Breast Cancer Drug Trial Under Scanner: Health Ministry, ICMR Inquiry Sought After Participant Suffers Cardiac Arrest

New Delhi: The National Human Rights Commission (NHRC) has instructed the Union Health Ministry and the Indian Council for Medical Research (ICMR) to conduct an inquiry into a drug trial conducted in Hyderabad last year, after a participant reportedly suffered a heart attack during the study.

According to a recent media report in The Deccan Chronicle, acting on a complaint, the NHRC issued directions on Wednesday, observing that the allegations “prima facie seem to be violations of the human rights of the victim."

The Commission emphasized that the matter must be thoroughly examined and that an action taken report be submitted within four weeks. The complaint highlighted serious concerns about the treatment and circumstances of the trial participant.

The complaint submitted to the NHRC was lodged by human rights lawyer Rama Rao Immaneni after Deccan Chronicle carried reports outlining the ordeal of Dipanker Dey, a migrant worker who had enrolled in a clinical trial conducted by a Hyderabad-based clinical research organisation (CRO) for a breast cancer drug. During the course of the study, Dey reportedly suffered a cardiac arrest but allegedly did not receive immediate medical attention from the CRO, which instead sent him to Gandhi Hospital for treatment.

Dey had earlier alleged that while seeking accountability from the CRO, he was subjected to intense pressure to remove his social media posts describing the medical and financial hardships he endured. After nearly two months of struggle, he eventually returned to his hometown, Kolkata, reportedly agreeing to accept whatever compensation was offered.

“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 stated.

In its notice to the Union health ministry, the NHRC stated, "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 Commission further noted, “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.”

According to the NHRC, the complainant has sought cancellation of the licenses of the companies involved and demanded compensation of Rs.1 crore for the victim. The plea also called for legal proceedings against those responsible for allegedly exploiting vulnerable and uneducated individuals in clinical trials. Deccan Chronicle reports that the case has now moved into the investigation stage following NHRC’s intervention.