Regulatory Focus™ > News Articles > CDSCO Releases Draft Formula for Clinical Trial Injury Compensation

CDSCO Releases Draft Formula for Clinical Trial Injury Compensation

Posted 02 May 2014 | By Louise Zornoza 

India's Central Drugs Standard Control Organization (CDSCO) has issued a call for comments on its new formula for determining compensation for patients injured in clinical trials.

According to the draft, Draft Formula to Determine the Quantum of Compensation in Case of Clinical Trial Related Injury (Other Than Death), in cases of Serious Adverse Events (SAE) other than death, the CDSCO will determine the cause of injury and decide the amount of compensation.

The regulator said it plans to take into consideration the reports of the clinical trial investigator, the trial sponsor and the Ethics Committee that approved the trial.

The deadline for submitting comments is 16 May 2014, after which the drafting committee convened by Shri R. K. Jain will prepare a final version drawing on the comments submitted.


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