Manipulated bioequivalence studies by GVK Biosciences – no affected preparations on the Swiss market
Bern, 06.02.2015 - Bern, 06.02.2015 - The Indian company GVK Biosciences is suspected of having manipulated studies for the authorisation of generics. Hundreds of medicines in European Union countries and in Norway and Iceland are affected and their marketability called into question as a result. The Swiss Agency for Therapeutic Products has checked whether any products that are authorised on the basis of the clinical trials by GVK Biosciences in Hyderabad (India) are currently on the market in Switzerland. Three preparations with export authorisations were identified. These authorisations are granted for medicinal products that are not distributed in Switzerland, but intended exclusively for export. These authorisations will now be reviewed in detail.
After the irregularities were disclosed, Swissmedic initially examined the authorisations granted for generics in Switzerland on the basis of studies by the company GVK Biosciences. Around 250 authorisations were checked using active substance lists published by the German Federal Institute for Drugs and Medical Devices (BfArM) and the French National Agency for Medicines and Health Products Safety (ANSM). Swissmedic then checked around 350 preparations which – according to the European Medicines Agency (EMA) – have been authorised in European Union countries and in Norway and Iceland on the basis of defective bioequivalence studies by GVK Biosciences. In bioequivalence studies, which are required for the authorisation of generics (medicinal products with known active substances), manufacturers must demonstrate that the generic preparations work just as well as the original preparations. The comprehensive analysis revealed that no corresponding preparations are available on the Swiss market. However, Swissmedic did find three products that have been authorised for distribution abroad. As indicated above, Swissmedic is initiating a review procedure for these authorisations. The affected companies have been asked to issue statements on the available documentation. Swissmedic will then take the required measures and, if necessary, suspend or withdraw the authorisations. Swissmedic would stress once again that there is no evidence of any threat to patient safety. The three medicines concerned contain the correct dosage of the correct active ingredient.
Address for enquiries
Swissmedic, Swiss Agency for Therapeutic Products
Peter Balzli, Acting spokesman
+41 58 462 02 76
media@swissmedic.ch
Publisher
Swiss Agency for Therapeutic Products
http://www.swissmedic.ch/?lang=2
