NHRC Accepts Plea from Clinical Trial Subject Who Suffered Heart Attack

 Hyderabad: The case of Dipankar Dey, a clinical trial participant in Hyderabad who alleged negligence after he suffered a heart attack, has reached the National Human Rights Commission, with a case being filed seeking damages and action against the contract research organisation (CRO) conducting the trial, and the sponsor manufacturing the drug being tested on human subjects.

According to advocate Rama Rao Immaneni, who filed the petition with the NHRC on Dey’s behalf, the commission was asked to direct the CRO, Jeevan Scientific Technology Ltd., a Hyderabad-based company conducting the trial in which Dey was a participant, and Dr Reddy’s Labs, the sponsor of the trial for the anti-breast cancer drug Palbociclib, to pay Dey a compensation of `1 crore for loss of pay, injury, and agony.

The petition said Dey, a labourer, volunteered for the trial on a promise by an agent. Rama Rao said Dey was administered the breast cancer drug. After he suffered a heart attack, “the ethics committee, along with the CRO & sponsor started coercing the victim to sign on a declaration reporting complete cure, as the victim refused, ethics committee deliberately disengaged from reporting the adverse event” to Drugs Controller General of India, Rama Rao said.

The petition sought that the DCGI be directed to “immediately cancel licences granted to Dr Reddy Labs and Jeevan Scientific Technology Ltd, and that the Director General of Drugs Control Administration-Telangana may be directed to withdraw licences granted to both companies “for conducting clinical trials on humans by clinically testing harmful composition termed as Palbociclib any further.”

In addition, the petition sought a direction to the Director General of Police to take necessary action on the two companies for duping innocent victims of clinical trials by taking advantage of their illiteracy and financial conditions.