The future of clinical trials business of GVK Biosciences Pvt Ltd seems to be bleak after some of its studies came under scrutiny of the European regulators for alleged lapses.

“It’s a body-blow we have taken. It is difficult to get back to normalcy and we don’t know what is going to happen,’’ Manni Kantipudi, Chief Executive Officer, GVK Biosciences, told newspersons here on Monday.

Market authorisation After a report by the French watchdog ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Sante) which faulted the quality of some studies done by the Hyderabad-based company, regulators in France, Germany, Belgium and Luxembourg last weekend suspended the marketing approval of 25 generic drugs based on clinical trials conducted by GVK.

More regulators are likely to follow suit as ANSM suggested suspension of market authorisation for all drugs based on about 100 studies done by GVK Bio in its Hyderabad clinic between 2008 and 2014.

Challenges “We do not have a single order since August this year and the existing order book of about ₹50 crore has also been suspended by customers,’’ Kantipudi said.

The company has about 400 customers of which 50 per cent are related to the clinical trials business.

Some customers are asking the company to re-do the studies in its Ahmedabad facility. “While some of them are for getting it done by some other agency, there are also demands for refund of money,’’ he said. The worst fear for the company is facing legal problems as the drug-makers who have to withdraw drugs from markets might sue GVK for the loss it could cause.

As each clinical study could cost ₹30 lakh, it would result in a burden of ₹30 crore for the company to re-do 100 studies it had done in the last six years.

Though the privately-held company does not prefer to spell out its total revenue, the clinical trials business accounts for 12 per cent of it. Efforts are on to prevent the company’s image being dented further.

GVK Biosciences has been maintaining that it had no reasons to manipulate the studies. The ANSM had said that the company manipulated ECG data and also expressed concerns over deployment of same set of employees in different processes.

“But the ECGs which are part of the check-out procedure for volunteers are done only for 35 per cent of studies and do not have a bearing on the core component of clinical trials,’’ Kantipudi said, adding that four independent cardiologists also certified that there might not be any scope for manipulation of data.

The ANSM had visited GVK’s facility in May and gave its final report in August ignoring the company’s response.

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