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 13,2024

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Bengaluru: An estimated overall 10.14 per cent voter turnout was recorded during the first two hours, since the voting began for bypolls to three Assembly segments in Karnataka on Wednesday, election officials said.

The voting began at 7 am and will go on till 6 pm.

More than seven lakh voters are eligible to cast their votes in about 770 polling stations in Shiggaon, Sandur and Channapatna, where a total of 45 candidates are in the fray.

While Channapatna recorded 10.34 per cent voter turnout till 9 am, it was 10.08 per cent in Shiggaon, and 9.99 per cent in Sandur, election officials said.

Voters, including women and elderly were seen queuing up in front of polling booths in these segments.

By-polls for Sandur, Shiggaon, and Channapatna are necessitated, as the seats fell vacant following the election of their respective representatives -- E Tukaram of Congress, former CM Basavaraj Bommai of BJP, and Union Minister H D Kumaraswamy of JD(S) -- to Lok Sabha in May elections.

As many as 31 candidates are in the fray from Channapatna, while Sandur and Shiggaon have six and eight contenders, respectively.

Elaborate security arrangements have been made in the three segments for the smooth conduct of the polls.

The by-polls will witness a straight fight between the ruling Congress and BJP in Sandur and Shiggaon segments, while in Channapatna, JD(S) which is part of the NDA alliance is in contest against the grand old party.

Among the three segments, Channapatna is considered to be a "high profile", where the contest is between C P Yogeeshwara, a five time MLA from the segment and former Minister, who joined the Congress quitting BJP ahead of nomination, and actor-turned -politician Nikhil Kumaraswamy, who is Kumaraswamy’s son and former PM H D Deve Gowda's grandson.

BJP's Bharath Bommai, son of Basavaraj Bommai, is fighting Congress Yasir Ahmed Khan Pathan, who had faced defeat against the former Chief Minister in the 2023 Assembly polls, in Shiggaon.

Bharath Bommai and his father cast their vote at a polling booth in Shiggaon segment.

In Sandur, Bellary MP Tukaram's wife E Annapurna of Congress is contesting from the seat vacated by her husband, against, BJP ST Morcha president Bangaru Hanumanthu, who is considered close to party leader and former mining barron G Janardhan Reddy.

Annapurna, Tukaram and other family members cast their votes at a booth in the segment.

With Nikhil Kumaraswamy and Bharath Bommai contesting, the third generation of Gowda and Bommai families are in the fray in this by-poll. Both their fathers and grandfathers have served as Karnataka's Chief Ministers in the past.

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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 25,2024

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Bengaluru: Karnataka Chief Minister Siddaramaiah has instructed the Hindu Religious Endowment Department to submit a proposal for constructing a gold chariot for the presiding deity of the state, Chamundeshwari, official sources said on Monday.

The directive follows a request from Member of Legislative Council (MLC) Dinesh Gooligowda, who highlighted the historical and cultural significance of the Chamundeshwari Temple on Chamundi Hill in Mysuru, which dates back to the 12th century AD.

Gooligowda noted that the existing wooden chariot, donated by devotees from Coimbatore, Tamil Nadu, has deteriorated over time.

“Devotees have expressed their desire to organise a ‘rathotsava’ using a gold chariot for Goddess Chamundeshwari. This proposal has been under consideration for some time, with an estimated cost of Rs 100 crore,” the MLC said.

He emphasised that the government’s financial involvement would not be required, as devotees are willing to contribute towards making the chariot a reality.

Gooligowda proposed a deadline for the 2025 Dasara festival for the completion of the chariot, ensuring it is ready for the grand procession featuring the idol of Chamundeshwari.

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