How blood product rules are changing

Centre plans to update India’s regulatory framework for blood products and life-saving medicines derived from human plasma, aligning domestic testing protocols with global standards.

- Priyanka Sharma

Centre plans to update the regulatory norms for blood products and life-saving medicines derived from human plasma.

(REUTERS)

Mint explains the proposal to eliminate “double testing” for viral markers such as HIV and hepatitis at both raw material and finished product stages.

The government argues that once the source plasma is verified as safe according to international standards, repeating the same tests on the final medicine adds time and cost without improving safety. The change aims to accelerate production of essential treatments such as albumin for trauma patients, immunoglobulins for immune disorders and clotting factors for haemophilia.