[india-drug] Response to National Pharmacovigilance Centre

["Mr. Deepak Gupta" <jsd@nb.nic.in>]

Response to National Pharmacovigilance Centre
-----------------------------------------------


This e-mail is being forwarded to Shri Ashwani Kumar, Drug Controller
General of India for necessary action.  His -email is dci@nb.nic.in


Deepak Gupta


----- Original Message -----
From: "Dr.Pipasha Biswas" <b_pipasha@yahoo.co.uk>
Subject: [india-drug] Re: National Pharmacovigilance Centre



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 
Center 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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