Bharat Serums Gets CDSCO Panel Nod for Phase III Trial of IVIG in Chronic ITP
New Delhi: Bharat Serums and Vaccines has received approval from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organisation (CDSCO) to conduct a Phase III clinical trial of Human Normal Immunoglobulin for Intravenous Use (IVIG) 5% Solution.
This came after the firm presented the revised protocol — updated as per the recommendations given by the committee during the SEC meeting held on February 11, 2025 — for the proposed Phase III clinical trial titled:
“An Open-Label, Multicenter, Phase III Clinical Study in India to Evaluate the Efficacy and Safety of Human Normal Immunoglobulin for Intravenous Use (IVIG) in Chronic Immune Thrombocytopenia (ITP)”, vide Protocol No. BSV_IVIG_ITP_2023_02, Version 4.0, dated April 17, 2025.
Human Normal Immunoglobulin for Intravenous Use (IVIG) 5% solution is a plasma-derived product containing primarily IgG antibodies, used to enhance immunity in individuals with immune deficiencies or autoimmune disorders. Administered intravenously, it helps the body fight infections and regulate immune responses.
At the recent SEC (Hematology) meeting held on June 10, 2025, the expert panel reviewed the revised protocol and, after detailed deliberation, “recommended the grant of permission to conduct the Phase III clinical trial as per revised Protocol No. BSV_IVIG_ITP_2023_02, Version 4.0 dated 17.04.2025.”
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