(This article was originally published on 22.04.20 and has been republished in light of clinical trials starting, and recovered Tablighi patients pledging to donate plasma.)
Blood plasma is a component of blood, separate from blood cells, and contains, among other things, proteins. Around the world, plasma therapy trials of convalescent plasma in COVID-19 cases with antibodies are being carried out. Although these are early stages, reports have emerged that harvesting the plasma from recovered patients and giving it those who are critically ill is an effective treatment option – one which would decrease the fatality from COVID-19, altering the nature of the public health emergency.
The Karnataka government, in a circular issued on 6 April 2020, has recommended that clinical trial be started for plasma therapy for coronavirus. Delhi has also directed a clinical trial, and the Indian Council for Medical Research (ICMR) has also asked for the same.
These trials, and the subsequent use of this therapy if it shows results, require not only testing approval, but also changes in the regulatory regime for plasma collection.
The Karnataka government has asked for clinical trials to start, after seeking permission from the authorities. States have little power to do otherwise, as the power rests with the Drug Controller General of India, and other central agencies.
Collateral Damage to Past Problems of Blood Donation
Plasma products can be used for the treatment of a number of illnesses, including possibly coronavirus, but India does not process plasma to make plasma products. This is perhaps collateral damage to the past problems of blood donations. The Supreme Court of India, in 1996, in a case bought by Common Cause, reacting to the frequent selling of blood by people and the unregulated nature of the industry, mandated much needed strict regulations, including a ban on ‘professional donors’. It also established a National Council for Blood Transfusion (NBTC) and directed other fundamental changes in the regulatory system, including centralising the regulatory powers.
This was a necessary reaction, but it also led to numerous problems in the already scarce blood supply of the country.
Although comprehensive regulations have come forth on the licensing of blood banks, and their safety regulations, there is a perennial shortage of blood donation, and often, those undergoing treatment must arrange for voluntary blood donors for their blood transfusion.
Moreover, it failed to consider the potential impact of the regulations on plasma protein therapy.
Plasma is only allowed to be collected within blood banks. This is problematic because the system of plasma recovery for plasma products should ideally be from plasma taken directly (source plasma), often from donors with a particular profile, rather than as a by-product of blood donations (recovered plasma). This process is entirely non-functional. Therefore, India has to import most of its human plasma products, such as Albumin, Immunoglobulins, and other proteins, and, as a result, often these products are in short supply.
For Plasma Therapy to be Tested Adequately Here’s What We Need
In India, it is ‘recovered plasma’ that is at present being used clinically or in the almost negligible plasma fractionation (where the different components are separated). However, as stated above, domestic production of plasma products needs source plasma. The reason we cannot have that is that regulations as per the Drugs and Cosmetics Rules are incomplete.
On the one hand, there are no regulations for the profiling of donors and making reasonable compensation available to them.
On the other hand, there are severe regulations on the amount of plasma one can donate, and their frequency. There is also poor infrastructure to extract the plasma, screen it for infections, and to transport it. Plasma can only be collected in blood banks. There is negligible fractionation capability in India.
For plasma therapy to be tested adequately, and where necessary, used widely, the plasma regulations must be amended.
Specific and profiled donors of plasma must be allowed to donate more than the limited amount so that antibody plasma can be used effectively. Fair and regulated compensation must be allowed to be paid to them. The frequency of source plasma that can be collected from donors must be increased.
Private hospitals and companies must be allowed to set up plasma collection centres.
These are some changes that those in the plasma industries have been asking for some time, but their implementation takes on a new imperative in light of the COVID-19 pandemic.
(Avi Singh is an advocate who specialises in transnational law and serves as the Additional Standing Counsel for the government of NCT of Delhi. This is an opinion piece and the views expressed are the author’s own. The Quint neither endorses nor is responsible for them.)
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