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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

Pawan Khera faces fresh setback as Supreme Court refuses relief in passport row case

Congress leader Pawan Khera faces fresh setback as Supreme Court refuses interim relief and directs him to seek bail from Guwahati High Court.

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Pawan Khera

Congress leader Pawan Khera suffered another legal setback on Friday after the Supreme Court of India declined to extend protection in a case linked to his remarks about Himanta Biswa Sarma’s wife.

A bench of the apex court refused to interfere with an earlier order that had stayed the transit anticipatory bail granted to Khera by the Telangana High Court. This decision leaves the Congress leader open to possible arrest by Assam Police in connection with the case.

During the hearing, Khera’s counsel sought interim protection, but the court declined the request and advised him to approach the appropriate court in Assam for relief. The bench clarified that the Guwahati High Court should decide any bail plea independently and on its merits.

“Am I a terrorist?” remark during hearing

While seeking protection, Khera’s legal team expressed concern over the urgency of the situation. In court, his counsel remarked, “Am I a terrorist?” highlighting the plea for temporary relief until a fresh bail application could be filed.

The Supreme Court also raised concerns over the submission of incorrect documents during the proceedings, adding another layer to the legal complications faced by the Congress leader.

Case linked to remarks on CM’s wife

The case stems from a press conference held earlier this month, where Khera made allegations regarding the citizenship status and financial assets of the Assam Chief Minister’s wife, Riniki Bhuyan Sharma.

He had claimed that she possessed multiple passports and owned undisclosed overseas properties. These allegations were strongly denied by the Chief Minister’s family, who termed them fabricated and misleading.

Legal battle intensifies

Earlier, the Telangana High Court had granted Khera temporary transit anticipatory bail, allowing him time to seek relief from a competent court in Assam. However, the Supreme Court stayed that order following a challenge by Assam authorities, escalating the legal battle.

With the latest ruling, Khera is now expected to move the Guwahati High Court for anticipatory bail as the case continues to unfold.

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Congress suspends 5 Haryana MLAs over cross-voting in Rajya Sabha polls

Congress suspends five Haryana MLAs for cross-voting in Rajya Sabha elections, citing serious indiscipline and anti-party activities.

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The Congress has suspended five of its MLAs in Haryana for cross-voting during the recent Rajya Sabha elections, taking disciplinary action over what it described as “anti-party activities”.

The move came after the state unit reviewed the conduct of certain legislators during the polls, where some were found to have voted against the party’s authorised candidate.

Five MLAs suspended after disciplinary process

According to party sources, the MLAs were issued show-cause notices seeking an explanation for their actions. After reviewing their responses, the Congress disciplinary committee recommended suspension.

The decision was approved by the party leadership, including Congress president Mallikarjun Kharge, and has been implemented with immediate effect.

Party calls it ‘grave indiscipline’

Haryana Congress chief Udai Bhan said the action was necessary to uphold party discipline, stressing that defying the official party line during elections weakens organisational unity.

He said the party takes such violations seriously and will continue to act against any form of indiscipline.

Leadership backs strict action

Senior Congress leader and Leader of Opposition Bhupinder Singh Hooda supported the decision, saying it was taken after due consideration.

He noted that while Rajya Sabha elections are conducted through an open ballot system, allowing legislators some flexibility, the party retains the authority to initiate internal disciplinary action in cases of deviation.

Background

The action follows cross-voting reported during the recent Rajya Sabha elections in Haryana, which led to internal concerns within the party. The development has highlighted organisational challenges and prompted the leadership to take corrective steps to reinforce discipline.

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Harivansh set to be elected Rajya Sabha Deputy Chairperson unopposed

Harivansh is set to be elected unopposed as Rajya Sabha Deputy Chairman after no opposition nominations were filed before the deadline.

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Former Rajya Sabha Deputy Chairman Harivansh is set to be re-elected to the same post unopposed in the election due to be held later today.
The date has been fixed by the Chairman under the relevant rules governing the conduct of business in the Upper House.
According to sources, the deadline for submitting motions for the election was 12 noon on April 16. A total of five notices were received within the stipulated time, all proposing Harivansh for the post.

Multiple nominations, single candidate
The motions were submitted by members across parties, including Jagat Prakash Nadda, Nitin Nabin, Nirmala Sitharaman, Sanjay Kumar Jha, and Jayant Chaudhary, each backed by seconding members.
All five motions explicitly state that Harivansh be chosen as the Deputy Chairman of the Rajya Sabha.

No opposition nomination filed

Notably, no motion was submitted by the Opposition before the deadline. This effectively clears the path for a unanimous election, as there is no contest for the position.
As per parliamentary procedure, motions will be taken up one by one. Once any one motion is adopted by the House, the remaining motions will not be put to vote.

Likely to be elected by voice vote
In line with established practice, the first motion — expected to be moved by Nadda — may be adopted through a voice vote. Following this, the Chairman will formally declare Harivansh as elected Deputy Chairman.
After the declaration, Harivansh will be escorted to the Chair by members from both the Treasury and Opposition benches, adhering to parliamentary convention.

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