New Delhi, August 6, 2025 — In a bid to overhaul the regulatory framework for plasma-derived medicines, the Union Health Ministry has proposed new guidelines for establishing and operating Plasma Fractionation Centres across India. This move aims to ensure quality, safety, and availability of critical plasma-based therapies in the country.
These centres play a vital role in separating plasma into life-saving components like immunoglobulins, clotting factors, and albumin — essential treatments for conditions such as hemophilia, immune disorders, and liver diseases.
What Are Plasma Fractionation Centres?
Plasma fractionation involves extracting specific proteins from plasma (the liquid component of blood) to produce medications used for various medical conditions. Despite India having a massive population and significant blood donation potential, the country relies heavily on imports for plasma-derived medicinal products.
This dependence on foreign manufacturers has been a longstanding challenge. The Health Ministry’s new proposal is expected to change this by encouraging local facilities and stricter compliance.
Proposed Guidelines at a Glance
According to the draft Standard Operating Procedures (SOPs), the new framework focuses on:
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Setting up facilities that meet WHO-GMP standards.
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Licensing protocols under Drugs and Cosmetics Act, 1940.
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Quality controls during plasma collection, transport, testing, storage, and fractionation.
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Traceability mechanisms for donor safety and batch tracking.
The National Blood Transfusion Council (NBTC) and the Central Drugs Standard Control Organization (CDSCO) will jointly oversee implementation.
Why It Matters
India has only a few operational plasma fractionation centres — most of them are in the private sector. This has led to high costs, inconsistent supply, and dependence on imported plasma-derived products (PD
Ps).
Industry insiders point to delays in licensing, lack of incentives, and absence of clear regulations as key roadblocks. The new SOPs aim to resolve these and streamline plasma supply chains nationwide.
Dr. Ritu Singh, a transfusion medicine expert at AIIMS, said, “With the right policies, India can become a hub for affordable plasma medicines. These SOPs are long overdue.”
Global Comparison
Globally, countries like the United States, Germany, and Japan run highly regulated plasma industries with public-private partnerships. India’s revised guidelines are expected to draw from global best practices to ensure both efficacy and ethical sourcing.
WHO and the http://International Plasma Fractionation AssociationInternational Plasma Fractionation Association (IPFA) have also advocated for self-sufficiency in plasma-derived product manufacturing — especially for populous countries like India.
What’s Next?
The Health Ministry has invited stakeholder feedback on the draft SOPs until August 31, 2025. A final version will be issued later this year, potentially laying the foundation for a plasma policy under the National Blood Policy 2025 revision.
The government is also considering financial incentives for private firms and research support to boost domestic fractionation capabilities.
For continued updates, visit MedicarePharmaBusiness.com.
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