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India Overhauls Blood Product Viral Testing
11 Mar
Summary
- Government proposes amendments to eliminate duplicate viral tests on blood products.
- New rules align testing with international pharmacopeial standards.
- Draft changes affect Para G, Part XII C, Schedule F of the Drugs Rules 1945.
The government has introduced draft amendments to the Drugs Rules 1945, specifically targeting Para G, Part XII C, and Schedule F, to eliminate redundant viral testing of blood products. This initiative aims to harmonize India's regulatory framework with globally accepted pharmacopeial standards. By removing unnecessary duplicate tests, the move seeks to enhance regulatory efficiency and reduce compliance burdens for manufacturers.
The proposed changes will ensure that only plasma pools testing negative for critical viral markers, such as Hepatitis B, Hepatitis C, and HIV, proceed to fractionation. This standardization is a scientific rationalization of testing requirements, designed to uphold patient safety without imposing extra, unwarranted tests on products. Stakeholders are invited to provide comments on the draft notification.
This regulatory update reflects a broader effort to strengthen the care ecosystem and adopt international best practices. It complements recent discussions on developing a skilled caregiver workforce and aligns with the Union Budget's push for enhanced caregiving training programs.
