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Oxford Covid-19 vaccine may become first to get DCGI’s nod for emergency use in India

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New Delhi, Dec 26: With preparations underway for a possible vaccine-rollout by January, the Indian drug regulator is looking at the UK, which sources believe may give its nod to the Oxford COVID-19 vaccine next week, before deciding on giving emergency use authorisation to the Serum Institute that is manufacturing the shots here.

Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the CDSCO will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.


The process of granting emergency use approval for Bharat Biotech’s COVID-19 vaccine ‘Covaxin’ may take time as its phase 3 trials are still underway, while Pfizer is yet to make a presentation. “Going by this, Oxford vaccine ‘Covishield’ is likely to be the first to be rolled out in India,” a source said.


Serum Institute of India (SII)last week also had submitted some additional data required by the Drug Controller General of India (DCGI), the sources said. Amid fears about the mutated variant of SARS-CoV-2 detected in the UK, government officials recently said that it will have no impact on the potential of emerging vaccines that are being developed in India and other countries.


Bharat Biotech, Serum Institute of India (SII) and Pfizer had applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their COVID-19 vaccines early this month.


The subject expert committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on December 9 had sought additional safety and efficacy data for COVID-19 vaccines of SII and Bharat Biotech after deliberating upon their applications.


The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation as the company had sought more time for making a presentation before the committee. The Pfizer vaccine has already been approved by several countries including the UK, the US, and Bahrain.


While considering SII’s application, the SEC had recommended that the firm should submit an updated safety data of phase 2 and 3 clinical trials in the country, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for grant of EUA.


As for Hyderabad-based Bharat Biotech, “after detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in the country for further consideration”, the SEC had said.


The Pune-based SII, the world’slargestvaccine manufacturer, has made a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine. The SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling licence from the DCGI, officials recently had said.(Agencies)

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AIIMS doctor booked for raping colleague

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(Asian News Hub) – Delhi Police on Friday registered a rape case against a senior doctor of All India Institute Of Medical Science in the national capital, ANI reported.

A complaint of alleged sexual harassment was received from AIIMS, Delhi on October 11 at Hauz Khas police station, informed the police.

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The victim is also a doctor at the hospital, who had informed the police that a senior doctor colleague had allegedly raped her when she went to his room for a birthday celebration of one of their colleagues on September 26, as per ANI.

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Based on her statement, the police registered an FIR under sections 376 and 377 of the Indian Penal Code (IPC) at Hauz Khas police station and an investigation into the matter was taken up.

During the investigation, a statement of the victim was recorded before the Magistrate under section 164 of Code of Criminal Procedure (CrPC) and raids were conducted at possible hideout places to catch the absconding doctor.

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Technical surveillance has already been mounted to nab the accused and continuous efforts are going on to trace him out at the earliest, said the police.

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Tollywood actress Anuradha dies by suicide

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AGENCY

(Asian News Hub) – In a shocking turn of events, actress Anuradha reportedly died by suicide at her residence in Hyderabad’s Film Nagar. She was 22.

According to reports, her neighbours grew suspicious as the junior artiste didn’t come out of her house for the last four days.

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Reportedly, they found her body inside the house and alerted the police. Though the reason behind the death is not known, reports suggest that she was planning to get hitched to her long-time boyfriend Kiran, however, the latter allegedly backed off due to differences in opinions.

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Soldiers of the People’s Liberation Army transgressed at least 5 kilometres inside Uttarakhand: Report

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(Asian News Hub) – Around 100 Chinese soldiers entered the Indian territory in Uttarakhand and damaged a bridge in Barahoti area before retreating back to China, said a report published in the Economic Times.

According to the reports, the soldiers of the People’s Liberation Army (PLA) transgressed at least 5 kilometres inside the Indian territory through the Tunjun-La pass.

They had come on 55 horses, damaged Indian infrastructure, and left before they could be confronted by the Indian troops.

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The ET report, based on sources in the security departments, claimed that the PLA soldiers roamed in Barahoti for around 3 hours.

The transgression by Chinese troops was reported by locals, after which teams from the Indian Army and the Indo-Tibetan Border Police were dispatched to verify the report.

In the Central Sector (a 545-km stretch of border with Tibet in Himachal Pradesh and Uttarakhand), the dispute between India and China is over 2,000 square km of territory, in eight separate areas.
Barahoti lies on the border with China in the Chamoli district of Uttrakhand, north of the Nanda Devi National Park.

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Back in July 2017, Chinese soldiers had transgressed into Barahoti twice during India’s standoff with China in Bhutan’s Doklam.

An ITBP source had then told the Indian Express that, “On both occasions [on July 15 and July 25] about 15-20 Chinese soldiers transgressed into the territory at Barahoti that India and China lay claim upon. The soldiers stayed there for a while and returned.”

Earlier in July this year, an ANI report claimed, “Recently, a platoon (about 35 soldiers) from the PLA was seen operating around the Barahoti area in Uttarakhand. The Chinese were seen doing some activity in this area after a significant breach.”

Also Read: RSS chief Mohan Bhagwat to start 4-day Jammu sojourn from Sept 30

In order to avoid a Ladakh-like situation in Uttarakhand, the Indian Army has increased deployments in the central sector after hightened Chinese activity was noticed.

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