The US Food and Drug Administration's emergency approval of blood plasma as a COVID-19 treatment was put on hold last week after senior health officials said that data supporting the therapy is too weak for it to be used on coronavirus patients.
The move has caused a big concern in India where plasma therapy is being widely used for the virus treatment.
The Indian Council of Medical Research (ICMR) had in April began a randomised controlled study to assess safety and efficiency of the therapy. While the results of the therapy are yet to be made public, doctors in several states, including Delhi, Maharashtra and Haryana, have been actively prescribing plasma therapy to Covid-19 patients. Several plasma banks have also been set up across the country.
According to a report in Economic Times, the clinical trial has not shown promising results and experts now want ICMR to make the study public. “So far there is no evidence providing that evidence. The clinical trial started way back in April in India and today we are in Aug. I am amazed at this that the data has still not come,” Amar Jesani, editor of the Indian Journal of Medical Ethics, was quoted as saying by the newspaper.
The New York Times on Thursday reported that the FDA approval for plasma therapy is currently on hold as "more data is under review and the approval could still be issued in the near future, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases".
India’s first plasma bank was started in Institute of Liver and Biliary Sciences (ILBS) in New Delhi on July 2, with an objective to provide convalescent plasma to patients. Within days, another one was launched at the Lok Nayak Jai Prakash Narayan Hospital (LNJP).
This approach has been a crucial element in the Delhi model of Covid-19 response and is now, being adopted by other states as well.
So far, around 710 units of convalescent plasma have been provided to patients across hospitals in Delhi.