Following the news that domestic pharma giants Cipla and Hetero have received the Drugs Controller General of India’s (DGCI) approval to launch generic versions of remdesivir for COVID-19 treatment under the brand names Cipremi and Covifor respectively;

Ms. Sasmitha Sahu, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:

“The approval will facilitate the direct availability of remdesivir for patients with moderate to severe COVID-19 who face higher risks of mortality in India. Currently the supply is restricted only to government channels or hospitals / institutions and not through retail channels.  Prior to this, patients in India could get access to remdesivir only through alternative means like importing or on compassionate grounds.

“In addition, Jubilant, Mylan, Dr. Reddy’s, Zydus, Cadila and BDR Pharmaceuticals are in the process of seeking approval for generic remdesivir in India. Gilead is yet to launch remdesivir in India despite being the first company to receive approval in the country for import and launch.

“The accelerated approval of remdesivir by multiple manufacturers in India will not only ensure prompt and steady supply but also mean a reduction in the overall price in the long run. Cipla did not disclose the price for Cipremi 100mg vial, although it is expected to be priced close to INR5,000-6,000 (US$65-80*) per vial like Hetero’s Covifor 100mg vial.

“According to GlobalData COVID-19 dashboard, there were 14,011 deaths as of 22 June 2020. Although India is in the top five affected nations in terms of total number of confirmed COVID-19 cases, the death rate in India is 3.22 vs. 5.20 globally. While India was able to maintain a relatively lower death rate, this is expected to increase owing to the relaxation of the lockdown norms.

“Moreover, the revised national clinical management protocol for COVID-19 also recommended remdesivir 200 mg IV on day one followed by 100 mg IV daily for five days in hospitalized COVID-19 patients with moderate disease and needing supplemental oxygen therapy.

“Preliminary clinical data demonstrated that mortality in hospitalized patients with COVID-19 and requiring supplemental oxygen therapy was lower, although not statistically significant, in the remdesivir group at 7.1% vs. 11.9% in the placebo group. Since the approval was only for ‘restricted’ emergency use, the proposed post marketing surveillance and Phase IV clinical trial on Indian patients will help in further refining its regulatory status and could further influence its position in the continuously evolving COVID-19 clinical management protocol as well as unrestricted drug availability in the Indian market.”

*Currency converted from INR to US$