Blog 20 | HEaL Institute & IJME – Covid-19 Insights | Jan.12, 2021

Irregularities and ethical violations in the conduct of the clinical trial for Bharat Biotech’s COVAXIN | Bhopal Gas Peedit Mahila Stationery Karmchari Sangh, Bhopal Gas Peedit Mahila Purush Sangharsh Morcha, Bhopal Group for Information and Action, Children Against Dow Carbide



Shri Narendra Modi
Hon’ble Prime Minister of India
South Block, Raisina Hill
New Delhi 110011

Dr. Harsh Vardhan
Hon’ble Union Minister
Ministry of Health and Family Welfare (MOHFW)

10 January 2021

Dear Sirs,

Irregularities and ethical violations in the conduct of the clinical trial for Bharat Biotech’s COVAXIN by People’s Hospital, Bhopal and resultant exploitation of trial participants belonging to vulnerable groups: Survivors demand stoppage, punishment and compensation

On behalf of the survivors of the Union Carbide disaster in Bhopal and those poisoned by contaminated ground water, we wish to draw your attention to serious violations taking place in the Phase 3 clinical trial that is underway in People’s College of Medical Sciences & Research Centre,  Bhopal  to  assess  the  safety,  immunogenicity  and  efficacy  of  the  vaccine  candidate COVAXIN.

As you know, COVAXIN is a COVID-19 vaccine candidate co-developed by ICMR-NIV, Pune and Bharat Biotech International Limited (BBIL) that was given restricted emergency use approval by the DCGI on 3 January 2021. The Phase 3, randomised, double-blind  multi-centre study of the vaccine candidate is being sponsored by BBIL and the Indian Council of Medical Research (ICMR). Many people from communities affected by the Union Carbide gas disaster in Bhopal and by contaminated water were recruited into the trial in violation of ethical procedures established under the law. Some of these individuals have faced adverse events since dosing in the trial, and even a death has taken place.

We are writing to you to apprise you of the on-ground situation with regard to the conduct of the trial. Evidence has emerged that the trial in Bhopal is being conducted in gross violation of laws and guidelines governing clinical trials in India. This is leading to exploitation and harm to a community of people that are not just economically and socially deprived, but whose health is compromised owing to the destructive impact of the Bhopal gas tragedy and its consequences. The same are elaborated below:

1. Vulnerable people being misguided and herded

In early December, People’s Hospital, a private medical college & hospital, sent vehicles into communities  situated  behind  the  abandoned  Union  Carbide  factory  -Gareeb  Nagar,  Shankar Nagar,  Oriya  Basta,  Kainchi  Chhola,  JP  Nagar  and  others  –  and  announced  that  COVID-19 vaccine injections were available and everyone would be paid Rs 750 as well for getting each vaccination shot. The amount of Rs 750 meant to be reimbursement of travel expenses and loss of daily wages to trial participants is in fact a substantial sum for such poor communities and appears  to have been used as an inducement  to make  people  come  forward.  These  vehicles were accompanied by staff of the Hospital who recruited several hundred residents of these communities. In other cases, daily wage labourers were recruited from their peetha (gathering for daily wage labourers) for the trial.

Majority of the people who were recruited for this trial were those who have been exposed to poisons of Union Carbide and are poor and illiterate. Many of the residents claim that they were not told that they were being recruited for a trial but were under the belief that they were in fact getting the vaccination to protect them from COVID-19.

The National Ethical Guidelines for Biomedical and Health Research involving Human Participant of 20171 and the National Guidelines for Ethics Committees Reviewing Biomedical and Health Research  During  COVID-19  Pandemic2   of April  2020  published  by  ICMR  deems  communities that  are  socially,  economically  or  politically  disadvantaged;  and  those  who  are  able  to  give consent but whose voluntariness or understanding is compromised due to their situational conditions, as vulnerable groups and mandates that additional safeguards in the conduct of research. The participants, owing to their economic, education and compromised health status owing  to  the  gas  disaster   and  water  contamination   clearly  fall  within  the  definition   of vulnerable groups as per the above.

The onus to ensure that the dignity, rights, safety and well-being of individuals belonging to vulnerable communities are protected rests on all stakeholders especially the sponsors, investigators and Ethics Committee. The Guidelines issued by ICMR specify that rewards/credits/incentives  must be avoided as participants may feel intimidated or unduly pressured  to  participate  in  the  trial  in return  for  the  reward.  The  guidelines  also  mandate setting  up  of  support  systems  to  deal  with  associated  medical  and  social problems,  and provision of ancillary care including medical care.

In the present clinical trial, all of the abovementioned requirements have been violated. Researchers did not take cognisance of the educational status and economic vulnerability of the participants, and take into account the fact that they are victims of the gas disaster.

Adequate of the clinical trial, and their rights related to the same. By converting the provision of reimbursement of expenses for participation into monetary inducement, the researchers made it difficult for members of this impoverished and poor community to refuse participation in the trial or assert their right to information, documentation and treatment for adverse events.

2. Violation of  Informed  Consent  Procedures  under  the  law  and  the  New  Drugs  and Clinical Trials Rules, 2019

The  informed  consent  form  is  a  fundamental  part  of  the  trial  as  it  explains  the  risks  and benefits of the study, rights of trial participants and purpose of the study. The consent form for this trial clearly states that participants would be given a copy of the signed and dated consent form. In the majority of cases that we have interacted with, the participants from these communities had not received any hard copy of their signed consent forms even after receiving the first dose. Participants remembered signing in many places during the visit but they were not given copies of their consent forms. In several instances participants who wanted to read the participant information sheet and consent form were not given the time to read. This is a clear violation of ethical and regulatory requirements with regard to informed consent.

After  the  irregularities  with  regards  to  the  informed  consent  forms  were  reported  by  the media,  in  some  cases participants were  given  their  informed  consent  forms  at  the  visit  to receive the second dose. However, these were not signed by the appropriate authorities.

The participant information sheet and consent form also provides the opportunity to trial participants to take a copy of the unsigned consent form to consult with family or friends, and decide whether to participate in the trial or not. Given that the trial participants belong to a vulnerable  group,  and  given  the  additional  safeguards  provided  in statutory  provisions  and ICMR  ethical  guidelines,  this  was  a crucial  safeguard  to mitigate  and  minimise  any possible duress or coercion any participant may feel to agree to be part of the trial. A consequence of the investigators  not  following  informed  consent  procedures,  participants  were  deprived  of the option to refuse to take the first dose in the initial visit,  which represents yet another violation of statutory and institutional safeguards.

We  note  that  the  Hindi  participant  information  sheet  and  consent  form  contains  technical language that is beyond the comprehension of any layperson, let alone persons with minimal education. This made it all the more critical for ethical safeguards to have not been bypassed during the consent process.

  • New Drugs  and  Clinical  Trials  Rules,  2019  and  Ethical  Guidelines  for  Biomedical and Health Research

The Third Schedule of the New Drugs and Clinical Trials Rules, 2019 prescribes the principles and guidelines to be followed in the conduct of a clinical trial for protection of trial subjects. As per 2(d) of the Third Schedule, trial participants who are unable to read or write, an impartial witness  has  to  be  present  during  the  informed  consent  process  who  must  append  their signature to the consent form. As per 2(g), an audio-video recording of the informed consent process  is  required  in  the  case  of  vulnerable   subjects.  This  recording   is  to  include  the procedure  of  providing  information  to  the  participant  and  his/her  understanding  of  such consent.  The  Third  Schedule  prescribes  that  the  responsibility  to  ensure  that  the  trial  is conducted as per protocol, and as per statutory provisions lies on the sponsor, investigator and ethics committee of the clinical trial.

Further, ICMR’s National Ethical Guidelines for Biomedical and Health Research involving Human Participant,  2017  mandate additional  measures  for  informed  consent  such  as  recording  of assent and re-consent when applicable including repeated education/ information about the research,   benefits,   risks   and   alternatives.   The  National   Guidelines   for  Ethics   Committees Reviewing Biomedical and Health Research During COVID-19 Pandemic similarly prescribes additional  safeguards  to ensure,  inter alia, that  there  is no coercion,  force,  undue  influence, threat or misrepresentation or incentives; that informed consent process is conducted in a respectful manner; and that privacy, confidentiality and rights are protected at all times. As per evidence, these too were violated by the actions of those conducting the trial.

  • Audiovisual recordings of informed consent

Most  of  the  participants  were  illiterate  and  could  not  read  or  write.  However,  in  complete violation of statutory provisions, audio visual recordings of the informed consent process were not made.  The Participant  Information  Sheet  and Informed  Consent  Form  being  used in the clinical  trial  contains  a  consent  form  for  audio-visual   recording.  However,  despite  being included   in   the   participant   information   document   and   consent   form   and   being   legally mandated, the same was not employed in the informed consent process.

3. Denial of medical management to participants experiencing adverse reactions and adverse events

Trial participants who experienced complications after receiving their first shot were refused treatment  by the trial site. Only after the media reported on the adverse events were efforts made by the trial site to investigate the adverse events and their connection to the trial.

to provide medical treatment and compensation to trial participants who experience adverse events or injuries as a result of the clinical trial. Not taking immediate cognizance of adverse events and illness reported by participants and denying them medical treatment for the same is a violation of the New Drugs and Clinical Trials Rules, 2019.

  • Insurance policy

The consent form mentions that as a liability/responsibility  of the sponsor, participants will be covered  by  an  insurance  policy.  However,  no  details  have  been  provided  to  any  of  the participants about the nature of the insurance. The sponsors have also maintained that all applicable  laws  regarding  insurance  of  trial  subjects  will  be  followed  in  the  trial.  Yet  the liability and insurance provisions of the study as specified in the arrangement between the sponsors   and   investigators   are  so  far  unknown   to  the  intended   beneficiaries,   i.e.,  trial participants.

  • Nonreporting of adverse events in trial

If the trial participants are not even being provided free medical management at the trial site, then it is highly unlikely that any of their problems are being recorded as adverse events. Non- reporting of adverse events experienced by the trial participants will directly impact the safety analysis of the vaccine candidate and produce erroneous results from this trial site.

4. No monitoring and follow up of participants

As  per  the  New  Drugs  and  Clinical  Trials  Rules,  2019,  it  is  incumbent  upon  the  Ethics Committee  for the clinical trial to oversee the conduct of the clinical trial, to ensure that the rights, safety and well-being of trial participants is safeguarded, and that good clinical practices are  being  followed  by  the  investigators.  As  per  the  Third  Schedule  of  the  New  Drugs  and Clinical   Trials  Rules,  2019  the  sponsors   are  duty  bound   to  make  payment   for  medical management  of  the  participant  and  provide  financial  compensation  for  clinical  trial  related injury  or  death.  The  investigator  is  duty  bound  to  ensure  that  adequate  medical  care  is provided to participants for any adverse events.

Thus, it is the duty of the sponsors, investigators and ethics committee to ensure that the health and well-being of trial participants is being regularly and effectively monitored, particularly so when the trial participants belong to a vulnerable group.

Evidence suggests that there were glaring irregularities on the part of the investigators and the Ethics Committee to ensure that the trial participants were being monitored for signs and symptoms of adverse events. It seems the onus of such monitoring  was shifted onto the trial

participants by providing them with blank sheets to record health problems experienced after the shot. The investigators did not take into account that most of the participants are illiterate and are not able to fill any of these forms, and would thus require more hands on monitoring and support.

The  participants  are  also  economically   disadvantaged   and  therefore  are  not  always  in  a position to keep their phones recharged to receive phone calls. The limited telephonic follow up efforts of the study investigators were not contextually sensitive to the circumstances of the trial  participants,  and  were  inadequate  as  trial  participants  were  not  always  reachable  by phone such as when their balance ran out. This constitutes a violation of the Third Schedule of the New Drugs and Clinical Trials Rules, 2019, the National  Ethical Guidelines  for Biomedical and Health Research involving Human Participant of 2017 and the National Guidelines for Ethics Committees   Reviewing  Biomedical  and  Health  Research  During  COVID-19  Pandemic,  which require additional measures to protect the health, safety and well being of vulnerable communities

According  to  the  trial  protocol,  the  study  excludes  participants  from  immunogenicity  and efficacy analysis if there is evidence at baseline that they have had or currently have COVID-19. In the trial, the first dose is given on the first visit rather than keeping a gap for screening of participants. Therefore, if any person gets a positive result for the COVID tests done on the first day  (i.e.,  at  baseline),  they  are  subsequently   excluded  from  immunogenicity   and  efficacy analysis but are nonetheless supposed to be followed up for safety outcomes. One person who was found to be COVID-19 positive after the first visit and developed symptoms that required medical attention was not provided free care, was asked to purchase expensive medicines  at his own cost and his condition was not followed up.

Any  participant  who  is discontinued  early  from  the  study  also  needs  to  be  followed  up  for safety and occurrence of adverse events. Yet, some participants that were made to discontinue the trial because of health problems are not being followed up for safety, which is against the study protocol.

  • Unexpected success of People’s Hospital in recruiting trial participants

We  note  People’s   Medical   College’s   unexpected   successful   in  enrolling   more  than  1700 participants in the Phase III trial, after meeting the initial target of 1000 participants3, at a time when  it was reported  that other  sites including  AIIMS  New  Delhi, were  facing  difficulties  in recruiting volunteers4.

According  to  news  reports,  Gandhi  Medical  College  also  in  Bhopal  was  unable  to  qualify  to become  a  trial  site  for  the  Phase  III  trial  as  it  was  unsuccessful  in  recruiting  even  100 volunteers which was the minimum number needed.5

Indeed, People’s Hospital’s haste to enroll participants was without regard for the rights of the individuals being actively recruited from particularly vulnerable communities.

5. Death of participant following dosing in the trial

We have grave concerns  around  the death of a participant  on 21 December  2020, around  9 days  after  being  dosed  in  the  trial. There  was  no  follow  up  done  by  the  trial  site  with  the participant during the 9 days. Given the ethical violations in consenting participants, it is no surprise that the participant did not approach the trial site when he started experiencing symptoms and his health  deteriorated.  Had the investigators  and Ethics  Committee  ensured follow ups and monitoring  of participants,  his deteriorating  health would have perhaps been taken  note  of earlier  and his life may  have  been  saved  by providing  him  the necessary  and legally mandated medical attention.

The occurrence of the death in the trial was never made public by the sponsors or the regulator and  only  came  to  light  when  the media  reported  it.  There  is  no  information   about  the procedure  being  followed  by  various  parties  –  the  PI,  Institutional Ethics  Committee,  Data Safety Monitoring Board and DCGI – in investigating the death or its current status.

The deceased’s family managed to access a copy of the Post Mortem report only after weeks of the event, and several days after People’s Hospital obtained the report. The family has still not been given a copy of the deceased’s informed consent form or any documents related to his participation in the COVAXIN trial.

  • Death is not recorded in meeting minutes of the COVID-19 Subject Expert Committee (SEC)

It is alarming that during the SEC’s consideration of the company’s application for emergency approval, there was no deliberation of the death in the trial, as gleaned through the publicly available SEC meeting minutes.

On 30 December 20206, the SEC noted that BBIL presented the updated recruitment status and safety data including SAE data of the ongoing Phase III clinical trial in the country.

However, it did not explicitly mention   the death of a trial participant, which is still under investigation. In each of the two successive SEC meetings on 1 and 2 January 20217, the SEC noted that more than 22,000 participants had been enrolled in the trial, including subjects with comorbid conditions, and stated that the trial “demonstrated safety till date”.

The lack of any serious adverse events even in participants having comorbid conditions played a critical role in the grant of emergency approval of COVAXIN, especially amid the lack of any interim efficacy data from the Phase III trial. However, it appears that the SEC may not have been aware of the death that took place in the trial on 21 December  2020 and which is still under investigation. This calls into question the basis of the restricted emergency use approval, albeit with all its caveats, that was granted by the DCGI on the recommendation of the SEC.


That a trial co-sponsored by ICMR is committing such glaring and grave violations of statutory provisions and the ethical guidelines laid down by ICMR itself is alarming and deeply troubling. That  one  of  the  oldest  biomedical  research  institutions  of  national importance  and international  repute,  and  one  that  is  tasked  with  ensuring  ethical  conduct  of  research  is complicit in endangering lives of Indian citizens is a national tragedy that must be immediately addressed to ensure that people do not lose faith in the COVID-19 vaccinations. Loss of faith in vaccines would amount to a fear and panic in individuals who may refuse to get vaccinated and thereby damaging the national effort to curtail the COVID-19 pandemic.

In view of the above egregious violations by the trial site, we urge you to:

(a)  Immediately  stop  the  clinical  trial  for  Bharat  Biotech’s  COVAXIN  at  People’s  College  of Medical Sciences & Research, Bhopal given the severity of the violations of ethical standards set by the ICMR and statutory provisions, and the gross negligence in taking care of the trial participants.

(b) Form an independent body to conduct an impartial, transparent, thorough, and time-bound investigation  to ascertain  violations of ethics, protocols  and legal requirements  pertaining  to conduct  of the clinical  trial. The findings  of this enquiry  must  be put in public domain.

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.

(c)  The  Principal  Investigator  and  the  Co-investigators  of  the  clinical  trial  at  the  site,  the People’s  Hospital,  have  failed  to adhere  to the scientific  and  ethics  standards,  legal requirements,  and have been insensitive  and negligent in ensuring safety, well being and the rights of the participants of the trial. All the responsible parties found to be negligent of their duties must be punished. They must be suspended from all research forthwith and their competence to do such research must be reviewed in addition to making them accountable for the violations and negligence.

(d) The People’s College Institution Ethics Committee is a body registered with the CDSCO. It has failed to demonstrate  its independence  and competence  in monitoring  the COVAXIN trial and ensuring that all protocols and statutory requirements are adhered to. Its registration may be suspended  forthwith  and the CDSCO  must inspect  and audit its functioning  and make its Chair and Member-Secretary  accountable for the lapses in the conduct of the clinical trial, and resultant harm to people’s lives.

(e) Conduct a separate audit of the People’s College of Medical Sciences & Research, Bhopal for its scientific and ethical standards of drugs, biomedical and health research. If such standards are  found  to  be  deficient,  it  should  not  be  allowed  to  undertake  any  research  unless  the institution carries out necessary improvements.

(f) Due to shoddy follow up of the participants, prima facie it appears that the COVAXIN trial at People’s College has violated not only ethics, but also compromised scientific integrity. The deficient scientific data would lead to wrong and misleading conclusions of the research. Thus, the vaccine  trial data of this site should  be separated  out and not used in the trial outcome analysis.

(g) Ensure that all the trial participants from the vulnerable sections who were enrolled in the trial get access to free medical care and compensation  for any injuries or death related to the trial.

(h) Share details of the process and timelines through which the death of the trial participant is being investigated by the various parties – the PI, Ethics Committee, DSMB, and DCGI – and the findings when the final determination has been completed.

We look forward to your urgent intervention in consideration of our plea.


Rashida Bee
Bhopal Gas Peedit Mahila Stationery Karmchari Sangh

Nawab Khan
Bhopal Gas Peedit Mahila Purush Sangharsh Morcha

Rachna Dhingra
Bhopal Group for Information and Action

Nausheen Khan
Children Against Dow Carbide

Copy to:

  1. Dr. V. G. Somani, Drugs Controller General (India), CDSCO
  2. Dr. S. Eswara Reddy, Joint Drugs Controller (India), CDSCO
  3. Shri A. K. Pradhan, DDC (I), CDSCO
  4. Dr. Vinod K. Paul, Member, Niti Aayog and Chair, NEGVAC
  5. Shri Rajesh Bhushan, Secretary, MOHFW and Co-Chair, NEGVAC
  6. Ms. S. Aparna, Secretary, DOP, Ministry of Chemicals and Fertilizers
  7. Dr. Renu Swarup, Secretary, Department of Biotechnology
  8. Dr. Randeep Guleria, Director, AIIMS, New Delhi
  9. Dr. Shekhar C. Mande, Secretary, DSIR and DG, Council of Scientific & Industrial Research
  10. Prof. K. VijayRaghavan, Principal Scientific Adviser to the Government of India
  11. Dr. Balram Bhargava, Director General, ICMR
  12. Dr. Samiran Panda, Director, ICMR-National AIDS Research Institute
  13. Dr. Nivedita Gupta, Scientist F, Epidemiology and Communicable Diseases, ICMR
  14. Dr. P K Mishra, Principal Secretary to Hon’ble PM
  15. Shri P. K. Sinha, Principal Advisor to Hon’ble PM
  16. Shri S. Gopalakrishnan, Additional Secretary to Hon’ble PM
  17. Ms. P. Amudha, Joint Secretary to Hon’ble PM
  18. Shri. Mohammad Suleman, Additional Chief Secretary-Health, Govt of Madhya Pradesh
  19. Shri Basant Kurre, Commissioner Bhopal Gas Tragedy Relief & Rehabilitation, Govt ofMadhya Pradesh
  20. 20. Shri. Avinash Lavania, Collector Bhopal District, Govt of Madhya Pradesh


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