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SC To Hear PIL On Gujarat’s Unethical Clinical Trials Today

| Updated: April 30, 2025 11:29

A critical public interest petition highlighting illegal clinical trials conducted in Gujarat is scheduled to be heard in the Supreme Court today. The case has gained renewed urgency following revelations of unethical drug testing on patients at a government-run hospital in Ahmedabad.

The focus is on Sheth Vadilal Sarabhai (VS) Hospital, where 58 domestic and foreign pharmaceutical companies are accused of conducting unapproved clinical trials on almost 500 patients between 2021 and 2024. The New Drugs and Clinical experiments Rules, 2019 were reportedly violated by conducting these experiments without the consent of a legally formed ethics committee.

An investigative committee formed by the Ahmedabad Municipal Corporation (AMC) revealed that pharmaceutical companies paid Rs 200–Rs 500 ‘per subject’, with some paying significantly higher sums. The companies reportedly deposited Rs 17–Rs 20 crores into the personal accounts of doctors involved in the trials. 

The petition has been filed by Swasthya Adhikar Manch, an Indore-based health rights organisation, through its convener Amulya Nidhi. In an additional affidavit submitted on April 23, 2025, Nidhi emphasised that the clinical trials conducted at VS Hospital were neither ethically sanctioned nor legally authorised.

With the backing of the Gujarat State Unit’s Jan Swasthya Abhiyan, Swasthya Adhikar Manch has called for a thorough probe by the federal and state governments. Transparency about trial approvals, adverse events, compensation status, and accountability for all parties involved—including sponsors, investigators, and regulators—is demanded in the petition. The affidavit pointed out that no criminal investigation has been launched as of yet, despite interim findings and the suspension of eight doctors, which raises questions regarding institutional impunity.

Alongside VS Hospital, a total of 50 clinical trial centers in Gujarat are mentioned. “The names of those 50 institutions were given in the complaint. It is required to be inquired into whether these institutions were conducting clinical trials in accordance with law or were illegal,” a part of the affidavit reads. 

The complete list includes both public and private institutions across the state:

1. Institute of Post Graduate Teaching and Research in Ayurveda

2. Apple Hospital

3. Shree Giriraj Multi Speciality Hospital

4. SAL Hospital & Medical Institute

5. Dia Care

6. Vijayratna Diabetes Diagnosis & Treatment Centre

7. Government Medical College, Surat

8. GCS Medical College Hospital and Research Centre

9. HM Patel Center for Medical Care and Education

10. Sir Takhtasinghji General Hospital

11. Institute of Kidney Diseases and Research Center (IKDRC)

12. Muljibhai Patel Urological Hospital

13. Apollo Hospital International Ltd

14. Care Institute of Medical Sciences (CIMS) Hospital

15. Sanjivani Super Speciality Hospitals Pvt. Ltd.

16. Civil Hospital

17. Parul Ayurveda Hospital

18. Himalaya Cancer Hospital

19. Kailash Cancer Hospital and Research Centre

20. GMERS Medical College and Civil Hospital

21. Vadodara Institute For Reconstructive Orthopedic Care (VIROC Hospital)

22. Sir Sayajirao General Hospital

23. Govt Akhandanand Ayurved College

24. Kanoria Hospital and Research Centre

25. Ratandeep Multispecialty Hospital

26. Shri Hatkesh Healthcare Foundation

27. Ahmedabad Institute of Medical Sciences

28. BJ Medical College & Civil Hospital, Asarwa, Ahmedabad

29. Hemato-Oncology Clinic Vedanta Institute of Medical Sciences

30. Bodyline Hospital

31. Manibhai Shivabhai Patel Cancer Centre

32. Unique Hospital Multispecialty and Research Institute

33. Life Care Institute of Medical Sciences and Research

34. Government Medical College & Sir Sayajirao General Hospital (SSGH)

35. Shraddha Onco Care

36. Dr Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre

37. Zydus Hospitals and Healthcare Research Pvt. Ltd.

38. F7, Paediatric Operation Theatre, Civil Hospital, Ahmedabad

39. Dept. of Infectious Diseases, Vedanta Institute, Navrangpura, Ahmedabad

40. PICU, Shree Krishna Hospital, Karamsad

41. Dept. of Cardiology, HCG Hospitals, Mithakhali, Ahmedabad

42. Stavya Spine Hospital and Research Institute, Mithakhali, Ahmedabad

43. GMERS Medical College & Hospital, Sola, Ahmedabad

44. Medistar Multispecialty Hospital, Himmatnagar

45. OPD of Panchkarma Dept., Govt. Akhandanand Ayurved College and Hospital

46. Aalok Orthocare Super Speciality Centre, Ahmedabad

47. Yashfeen Hospital, Navsari

48. Rhythm Heart Institute, Vadodara

49. Unique Hospital Multispecialty & Research Institute, Surat

50. Government Akhandanand Ayurved Hospital and Maniben Ayurved Hospital

The affidavit highlights serious lapses in oversight and accountability surrounding the clinical trials at VS Hospital. For four years, trials were conducted without attracting scrutiny from hospital authorities or government regulators. Payments by pharmaceutical companies were allegedly made without formal authorisation or signatures from department heads or the hospital superintendent. 

Although some individuals were reportedly suspended, no police complaints have been filed against those involved. The affidavit points to the absence of action against those responsible for causing financial losses worth crores to the municipal treasury. Only contract-based doctors appear to have faced disciplinary measures, while more senior officials remain untouched. 

There has been no investigation into the records of the hospital’s Ethical Committee over the past decade, nor any audit of ethical review processes in other municipal hospitals. Furthermore it notes that key data have been withheld in the form specific drugs administered, the exact number of patients involved, the compensation they received, and the identities of the pharmaceutical companies that conducted the trials.

The case is expected to raise far-reaching questions about ethical governance, patient rights, and transparency in India’s rapidly expanding clinical research sector.

Timeline of Events

2012:

– Swasthya Adhikar Manch files a Public Interest Litigation (Writ Petition Civil No. 33 of 2012) in the Supreme Court against unethical clinical trials in India.

2021–2024:

– Unapproved clinical trials conducted by at least 58 pharmaceutical companies at VS Hospital, Ahmedabad.

– Trials carried out without a legally recognized ethics committee.

– An estimated Rs 17–Rs 20 crore allegedly deposited into doctors’ personal bank accounts.

April 2025:

– Local media reports the issue publicly for the first time.

– Ahmedabad Municipal Corporation forms a probe committee following pressure from elected officials.

– Committee submits interim report highlighting ethical and financial irregularities.

– Swasthya Adhikar Manch files an additional affidavit in the Supreme Court with detailed evidence.

– List of 50 clinical trial centers across Gujarat submitted for investigation.

April 30, 2025

– Supreme Court scheduled to hear the petition.

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