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# All India Institute Clinical Trial Issues
- URL: https://www.fdaweb.com/all-india-institute-clinical-trial-issues/
- Published: 2026-05-20T12:00:00.000Z
- Updated: 2026-09-14T13:39:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161172

A 3/17-3/20/2025 FDA Bioresearch Monitoring Program inspection of a clinical trial conducted by Dr. **Sourav Mishra** at the All India Institute of Medical Sciences in Bhubaneswar, Odisha, India, found that the clinical investigation failed to meet statutory and regulatory requirements for the conduct of clinical investigations and the protection of human subjects. A 4/29 Warning Letter says Mishra:

- failed to ensure that the investigation was conducted according to the investigational plan; and
- failed to obtain informed consent.

Mishra was told to respond with a list of specific actions he has taken or will take to ensure that similar violations do not occur in the future.