Pharmacovigilance

1. Adverse Drug
Reaction and
pharmacoviglence in
India

2. Introduction
Adverse Drug Reactions (ADRs) are a
major concern in India's healthcare
industry. This presentation will explore
the challenges faced by patients,
doctors, and pharmaceutical companies
in dealing with ADRs.

3. The Indian Healthcare
Landscape
India's healthcare industry is growing rapidly,
but it still faces many challenges. The lack of
regulation and oversight makes it difficult to
ensure patient safety. ADRs are a major concern
in this context.

4. Understanding Adverse Drug
Reactions
An ADR is any harmful or unintended
reaction to a medication. These can
range from mild side effects to life-
threatening complications. It is
important to understand the different
types of
ADRs and how they can be prevented.

5. The Impact of Adverse
Drug Reactions
ADRs can have a significant impact on
patients, healthcare providers, and
pharmaceutical companies. Patients
may experience physical and emotional
harm, while doctors may face legal
action. Pharmaceutical companies may
face financial losses and damage to
their reputation.

6. Challenges Faced by
Patients
Patients may not be aware of the
potential risks associated with their
medication. They may also be
hesitant to report side effects,
fearing that their treatment will be
discontinued. It is important to
educate patients about ADRs and
encourage them to speak up.

7. Challenges Faced by
Doctors
Doctors may not have access to accurate
information about medications and their
potential side effects. They may also be
under pressure to prescribe certain
medications, even if they are not the best
option for their patients. It is important
to provide doctors with the resources
they need to make informed decisions.

8. Challenges Faced by
Pharmaceutical Companies
Pharmaceutical companies may face
challenges in identifying and reporting
ADRs associated with their products.
They may also be hesitant to disclose
this information, fearing legal action and
damage to their reputation. It is
important to promote transparency and
accountability in the industry.

9. Medicines and vaccines have transformed the
prevention and treatment of diseases. In
addition to their benefits, medicinal products
may also have side effects, some of which may
be undesirable and / or unexpected.
Pharmacovigilance is the science and
activities relating to the detection,
assessment, understanding and prevention of
adverse effects or any other medicine/vaccine
related problem.
What is Pharmacoviglence ?

10. • Collecting and managing data on the safety of medicines
Looking at the data to detect "signals" (any new or
changing safety issue)
•Evaluating the data and making decisions with regard to
safety issues
•Pro-active risk management to minimise any potential
associated risks
•Acting to protect public health (including regulatory
action)
Communicating with and informing stakeholders and the
public
Role of Pharmacoviglence

11. Legal Remedies for ADRs
Patients who have suffered harm as a
result of an ADRs may have legal
remedies available to them. These may
include compensation for medical
expenses, lost wages, and pain and
suffering. It is important to understand
the legal options available.

12. Preventing Adverse Drug
ReactionsPreventing ADRs requires a collaborative
effort from patients, healthcare
providers, and pharmaceutical
companies. This may include education
and awareness campaigns, improved
regulation and oversight, and better
reporting and monitoring systems.

13. Navigating ADRs in India is a complex and
challenging task. However, by working together, we
can improve patient safety and ensure that everyone
involved in the healthcare industry is held
accountable for their actions.
Conclusion

14. Thankyou
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