK site.
For over 300 of them, sufficient supporting data from other sources were available; these will therefore remain on the market in the EU as EMA is satisfied with the available data.
The list of medicines for which the CHMP recommends suspension is available on the EMA website. The EMA statement said that the agency and the national authorities worked closely with international partners to ensure that studies underpinning marketing authorisations in the EU were carried out to the highest standards and that the companies involved comply fully with all aspects of Good Clinical Practice (GCP).
There is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences, it added. The EMA said that some medicines, for which insufficient alternatives are available to meet patients' needs would remain on the market in some countries as new data were being awaited.
The EMA awaits new data to make final decisions on whether to suspend or allow continued availability of medicines and the national authorities in the EU would consider the availability of individual medicines in their countries.
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