A day after the DCGI gave nodes to Glenmark for the manufacture and commercialization of favipiravir for treating COVID-19 patients, Hetero and Cipla were also able to manufacture and commercialize the anti-viral medicinal medicinal remanesivir of Gilead Sciences for “restricted emergency” use in hospital patients. “On Saturday, approval was granted to Hetero and Cipla,” PTI reported citing sources.
The coronavirus cases in India have been approved at a time when they spiral and put tremendous pressure on our health care system. India now has nearly 4.10 lakh COVID-19 patients, with more than 13.000 deaths and a 3.28 percent fatality rate. 15,413 new cases were reported in India on 20 June.
The Union Ministry of Health and Family Affairs has also approved the use of remdesivir in patients with moderate COVID-19 symptoms in compliance with the recently released Guidelines ‘Clinical Management Protocols for COVID-19’.
However, the manual on ‘Clinical Management Guidelines for COVID-19’ is not recommended for individuals with a serious renal deficiency and a high level of liver enzymes and pregnant and lactating women and those below 12 years. The injection drug is administered at a dose of 200 mg on day one followed by 100 mg daily for five days, the guidelines state.
Hospitals need their permission in order to administer remdesivir in COVID-19 patients. Outcomes of additional clinical trials should also be submitted, active postmarketing monitoring data and reports of serious adverse events.
Notably, apart from Hetero and Cipla, Gilead has already signed agreements to produce and sell remanufacturing equipment in India with Jubilant Life Sciences and Mylan NV. Gilead has been able to sign agreements with four other pharmaceutical firms – Dr. Reddy’s Laboratories Ltd, Dr. Biocon arm Syngene International Ltd, Zydu Cadila Ltd., and Eva Pharma Pvt Ltd, Egyptian, to produce and sell redesivir as the medication has proven to be successful in dealing with COVID-19.
Remdesivir was previously said by the California-based biotech firm to have improved symptoms when given to moderately ill, hospitalized patients with COVID-19 for five days. A major study led by National Health Institutes recently also found that the average recovery time for hospital patients with severe disease could be reduced from 15 days to 11 days, Associated Press reported. The medicine is designed to interfere with an enzyme used by the virus to copy its genetic material. It is also authorized for treatment of Covid-19 in Japan and for emergency use in the United States for some patients.