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LATEST NEWS UPDATES | Pharma companies to compensate for clinical trial death, injury

Pharma companies to compensate for clinical trial death, injury

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published Published on Feb 7, 2013   modified Modified on Feb 7, 2013
-The Economic Times

Pharma companies sponsoring clinical trials in India would now need to compensate volunteers in cases of trial-related deaths or injuries. Firms and clinical research organisations failing to pay up, could face suspension of trials and even a permanent ban.

The decision to make compensation mandatory in such cases comes four weeks after the Supreme Court chided the government for its sloppy regulation of clinical trials.

A senior government official said that the amount of compensation will be decided on a case-to-case basis by an independent expert committee constituted by the Drug Controller General of India (DGCI).

Failure to pay up the compensation within the stipulated time may not only lead to suspension or cancellation of ongoing trials, but could also lead to a permanent ban on the pharma company and the clinical research organisation (CRO).

"The government has prescribed that the trial subject should be provided free medical management in case of an injury. But, what if that injury happens due to road accident and not the trial itself ?" said a Indian Society of Clinical Research spokesperson.

The new norms notified by the health ministry state that in the event of death or injury during the clinical trial, the doctor or the investigator must inform the pharma company, the CRO and the ethics committee within 24 hours.

The pharma company and the CRO would have to submit a detailed report on the adverse event to the ethics committee within 10 days. This report would also be sent to the independent expert committee in the DCGI in cases of death.

The ethics committee would communicate its opinion on compensation to the independent expert committee within 21 days of the adverse event. The expert panel, after examining the merits of the case, would recommend the possible quantum of financial compensation to the drug regulator within 30 days of receiving the ethics committee report.

The Economic Times, 7 February, 2013, http://economictimes.indiatimes.com/news/news-by-industry/healthcare/biotech/pharmaceuticals/pharma-companies-to-compensate-for-clinical-trial-death-injury/articl


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