Government Plans to Scrap Redundant Virus Tests for Plasma Medicines

The Indian government has proposed updates to existing drug regulations that would eliminate the requirement for repeating virus tests on medicines derived from human plasma. This decision is based on the premise that the raw plasma undergoes thorough screening for infections including HIV and hepatitis prior to the manufacturing process, ensuring safety from the outset. Plasma-derived products such as albumin, intravenous immunoglobulin (IVIG), and clotting factors like Factor VIII and Factor IX play crucial roles in treating immune disorders, severe infections, and bleeding conditions such as hemophilia.

Officials indicated that this amendment is intended to bring India’s drug regulations in line with international pharmacopoeia standards. According to global guidelines, pooled plasma must be tested for hepatitis B surface antigen, hepatitis C virus RNA, and HIV antibodies before it can be fractionated. Only plasma testing negative for these markers is approved for the manufacturing of such medicines.

Currently, plasma collected for these products undergoes a series of tests, including checks for viruses like HIV and hepatitis B and C. However, the existing rules mandate a second round of testing for the finished medicines produced from this screened plasma. The proposed amendments seek to eliminate this redundant testing cycle, stating that it does not align with international practices.

The Ministry of Health has released a draft notification requesting public input regarding the proposed changes to the Drugs Rules, 1945, which govern the testing and approval of blood-derived products. Dr. Aseem Kumar Tiwari, Senior Director at the Department of Transfusion Medicine in Medanta, Gurugram, highlighted that surplus plasma gathered from blood donations can be utilized for producing various lifesaving medicines at specialized fractionation facilities.

Dr. Tiwari reiterated the importance of plasma-derived medicinal products (PDMPs), including albumin and IVIG, in addressing immune disorders, severe infections, and bleeding conditions. He noted that blood centers often generate excess plasma once patient demands are met, enabling the supply of this surplus to plasma fractionators for the manufacturing process.

He further emphasized that PDMPs are subject to numerous safety protocols before they reach patients. Donated plasma is rigorously screened for various infections such as HIV, hepatitis B, hepatitis C, malaria, and syphilis. The manufacturing procedures also incorporate viral inactivation steps to enhance overall safety.

According to Dr. Tiwari, these globally recognized plasma-derived medicines have not been associated with the transmission of infections, attributing their safety to comprehensive testing and viral inactivation methods implemented during production. Officials stated that the duplication of testing at the finished product stage creates unnecessary redundancies that the proposed change intends to address while still upholding stringent safety regulations at the plasma screening stage.

The draft amendments were developed following consultations with the Drugs Technical Advisory Board. Stakeholders have been allotted a period of 30 days to provide their feedback before the amendments are finalized and implemented.

Long or Short, get news the way you like. No ads. No redirections. Download Newspin and Stay Alert, The CSR Journal Mobile app, for fast, crisp, clean updates!

App Store –  https://apps.apple.com/in/app/newspin/id6746449540 

Google Play Store – https://play.google.com/store/apps/details?id=com.inventifweb.newspin&pcampaignid=web_share