Civil society organisations across the country have raised concerns and demanded an immediate stop of the clinical trial of Bharat Biotech’s COVAXIN at People’s College of Medical Sciences and Research, Bhopal citing gross violation of clinical trial rules and ethics.
The backlash comes in the aftermath of the death of a male trial participant that came to light recently through the media. Several people who were inducted into the clinical trial have also shared their experiences which indicate that there have been gross violations of laws and guidelines governing clinical trials in India, namely the New Drugs and Clinical Trials Rules, 2019 and the National Ethical Guidelines for Biomedical and Health Research involving Human Participant, 2017 and the National Guidelines for Ethics Committees Reviewing Biomedical and Health Research During COVID-19 Pandemic, April 2020 published by the ICMR.
So, on January 10, Bhopal-based civil society group had written a letter to Prime Minister Modi along with Health Minister and other concerned authorities demanding the immediate stop of COVAXIN clinical trial site in Bhopal. It has also requested to form an independent body to conduct an impartial, transparent, thorough, and time-bound investigation to ascertain violations of ethics, protocols and legal requirements about the conduct of the clinical trial. And also suggested that the findings of this enquiry must be put in the public domain. Besides this, it also insisted that the independent body must consist of experts, especially civil society representatives who do not have any conflict of interest or connection with the sponsors (BBIL and ICMR), the site (People’s College of Medical Sciences & Research, Bhopal) or the researchers.
Now, 42 civil society organisations from across the country have come together and jointly signed a letter stating, “We are supportive of the demands put up by the Bhopal-based organisations on behalf of the trial participants. We demand an immediate, thorough investigation of the issue at hand from the concerned regulatory and ethics compliance offices to look into gross violations. Suitable action needs to be taken against all individuals and structures that are found to be responsible for ethical violations, negligence and endangering the safety of trial participants including investigators, ethics committee, administrators of People’s Hospital and the trial sponsors. The immediate action warranted is that the trial at People’s Hospital, Bhopal must be immediately brought to a complete halt. The trial sponsors, Bharat Biotech and ICMR, must take full responsibility for the serious, unconscionable and unlawful lapses in the Bhopal trial.”
They highlight that a clinical trial co-sponsored by ICMR is violating both statutory provisions and ethical guidelines laid down by ICMR for the conduct of clinical trials, and this is alarming.
Dr Sulakshana Nandi, National Joint Convenor, Jan Swasthya Abhiyan, said, “The Bhopal site of COVAXIN clinical trial needs to be blacklisted immediately although we are not against any clinical trial. The only thing we require to have transparency and ethical guidelines need to be followed. Participants rights need to be upheld and clinical trial protocol should be followed.”