The Hyderabad-based firm will first make the drug available in high case load areas of Maharashtra and Delhi under the brand Covifor. A single dose vial is likely to cost Rs 5,000-6000.
Hetero will launch Remdesivir, an injectable drug from Gilead, to treat hospitalised Covid-19 patients this week.
The firm, which got the approval letter from the Drug Controller General of India (DCGI) on Saturday, will first make the drug available in high case load areas of Maharashtra and Delhi under the brand Covifor.
A single dose vial is likely to cost Rs 5,000-6000, the Hyderabad-based firm said.
Cipla, too, said it was launching Remdesivir under the brand Cipremi. It said it received DCGI nod for “restricted emergency use” in the country.
Cipla said it would provide training on the use of the drug, conduct post-marketing surveillance as well as conduct a phase-IV clinical trial on Indian patients, the company said.
Umang Vohra, managing director and global chief executive, Cipla, said: “We have been deeply invested in exploring all possible avenues to save millions of lives impacted by Covid-19, and this launch is a significant milestone in that direction.”
Vamsi Krishna Bandi, managing director of the Hetero group of companies, said: “We will be taking a call on the (exact) pricing by Monday or day after. It would be Rs 5,000-6,000 for a dose.”
Hetero has already been exporting to Africa apart from some Asian countries. “So, some stock made for exports will be diverted to cater to the national emergency,” Bandi said.
Hetero will start producing for India this week. In a week to 10 days, more stock would be available for India. In the next two to three weeks, Hetero can supply 100,000 vials in India, Bandi said.
B Partha Saradhi Reddy, chairman, Hetero group of companies, said: “In the light of increasing Covid-19 cases in India, the approval for Covifor can prove to be a game-changer, given its positive clinical outcomes. Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country.”
Sources estimate at least 10,000 patients need the drug urgently. Remdesivir would, however, be sold through hospital channels only and would not be available at retail stores. “We will not dump the drug in the market. We will calibrate (supply) based on patient load,” Bandi said.
Cipla, meanwhile, said it would commercialise Remdesivir through its own facilities and partner sites to enable speedy access to the drug. According to Cipla, the drug will be supplied through the government and open-market channels.
Since Remdesivir has not been approved as treatment for Covid-19 yet and has been approved by the DCGI only for “restricted emergency use”, a patient would need to sign a consent form in case it is administered.
Remdesivir is a repurposed Ebola drug that is showing promise in treating Covid-19 patients, as it is found to reduce the viral load and enhance recovery process.
Gilead had signed voluntary licence agreements with a handful of companies in the country to make and market the drug. The companies are free to price the drug.
Bandi said the licensees will submit more data on the drug to the DCGI in 60 days. Right now, the product has a shelf life of 90 days. After the next set of data is submitted, the shelf life can be enhanced.
Meanwhile, Glenmark has got approval for oral antiviral drug Favipiravir on Friday and it would sell under the brand FabiFlu here. The drug is targeted at mild Covid-19 patients.