Hetero Gets Dgci Approval For Generic Version Of Tocilizumab For Treatment Of Covid-19
Hyderabad-based drug maker Hetero today said that the drug regulator has issued Emergency Use Authorisation (EUA) to the generic version of tocilizumab, a key drug being used in treatment of Covid patients in India.
"The Drug Controller General of India (DCGI) has issued for restricted use, Emergency Use Authorisation (EUA) for the generic version of Tocilizumab," it said in a statement.
India has faced a huge shortage of tocilizumab, used to treat critically ill Covid patients-during the Covid surge.
The originator of the product, Swiss pharmaceutical company Roche, currently exports the drug to India, through Mumbai-based Cipla.
Hetero said that the authorisation will enable the medical practitioners to use the generic drug for the treatment of Covid-19 in hospitalised adults "who are receiving systematic corticosteroids and require supplemental oxygen, non invasive or invasive mechanical ventilation or exxtracorporeal membrane oxygenation (ECMO)," it said.The company had in May submitted the application to conduct clinical trials to the drug regulator.
"We are pleased with the approval of Hetero's Tocilizumab (Tocira) in India. This approval is extremely crucial for supply secutiry in India considering a global shortage of Tocilizumab," said B Partha Saradhi Reddy, chairman, Hetero. Hetero's Tocira will be marketed by its assocaite company Hetero healthcare. The company did not disclose the price of the drug. Hetero Labs has a strong portfolio of Covid-19 drugs. It also manufactures remdesivir and favipiravir, being used in Covid treatment.