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
May 10,2024

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Mangaluru, June 10: The National Investigation Agency (NIA) has arrested another prime accused in 2022 BJP Yuva Morcha worker Praveen Nettaru murder case. 

32-year-old Jilla BJP Yuva Morcha committee member Nettaru was hacked to death in front of his broiler shop in Bellare of Dakshina Kannada by bike-borne miscreants in July 2022. The case is being investigated by the NIA and several arrests have been made so far.

Mustafa Paichar, accused number four in the case, was absconding after the murder and the NIA had declared a Rs 5 lakh reward to catch him. 

He was arrested at Sakleshpur in Hassan district by the NIA team led by Inspector Shanmugam. 

According to officials Mustafa was reportedly a member of now banned Popular Front of India and a resident of Shantinagar in Sullia in Dakshina Kannada.

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News Network
May 14,2024

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Bengaluru, May 14: JD(S) leader HD Revanna has been released from Parappana Agrahara Jail today, on May 14 after he was granted conditional bail. 

He was granted a conditional bail yesterday by a Bengaluru court in connection with a kidnapping case linked to sexual abuse allegation against him and his son Prajwal.

Revanna was arrested on May 4 by Special Investigative Team (SIT) officials in a kidnapping case registered against him at KR Nagar police station in the city. The case is linked to his son and Hassan MP Prajwal Revanna’s mega sex scam. 

Representing the JD(S) MLA from Holenarsipura, he termed this case a "political conspiracy" against him.

A SIT, constituted by the Karnataka government, is probing the alleged sexual abuse against against HD Revanna and his son Prajwal Revanna.

Prajwal Revanna, the incumbent MP, is seeking another term from Hassan Lok Sabha constituency. The voting for the seat took place on April 26.

Earlier, JD (S) chief HD Kumaraswamy alleged that Karnataka government does not want a fair inquiry.

"They are misusing the office. Nothing is going to happen ultimately. They wanted character assassination of HD Revanna and for that reason, they are using their office," Kumaraswamy told ANI.

Meeting Karnataka Governor Tawara Chanda Gehlot on May 9, a delegation of the Janata Dal (Secular) submitted a memorandum and urged Gehlot to recommend a CBI probe.

Prajwal sill absconding

The JD(S) MP, Prajwal, fled to Germany after Karnataka State Commission for Women Nagalakshmi Chowdhary wrote to Chief Minister Siddaramaiah seeking an investigation into over obscene videos of Prajwal Revanna allegedly sexually abusing several women. He has also skipped summons issued by the SIT to appear before it.

The ‘obscene videos’ involving Prajwal Revanna started making the rounds ahead of the first phase of Lok Sabha elections in Karnataka on April 26, triggering a political slugfest.

A lookout notice against Prajwal Revanna has been issued at all airports in India, along with a Blue Corner notice. A Blue Corner notice issued by Interpol helps countries collect and share information regarding a person's location and their activities as part of a criminal investigation.

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News Network
May 18,2024

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In a humanitarian move, Spain has refused entry to a ship carrying arms from India’s Chennai to Israel to dock at one of its ports, its Foreign Minister José Manuel Albares has said.

The Denmark-flagged cargo ship Marianne Danica sailed from Chennai on April 8 when people in Gaza were observing Ramadan fasting, and was headed to the port of Haifa in Israel, according to maritime tracking portals and Spanish media.

Spain has been extremely critical of the rising civilian casualties due to the Israeli offensive in Gaza and, along with Belgium, has suspended arms exports licenses to Tel Aviv. 

Spokesperson of the Ministry of External Affairs Randhir Jaiswal, at the weekly press conference, only said that they have seen the report of the ship and will revert with more information.

Meanwhile, a source said, “Investigation will reveal if the items on board were cleared for export and if the end user is the same as reported by The Guardian because there are items that are not banned for exports.”

Speaking to reporters in Brussels on Thursday on the issue, Mr. Albares had said, “This is the first time we have done this because it is the first time we have detected a ship carrying a shipment of arms to Israel that wants to call at a Spanish port.”

“This will be a consistent policy with any ship carrying arms to Israel that wants to call at Spanish ports. The Foreign Ministry will systematically reject such stopovers for one obvious reason: the Middle East does not need more weapons, it needs more peace,” he stated.

The ship was carrying 27 tonnes of explosives according to local reports. It was to make a port call at Cartegena in Spain.
In February, Mr. Albares said that they had suspended arms export licences to Israel since October 7, which he said made them “realise” the importance of a “fair and lasting solution” to the Palestinian cause.

The incident comes amid an ongoing row between Spanish Prime Minister Pedro Sánchez’s party and his coalition partners over another ship, Borkum, that was due to dock at Cartegena port on Friday over allegations that it was carrying arms meant for Israel. However, the Spanish government has said that the arms it is ferrying are meant for the Czech Republic.

Belgium had suspended two arms export licences to Israel.

“We welcome the decision of the Spanish government to deny the transit authorisation of the vessel Marianne Danica, in accordance with Tratado (treaty) on Arms Trade and Spanish law,” Amnesty International Spain said on social media platform ‘X’.

The timing also coincides with the Israeli ground offensive inside Rafah. According to the UN Agency for Palestinian Refugees (UNRWA) at least 6,30,000 Palestinians have been forced out of Rafah since the launch of the incursion on May 7.

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