Healthcare Global, under KKR control, faces scrutiny due to ethical breach accusations
In a significant development, the Karnataka health ministry has launched an investigation into Healthcare Global Enterprises Ltd (HCG), a leading oncology chain based in Bengaluru, over allegations of procedural lapses and potential conflicts of interest in clinical trials.
The probe was triggered by concerns raised by Justice P Krishna Bhat (Retd), former chairperson of HCG’s Institutional Ethics Committee (IEC), who highlighted potential patient safety issues and procedural violations in the clinical trial approval process. One of the main concerns cited was a conflict of interest involving the director of clinical trials simultaneously serving as principal or co-principal investigator in several ongoing trials, which could compromise the integrity of the trials and the ethics committee’s oversight.
In response to these concerns, the Karnataka Health Minister Dinesh Gundu Rao confirmed that the state government formally requested the Central Drugs Standard Control Organisation (CDSCO) to conduct an independent investigation. The CDSCO has since formed a team to inspect HCG’s ethics committee, focusing on compliance with the New Drugs and Clinical Trials Rules, 2019, aiming for a risk-based assessment of potential violations that may affect patient safety and regulatory adherence.
HCG, in response to the allegations, has strongly denied any wrongdoing. Dr. B.S. Ajaikumar, the founder and chairman of HCG, asserted that the organization adheres strictly to all regulatory guidelines set by the CDSCO and Indian Council of Medical Research (ICMR), emphasizing transparency and patient safety in their clinical trials. HCG maintains it conducts a substantial number of trials approved by its ethics committee and remains committed to upholding high ethical standards.
Meanwhile, private equity firms have been making moves in the business world. KKR, a private equity firm, acquired Healthcare Global Enterprises Ltd earlier this year. Separately, KKR is involved in a M&A deal with JB Chemicals. The exit from JB Chemicals by KKR is reportedly beating the benchmark, worth $1.4 billion.
The ongoing investigation by the CDSCO is expected to clarify the validity of the allegations and ensure that clinical trials at HCG meet the required standards of ethics and safety. The impact of the scrutiny on Healthcare Global Enterprises Ltd's operations was not provided in the article.
- The ongoing investigation by the Central Drugs Standard Control Organisation (CDSCO) could potentially affect the business operations of Healthcare Global Enterprises Ltd (HCG), following allegations of procedural lapses and conflicts of interest in clinical trials.
- In a parallel development, private-equity firm KKR, which acquired Healthcare Global Enterprises Ltd earlier this year, is currently involved in another investment move through a M&A deal with JB Chemicals.
- Amidst these events, the impacts of investigations on financing and investing in medical-condition focused businesses like HCG could be a topic of interest for the finance and private-equity communities.
