Germany’s decision to withdraw 80 generic drugs from the market cannot apply to 18 of the products because of the legal challenges brought by their manufacturers against the ban, the national drug regulator has said.
On December 7, the Federal Institute for Drugs and Medical Devices (BfArM) said it was suspending, with immediate effect, the marketing authorisations (MA) of 80 products made by 16 companies, because of “serious and systematic deficiencies” in the bioequivalence studies conducted for the products by the Indian contract research organisation (CRO) GVK Biosciences.
However, BfArM has now said that the ban cannot be applied to 18 of the products until a decision is made on the appeals lodged by their manufacturers. It is reported that most of the 18 generics are produced by German drugmaker betapharm, with Heumann Pharma and Stada also having launched appeals.
The agency also said that those products whose sales have been suspended would be permitted to return to the market if their makers provide it with new clinical trial data.
In September, France’s Agency for the Safety of Health Products (ANSM) reported that it had found falsifications of electrocardiograms in nine studies carried out by GVK at its clinical development unit in Hyderabad, India, between 2008 and 2014. Then on September 24, the European Medicines Agency (EMA) announced that the Committee for Medicinal Products for Human Use (CHMP) would review studies conducted at the site and adopt a final opinion on whether the MAs of the products involved should be maintained, varied, suspended or withdrawn across the European Union (EU).
Since then, Belgium, France and Luxembourg as well as Germany have suspended the MAs for a number of generic drugs for which clinical trials were conducted at the site by GVK Biosciences.
Commenting, GVK Biosciences says that in the last 10 years, its Hyderabad unit has been inspected more than 25 times by regulatory agencies, none of which have reported any critical findings.
“We believe that the conclusions of the ANSM and the subsequent actions by the EMA are highly disproportionate to the actual risk posed to human health. At the same time, we respect and honour the conclusion made by the European regulators and are working with our clinical development customers to provide new data that meets all regulatory requirements,” said the company’s CEO, Manni Kantipudi.
The CHMP’s final opinion is expected in January 2015. It will be forwarded to the European Commission, which will then adopt a legally binding decision.