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India Tweaks More Trial Rules But Can It Change The Narrative?

 
• By Anju Ghangurde

India has tweaked another set of trial rules including one that capped the number of trials per investigator as it seeks to clear the logjam of regulatory requirements that has been stifling the clinical research segment in the country. Much though could depend on actual implementation and it remains to be seen if such measures can alter the course of sector.

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An Aug. 2 circular from India's Central Drugs Standard Control Organization (CDSCO) has said that restrictions which specify that no investigator can conduct more than three trials at any given period of time are being "removed".

"It has been decided that the ethics committee (EC) after examining the risk and complexity involved in the trial being conducted/proposed shall decide about how many trials an investigator can...

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