The document provides an overview of pharmacovigilance in India, including: 1) The history of adverse drug reactions and establishment of regulatory systems following tragedies like thalidomide. 2) The development of India's national pharmacovigilance program over time, from regional centers established in 1986 to the current Pharmacovigilance Programme of India. 3) The functioning of the National Coordination Centre and monitoring centers like NRSMCH in Kolkata, including their roles in adverse reaction reporting and analysis to improve patient safety.

1. Pharmacovigilance – An Overview and
functioning of NRSMCH, Kolkata as an
ADR Monitoring Centre
Presented By:
Anindya Banerjee
Patient Safety – Pharmacovigilance Associate
Dept of Pharmacology
NRSMCH, Kolkata
and
NCC-PvPI , IPC
Ministry of Health & Family Welfare,
Govt of India
Ghaziabad - 201002

2. Introduction
Adverse Drug Reaction
use to occur because of
many reasons.
- Self Medication
- Over the Counter Drug
- Medication Error
- Race and Ethnicity

3. History of Thalidomide Disaster
•Thalidomide tragedy (1961-62): The
greatest of all drug disasters.
Thalidomide had been introduced and
welcomed as a safe and effective
hypnotic and antiemetic. It rapidly
became popular for the treatment of
nausea and vomiting in early
pregnancy.
•Tragically the drug proved to be a
potent human teratogen that caused
major birth defects in an estimated
10,000 children
•Phocomelia was a characteristic
feature 3

4. Other Historical Violations
• Sulfanilamide tragedy: Elixir sulfanilamide was an
improperly prepared sulfanilamide medicine that caused
mass poisoning in the United States in 1937. It caused the
deaths of more than 100 people. The public outcry caused
by this incident and other similar disasters led to the passing
of the 1938 Federal Food, Drug, and Cosmetic Act
• The thalidomide disaster led, in Europe and else where ,to
the establishment of the drug regulatory mechanisms of
today.
• These mechanisms require that new drugs shall be licensed
by well –established regulatory authorities before being
introduced into clinical use
4

5. Pharmacovigilance
5

6. Pharmacovigilance?
Pharmacovigilance is a science and activities related
to
 Detection
 Assessment
 Understanding
&
 Prevention
of adverse drug reactions or any other possible drug
related problems
WHO 2002

7. India?

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

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

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

11. 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

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

13. NCC-PvPI
Functioning: Indian Pharmacopoeia Commission,
Ministry of Health & Family Welfare, Government of
India, is functioning as NCC for PvPI since 15th
April 2011

14. Mission & Vision
• Mission: To safeguard the health of the Indian population by
ensuring that the benefits of use of medicine outweighs 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

15. Aim of Pharmacovigilance
Aim:-
• To improve the benefit of use of medicine which
can outweighs the risk, thus can safeguard the
patient population.

16. Objective of Pharmacovigilance
Objective:-
• To create a nation-wide system for patient safety reporting
• To identify and analyse the new signal (ADR) from the reported cases
• To analyse the benefit - risk ratio of marketed medications
• To generate the evidence based information on safety of medicines
• To support regulatory agencies in the decision-making process on use of
medications
• To communicate the safety information on use of medicines to various
stakeholders to minimise the risk
• To emerge as a national centre of excellence for pharmacovigilance
activities
• To collaborate with other national centres for the exchange of
information and data management

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

19. 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

20. 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

21. Este Zone AMCs under NCC-PvPI

22. NRSMCH as AMC
How to report & 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 in reporting form can be submitted to the AMC or
directly to the NCC
 By calling at the given mobile number: 9804561488
 Or by using Toll free number 1800-180-3024 for reporting
ADR
 Email: anindyabanerjee1988@gmail.com
 Or A reporter can also mail the form at
pvpi.ipcindia@gmail.com
 Pink colored ADR Reporting Poster is available at centre as
well as all OPDs & IPDs.
 Contact detail: Pharmacovigilance Centre, Dept of
Pharmacology,4th Floor, Academy Building, NRS Medical
College,138,AJC Bose Road,Kolkata - 14

23. Role of Pharmacovigilance Associate at an
AMC under NCC-PvPI
• Individual Sensitization of Clinicians for reporting ADRs.
• Visiting Outdoor and Indoor in regular manner
• Direct interaction with patient.
• Collection and Collation of all ADR reports.
• Meeting of Causality Assessment Committee members, committee
performs Causality Assessment.
• Case Processing through Vigiflow Software to NCC-PvPI
• Month wise documentation of all ICSRs with Issued Worldwide
Unique No.
• Documentation of Case Safety Report (Softcopy)
• Documentation of Monthly Progress Report which issued by NCC at
the end of the month.
• Maintain Register with OPD No./IPD No. and Worldwide Unique no.
for quick verification at the time of MCI or CDSCO (EZ) inspection.

24. Suspected Adverse Drug Reaction Reporting Form

25. Completeness Criteria of a Suspected Adverse
Drug Reaction Reporting Form
• An Identifiable Patient
• Suspected Adverse Drug Reaction
• Suspected Medicine
• An Identifiable Reporter

26. Contd..

27. Comparative study on Month wise sent ADR
reports in session 2014-2015 & 2015-2016
9
7 7
28
7
12
5
1
24
22
25
13
14
23
28
18
13
17 19 21
14
18
17 19
2014-2015 2015-2016

28. Comparative study on Departmental involvement in session
2014-2015 & 2015-2016
0.00%
5.00%
10.00%
15.00%
20.00%
25.00%
30.00%
2014-2015
2015-2016

29. Comparative study on Gender Distribution in session
2014-2015 & 2015-2016
2014-2015 2015-2016
Male 53.8% 43.9%
Female 46.2% 56.1%
2014-2015
2015-2016
53.80%
43.90%
46.20%
56.10%
Female Male

30. Comparative study on Age Distribution in session
2014-2015 & 2015-2016
2014-2015 2015-2016
Neonate 3.75% 1.80%
Infant 6.875% 2.71%
Child 4.375% 5.42%
Adolescent 5.625% 5.88%
Adult 73.75% 78.73%
Elderly 5.625% 5.42%
Neonate
Infant
Child
Adolescent
Adult
Elderly
3.75%
6.88%
4.38%
5.62%
73.75%
5.62%
1.80%
2.71%
5.42%
5.88%
78.73%
5.42%
2015-2016 2014-2015

31. Comparative study on Systems Involvement (SOC) in session
2014-2015 & 2015-2016
Skin
GIT
CNS
Psychosomatic
Metabolic
Cardiovascular
Muscular
Endocrine
Respiratory
Haemopoetic
Hepatic
Urinary
Others
39.80%
18.90%
13.40%
7.40%
4.00%
4.97%
0%
2.49%
2.49%
0.90%
4.47%
31.85%
19.32%
10.18%
7.57%
5.74%
5.48%
5.48%
3.13%
2.61%
2.09%
1.82%
0.78%
3.91%
2015-2016 2014-2015

32. Comparative study on Medicines Involvement to produce ADR(s) in session 2014-
2015 & 2015-2016 (on the basis of ICSRs collected throughout the period)
Antimicrobial
Antifungal
Cardiovascular
Antiasthmatic
Steroid
Antispasmotic
Antianalgesic
Antidiabetics
Antiulcer
Anticonvulsant
CNS
Antipsychotic
Antineoplastics
Anticoagulants
Antiemetic
Antiparkinsonian
Antihistamine
Anticoagulant
Others
29.15%
0%
4.00%
5.53%
3.70%
0%
14.40%
3.32%
5.90%
4.00%
0%
14.00%
12.90%
4.00%
0%
0%
0%
1.10%
5.17%
19.57%
4.06%
6.92%
3.61%
1.35%
1.50%
16.57%
4.81%
12.04%
3.91%
2.40%
10.99%
4.06%
0.90%
2.40%
1.35%
2.87%
0%
5.27%
2015-2016 2014-2015

33. Comparative study on Outcome in session
2014-2015 & 2015-2016
2014-2015 2015-2016
Recovered 56.9% 57.47%
Recovering 32.5% 41.62%
Recovered with sequel 8.1% 0%
Fatal 2.5% 0.9%
Recovered
Recovering
Recovered with sequel
Fatal
56.90%
32.50%
8.10%
2.50%
57.47%
41.62%
0%
0.90%
2015-2016 2014-2015

34. Comparative study on Seriousness of ADR(s) in session
2014-2015 & 2015-2016
2014-2015 2015-2016
Not Serious 72.5% 66.5%
Serious 27.5% 33.5%
2014-2015
2015-2016
72.50%
66.50%
27.50%
33.50%
Serious Not Serious

35. Comparative study on Seriousness Criteria of ADRs in session
2014-2015 & 2015-2016
2014-2015 2015-2016
Death 9.76% 2.70%
Life Threatening 7.31% 2.70%
Hospitalization/Prolongation of Hospitalization 82.9% 52.7%
Disability 0% 0%
Congenital Anomaly 0% 0%
Required Intervention 0% 5.4%
Other 0% 36.5%
Death
Life Threatening
Hospitalization/Prolongation of Hospitalization
Disability
Congenital Anomaly
Required Intervention
Other
9.76%
7.31%
82.90%
0%
0%
0%
0%
2.70%
2.70%
52.70%
0%
0%
5.40%
36.50%
2015-2016 2014-2015

36. Some Photography of Serious Adverse Drug Reaction(s)

37. Other Co-curricular Activities
1. Attended and Worked
as resource person in
Pre-Conference
Workshop of 25th
Annual State
Conference of Indian
Pharmacological
Society on hands on
training of how to fill up
ICSR and to upload the
data on Vigiflow
software

38. Other Co-curricular Activities
2. Conducted training
program on
Pharmacovigilance of
3rd Year B.Pharm
Students of Orissa
Pharmacy College
under guidance of AMC
Coordinator
3. Conducted training
program on
Pharmacovigilance of
M.Pharm in Clinical
Pharmacy Students of
Jadavpur University
under guidance of AMC
Coordinator Sample of Certificate Provided to
B.Pharm 3rd Year Student
Sample of Certificate Provided to
M.Pharm in Clinical Pharmacy
Students of Jadavpur University

39. Feedback From Students of B.Pharm 3rd Yr Students

40. Feedback From Students of M.Pharm in Clinical Pharmacy
Students of Jadavpur University

41. Other Activity
Poster of ADR
Monitoring has been
stuck at Jadavpur
University to aware
and sensitizes
students and faculties
of Jadavpur
University regarding
Pharmacovigilance.

42. Conclusion
•Throughout December 2014 – till date it was an immense pleasure to work
with all.
•Clinicians at NRSMCH, Kolkata are cooperative specially General Medicine,
Dermatology, Psychiatry, Haematology, Paediatrics, Endocrinology.
•Faculties of Dept of Pharmacology are also very cooperative. I use to get
critical guidance from Coordinator Madam and Dr. Tania Sur, Associate
Professor, Dept of Pharmacology, As she is also a Member of Causality
Assessment Committee.
•I am cordially thankful to Dr.V.Kalaiselvan ,Principal Scientific Officer, NCC-
PvPI for choosing me in this profession, as Pharmacovigilance is my area of
Interest.
Acknowledgement

43. Take Home Message
To keep awake or alert, to keep watch.

46. Thank You
Anindya Banerjee
Patient Safety - Pharmacovigilance Associate
Dept of Pharmacology
NRSMCH, Kolkata
&
NCC-PvPI, Ghaziabad
Email: anindyabanerjee1988@gmail.com