The Swiss regulator made the announcement last week after a review prompted by the European Medicines Agency’s (EMA) recommendation that hundreds of drugs trialled at a GVK site in Hyderabad, India be suspended.
Swissmedic said none of the drugs on the EMA list are sold in the country, although “three preparations with export authorisations were identified.” The organisation explained that these authorisations are granted for drugs not distributed in Switzerland, but intended exclusively for export.
“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.
Swissmedic added that: "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).”
Norway, Iceland and Switzerland
The Bern-based regulator also said it had checked a further 350 drugs that had been approved in the European Union and Norway and Iceland – which like Switzerland are not in the EU – on the basis of defective GVK bioequivalence studies.
“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.
It added that: “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.”
The EMA’s proposal has been sent to the European Commission for the final decision which, if in agreement with the recommendation, will apply to all Member States irrespective of whether or not they have taken interim measures to suspend medicines.