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 19,2024

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In the wake of the tragic drowning of three students at a resort near Ullal on the outskirts of Mangaluru city, the tourism department in Dakshina Kannada is set to implement comprehensive safety guidelines for properties with swimming pools or beach access. This initiative aims to ensure guest safety and prevent similar incidents in the future.

New Safety Mandates for Resorts and Homestays

Rashmi S.R., deputy director (in-charge) of the tourism department, announced, “We will instruct all homestays and resorts to enforce precautionary measures, especially those with pools or direct beach access. Properties must ensure 24/7 supervision, particularly during guest hours. This tragedy highlights the importance of having trained personnel on-site.”

Key Safety Guidelines

The district, home to around 150 homestays and 130 resorts, will see the following measures enforced:

  • Clearly displaying pool depths.
  • Installing adequate safety equipment, such as life buoys.
  • Employing trained lifeguards at all times.
  • Establishing clear pool operating hours.
  • Reviewing and implementing standard operating procedures (SOPs) for pool and beach usage.

Booming Beach Tourism Calls for Vigilance

Manohar Shetty, president of the Association for Coastal Tourism (ACT), Udupi, highlighted the growing popularity of beachside resorts, particularly during peak seasons. Properties in Udupi, often fully booked with tourists from Bengaluru, Mysuru, Kodagu, and Shivamogga, face increasing pressure to maintain safety standards.

Udupi district boasts 22 beachside commercial properties catering to this rising demand.

Shetty emphasized, “Authorities must scrutinize safety measures and carefully evaluate guidelines before issuing new resort licenses. Panchayats should rely on the Karnataka Town and Country Planning Act when handling such cases.”

Long-Term Solutions for Water Safety

Recognizing the need for a cultural shift in water safety, Shetty proposed integrating swimming lessons into school curricula. This move would not only equip students with essential skills but also encourage safe participation in water-based activities.

A Safer Tomorrow for Coastal Tourism

As the tourism sector thrives, Mangaluru’s proactive approach underscores its commitment to visitor safety. The tragic incident serves as a wake-up call, propelling the industry towards stricter regulations and better preparedness, ensuring that coastal vacations remain both enjoyable and safe.

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News Network
November 21,2024

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Shares of Adani Group companies lost about $28 billion in market value in morning trade on Thursday after US prosecutors charged the billionaire chairman of the Indian conglomerate in an alleged bribery and fraud scheme.

Gautam Adani's flagship company Adani Enterprises tumbled 23 per cent, while Adani Ports, Adani Total Gas, Adani Green, Adani Power, Adani Wilmar and Adani Energy Solutions, ACC , Ambuja Cements and NDTV fell between 20 per cent and 90 per cent.

Adani group's 10 listed stocks had a total market capitalisation of about $141 billion at 0534 GMT, compared to $169.08 billion on Tuesday.

US authorities said Adani and seven other defendants, including his nephew Sagar Adani, agreed to pay about $265 million in bribes to Indian government officials to obtain contracts expected to yield $2 billion of profit over 20 years, and develop India's largest solar power plant project.

Adani Green in a statement on Thursday said the US Justice Department had issued a criminal indictment against board members Gautam Adani and Sagar Adani and the Securities and Exchange Commission had issued a civil complaint against them.

The US Justice Department also included Adani Green board member Vneet Jaain in the criminal indictment, it said.

Adani Green's units had decided not to proceed with the proposed US dollar denominated bond offerings due to developments, it added.

"Investors will shy away from Adani Group stocks ... and that's what this sharp selling is signifying," said Saurabh Jain, assistant vice president of retail equities research at SMC Global Securities.

"This could hurt the credibility of the group and maybe borrowing costs will rise," he said.

The indictment comes nearly two years after US shortseller Hindenburg Research alleged that Adani had improperly used tax havens and was involved in stock manipulation, allegations the conglomerate denied.

Also in early Asian trading on Thursday, Adani dollar bonds slumped, with prices down 3c-5c on bonds for Adani Ports and Special Economic Zone. The falls were the largest since the Adani Group came under a short-seller attack in February 2023.

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News Network
November 11,2024

Mangaluru: Six youths including teenagers have been arrested by the Bantwal Rural Police in connection with a brutal assault on 21-year-old Aboobakar (name changed to hide identity), an incident that was widely shared on social media after footage revealed the victim tied to a pole and violently beaten.

The arrested individuals, all from Kanchinadkapadavu, Sajipanadu village in Ullal Taluk, have been identified as Mohammad Sapwan (25), Mohammad Rizwan (25), Irfan (27), Anis Ahmad (19), Nasir (27), and Shakeer (18). According to police reports, the assault took place on November 7 in Kanchinadkapadavu.

The sequence of events began when Aboobakar was reportedly called to a residence in Kanchinadkapadavu by a female relative. Upon his arrival, he was confronted by the accused, who questioned his presence, tied him to a pole with ropes, and attacked him while he was shirtless. 

Aboobakar managed to file a police complaint the following day, detailing the assault. As his injuries worsened, he was admitted to a private hospital in Mangaluru.

While in the hospital, Aboobakar alleged that his attackers intended to kill him during the assault. This statement led to additional charges of attempted murder being filed. 

Police officials stated that the suspects were subsequently apprehended, charged with group assault and attempted murder, and placed in judicial custody. The investigation is ongoing, and further details are awaited.

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