Perspectives in Clinical Research

PHARMACOVIGILANCE
Year
: 2011  |  Volume : 2  |  Issue : 2  |  Page : 49--53

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


Ballari Brahmachari, Melanie Fernandes, Arun Bhatt 
 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

Keeping in mind India«SQ»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«SQ»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«SQ»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.


How to cite this article:
Brahmachari B, Fernandes M, Bhatt A. Pharmacovigilance for clinical trials in India: Current practice and areas for reform.Perspect Clin Res 2011;2:49-53


How to cite this URL:
Brahmachari B, Fernandes M, Bhatt A. Pharmacovigilance for clinical trials in India: Current practice and areas for reform. Perspect Clin Res [serial online] 2011 [cited 2019 Sep 18 ];2:49-53
Available from: http://www.picronline.org/article.asp?issn=2229-3485;year=2011;volume=2;issue=2;spage=49;epage=53;aulast=Brahmachari;type=0