(Photo: REUTERS/Mike Blake/File Photo)
India's drug regulator has granted Hetero Labs and Cipla Ltd the authorization to produce and market their generic version of the experimental COVID-19 medication remdesivir from Gilead Sciences Inc, the Indian pharmaceutical groups disclosed on Sunday.
The medication, to be sold under the Covifor brand name, is expected to be priced at 5,000 to 6,000 rupees ($66-$79) for a dosage of 100 milligrams, Hetero stated. India's Cipla said it will call their generic version of remdesivir Cipremi. India's Drug Controller General was not available immediately for comment.
Cipla has also received a marketing go signal for remdesivir on hospitalized COVID-19 patients for restricted emergency use. Under a licensing deal with US-based Gilead Sciences, the product is launched to expand access to COVID-19 treatment in low- and middle-income nations.
Gilead Sciences has decided to establish a consortium of manufacturing partners to maximize remdesivir's global supply. Covifor will be administered in hospitals on severely sick COVID-19 patients.
Gilead Sciences approved a non-exclusive licensing deal last month with five generic vaccine companies based in India and Pakistan to boost the supply of its COVID-19 medication.
The agreements allow Jubilant Life Sciences Ltd, Hetero Labs, Cipla Ltd, Mylan NV, and Ferozsons Laboratories to produce and sell the vaccines in 127 nations. Indian pharmaceutical company Zydus Cadila last week announced it signed a non-exclusive licensing deal with Gilead Sciences to produce and sell remdesivir.
The Union Health Ministry, in its Clinical Management Protocols for the coronavirus, recommended administering remdesivir on patients with moderate illness, meaning those on respirators.
The vaccine has been listed as investigational therapy only for restricted emergency purposes. The drug is not recommended for patients with severe renal impairment and high-level of enzymes in the liver, pregnant, and lactating women, and those under 12 years old, the document on Clinical Management Protocols noted.
On June 19, India's health authorities authorized anti-viral vaccine favipiravir for restricted emergency use in mild to moderate cases of the virus, a top government official confirmed to ANI. The Drug Controller General of India has approved the accelerated development of Indian drug company Glenmark to produce and sell favipiravir tablets.
Hetero is the world's biggest producer of anti-retroviral drugs. The group has 36 high-tech manufacturing facilities located around the world and approved by strict global regulatory authorities.
India reported a record increase of 14,516 COVID-19 cases on Saturday, the health ministry disclosed, taking the total figure to 395,047 with 12,948 fatalities.
