Establishment of national pharmacovigilance systemsfor the reporting of adverse events, including nationaland, if appropriate, regional pharmacovigilance centres. Development of legislation/regulation for medicinemonitoring. National policy development (to include costing,budgeting and financing). The Pharmacovigilance Programme of India (PvPI) was operationalized in July 2010 by the Ministry of Health and Family Welfare, Government of India with the mission to safeguard the health of Indian population by ensuring that the benefits of use of medicine outweigh the risks associated with its use.

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1
National Programs related to Pharmacovigilance

2. Content
 Introduction
 What is pharmacovigilance
 Pharmacovigilance programme of India(PvPI)
 Mission
 Objective
 Goal
 Working pattern of pharmacovigilance
 ADR Monitoring centre in medical college
 National Coordinating Centre
 CDSCO
 Regional centre under PvPI
 Whom to report
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3. What is Pharmacovigilance?
 Pharmacovigilance: Pharmaco (drug) + Vigilance(keep watching)
Is a system to monitor the safety and effectiveness of medicines and other pharmaceutical
product.
As per WHO:
Pharmacovigilance as ‘science and activities relating to the detection, assessment,
understanding, reporting and prevention of adverse effect.’
 Aim/objectives: reduce drug related harm to patient.
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4. Activities :
 Post marketing study – report by doctors or other healthcare professionals.
 Format
Drug name-brand name
Manufactured by
Batch no
Expiry date
Dose use
Route of administrations
Frequency
Reason for prescription
Therapy date
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5. CONT…
 Prescription event monitoring.
 Computerized medical record linkage.
 Dissemination of ADR data through- drug alert , advisory sent to
physicians by regulatory agencies.
 Change in the labelling of medicines- warning, precautions.
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6. Why we need Pharmacovigilance in India?
 India is a vast country with a population of over 1.3 billion with
 Vast ethnic variability.
 Difference disease prevalence patterns.
 Practice of different system of medicines.
 Different socioeconomics status.
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7. Pharmacovigilance of India
 1986- started the ADR monitoring centre with 12 regional centres.
 1997- India joined WHO-ADR monitoring programme.
 2004- National pharmacovigilance programme.
 2010- Pharmacovigilance programme of India.
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8. Pharmacovigilance programme of India(PvPI)
 Initiated by the Central Drugs Standard Control
Organisation(CDSCO) and
initially coordinated by the AIIMS New Dealhi.
 Then in 2011 it was shifted to
• National Coordinating Centre(NCC)
- Indian Pharmacopeia Commission, Gaziabad.
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9. Mission:
 To ensure that
 Benefits of use of medicine outweighs the risk and
 Safeguard the health of the Indian population.
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10. Objectives:
 To monitor adverse drug reactions (ADRs) in Indian populations.
 To create awareness amongst health care professionals about the importance
of ADR reporting in India.
 Generate independent, evidence based recommendations on the safety of
medicines.
 Support the CDSCO for formulating safety related regulatory decisions for
medicines.
 Communicate findings with all key stakeholders.
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11. Goals:
 Short term goals:
 To develop and implement pharmacovigilance system in India.
 To enrols, all MCI approved medical colleges in the programme covering north,
south, east and west of India.
 To encourage healthcare professionals in reporting of adverse reaction to drugs,
vaccines, medical devices and biological product.
 Collection of case report and data.
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12. Cont…
 Long term:
 To expand pharmacovigilance programme to all hospitals (gov & private) and
centres of public health programs located across India.
 To develop reporting and implement electronic reporting system (e-reporting)
 To develop reporting culture amongst healthcare professionals.
 To make ADR reporting mandatory for all healthcare professionals.
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GOVERNANCE STRUCTURE - PVPI

14. Working pattern of pharmacovigilance of India:
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Health professionals
ADRs Monitoring Centre/ National Coordinating Centre
Data entered in Vigiflow
National Coordinating centre
WHO Uppasala centre,swden
To fill the suspected ADRs form
check the completeness of the data
Forwarded to
Analysed CDSCO for regulatory intervention

15. ADR monitoring centre in medical college
 Collection of ADR reports.
 Perform follo up with the complaints to check completeness as per SOPs.
 Data entry into Vigiflow.
 Postgraduate / undergraduate training in pharmacovigilance.
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16. National Coordinating Centre
 Preparations of SOPs, guidance documents & training manuals.
 Cross check completeness, casuality assessment as per SOPs.
 Reporting to CDSCO headquarters.
 Conduct training workshops of all enrolled centres.
 Publications of medicine safety newsletters.
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17. CDSCO
 Take appropriate regulatory decisions and actions on the basis of
recommendations of NCC.
 Propagation of medicine safety related decisionto stakeholders.
 Collaboration with WHO-Uppsala Monitoring Centre.
 Provide for budgetary provision and administrative support to run PvPI.
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18. Regional Centre under PvPI
 These regional centres are recognized as regional resource centre.
 Eastern region: IPGMER, Kolkata.
 Western region: KEM Hospital,Mumbai.
 Northen region: PGIMER,Chandigarh.
 Southern region: JSS Hopspital,Mysore.
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19. Whom to report
 Use the “Suspected Adverse Drug Reaction Form” to report any ADRs.
 Form is available in all AMCs or downloaded from www.ipc.gov.in or
www.cdsco.gov.in
 The filled reporting form can be submitted to the AMC or directly to the NCC.
 A reporter can also mail the form at pvpi.ipcindia@gmail.com
 Toll free number 1800-180-3024 for reporting ADR.
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