GVK Bio offers to re-do studies after EU ruling

Pharmaceutical research company GVK Biosciences has offered to re-do studies at its own cost after the European Union suspended marketing approval of some generic drugs due to alleged manipulation of data related to clinical trials.

The Hyderabad-based company Monday said it would re-do the studies if customers approach it for the same.

The studies can be done at the firm's clinical trial facility at Hyderabad or Ahmedabad or at some other organisation, GVK Bio's CEO Manni Kantipudi told reporters here.

He said a couple of clients have already approached the firm.

The contract research organisation may have to re-do 115-120 studies, if all the clients make a request.

It may cost Rs.30 lakh for the company to re-do each study, and the CEO was confident that the company can complete 15-20 studies a month.

French regulatory authority ANSM found falsification of ECGs carried out by some employees in the company's Hyderabad facility. The doubts were raised about the data of studies done between 2008 and 2014.

The company has clarified that ECGs done on the volunteers at the 'check out' have nothing to do with the core clinical data and hence did not compromise the quality of drugs.

The French watchdog was also not convinced with the independent review of the ECGs done by four cardiologists including one from the US.

The firm also maintained that none of the 25 regulatory agencies who has done audit since the company began its operations 10 years ago has made any critical observation.

The issue dealt a body blow to the company as it has not received any orders from its clients since August. Manni said the episode impacted the company orderbook to the tune of Rs.50 crore.

GVK Bio has 50 clients in clinical trials, which contribute 10-12 percent of its total revenue. The privately-held company doesn't reveal its revenues and other details.