COVID-19 treatment: Remdesivir most likely to be in shops by June-end in India

Remdesivir has been found to speed up recovery of COVID-19 patients. Currently, the drug is only used for severely ill patients under "restricted emergency use" in India.

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Written By: Longjam Dineshwori | Updated : June 20, 2020 1:20 PM IST

The much touted COVID-19 drug, remdesivir, is likely to be widely available in the Indian market by June-end. Remdesivir is an antiviral drug origially produced for the treatment of Ebola and hepatitis C. The US Food and Drug Administration (FDA) has approved this drug for the treatment of COVID-19. It also been approved by the Drug Controller General of India (DCGI) for "restricted emergency use" on severely ill hospitalised coronavirus patients.

Last month, pharmaceutical company Gilead Sciences - the patent holder of the drug - had signed license agreements with Indian drugmakers for production and sale of remdesivir. However, India-based licensees including Dr Reddy's Laboratories, Cipla, Mylan, Hetero and Zydus Cadila have not yet received the go ahead signal from DCGI.

Some officials belonging to the Indian drugmakers told media persons that the Central Drugs Standard Control Organisation (CDSCO) will be checking the test batches for stability and if all things go well, they may get the green light in eight to 10 days, and the drug will be in the shops by the end of this month.

The officials also noted that once local production starts, the cost of treatment will come down drastically. Currently, the drug is being imported from Bangladesh and it costs as much as Rs 10,000 per dose. Once locally available, this would reduce to half i.e. Rs 5,000 per dose and it would cost Rs 55,000 for an 11-dose course per patient, according to them.

Bangladesh imports active pharmaceutical ingredients (API) for remdesivir from China. But Indian pharmaceutical companies have the capacity to produce the drug without APIs import from China, which could bring the prices of the drug, the officials added.

Clinical trials of remdesivir still underway

Clinical trials are still on in many countries including China and US to determine the safety and efficacy of the drug as a treatment for the novel coronavirus.

The health ministry on June 1 granted permission for use of remdesivir under emergency use authorization "in the interest of patient safety and to draw more data." It was allowed as an "investigational therapy" only for COVID-19 patients on oxygen support. In the US too, remdesivir is used only under emergency use authorization.

A study recently published in the New England Journal suggested that remdesivir can speed up the recovery of COVID-19 patients. It claimed that the drug helped reduced the recovery time from 15 days to 11 days. However, it was found effective only for COVID-19 patients who needed supplemental oxygen therapy, but not the severe cases requiring ventilation.

Remdesivir is also part of WHO's Solidarity trial that also include three other formulations - which are hydroxychloroquine, a combination of two HIV drugs, lopinavir and ritonavir and a formulation with lopinavir, ritonavir and interferon-beta.

How remdesivir works against COVID-19

Remdesivir works by preventing viruses (such as the novel coronavirus) from replicating themselves. It imitates the actions of the building blocks of a virus' genetic material. This makes the virus use remdesivir instead of its own gene's building blocks when it tries to copy itself. Remdesivir is administered as an injection. This drug can be used only for the treatment of adult and adolescent patients infected with COVID-19 virus. It is not a way to prevent the infection warn experts. It is also not recommended for people with severe renal problems and in children below 12 years, pregnant and lactating women.

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