New Delhi: After Hetero, Cipla and Mylan, another pharmaceutical major Jubilant Generics Ltd, Uttar Pradesh was given permission by India's drug regulator on Monday to manufacture and market anti-viral drug Remdesivir for "restricted emergency use" on hospitalised COVID-19 patients, official sources told PTI.
Written informed consent of each patient is required before the use of the drug while active post-marketing surveillance data and reporting of serious adverse events have to be submitted.
On June 21, Hetero and Cipla and on July 2 Mylan were given permission to manufacture and market the drug on the same conditions.
The Union Health Ministry in its 'Clinical Management Protocols for COVID-19' had recommended the use of the drug in COVID-19 patients with moderate stages of the illness (those on oxygen support).
The drug, administered in the form of an injection, has been included as an investigational therapy only for restricted emergency use purposes.
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 of age, the document stated.
"The approval was given by the CDSCO (Central Drugs Standard Control Organisation) on Monday. This will further increase capacity of production of Remdesivir in India," an official source in the know of the developments told PTI.
States recently were also 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, the health ministry said in a statement recently.
"It has to be used with extreme caution due to its potential for serious adverse effects including liver and kidney injury," it said.
Remdesivir has been included as an investigational therapy in the 'Clinical Management Protocols for COVID-19' based on limited available evidence at present.
Mylan on Monday said it has commercially launched the generic version of Remdesivir drug under the brand name ''Desrem'' in India for treatment of coronavirus patients.
Hetero and Cipla have already launched their generic versions of Remdesivir in India.
In May, Mylan and domestic pharma firms Hetero, Cipla and Jubilant Life Sciences had entered into non-exclusive licensing agreements with drug major Gilead Sciences Inc, which is the patent holder of Remdesivir, for manufacturing and distribution of Remdesivir.
US pharma giant, Gilead Sciences, had applied to the Indian drug regulatory agency, Central Drugs Standard Control Organisation (CDSCO), for import and marketing of Remdesivir on May 29.
After due deliberations, permission under emergency use authorisation was granted by the Drug Controller General of India (DCGI) on June 1 in the interest of patient safety and obtaining further data....