A day after the Drug Controller General of India (DCGI) gave nod to domestic major Glenmark to manufacture and market favipiravir to treat COVID-19 patients, it has also allowed Hetero and Cipla to manufacture and market Gilead Sciences' anti-viral drug remdesivir for "restricted emergency use" on hospitalised patients. "The approval to Hetero and Cipla was given on Saturday," PTI reported citing sources.
These two companies have been approved at a time when coronavirus cases in India are spiralling like never before and putting tremendous pressure on our healthcare system. India has nearly over 4.10 lakh COVID-19 patients now, with over 13,000 deaths and fatality rate of 3.28%. On 20th June, 15,413 new cases were reported in India.
The Union Ministry of Health and Family Affairs had also approved the use of remdesivir for patients with mild COVID-19 symptoms under the 'Clinical Management Protocols for COVID-19' guidelines issued recently.
However, it is not recommended for those with severe renal impairment and high level of liver enzymes, pregnant and lactating women, and those below 12 years, the document on 'Clinical Management Protocols for COVID-19' stated. The drug, administered in the form of injection, should be given at a dose of 200 mg on day one followed by 100 mg daily for five days, says the guidelines.
To administer remdesivir in COVID-19 patients, hospitals need to take consent from them. Results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events also need to be submitted.
Notably, apart from Hetero and Cipla, Gilead has already signed pacts with Jubilant Life Sciences and Mylan NV to manufacture and sale remdesivir in India. Since the drug has proved efficient in dealing with COVID-19, Gilead signed agreements with four more pharma companies recently -- Dr Reddy's Laboratories Ltd, Biocon arm Syngene International Ltd, Zydu Cadila Ltd and Egypt-based Eva Pharma Pvt Ltd -- to make and market remdesivir.
The California-based biotech company had earlier said remdesivir improved symptoms when given for five days to moderately ill, hospitalised patients with COVID-19. A large study led by the National Institutes of Health recently also found it could shorten average recovery time from 15 days to 11 days in hospitalised patients with severe disease, Associated Press reported. The drug is designed to interfere with an enzyme the virus uses to copy its genetic material. It's also approved for treating Covid-19 in Japan and is authorised for emergency use in the US for certain patients.