The Union health ministry is amending the Drugs and Cosmetics Rules to make the National Institute of Biologicals (NIB), based in Noida here, as the apex national laboratory for several products like blood products and diagnostic kits with a view to ensure high level quality for these products in the market.
The Ministry has prepared a draft notification to amend the rule, in accordance with the recommendations by the Drugs Technical Advisory Board (DTAB). The rule, published for the comments from the stakeholders, will come into effect with the final notification after the mandatory period of 45 days.
“These rules may be called the Drugs and Cosmetics (Sixth Amendment) Rules, 2014. In the Drugs and Cosmetics Rules, 1945, in rule 3A, for sub-rule (8), the following sub-rule shall be substituted, namely:- “(8) The functions of the Laboratory in respect of the following kits or class of drugs shall be carried out at the National Institute of Biologicals and the functions of the Director in respect of the said drugs or class of drugs shall be exercised by the Director of the said institute,” said the notification.
The products named under the rule are blood grouping reagents, diagnostic kits for human immunodeficiency virus, hepatitis B surface antigen and hepatitis C, among others. The blood products include human albumin, human normal immunoglobulin (intramuscular & intravenous), human coagulation factor VIII, human coagulation factor IX, plasma protein fractionation, fibrin sealant kit, and anti Inhibitor coagulation complex.
The rules also listed recombinant products like recombinant insulin and insulin analogues, r- erythropoietin (EPO) and r-Granulocyte colony stimulating factor (G-CSF). Besides, biochemical kits like glucose test strips and fully automated analyser based glucose reagents are also included.
NIB, an autonomous institution under the Ministry of Health & Family Welfare, is a premier scientific organisation and a centre of excellence to ensure quality of biologicals and vaccines in the country. The institute reviews the quality of biological products available through domestic manufacturers or imports with the help of a state-of-the-art facility.