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Regulatory Focus™ > News Articles > India Releases Clinical Trial Adverse Event Compensation Formula

India Releases Clinical Trial Adverse Event Compensation Formula

Posted 11 September 2013 | By Louise Zornoza

India's Central Drugs Standard Control Organization (CDSCO) has issued a "provisionally final" formula to be used in determining the amount of compensation that a clinical trial sponsor must pay a clinical trial subject for an adverse event or death related to the trial. 

According to the formula, the compensation amount for an adverse event or death would vary from a minimum of Rs.4 lacs (approximately $6,300 to a maximum of Rs.73.60 lacs (approximately $1,150,000) depending on the age of the trial subject and the risk factor-the seriousness and severity of the disease, presence of co-morbidity and duration of disease of the subject at the time of enrollment in the trial.

The formula was developed by three Independent Expert Committees convened by the CDSCO according to the provisions of the 1 January 2013, amendment to the Drugs and Cosmetics Rules to determine the amount of compensation, if any, to be paid by the sponsor or his representative.

When an adverse event occurs during a clinical trial, an Independent Expert Committee will evaluate it and make a recommendation to CDSCO within 30 days as to appropriate compensation. CDSCO will issue an order with a final decision within three months of receiving the Committee's recommendation, and the sponsor will then have 30 days to pay.

Editor's note: The exact compensation amounts have been corrected and now include the price in rupees.

CDSCO Formula

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