GVK Biosciences, a contract research organization based in Hyderabad, has made a strong defence against all allegations of manipulation of bio-equivalence (BE) studies and had offered to re conduct the clinical studies for its clients to wade off apprehensions and doubts raised by some of the regulators in the western countries.
As it is known, a few months ago, the European Medicines Agency (EMA) had raised an alarm over manipulation of data of bio-equivalence studies by GVK Biosciences and since then the company’s business had hit a low with a loss of Rs.60 crore.
According Manni Kantipudi, CEO of GVK Bio, the company has no new orders since August when a French based drug regulatory agency ANSM (Agence Française de Sécurité Sanitaire des Produits de Santé) reported its findings of manipulation of data. “It is unfortunate that GVK bio has come on regulators radar. The findings of the ANSM inspectors were related to the alleged manipulation of certain portion of ECG reports of the volunteers at the check-out stage and it had nothing to do with the core clinical research process. We are willing to take the entire burden of conducting the tests again for the sake of the clients,” informed the CEO at a press conference in Hyderabad.
As per information, on an average each clinical study of more than 100 drugs handled by GVK Bio costs them around Rs.30 lakhs for doing bio-equivalence studies. With the European regulators raising alarm four European countries including France had suspended the marketing authorization of about 25 generic drugs approved based on the bio-equivalence studies conducted by GVK Bio.
As the drug regulators are apprehensive about the facilities in Hyderabad, the management of GVK Bio has come forward to conduct the clinical trials again for its clients at its Ahmadabad facility in accordance with the client’s requirements. If required the company has also offered to engage other agencies to ease out the workloads and speed up the BE studies.
Though the clinical research is not the core revenue generator for the company, which contributes just 10-12 per cent of its total revenue, the GVK management does not want to be on the wrong side and has come forward to clear all doubts and apprehensions of the regulators as well as the clients. “We have nothing to hide and have not resorted to any kind of manipulation whatsoever; we will give full cooperation to any regulating authority. Particularly we want to clear all the apprehensions raised by the EME regulators over all kinds of clinical research under taken by GVK Bio,” asserted the CEO.