[india-drug] Re: National Pharmacovigilance Centre

["Dr.Pipasha Biswas" <b_pipasha@yahoo.co.uk>]

National Pharmacovigilance Centre
-----------------------------------

Dear Prof Gupta, 

I am Dr Pipasha Biswas, a pharmacovigilance and pharmacoepidemiologist 
from the UK.  My background is Medicine, with post graduation in 
Pharmaceutical Medicine from UK and a DM in Pharmacopeidemiology & 
Pharmacovigilance from UK.  I have quite some interest in the
Pharmacovigilance activities in India and would be happy to get more
information on the National Pharmacovigilance centre at AIIMS.  It
would be great if you could provide me with the following information 

1. How many ADR reports does the center receive a month and annually? 
2.  How are the cases assessed for causality?  Which methodology is 
used? 
3.  If required, can you follow up cases with the doctors that have 
reported? If yes, how do you do it? 
4.  Is coding of the events reported done?  If so, which dictionary is 
used? WHOART, COSTART, MeDRA? 
5.  Do you have a database of events?  And if yes, do you do signal 
generation?  If you do signal generation, how do you do it, and which 
method do you use? PRR (Proportional Rate Ratios); IRR (Incidence Rate 
Ratios or some other? 
6.  How many ADRs were reported for nimesulide (since its launch in 
India) and how many of them were hepatic ADRs?  How many of these
hepatic ADRs were fatal or of serious nature? 

I have a whole lot of questions to ask on the Pharmacovigilance centre 
of India.  I would be happy to be in touch with you.  Look forward to 
getting the answers to all my questions soon. 

Best Regards. 
Pipasha 

 


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