1. PHARMACOVIGILANCE:
CURRENT SCENARIO & FUTURE
CHALLENGES IN INDIA
JANESHWAR VERMA

2. PRESENTATION CONTENTS
 Introduction
 Why Pharmacovigilance
 ADR Reporting procedure
 Aim of Pharmacovigilance
 Pharmacovigilance: Future challenges, Need & issues
 Outcome of a successful program in Pharmacovigilance
 Summery and Conclusion
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3. INCREDIBLE INDIA
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The zero and decimal system were
developed.
38% Doctors in America are Indian
12% Scientist in America are Indian
36% NASA employees are Indian
World’s largest democracy
Clinical Research Hub
Fourth largest exporter by volume of drugs
USFDA office in Delhi, Mumbai & ….
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4. PHARMACOVIGILANCE
The science and activities relating to the
detection, assessment, understanding
and prevention of adverse effects or any
other drug-related problem (WHO 2002).
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Pharmakon vigilare
Greek Latin
Drug to be awake or alert,
to keep watch
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5. 6
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6. 7
WHY PHARMACOVIGILANCE?
 Patients affected by preventable harm.
 Top ten causes of mortality.
 >10% of hospital admissions.
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7. 8
HISTORY OF
PHARMACOVIGILANCE
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8. 9
BRIEF HISTORY OF PHARMACOVIGILANCE
The Thalidomide Disaster
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9. 10
BRIEF HISTORY OF PHARMACOVIGILANCE
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10. 11
BRIEF HISTORY OF PHARMACOVIGILANCE
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11. INDIA ?
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12. 13
BRIEF HISTORY OF PHARMACOVIGILANCE
Pharmacovigilance in India
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13. PHARMACOVIGILANCE HIGHLIGHTS:
GROWTH OF THE WHO GLOBAL ICSR DATABASE
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individual case safety reports
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14. 15
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15. WHAT TO REPORT?
All suspected reactions
Lack of effect
Resistance
Interaction
Dependence and abuse
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16. WHICH TO REPORT?
Allopathic medicines including OTC
Traditional Medicines
Biologicals like vaccines and sera
Herbals
Blood products
Medical devices
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17. WHERE TO REPORT ?
Patient
Health
Professional
Regional
Centre
Manufacturer
Hospital
National
Centre
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18. MAJOR HEALTH PROFESSIONALS
 Physicians
 Dentists
 Pharmacists
 Nurses
 Other health workers
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19. WHEN IS AN ADR SERIOUS?
 Death / life-threatening (real risk of dying)
 Hospitalization (initial or prolonged)
 Disability (significant, persistent or permanent)
 Congenital anomaly
 Requires intervention to prevent
 Permanent impairment or damage
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20. Reporting form
1. The patient
2. Adverse event
3. Suspected drug(s)
4. All other drugs used
5. Risk factors
6. Name and address of reporter
 Reporting forms will be distributed.
 Telephone, fax and email used to reporting ADR’s.
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REPORTING OF ADVERSE DRUG REACTION
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21. 22
AIM OF
PHARMACOVIGILANCE
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22.  Improve patient care and safety
 Improve public health and safety
 Early detection of unknown safety problems
 Identification of risk factors
 Quantifying risks
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AIMS OF PHARMACOVIGILANCE
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23.  Assessment of benefit, harm & effectiveness
 Promote understanding, education in PV.
 Encouraging safe, rational, and effective use
 Preventing patients from being affected
unnecessarily
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AIMS OF PHARMACOVIGILANCE
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24. PARTNERS IN PHARMACOVIGILANCE
Partners in the practice of drug safety monitoring.
Government
Industry
Hospitals and academia
Medical and pharmaceutical associations
Health professionals
Patients
Consumers
Media
WHO
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25. INDIA TODAY
 PV is still in its infancy in INDIA
 Major advancement are in western countries
 More clinical research conducted in India
 Immense need to understand the importance of PV
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26. PHARMACOVIGILANCE,
CHALLENGES, NEEDS & ISSUES
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27.  Population that is predominantly rural.
 Use of traditional medicines.
 Poor reporting.
 Lake of physician and consumer awareness.
 Inadequate post marketing surveillance.
 Surfeit no. of licensed drug manufactures (>6,000)
 Surfeit no. of branded formulations (>60,000).
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PHARMACOVIGILANCE
CHALLENGES, NEEDS AND ISSUES

28. Need to move toward more active Pharmacovigilance
 PSURs (Periodic Safety Update Reports)
 Post marketing studies
 Risk Management plans (periodicity driven by risk)
 Improved communication
Need to Strengthen Safety Reporting Requirements for:
 Medical Devices,
 Food Supplements and
 Herbal products. 29
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PHARMACOVIGILANCE
CHALLENGES, NEEDS AND ISSUES

29. Each country should:
 Establish a PV system and collect information
 Training of HCPs and Health Authorities.
 Promote Product Safety Awareness.
 Encourage all HCPs to report suspected ADRs.
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PHARMACOVIGILANCE
CHALLENGES, NEEDS AND ISSUES

30. OUTCOME OF A
SUCCESSFUL PROGRAM IN
PHARMACOVIGILANCE
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31. OUTCOME OF A SUCCESSFUL PROGRAM IN
PHARMACOVIGILANCE
 Assessment of benefit, harm, effectiveness & risk.
 Improve patient care and safety.
 Improve public health and safety.
 Promote understanding, education & training in PV.
 Effective communication to the public.
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32. SUMMARY & CONCLUSION
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33. To minimize the harm, medicine should have good:
Efficacy: Evaluated from clinical trials.
Quality: Established standards by GMP.
Safety : By toxicology, clinical trials.
In all, Pharmacovigilance will promote:
Systematic and rational use of medicines
Boost confidence for safety.
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SUMMARY &
CONCLUSIONS

34. KEY MESSAGES
 The NPvP launched to improve the current state
 Its basic purpose is to analyze ADR data
 Healthcare team actively participate in the program
 They should start reporting AE
 Help to ensure that children’s safety
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35. THANK YOU
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‘People who are vigilant do not
die; people who are negligent are
as if dead’.
Shakyamuni Buddha
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