Commerce Secy may take the GVK BIO case to WTO
In what is probably the first instance of its kind, the Department of Commerce has decided to intervene on behalf of an Indian pharma company charged with data manipulation by overseas regulators, even threatening to take the matter to the World Trade Organisation.
Manni Kantipudi, Chief Executive Officer, GVK BIO informed Express Pharma that in late March, the Drug Controller General, (India) (DCGI) and Joint Secretary, Department of Commerce had travelled to Europe to visit officials of the European and French drug regulatory agencies to discuss their concerns.
Commerce Secretary Rajiv Kher reportedly sees these allegations as unjustified and driven by vested interests working to discredit the country by targeting individual companies.
The GVK BIO case dates back to May 2014, when a regulatory inspector from ANSM (the French drug regulatory agency, National Security Agency of Medicines and Health Products) had visited the Clinical Development facility of GVK Biosciences in Hyderabad and concluded that some of the employees had taken print-outs of ECGs from one volunteer and used them for other volunteers. In September 2014, US FDA along with French and Dutch regulators visited the facility and cleared the ECG reports. However the French agency remained firm on its earlier decision. Inspite of the ANSM website stating that ‘this decision is taken out of precaution. No element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs’, GVK BIO remains under a cloud.
GVK BIO was later invited by the European Medicines Agency wherein the company presented data and evidence to demonstrate that standard operating procedures were being followed and all key activities such as dosing, blood sampling and processing were adequately controlled and supervised by qualified staff.
Kantipudi said, ““We are concerned about our reputation and integrity. The Clinical business accounted for around 10 per cent of our overall revenue. As a business leader, I am happy of the government’s proactive support. I am hopeful of a new era under PM Modi’s government.”
EP News Bureau – Mumbai
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