Government recommends abandoning repeated virus testing for plasma drugs

NEW DELHI: The Center has proposed amending drug rules to stop repeated viral testing of drugs made from human plasma, saying the original plasma used to make these products is screened for infections like HIV and hepatitis before production begins.These drugs include albumin, intravenous immune globulin (IVIG), and clotting factors such as factor VIII and factor IX, and are used to treat immune disorders, serious infections, and bleeding disorders such as hemophilia.Officials said the move is aimed at bringing India’s drug regulations in line with international pharmacopeia standards. Global guidelines require that pooled plasma must be tested for hepatitis B surface antigen, hepatitis C virus RNA and HIV antibodies before being used for isolation, and only plasma that tests negative can be used to make plasma-derived drugs.Currently, the plasma collected to make these drugs is first pooled and tested for viruses, including HIV, hepatitis B and hepatitis C. However, once a drug is produced from this screened plasma, the finished product will be tested again for the same viral markers under existing rules. The government is now proposing to cancel the second round of testing.The health ministry has issued a draft notification seeking public views on the amendments to the Drugs Rules, 1945, which regulate the testing of blood products. Dr Aseem Kumar Tiwari, senior director, Department of Transfusion Medicine, Medanta, Gurgaon, said the remaining plasma collected from blood donors can be used by plasma separators to produce a variety of life-saving drugs.“Albumin, plasma-derived medicinal products (PDMPs) such as intravenous immunoglobulin (IVIG), and coagulation factors such as factor VIII and factor IX are widely used to treat immune disorders, serious infections and bleeding disorders such as hemophilia,” he said.He added that blood centers often generate surplus plasma after meeting patient demand, which can be supplied to specialized 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 such as HIV, hepatitis B, hepatitis C, malaria and syphilis, and the production process includes viral inactivation steps to ensure safety,” he said.“These drugs, known globally as plasma-derived medicines, are not associated with the spread of infection due to stringent testing and viral inactivation during the manufacturing process,” he added.Officials say repeating the same virus tests at the finished product stage would create unnecessary duplication in global practice. The proposed amendments aim to rationalize testing requirements while maintaining strict safety checks during the plasma screening phase.The draft rule was released in consultation with the Pharmaceuticals Technical Advisory Committee, and stakeholders have 30 days to submit comments before the amendments are finalized.