Anti-viral remdesivir cleared for use on Covid patients

New Delhi: India's drug regulator has granted United States 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, a source in the know of the developments told PTI.

The drug has been allowed for restricted emergency use 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 setup only," the source told PTI.

"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," the source said.

Gilead Sciences had on May 29 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.

"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.

Gilead Sciences, the patent holder of the drug, has the complete data about the pre-clinical and clinical studies for remdesivir, the source added.

The medicine has been issued an Emergency Use Authorization by the United States Food and Drug Administration to treat hospitalised coronavirus-infected patients.