Eli Lilly and Company announced that it has issued royalty-free, non-exclusive voluntary licenses to established Indian pharmaceutical manufacturers of generic medicines, Cipla, Lupin and Sun Pharmaceutical Industries, who are collaborating with Lilly to accelerate and expand the availability of baricitinib in India. Lilly is also in discussions with several other Indian manufacturers for the potential grant of additional voluntary licenses.
Lilly has recently received permission for restricted emergency use by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health, for baricitinib to be used in combination with remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Commenting on the development, Luca Visini, MD, India Subcontinent, Lilly India, said, “During the current surging Covid-19 pandemic, we have responded by issuing three voluntary licenses for baricitinib by pharmaceutical companies in India to accelerate its local manufacturing and distribution under best quality conditions. More licenses to additional Indian generic manufacturers are expected to be announced soon. This is in addition to the donations being offered by Lilly to the Indian Government that will potentially help alleviate the burden of COVID-19. We will continue to explore other possible initiatives to support patients and the healthcare system in India.”
On May 4, Lilly also announced that an initial donation of 400,000 baricitinib tablets was being made immediately available through the humanitarian aid organization, Direct Relief, to the Indian government for eligible hospitalised COVID-19 patients in India, while urgently working to increase product supply over the coming days.
“Meanwhile Lilly continues to engage in active dialogue with the regulatory authorities and government in India to donate Lilly’s anti-COVID-19 treatments, including Lilly’s neutralizing antibodies (bamlanivimab and bamlanivimab and etesevimab to be administered together)”, informed a company statement.