Bharat Serums gets CDSCO panel nod to Recombinant Anti Rho-D Immunoglobulin Injection
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted permission to Bharat Serums and Vaccine Limited to manufacture the additional strength of 150 mcg of Recombinant Anti Rho-D Immunoglobulin Injection.
Anti-Rho (D) immunoglobulin is a human, IGg monoclonal antibody. It is developed by Bharat Serums and Vaccines for the prevention of haemolytic disease of newborn. The product is a sterile liquid injection derived from stable heterohybridoma cell line HG-92 and purified using protein affinity chromatography.
The approval came in wake of the proposal presented by Bharat serums and Vaccine Limited for manufacturing and marketing of additional strength of Recombinant Anti Rho-D Immunoglobulin Injection 150mcg .
At recent SEC meeting for Reproductive & Urology held on 29.07.2021, the committee reviewed the Bharat serums and Vaccine's proposal.
Following extensive consideration, the committee noted that the firm is already holding new drug permission for higher strength i.e Anti Rho-D 300mcg based on conduct of clinical trials in India. Further, the committee noted that there is no change in composition.
After detailed deliberation the committee recommended for grant of permission to manufacture the additional strength of 150 mcg of Recombinant Anti Rho-D Immunoglobulin Injection.