FDA Cites Sourav K. Mishra, M.D. / All India Institute of Medical Sciences in April 29, 2026 Warning Letter — In Vivo Bioavailability-Bioequivalence Studies – Clinical

FDA Warning Letter — Violations FDA cited at Sourav K. Mishra, M.D. / All India Institute of Medical Sciences

WARNING LETTER Sourav K. Mishra, M.D. / All India Institute of Medical Sciences MARCS-CMS 724881 — April 29, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA UNITED PARCEL SERVICE AND VIA E-MAIL Reference #: 26-HFD-45-04-02 Product: Drugs Recipient: Recipient Name Sourav K. Mishra, M.D. Sourav K. Mishra, M.D. / All India Institute of Medical Sciences Sijua, Patrapada Bhubaneswar 751019 Odisha India Issuing Office: Center for Drug Evaluation and Research (CDER) United States WARNING LETTER FDA Ref. No.: 26-HFD-45-04-02 Dear Dr. Mishra: This Warning Letter informs you of objectionable conditions observed during the U.S. Food and Drug Administration (FDA) inspection conducted at All India Institute of Medical Sciences in Bhubaneswar, Odisha, India, between March 17 and March 20, 2025. The investigator representing FDA reviewed your conduct of a clinical in vivo bioequivalence study (Protocol 0270-22, “A Multicenter, Open Label, Balanced, Randomized, Two-Treatment, Two-Period, Two-Sequence, Single Dose, Crossover, Bioequivalence Study between two formulations of Doxorubicin Hydrochloride Liposome Injection 20 mg/10 mL (50 mg/m 2 dose) (Doxorubicin-Test compared with Doxorubicin-Reference) in Patients with Advanced Ovarian Cancer”) of the investigational product doxorubicin hydrochloride liposome injection 20 mg/10 mL, performed for Qilu Pharmaceutical (Hainan) Co., Ltd. This inspection was conducted as a part of FDA’s Bioresearch Monitoring Program, which includes inspections designed to evaluate the conduct of research and to help ensure that the rights, safety, and welfare of human subjects have been protected. From our review of the FDA Establishment Inspection Report and the documents submitted with that report, it appears that you did not adhere to the applicable statutory requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and applicable regulations contained in Title 21 of the Code of Federal Regulations, parts 312 (21 CFR 312) and 50 (21 CFR 50) governing the conduct of clinical investigations and the protection of human subjects. 1 We wish to emphasize the following: 1. You failed to ensure that the investigation was conducted according to the investigational plan [21 CFR 312.60]. As a clinical investigator, you are required to ensure that your clinical investigations are conducted in accordance with the investigational plan. The investigational plan for Protocol 0270-22 2 required you to prohibit the use of cytochrome P450 CYP3A4 and CYP2D6 inhibitors to subjects during the entire study duration, and before baseline for at least five half-lives of the given drug, if given prior to the first dose of the study intervention. You failed to adhere to this requirement. Specifically, all three enrolled subjects were orally administered Aprecap (aprepitant), a moderate inhibitor of CYP3A4, during the study. Examples of these failures include: a. Subject (b)(6) signed the informed consent on October 17, 2023, and was administered investigational product on November 1, 2023 (Period I) and on December 1, 2023 (Period II). However, this subject was administered Aprecap between November 1 and November 3, 2023, and between December 1 and December 3, 2023. b. Subject (b)(6) signed the informed consent on October 30, 2023, and was administered investigational product on November 10, 2023 (Period I). However, this subject was administered Aprecap between November 10 and November 12, 2023. c. Subject (b)(6) signed the informed consent on November 16, 2023, and was administered investigational product on November 29, 2023 (Period I) and on December 27, 2023 (Period II). However, this subject was administered Aprecap between November 29 and December 1, 2023, and between December 27 and December 29, 2023. During the inspection, you stated that it is the oncology department’s usual practice to administer Aprecap 125/80 capsules before a patient receives chemotherapy. You also s