The plasma therapy for treatment of coronavirus patients is at an experimental stage and it has the potential to cause life-threatening complications, the Union Health Ministry said on Tuesday, warning against its use.
The comments by the ministry came in the midst of hope that plasma therapy could provide a possible cure from the coronavirus infection.
The ministry said the therapy is at an experimental stage and that there is no evidence yet to support that it can be used as treatment for COVID-19.
It is not immediately clear what prompted the government to strongly recommend against plasma therapy for the COVID-19 patients.
On Sunday, Delhi Chief Minister Arvind Kejriwal spoke about the success of Delhi's first case of plasma therapy and appealed to all people who have recovered from COVID-19 to come forward and donate plasma for the virus-infected patients.
Following the appeal, a number of people who contracted the virus during the Tablighi Jamaat congregation in the capital and recovered from it pledged to donate plasma for the treatment of other patients.
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Till the effectiveness of this mode of treatment is scientifically proven, its application except for research and clinical trial is illegal, Joint Secretary in the Ministry of Health Lav Agarwal said at a media briefing.
He said, at present, there are no approved therapies for coronavirus and there is not enough evidence to claim that plasma therapy can be used for treatment of the deadly disease.
"Till ICMR concludes its study and a robust scientific proof is available, plasma therapy should be used only for research or trial purpose. If plasma therapy is not used in a proper manner under the proper guidelines, then it can also cause life threatening complications," he said.
A number of medical experts too concurred with Agarwal.
"The convalescent plasma therapy is still in an experimental form in the treatment for COVID-19. It is being evaluated and needs to have good and well conducted research trials before the therapy can be recommended for routine use in coronavirus infected patients," AIIMS Director Randeep Guleria told PTI.
He said it is necessary for all institutes to take necessary approvals from the ICMR and Drug Controller General of India to carry on with the clinical practice for the research on the therapy.
"In very limited studies, globally, convalescent plasma as an adjunct to other supportive therapies and treatments has shown some benefit in the management of severe patients of COVID-19," he said.
Guleria said giving plasma from a recovered patient without testing whether it has enough antibody or not may cause more harm than benefitting a patient. He said that AIIMS is working with the ICMR to conduct a clinical trial on the efficacy of convalescent plasma therapy in COVID-19 patients.
Dr Neeraj Nischal, Associate Professor in the department of medicine at AIIMS, too said that plasma therapy is not fool-proof.
"This therapy is not fool-proof and is associated with risks like inadvertent transfer of blood borne infections and reactions to serum constituents, including immunological reactions such as serum sickness and may worsen the clinical condition," Dr Nischal said.
In a tweet, chairperson of Biocon Limited Kiran Mazumdar Shaw called the health ministry's statement "inaccurate given the amount of global data available on the efficacy of the therapy.
"It is saving lives," she said.
The ICMR, in a series of tweets, said that there are no approved and definitive therapies for COVID-19 at present, adding plasma therapy is one of the several emerging therapies.
Even the US Food and Drug Administration has viewed it as an experimental therapy, it said.
"Despite the threat of the COVID-19 pandemic, there is a need to ensure the ethical integrity and establish the scientific basis of using the convalescent plasma therapy in patients with coronavirus infection," the ICMR said in a tweet.
Meanwhile, Agarwal, pointed out that 20 nations, which according to the WHO have maximum number of COVID-19 cases, reported 200 times more deaths and 84 times more cases than that in India.
The combined population of these 20 countries, which have reported maximum number of coronavirus cases according to the WHO data as on Monday, is almost equal to that of India, the official underlined.
"The reason we have been able to manage little better as compared to other countries is because our response has been proactive, preemptive and graded towards tackling the challenge of COVID-19 crisis," he said.
Agarwal further said that the doubling time of coronavirus cases in India was 3 to 3.25 days before the lockdown was imposed and now it is around 10.2 days. "This is mainly because of our focus on containment, physical distancing and lockdown measures," he highlighted.
Talking about medical professionals getting infected across the country, Agarwal said that if a healthcare professional does not take precautions and follow the laid down guidelines then he can contract the disease and it has been an issue of concern.
"We have been conducting training in this regard. If required guidelines are not followed then there is a risk of contracting the disease. Even, in the case of other diseases the health professionals have to take due precautions," he said.
Reacting to reports about cases of infection in patients after they have recovered, Agarwal said that globally the percentage of such cases is minuscule.
"Miniscule percentage of recovered patients again were found to be infected by the disease. As the number is so small, it is not enough to have conclusive evidence over it."