India’s drug regulator has granted US pharma giant Gilead Sciences marketing authorisation for its anti-viral drug remdesivir for ‘restricted emergency use’ on hospitalised Covid-19 patients in view of the crisis posed by the pandemic.
The approval process for remdesivir was accelerated in view of the emergency situation and the unmet need for medicines in light of the coronavirus outbreak, it is said.
The drug has been allowed for restricted emergency use for a maximum of five-day period for treatment of suspected or laboratory-confirmed cases of Covid-19 in adults and children hospitalised with severe symptoms, subject to several safeguards, the source said.
The drug, which is administered in the form of an injection, has been approved to be sold by retail on the prescription of specialists for use in hospital or institutional set-up only. It has been approved for use for a maximum of five days as against 10 days. Extended use does not seen to have any beneficial effects based on the evidence submitted at the time of approval, news agency PTI reported.
“The approval process for remdesivir was accelerated by invoking special provisions under the New Drug and Clinical Trial Rules, 2019, which provides for waiver of clinical trials in special circumstances,” it quoted a source as saying.
Gilead Sciences had on 29 May applied for marketing authorisation for remdesivir in India. The drug is being touted as a potential treatment for Covid-19. The approval was given following consultation with the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO).
“The drug is given in the form of an injection and that is why it has to be administered under the supervision of a doctor in a hospital setting,” the source said.
The drug, from the Gilead’s manufacturing site, would be imported by Mumbai-based Klinera Global Services, it is learnt. Sciences, the patent holder of the drug, has the complete data about the pre-clinical and clinical studies for remdesivir.
The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (FDA) for the treatment of hospitalized patients with severe Covid-19.
Meanwhile, the applications of two Indian pharmaceutical companies—Cipla and Hetero Labs—seeking permission to manufacture and sell remdesivir in India are still under consideration.
Gilead Sciences Inc has entered into non-exclusive licensing agreements with pharma firms, including three domestic majors Cipla, Jubilant Life Sciences and Hetero, for manufacture and distribution of remdesivir.
The Indian Council of Medical Research had earlier said anti-viral medication remdesivir, which was used during the Ebola outbreak, may inhibit the SARS-CoV-2 replication and research on its efficacy in the treatment of Covid-19 is a part of the WHO’s ‘Solidarity Trial’.
According to a recently published study in the New England Journal of Medicine, two out of three critically ill coronavirus patients who were on oxygen support showed signs of improvement when they were administered remdesivir. All players, including domestic and foreign, should get equal space in this war against Covid-19.