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Hyderabad-based pharma company has approached the Drug Controller General of India to seek Emergency Use Authorization for the investigational drug in India

The Companies manufacturing COVID-19 vaccination in India have given only "Emergency Use Authorization for vaccinating people of 18 years age and above

The drug has been developed by Institute of Nuclear Medicine and Allied Sciences (INMAS), a leading laboratory of Defence Research and Development Organisation (DRDO).

Covid-19 drug candidate was developed by VINS Bioproducts in collaboration with CCMB and University of Hyderabad

Covid-19 drug candidate has been developed by VINS Bioproducts in collaboration with Centre for Cellular and Molecular Biology and University of Hyderabad

Zydus has received restricted emergency use approval from DCGI for the use of 'Virafin', PegIFN in treating moderate COVID-19 infection in adults

According to the Hyderabad-based company, emergency use will be as per the provisions of the new drug and clinical trials rules, 2019 under the Drugs and Cosmetics Act

As part of the review process, the drug major will present the safety profile of phase 2 study, and interim data of phase 3 trial, which is expected to be complete by February 21

The nasal vaccine is different from the two intramuscular vaccines which recently got approval, due to being non-invasive, needle-free, not requiring trained healthcare workers, eliminating needle-associated risks, and suitable for children and adults, having scalable manufacturing.

The Nation's first indigenously developed DNA vaccine candidate against COVID-19, ZyCoV-D, by M/s Zydus Cadila has been approved by Drugs Controller General of India (DCGI), for the conduct of the Phase III clinical trials

"Following the emergency use permission, the company is in a position to meet any production requirement that the government may have at this time,” company officials said

While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses

This is a major relief for India which has the second highest number of infections in the world, after the US. The Central government plans to vaccinate nearly 30 crore people in the first phase of drive in the next six to eight months.

The final decision on its approval will, however, be taken by the Drug Controller General of India (DCGI)

The application will be sent to Drugs Controller General of India (DCGI) V.G. Somani for final approval

"SII has applied for emergency use authorisation to DCGI. The application will be reviewed by the expert committee and after that final call will be taken," a senior government official confirmed ANI.

This will be a multi-centre and randomised controlled study, which will include safety and immunogenicity study, Dr Reddy’s said in a statement.

Favipiravir is a broad spectrum antiviral agent and selectively inhibits RNA polymerase of influenza virus and prevents viral replication