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Overview of Blood Plasma Fractionation in India

Blood Plasma Fractionation 

The importance of blood is often overlooked, as we forget to acknowledge this crucial fluid pumping through our body. Blood comprises ~55% plasma (to transport nutrients, hormones and proteins), ~44% red blood cells (carrying oxygen) and <1% white blood cells and platelets (containing immune cells and clotting factors).

Plasma specifically carries essential nutrients, hormones and proteins across the body, aside from salt, water and enzymes. For this reason, plasma forms a critical part of treatment for several serious health problems. Its vital components including antibodies, clotting factors, and the proteins albumin and fibrinogen can be separated and used as therapies for those suffering from trauma, shock, burns, immune deficiency disorders as well as rare chronic conditions. This process of separating the plasma into its constituent proteins is known as blood plasma fractionation. Therapeutic uses of these fractions are vast, including for congenital or immune deficiency disorders, restoration of blood volume in trauma and highly effective technologies for the inactivation of viral contaminants, such as hepatitis viruses and Human Immunodeficiency Virus (HIV). 

biotech

 

Obtaining the plasma can be done in two ways:

  1. Whole blood (recovered plasma): Recovered plasma is plasma recovered by centrifugal separation from the cells and cellular debris of whole blood
  2. Apheresis (source plasma): Apheresis is a medical procedure that involves removing whole blood from a donor or patient and separating the blood into individual components so that one particular component can be removed. The remaining blood components then are re-introduced back into the bloodstream of the patient or donor. It is usually done to remove disease-provoking elements. Commercial apheresis is not permitted in India. Collection of source plasma could be encouraged only as a voluntary activity and donors cannot be compensated.
 

Blood Plasma Fractionation Centres in India 

As per government records, India has more than 2,700 blood banks collecting about 10–11 million units of blood on an annual basis, but it is often in short supply. India’s usage of plasma derivatives per capita is less than that of developed countries. Thus, India relies heavily on imports for plasma products, considered to be life-saving medicines. India currently only produces 2 plasma products; albumin and intravenous immunoglobulin, however, ten other plasma products are imported, resulting in a huge demand-supply gap in the country. 

As of 2018, India has four plasma fractionation units and fractionates albumin, immunoglobulins, factor VIII, factor IX and fibrin glue. Since source plasma collection is not permitted in India, India remains completely import-dependent as far specialized immunoglobulins are concerned. This dependency could be either in the form of getting full finished products or importing in the form of bulk or plasma.

Wastage: 

Unfortunately, due to rampant whole blood therapy, only 40% of blood is componentized to blood cells and plasma, while excessive clinical usages of plasma and regulatory hurdles leaves only 0.50–0.55 million L of plasma available for fractionation

Self-sufficiency:

Self-sufficiency ratio is the key parameter to assess the ability of a country to meet its need for plasma derived medicines, through the utilization of locally collected plasma, either fractionated domestically or abroad. This ratio is product specific and can vary from country to country based on the requirement for the product in question.

In the context of India, the self-sufficiency ratio of:

  • IVIG – 46%
  • Human albumin – 24%
  • Factor VIII – 75% (90% comprising imports)
 

Regulation

  • The Drugs and Cosmetics Rules, 1945, framed under the Drugs and Cosmetics Act, 1940:
    • Includes human blood under the definition of “Drugs” under Section 2(b)
    • Regulates functions of blood banks, which provide recovered plasma for plasma fractionation
    • Part XII C specifically regulates the collection and storage of plasma for fractionation
  • The National AIDS Control Organization (NACO), under the Ministry of Health and Family Welfare) to oversee operation of blood banking services in India 
  • National Blood Transfusion Council (NBTC) is the apex policy-making body, under NACO, making central licensing mandatory, increasing voluntary donation base and setting of quality standards. Similarly, State Blood Transfusion Councils (SBTCs) are responsible for the smooth functioning of blood transfusion services at a state level. 
  •  Drug Standard Control Organisation (CDSCO) and State Drug Control Organisations play a vital role in key aspects such as, approval of licenses, and enforcement of standard transfusion practices to ensure safe, quality and efficacious blood and its components in clinical practices.
  • National Institute of Biologicals (NIB) is the nodal governmental organization under the Ministry of Health and Family Welfare responsible for the testing and release of biologicals in India including blood plasma. 
 

Policies and Guidelines for Fractionation

  • The National Blood Policy 2002 regulates blood quality and the Guidelines of NBTC 2016 has been brought out by NACO. NBTC has formulated guidelines for recovery of Processing Charges for Blood and Blood Components across blood banks in all sectors. It has also laid down uniform norms for issuance of No Objection Certificates (NOCs) for new blood banks, renewal of license, criteria for designation Blood Bank as RBTC, Guideline on Bulk Transfer of Blood and Guidelines on exchange of surplus plasma with indigenous fractionators has been released by NBTC to support voluntary blood donation and rationalize blood utilization. 
  • National Policy for Access to Plasma Derived Medicinal Products from Human Plasma for Clinical / Therapeutic Use covers the process of collecting standard plasma and transporting them under optimum conditions for fractionation, identifying critical parameters for safety, and ensuring compliance with regulatory requirements and training.
  • Price control: Under the Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals, the prices of medicines are controlled by the National Pharmaceutical Pricing Authority. Currently, plasma products under price control include albumin, AHF, anti-D immunoglobulin, anti-tetanus immunoglobulin and anti-rabies immunoglobulin however plasma itself is not under price control. 
  • See also: Changes to the NABH Blood Bank Accreditation Standards (Edition 3)