India's drug regulator has suspended the Ethics Committee at HCG-Bangalore's Kalinga Rao Road unit for 24 months after finding serious lapses in clinical trial oversight, including nine unreported serious adverse events and three participant deaths. The action raises important questions for patients participating in clinical trials about how safety is monitored and what rights they have if something goes wrong.
The Central Drugs Standard Control Organisation (CDSCO) issued the suspension order on 12 June 2026 after finding that the Ethics Committee had failed to report serious adverse events, including participant deaths, and had allowed a conflict of interest to go undisclosed during trial reviews.
As of early August 2026, Deccan Herald reported that the hospital had still not complied with the monthly safety reporting required under CDSCO's suspension order. Importantly, the regulatory action applies specifically to the Ethics Committee responsible for overseeing clinical trials at the Kalinga Rao Road unit. It does not mean HCG's hospital services or cancer treatment operations have been suspended.
HCG's case is not an isolated instance of regulatory action involving Ethics Committees in India, although the actions are unrelated. CDSCO has also cancelled the registration of seven other Ethics Committees nationwide, with most of those orders issued in 2025 and made public on 27 July 2026. HCG is not among those committees, and its Ethics Committee remains under a separate 24-month suspension.
Understanding how Ethics Committees function, and what protections participants are entitled to under Indian law, can help patients make informed decisions before enrolling in a clinical trial.
| Date | Event |
|---|---|
| 29 June 2025 | South First first reports Ethics Committee irregularities, based on concerns raised by then-Chairperson Justice P. Krishna Bhat. |
| July 2025 | Bhat resigns; HCG's CEO and senior surgeons also step down. CDSCO conducts risk-based inspections. |
| 12 June 2026 | CDSCO suspends HCG's Ethics Committee for 24 months, citing unreported SAEs and undisclosed conflict of interest. |
| 19-26 June 2026 | CDSCO debars Dr. Satheesh C.T. (24 months) and Dr. Govind Babu (6 months) over an undisclosed conflict of interest. |
| 2025-2026 | CDSCO separately cancels seven other Ethics Committees nationwide (mostly dated 2025); the notice is made public on 27 July 2026. HCG is not among them. |
| 4 August 2026 | Per Deccan Herald, HCG has still not complied with the mandatory monthly safety reporting the order required. |
An Ethics Committee is legally responsible for protecting a trial participant's rights, safety, and well-being.
Under the NDCT (New Drugs and Clinical Trials) Rules, 2019, every regulated trial site needs a CDSCO-registered Ethics Committee to review and continuously monitor its trials.
An Ethics Committee functions independently from the investigators conducting the trial. It reviews study protocols before recruitment begins, monitors participant safety throughout the study, evaluates serious adverse events, and can recommend modifying, suspending, or stopping a clinical trial if participant safety is at risk. This independent oversight is a key safeguard designed to protect research participants.¹
When a Committee's registration is suspended, as with HCG's KR Road unit, the site cannot approve or oversee any new trial for the suspension period. Existing participants stay enrolled and must still be monitored, with monthly safety reports going to CDSCO.
CDSCO's order cites unreported adverse events, missing records, and an undisclosed conflict of interest.
According to the CDSCO order, nine adverse events, including three deaths, went unreported.
Signed minutes from 2022 Ethics Committee meetings were never submitted, and conflict-of-interest declarations weren't collected from all members.
Dr. Govind Babu declared no conflict of interest at a September 2024 meeting while serving as Principal Investigator on the trial under review; he was later debarred for six months.
South First reported that one participant with fatigue, breathlessness, and cough was kept on existing medication without documentation and died on 11 February 2023. The required Ethics Committee notification was allegedly not followed.
Free Press Journal reported that another participant was reportedly sent to the outpatient department instead of emergency care and died within 24 hours. The case reportedly remained undisclosed for about ten months.
In another case reported by South First, a participant's casualty report described the individual as recovered and discharged while separately noting progressive liver disease with lung carcinoma. Required follow-up records were reportedly never submitted.
Anyone considering participation in a clinical trial has the right to ask whether the site's Ethics Committee is currently registered with CDSCO and to receive information about the study's risks, oversight, and any adverse events that may affect participant safety.
Every trial site's Ethics Committee must be CDSCO-registered. Check the status on CDSCO's official portal or ask the trial coordinator directly.
Before signing the informed consent form, prospective participants may also request:
The Ethics Committee's CDSCO registration number
The Clinical Trials Registry-India (CTRI) registration number of the study, where applicable
The Principal Investigator's or study team's contact details
A copy of the Participant Information Sheet and Informed Consent Form
Information on the compensation policy and medical management available in case of a trial-related injury
Under Rule 40 of the NDCT Rules, 2019, sponsors must provide free medical management for any trial-related injury for as long as needed.
Indian clinical trial rules also require financial compensation for trial-related disability or death, separate from free medical management, under Rules 39 and 42 of the NDCT Rules, 2019.¹
If an adverse event was not disclosed to the participant, it can be reported directly to CDSCO's Central Licensing Authority through its grievance mechanism.
HCG's case isn't isolated, though the two actions aren't directly linked.
CDSCO cancelled the registration of seven other Ethics Committees nationwide, including
Hurip Independent,
Rational Independent, and
Royal Pune Independent
Six date to 2025, mostly months before HCG's suspension; the notice was only made public on 27 July 2026.
HCG is not among those seven committees, and its Ethics Committee remains under a separate 24-month suspension.
Ethics Committee oversight gaps have been documented in India for over a decade, from inconsistent record-keeping flagged in a 2011 review,³ to enforcement gaps noted in a 2019 commentary on the NDCT Rules,⁴ to inconsistent registration data found in a 2022 review of India's Clinical Trials Registry.⁵
No. Under the NDCT Rules, 2019, an investigator's initial notification of a serious adverse event, including death, is expected within 24 hours, with a detailed report to follow. The Ethics Committee must separately forward its own analysis to the Central Licensing Authority. Not doing so is a compliance violation.
CDSCO is the national regulator that registers, monitors, and can suspend Ethics Committees. The Ethics Committee is the hospital-level body that reviews and approves individual trial protocols and monitors participant safety.
CDSCO lists registered Ethics Committees, along with any suspension or cancellation, on its official portal. You can also ask your trial coordinator directly for the EC's current registration number.
Under Rule 40, sponsors must provide free medical management for as long as needed. Under Rules 39 and 42, financial compensation for trial-related disability or death is separately mandated, on top of medical costs.
Central Drugs Standard Control Organisation, Ministry of Health and Family Welfare, Government of India. The New Drugs and Clinical Trials Rules, 2019. Rule 7. pdf
HealthCare Global Enterprises Limited. Disclosure under Regulation 30 of SEBI Listing Regulations, 17 June 2026 (re: CDSCO suspension order dated 12 June 2026). pdf
Pandiya, Anvita. "Quality of Independent Review Board/Ethics Committee Oversight in Clinical Trials in India." Perspectives in Clinical Research 2, no. 2 (2011): 45-47. https://doi.org/10.4103/2229-3485.80364.
Jesani, Amar, and Sandhya Srinivasan. "New Drugs and Clinical Trials Rules, 2019: The Market Trumps Ethics and Participant Rights." Indian Journal of Medical Ethics 4, no. 2 (2019): 89-91. https://doi.org/10.20529/IJME.2019.020.
Chakraborty, Indraneel, Adya Shreya, Jaishree Mendiratta, Anant Bhan, and Gayatri Saberwal. "An Analysis of Deficiencies in the Ethics Committee Data of Certain Interventional Trials Registered with the Clinical Trials Registry-India." PLOS Global Public Health 2, no. 10 (2022): e0000617. https://doi.org/10.1371/journal.pgph.0000617.