HYDERABAD: Trouble seems to be compounding for city-based GVK Biosciences Pvt Ltd with the World Health Organization (WHO) too initiating an investigation to determine the authenticity of GVK Bio’s Bio-Equivalence (BE) studies.
WHO, which manages the UN’s Pre-Qualification Medicines Programme, joins the European health regulatory bodies, including the European Medical Agency (EMA) that’s inspecting all the BE trials the company had conducted between 2008 and 2014.
The WHO Pre-qualification Team has contacted GVK Bio and the respective holder of pre-qualification to obtain further information, including the results of a thorough risk-assessment, regarding the extent to which deficiencies identified by the French Medical Agency, ANSM, apply to the pre-qualified products, WHO said in a note dated August 7. It added that WHO will gather and analyse information obtained from GVK and the pre-qualification holder, and will inform regulators and other parties concerned accordingly.
It may be noted that WHO has pre-qualified — WHO pre-qualification allows companies to provide medicines for national and international immunisation programmes — two medicinal products for which assessment of product safety and efficacy was supported by the results of clinical BE trials performed by GVK Bio. It is unclear if the WHO probe is limited to these two products or GVK’s entire clinical research operations.
According to WHO, the investigation was initiated following the French Medical agency ANSM’s inspection, and with the Co-ordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh of the EMA) requesting that, within Europe, all applicants seeking marketing authorization for any product for which GVK Bio had conducted a BE trial since July 2008, and all holders of a marketing authorization for any product for which GVK Bio has conducted clinical studies since July 2008, provide information on the significance of these studies.
When contacted, GVK Bio said it had provided the data WHO had asked for. While the EMA had found all GVK BE studies insufficient, some EU members suspended 25 medicines that used the data.