The European Commission (EC) has banned the sale and distribution of around 700 generic medicines in the European Union countries for alleged manipulation of clinical trials conducted by India's pharmaceutical research company GVK Biosciences.
The sales ban, the largest ordered by the European Commission so far, will come into effect on 21 August and will be applicable to all 28 member nations, according to Germany's drug regulator, the Federal Institute for Medicines and Medical Products (BfArM).
The ban follows confirmation by the European Medicines Agency (EMA) of its recommendation to suspend a number of medicines for which authorisation in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India.
According to EMA, the ban is the outcome of a re-examination requested by marketing authorisation holders for seven of the medicines concerned.
EMA's Committee for Medicinal Products for Human Use (CHMP) had adopted its original recommendation in January 2015 following an inspection of GVK Biosciences' site at Hyderabad by the French medicines agency (ANSM) that raised concerns about how GVK Biosciences conducted studies at the site on behalf of marketing authorisation holders.
The agency had reported data manipulations of electrocardiograms (ECGs) during the conduct of some studies of generic medicines, which 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 conduct of trials at the site generally and on the reliability of data generated,'' EMA stated in a release.
During the re-examination, the CHMP concluded that concerns about reliability of the clinical studies remain and therefore maintained its recommendation of January 2015 to suspend medicines for which no supporting data from other studies were available.
However, the agency had found an exception in one of the medicines included in the re-examination for which concerns about studies were addressed. This medicine is now no longer recommended for suspension.
As a result of the CHMP's January 2015 opinion and the re-examination, around 700 pharmaceutical forms and strengths of medicines studied at the Hyderabad site remain recommended for suspension.
For around 300 other pharmaceutical forms and strengths, sufficient supporting data from other sources had been provided; these medicines will therefore remain on the market in the EU, it added.
Medicines affected by the sales ban will lose their validity for use in the EU from that date and they can no longer be distributed or sold by pharmaceutical companies, wholesale dealers, drugs stores and other outlets, Bonn-based CHMP said in a press statement on Thursday.
Pharmaceutical companies have the possibility to appeal against the suspension of marketing approvals, but it will have no immediate effect and the ban will remain in force, the statement said.