Indian plasma fractionation industry: challenges and opportunities

Under Indian regulation of biopharmaceutical products, transfusion medicine and plasma protein therapies are largely governed under the same regulatory framework. Since apheresis “Source” plasma collection for fractionation is not permitted under the Indian laws, domestic plasma product production is largely dependent on the domestically available recovered plasma. According to World Health Organization (WHO) each country must plan for its safe and consistent supply of blood and plasma products for regular clinical needs as well as in case of any disaster. WHO also suggests that at least 1% of citizens should donate the blood to take care of the country’s need from the point of blood component supply, but the same may not be enough for making plasma products therapy available to all needy patients, as India does not componentize all collected blood. India annually collects about 10–11 million units of blood, which is about 0.9% rate of blood donation. This may not be sufficient and therefore many times, especially in the situations of crisis, blood is in short supply in urban and rural areas. This 1% could be an ideal situation; but looking at the emerging disease pattern and the medical tourism, it is estimated that actual demand of blood in India may be much higher. This situation is further compounded by the fact that only 40% of collected blood is componentized to the packed cells, platelets and plasma. This results into a huge wastage of blood and very low availability of domestic plasma for manufacturing the plasma protein therapies. Though the situation of supply of blood and plasma products has improved in the last one decade, but a lot needs to be done to achieve self-sufficiency in the field of blood and plasma protein therapies.