Following the news that the Indian state of Maharashtra is planning to procure Gilead Sciences’ antiviral drug remdesivir from Bangladesh-based pharmaceutical giant Eskayef Pharmaceuticals;
Anupama Mishra, Pharma Analyst at GlobalData, a leading data and analytics company, offers her view:
“Maharashtra is the worst affected state of the COVID-19 outbreak in India. The state has reported 97,648 confirmed cases and 3,590 deaths as of 12June 2020, the highest in the country. On 6June 2020, the state announced its decision to import 10,000 doses of remdesivir from Dhaka headquartered Eskayef Pharmaceuticals for INR12,000 (US$160) per vial. This decision has been met with dissonance by the Indian pharmaceutical sector. As a result, the decision has been put on hold as the state officials plan to wait for the Drugs Controller General of India (DCGI) approval for remdesivir by Indian or Foreign pharmaceutical companies.
“According to GlobalData’s COVID-19 dashboard, as of 12 Jun 2020, India has 297,535 confirmed cases and the dashboard forecasts 1,009,861 confirmed cases in India in a low transmission risk scenario 22 June 2020.
“Currently, four Indian companies – Cipla, Hetero, Mylan, and Jubilant Life Sciences -have signed licensing agreements with Gilead for remdesivir and awaiting marketing authorization from DCGI. Furthermore, India-based BDR pharmaceuticals has submitted its application to DCGI for approval to sell and manufacture generic remdesivir in India.
“Notably, remdesivir has been approved for emergency usage in COVID-19 treatment in India, the US, and Japan. Since remdesivir is the only approved drug for COVID-19 treatment, Indian companies are vying to become the first-to-market remdesivir in the country. Gilead owns the patent rights for remdesivir globally and already received approval for remdesivir in India.
“However, Bangladesh-based pharmaceutical firms have taken advantage of the least developed country (LDC) status granted by the United Nations to manufacture the generic version of Gilead’s patented drug remdesivir. Generic remdesivir is available for COVID-19 treatment in Bangladesh.
“Reportedly, the Central Drugs Standard Control Organization (CDSCO) has not received an application from any Bangladeshi companies for a remdesivir import license. Hence, there is a probability that Indian pharma companies can get DCGI approval before Bangladesh-based companies whenever they decide to file for remdesivir import license. However, this episode has indeed spurred remdesivir cost-related debate in India. The cost of generic remdesivir is expected to be far less than the patented product. Though Indian pharma companies have free rights to price remdesivir according to their agreement with Gilead India, they will face stiff competition in the future from generic imports.
“With limited therapeutic options for COVID-19 management, the Indian government and private sector will have to collaborate on the pricing of remdesivir. In the wake of rising COVID-19 cases, India should focus on increasing the accessibility of the drug by making it more affordable for patients. Hence, Indian pharmaceutical companies will have to price remdesivir cautiously to ward off generic competition in the near future.”