Drugs Controller General of India (DCGI) has issued an Emergency Use Authorization (EUA) for the use of a generic version of tocilizumab for hospitalized COVID-19 patients, according to The Indian Wire.
Hetero Drugs, an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs, received the DCGI approval for its generic tocilizumab.
DCGI is an Indian drug regulatory body responsible for the approval of drugs, blood and blood products, IV fluids, vaccines, and sera in India.
Sold under the brand name Actemra and others, tocilizumab is an immunosuppressive drug that is used for the treatment of rheumatoid arthritis and systemic juvenile idiopathic arthritis. It is a humanized monoclonal antibody against the interleukin-6 receptor.
The DCGI approval will allow Indian doctors to prescribe the drug to the hospitalized adult patients who receive systemic corticosteroids and need supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
In July, the World Health Organization (WHO) announced that tocilizumab can be used for severely ill COVID-19 patients.
Dr. Partha Saradhi Reddy, Chairman of Hetero Group, called the approval “extremely crucial,” adding that it will ensure supply assurance in the nation, as globally there is a shortage of tocilizumab.
He said, “We are pleased with the approval of Hetero’s tocilizumab (Tocira) in India. This demonstrates our technical capabilities and commitment to bringing important therapeutics relevant to COVID care.”
“This approval is extremely crucial for supply security in India considering a global shortage of Tociluzumab,” he added. “We will be working closely with the Government to ensure equitable distribution.”
Hetero’s generic version of tocilizumab will be available from the last week of September. Tocira 400mg is a biosimilar version of Roche’s Actemra.
In April, Hetero announced a collaboration with US-based MSD for manufacturing and distributing an experimental oral antiviral drug called Molnupiravir, which will be used in non-hospitalized COVID-19 patients.
This deal will enable Hetero to expand access to Molnupiravir in India and other low-and middle-income countries. It is waiting for the permission of local regulatory bodies for EUA. The article was published in The Indian Wire.
