;   Medical Translation Insight: India to toughen up clinical trial regulations - ForeignExchange Translations

India to toughen up clinical trial regulationsIndian regulations continue to evolve. Just a few months ago, we wrote about the evolution of Indian medical device regulations.

Now, the Times of India reports that tough new rules are in the pipeline to monitor human clinical trials. According to the article:

In an interaction with the media at the National Institute of Nutrition (NIN) here on Monday, Katoch said there will have to be surveillance on the human subjects to see if they are developing any side effects of the drugs being clinically tested on them. While the local ethics committees are supposed to be monitoring this, not all instances of harmful side-effects get noticed.
A law to regulate "bio-medical research on human participation" is expected to be introduced in the Indian Parliament later this year. Stay tuned for more!

[Thanks to GCPWorks' Twitter feed for the tip]

For more about India, take a look at the following:
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