NEW DELHI: The Centre has proposed amending drug regulations to eliminate repeated virus testing on medicines derived from human plasma, noting that the plasma used to manufacture these products is already screened for infections such as HIV and hepatitis before the production process begins.
The medicines involved 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 like haemophilia.
Officials said the proposed change aims to align India’s regulatory framework with international pharmacopoeia standards. Under global guidelines, pooled plasma must 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 the manufacture of plasma-derived medicines.
At present, plasma collected for producing these medicines is first pooled and tested for viruses including HIV, hepatitis B and hepatitis C. However, once medicines are manufactured from this screened plasma, the finished products are again tested for the same viral markers under existing rules. The government now proposes to eliminate this second round of testing.
The health ministry has issued a draft notification seeking public comments on amendments to the Drugs Rules, 1945, which govern the testing of blood-derived products.
Dr Aseem Kumar Tiwari, Senior Director at the Department of Transfusion Medicine, Medanta in Gurugram, said surplus plasma collected from blood donors can be used by specialised plasma fractionators to produce several life-saving medicines.
“Plasma-derived medicinal products 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 explained that blood centres often generate surplus plasma after meeting immediate patient needs, which can then be supplied to specialised fractionation facilities where different proteins are separated to produce these medicines.
According to Dr Tiwari, plasma-derived medicinal products undergo multiple layers of 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 due to stringent testing and viral inactivation during manufacturing,” he added.
Officials said repeating the same viral tests on the finished products creates unnecessary duplication that is not required under global practices. The proposed amendment aims to streamline testing procedures while maintaining strict safety protocols during the plasma screening stage.
The draft rules were issued after consultations with the Drugs Technical Advisory Board, and stakeholders have been given 30 days to submit their comments before the amendment is finalised.
