Friday, June 10, 2011

Snippets: Draft Guidelines on Reporting Serious Adverse Events in Clinical Trials

A few days ago I was in a meeting as part of the Ethics Committee of the National Heart Institute, New Delhi and it struck me that drug laws and related issues, such as clinical trials, haven’t received rigorous critical attention, barring instances where the debate on pharmaceutical patents has stirred public interest occasionally.

Even in these debates, drug laws themselves have rarely been discussed and critiqued. This led me to decide that this is an issue which is best addressed holistically along with the Great Indian Pharma IP debate, instead of compartmentalizing different aspects of the pharma business.

To start with, early this May, draft guidelines on reportage of “Serious Adverse Events” in clinical trials were proposed by the Drugs Controller General of India (DCGI) and comments were invited on the draft guidelines. Only a fortnight was allotted for submission of comments, which I think is too narrow a time-window.

Ideally, submission of comments ought to have been allowed for 2 months, which would have given stakeholders sufficient time to get their organizations moving and to come up with meaningful suggestions. Nevertheless, one hopes the DCGI is not too rigid about the deadline.

We welcome our readers to share with us their suggestions on the draft guidelines.

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