COVID 19: India to start domestic production of Remdesivir

With a rapid increase in the number of coronavirus cases in India, the country is gearing up to start domestic production of the anti-viral Remdesivir drug.

The drug will be allowed only for "restricted emergency use" on COVID-19 patients. The approval was granted by India's Drug Controller General of India (DCGI), on the condition that it will be strictly used only for severely ill hospitalised coronavirus patients.

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DCGi is currently evaluating application from India's top four 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 told a local news agency.

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The drug will only be allowed in small quantities for severely ill patients, as the drug is undergoing trials for now. The doctors resorting to the drug will have to fill prescribed forms seeking approval for usage.

"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," he explained.

The pharma companies manufacturing the drug will also have to do  an 'Active-Post Marketing Surveillance' through which they will have observe and study the benefits that each patient has registered through the use of the drug, and provide the data report to the government.

Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorisation (EUA) by the US Food and Drug Administration (USFDA) to treat 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.

(With inputs from Reuters)