GVK GCP NC

M. Faisal ShahidUniversity of Karachi

GVK Biosciences

l A Contract Research Organization, Stationed at Hyderabad, India

l Acquired Aragen Bio in 2014

l Provides multidisciplinary biosciences services

l Produces pharmaceutical and biological formulations

l Inspected by French Regulatory Authority (ANSM)

l (19-23 May, 2014)

l Suspected for FABRICATION in CLINICAL TRIALS and CGP NCs

l NC(s) reported to EMA

l EMA “Requested as Precaution”, Suspending 700 GVK Formulations under Article 31, Directive 2001/83/EC

Outcome

l EMA Requirement:l “GVK to report data in next 12-25 months”*

l Germany: Suspended 80 formulations

l Belgium, France, and Luxembourg: Each Suspended 25 formulations

l UK: Waiting for EU verdict

*Bio-equivalence studies

GVK's Response

l Will repeat and provide experimental data

l Statesl Facility has PASSED an FDA audit

Possible Consequences if Found Guilty

Heavy Fine(s)350 mln. $(GSK, 2014), 500 mln. $: (Ranbuxy, 2013)

Suspension/barred from market

10 officials accused can be sued by Indian Government