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[e-drug] India?s new policy to protect research participants

E-DRUG: India�s new policy to protect research participants

Dear friends,�
Last week, an editorial co-authored by me with colleagues from Hopkins was 
published in the BMJ on some of the unintended consequences�and shortcomings of 
India's recent regulatory policy changes for clinical trials. We stress that 
regulatory overhaul is necessary and the steps taken are positive, but the 
haste and lack of clarity in the regulations might create problems for planning 
and conducting clinical trials, especially in the areas of public health 
research on areas such as TB, malaria, HIV.

This might be of interest to those of you interested in or working on issues 
around clinical trials. An excerpt from the article is below.�

The article can be accessed at


Article excerpt: 'A recent policy that was meant to mitigate important ethical 
concerns may have profound and unintended consequences for public health and 
may threaten the viability of�clinical research in India. Although efforts to 
provide robust protections to research participants and to enhance the quality 
and integrity of research should be applauded, some aspects of this policy are 

Promulgating overarching regulations that are not sensitive to science can 
ultimately undermine public health and harm those whom the regulations were 
intended to protect...it is essential that the unintended consequences of the 
new policy are dealt with effectively but rapidly to help ensure that India 
remains an active partner and leader in global health efforts.'

Anant Bhan
Public Health Physician
Anant Bhan <dranantbhan@yahoo.com>
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