A health agency has raised concerns over the clinical trials conducted by the Hyderabad-based GVK Biosciences Pvt Ltd.
Based on an observation of France’s committee for medicinal products for human use ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) in October this year, the authorities had concluded that bio-equivalence studies conducted by GVK’s Hyderabad clinic were not sufficient to support marketing authorisation holders (MAHs) for the products approved.
This would mean that MAHs would have to repeat the studies in the next 12-15 months.
In a conference call with the newspersons, GVK Bio Chief Executive Officer Manni Kantipudi, however, said: ``We at GVK BIO believe that the studies conducted are in accordance with the GCP guidelines while we honour the conclusion made by committee.’’
It was working with its clinical development customers to provide new data that meets all regulatory requirements, he added.