Govt proposes to drop repeat virus tests on plasma-based medicines | India News
NEW DELHI: The Center has proposed amending drug rules to stop repeated virus testing of drugs made from human plasma, saying the raw plasma used to make these products is already screened for infections like HIV and hepatitis before production begins.These drugs include albumin, intravenous immunoglobulin (IVIG), and clotting factors such as factor VIII and factor IX, which are used to treat immune disorders, serious infections, and bleeding conditions such as hemophilia.Officials said the move aims to align India’s drug regulations with international pharmacopoeia standards. Global guidelines require pooled plasma to be tested for hepatitis B surface antigen, hepatitis C virus RNA, and HIV antibodies before use for fractionation, and only those that test negative are cleared for plasma-derived drug preparation.Currently, plasma collected to make these drugs is first pooled and tested for viruses including HIV, hepatitis B and hepatitis C. However, once drugs are manufactured from this screened plasma, the manufactured products are tested again for the same viral markers under existing regulations. The government has now proposed to do away with this second round of exams.The Health Ministry has issued a draft notification seeking public opinion on amendments to the Medicines Rules, 1945, which regulate testing of blood products. Dr Asim Kumar Tiwari, Senior Director, Department of Transfusion Medicine, Medant, Gurugram, said that the surplus plasma collected from blood donors can be used by plasma fractionators to make various life-saving medicines.“Plasma-derived medicinal products (PDMP) such as albumin, intravenous immunoglobulin (IVIG), and clotting factors such as Factor VIII and Factor IX are widely used to treat immune disorders, serious infections, and bleeding conditions such as hemophilia,” he said.He added that blood centers often produce surplus plasma after meeting patient needs, which can be supplied to special fractionation facilities where different proteins are separated to make these drugs.Dr Tiwari said PDMPs undergo multiple safety checks before reaching patients. “Donated plasma is screened for infections like HIV, hepatitis B, hepatitis C, malaria and syphilis and the manufacturing process includes viral inactivation steps to ensure safety,” he said.“These drugs, known worldwide as plasma-derived medicinal products, have not been linked to infectious diseases due to rigorous testing and viral inactivation during manufacturing,” he added.Officials say repeating the same viral test at the finished product stage does not require duplication under global practice. The proposed amendment seeks to rationalize testing requirements while maintaining strict safety testing at the plasma screening stage.The draft rules have been issued after discussions with the Drugs Technical Advisory Board and 30 days have been given to stakeholders to submit their views before the amendments are finalised.
