ISSN (Print) - 0012-9976 | ISSN (Online) - 2349-8846

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Clinical Trial Compensation: A Clarification

This is with reference to the article “Clinical Trial-Related Injury: Note on Formula to Determine Compensation” (EPW, 4 April 2015). We would like to clarify that we had submitted the article to EPW in May 2014. By April 2015, much has happened, and the compensation formula is no more in the draft form, and has been approved in an amended form.

On 12 December 2014, the Ministry of Health and Family Welfare issued a notification amending the Drugs and Cosmetics Act that amended Rule 122DAB and Schedule Y. The amended Rule 122DAB included sub-rule 2A that stated, “in case, there is no permanent injury, the quantum of compensation shall commensurate with the nature of the non-permanent injury and loss of wages of the subject.” Thereafter, on 15 December 2014, the Central Drugs Standard Control Organization (CDSCO) issued an order approving a formula for quantum of compensation in case of clinical trial injury (other than death).

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