German drug regulator has hailed the European Medicine Agency's decision to
suspend the marketing authorisation of more than 700 generic drugs subjected to
clinical trials by India's GVK Biosciences.
The decision is being seen as the EU's determination to maintain high
ethical and medical standards for approval of medicines.
The EU drug regulator's announcement is also an endorsement of the Federal
Institute for Drugs and Medical Devices' (BfArM) decision last month to ban the
sale of 80 generic drugs on account of 'substantial deficiencies' in clinical
The German watchdog said it would take a decision shortly on whether to add
more medicines to the list of banned drugs in the wake of the EMA's
The agency based in Bonn had so far reviewed the marketing approvals of 176
generic drugs granted on the basis of clinical trial data provided by GVK
Biosciences during the period between 2008 and 2014, the agency said in a
The EU drug regulator on Friday suspended the marketing authorisation of
around 700 generic drugs on the grounds that their approvals were supported by
'flawed' clinical trial data provided by the Indian company.