IGMPI India

After observations were made about the use corrupt practices in the regulatory approval processes for the drugssuspension of sales was called by the European Medicines Agencyin all of Europe of many commonly used generic drugs, including at least four widely used psychiatric medications. The EMA press release stated that "A number of medicines for which authorization in the European Union (EU) was primarily based on clinical studies conducted at GVK Biosciences in Hyderabad, India should be suspended. The recommendation is based on findings from an inspection that raised concerns about how GVK conducted studies at the Hyderabad site on behalf of marketing authorization holders."

An investigation of GVK Biosciences revealed that staff was falsifying electrocardiograms during clinical trials. The EMA press release also stated that “These manipulations appeared to have taken place over a period of at least five years. Their systematic nature, the extended period of time during which they took place and the number of members of staff involved cast doubt on the integrity of the way trials were performed at the site generally and on the reliability of data generated at that site."

If the scientific information about the drugs available from other sources was adequate, recommendation for suspension might not have been given by the EMA. The EMA has recommended banning sales of the drugs in cases where the drug's approval was based almost entirely on studies conducted by GVK Biosciences. These drugs include the antipsychotic quetiapine, widely used off-label as a sleep aid, the common SSRI antidepressants escitalopram and venlafaxine andclonazepam, a benzodiazepine and an anti-anxiety agent. These recommendations will be looked upon by the parliament of the European Union.

Also, it was reported that US FDA may take fast and appropriate action if issues concerning products of GVK Biosciences approved by the FDA are identified.