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India limits trials per investigator but finite expert pool a concern

 
• By Anju Ghangurde

India has issued a string of new orders regarding clinical trials, including restricting the number of studies that an investigator can be involved in and an apparent tightening of the clause that permits a waiver of trials in the Indian population for new drugs already approved elsewhere.

India has issued a string of new orders regarding clinical trials, including restricting the number of studies that an investigator can be involved in and an apparent tightening of the clause that permits a waiver of trials in the Indian population for new drugs already approved elsewhere.

The new orders, though, have left an already struggling industry tense, with officials indicating that the order pertaining to investigators exceeds the suggestions of the expert committee set up to formulate policy/guidelines for approval of new drugs and trials, while other

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