Another good news for India who has been fighting with the deadly Coronavirus from the past 3 months as Hetero and Cipla have been given a nod by India’s drug regulator to manufacture and market antiviral drugs Remdesivir for “restricted emergency use” on hospitalised Covid-19 patients.
“The approval to Hetero and Cipla was given on Saturday,” news agency PTI quoted a source as saying.
With this written informed consent of each patient is required before the use of remdesivir and results of additional clinical trials, active post-marketing surveillance data, and reporting of serious adverse events have to be submitted.
The Union health ministry, in its ‘Clinical Management Protocols for COVID-19’, recommended the use of remdesivir on patients in the moderate stage of the disease that is, those on oxygen.
The drug has been included as an “investigational therapy” only for restricted emergency use purposes.
Gilead Sciences had applied to the Indian Drug Regulatory Agency, Central Drug Control Standard Organisation (CDCSO), for import and marketing of remdesivir on May 29. After due deliberations, permission under emergency use authorisation was granted by DCGI on June 1 in the interest of patient safety and obtaining further data.
Although Cipla and Hetero have not officially confirmed the news.
Recently Glenmark becomes the first pharmaceutical company in India to receive regulatory approval for oral antiviral Favipiravir, for the treatment of mild to moderate COVID-19. The drug will be available as a prescription-based medication for Rs 103/tablet, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14.