Bharat Biotech announces India's first COVID-19 vaccine candidate 'COVAXIN' with DCGI approval for human clinical trials

News Network
June 30, 2020

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.

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News Network
February 28,2020

Hyderabad, Feb 28: The Cyber Crime Police of Hyderabad has registered an FIR against social media platforms- WhatsApp, Twitter and TikTok- for allowing people to spread anti-national activities, as per a complaint filed by one S Srishailam.

Raghuveer, Additional DCP Cyber Crimes said," We have received a court referred complaint, which was filed by S Srisailam in the concerned court stating that social media platforms Whatsapp, Twitter and TikTok are allowing few people to spread anti-national activities and videos."

S Srisailam also claimed that a few people are running a campaign against the CAA on social media platforms to spread hatred which in turn is causing damage to national integrity.

"In this regard, because the complaint was referred by a court a case has been registered against Whatsapp, Twitter & TikTok under the relevant section of Indian Penal Code and IT Act and took up the investigation," the DCP added.

He also added that the police cannot take action against these platforms as they are not banned in India but can initiate action against persons who intentionally indulge in spreading hatred.

"The police are conducting the investigation and if allegations of the complainant are found to be false then we will drop the case. We had received the case one week ago," informed the DCP.

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News Network
February 14,2020

London, Feb 14: Liquor tycoon Vijay Mallya once again asked the Indian banks to take back 100 per cent of the principal amount owed to them at the end of his three-day British High Court appeal on Thursday against an extradition order to India.

The 64-year-old former Kingfisher Airlines boss, wanted in India on charges of fraud and money laundering amounting to an alleged Rs 9,000 crores in unpaid bank loans, said the Enforcement Directorate (ED) and the Central Bureau of Investigation (CBI) are fighting over the same assets and not treating him reasonably in the process.

“I request the banks with folded hands, take 100 per cent of your principal back, immediately,” he said outside the Royal Courts of Justice in London.

“The Enforcement Directorate attached the assets on the complaint by the banks that I was not paying them. I have not committed any offenses under the PMLA (Prevention of Money Laundering Act) that the Enforcement Directorate should suo moto attach my assets," he said.

"I am saying, please banks take your money. The ED is saying no, we have a claim over these assets. So, the ED on the one side and the banks on the other are fighting over the same assets,” he added.

Asked about heading back to India, he noted: “I should be where my family is, where my interests are.

"If the CBI and the ED are going to be reasonable, it’s a different story. What all they are doing to me for the last four years is totally unreasonable.”

Lord Justice Stephen Irwin and Justice Elisabeth Laing, the two-member bench presiding over the appeal, concluded hearing the arguments in the case and said they will be handing down their verdict at a later date after considering the oral as well as written submissions in the “very dense” case over the next few weeks.

On a day of heated arguments between Mallya’s barrister, Clare Montgomery, and Crown Prosecution Service (CPS) counsel Mark Summers, arguing on behalf of the Indian government, both sides clashed over the prima facie case of fraud and deception against Mallya.

“We submit that he lied to get the loans, then did something with the money he wasn’t supposed to and then refused to give back the money. All this could be perceived by a jury as patently dishonest conduct,” said Summers.

“What they [Kingfisher Airlines] were saying [to the banks] about profitability going forward was knowingly wrong,” he said, as he took the High Court through evidence to counter Mallya’s lawyers’ claims that Westminster Magistrates Court Judge Emma Arbuthnot had fallen into error when she found a case to answer in the Indian courts against Mallya.

Mallya, who remains on bail on an extradition warrant, is not required to attend the hearings but has been in court to observe the proceedings since the three-day appeal opened on Tuesday. A key defence to disprove a prima facie case of fraud and misrepresentation on his part has revolved around the fact that Kingfisher Airlines was the victim of economic misfortune alongside other Indian airlines.

However, the CPS has argued that “there is enough in the 32,000 pages of overall evidence to fulfil the [extradition] treaty obligations that there is a case to answer”. “There is not just a prima facie case but overwhelming evidence of dishonesty… and given the volume and depth of evidence the District Judge [Arbuthnot] had before her, the judgment is comprehensive and detailed with the odd error but nothing that impacts the prima facie case,” said Summers.

At the start of the appeal, Mallya’s counsel claimed Arbuthnot did not look at all of the evidence because if she had, she would not have fallen into the multiple errors that permeate her judgment. The High Court must establish if the magistrates’ court had in fact fallen short on a point of law in its verdict in favour of extradition.

Representatives from the Enforcement Directorate (ED) and Central Bureau of Investigation (CBI), as well as the Indian High Commission in London, have been present in court to take notes during the course of the appeal hearing.

Mallya had received permission to appeal against his extradition order signed off by former UK home secretary Sajid Javid last February only on one ground, which challenges the Indian government's prima facie case against him of fraudulent intentions in acquiring bank loans.

At the end of a year-long extradition trial at Westminster Magistrates’ Court in London in December 2018, Judge Arbuthnot had found “clear evidence of dispersal and misapplication of the loan funds” and accepted a prima facie case of fraud and a conspiracy to launder money against Mallya, as presented by the CPS on behalf of the Indian government.

Mallya remains on bail since his arrest on an extradition warrant in April 2017 involving a bond worth 650,000 pounds and other restrictions on his travel while he contests that ruling.

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News Network
June 9,2020

New Delhi, Jun 9: A record rise in COVID-19 cases in India for the seventh consecutive day has pushed the tally to over 2.6 lakh on Tuesday, with the daily nationwide spike in coronavirus cases inching close to 10,000.

The rise in cases comes at a time when the country has stepped out of a 75-day coronavirus lockdown with malls, religious places and offices opening in several parts of the country under strict conditions.

Since the onset of June, the country has also been witnessing over 200 COVID-19 fatalities each day that has taken the country's death toll to 7,466.

India is the fifth worst-hit nation by the COVID-19 pandemic after the US, Brazil, Russia and the UK, according to the Johns Hopkins University data.

Several states like Haryana, Jammu and Kashmir, Assam, Haryana, Karnataka, Chhattisgarh and Tripura among others have been showing a spurt in cases.

A total 266 new COVID-19 fatalities and 9,987 cases have been reported in the last 24 hours till Tuesday 8 am, according to the Union Health Ministry data.

The country has registered over 9,000 coronavirus infection cases for the sixth day in a row taking the country tally to 2,66,598.

The number of active novel coronavirus cases stands at 1,29,917, while 1,29,214 people have recovered and one patient has migrated, according to the Health Ministry data updated till 8 am.

"Thus, 48.47 per cent patients have recovered so far," a ministry official said.

According to the ICMR, a total of 49,16,116 samples have been tested as on 9 am, Tuesday, with 1,41,682 samples been tested in the last 24 hours.

Out of the total 7,466 fatalities reported till Tuesday 8 am, Maharashtra tops the tally with 3,169 deaths followed by Gujarat with 1,280 deaths, Delhi with 874, Madhya Pradesh with 414, West Bengal with 405, Tamil Nadu with 286, Uttar Pradesh with 283, Rajasthan with 246 and Telangana with 137 deaths.

The death toll reached 75 in Andhra Pradesh, 64 in Karnataka and 53 in Punjab.

Jammu and Kashmir has reported 45 fatalities due to the coronavirus disease, while 39 deaths have been reported from Haryana, 31 from Bihar, 16 from Kerala, 13 from Uttarakhand, nine from Odisha and seven from Jharkhand.

Himachal Pradesh and Chandigarh have registered five COVID-19 fatalities each and Assam and Chhattisgarh have recorded four deaths each so far.

Meghalaya and Ladakh have reported one COVID-19 fatality each, according to ministry data.

More than 70 per cent of the deaths are due to comorbidities, the ministry's website stated

The highest number of confirmed cases in the country are from Maharashtra at 88,528 followed by Tamil Nadu at 33,229, Delhi at 29,943, Gujarat at 20,545, Uttar Pradesh at 10,947, Rajasthan at 10,763 and Madhya Pradesh at 9,638, according to the Health Ministry's data updated in the morning.

The number of COVID-19 cases has climbed to 8,613 in West Bengal, 5,760 in Karnataka, 5,202 in Bihar and 4,854 in Haryana.

It has risen to 4,851 in Andhra Pradesh, 4,285 in Jammu and Kashmir, 3,650 in Telangana and 2,994 in Odisha.

Punjab has reported 2,663 novel coronavirus cases so far, while Assam has 2,776 cases. A total of 2,005 people have been infected by the virus in Kerala and 1,411 in Uttarakhand.

Jharkhand has registered 1,256 cases, while 1,160 cases have been reported from Chhattisgarh, 838 from Tripura, 421 from Himachal Pradesh, 330 from Goa and 317 from Chandigarh.

Manipur has 272 cases, Puducherry has 127 and Nagaland has reported 123 cases till now.

Ladakh has 103 COVID-19 cases, Arunachal Pradesh has 51, Mizoram has 42, Meghalaya 36 while Andaman and Nicobar Islands has registered 33 infections so far.

Dadar and Nagar Haveli has 22 cases, while Sikkim has reported seven cases till now.

The ministry's website said that 8,803 cases are being reassigned to states and "our figures are being reconciled with the ICMR".

State-wise distribution is subject to further verification and reconciliation, it said.

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