India to begin production of antiviral Remdesivir drug to combat coronavirus

Guwahati: Amid the surge in coronavirus cases, India will soon begin trials for the antiviral Remdesivir drug and will have its domestic production which would have safety, efficacy, and stability for "restricted emergency use" on COVID-19 patients.

The Drug Controller General of India (DCGI) has given the approval to Remdesivir for "restricted emergency use" on severely ill hospitalized coronavirus patients.

For this, the country's top drug regulator is evaluating the application submitted by four domestic pharma giants who want to seek the approval to manufacture and sell Remdesivir in India.

"Their applications are being thoroughly studied and examined day and night. It had certain shortcomings for which the respective pharma companies are furnishing their report. The testing of the drug's molecular compound will be done at our government laboratory. When it fulfills the safety parameters at the dose, India would soon have the benefit of its domestic product (Remdesivir) which have efficacy, stability and safety for 'restricted emergency use' on COVID-19 patients," a senior government official said.

"Remdesivir is a drug that is still under trial. Hence, looking at the COVID-19 situation in the country, it has been permitted for 'restricted emergency use' on COVID-19 patients.

Doctors have to get the consent-form duly filled by the patient in a prescribed manner before using it," he stated, adding that it is the first drug in India which has such strong control.

"The drug will be administered in the form of infection in five doses. On the first day, a patient will be given two doses followed by one dose for the next four days under the strict monitoring of doctors. The drug has to be given only to those severe COVID-19 patients with oxygen saturation level below 94 and respiratory rate more than 24," the senior government official further said.

He also informed that in other countries, patients have been supervised with 10 doses of the drug.

Besides this, companies have to follow up each and every patient's case with regard to the safety and efficacy of the drug to whom it is being administered.

"Pharma companies have been directed to conduct Active-Post Marketing Surveillance of each case and prepare a report on the benefit or recovery of a patient and provide the data report to us," the official said, adding that these pharma companies have to submit a report to the government and also of a clinical trial being conducted anywhere in the world.

Remdesivir is authorized for the treatment of hospitalized patients with severe COVID-19 disease.

Remdesivir, an investigational antiviral therapy has been developed by Gilead, received Emergency Use Authorisation (EUA) by the US Food and Drug Administration (USFDA) to treat COVID-19. However, multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of the drug as a treatment for the virus.

In the recent past, Gilead had signed non-exclusive voluntary licensing agreements with four generic pharma firms — Cipla, Jubilant Life Sciences, Hetero, and Mylan to manufacture and distribute Remdesivir, a potential antiviral therapy for COVID-19.

According to Gilead, under the licensing agreements, the companies have a right to receive a technology transfer of the Gilead manufacturing process for Remdesivir to enable them to scale up production more quickly.

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