NEW DELHI: The 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 scientific standards.
Mint explains the proposal to eliminate “double testing” for viral markers such as HIV and hepatitis at both the raw material stage and the finished product stage.
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.
Harpreet Kaur, medical superintendent, head , Lab Services and Blood Centre, Aakash Healthcare in Delhi, said, “The process of production of the product involves multiple viral inactivation processes, and the blood products undergo testing at the donor level and pre-processing. The second testing causes delays and adds to the cost of production. India still imports more than 60% of plasma-derived products, so rational and cost-efficient manufacturing will help support domestic manufacturers, which in turn will improve availability of immunoglobulins, clotting factors and other essential therapies.
“However, what needs to be strengthened is the quality of donor testing across pan-India blood centres, ensuring NAT testing for all, and ensuring full traceability of plasma units. Another challenge may be emerging new viral diseases where additional testing could sometimes be required. If this is stringently followed at the collection level, the public perception of safety of not only blood products but plasma-derived medicines will also improve.”
What specific legal change is being introduced to the Drugs Rules?
The ministry of health and family welfare issued a draft notification on 9 March proposing changes to the Drugs Rules, 1945. The proposal removes the requirement to test finished blood products for HIV, Hepatitis B and Hepatitis C.
By eliminating this mandate, the government aims to streamline a market that was valued at $383.5 million in 2024 and is expected to grow rapidly by 2032.
Why has the government decided to remove these final-stage tests?
The decision follows global scientific practice that prioritizes testing the “first homogeneous pool” of raw plasma. Leading international standards, including the Indian Pharmacopoeia (IP), British Pharmacopoeia (BP), United States Pharmacopeia (USP) and European Pharmacopoeia (EP), focus on verifying the safety of the source material rather than repeating identical tests on the finished medicine.
The government argues that removing this step reduces administrative and financial pressure on manufacturers and allows essential treatments to be produced more efficiently.
Which viral markers are affected by this move to end double-testing?
Previously, manufacturers were required to test twice for three markers: HIV I and II antibodies, the Hepatitis B surface antigen and Hepatitis C virus antibodies.
Under the proposed rules, these checks will remain mandatory at the raw material stage to confirm safety at the start of the manufacturing process, but will no longer be required for the finished product.
How will this shift impact patients and the medical industry?
Removing redundant testing steps could speed up the production of critical medicines such as albumin for trauma and liver disease, immunoglobulins for immune disorders and clotting factors for haemophilia.
It also supports the use of fibrin sealants, which act as biological glue during surgery. The change could lower production costs and reduce the risk of medicine shortages by shortening regulatory timelines.
Does this amendment bring India in line with international medical standards?
Yes. By updating these rules, India is aligning its regulatory approach with systems used in the UK, the US and Europe.
The focus shifts to verifying the safety of the source plasma, the method widely used to ensure safety across the manufacturing chain. The ministry of health has invited public comments on the draft notification within 30 days.