IPSIndian Journal of Pharmacology
Home  IPS  Feedback Subscribe Top cited articles Login 
Users Online : 166 
Small font sizeDefault font sizeIncrease font size
Navigate Here
 »   Next article
 »   Previous article
 »   Table of Contents

Resource Links
 »   Similar in PUBMED
 »  Search Pubmed for
 »  Search in Google Scholar for
 »Related articles
 »   Citation Manager
 »   Access Statistics
 »   Reader Comments
 »   Email Alert *
 »   Add to My List *
 * Requires registration (Free)
 

 Article Access Statistics
    Viewed12249    
    Printed299    
    Emailed32    
    PDF Downloaded2152    
    Comments [Add]    
    Cited by others 12    

Recommend this journal

 

 INVITED ARTICLE
Year : 2007  |  Volume : 39  |  Issue : 3  |  Page : 124-128

Setting standards for proactive pharmacovigilance in India: The way forward


Symogen Ltd, Bucks, United Kingdom

Correspondence Address:
Pipasha Biswas
Principal Consultant & Director, Pharmacovigilance & Pharmacoepidemiology, Symogen Ltd
United Kingdom
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0253-7613.33431

Rights and Permissions

An increase in drug safety concerns in recent years with some high profile drug withdrawals have led to raising the bar by various stakeholders more importantly by the regulatory authorities. The number of Adverse Drug Reactions (ADRs) reported have also resulted in an increase in the volume of data handled and to understand pharmacovigilance a high level of expertise is required to rapidly detect drug risks as well as to defend the product against an inappropriate removal. Proactive pharmacovigilance throughout the product life cycle is the way forward and the future direction for drug safety. It is a challenge to codify and standardize the act of signal detection and risk management in the context of clinical trials and post-marketing pharmacovigilance. While major advancements of the discipline of oharmacovigilance have taken place in the West, not much has been achieved in India. However, with more clinical trials and clinical research activity being conducted in India, there is an immense need to understand and implement pharmacovigilance. For this to happen in India, the mind set of people working in regulatory agency (DCGI Office) and the Indian Pharmaceutical companies need to change. This article describes and discusses the various strategies and proposals to build, maintain and implement a robust pharmacovigilance system for various stakeholders and eventually make it happen in India!






[FULL TEXT] [PDF]*


        
Print this article     Email this article

Site Map | Home | Contact Us | Feedback | Copyright and Disclaimer
Online since 20th July '04
Published by Wolters Kluwer - Medknow