The Drugs Controller General of India has given approval for emergency use to an oral drug, developed by the Defence Research and Development Organisation, for the treatment of moderate to severe coronavirus patients. The approval was given on May 1.
The Ministry of Defence said on Saturday that the drug developed from the molecule 2-deoxy-D-glucose, also called 2-DG, has been permitted to be used as an adjunct therapy. This means that 2-DG can be used along with the primary treatment given to Covid-19 patients. The Defence Research and Development Organisation, or DRDO, is an agency under the Ministry of Defence.
A statement released by the defence ministry said that 2-DG can be easily produced and made available in plenty in the country as it is an analogue of glucose, meaning it has a similar structure to the compound. Glucose is commonly known as simple sugar.
The statement said that the drug comes in the form of powder and can be taken orally. The drug accumulates in the virus-infected cells and prevents its growth. “Its selective accumulation in virally infected cells makes this drug unique.”
The ministry said that DRDO began developing anti-Covid therapeutic application of the drug during the first coronavirus wave last year. The early tests conducted by DRDO’s Institute of Nuclear Medicine and Allied Sciences along with the Centre for Cellular and Molecular Biology, Hyderabad, showed effective results against the coronavirus.
India’s drug regulator then allowed Phase 2 clinical trial, which was conducted between May and October of 2020. “The drug was found to be safe in Covid-19 patients and showed significant improvement in their recovery,” the statement said.
The efficacy trends showed that 2-DG cured symptomatic patients faster than the standard of care procedure, the statement said. The standard of care is a general medical or psychological treatment guideline.
Based on these results, the Drugs Controller General of India allowed the DRDO to conduct Phase 3 trials between December 2020 and March 2021. The trial was conducted at 27 Covid-19 hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka and Tamil Nadu.
The Phase 3 results showed that 42% of patients improved symptomatically and became free from supplemental oxygen dependency by day 3 in comparison to 31% given the standard of care treatment.
“In the ongoing second Covid-19 wave, a large number of patients are facing severe oxygen dependency and need hospitalisation,” the ministry said. “The drug is expected to save precious lives due to the mechanism of operation of the drug in infected cells. This also reduces the hospital stay of Covid-19 patients.”
India is reporting an unprecedented surge in coronavirus cases and deaths. The health infrastructure has collapsed under the pressure. There is an acute shortage of medical supplies and equipment such as medicines and beds, and especially oxygen.
On Saturday, India recorded 4,187 coronavirus-related deaths, the highest ever since the pandemic broke out last year. With this, the toll rose to 2,38,270.
The country also recorded 4,01,078 new cases in 24 hours, taking the tally of infections to 2,18,92,676. This is the fourth time since May 1, when the daily infection count rose by more than 4 lakh.