Health Ministry Proposes Removing Duplicate Viral Testing Of Blood Products

The Ministry of Health and Family Welfare has issued a draft Gazette notification proposing amendments to remove duplicate viral testing of blood products in India.

The Health Ministry has invited public comments on a draft proposal to remove duplicate viral testing of blood products and align regulations with international pharmacopeial standards.

The proposed amendment relates to Para G (Testing of Blood Products), Part XII C, Schedule F of the Drugs Rules, 1945.

Officials said the move aims to harmonise regulations, rationalise testing requirements and reduce compliance burdens while maintaining patient safety.

Under the draft norms, laboratories must test the first homogeneous pool of human plasma used for fractionation for key viral markers such as Hepatitis B surface antigen, Hepatitis C virus RNA and antibodies to HIV.

Manufacturers will use only plasma pools that test negative to produce plasma-derived medicinal products.

Currently, regulators require another round of viral testing on final products made from already tested plasma pools.

The amendment removes this duplication because authorities already test the same viral markers at both the pooled plasma and finished product stages.

Officials said eliminating the repetition will streamline regulatory procedures without compromising safety and reduce avoidable compliance requirements for manufacturers.

The government has asked stakeholders to review the draft notification and submit comments within the prescribed timeline.

Separately, the government is also working to strengthen India’s care economy.

Discussions have been held on developing around 1.5 lakh multiskilled caregivers to meet domestic healthcare needs and global opportunities.

The Union Budget 2026–27 also proposed expanding training programmes aligned with the National Skills Qualifications Framework (NSQF), combining caregiving skills with wellness support, yoga and the use of medical and assistive devices.

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