FDA WARNING_LETTER - Mukesh B. Chandre, M.D., MBBS/Ashirwad Hospital & Research Centre - May 09, 2025

The FDA issued a Warning Letter to Mukesh B. Chandre, M.D., and the Ashirwad Hospital & Research Centre in Maharashtra, India, following an inspection conducted from May 5 to May 9, 2025. The investigation focused on a clinical bioequivalence study for Doxorubicin Hydrochloride Liposome Injection conducted for Qilu Pharmaceutical. The primary violation identified was the failure to obtain legally effective informed consent from research participants. The FDA determined that the informed consent documents were misleading and potentially coercive. Specifically, the forms used ambiguous language that failed to distinguish between the approved reference drug and the unapproved test product. Furthermore, the documents overstated the potential benefits and effectiveness of the investigational drug, which may have unduly influenced patients to participate without a full understanding of the experimental risks. These actions violated the Federal Food, Drug, and Cosmetic Act and federal regulations (21 CFR Parts 312 and 50) designed to protect the rights and safety of human subjects. While the hospital implemented some corrective measures, the FDA found their initial response lacked sufficient detail. Dr. Chandre must provide a written response within 15 business days outlining specific procedures to ensure future regulatory compliance and prevent similar violations.