The Drug Controller General Of India (DCGI) has given a restricted emergency use approval to Zydus Cadila's 'Virafin' for treating the adult patients showing moderate Covid-19 symptoms. Virafin is a pegylated interferon alpha-2b(PegIFN), which when subcutaneously injected to the patient in the early stages of infection, resulted in their faster recovery.
For the development of Virafin, the multinational pharmaceutical company headquartered in Ahmedabad appreciated the support provided by the Covid-19 research consortium of Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC) through the National Biopharma Mission (NBM).
The Phase II human clinical trial studies have confirmed the safety, tolerability and efficacy of Virafin. The studies also reported that Viarfin reduces viral load and aid in managing the disease in a better way, such as reduction in the need for supplemental oxygen, thereby reducing the respiratory tension caused due to low oxygen levels.
"The government has been committed to provide all possible facilitation to our industries to work towards mitigation strategies and interventions against Covid-19 pandemic. The emergency nod provided to Virafin is another milestone which is a boon for the medical facility providers. I highly appreciate the efforts put in for this achievement," said Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC.
Phase III clinical trial studies reported that a larger proportion of patients when administered subcutaneously with Virafin turned out to be RT-PCR negative by day 7, apart from faster recovery as compared to other anti-viral agents.
"The realisation that we can provide a therapy that reduces viral load substantially when given early and can aid in better disease management. It comes at a critical time for patients, and we will continue to give them access to the critical therapies as we together fight against Covid-19," said Dr. Sharvil Patel, the Managing Director of Cadila Healthcare Limited.
The Department of Biotechnology (DBT), under the Ministry of Science & Technology, promotes the use and application of biotechnology in the areas of agriculture, healthcare, animal sciences, environment and industry. It is focused on attaining new heights in biotechnology research, shaping biotechnology into a premier precision tool of the future for creation of wealth and ensuring social justice – specially for the welfare of the poor.
On the other hand, Biotechnology Industry Research Assistance Council (BIRAC) is a not-for-profit Section 8, Schedule B, Public Sector Enterprise, set up by Department of Biotechnology (DBT), Government of India as an Interface Agency to strengthen and empower the emerging Biotech enterprise to undertake strategic research and innovation, addressing nationally relevant product development needs.
