The document outlines the evolution of India's pharmacovigilance program over time from 1986 to present. It began with proposals for regional adverse drug reaction (ADR) monitoring centers and eventually became the National Pharmacovigilance Program (PvPI) in 2004 with multiple zonal, regional, and peripheral centers. PvPI is administered by steering and advisory committees and collects ADR reports through over 250 ADR Monitoring Centers to analyze patterns and make regulatory recommendations. The role of monitoring centers is to collect, process, and report ADR data using the Vigiflow software system.

1. Role of ADR Monitoring Centre
Dr Latha Kamath, Assistant Professor

2. 1986
• ADR monitoring system for India proposed
(12 regional centres)
1997
• India joined WHO-ADR Monitoring
Programme (3 centres)
2004 – 08
• National Pharmacovigilance programme
(2 Zonal, 5 Regional, 24 Peripheral Centres)
2010
Introduction

3. To ensure that the benefit of the medicine outweighs the
risks, associated with its use.
Mission of PvPI

4. Use of the Inferences
• Recommend regulatory interventions
• Communicating risks- healthcare professionals & public
Purpose of PvPI
Collate
Process
Analyse

5. Methodologies in Pharmacovigilance
1. Spontaneous Reporting
2. Case series
3. Stimulated reporting
Active Surveillance
1. Sentinel sites
2. Medicine event monitoring
3. Registries
4. Cross sectional studies
5. Case control study
6. Cohort study
Passive Surveillance

6. Stakeholders- PvPI
1. NCC IPC, Ghaziabad
2. CDSCO Headquarters, New Delhi
3. CDSCO Zonal Centres
4. ADR Monitoring centres

7. Pharmacovigilance Program in India - PvPI
Programme is–administered & monitored by the following:-
1. Steering committee.
2. Strategic advisory committee
Technical support provided by
• Signal review panel
• Quality review panel
• Core training panel
SIGNAL - Reported information
on a possible causal relationship
between Adverse event & drug

8. PvPI Programme communication

9. ADR Monitoring Centres under PvPI
• ADR Monitoring Centres (AMCs) under PvPI play a vital role of collection
and follow-up of ADR reports from the patients.
• The PvPI started with the enrollment of 22 ADR monitoring to 90 centres
across the country in the year 2010, which has increased more than 250
• MCI Approved Medical Colleges & Hospitals
• Private Hospitals
• Public Health Programmes
• Autonomous Institutes (ICMR etc.)
What qualifies as a ADR Monitoring Centre ?

10. Role of AMC
1. Collection of ADR reports
2. Perform follow up with the complainant to check completeness as per
SOPs
3. Data entry into Vigiflow
5. Training/ sensitization/ feedback to physicians through newsletters circulated by the PvPI
NCC
4. Reporting to PvPI National Coordinating Centre (PvPI NCC) through Vigiflow with the
source data (original) attached with each ADR case
6. Centre coordinator responsible for sending monthly reports of their AMC to NCC

11. • Web-based Individual Case Safety Report (ICSR) management system
that is specially designed for use by national centres in the WHO
Programme for International Drug Monitoring.
Vigiflow

12. VigiFlow, VigiBase,
VigiLyze????

14. PHARMACOLOGY, VIMS & RC 14

15. How & whom to report ?

16. PHARMACOLOGY, VIMS & RC

17. WHO-UMC LOGIN PAGE

18. WHO-UMC Main Screen

19. WHO-UMC Webpage

20. Data Flow

22. Outcome
Signal Generation
Drug Alerts
Recommendation to Regulators
Education

23. PvPI website view

24. DRUG SAFETY
ALERT JULY
2020

25. NOTIFICATIONS
CDSCO website view

26. CDSCO website view

27. ADR related Notification letter

28. ADR related Notification letter

29. Active surveillance of the ADRs
Vydehi Experience-
Prospective, non-interventional, observational, cross-sectional
study; 1 Year
Causality and severity - Naranjo and modified Hartwig and Siegel
scales, respectively.
Analysed reports 433 patients developing ADR
Ingale, A. M., P. Nadig, and A. Chakraborty. “ANALYSIS OF THE ADVERSE DRUG REACTIONS COLLECTED THROUGH ACTIVE SURVEILLANCE IN THE
PHARMACOVIGILANCE UNIT OF A TERTIARY CARE HOSPITAL”. Asian Journal of Pharmaceutical and Clinical Research, vol. 11, no. 8, Aug. 2018, pp. 383-7

30. Active surveillance of the ADRs
Results 53.59% were females
ADRs- Skin and appendages (27.6%);
Gastrointestinal system (22.8%)
Maximum reports-probable and mild severity.
74 were serious
Antimicrobials and chemotherapy

31. Take home message
• Pharmacovigilance systems are needed to safeguard public health
• AMCs act as a very important bridge between the ADRs at the
grassroot level & the NCC
• Good pharmacovigilance will identify the risks and risk factors in
shortest possible time so that the harm can be avoided or minimized.