Serum Institute pauses covid 19 vaccine trials in India on DGCI instructions

Agencies
September 10, 2020

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New Delhi, Sept 10: The Serum Institute of India (SII), which was conducting the India trials for the coronavirus vaccine being developed by Oxford University, on Thursday paused the clinical trials of the vaccine in India.

In a statement, the Serum Institute of India said: "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials."

The declaration by the Pune-based vaccine manufacturer came a day after the Drug Control General of India (DCGI), V.G. Somani, issued a show-cause notice to them asking for an explanation as to why the institute decided to go ahead with the clinical trial of Covid-19 vaccine candidate while doubts about patient safety are yet unclear.

The notice was issued in the wake of an advert incident where one of the participants in the UK reported a suspected severe adverse reaction when administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and University of Oxford, on Tuesday.

"Whereas, Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns," the notice by DGCI read.

The DGCI further asked the institute why the authority does not suspend the permission given to the SII for the clinical trials of Covishield.

"In view of the above, I, Dr V G Somani, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established," the notice further said.

SII is the partner of the University of Oxford's Jenner Institute's to conduct the vaccine trials. SII is currently progressing the second and third phase study of the vaccine candidate at 17 trial sites across India.

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News Network
November 14,2024

Bengaluru: Karnataka Deputy Chief Minister D K Shivakumar on Thursday backed Chief Minister Siddaramaiah over his claim that the BJP had offered Rs 50 crore each to 50 Congress MLAs in an attempt to "topple" the state government.

Addressing reporters here, Shivakumar, also the Congress state president, said, “The BJP indeed lured 50 Congress MLAs with Rs 50 crore each.”

He defended Siddaramaiah’s statement and said the Congress MLAs were briefed about the BJP’s alleged 'Operation Lotus', a term used to describe the BJP's attempts to destabilise ruling governments through horse-trading.

“Some of our MLAs informed the Chief Minister about this matter, and he, in turn, shared it with the media,” Shivakumar said.

At an event in Mysuru, Siddaramaiah reiterated the claim that "none of the Congress MLAs had accepted the offer".

He also accused the BJP of filing false cases against him in a bid to "remove him and overthrow his government".

The BJP has yet to respond to the allegations.

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News Network
November 12,2024

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The Taliban regime has appointed Ikramuddin Kamil as the acting consul in the Afghan mission in Mumbai, Afghan media has reported.

It is the first such appointment made by the Taliban set up to any Afghan mission in India.

There was no immediate comment from the Indian side on the appointment that came.

The Ministry of Foreign Affairs of Afghanistan has announced the appointment of Kamil as the acting consul in Mumbai, the Taliban-controlled Bakhtar News Agency reported on Monday, citing unnamed sources.

"He is currently in Mumbai, where he is fulfilling his duties as a diplomat representing the Islamic Emirate," it said.

The appointment is part of Kabul's efforts to strengthen diplomatic ties with India and enhance its presence abroad, the media outlet said

Kamil holds a PhD degree in international law and previously served as the deputy director in the department of security cooperation and border affairs in the foreign ministry, it said.

He is expected to facilitate consular services and represent the interests of Afghanistan in India, the report added.

Kamil's appointment comes days after the external affairs ministry's point-person for Afghanistan held talks with the Taliban's acting defence minister, Mullah Mohammad Yaqoob, in Kabul.

Sher Mohammad Abbas Stanikzai, the Taliban's deputy foreign minister for political affairs, also posted on X about Kamil's appointment.

The appointment of Kamil is seen as part of efforts to facilitate consular services to the Afghan population in Mumbai.

There has been almost negligible presence of diplomatic staff at the Afghan missions in India.

Most of the diplomats appointed by the Ashraf Ghani government have already left India.

In May, Zakia Wardak, the seniormost Afghan diplomat in India, resigned from her position after reports emerged that she was caught at the Mumbai airport for allegedly trying to smuggle 25 kg of gold worth Rs 18.6 crore from Dubai.

Wardak had taken charge as the acting ambassador of Afghanistan to New Delhi late last year, after working as the Afghan consul general in Mumbai for more than two years.

She took charge of the Afghan embassy in New Delhi last November, after the mission helmed by then ambassador Farid Mamundzay announced its closure.

Mamundzay, who was an appointee of the Ghani government, had moved to the United Kingdom.

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News Network
November 21,2024

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After the US prosecutors charged Gautam Adani with bribery and fraud, Congress reiterated its call for a Joint Parliamentary Committee (JPC) probe into the transactions of the Adani group, and hit out at Prime Minister Narendra Modi, alleging an "internal nexus" between him and "his favourite businessman."

Senior Congress leader Jairam Ramesh said the indictment of Gautam Adani and others by the US Securities and Exchange Commission validates his party’s call for a Joint Parliamentary Committee investigation.

The Congress has been pushing for the probe since January 2023, raising concerns over alleged irregularities involving Adani and his business dealings, said Ramesh.

Ramesh referred to the party’s “Hum Adani ke Hain” series, where 100 questions were raised about the alleged scams and the links between Prime Minister Narendra Modi and Gautam Adani.
He noted that the questions remain unanswered, reiterating the need for accountability in the matter.

The US prosecutors have charged Adani with deceiving investors by concealing information about his firm's solar energy project in India, which allegedly involved bribery.

Adani has been charged with securities fraud and conspiracy, according to an indictment unsealed on Wednesday. The case focusses on an agreement between Adani Green Energy Ltd. and another organisation to supply 12 gigawatts of solar power to the Indian government.

'BETRAYAL OF INDIAN INVESTORS'

Congress leader Pawan Khera described the allegations against Gautam Adani and his conglomerate as a “betrayal of Indian investors.”

Taking to X, Khera outlined the US charges, including claims that Adani’s group bribed Indian government officials between 2020 and 2024 to secure contracts. Citing media reports, he also pointed out that Gautam Adani personally met a government official to advance the scheme.

Khera referred to a March 2024 incident where the Adani Group allegedly misled the Bombay Stock Exchange and the National Stock Exchange, calling it a “grave violation of investor trust.”

He further highlighted a March 2023 FBI raid on the premises of Sagar Adani, Gautam Adani’s nephew, where electronic devices were seized as part of the investigation.

'SEBI NOT ABLE TO PROVE ANY CHARGES AGAINST ADANI'

Shiv Sena (UBT) leader Priyanka Chaturvedi criticised central probe agencies following US charges against Gautam Adani and others in an alleged bribery case linked to solar energy contracts.

Chaturvedi raised concerns about corporate governance and regulatory oversight in the country. “They talk about corporate governance, responsibility, and accountability. The industrialists should be asked to follow the rules and regulations, but even the agencies were defending him. The SEBI has not yet been able to prove charges against him,” she said, pointing to what she viewed as failures in ensuring accountability.

'BROUGHT DISREPUTE TO INDIA'

On US charges against Gautam Adani, AAP leader Sanjay Singh called for a probe against the industrialist. He said that the probe should be conducted by an investigation agency under the Supreme Court.

"Adani Group has brought disrepute to India. This is a very serious matter. The PM of India should come forward and answer this. All the pending matters against Adani should be probed by an investigation agency under Supreme Court monitoring, and all the corruption done by him, within and outside the country, should come out before the country and action should be taken against him," he said.

BJP DFENDS

BJP IT cell chief Amit Malviya responded sharply to the Opposition’s criticism regarding allegations involving Adani Green Energy and US-based Azure Power. He pointed out that the charges in the indictment are only allegations and emphasised, “The defendants are presumed innocent unless and until proven guilty.”

Malviya argued that the crux of the case concerns agreements to supply 12 GW of power to the Solar Energy Corporation of India (SECI), contingent on SECI securing power purchase agreements with state electricity distribution companies (SDCs).

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