Regulator’s view a body blow, admits MD of GVK Bio


“It is a body blow we have taken,” said GVK Biosciences CEO Manni Kantipudi.

He was reacting to the conclusions arrived at by the European regulators on the studies the company had conducted as part of clinical trials.

The company is unsure of when it will emerge from this. The impact is multiple-pronged. It ranged from the drug manufacturers, for whom the trials were conducted at the firm’s facility in Hyderabad, asking for a re-test at the Ahmedabad facility; demanding a re-test at some other facility at GVK Bio’s cost; and refund of the money paid for the trials.

The company is not ruling out the possibility of some of the drug manufacturer-customers seeking compensation from GVK Bio for the loss the regulators orders could cause to them.

“We are ready for the first three options, but not for the last one,” he added.

Around 120 studies, conducted since 2008 for about 35 pharmaceutical companies whose product are sold in Europe, are under scanner. According to Mr. Kantipudi, multiple studies were warranted for some drugs trials and each study cost around Rs.30 lakh.

Prior to this, French regulator had raised concerns over the check-out ECG's conducted at the company’s clinical facility here.

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Printable version | Jan 22, 2020 5:24:28 PM |

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