The union health ministry will soon amend Rule 3A of the Drugs & Cosmetics Rules by which the government will accord the status of the Central Drug Laboratory to National Institute of Biologicals (NIB), Noida for testing blood products, certain enzymes and hormones, recombinant products and biochemical kits.
A decision to amend the law in this regard was taken by the Drugs Technical Advisory Board (DTAB), the highest decision making body of the union health ministry, in its meeting held on May 16 this year. The DTAB felt that the NIB, Noida has the expertise to test many of the biological products for their quality.
Earlier, the ministry had constituted an expert team for the inspection of the laboratory in order to utilise the capacity of the laboratory for testing more biological products for their quality. After conducting the inspection, the expert team recommended that the laboratory could be declared as Central Drug Laboratory for testing more products for their quality. So far, the NIB is being used for testing of Blood Grouping reagents and diagnostic kits for HIV, Hepatitis B Surface Antigen and Hepatitis C virus only.
Once the rule 3A of the D&C Rule is amended, the NIB will be utilised for testing blood grouping reagents; diagnostic kits for human immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus; blood products such as human albumin, human normal immunoglobulin (IM&IV), human coagulation factor VIII, human coagulation factor IX, plasma protein fractionation, fibrin sealant kit and anti inhibitor coagulation complex; enzymes and hormones such as streptokinase (natural & recombinant), human chorionic gonadotropic and human menopausal gonadotropin; recombinant products like recombinant insulin and insulin analogues, r- erythropoietin (EPO) and r-granulocyte colony stimulating factor (G-CSF); and biochemical kits including glucose test strips and fully automated analyser based glucose reagents.