The Pharmacovigilance Programme of India is an Indian government organization which identifies and responds to drug safety problems. Its activities include receiving reports of adverse drug events and taking necessary action to remedy problems.

1. Pharmacovigilance Programme
Presented by-
Mr. Vijay Salvekar
Associated Professor
GRY Institute of Pharmacy,Borawan

2. Pharmacovigilance?
Pharmacovigilance: science and activities relating to the
Detection
Assessment
 Understanding &
Prevention
of adverse drug reactions or any other possible drug related
problems
WHO 2002

3. Pharmacovigilance
prevention
of adverse
effects
Assessment
&Understand
ing
Detection

4. •Early 20th century there were no controls over the drug
development process
• Claims over treating diseases and uncontrolled
marketing.
• Safety or effectiveness of the drug- NOT a concern for
government.
• 1883 Dr. Harvey Wiley initiated the campaign for
Federal law for Food and Drugs Act that was finally
passed in 1906.
• The law was further tightened following incidents such
as poisoning of children by Sulphanilamide and the
Thalidomide tragedy.
• 1938 Federal Food, Drug, and Cosmetic Act

5. Learning from History
Thalidomide Disaster:
(anti-leprosy drug)
•Tranquilizer launched - 1957
• First reports of birth defects - 1959
• 13 reports of birth defects - 1961
•Withdrawn shortly afterward
•10000 infants affected by
Phocomelia.
•No teratogenicity detected in testis
during clinical trials and prior to
launch.

6. Why do we need
Pharmacovigilance?

7. Reason
Humanitarian concern
Insufficient evidence of safety
from clinical trials, Animal
experiments & Phase 1 – 3
studies prior to marketing
authorization

9. Limitations of clinical trials
•Small number of patients
studied
•Restricted populations (age,
sex, ethnicity)
•Narrow indications
•Short duration of drug
exposure

10. Reason 2:
Medicines are supposed to
save lives

11. • ADRs were 4th-6th
commonest cause of death
in the US
USA
• It has been suggested that
ADRs may cause 5700
deaths per year in UK.
UK

12. Reason 3:
ADRs are expensive !!
• Cost of drug related morbidity
and mortality exceeded $250.4
billion in 2020
• ADR related cost to the
country exceeds the cost of
the medications themselves.

13. Reason 4:
Promoting rational use of
medicines and adherence
Reason 5:
Ensuring public confidence
Reason 6:
Ethics Toknow of something
that is harmful to another
person who does not know, and
not telling, is unethical

14. Pharmacovigilance is needed in
every country
because of differences in:
• Drug production
• Distribution and use ( e.g.
indications, dose, availability)
• Genetics, diet, traditions of the
people (e.g. use of herbal
remedies, etc.)
• Pharmaceutical quality and
composition (active/inactive
ingredients )

15. •
•
•
1962
USA revised law requiring to prove safety and
efficacy before issuing marketing authorization 1963
British Committee on Safety of drug monitoring
1964
UK starts “yellow cards” system

20. A VALID REPORT CONSISTS OF:-
• Identifiable patient
• Identifiable drug (pharmaceutical product)
• Identifiable reaction
• Identifiable reporter

21. Who should report?
• Healthcare Professionals
• Marketing authorization
holder (MAH)
• Patients & their relatives
• Nurses
• Pharmacists

22. Reports Journey
Reporter P-Vigilator Data entry
Rregulatory
Authority

23. Need of pharmacovigilance
There is a need to monitor the effects of drugs
during the clinical trials and after its launch in a
market.
Because adverse events can even happen during
the clinical trials and event after its launch market.

24. Why pharmacovigilance in clinical trials
After the completing preclinical studies in
animals, first time trial drug will be administered
to the human.
At this time the drug will act in different way to
the human body.
Chances of adverse will also persist

25. Pharmacovigilance in post marketing – Why?
At the time of approval, clinical trial data are available
on limited numbers of patients treated for relatively
short periods
Once a product is marketed, large numbers of patients
may be exposed, including:
Patients with co-morbid illnesses
Patients using concomitant medications
Patients with chronic exposure
Genetic diversity in large population

26. Importance of Pharmacovigilance in every country
There are differences among countries ( and even
within countries ) in the occurrence of ADRs (Adverse
drug reactions) and other drug related problems
Differences in diseases
Prescribing practices
Genetics
Diet
Traditions/lifestyle of people
Drug manufacturing processes
Drug distribution
The use of drugs (dose, indications and availability)

27. • 1964-65
National ADR reporting system UK,
Australia, New Zealand, Canada, West Germany,
Sweden.

28. Uppsala Monitoring Centre
•
•
•
•
•
•
1968 - WHO Collaborating Centre for
International Drug Monitoring, Geneva
1978 - Moved to Uppsala after agreement between
Sweden and WHO
Non-profit foundation with
international administrative board
WHO Headquarters responsible for policy
Self-financing
Global Pharmacovigilance

29. India?

30. Pharmacovigilance in India
1986
 ADR monitoring system for India proposed with
12 regional centres
 Oversaw areas with population sizes of
approximately 50 million each

31. Cont…
1997
 India joined WHO-ADR reporting program based
in Uppsala, Sweden
 3 centres viz, AIIMS, KEM andAMU

32. National Pharmacovigilance
Program (NPP)
2004
 The National Pharmacovigilance Program (NPP)
officially inaugurated by the Central Health
Minister at New Delhi

33. Cont…
2005
 The Ministry of Health and Family Welfare in
India initiated the NPP, coordinated by the Central
Drugs Standard Control Organization (CDSCO)
 Programme was started with 2 zonal, 5 regional
and 24 peripheral centres

34. Pharmacovigilance Programme of India
July 2010
 The Pharmacovigilance Programme of India (PvPI)
initiated with AIIMS, New Delhi as National Coordination
Centre (NCC) for monitoring ADRs in the country

35. Cont…
15th April 2011
 The NCC shifted from AIIMS, New Delhi to Indian
Pharmacopoeia Commission (IPC), Ghaziabad

36. Mission
Safeguard the health of the Indian population by
ensuring that the benefits of use of medicine
outweigh the risks associated with its use

37. Objectives
To create a national-wide system for patient safety reporting
To identify and analyze new signal from the report cases
To analyze the benefit-risk ratio of marketed
medications
To generate evidence based information on safety of
medicines
To support regulatory agency in the decision- making
process on use of medications
To promote rational use of medicine

38. Short term goals
• To develop & implement pharmacovigilance
system in India
• To enroll, initially all MCI approved medical
colleges in the program covering north, south, east
and west of India
• To encourage healthcare professionals in reporting
of adverse reaction to drugs, vaccines, medical
devices and biological products
• Collection of case reports and data

39. Long term goals
• To expand the PvPI to all hospitals (govt. &
private), public heath programs located across
India
• To develop & implement e-reporting system
• To develop reporting culture amongst HCPs
• To make ADR reporting mandatory for HCPs

40. Committees under NCC
 Steering Committee
 Working Group
 Quality Review Panel
 Signal Review Panel
 Core Training Panel

42. Communication under PvPI
Uppsala Monitoring
Centre, Sweden
National Coordination
Centre, IPC, Ghaziabad
ADRs Monitoring
Centre
Healthcare
Professionals
CDSCO Zonal Offices
South Zone, Chennai
West Zone, Mumbai
East Zone, Kolkata
North Zone, Ghaziabad
CDSCO
Headquarter,
New Delhi

43. CDSCO Headquarter
The CDSCO HQ is responsible for:
• Taking appropriate regulatory decision and action
regarding drug safety
• Propagating medicine safety related decisions to
stakeholders
• Provide administrative and Technical support to
run PvPI

44. Regional Centres under PvPI
These regional centres are recognized as Regional
Resource Centre.
 Eastern Region: IPGMER, Kolkata
 Western Region: KEM Hospital, Mumbai
 Northern Region: PGIMER, Chandigarh
 Southern Region: JSS Hospital, Mysore

45. Whom to
Report?
 Use the ‘Suspected Adverse Drug Reaction Reporting
Form’ to report any ADR
 Form available in all AMCs or download from
www.ipc.gov.in or www.cdsco.nic.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

46. Current status of NCC-PvPI
Till 31stJan 2015-
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Total number of ADR monitoring centres: 90
Total number of proposed ADR monitoring centres: 60
Number of ADRs committed by NCC toWHO-UMC:
75,663
Number of ADRs under assessment of NCC: 6421
Number of reports reverted back to AMCs: 705
Total number of Individual Case Safety Reports
(ICSRs) in PvPI database: 84,470

47. ADRs Reporting Status
 ADR reporting rate in India has gradually
increased as compared to previous year
 PvPI in-house assessment shows that;
64.66% of ICSRs reported by Clinicians
• 14.75% by Pharmacists
• 18.83% by Nurses and Dentists

48. India’s contribution to WHO-
UMC, 2013
 117 countries participating in the WHO
programme for International Drug Monitoring
 India stood at 7thposition in contributing to
global ICSRs safety database for the year 2013

49. EXPANSION OF PvPI

50. Medical Council of India (MCI)
 Mandatory for every medical college in India to
have a Pharmacovigilance committee, as per
regulations of Medical Council of India, 2010

51. Haemovigilance
NIB AND
COLLABORATION BETWEEN
PvPI
IPC in collaboration with National Institute of
Biologicals (NIB) has launched Haemovigilance
Program of India on 10th Dec 2012 as an integral
part of PvPI

52. Revised National TB Control Programme
(RNTCP)
COLLABORATION BETWEEN RNTCP
AND PvPI
In order to improve patient care and safety in
relation to the use of anti-tubercular drugs.
RNTCP formally collaborated with PvPI on
October 11th, 2013

53. Participation of Nursing Professionals
NCC-PvPI oraganized a meeting with president Nursing
Coumcil of India (NCI), on July 16, 2014, New Delhi to
initiate the participation of nursing professionals in PvPI.

54. National AIDSControl Organization (NACO)
• COLLABORATION BETWEEN NACO & PvPI
• To ensure the safety of ARV medicines
• Organization(NACO) formally agreed on15
September 2014.

55. ADR Monitoring Centres (AMCs)



All MCI approved teaching hospitals established
as AMCs under the PvPI.
Total number of AMCs in India till now is 150
Department of Pharmacology, MAMC has been
established as an AMC under the PvPI.

56. 34
MAMC as AMC
 As per the MCI guideline, all Medical Colleges to
have a college pharmacovigilance committee.
 MAMC has made a College Pharmacovigilance
Committee involving 30 Departments of college
and associated hospitals.

57. MAMC as AMC
 Total number of Individual Case Safety reports
(ICSRs) collected at AMC (Sep-2014 to Mar-
2015): 198
 Total number of ICSRs reported from MAMC to
NCC : 135

58. MAMC as AMC
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Departments actively involved in reporting of
ADRs:
Radiotherapy
HIV/ART Clinic
Medicine
TB & Chest Clinic
Surgery
Dermatology
Obs & Gyn
Psychiatry
Radio-diagnosis

59. MAMC as AMC
How to report & Whom to report?
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Pink colored ADR reporting form available at
centre as well as all OPDs & Nursing stations
Through mobile number: 9560627611
Email: pvpi.mamc@gmail.com
Contact detail: ADR Monitoring Centre, Room
No. 176, Department of Pharmacology, Pathology
Block, MAMC

60. MAMC as AMC
Pink-colored ADR reportingform

62. Recently banned drugs in India
Dextropropoxyphene (23rdMay, 2013)

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Serodiagnostic test kits for diagnosis of
tuberculosis (7thJun, 2013)
Fixed dose combination of Flupentixol+Melitracen
(18thJun, 2013)
Analgin (18thJun, 2013)
Pioglitazone (18thJun, 2013)