Gujarat Stem Cell Scandal: 741 Deaths Linked to Unapproved Trials
Summary: A political storm has broken in Gujarat after revelations that over 2,300 kidney disease patients may have been given unauthorised stem cell therapy at Ahmedabad’s government hospital, and which may have resulted in 741 deaths. A Comptroller and Auditor General (CAG) report as quoted by Gujarat Congress, has serious doubts regarding unapproved clinical trials, unsuccessful interventions, and negligence, and there are calls for accountability as well as action from the authorities.dards.
Did unauthorised clinical trials cost hundreds of lives in Gujarat?
A shocking healthcare controversy has erupted in Ahmedabad after reports emerged that hundreds of kidney patients may have died due to unapproved stem cell therapy trials conducted at a government-run hospital.
Experimental Therapy Without Approval
During the period between 1999 and 2017, about 2,352 patients of the Institute of Kidney Diseases and Research Centre (IKDRC) in Ahmedabad were apparently given the stem cell treatment without appropriate clearances from national regulatory authorities. Gujarat Congress spokesman Parthivrajsinh Kathavadia made this shocking disclosure at a recent press conference.
Kathavadia used a Comptroller and Auditor General (CAG) report to base his allegations. Such facts, in his opinion, are:
- 741 patients died after treatment
- The therapy had a 91% failure rate
- 569 patients experienced kidney transplant failure
- 110 patients couldn’t undergo transplants due to complications
- 2,132 out of 2,352 patients had failed outcomes
Such figures are very serious in terms of ethical oversight, consent, and institutional responsibility.
Allegations of Negligence and Cover-Up
Kathavadia criticized IKDRC for performing these unauthorized experiments, in the absence of approval from the Institutional Committee for Stem Cell Research and Therapy. He also regretted that the National Apex Committee never sanctioned the therapy, and therefore it was suspended in the year 2017.
The Congress party has demanded strict action against those responsible, questioning:
“Who will be held accountable for the loss of those lives?”
National Response and Wider Fallout
The matter has triggered a response from the National Organ and Tissue Transplant Organisation, which has now requested the Gujarat Health Department to submit a detailed report on the issue.
What Went Wrong with Stem Cell Therapy?
Stem cell therapy holds promise for regenerative medicine, but in India, it remains highly regulated. Any clinical trial must undergo rigorous scrutiny by:
- The Institutional Ethics Committee
- The National Apex Committee for Stem Cell Research and Therapy
- The DCGI, under India’s clinical trial framework
Without these approvals, any intervention is considered unethical and potentially illegal. Experts believe that unauthorised therapies could lead to severe complications, especially in vulnerable patients like those undergoing kidney transplants, including
- Organ rejection
- Infections
- Death
The CAG Report: A Wake-Up Call
The CAG report highlighted multiple red flags:
- No ethical clearance for experimental treatments
- Failure to obtain patient consent
- Inconsistent data tracking and poor outcome monitoring
- Continued use of therapy even after failure trends emerged
This raises serious concerns not only about patient safety but also about institutional accountability in India’s public health system.
Conclusion: Time for Accountability and Reform
This scandal sheds light on the urgent need for stricter regulation and ethical oversight in India’s clinical trial landscape. The alleged use of unauthorised stem cell therapy at IKDRC reflect a deep-rooted lapse in medical ethics and governance.
With more than 741 lives at risk of being lost, calls for justice, accountability, and regulatory change have never been greater. As the investigation continues, the focus is still on Gujarat’s health machinery, and India and the world are watching.
Inputs from various media sources.
Dane
I am an MBBS graduate and a dedicated medical writer with a strong passion for deep research and psychology. I enjoy breaking down complex medical topics into engaging, easy-to-understand content, aiming to educate and inspire readers by exploring the fascinating connection between health, science, and the human mind.
