To ensure regulatory harmonisation in testing blood products with global norms, the Centre has proposed doing away with testing of pooled blood plasma for Hepatitis B surface antigen and antibodies to HIV and Hepatitis C, considering these tests are done before the products are manufactured.
Pooled blood plasma is a standardised product created by the combination of plasma collected from multiple donors, which is then processed, tested and used for therapeutic, diagnostic and research purposes.
In a gazette notification amending the Drugs and Cosmetics Act, the Union health ministry said the requirement of final products to be tested for freedom from HIV I and HIV II antibodies, Hepatitis B surface antigen and Hepatitis C virus antibody shall be omitted.
'The proposed amendment is a progressive step towards regulatory harmonisation, scientific rationalisation of testing requirements, and reduction of avoidable compliance burden while continuing to uphold the highest standards of patient safety,' the ministry said in a press note.
It added that the first homogeneous pool of plasma is mandatorily tested for Hepatitis B surface antigen (HBsAg), Hepatitis C virus RNA and antibodies to HIV, according to the harmonised standards of Indian, British, European and United States pharmacopoeias.
-- Sanket Koul, Business Standard
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