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Pharmacovigilance Requirements for Biologic Products in India


Reddy, P.M., Venkatesh, M.P., Balamuralidhara, V., Abhishek, B.V.

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The term Pharmacovigilance mean all scientific and data gathering activities related to the detection, assessment, and understanding of adverse events. It principally involves the identification and evaluation of safety signals. It also requires detection of any change in benefit-risk balance during its entire life cycle. With the increasing complexity of medications available today, a comprehensive ADR monitoring system is necessary to detect, evaluate, and develop mechanisms to prevent ADRs. Risk assessment during product development should be conducted thoroughly and rigorously; however, it is impossible to identify all safety concerns during clinical trials. Therefore, postmarketing surveillance which may be passive or stimulating has a significant role in assessing the actual safety aspects of the vaccine product.


ADR, Safety signal, Post-marketing surveillance

Cite This Article

Reddy, P.M., Venkatesh, M.P., Balamuralidhara, V., Abhishek, B.V. (2017). Pharmacovigilance Requirements for Biologic Products in India. International Journal for Pharmaceutical Research Scholars (IJPRS), 6(3), 44-49.

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