Remdesivir, which is administered intravenously in hospital, is the first drug to show improvement in Covid-19 patients in formal clinical trials and is at the forefront of the battle against the disease, which has no approved treatment or vaccine.
The drug was granted emergency use authorisation by the US Food and Drug Administration last month and has received approval by Japanese health regulators.
The drug is being administered in some countries under compassionate use rules.
“(Remdesivir) approved on June 1 under emergency use with condition for five dose administration,” the Drugs Controller General of India said in an e-mail statement.
The approval comes a day after the US drugmaker reported that remdesivir showed modest benefit in patients with moderate Covid-19 given a five-day course, while those who received it for 10 days in the study did not fare as well.
The drug has been approved for the treatment of adults and children with severe Covid-19, the Indian Express newspaper reported yesterday, citing sources.
The regulator has decided against extending the use of the drug to 10 days, based on existing evidence presented to it at the time of approval, according to the paper.
Gilead did not respond to an e-mail seeking further details.
The company signed non-exclusive licensing pacts last month with five generic drugmakers based in India and Pakistan, including Cipla Ltd and Jubilant Life Sciences Ltd, to expand supply of the drug.
As yesterday, India has 198,706 cases of coronavirus and has recorded 5,598 deaths, health ministry data showed.
Ministry also said the coronavirus recovery rate is improving, while the fatality rate is on the decline and one of the lowest in the world.
“The recovery rate is continuously improving, a total of 95,527 patients have been cured,” the ministry’s Joint Secretary Lav Agrawal said.
The recovery rate is now 48.07%, up from 11.42% on April 15.”
He said that the fatality rate is also declining and stands at 2.82%, which he claims is the “lowest in the world”, compared to a global fatality rate of 6.13%.
“Our case fatality rate per lakh population too is amongst the lowest in the world, while there are countries with a figure as high as 62 and 82.”
“We have been able to achieve this due to timely identification of cases and proper clinical management,” he said.
Agrawal said 73% of the deaths in the nation have been of people with comorbidities such as diabetes, hypertension, heart and respiratory diseases.
