DC Impact: NHRC Directs Centre, ICMR To File Report on Improper Drug Trials in Hyderabad

Hyderabad: The National Human Rights Commission (NHRC) has directed the Union health ministry, and the Indian Council for Medical Research (ICMR) to investigate the case involving a drug trial in Hyderabad last year which resulted in one of the trial participants suffering a heart attack.

The NHRC, in its directions issued on Wednesday, said allegations in a complaint it received over the issues faced by the participant, “prima facie seem to be violations of the human rights of the victim.” In the directions, the NHRC made it clear that the complaint must be investigated and an action taken report submitted to it in four weeks.

The complaint with NHRC was filed by human rights lawyer Rama Rao Immaneni following reports in Deccan Chronicle on the trials and tribulations of Dipanker Dey, a migrant worker who signed up for the trial that was being conducted by a city-based clinical research organisation (CRO) for a breast cancer drug. During the course of the trial, Dey, reportedly suffered a cardiac arrest but was not attended to by the CRO which sent him off to Gandhi Hospital to get treatment.

Dey had also complained then when he was fighting with the CRO that he was under intense pressure from the CRO to delete his posts on social media platforms about the problems he was facing both health and financial wise, finally had said he was willing to take any compensation he can get and give a letter to the CRO giving it a clean chit, and after a nearly two month struggle, returned to his hometown Kolkata.

“He was under severe duress and with no one helping him and the CRO pressurising him for any compensation, he was likely tricked by agents to take whatever money the company gave him in return for his silence. Now that the NHRC has initiated action, he will hopefully receive justice finally,” Rama Rao Immaneni said.

In its notice to the Union health ministry, the NHRC said “the complainant alleged that a poor and illiterate labourer was made to participate in a clinical trial for a breast cancer drug by an agent who made false promises. During the trial, the victim suffered a heart attack but did not receive proper medical care until the police intervened.”

The NHRC continued, “Afterwards, the clinical research organisation and the sponsoring pharmaceutical company pressured the victim to sign a false declaration claiming he was cured. When he refused, the ethics committee and others involved failed to report the adverse event to the drug authorities. As a result, the victim suffered a second heart stroke, leading to permanent disability and loss of livelihood.”

“The complainant has requested that the licenses of the companies involved be cancelled and that they be ordered to pay compensation of Rs.1 crore to the victim. They also requested legal action against those responsible for exploiting poor and uneducated individuals in clinical trials,” the NHRC said.