References; 1. EMA's CHMP referral of GVK under article 31: http://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/GVK_Biosciences_31/WC500173713.pdf 2. ANSM Letter for Market Authorization Holders (Authoritative English Version): http://www.urpl.gov.pl/system/article_attachments/attachments/6026/original/Letter_to_MAHs_-_GVK_Bio.pdf?1406898510 3. Directive 2001/83/EC (Includes Article 31): http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf 4. Minutes of EMA Meeting EMA/679758/2014 (October 20-23, 2014): http://www.ema.europa.eu/docs/en_GB/document_library/Minutes/2014/11/WC500177883.pdf 5. List of Medicines under suspicion: http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/01/WC500180894.pdf. 6. List of 25 generics suspended in Belgium, France: http://ansm.sante.fr/content/download/70625/899815/version/4/file/PI_GVK_Liste-Specialites_15-12-2014.pdf 7. List of 80 generics suspended in Germany by BfArM: I. Press Release: http://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/EN/RV_STP/g-l/gvk-bioscience.html II. List (German): http://www.bfarm.de/SharedDocs/Risikoinformationen/Pharmakovigilanz/DE/RV_STP/g-l/gvk-bioscience.html?nn=4665424 8. Response from government of the UK: https://www.gov.uk/government/news/gvk-biosciences-mhra-responds-to-european-medicines-agencys-recommendation-to-suspend-meicines 9. WHO's Response in August 2014: http://apps.who.int/prequal/info_press/documents/GVK-Bio_07August2014.pdf 10. GVK's Response: http://www.fiercebiotech.com/press-releases/gvk-bios-response http://www.gvkbio.com/organization-update/gvk-bios-response/ http://www.fiercebiotech.com/story/indias-gvk-biosciences-gets-harsh-accusations-ema-fake-generic-trials/2015-01-26 11. Swissmedic response fom Switzerland: https://www.swissmedic.ch/aktuell/00673/02d528/index.html?lang=en 12. FDA Audit Clearance to GVK Biosciences: http://www.fdanews.com/articles/169065-fda-inspection-gave-beleaguered-gvk-bio-plant-clean-bill-of-health?v=preview

1. GVK GCP NC
M. Faisal Shahid
University of Karachi

2. GVK Biosciences
lA Contract Research Organization, Stationed at
Hyderabad, India
lAcquired Aragen Bio in 2014
lProvides multidisciplinary biosciences services
lProduces pharmaceutical and biological
formulations

3. lInspected by French Regulatory Authority (ANSM)
l(19-23 May, 2014)
lSuspected for FABRICATION in CLINICAL
TRIALS and CGP NCs
lNC(s) reported to EMA
lEMA “Requested as Precaution”, Suspending
700 GVK Formulations under Article 31,
Directive 2001/83/EC

4. Outcome
lEMA Requirement:
l “GVK to report data in next 12-25 months”*
lGermany: Suspended 80 formulations
lBelgium, France, and Luxembourg: Each
Suspended 25 formulations
lUK: Waiting for EU verdict
*Bio-equivalence studies

5. GVK's Response
lWill repeat and provide experimental data
lStates
lFacility has PASSED an FDA audit

6. 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