Panacea Biotec Ltd.

Pharmacovigilance Program
Annexure-I
Pharmacovigilance

Definition of pharmacovigilance (WHO, 2002):

Pharmacovigilance is the science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other possible drug - related problems.
Why Pharmacovigilance?
Pharmacovigilance is necessary because of the following reasons:

There is limited value of animal experiments in predicting human safety.

Clinical trials are limited in time and number of patients. They are largely artificial
because patients are selected based on stringent criteria e.g patients are adult, taking no
other medicines and with essentially no other diseases. Therefore, the subset of
population selected for clinical trials may not always represent the real life use of drugs.

Rare and delayed serious reactions are likely to remain unnoticed during clinical trials.

Pharmacovigilance helps in:

Improvement of patient care and safety in relation to the use of medicines and all medical
and paramedical interventions

Improvement of public health and safety in relation to the use of medicines

The assessment of benefit, harm, effectiveness and risk of medicines, encouraging their
safe, rational and more effective (cost effective) use

Increased awareness of product in general practice is achieved. Medical fraternity feels

more confident to prescribe a product if they know that the safety profile is being
monitored.

Please note that:

Any pharmacovigilance ADR reporting form should have atleast the following information to be
valid:

Identifiable Patient
Identifiable Reporter
Suspected Drug Name
Adverse Drug Reaction Term/ Description
You do not need to be certain, just suspicious to report.

For Additional Information:

http://www.cdsco.nic.in/
http://www.epha.org/a/605

Panacea Biotec Ltd.

Pharmacovigilance Program

http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev9.htm