India Moves to Streamline Testing for Plasma-Derived Medicines
The Central government has unveiled a significant proposal to amend existing drug regulations, aiming to eliminate the requirement for repeating virus tests on medicines manufactured from human plasma. This initiative is designed to align India's pharmaceutical standards with international pharmacopoeia norms while ensuring patient safety remains uncompromised.
Rationalizing Testing Protocols
Under current regulations, plasma collected for producing critical medicines is first pooled and rigorously screened for infectious agents including HIV, hepatitis B, and hepatitis C. However, after these medicines are manufactured from the already-screened plasma, the finished products undergo another round of testing for the same viral markers. The proposed amendment seeks to remove this second, redundant testing phase.
Officials from the health ministry emphasize that this duplication creates unnecessary procedural burdens without enhancing safety, as global guidelines already mandate comprehensive testing at the plasma screening stage before manufacturing begins.
Medicines Affected by the Change
The proposed rule change specifically impacts plasma-derived medicinal products (PDMPs), which include:
- Albumin – used for treating various medical conditions
- Intravenous immunoglobulin (IVIG) – crucial for immune disorders
- Clotting factors like Factor VIII and Factor IX – essential for managing bleeding conditions such as haemophilia
These life-saving medications are widely employed to treat immune disorders, severe infections, and bleeding conditions, with plasma often sourced as surplus from blood donation centers after meeting immediate patient requirements.
Safety Assurance Mechanisms
Dr. Aseem Kumar Tiwari, Senior Director of the Department of Transfusion Medicine at Medanta in Gurugram, explains that plasma-derived medicines undergo multiple safety checks before reaching patients. "Donated plasma is thoroughly screened for infections including HIV, hepatitis B, hepatitis C, malaria, and syphilis," he stated.
Furthermore, the manufacturing process incorporates viral inactivation steps that provide additional safety layers. Dr. Tiwari emphasized that these medicines "have not been linked to infection transmission globally due to stringent testing and viral inactivation during manufacturing."
International Alignment and Consultation Process
The proposed amendment to the Drugs Rules, 1945, follows international standards that require pooled plasma to be tested for hepatitis B surface antigen, hepatitis C virus RNA, and HIV antibodies before fractionation. Only plasma testing negative for these markers is cleared for manufacturing plasma-derived medicines.
The health ministry has issued a draft notification seeking public comments on the proposed changes, which were developed after consultation with the Drugs Technical Advisory Board. Stakeholders have been allocated 30 days to submit their feedback before the amendments are finalized.
This regulatory streamlining aims to reduce unnecessary testing burdens on pharmaceutical manufacturers while maintaining the rigorous safety protocols that have made plasma-derived medicines reliable treatment options for patients with serious medical conditions.
