Phamacovigilance Program of India

1. PHARMACOVIGILANCE
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2. 2
Medicine Safety
To undergo treatment you have to be
very healthy, because apart from your
sickness you have to withstand the
medicine.
Molière

3. PHARMAKON - Drug safety
VIGLARE - to keep watch
• Pharmacovigilance is defined by WHO as “the science and activities related to the
detection, assessment, understanding and prevention of adverse drug reaction or
any other possible drug-related problems”.
• Products covered by pharmacovigilance:
• Medicines
• Herbals
• Traditional
• Biologicals
• Vaccines
• Blood products
• Medical devices
3
World Health Organization. The Importance of Pharmacovigilance - Safety Monitoring of medicinal products. Who [Internet]. 2002;1–52.
Available from: http://apps.who.int/medicinedocs/pdf/s4893e/s4893e.pdf

4. Pharmacovigilance at different stages of drug
development
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5. AIM OF PHARMACOVIGILANCE
• Improve patient care and safety in relation to use of medicines in medical and
paramedical interventions, including vaccination.
• Improve public health and safety.
• Contribute to assessment of benefit, harm, effectiveness and risk of medicines
• Encourage safe, rational and effective (includes cost effective) use of medicines
• Promote understanding, education and clinical training in pharmacovigilance and
effective communication of it’s surveillance role to the public.
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6. Scope of
Pharmacovigilance
Adverse drug
reactions
Medication
Errors
Counterfeit
medicines
Abuse and
misuse of
medicines
Lack of efficacy
Interaction of
medicines
6World Health Organization. Pharmacovigilance Indicators: A practical manual for the assessment of pharmacovigilance systems. WHO [Internet]. 2015. Available from:
http://apps.who.int/medicinedocs/documents/s21970en/s21970en.pdf

7. Why is Pharmacovigilance required?
I. {a} Pre-marketing safety data
• Animal Experiments: Relevant?
• Clinical Trials: Complete?
I. {b} Post Marketing Topics
• Unexpected adverse reactions
• Interactions
• Risk factors
• Quality of life
• Long-term efficacy
• Cost assessment
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8. II. Medicines are supposed to save lives
III. Economic Impact-
IV. Promoting rational use of medicines and adherence
V. Ensuring public confidence
VI. Ethics- to know of something that is harmful to another person who
does not know, and not telling, is unethical

9. 9WHO. Joining the WHO Programme for International Drug Monitoring. Uppsala Monitoring Centre [Internet]. Available from: http://www.who-
umc.org/DynPage.aspx?id=98081&mn1=7347&mn2=7252&mn3=7322&mn4=7325

10. Pharmacovigilance Programme of India (PvPI)
• Launched with a broad objective to safe guard the health of the people of India
• The Central Drugs Standard Control Organisation (CDSCO) initiated a nation-wide
pharmacovigilance programme under the Ministry Of Health & Family Welfare in
2010 with AIIMS as National Coordinating Centre (NCC) for monitoring ADRs
• Adverse drug Reactions are reported from all over the country to NCC-PvPI
• It work in collaboration with the global ADR monitoring centre (WHO-UMC),
Sweden to contribute in the global ADRs data base
• NCC-PvPI monitors the ADRs among Indian population and helps the regulatory
authority of India (CDSCO) in taking decision for safe use of medicines
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11. • Mission-
Safeguard the health of the Indian population by ensuring that the
benefits of use of medicine outweigh the risks associated with its use.
• Vision-
To improve patient safety and welfare in Indian population by
monitoring the drug safety and thereby reducing the risk associated
with use of medicines.
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12. OBJECTIVES
Centre of
Excellence
Nation-
wide
system
Identify new
Signals
Benefit-Risk
ratio
Evidence
based
information
on medicine
safety
Support
regulatory
agencies
Communicate
safety
information
Collaborate
with other
centers
Training and
consultancy
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13. GOALS
Short term
Goals
• Develop and implement pharmaco-vigilance system
• Enrol all MCI approved medical colleges
• To encourage healthcare professionals in reporting of adverse reaction
• Collection of case reports and data
Long term Goals
• Expand the pharmacovigilance programme to all hospitals and centres of
public health programs
• Develop and implement electronic reporting system
• Develop reporting culture
• Make ADR reporting mandatory
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14. ORGANIZATION INVOLVED IN PvPI
• The Central Drugs Standard Control Organization Headquarters
• Indian Pharmacopoeia Commission
• WHO Collaborating Centre for International Drug Monitoring: The
Uppsala Monitoring Centre
• WHO Country Office for India
• National Institute of Biologicals
• AEFI surveillance
• Participation of nursing professionals
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15. 15
Identify and evaluate
signals from ICSR
Review quality,
causality and
completeness of ICSR
PvPI
administered
and monitored
Give technical
inputs to CDSCO

16. National Coordination Centre
• NCC shifted from AIIMS to Indian Pharmacopeia Commission (IPC),
Ghaziabad on 15th April 2011
• Committees under NCC:
• Steering committee
• Working group
• Quality review panel
• Signal review panel
• Core Training panel
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17. NCC- Responsibilities
• Preparing standard operating procedures (SOPs), guidance document and training manual
• Enrolment of new ADR Monitoring Centres (AMCs)
• Reviewing and analysing Individual Case Safety Report (ICSRs)
• Forwarding ICSRs to WHO-UMC
• Communicate with WHO-UMC for administrative logistic and technical issues
• Organising Continuous Medical Education (CME) on Pharmacovigilance
• Conducting periodic training and workshops
• Publishing the PvPI newsletter
• Reporting all concerned issues to CDSCO HQ
• Provide procurement, financial and administrative logistic with respect to PV
• Token of appreciation for ADR reporters
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18. ORGANOGRAM OF NCC
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NCC
Secretary-Cum-
Scientific
Director, IPC
Senior Scientific
officer
Scientific
Assistant
Technical
Associates
Finance and
Account Officer
Director, National
Institute of
Biologicals
National
Scientific
Coordinator
Advisor

19. UMC
• Independent foundation and a centre for international service and
scientific research
• Vision- safeguarding patients
• It provides a forum for WHO member states to collaborate in the monitoring of
drug safety
• Within the Program, individual case reports of suspected adverse drug reactions
are collected and stored in a common database
• Presently containing over 3.7 million case reports
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20. • It is responsible for the collection of data about ADRs from around the world
• Member countries send their reports to the Uppsala Monitoring Centre where they
are processed, evaluated and entered into the WHO International Database
• When there are several reports of adverse reactions to a particular drug this
process may lead to the detection of a signal — an alert about a possible hazard
communicated to member countries
• Through membership of The WHO International Drug Monitoring Program, a
country can know if similar reports are being made elsewhere
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21. WHO-UMC collaboration PvPI
VigiFlow:
• Web based ICSR management system
• It offers simple, fast and secure web based solution for ADR reporting
• Once completed and committed ICSR will automatically save in VigiBase
VigiBase:
• WHO global ICSR database
• Receives reports of ADRs from member countries
• Developed and maintained by UMC
• Computer based system which allows retrieval and analysis of data
VigiSearch:
• It is a search tool, provides access to all case reports in VigiBase
• Enables international comparison
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22. WHO-UMC collaboration PvPI
VigiMine:
• Gives access to statistical data on all drug-ADR pairs reported to VigiBase
• Allows filtering as well as stratification of reports
• Used to compare with national database
VigiMed:
• Web based forum for national centres
• Easy access to safety concerns
• Checks regulatory status
VigiLyze:
• Search and analysis tool
• Includes data on conventional and traditional medicines as well as biological
medicines and vaccine
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23. The responsibilities of WHO-UMC towards NCC are as follows:
• Training of the staff at the PvPI NCC at IPC
• Monitoring centres in medical colleges across the country
• Usage of UMC’s Vigiflow software (for medicines) at no cost to PvPI
• Access to Vigi-base, which contains worldwide medicines safety data
• Access to early information about potential safety hazards of medicines (worldwide data)
• Technical collaboration for a regular publication that will be issued by the PvPI NCC for
distribution to the AMCs and other stakeholders
• CDSCO Headquarters has held several meetings with UMC over the past few years to
discuss the potential role and approach for technical collaboration
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24. NATIONAL REGULATORY AUTHORITY
• Responsible for ensuring that every pharmaceutical product used within
the country is:
• Of good quality,
• Of known potency,
• Safe for the purpose or purposes for which it is proposed.
• They may conduct:
• Post-licensure surveillance of ADRs,
• Data collection on AEFIs using standardized methodologies,
• Data analysis,
• Regular communications with NCC to update safety profiles.

25. CDSCO Headquarter
Mission
• To safeguard and enhance the public health by assuring the safety, efficacy and quality of
drugs, cosmetics and medical devices
Responsible for:
• Facilitate in Uniform implementation of the provisions of the Drugs & Cosmetics Act
1940 and Rules 1945
• Regulatory control over the import of drugs, approval of new drugs and clinical trials
• Central license Approving Authority
• Taking appropriate regulatory decision and action regarding drug safety
• Propagating medicine safety related decisions to stakeholders
• Provide administrative and technical support to run PvPI
• Collaboration with WHO-uppsala monitoring centre – Sweden
• Providing training to the Indian regulatory personnel 25

26. ORGANIZATIONAL CHART OF CDSCO
26http://www.cdsco.nic.in/forms/list.aspx?lid=2121&Id=0

27. The Zonal/ Sub-zonal CDSCO office is responsible for:
• Reporting all drug safety issues to the CDSCO headquarter and NCC-PvPI
• Providing administrative and logistic supports to the AMC at their zone
• Auditing AMC in their respective zonal and submitting the inspection report to
CDSCO HQ
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28. Regional Resource centres
• EASTERN REGION: Department of Pharmacology, IPGMER, Kolkata
• WESTERN REGION: Department of Clinical Pharmacology, Seth GS Medical
College and KEM Hospital, Mumbai
• NORTHERN REGION: Department of Pharmacology, PGIMER, Chandigarh
• SOUTHERN REGION: Department of Clinical Pharmacy, JSS Medical College
Hospital, Mysore
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29. Adverse drug reaction Monitoring Centre
AMCs are the Medical Council of India (MCI) approved:
• Medical colleges & hospitals
• Medical/central/autonomous institutes
• Public health programmes
• Corporate hospitals
They are responsible for:
• Collecting the adverse event information from the patients
• Performing follow up with them to check the completeness of the ADR reports as per standard
operating procedures (SOPs)
• Entering information in the prescribed software (Vigiflow)
• Sending the information to NCC via the same software
• Some AMCs are also responsible for providing training and technical support at regional level.
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30. • PvPI started with the enrolment of 22 ADR monitoring centres across
the country in the year 2010, which has increased to 90 by the end of
2012
• 90 AMCs are categorised into four zones i.e. North, South, East and
West as per zonal offices of CDSCO in India and are functioning
under NCC
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31. • The main benefits include
• Access to Vigiflow and VigiBase
• Early information about potential safety hazards (based on analyses of country’s data
and communications from other AMCs)
• Terminologies and software (tools for carrying out national medicine safety tasks)
• Support, guidelines and resources (on pharmacovigilance practice) and access to the
national network (knowledge and expertise of other AMCs).
• Chance to contribute towards the public health safety and improving patient safety in
Indian population.
• In addition, members of the PvPI meet at various conferences and meetings to share
information and network.
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33. 33
ICSRs reportedAMCs Enrolled

34. AMCs in Delhi
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36. 36

37. Who can report?
• Any healthcare professional (Doctors including Dentists, Nurses and Pharmacists)
How to report?
• Suspected adverse drug reaction reporting form’ to report any ADR
• Form available in all AMCs or download from www.ipc.nic.in or www.cdsco.nic.In
Whom to report?
• 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
• A list of nationwide AMCs is available at: http://ipc.nic.in and also at
http://cdsco.nic.in/pharmacovigilance.htm
• Toll free number 1800-180-3024 for reporting ADR
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38. Channels:
• Suspected ADR form
• Helpline (1800-180-3024)
• Mobile Application
Launched on 22nd May 2015.
Joint venture of IPC and
NSCB Medical College, Jabalpur
• Medicines Side Effect Reporting Form
patients/ consumer
ten local languages
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39. What happens to the submitted information?
• Causality assessment is carried out at AMCs by using WHO-UMC scale
• Analysed forms are forwarded to NCC through the ADR database
• Data is again analysed and forwarded to the Global Pharmacovigilance Database managed by
WHO UMC in Sweden
• Reports are periodically reviewed by the NCC (IPC). The information generated on the basis
of these reports helps in continuous assessment of the benefit-risk ratio of medicines.
• Information is submitted to the Steering Committee of PvPI constituted by the Ministry of
Health and Family Welfare
• The Committee is entrusted with the responsibility to review the data and suggest any
interventions that may be required
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40. Causality Assessment of Adverse Event
• It is the evaluation of likelihood that a medicine was the causative
agent of an observed adverse event
• WHY???
Most case reports as suspected ADR
Some are certain or unlikely / possible or probable
AMC is responsible for performing causality assessment of reports
which are reviewed at NCC
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41. • PvPI follows WHO-UMC causality assessment scale to establish a
relationship
• What it can do:
• Decrease disagreement between assessors
• Classify relationship likelihood
• Mark Individual case reports
• Improvement of scientific evaluation
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42. WHO-UMC Causality Assessment Scale
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43. 43
Signal Generation and
strengthening
Risk Management
Drug Regulation Education
UTLIZATION OF
THE DATA

44. Haemovigilance Programme of India
• HvPI is a process of data collection and analysis of transfusion-related
adverse reactions in order to investigate their causes and outcomes and
prevent their occurrence.
• IPC in collaboration with National institute of Biology (NIB) has
launched haemovigilance under PvPI to:
• Track Adverse Reactions/ Events and incidence associated with blood transfusion and
blood product administration
• Help in identifying trends, best practices and interventions required to improve patient
care and safety
• HvPI was launched on 10th Dec 2012 as an integral part of PvPI
• NIB functions as NCC to collate and analyse data
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45. Vaccine Pharmacovigilance
Defined as “the science and activities relating to the
• Detection,
• Assessment,
• Understanding and
• Communication
of adverse events following immunization and other vaccine- or
immunization-related issues, and to the prevention of untoward effects
of the vaccine or immunization”.
45Vaccine Safety Basics

46. AEFI- any untoward medical
occurrence which follows
immunization and which
does not necessarily have a
causal relationship with the
usage of the vaccine.
Categories:
• Vaccine product – related
reaction
• Vaccine quality defect- related
reaction
• Immunization error-related
reaction
• Immunization anxiety-related
reaction
• Co-incidental event
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47. 47
REPORT
Serious AEFI
Signals and events associated with a newly introduced vaccine
AEFIs that may have been caused by an immunization error
Significant events of unexplained cause occurring within 30 days after a
vaccination
Events causing significant parental or community concern
Swelling, redness, soreness at the injection site IF it lasts for more than 3
days
Swelling at injection site extends beyond the nearest joint

48. • AEFI surveillance:
• monitors all aspects of immunization safety
• detects and responds to adverse events
• corrects unsafe immunization practices
• reduces negative impact of the event on health
• Vaccine safety in India is monitored by division of AEFI, Ministry of
health and family Welfare and PvPI
• Reporters report AEFI to either AMC or NCC
• Cases reported are further coordinated with AEFI committee and State
Expanded programme immunization officer for investigation
• The committee with local AEFI team furnish FIR/PIR/DIR to do the
causality assessment
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contributes to the quality
of immunization activities

49. 49
Components of global vaccine safety monitoring, investigation
and response system

50. 50
• Licensing
• Post marketing surveillance
• Vaccine lot release
• Laboratory access
• Regulatory inspection
• Oversight of clinical trails
NRA
• Makes sure that health staff respond to AEFI
• Makes sure that health staff is trained
• Responsible for storage, handling and administration
NIP
• Review individual AEFI
• Assess causal link between vaccine and AEFI
• Monitor AEFI data for signals
• Provide recommendation for investigation, corrective action and
communication
• Records it’s decision and feedback to all stakeholders
AEFI
Review
committee

51. 51

52. VACCINE PHARMACOVIGILANCE-
THREE STEPS
SIGNAL
DETECTION
DEVELOPMENT
OF CAUSALITY
HYPOTHESIS
TESTING
CAUSALITY
HYPOTHESIS
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53. 53
PvPI Collaboration
with

54. RNTCP
• Collaboration between RNTCP and PvPI in relation to the use of anti-tubercular
drugs. RNTCP formally collaborated with PvPI on October 11th , 2013
• PvPI as a core component of joint monitoring mission of RNTCP
• MoHFW and WHO Country Office (India) along with other technical partners
conducted a JMM to review India’s RNTCP from 10th April 2015.
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55. • Guidelines for Prevention and Management of Adverse reactions associated with
Anti TB drug’ and launched Bedaquiline – new drug for MDR TB as part of
RNTCP
• Developed a bridge application to ensure data flow
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56. Challenges for PV in India
• Gross underreporting of adverse effects
• Lack of medical expertise in drug administration
• Inadequate skilled resources in PV
• Inadequate nationwide awareness of PV.
• Lack of infrastructure
• Orthodox attitude to new drug research and PV
• Less regulatory inspections
• IT collaborations
• Easy access to Over The Counter medicines.
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57. 57
“Gaps in the system mean the
government has less data to
determine whether drugs might
have harmful side effects. Also,
relatively little information flows
from one of the world's largest
pharmaceutical markets to the
WHO database of over 12
million suspected adverse drug
reactions.”
Huffington Post, 16/02/2016

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59. • When her father's lung cancer worsened, Yin Min, a 51-year-old financial broker
from Shanghai, faced a choice: pay nearly $3,000 a month for an approved drug or
pay a fraction of the price for a generic drug not approved for use in China.
• Yin, like many families in China, turned to the increasingly popular, unregulated
market of online pharmacies, agents and peer groups for drugs.
• She bought a generic version of Iressa, not approved for use in China, directly
from a manufacturer in India.
• HEALTH NEWS | Mon Dec 26, 2016 | 2:13pm EST
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61. Future Prospects
• Strengthening the system- to detect new ADRs
• Generating information that can assist a healthcare professional or a
patient in the decision-making process.
• Integrating Good Pharmacovigilance Practice (GPP) into the processes
and procedures to help ensure regulatory compliance and enhance
clinical trial safety and post marketing surveillance.
• Transparency and communication would strengthen consumer
reporting.
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62. • Role of social media
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66. THANKYOU
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