The Medicines and Healthcare Products Regulatory Agency had suspended enrollment into the trial after a paper was published in the journal Lancet last month that suggested there was an increased death risk linked to the drug. The paper was found to be based on fraudulent data and was retracted.
India has been using hydroxychloroquine, commonly known as HCQ, for treatment of COVID-19 patients and as prophylactic in high-risk groups such as healthcare and other frontline workers.
The FDA on June 15 withdrew the EUA for Chloroquine Phosphate (CQ) and Hydroxychloroquine Sulfate (HCQ), as it no longer believes the drugs may be effective in treating COVID-19 and that their side-effects may outweigh any potential benefit.
"The hydroxychloroquine arm of the SOLIDARITY trial has been stopped," WHO expert Ana Maria Henao-Restrepo told a news briefing.
US FDA revoked the authorization following a request from Gary Disbrow, acting director of the Biomedical Advanced Research and Development Authority (BARDA).
Hydroxychloroquine has demonstrated in-vitro activity against SARS-CoV2 and was shown to be clinically beneficial in several small single-centre studies though with significant limitations, it stated.
The much-touted anti-malarial drug hydroxychloroquine will continue to be used while azythromycin may be dropped from the treatment protocol, sources in the know of the developments told PTI.
"Department of Pharmaceuticals has approved the lifting of ban on Export of Hydroxychloroquine API as well as formulations," India's minister for chemicals and fertilizers, Sadananda Gowda, said on Twitter.
Researchers found "no significant difference" in mortality rate after 28 days of administering HCQ to Covid-19 patients.
"There are two distinct trials with their own protocols, their own oversight committees. Therefore we will continue for now," Soumya Swaminathan, the WHO's chief scientist, told an online news briefing when asked about the British trial halt.
The World Health Organization had suspended the hydroxychloroquine (HCQ) arm of the clinical trials of experimental COVID-19 drugs over safety concerns
"Several concerns were raised with respect to the veracity of the data and analyses conducted by Surgisphere Corporation and its founder and our co-author, Sapan Desai, in our publication," the authors of the study wrote in the retraction statement published in The Lancet journal.
The global heath body had earlier suspended the hydroxychloroquine (HCQ) arm of the clinical trials of experimental COVID-19 drugs over safety concerns. However on Wednesday, it recommended the trial to be continued following a review of safety data.
"We are issuing an Expression of Concern to alert readers to the fact that serious scientific questions have been brought to our attention. We will update this notice as soon as we have further information," the editors of the journal said.
Researchers conducted a randomised, double-blind, placebo-controlled trial across the United States and Canada to test Hydroxychloroquine as a post-exposure prophylaxis.
Early hopes for the decades-old drug were based in part on laboratory experiments and its anti-inflammatory and antiviral properties. But its efficacy has so far failed to pan out in human trials, and at least two studies suggest it may increase the risk of death.
Hydroxychloroquine sulfate was first synthesised in 1946 and is in a class of medications historically used to treat and prevent malaria. It is approved by the US Food and Drug Administration to treat malaria, rheumatoid arthritis, lupus, childhood arthritis, and other autoimmune diseases.
The preliminary results suggest doctors may want to refrain from prescribing the decades-old malaria treatment hydroxychloroquine with the antibiotic azithromycin for these patients until more study is done, researchers said.
While some experts feel that after the WHO decisions, country's medical centres will have to take HCQ and chloroquine our of the treatment regimen of COVID-19 patients, others opined it is "not binding" for India to oblige with the decision of the world body.
The World Health Organization said Monday that it will temporarily drop hydroxychloroquine — the anti-malarial drug US President Trump says he is taking
Hydroxycholoroquine has been touted by Donald Trump and others as a possible treatment for the disease caused by the novel coronavirus. The U.S. President has said he was taking the drug to help prevent infection.
The authors said they could not confirm if taking the drug resulted in any benefit in coronavirus patients.
Trump disclosed on Tuesday that he was taking the drug despite medical warnings about potential serious side effects and questions about its effectiveness in preventing the coronavirus.
I'm just very curious myself, but it seems to be very safe,” Trump told reporters at the White House, a day after he disclosed that he has been taking the drug to ward off the deadly infection.
Trump volunteered the disclosure during a question-and-answer session with reporters at the White House as he met restaurant executives whose businesses are reeling from the impact of the virus.