Home  |  About us  |  Editorial board  |  Current issue  |  Archives  |  Submit article  |  Instructions  |  Subscribe  |  Advertise  |  Contacts  |  Login 
  Users Online: 1099Home Print this page Email this page Small font sizeDefault font sizeIncrease font size  
PHARMACOVIGILANCE
Year : 2011  |  Volume : 2  |  Issue : 2  |  Page : 49-53

Pharmacovigilance for clinical trials in India: Current practice and areas for reform


Medical and Regulatory Affairs, Clininvent Research Pvt. Ltd., Mumbai, Maharashtra, India

Correspondence Address:
Ballari Brahmachari
Clininvent Research Pvt. Ltd., A-103, Everest Chambers, Marol Naka, Andheri - Kurla Road, Andheri (E), Mumbai 400 059
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.80366

Rights and Permissions

Keeping in mind India's increasing participation in multinational trials, this article explores potential areas of Indian pharmacovigilance, requiring reform and provides recommendations for building a robust safety reporting system. Internal discrepancies exist between Schedule Y and Central Drugs Standard Control Organisation approval letter regarding what to report. Schedule Y's silence on expedited reporting requirements creates confusion for Indian sites that are part of multinational trial. Not allowing waiver for serious adverse events that are protocol specified or are study endpoints, along with lack of emphasis on causality as reporting criteria, adds substantial burden of uninformative cases for regulatory review. Despite global focus on Development Safety Update Report, Indian regulators are not yet insistent on real-time update of a drug's cumulative safety profile. Issues like reporting requirements for generic trials, pregnancy reporting and lenient timeline for death/life-threatening events need attention. Finally, the need to formulate an all-encompassing pharmacovigilance guideline for India, in sync with global practice cannot be overemphasized.


[FULL TEXT] [PDF]*
Print this article     Email this article
 Next article
 Previous article
 Table of Contents

 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
    Viewed5245    
    Printed176    
    Emailed2    
    PDF Downloaded1317    
    Comments [Add]    
    Cited by others 1    

Recommend this journal