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GVK Bio may redo studies doubted by European drug regulator

Replying to a query, company's CEO said it would cost about Rs 30 lakh to redo the studies, which the company is willing to bear on behalf of the clients.

twitter-logo PTI   Hyderabad     Last Updated: December 8, 2014  | 20:18 IST
GVK Bio may redo studies doubted by European drug regulator
Picture for representation purpose only. (Source: Reuters)

GVK Biosciences is ready to redo the studies that were questioned by the European drug regulator, European Medicines Agency (EMA), a top executive said in Hyderabad on Monday.

Maintaining that recent development is a 'body-blow', GVK Biosciences Chief Executive Officer Manni Kantipudi said the drug studies have come to a standstill at the Hyderabad facility as requested by the clients, resulting in erosion of order book to the tune of Rs 50 crore.

"Customers are asking one of the three things. They say please redo the studies in Ahmadabad. Some of them have said please redo the studies somewhere else but you bear the cost and some are saying please refund my money. we are willing to do any of the three options," Kantipudi said in a press conference, adding that it is essentially satisfying the customer.

He also opined that some of the customers may even ask GVK Bio to pay damages in the event of drug recalls related to the studies conducted by the city-based company.

European Medicines Agency (EMA) had recently said in a statement that it is reviewing findings of 'non-compliance' with good clinical practice at the GVK's Hyderabad facility and determining its impact on medicines authorised on the basis of studies performed there.

Germany, France, Luxembourg and Belgium have already decided to suspend marketing authorisations of these drugs.

Maintaining that they would respect EU's decision, Kantipudi said the company did not have any operational rationale to do 'manipulations' in terms of money or time.

"We have not had a single order since August. They stop coming. The customers say no more orders till this issue is resolved. I don't know how much time, it will take another 3 to 6 months to put it off.

"Even existing orders were put on hold. Each day we see order book dwindling. About Rs 50 crore order book was impacted," the CEO said.

He said the veracity of ECG reports that were 'questioned' by French regulator ANSM have been examined by independent cardiologists and their opinion was submitted to the EU.

Replying to a query, he said it would cost about Rs 30 lakh to redo the studies, which the company is willing to bear on behalf of the clients.

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