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Hyderabad, Jun 30: Hyderabad-based Bharat Biotech announced that it has successfully developed Covaxin, India's first vaccine candidate for Covid-19, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.

The indigenous, inactivated vaccine developed and manufactured in the company's Bio-Safety Level 3 (BSL-3) High Containment facility located in Genome Valley, Hyderabad.

Announcing the vaccine development milestone, Dr Krishna Ella, Chairman and Managing Director said: "We are proud to announce COVAXIN, India's first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine."

Dr Ella added, "The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform."
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.

Speaking about Bharat Biotech's prowess, Suchitra Ella, Joint Managing Director said, "Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic."
"Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India's strength in handling future pandemics," she added.

Bharat Biotech's track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.

New Delhi, Mar 7: Prime Minister Narendra Modi turned emotional on Saturday when a woman beneficiary of his government's generic medicine programme told him that she had seen God in him.

Dehradun-resident Deepa Shah, who suffered paralysis in 2011, was interacting with the prime minister through video-conference on the occasion of Jan Aushadhi Diwas.

"I have not seen god, but I have seen God in you," she said, tears rolling down her eyes.

Modi was visibly emotional as the woman repeated her remark.

She also thanked the Uttarakhand chief minister and others who had helped her all along and said doctors had once told her that she cannot be cured.

"But on hearing your voice I have become better," she told Modi while profusely thanking the prime minister for his efforts to reduce the cost of medicines.

An emotional prime minister paused for a moment before telling her that it was her courage that had won over her disease and that she must carry on with the spirit.

Shah was expressing her plight and how she had suffered due to high cost of medicines after she suffered from paralysis in 2011 and has now started saving Rs 3,500 every month after benefitting from the government's low-cost generic medicines programme.

Soon after Shah rose to express her views, Modi asked her to sit and speak as he said she was uncomfortable while standing.

"You have defeated disease with your own will power. Your courage is your god and that same courage has given you the strength to emerge from such a big crisis. You should carry on this confidence in you," Modi told her.

He said some people still keep spreading rumours about generic medicines, going by their past experience, wondering how can medicines be available so cheap and that there must be something wrong with the medicine.

"But, by seeing you countrymen would gain confidence that there is nothing wrong in generic medicines. These medicines are not at all of inferior quality than any other medicine. These medicines have been certified by the best laboratories. These medicines are made in India and is 'Make in India' and are cheap," the prime minister said.

He said there is demand for generic medicines from India across the world and the government has made it mandatory for doctors to prescribe generic medicines to patients, unless necessary.