Jubilant Life Sciences gets DCGI nod for generic version of COVID-19 drug

Published : Jul 21, 2020, 12:16 PM IST

Jubilant Life Sciences has received drug regulator DCGI approval for generic version of antiviral drug Remdesivir 100 mg/vial for restricted emergency use in India for treatment of severe COVID-19.

New Delhi: Jubilant Life Sciences on Monday said it has received drug regulator DCGI approval for generic version of antiviral drug Remdesivir 100 mg/vial for restricted emergency use in India for treatment of severe COVID-19.

The company's subsidiary Jubilant Generics has received the approval from Drug Controller General of India (DCGI) to manufacture and market investigational drug remdesivir 100 mg/vial (lyophilized injection), Jubilant Life Sciences said in a late night filing to BSE.

Jubilant's remdesivir will be marketed under the brand name 'JUBI-R' in India and will be made available in 100 mg vials (injectable), it added.

The company will distribute the drug in the Indian market through its network and it will be available by the first week of August 2020, the filing said.

The company said it is focused on quickly making this drug available in India in required quantities and at affordable prices.

Jubilant Life Sciences, however, did not provide any details about the price of the drug.

In May 2020, Jubilant entered into a non-exclusive licensing agreement with Gilead Sciences Inc that granted it the right to register, manufacture and sell Gilead's investigational drug remdesivir in 127 countries, including India.

Mylan launches generic version of Remdesivir in India for COVID-19 patients

Pharma major Mylan also on Monday commercially launched the generic version of Remdesivir drug under the brand name 'Desrem'in India for treatment of coronavirus patients.

The company had earlier said that its Remdesivir will be available in July in India at a price of Rs 4,800 per 100 mg vial.

The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalised with severe presentations of the disease, Mylan said in a statement.

The company has released the first batch of its generic Remdesivir and will continue to increase its supply across the country in the wake of the rising demand for the drug,it added.

The company has also launched a helpline number for accessing information about the availability of Desrem in India, the statement said.

Mylan will manufacture Desremin its injectable facility in Bengaluru, which will work to service the demand in India and other export markets where Mylan has received a licence from Gilead for the commercialisation of Remdesivir, it added.

"With the launch of Desremand our national24/7COVID-19 helpline, we aim to enhance access to this critical medicine, used for treating adults and children with severe presentations of COVID-19," Mylan,India and Emerging Markets,PresidentRakesh Bamzai said.

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 for manufacturing and distribution of Remdesivir.

Hetero and Cipla have already launched their generic versions of Remdesivir in India.

The medicine has been issued an Emergency Use Authorization (EUA) by the United States Food and Drug Administration (USFDA) to treat COVID-19 patients.

(PTI Report)