COVID-19: DCGI nod to Jubilant Generics to manufacture, sell remdesivir for 'restricted emergency use'

By Priyanka Sharma
New Delhi [India], July 20 : The Drug Controller General of India (DCGI) has granted permission to pharma giant- Jubilant Generics Ltd to manufacture and market the anti-viral drug remdesivir for "restricted emergency use" on hospitalised COVID-19 patients, a senior health ministry official said on Monday.
Previously, Dr VG Somani, DCGI, had given approval to Cipla, Hetero and Mylan laboratory to manufacture and market the anti-viral drug remdesivir for "restricted emergency use" on hospitalised COVID-19 patients in India.
"With this development, India will be able to have increased domestic production of anti-viral drug remdesivir which would have efficacy, stability, safety for "restricted emergency use" on COVID19 patients.
"Last month, ANI had reported that the Central Drug Control Standard Organisation (CDCSO) office of DCGI had granted permission to US-based Gilead Sciences for marketing authorization of its anti-viral drug Remdesivir in India for "restricted emergency use" on hospitalized COVID19 patients in the wake of virus pandemic.
Gilead had signed non-exclusive voluntary licensing agreements with five generic pharma firms -- Cipla, Jubilant Life Sciences, Hetero, BRD and Mylan to manufacture and distribute remdesivir, a potential antiviral therapy for COVID-19.
The union health ministry's clinical management guidelines for COVID19 describes the use of Remdesivir drug as investigational therapy on coronavirus patient.
"Patient can be administered with 200 mg IV on day 1 followed by 100 mg IV daily for 5 days. The drug cannot be administered to a pregnant or lactating mother and children below age of 12years. The drug is not recommended to patient with liver problems and renal complications," stated the clinical management protocol on COVID19.
As of now, six domestic pharma giants--Cipla, Hetero Labs, BRD, Mylan, Jubilant Life Sciences, Dr. Reddy's Labs have approached to the India's drug regulator to make and sell remdesivir in the country.
Recently, the Union health ministry had raised an alarm for all states, union territories and medical college hospitals that their (drugs) indiscriminate use or use in conditions for which they are not desirable, may cause more harm than good.
In a video conference with states on COVID case management, officials at the health ministry emphasised that in the absence of a cure, the clinical management protocol for COVID19 of health ministry would be most effective for the standard of care treatment for mild, moderate and severe coronavirus cases.
"The states have been told that the available evidence for Remdesivir suggests that it may decrease the time for clinical improvement when used in moderate to severe cases. However, there have been no benefits in terms of reduced mortality. It has to be used with extreme caution due to its potential for serious adverse effects including liver and kidney injury," said the health ministry official.
According to the health ministry, these "investigational therapies" are required to be carried out only in proper health care facilities where close monitoring of patients is possible so that potential complications can be managed.