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
January 7,2025

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New Delhi, Jan 7: Fifty-three people were killed after an earthquake of magnitude 7.1 hit Tibet near the Nepalese border today, news agency AFP said quoting Chinese media Xinhua. The tremors of the earthquake were felt in several parts of India, including Bihar, Assam and West Bengal.

The epicentre of the earthquake was in Tingri county in Shigatse city. Tingri is about 400 km southwest of Tibet's capital Lhasa and is on the border with Nepal. It is a tourism hub for those visiting Mount Everest. 

According to the National Centre for Seismology (NCS), the earthquake was recorded at 6:35 am. NCS data reveals that two more earthquakes hit the region shortly after the first one. 

The second earthquake of magnitude 4.7 was recorded at 7:02 am at a depth of 10 km and the third earthquake of magnitude 4.9 at 7:07 am at a depth of 30 km. 

Nepal is nestled in a geologically active region, where the Indian and Eurasian tectonic plates collide, forming the Himalayas and making earthquakes a frequent occurrence. In 2015, nearly 9,000 people died and more than 22,000 were injured when a 7.8-magnitude quake struck Nepal, destroying more than half a million homes.

The tremors were particularly felt in Bihar where people were seen outside their houses and apartments. There have been no reports of any damage to property because of the earthquake.

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News Network
January 8,2025

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Mangaluru, Jan 8: The serene beaches near Kulai Jetty under the limits of Surathkal police station turned into a scene of tragedy on Wednesday, January 8, as a group of four close friends saw their day of joy morph into heartbreak. 

Three young men lost their lives in the unforgiving waves, while one narrowly escaped death, saved by the heroic efforts of local fishermen.

The victims have been identified as: 

M. S. Manjunath (31), son of Shivlingappa, hailing from Upparigenahalli, Chitradurga district.

Shivakumar (30) from Shivamogga district.

Satyavelu (30) from JP Nagar, Bengaluru.

The sole survivor, Parameshwara (30), from Hangarga, Bidar district, now carries the weight of a harrowing ordeal and the devastating loss of his three closest friends.

These young men, all students of AMC Engineering College in Bengaluru, had embarked on a trip meant to create memories of joy and camaraderie. Driving overnight from Bengaluru, they reached Mangaluru on Wednesday morning. After breakfast at a local eatery, the group decided to visit the picturesque Kulai Jetty, seeking solace and adventure in the sea.

But their joyful outing took a tragic turn. While playing in the water, the four were caught in strong currents. Despite the swift intervention of local fishermen, only Parameshwara could be rescued in time. The lifeless bodies of Manjunath, Shivakumar, and Satyavelu were later found on the right side of the jetty, their dreams and futures cruelly cut short.

The Surathkal police, alerted to the incident, promptly arrived at the scene and began their investigation. The bodies were transported to AJ Hospital for post-mortem examinations, leaving their families and friends to grapple with the enormity of their loss.

A case has been registered at Surathkal Police Station. This incident serves as a stark reminder of the unpredictable and dangerous nature of the sea, urging visitors to prioritize safety above all else.

What was meant to be a day of joy has left a void that can never be filled, as three grieving families now face the unbearable pain of losing their loved ones.

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News Network
January 3,2025

Karnataka's Urban Development Minister, BS Suresha (Byrathi), has initiated a detailed investigation into ₹5,527 crore worth of projects executed under Prime Minister Narendra Modi’s flagship Smart Cities Mission in six cities of the state.

The minister expressed dissatisfaction with the quality of work in Belagavi, Davangere, Hubballi-Dharwad, Mangaluru, Shivamogga, and Tumakuru. To ensure accountability, Suresha announced the formation of a committee comprising experts from universities and the Indian Institute of Science. The committee will assess the projects and submit its findings within three months.

Bengaluru, however, is excluded from the probe as it falls under the jurisdiction of Deputy Chief Minister DK Shivakumar.

Launched in 2015, the Smart Cities Mission aims to enhance urban infrastructure across 100 cities in India, funded jointly by the central and state governments. Karnataka has spent ₹6,405 crore under this mission, including ₹877.72 crore in Bengaluru.

"Most of the funds have been allocated to roads, drainage, and park maintenance," Suresha lamented in a statement. "The focus should have been on creating permanent infrastructure such as smart schools, hospitals, libraries, and bus stands."

Suresha pointed out that, on average, each Smart City in Karnataka received ₹990 crore, with spending patterns revealing 36% on roads, 8% on energy, 2% on education, 2% on healthcare, and 5% on sports. He criticized this distribution, emphasizing that projects under the mission should have developed long-lasting government assets instead of temporary solutions like roads and drains.

With the mission slated to conclude in March 2025, Suresha urged the remaining funds to be directed towards constructing world-class smart schools. "This will enable children from economically weaker sections to access quality education," he said.

The minister also revealed that he had received multiple complaints from elected representatives about substandard work, particularly in Belagavi, Hubballi-Dharwad, and Shivamogga. The probe, he assured, will prioritize transparency and accountability.

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