GVK Biosciences is losing steam in its clinical trial business, which contributes about 10-12% to its total revenues, with the company losing over Rs 50 crore from its existing orderbook even as existing orders have been put on hold. Recently, French medical agency ANSM had suggested suspension of market authorisation for all drugs based on about 100 studies done by GVK Bio between 2008 and 2014 in its Hyderabad facility.

“This decision is taken out of precaution. No element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs,” ANSM said. Since then, the company has not received a single order after regulators in France, Germany, Belgium and Luxembourg suspended the marketing approval of 25 generic drugs based on bio-equivalence (BE) studies conducted by GVK Bio in its Hyderabad facility.

Talking to the media, Manni Kantipudi, CEO, said, “We have not resorted to any kind of manipulation with the data. We do accept that we did not have completely foolproof processes but we have improved it. While the EU has taken only a preliminary action, we have agreed to cooperate with the regulating agencies in the interest of public health to ensure quality drugs.” The whole issue is a question of good clinical practices (GCPs) and we will abide by it, he said.

However, the company maintains that this issue is “completely blown out of proportion.” The company says it costs about Rs 30 lakh per study,  depending on the nature of trials and the number of volunteers’ involved.

“We used to conduct over 15-20 studies per month, which has now fallen to six or seven.  We are watching the market impact. We have taken a body blow and it is difficult to gauge the impact. It’s difficult get back into normal position,” he said.

“On an average, the clinical trial business contributes about 10-12% of our total revenues which constitute about 50 clients to our total 400 clientele,” he added. He said the company did not manipulate any data but failed to get volunteers’ signature on each of the ECG reports, something the French agency ANSM found fault with.

“Only 35% of BE studies need a check-out ECG and there’s a potential that just about 2-10% of the ECGs of the nine trials ANSM investigated could have been mixed up,” he said. The European Medicines Agency (EMA) separately released a statement saying it would “issue a recommendation on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU.” That recommendation is expected in January 2015.

The regulator is investigating 176 approvals given to 28 drugmakers.