Tuesday, October 22, 2013

Indian Clinical Trials: Still on Hold

During the United States government shutdown, there were many reports that clinical trial progress in the United States had ground to a halt.  Meanwhile, in India, their clinical trials have been halted for a month by their governments own orders.

Yesterday, news emerged that the government would now require the recording on five new drugs in the country after they've met the safety requirements set forth by the new Indian government.  The Times of India, The patients who participate in the clinical trials will remain confidential.

This is an interium order that was was passed after petition from Swasthya Adhikar Manch. They see this as a way to document the trials in real time and avoid the loopholes that multinational drug companies have found in the Indian clinical trial regulations.  According to

India has put new safety regulations into place, however, the 157 drugs currently that were in clinical trails that are in limbo.  According to The Hindu, they will undergo scrutiny in three following categories: assessment of risk against benefits, innovation value compared to the existing options and medical need in the country.  The matter will be reassessed again on on December 16.

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How is the current clinical trial halt in India affecting your clinical trial procedures? 

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