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Bharat Biotech submits Covaxin phase 3 trial data to Drug Controller General of India, expert panel meet today

Hyderabad-based Bharat Biotech is also expected to hold a ‘pre-submission meeting on Wednesday with the World Health Organization for international emergency use listing (EUL) and approval of its Covid vaccine.

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Bharat Biotech

Bharat Biotech, the Hyderabad-based drugmaker has submitted data from phase 3 trials of the Covaxin, the Covid vaccine to the Drugs Controller General of India (DCGI), according to the news agency ANI.

The development comes nearly five months after Covaxin was authorized for emergency usage in the country.

The Hyderabad-based vaccine maker had stated that its coronavirus vaccine was 81 percent effective in preventing the infection, according to early analysis of the results from late-stage trials.

However, the drug regulator’s SEC (subject expert committee) is expected to meet around noon to discuss the results of Phase 3 data of Covaxin, the country’s first indigenous Covid vaccine.

Hyderabad-based Bharat Biotech is also expected to hold a ‘pre-submission meeting on Wednesday with the World Health Organization for international emergency use listing (EUL) and approval of its Covid vaccine. The company would be submitting a summary of its report at the WHO meeting. For it to supply the Covid vaccine to other countries, approval from WHO is necessary.

A ‘pre-submission meeting will provide an opportunity to receive guidance from WHO authorities before final submission. EULs involve rigorous assessment of clinical trial data – as well as data on safety, efficacy, and quality – and a risk management plan.

The company also told news agency ANI, it is critical to understand that Phase III data will first be submitted to CDSCO (the Central Drugs Standard Control Organisation)… followed by peer-reviewed journals with a timeline of approximately three months for publication.

Read Also: 86 lakh people jabbed on Day 1 of Centre’s new vaccination policy

In a press briefing a few days ago by the Union Health Ministry, Dr VK Paul, who is a member (Health) Niti Aayog and also the head of the COVID task force of the country, said that the company would be submitting the data within seven to eight days. 

India News

INDIA Bloc protest intensifies, Opposition MPs plan Rajghat march

The INDIA bloc has planned another round of protests against Chief Election Commissioner Gyanesh Kumar, with Opposition MPs expected to march to Rajghat on Thursday.

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The INDIA bloc is set to intensify its protest in Delhi against Chief Election Commissioner Gyanesh Kumar, with Opposition MPs expected to march to Rajghat on Thursday.

The fresh mobilisation comes a day after several Opposition leaders, including Congress leader Rahul Gandhi, were detained during protests against the Election Commission. The leaders were later released.

The Opposition has been demanding the resignation of CEC Gyanesh Kumar over allegations linked to electoral rolls and what it has described as “vote chori”.

Opposition leaders discuss next course of action

INDIA bloc MPs met at a cafe in Delhi on Thursday to discuss the next steps in their protest. Following the meeting, the leaders were expected to proceed towards Rajghat.

Congress president Mallikarjun Kharge hosted an INDIA bloc luncheon meeting on Wednesday, after which buses were arranged to transport MPs. Several Opposition leaders later staged a sit-in and raised slogans demanding the resignation of the poll body chief.

Mamata Banerjee among leaders expected to join

Trinamool Congress chief Mamata Banerjee is likely to be part of the Opposition’s 10-member delegation that will meet President Droupadi Murmu on Friday.

The INDIA bloc has also sought an appointment with the President. Ten Opposition leaders, including Mallikarjun Kharge, Rahul Gandhi and Akhilesh Yadav, have been given an appointment to meet the President on Friday.

The INDIA bloc had sought a meeting with a 15-member delegation, but Rashtrapati Bhavan agreed to a 10-member delegation.

Case against Rahul, Priyanka Gandhi

The Delhi Police has registered a case against Rahul Gandhi, Priyanka Gandhi Vadra and several other leaders and workers over alleged misconduct during the protests.

Police sources said the FIR alleges assaulting police personnel and obstructing government work during Wednesday’s protest.

The INDIA bloc’s agitation follows an earlier march towards the Election Commission headquarters, during which Opposition MPs demanded action over their concerns regarding electoral rolls and alleged irregularities.

Election Commission protest continues

The Opposition has announced further protests as it seeks to keep the issue in focus.

Congress has described October 8 as a “Black Day” nationwide, while Opposition MPs are continuing their campaign against the Election Commission.

The latest protest comes amid heightened security at CEC Gyanesh Kumar’s Delhi residence and around the Election Commission headquarters.

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Delhi Building Collapse: Many trapped as 5-storey structure comes down

A building collapsed in Delhi’s Seemapuri area on Wednesday, with several people feared trapped under the debris. Rescue teams have reached the spot.

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A building collapsed in Delhi’s Seemapuri area on Wednesday, with several people feared to be trapped under the debris.

The incident took place in northeast Delhi, where emergency teams were rushed to the site after the collapse was reported.

Rescue operation underway

A search and rescue operation has been launched at the site as authorities work to determine whether people are trapped beneath the debris.

The Delhi Fire Service received information about the collapse at around 3:30 pm and sent fire tenders to the location. An official said some people might be trapped in the debris.

The incident has prompted an emergency response in the area, with rescue personnel working to locate anyone who may be trapped.

Collapse comes a month after Satya Niketan tragedy

The Seemapuri incident comes about a month after a building collapse in Delhi’s Satya Niketan area, where people were trapped after a multi-storey structure came down.

Further details about the Seemapuri collapse, including the number of people trapped and any casualties, are awaited as the rescue operation continues.

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Bhagwant Mann hits back at BJP over CBI search in Sangrur

Bhagwant Mann hit out at the BJP over a CBI search in Sangrur, alleging political targeting and claiming the agency returned empty-handed after a nearly six-hour search.

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Punjab Chief Minister Bhagwant Mann has criticised the BJP over a CBI search at the residence of his officer on special duty (OSD) Rajbir Singh Ghuman in Sangrur, alleging that central agencies are being used against political opponents ahead of elections.

Mann said the CBI action was an indication that elections were approaching and accused the BJP of using agencies such as the CBI and Enforcement Directorate against Opposition leaders or their associates.

“The CBI raid shows that elections have arrived,” Mann said.

The Punjab Chief Minister cited cases involving Jharkhand Chief Minister Hemant Soren and leaders close to former West Bengal Chief Minister Mamata Banerjee while alleging that central agencies have been used ahead of elections. He also said Aam Aadmi Party leaders faced similar action before the Delhi Assembly elections.

Mann says CBI returned empty-handed

According to Mann, the CBI search at Gharachon village in Sangrur lasted nearly six hours.

The Chief Minister claimed that the agency “did not find anything” during the search and returned empty-handed. He alleged that the action was part of a BJP conspiracy to defame him and his government.

Mann also linked the CBI action to the BJP’s anti-drug campaign in Punjab and questioned the political impact of the campaign.

He alleged that the CBI action was politically motivated and intended to create a narrative against the AAP government ahead of upcoming elections.

CBI search at Mann aide’s house

Earlier, a CBI team searched the house of Mann’s OSD Rajbir Singh Ghuman in Gharachon village in Sangrur.

The search triggered a political confrontation involving the ruling AAP and Opposition parties. Representatives of Waris Punjab De and Akali Dal Punar Surjeet gathered in the village and welcomed the CBI team.

After the CBI vehicles left the area, people were seen beating dhols, performing bhangra and showering flower petals on the vehicles carrying the agency officials.

Sources cited in the report said the CBI was investigating allegations involving people accused of causing significant losses to Punjab and looting public money.

BJP hits back at Bhagwant Mann

BJP leader Tarun Chugh criticised the response to the CBI search, calling it an “extraordinary display of shamelessness”.

Taking a swipe at AAP chief Arvind Kejriwal, Chugh said the time for political drama was over and that those responsible would have to answer for money allegedly stolen from the people of Punjab.

“Stop the drama. Let the investigation proceed and let the facts speak,” he said.

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