In view of the crisis of corona pandemic, India’s drug regulator Drug Controller General of India VG Somani has approved the use of Gilead Sciences Inc’s novel drug remdesivir to treat COVID-19 patients, Lav Aggarwal, joint secretary in the health ministry, said on Tuesday
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 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,” 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 (CDSCO).
