Hetero’s Tocilizumab gets DCGI approval for COVID-19 treatment

The Drugs Controller General of India (DCGI) has approved Emergency Use Authorisation (EMU) for the generic version of Hetero‘s Tocilizumab for treating COVID-19 in hospitalised adults, the Hyderabad-based pharmaceutical company confirmed on Monday. 

“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,” Dr B Paratha Sarahi Reddy, Chairman of Hetero Group, was quoted as saying in a statement by news agency ANI. 

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“This approval is extremely crucial for supply security in India, considering a global shortage of Toclizumab. We will be working closely with the Government to ensure quitable distribution.”

The granting of EMU allows medical practitioners across the country to use Tocilizumab for treating COVID-19 in hospitalised adults who are receiving systemic corticosteroids and require a supply of oxygen, non-invasive or invasive mechanical ventilation or extracoporeal membrane oxygenation (ECMO), the statement added. 

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The drug will be marketed in India by Hetero’s associate company ‘Hetero Healthcare’ which has an established distribution network across the country. 

The company’s biologics arm, ‘Hetero Biopharma’ will manufacture the drug at its facility in Jadcherla in Hyderabad. The firm also has 36 dedicated facilities located worldwide. 

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Tocilizumab is a biosimilar version of Swiss pharmaceutical company Roche’s Actemra/RoActemra and is slated to be available in the Indian markets by the end of September. 

Hetero caters to around 40% of the worldwide demand for Anti-Retroviral (AVR) APIs and Finished Dosage Forms (FDFs) that are used in the treatment for HIV/AIDS. 

Meanwhile, India is ramping up its COVID-19 vaccination campaign ahead of a potential third wave of the pandemic. On August 28, India administered over 10 million (1 crore) doses of the COVID vaccine in a single day, which also helped India achieve 50% coverage (at least one dose) in its adult population. 

Currently, India has administed a total of 68,75,41,762 doses of the COVID-19 vaccine.