- France, Germany, Belgium and Luxembourg are among the EU countries that have suspended approval of 25 generic drugs manufactured in India because of concerns about the quality of the clinical trials conducted by GVK Biosciences in India.
- This is a precautionary move made by regulatory agencies in several EU countries in light of new-found knowledge that regulatory authorities in France discovered abnormalities in the way ECGs were monitored during bioequivalence studies in Hyderabad-based GVK.
- The implications are far-reaching. Concerns about quality-control in India have now become multinational efforts, with EU oversight. Plus, it is likely that consumers will be impacted by higher generics prices as the pool of available medications shrinks while this issue is resolved.
There have been continuous reports about problems with Indian manufacturing facilities that lead to recalls of specific medications—usually one to three products at a time. This, however, is a whole new twist in what is becoming a quality-control crisis.
Challenges with clinical trial integrity that affects 25 drugs, and Germany's investigation in more than 170 drug approvals given to 28 manufacturers, has ratcheted the problem up several notches. However, pharma executives in India are pragmatically addressing problems one at a time, and have already started the process of re-conducting several clinical trials.