This comes in the backdrop of several blood recipients and organisations pushing for more stringent norms when it comes to blood and blood products. (Photo: Freepik)
The union health ministry has proposed doing away with testing blood products such as plasma for Hepatitis B surface antigen and antibodies to HIV and Hepatitis C, considering these tests are done before the products are manufactured. According to the draft notification, the words “The final products shall be tested for freedom from HIV I and HIV II antibodies, Hepatitis B surface antigen and Hepatitis C virus antibody” will be removed from the drug rules.
Comments have been invited from stakeholders over the period of one month.
The health ministry in a note explained that this has been done for “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 explained that the requirements for pooled blood plasma — plasma derived from the blood of several donors — already has to be tested as per the various pharmacopeia standards, including Indian Pharmacopeia. The ministry explained that when human plasma is pooled, it is mandatorily tested for these infections. Only the pools that are found to be negative for the infections are then used for fractionation — a process where different blood components get separated.
“Despite this, under the current regulatory framework, the final products manufactured from already tested and qualified plasma pools are again tested. This results in duplication of testing for the same viral markers at both the pooled plasma stage and the finished product stage,” the ministry said.
This comes in the backdrop of several blood recipients and organisations pushing for more stringent norms when it comes to blood and blood products, including the more accurate nucleic acid amplification testing that reduces the window period — time between an infection occurring and it showing up on the tests.
Anonna Dutt is a Principal Correspondent who writes primarily on health at the Indian Express. She reports on myriad topics ranging from the growing burden of non-communicable diseases such as diabetes and hypertension to the problems with pervasive infectious conditions. She reported on the government’s management of the Covid-19 pandemic and closely followed the vaccination programme.
Her stories have resulted in the city government investing in high-end tests for the poor and acknowledging errors in their official reports.
Dutt also takes a keen interest in the country’s space programme and has written on key missions like Chandrayaan 2 and 3, Aditya L1, and Gaganyaan.
She was among the first batch of eleven media fellows with RBM Partnership to End Malaria. She was also selected to participate in the short-term programme on early childhood reporting at Columbia University’s Dart Centre. Dutt has a Bachelor’s Degree from the Symbiosis Institute of Media and Communication, Pune and a PG Diploma from the Asian College of Journalism, Chennai. She started her reporting career with the Hindustan Times.
When not at work, she tries to appease the Duolingo owl with her French skills and sometimes takes to the dance floor. ... Read More