pharmacovigilance program in india .pptx

Pharmacovigilance
Presenter: Dr. Siddhant Mehrotra (JR-1)
Department of Pharmacology & Therapeutics
King George’s Medical University, Lucknow U.P.
Email: dr.sidmehrotrakgmu@gmail.com

10/07/2025 Dr. Siddhant Mehrotra 2
Celebrating 4th
National Pharmacovigilance Week

• Adverse drug reaction caused 100,000 annual deaths worldwide
Feb. 2007
Feb 2011
For child < 12 years

Content
• Introduction
• Need for Pharmacovigilance
• Pharmacovigilance in India
• Responsibilities and objectives
• Short term & long term goals
• International status of Pharmacovigilance
• ADR reporting
• Scope of Pharmacovigilance

List of Important Abbreviations Used
• ADR- Adverse drug reaction
• PvPI- Pharmacovigilance programme of India
• AMC- ADR monitoring centre
• CDSCO- Central drug standard control organization
• ICSR- Individual case safety report

Specific learning objectives
At the end of this PG -teaching session my co- learners will be able to:
• Get sensitize with pharmacovigilance
• Objectives, roles and importance of pharmacovigilance
• Pharmacovigilance program in India
• Scope of pharmacovigilance after MD pharmacology

What is Pharmacovigilance?
• Pharmacovigilance is the science and activities related to
Detection
Assessment
Understanding
Prevention
Of adverse effects or
any other medicine
related problems

Need for Pharmacovigilance
• To protect patients from unnecessary harm and increasing healthcare cost from
medicines
• For signal detection and risk minimisation measures
• Early detection of new ADRs on patients subgroups of exceptional sensitivity
(Paediatrics, Geriatrics, Pregnant women)
• Promoting rational use of medicines
• To support regulatory agencies in decision making process for safe use of
medicines

Brief history of Pharmacovigilance in India
In 1986,there was formal ADR monitoring system consisting of 12
regional centres, each covering 50 million population
In 1989, under the drug controller of India,6 regional centres were set
up in Mumbai, Delhi, Kolkata, Lucknow, Pondicherry and Chandigarh
In 1997, India joined WHO programme for international drug
monitoring managed by Uppasla Monitoring Centre, Sweden

NPVP (National Pharmacovigilance Programme ) was launched in
November 2004.
NPVP was overseen by the National Pharmacovigilance Advisory
Committee based in CDSCO, New Delhi
PvPI was initiated by GOI on 14 July,2010 with AIIMS, New Delhi as NCC
for monitoring adverse drug reaction
Shifted from AIIMS, New Delhi to Indian Pharmacopoeia Commission,
Ghaziabad, Uttar Pradesh on 15th
April,2011
Brief history of Pharmacovigilance in India

Mission of PvPI Vision of PvPI
To safeguard the
health of the Indian
population by
ensuring that the
benefit of use of
medicine outweighs
the risks associated
with its use
To improve patient
safety and welfare in
Indian population by
monitoring drug
safety and thereby
reducing the risk
associated with use of
medicines
Pharmacovigilance Programme in India

Responsibilities of Pharmacovigilance
Creates appropriate structures and means of
communication needed to perform its tasks
Expedited and Periodic recording
Timely Collection of Data and Appropriate
assessment

Objectives of PvPI
• To create a nationwide system for patient safety reporting
• Identify & 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

10/07/2025 15
• To communicate the safety information on use of
medicines to various stakeholders to minimize the risk
• To collaborate with other national centres for the
exchange of information and data management
• To provide training and consultancy support to other
national pharmacovigilance centres located across globe
Objectives of PvPI
Dr. Siddhant Mehrotra

What is Signal?
• Signal is reported information on possible
causal association between drug and adverse
event
• Signal is not a confirmatory finding but it is
hypothesis generating situation that must be
validated

International Status of Pharmacovigilance
•WHO- Uppsala monitoring center (UMC)
• WHO’s program for International Drug monitoring was
started in 1968
• Currently more than 100 countries participate in the
program
• The program is coordinated by WHO along with
collaborating centre in Uppsala, Sweden

• This center is responsible for
maintaining the global ADR
database, Vigibase
• As of February 2025, the
database contains over 40
million ADR reports
5
million
15
million
40
million
2009 2017 2025
International Status of Pharmacovigilance

Pharmacovigilance In India:
Present status:
• India contributed 2% of Vigibase (WHO-UMC global database of ICSR)
• Presently, there are 760 functioning Adverse Drug Monitoring
Centers (AMCs) in the country under PvPI
• AMCs are located in medical colleges and corporate hospitals

Short Term Goals
• To develop and implement pharmaco-vigilance system in
India
• To enroll, initially, all NMC 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

Long Term Goals
• To expand the pharmacovigilance program to all hospitals
(govt. & private) and centers of public health programs located
across India
• To develop and implement electronic reporting system
(e-reporting)
• To develop reporting culture amongst healthcare professionals
• To make ADR reporting mandatory for healthcare professional

PvPI Data Sources
• Patients
• National Health Programs
• Marketing Authorization Holders
• ADR Monitoring Centre

Expansion of PvPI
PVPI after its launch expanded further
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
Participation of Nursing Professionals
• NCI-PvPI organized a meeting with president Nursing Council of India (NCI), on July
16, 2014, New Delhi to initiate the participation of nursing professionals in PvPI.

Why to report?
• Ensure safety of patients on drugs
• Reduce economic burden of patients, society
& nation
• Identify risk factors
• Genetic & Ethnic variability
• Poor patient compliance

What to report?
• ADRs related with the use of allopathic medicines,
vaccines, traditional medicines, blood products, medical
devices, contrast media can be reported
• Report all the suspected ADRs irrespective to:
• Known or Unknown
• Serious or non serious
• Frequent or Rare

How to report
• Suspected ADR reporting forms for healthcare : professional and
consumers
• To remove language barrier in ADR reporting, the consumer
reporting form are made available in 10 vernacular languages
• ADRs via PvPI helpline number (1800-180-3024) on weekdays from
9:00 am to 5:30 pm.
• Mailing the filled ADR reporting form directly to pvpi@ipcindia.net or
pvpi.ipcindia@gmail.com
❓

• The mobile Android application for ADR reporting has also been made available
to the public.

Who can report

What happens to the information submitted
The information in the form shall be handled in strict confidence
Peripheral pharmacovigilance centre
Regional Centre
Zonal centre (data will be statically analysed)
Global Pharmacovigilance Database(WHO-UMC)

Minimum requirements for a functional
Pharmacovigilance system
• A national pharmacovigilance center with designated staff (at least one full time), well
defined structures and collaborating with the WHO Program for International Drug
Monitoring
• The existence of a national spontaneous reporting system with a national individual
case safety report (ICSR) form i.e. an adverse drug reaction (ADR) reporting form
• A national database or system for collecting and managing ADR reports (Vigibase
database and Vigiflow software for PvPI)

Communication
• Press and Media
• Website
• Newsletter
• Poster and Pamphlets
• Communication through social media

Scope of Pharmacovigilance
Govt. Sector:
• CDSCO
• AMC coordinator or safety reviewer
• Public sector hospitals for ADR monitoring committee member
CRO Industry:
• Drug safety associate
• Pharmacovigilance scientist
Academics:
• Head institutional Adverse drug monitoring center

Summary
• Pharmacovigilance is the science and activities related to detection, assessment, prevention
and understanding of adverse effects related to drugs
• Visions to improve patient safety and welfare in Indian population by monitoring drug safety
and thereby reducing the risk associated with use of medicine
• WHO- Uppsala monitoring center (UMC): program for International Drug monitoring was
started in 1968
• As of February 2025, the database contains over 40 million ADR reports
• Collaborating centre is in Uppsala, Sweden which is responsible for maintaining the global
ADR database, Vigibase

Suggested Readings
• WHO – Uppsala monitoring centre causality assessment
• Types of ADRs
• Difference between ADR and side effects

References
• B. Medhi, A. Prakash, Advanced Pharmacology, 2ND
edition. PharmaMed
Press, 2019
• Tripathi KD. Essentials of medical pharmacology. 8th
edition. New Delhi:
Jaypee Brothers Medical Publisher (P) ltd;2019
• Sharma HL, Sharma KK. Principles of Pharmacology. 3rd ed. Hyderabad,
India: Paras Medical Publisher; 2017
• https://www.ncbi.nlm.nih.gov/pmc

Specific learning objectives achieved
At the end of this PG -teaching session my co – learners are able to:
• Get sensitize with pharmacovigilance
• Objectives, roles and importance of pharmacovigilance
• Pharmacovigilance program in India
• Scope of pharmacovigilance after MD pharmacology

THANK YOU

pharmacovigilance program in india .pptx

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