Asian Journal of Research in Pharmaceutical Sciences

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Importance of Pharmacovigilance in Indian Pharmaceutical Industry


Affiliations
1 Columbia Institute of Pharmacy, Raipur (C.G.), India
2 University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur (C.G.), India
     

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Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. It is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to:

Identifying new information about hazards associated with medicines Preventing harm to patients.

Phase IV of the evaluation of a drug starts when the marketing license is granted and extends over many years. It consists of pharmacoepidemiological studies to evaluate the effectiveness, safety, and utilization of the drug in large populations, under real-life conditions. The results confirm or disprove the effectiveness of the drug in clinical practice (confirmation of the therapeutic effect), determine whether approved uses should be expanded or restricted, any untoward interactions (pharmacovigilance) and pharmacoeconomics of the drugs.


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  • Importance of Pharmacovigilance in Indian Pharmaceutical Industry

Abstract Views: 264  |  PDF Views: 0

Authors

S. S. Shuka
Columbia Institute of Pharmacy, Raipur (C.G.), India
Bina Gidwani
Columbia Institute of Pharmacy, Raipur (C.G.), India
R. Pandey
Columbia Institute of Pharmacy, Raipur (C.G.), India
S. P. Rao
Columbia Institute of Pharmacy, Raipur (C.G.), India
V. Singh
Columbia Institute of Pharmacy, Raipur (C.G.), India
Amber Vyas
University Institute of Pharmacy, Pt. Ravishankar Shukla University, Raipur (C.G.), India

Abstract


Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long term and short term side effects of medicines. It is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to:

Identifying new information about hazards associated with medicines Preventing harm to patients.

Phase IV of the evaluation of a drug starts when the marketing license is granted and extends over many years. It consists of pharmacoepidemiological studies to evaluate the effectiveness, safety, and utilization of the drug in large populations, under real-life conditions. The results confirm or disprove the effectiveness of the drug in clinical practice (confirmation of the therapeutic effect), determine whether approved uses should be expanded or restricted, any untoward interactions (pharmacovigilance) and pharmacoeconomics of the drugs.