Hyderabad-based Pharmaceutical company Hetero announced on Monday that the Drugs Controller General of India (DCGI) had given Emergency Use Authorisation (EUA) for the use of a generic version of the anti-arthritis drug, Tocilizumab in treating adults who get hospitalised due to the coronavirus disease (Covid-19).
The approval will allow the medical practitioners to prescribe Tocilizumab to the hospitalised adult patients who are receiving systemic corticosteroids and need supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
In July, the World Health Organization (WHO) said that the drug can be used for critically ill patients of Covid-19.
In a statement, Dr P Sarathi Reddy, chairman, Hetero Group, expressed that the approval was “extremely crucial” to ensure supply assurance in the country as globally there is a shortage of Tocilizumab.
“We are pleased with the approval of Hetero’s Tociluzumab (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. We will be working closely with the Government to ensure equitable distribution,” Dr Reddy noted.
Associate company ‘Hetero Healthcare’ in India will take the charge of marketing Hetero’s TOCIRA (Tocilizumab) as it has a strong distribution network across the country. Hetero’s biologics arm ‘Hetero Biopharma’ will undertake manufacturing of the drug at its dedicated biologics facility, based at Jadcherla in Hyderabad, India.
The company’s Tocilizumnab will be available from September end and the 400mg/20ml drug is a biosimilar version of Roche’s Actemra/RoActemra.
Earlier, in April this year, India’s leading generic pharmaceutical company, announced entering into a licensing agreement with MSD for manufacturing and distributing investigational oral therapeutic antiviral drug ‘Molnupiravir’. The drug will be used for the treatment of non-hospitalized patients with confirmed Covid-19.
This licensing deal enables Hetero to expand access to Molnupiravir in the country and other low-and middle-income countries (LMICs), following the permission of local regulatory bodies for emergency use authorisation.