FDA WARNING_LETTER - Sourav K. Mishra, M.D. / All India Institute of Medical Sciences - March 20, 2025

The FDA issued a Warning Letter to Dr. Sourav K. Mishra at the All India Institute of Medical Sciences following an inspection conducted from March 17 to March 20, 2025. The inspection focused on a clinical bioequivalence study for an investigational chemotherapy drug, Doxorubicin Hydrochloride Liposome Injection. The FDA identified two major violations of the Federal Food, Drug, and Cosmetic Act and federal regulations governing human subject protection. First, the investigator failed to follow the study protocol by administering prohibited medications to study subjects. Specifically, three patients were given Aprecap, a drug that interferes with the metabolism of the study medication, thereby compromising the safety of the participants and the integrity of the resulting data. Second, the investigator failed to obtain proper informed consent. The consent forms used misleading language that suggested the investigational drug was already proven effective and approved by regulatory authorities, which may have unduly influenced patients to participate. These failures violate clinical investigation standards designed to protect subject welfare and data reliability. Dr. Mishra is required to provide a written response within 15 business days outlining specific corrective actions to prevent these issues from recurring. Failure to adequately address these concerns may result in further regulatory action.