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by IANS |
New Delhi, March 11 (IANS) The government has issued a draft Gazette Notification proposing amendments to avoid duplicate viral testing of blood products and invited public comments on it, an official statement said on Wednesday.
The amendment aims to align regulatory requirements for testing of blood products with internationally accepted pharmacopeial standards and to remove additional testing requirements on products that are not warranted under global best practices, the Ministry of Health and Family Welfare said in the statement.
The amendments were proposed to "Para G (Testing of Blood Products), Part XII C, Schedule F of the Drugs Rules 1945".
The ministry described the move as a step toward regulatory harmonisation, scientific rationalisation of testing requirements and reduction of avoidable compliance burden while continuing to uphold patient safety.
Under harmonised standards cited in the draft, the first homogeneous pool of human plasma for fractionation must be tested for Hepatitis B surface antigen, Hepatitis C virus RNA and antibodies to HIV, and pooled plasma must test negative for these viral markers before fractionation.
The draft noted that only plasma pools meeting these safety requirements should be used to manufacture plasma?derived medicinal products.
Under the current regulatory framework, the final products manufactured from already tested and qualified plasma pools are again tested.
The new rules prevent duplication of efforts, which currently test the same viral markers at both the pooled plasma stage and the finished product stage.
"Stakeholders are encouraged to review the draft notification and submit their comments and suggestions within the prescribed timeline," the statement noted.
The government recently conducted a discussion session on developing 1.5 lakh "multiskilled caregivers" capable of meeting India’s increasing domestic needs while also tapping into emerging global opportunities in the care economy.
The Union Budget 2026–27 has announced a significant push to strengthen the care ecosystem by introducing NSQF-aligned training programmes that combine core caregiving competencies with allied skills, including wellness support, yoga, and the operation of medical and assistive devices.
—IANS
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