The US Food and Drug Administration has approved Remdesivir, an anti-viral drug, for the usage in COVID-19 hospitalised patients among adults and the pediatric population i.e. 12 years and above. However, it might not lead to extensive use as a treatment option in India. Doctors have said that only restricted or emergency use of Remdesivir will be used in Indian patients till more robust data arises.

On 22nd October, Remdesivir received a full regulatory acceptance and became the 1st drug for COVID-19 to receive US FDA approval.

The approval was given even though in the recent World Health Organisation’s Solidarity Trials presented that the drug was ineffective in decreasing the mortality or length of hospital stay. In May, the US regulator authorised Veklury or Remdesivir only for emergency use.

In India, the indiscriminate use of the drug in patients needs to be limited as almost all scientific studies have shown that it was ineffective in reducing mortality or hospital stay. At present, it is approved only for restricted emergency use.

Dr SP Kalantri Professor of Medicine of Mahatma Gandhi Institute of Medical Sciences, Sevagram said that India needs affordable, scalable and unbiased treatments. The WHO Solidarity trial has produced data that is remarkably independent, clear and also robust. They don’t think that they should let the US FDA initiate the treatment protocols. Physicians have a moral authoritative and an ethical responsibility to use interventions which are proven, known to save lives and also are cost-effective.

Experts have argued that the need for earlier use of Remdesivir, however, even if it gave modest benefits, the absolute numbers of saved lives are very less.

Dr Shashank Joshi, who is a member of the state’s COVID-19 task force said that if the drug is used early, in the first nine days of the infection then it can improve recovery.

Maharashtra had issued a warning against the rampant use of Remdesivir and had advised only a restricted use policy in moderate to severe hospitalised cases since August.

The agency’s analysis of information from 3 controlled and randomized clinical trials that included mild-to-severe coronavirus hospitalized patients, supported the US FDA approval.

Source: The Times of India