NEW DELHI: The Centre has proposed amending drug rules to stop repeating virus tests on medicines made from human plasma, saying the raw plasma used to produce these products is already screened for infections such as HIV and hepatitis before manufacturing begins.These medicines include albumin, intravenous immunoglobulin (IVIG), and clotting factors such as Factor VIII and Factor IX, which are used to treat immune disorders, severe infections and bleeding conditions such as haemophilia.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 it is used for fractionation, and only plasma that tests negative is cleared for manufacturing plasma-derived medicines.
Currently, plasma collected for manufacturing these medicines is first pooled and tested for viruses, including HIV, hepatitis B and hepatitis C. However, once medicines are produced from this screened plasma, the finished products are again tested for the same viral markers under existing rules. The government now proposes to remove this second round of testing.The health ministry has issued a draft notification seeking public comments on amendments to the Drugs Rules, 1945, which regulate the testing of blood-derived products.
Dr Aseem Kumar Tiwari, Senior Director, Department of Transfusion Medicine, Medanta, Gurugram, said that surplus plasma collected from blood donors may be used by plasma fractionators to manufacture several life-saving medicines.“Plasma-derived medicinal products (PDMP) such as albumin, intravenous immunoglobulin (IVIG), and clotting factors like Factor VIII and Factor IX are widely used to treat immune disorders, severe infections and bleeding conditions such as haemophilia,” he said.He added that blood centres often generate surplus plasma after meeting patient needs, which can be supplied to specialised fractionation facilities where different proteins are separated to manufacture these medicines.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 manufacturing process includes viral inactivation steps to ensure safety,” he said.“These medicines, known globally as plasma-derived medicinal products, have not been linked to infection transmission because of stringent testing and viral inactivation during manufacturing,” he added.Officials say repeating the same viral tests at the finished product stage creates duplication not required under global practices. The proposed amendment seeks to rationalise testing requirements while maintaining strict safety checks at the plasma screening stage.The draft rules were issued after consultation with the Drugs Technical Advisory Board, and stakeholders have been given 30 days to submit comments before the amendment is finalised.
