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GVK BioSciences:
Blunder or Blown out of Proportion?
9/25/2015 Pharma Reading: Group No. 6 1
What is ?
• Part of GVK conglomerate
• Provides R&D, contract manufacturing, discovery research, clinical
development, formulations and informatics services to over 300
customers
• Based in Hyderabad. Centers in Mumbai, Bengaluru, Hyderabad,
Gurgaon, Ahmedabad and even in US (recently acquired)
• Certified Clinical Research Centers: Hyderabad and Ahmedabad
9/25/2015 Pharma Reading: Group No. 6 2
•GVKBIO stands above its competitors when it comes to regulatory
approval process, turn-around-time and reporting quality. The
facilities are audited by DCGI, US FDA, ANSM, WHO, MHRA, ANVISA &
MoH Turkey, thereby crediting it with global submission footprint
•GVK BIO provides a complete spectrum of Clinical Research Services
right from Phase I to III clinical trials which includes, Clinical
Operations Services, Project Management Services, Clinical
Monitoring Services and Medical Monitoring and Advisory Services to
Late Phase Clinical trials
9/25/2015 Pharma Reading: Group No. 6 3
What happened?
• Inspection of Hyderabad facility by French Authorities ANSM (Agency for
Medicines & Health Products Safety) in September last year
• Raised concerns over GCP guidelines followed during 2008-14 period
• The concern: Systematic falsification of check-out ECG records as part of
bioavailability/bioequivalence (BA/BE) studies stretching over the last six
years (9 trials).
• Result: ANSM recommended suspension of marketing authorizations of all
MAHs having clinical trial data generated at GVK Bioscience, Hyderabad
facility.
Also, at the request of EC, EMA opened investigations, looked into 1000
products approved, ‘trialed’ at Hyderabad facility.
(700 MA suspended)
9/25/2015 Pharma Reading: Group No. 6 4
Companies Impacted…
9/25/2015 Pharma Reading: Group No. 6 5
Companies Impacted…
Sr. No. Therapeutic Area Molecule/Company
1 Anti-epileptic Donepezil (Mylan), Leviteracetam (DRL), Clonazepam (Sandoz)
2 Anti-diabetic Repaglinide (Mylan), Pioglitazone (DRL), Metformin (Actavis),
3 Anti-hypertensive/Anti-
hyperlipidemic
Candesartan (Mylan), Irbesartan (Torrent), Atorvastatin
(Mylan), Telmisartan, Valsartan (DRL), Amlodipine (FDC)
4 Anti-ulcerants Esomeprazole (Mylan), Pantoprazole (Lupin)
5 Anti-histamine Desloratidine (Teva, Zydus)
6 Anti-platelet Clopidogrel (Wockhardt)
7 Anti-depressant Escitaprolam (Abbott, Zydus), Venlafaxine (Alembic)
8 Anti-osteoporosis Alendronic acid (Ranbaxy)
9 Anti-infective Aciclovir (Ranbaxy)
10 Analgesic/Anti-inflammatory Ibuprofen (Zydus), Tramadol Paracetamol (Zydus),
9/25/2015 Pharma Reading: Group No. 6 6
GVK’s Stand
• GVK officials maintained that the company had followed standard
compliance requirements throughout the stages of its BA/BE studies.
Additionally, it said it strengthened its operating procedures around
taking ECGs.
• Follows three levels of checks for every function starting from the
person who is assigned a task, which is reviewed by another staff
following which it is approved by another senior executive. The final
stamp of approval is given by the QA executive.
• In this case for check-in and check-out processes, GVK Bio said, the
same system is not followed as those were not part of a full-fledged
operation and varies according to the trial design and protocols
9/25/2015 Pharma Reading: Group No. 6 7
• In their report to the company, ANSM is believed to have cast doubt on the
time taken to complete an ECG noting that the Indian CRO could not have
completed the ECGs on volunteers within a very short time.
• But GVK refuted the point and supplied videos of volunteers to prove that
each ECG can be completed in less than three minutes or five ECGs can be
done in a span of 10 minutes.
• Notably GVK Bio claims it has never encountered any critical findings in
about 20 audits that it has undergone in the last 11 years, since 2004.
• To add to the complexity, an official with GVK Bio said the U.S. FDA had
audited the same facility in August, three months after the ANSM audit,
but gave a clean chit to the facility on compliance standards
9/25/2015 Pharma Reading: Group No. 6 8
GVK’s Stand
Was this the first?
• Two deaths in CT's acc. to a study in Indian Journal of Medical Ethics
1. Wyeth Pharmaceuticals – Pneumonia vaccine – St. John’s Hospital,
Bangalore
2. BE study of Felodipine – Hyderabad facility
9/25/2015 Pharma Reading: Group No. 6 9
Was this the last?
Quest Life Sciences, Chennai
• Joint inspection by WHO & USFDA in October, 2014
• Issued five 483 and a NOC (Notice of Concern) dated 30th June, 2015
• Duplication of ECG reports and deviations from GLP & GCP observed
and cited in NOC
• Lifting only after submission of repeat study indicates BE was indeed
established
9/25/2015 Pharma Reading: Group No. 6 10
Learnings from GVK case…
• Global regulators wont tolerate even a shadow of doubt when it comes to
safeguarding health of their citizens.
• Pharma companies from India will have to ensure that their protocols
measure up to global standards and scrutiny.
• Any shortcomings in requirements by EMA/US FDA results in suspension of
marketing authorizations which translates into huge loss of revenues for
the pharma companies involved
• Pharmaceutical companies must thoroughly review their contracted
organizations periodically for regulatory compliance apart from routine
regulatory body inspections
• Indian pharmaceutical and allied organizations need to let go of the
complacent attitude and adopt strict adherence towards international
protocol to attain trust of foreign regulatory bodies
9/25/2015 Pharma Reading: Group No. 6 11

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GVK BioSciences Case

  • 1. GVK BioSciences: Blunder or Blown out of Proportion? 9/25/2015 Pharma Reading: Group No. 6 1
  • 2. What is ? • Part of GVK conglomerate • Provides R&D, contract manufacturing, discovery research, clinical development, formulations and informatics services to over 300 customers • Based in Hyderabad. Centers in Mumbai, Bengaluru, Hyderabad, Gurgaon, Ahmedabad and even in US (recently acquired) • Certified Clinical Research Centers: Hyderabad and Ahmedabad 9/25/2015 Pharma Reading: Group No. 6 2
  • 3. •GVKBIO stands above its competitors when it comes to regulatory approval process, turn-around-time and reporting quality. The facilities are audited by DCGI, US FDA, ANSM, WHO, MHRA, ANVISA & MoH Turkey, thereby crediting it with global submission footprint •GVK BIO provides a complete spectrum of Clinical Research Services right from Phase I to III clinical trials which includes, Clinical Operations Services, Project Management Services, Clinical Monitoring Services and Medical Monitoring and Advisory Services to Late Phase Clinical trials 9/25/2015 Pharma Reading: Group No. 6 3
  • 4. What happened? • Inspection of Hyderabad facility by French Authorities ANSM (Agency for Medicines & Health Products Safety) in September last year • Raised concerns over GCP guidelines followed during 2008-14 period • The concern: Systematic falsification of check-out ECG records as part of bioavailability/bioequivalence (BA/BE) studies stretching over the last six years (9 trials). • Result: ANSM recommended suspension of marketing authorizations of all MAHs having clinical trial data generated at GVK Bioscience, Hyderabad facility. Also, at the request of EC, EMA opened investigations, looked into 1000 products approved, ‘trialed’ at Hyderabad facility. (700 MA suspended) 9/25/2015 Pharma Reading: Group No. 6 4
  • 5. Companies Impacted… 9/25/2015 Pharma Reading: Group No. 6 5
  • 6. Companies Impacted… Sr. No. Therapeutic Area Molecule/Company 1 Anti-epileptic Donepezil (Mylan), Leviteracetam (DRL), Clonazepam (Sandoz) 2 Anti-diabetic Repaglinide (Mylan), Pioglitazone (DRL), Metformin (Actavis), 3 Anti-hypertensive/Anti- hyperlipidemic Candesartan (Mylan), Irbesartan (Torrent), Atorvastatin (Mylan), Telmisartan, Valsartan (DRL), Amlodipine (FDC) 4 Anti-ulcerants Esomeprazole (Mylan), Pantoprazole (Lupin) 5 Anti-histamine Desloratidine (Teva, Zydus) 6 Anti-platelet Clopidogrel (Wockhardt) 7 Anti-depressant Escitaprolam (Abbott, Zydus), Venlafaxine (Alembic) 8 Anti-osteoporosis Alendronic acid (Ranbaxy) 9 Anti-infective Aciclovir (Ranbaxy) 10 Analgesic/Anti-inflammatory Ibuprofen (Zydus), Tramadol Paracetamol (Zydus), 9/25/2015 Pharma Reading: Group No. 6 6
  • 7. GVK’s Stand • GVK officials maintained that the company had followed standard compliance requirements throughout the stages of its BA/BE studies. Additionally, it said it strengthened its operating procedures around taking ECGs. • Follows three levels of checks for every function starting from the person who is assigned a task, which is reviewed by another staff following which it is approved by another senior executive. The final stamp of approval is given by the QA executive. • In this case for check-in and check-out processes, GVK Bio said, the same system is not followed as those were not part of a full-fledged operation and varies according to the trial design and protocols 9/25/2015 Pharma Reading: Group No. 6 7
  • 8. • In their report to the company, ANSM is believed to have cast doubt on the time taken to complete an ECG noting that the Indian CRO could not have completed the ECGs on volunteers within a very short time. • But GVK refuted the point and supplied videos of volunteers to prove that each ECG can be completed in less than three minutes or five ECGs can be done in a span of 10 minutes. • Notably GVK Bio claims it has never encountered any critical findings in about 20 audits that it has undergone in the last 11 years, since 2004. • To add to the complexity, an official with GVK Bio said the U.S. FDA had audited the same facility in August, three months after the ANSM audit, but gave a clean chit to the facility on compliance standards 9/25/2015 Pharma Reading: Group No. 6 8 GVK’s Stand
  • 9. Was this the first? • Two deaths in CT's acc. to a study in Indian Journal of Medical Ethics 1. Wyeth Pharmaceuticals – Pneumonia vaccine – St. John’s Hospital, Bangalore 2. BE study of Felodipine – Hyderabad facility 9/25/2015 Pharma Reading: Group No. 6 9
  • 10. Was this the last? Quest Life Sciences, Chennai • Joint inspection by WHO & USFDA in October, 2014 • Issued five 483 and a NOC (Notice of Concern) dated 30th June, 2015 • Duplication of ECG reports and deviations from GLP & GCP observed and cited in NOC • Lifting only after submission of repeat study indicates BE was indeed established 9/25/2015 Pharma Reading: Group No. 6 10
  • 11. Learnings from GVK case… • Global regulators wont tolerate even a shadow of doubt when it comes to safeguarding health of their citizens. • Pharma companies from India will have to ensure that their protocols measure up to global standards and scrutiny. • Any shortcomings in requirements by EMA/US FDA results in suspension of marketing authorizations which translates into huge loss of revenues for the pharma companies involved • Pharmaceutical companies must thoroughly review their contracted organizations periodically for regulatory compliance apart from routine regulatory body inspections • Indian pharmaceutical and allied organizations need to let go of the complacent attitude and adopt strict adherence towards international protocol to attain trust of foreign regulatory bodies 9/25/2015 Pharma Reading: Group No. 6 11

Editor's Notes

  1. GVKBIO stands above its competitors when it comes to regulatory approval process, turn-around-time and reporting quality. The facilities are audited by DCGI, US FDA, ANSM, WHO, MHRA, ANVISA & MoH Turkey, thereby crediting it with global submission footprint GVK BIO provides a complete spectrum of Clinical Research Services right from Phase I to III clinical trials which includes, Clinical Operations Services, Project Management Services, Clinical Monitoring Services and Medical Monitoring and Advisory Services to Late Phase Clinical trials
  2. GVK Bioscience exit protocol involves an ECG exam, not required for approval process, but to be sure of patients’ vitals. Out of the randomly selected ECGs, each and every one of them was identical, except for name of patient and time. This was found in every one of the total nine trials conducted in 2008-14 period. Duplication of ECG reports done consistently across trials questionable.
  3. In their report to the company, ANSM is believed to have cast doubt on the time taken to complete an ECG noting that the Indian CRO could not have completed the ECGs on volunteers within a very short time. But GVK refuted the point and supplied videos of volunteers to prove that each ECG can be completed in less than three minutes or five ECGs can be done in a span of 10 minutes. Notably GVK Bio claims it has never encountered any critical findings in about 20 audits that it has undergone in the last 11 years, since 2004. To add to the complexity, an official with GVK Bio said the U.S. FDA had audited the same facility in August, three months after the ANSM audit, but gave a clean chit to the facility on compliance standards
  4. Infant death – GVK defense: Infant died of congenital heart disease – infant was in control group Young adult – Controversial as GVK claims the patient was part of multiple trials with various CROs (unethical and dangerous) Ref: http://www.outsourcing-pharma.com/Clinical-Development/French-regulator-raises-concerns-over-Indian-CRO-studies
  5. 483 Notice: Issued by Office of Regulatory Affairs, ORA, FDA when after an inspection, the observed conditions/practices are found to be in violation of the requirements. Notice of Concern: Issued by WHO when inspection reveals serious concern over following of GMP and GLP in a facility
  6. Adherence to protocol and guidelines Strict regulatory control and monitoring Deferment of EU FTA talks by disappointed India. EU’s displeasure over heavy import duty on automobiles and fuel from EU resulted in powerplay