Pharmacovigilance in India has progressed significantly since the 1980s but still faces challenges due to the large population, many drug manufacturers, and lack of awareness and reporting. The Pharmacovigilance Programme of India was launched in 2010 to help ensure the benefits of medicines outweigh the risks. Areas for continued reform include increasing participation in international clinical trials, harmonizing guidelines with global practices, and improving adverse event reporting timelines. Industry, healthcare professionals, and the public all have important roles to play in ongoing pharmacovigilance efforts.

1. Pharmacovigilance in India
Dr. Kamlesh Patel, M.D.
GM- Medical & Head PV, Abbott Health Care
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2. Banned in India
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Dr. Kamlesh Patel

3. India-Generic Destination
What more permutation combination
you can think of ?
• One molecule marketed by various
companies
• Biosimilars marketed by more than
one companies
• Same drug, different indications,
different companies
• Same drug different formulations
different companies
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Dr. Kamlesh Patel

4. Challenges
• More than 6000 licensed drug manufacturers
• Over 60,000 branded formulations
• Large population, predominantly in rural area
• Poor spontaneous reporting
• Lack of physician and patient awareness
• Inadequate PMS
PV is still in its infancy in India
Major advances in western countries
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Dr. Kamlesh Patel

5. Pharmacovigilance in India
1997
1986
India joined WHO-ADR
ADR monitoring system for India
monitoring programme (3 centres:
proposed (12 regional centers)
AIIMS, KEM, JLN)
2004 – 2008
2010…
National Pharmacovigilance
prog.
(2 Zonal, 5 Regional, 24 Peripheral
Centres)
Dr. Kamlesh Patel

6. Pharmacovigilance Programme
of India (PVPI)
Pharmacovigilance Programme of India (PVPI) was
launched in July 2010.
Goal
To ensure that the benefits of use of medicine outweighs
the risks and thus safeguard the health of the Indian
population
Dr. Kamlesh Patel

7. PVPI
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8. Delhi Training
Conducted
till 2010
• Ahmedabad
• Bombay Bhubaneshwar

9. Adverse Event reporting Form

10. PSURs
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11. Latest CDSCO Vigilance
• PSUR submission- Cancellation of Registration
• Important safety label changes to cholesterol-lowering statin
drugs
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Dr. Kamlesh Patel

12. Emerging Scenario
(Clinical Research & Industry)
Safe
AE
Pharmaco-
Reporting
therapeutics
GCP
Ongoing reviews QC
Regulatory Credible Data
Inspections
Vigilant Ethics Trained
Committees Investigators
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Dr. Kamlesh Patel

13. Corporate Responsibilities
• Safety officer to receptionist
• Spontaneous report to literature search
• Registry to Compassionate use
• Signal detection to RMP
• Stringent timelines and CAPA
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Dr. Kamlesh Patel

14. Pharmacovigilance
Industry Point of View
 Ensure Acceptable Risk-Benefit Profile
• Following market introduction
• Following new indication approvals
• Comparison with similar products in its class
 Detect Inappropriate Use
 Update Core Data Sheets, IB and Label
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Dr. Kamlesh Patel

15. Peri-Launch Drug Safety
Blockbusters are hard to make,
easy to break
Pro-active Pharmacovigilance is not
a painful burden but it’s an opportunity to positively
provide safety to humanity.
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Dr. Kamlesh Patel

16. Areas of Reform
• Increasing Participation in Multinational trials
need of hour 3Rs :
– Reform Recommendations Robust Safety reporting
• Internal discrepancies bet Shc Y and CDSCO approval letter
• No waiver for protocol specific SAE
• Lack of emphasis on causality as reporting criteria
• Real time update of a Cumulative safety profile
• Need attention
– Reporting requirement for generic trials
– Pregnancy reporting
– Uniform timelines for SUSAR
PV guidelines for India- In sync with Global Practice
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Dr. Kamlesh Patel

17. Lenient Reporting Timeline
• Sch Y : All Unexpected Serious AEs: from
site to EC within 7 working days
• Global practice: Fatal/Life threatening
SUSAR to regulatory agency is 7 calendar
days
Issue : EC will come to know about Life
threatening only in 7 working days..exceed 7
calendar days
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Dr. Kamlesh Patel

18. Expedited Reporting Timeline
• Sch Y : Definition and Std for Expedited reporting is
missing
Any Unexpected and serious : to CDSCO and
Other investigators within 14 calendar days
• ICH E2A and 21 CFR 312.32 :
Mandatory reporting of fatal or life threatening
suspected unexpected serious ADR (SUSAR)
to regulatory within 7 calendar days, while other
SUSAR in 15 days time
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Dr. Kamlesh Patel

19. Future is in UR Hands
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Dr. Kamlesh Patel

20. Potential Sources of Errors in
Pharmaceutical Care
• Handwriting of prescriptions
• Prescribing doctors missing information on other
prescriptions for a patient (drug interactions)‫‏‬
• Similar-sounding and look-alike names and packages of
medication
• Level of stress on workplace
• Unclear records in information system
• Bad system of stock alignment/organization
• Disruptions in information availability and flow
Dr. Kamlesh Patel

21. Detecting ADR: Do we accept it?
• Top priority : Diagnosis and Disease management
• Lack of proper E3 (Exposure Emphasis Education)
during undergraduate and post graduate program
• 50-150 pt in a day, per pt time..Too BUSY
• Fear of allegation
• Proper process and system to report
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Dr. Kamlesh Patel

22. Sometimes …Faulty practice
• Irrational combinations/Rational practice
• Treatment without provisional diagnosis
• Empirical therapy
• Wrong choice and incorrect dose
• Lack of documentation
• Adequate sharing information between
physician and pt
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Dr. Kamlesh Patel

23. Is there any solution ?
• Ethical practice as per protocol and
guidelines
• Stress during Academic Course
• Ethical promotion and marketing practices
• Training and workshop
• Restrict to commonly used few drugs
(including life saving drugs)
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Dr. Kamlesh Patel

24. I hear nothing, I see nothing
and I say nothing
Not We, as a vigilant custodian of Human Life and India
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Dr. Kamlesh Patel

25. What is BEST for FUTURE ?
• Training Programs
– HCP, Medical Students, nursing and pharmacy graduates, Workers in rural
areas
• Robust Uniform Nation Database
– Uniform format
– Strong network of PV and Pharmacoepidemiologists
• Industry (Domestic and MNC) active participation in drug safety
monitoring during CT and PMS/PMOS
• Mandatory PMOS once Marketing Authorization is granted if it is a New
drug or relatively new drug
• ICH GCP Sch Y India GCP Harmonisation
– “GO SLOW, WORK IN PROGRESS”
– “GO, SLOW WORK IN PROGRESS”
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Dr. Kamlesh Patel

26. Partnering for
Progress …
Thank you
Dr. Kamlesh Patel, M.D.,
Head Medical & PV,
Abbott Health Care
Permission to use slide/slides/complete presentation must be obtained directly