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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The Karnataka Police’s Anti-Naxal Force (ANF) achieved a major breakthrough on Monday night by eliminating Vikram Gowda, one of Karnataka’s most wanted Naxal leaders for over two decades. The encounter occurred in the dense Kabbinale forest of Udupi district, marking a significant victory against Naxal insurgency in the region.

Who Was Vikram Gowda?

Hailing from Hebri in Udupi, Vikram Gowda, 44, was a prominent figure in the Naxal movement. He went underground in 2002, initially serving as a courier and fund collector before rising to lead a breakaway Naxal group. Despite having only a fourth-grade education, he was a staunch advocate for tribal rights and a key player in the movement’s survival in Karnataka.

Bounty: ₹3 lakh from Karnataka and ₹50,000 from Kerala.

Legacy: The last major Naxal leader in Karnataka after the 2021 arrest of B G Krishnamurthy.

The Encounter

Police revealed that Gowda and his team visited Kabbinale village to collect groceries on Monday night. Acting on a tip-off, ANF ambushed the group. When the Naxals opened fire, ANF responded, leading to Gowda's death.

Escapees: Three Naxals fled, including prominent members Latha (aka Mundgaru Latha) and Raju.

Significance: This was the first Naxal casualty in Karnataka in over two decades.

Home Minister G. Parameshwara confirmed the operation, stating, “Gowda was elusive for 20 years, escaping multiple encounters. His death is a critical step in dismantling Naxal operations in the region.”

The Decline of Naxal Activity in Karnataka

Karnataka's Naxal movement has been dwindling, with members seeking refuge in Kerala and Tamil Nadu. The group’s strength had reduced to just 19 members by 2018, but recent sightings indicate attempts at revival:

2023 Activity: Reports of Gowda-led movements in the Kodagu and Hassan districts reignited concerns.

Political Heat: The BJP criticised the Congress government, alleging it created a “safe haven” for Naxals.

A Glimpse into Gowda’s Past

Personal Life: Gowda’s ex-wife, Savitri (alias Rajita), was arrested in 2021. She was a senior Naxal commander involved in insurgency since 2004.
Rehabilitation Efforts: Since 2013, Karnataka’s rehabilitation policy has seen 14 Naxals surrender and reintegrate into mainstream society.

A Milestone in Karnataka’s Fight Against Insurgency

The operation signifies a decisive blow to Naxal resurgence in the Western Ghats. While the ANF continues its search for escapees, the Karnataka government reaffirmed its commitment to offering rehabilitation to those willing to surrender.

As Karnataka celebrates this triumph, the message is clear: there is no room for insurgency in the state.

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News Network
November 15,2024

Udupi: The Tourism Department is planning a major eco-friendly development initiative for Kamini Island, located near the Blue Flag-certified Padubidri End Point beach, aiming to attract more visitors while maintaining environmental sustainability.

Assistant Director Kumar CU emphasized that, given the island’s proximity to the Blue Flag beach, all development efforts will center around eco-friendly practices. “We are looking to enhance the Kamini River and the island’s surroundings by adding a hanging bridge, nature trails, and eco-friendly food courts offering traditional cuisine. Visitors will also be able to reach the island by pedal boats or kayaking,” he said.

The development project is estimated to cost between Rs 3 crore and Rs 4 crore. Meanwhile, the Blue Flag beach, Padubidri, continues to see a steady flow of visitors. Vijay Shetty, manager of the beach, shared that tenders for food courts and water sports have been awarded to private parties. Recently, three new coracles have been introduced, which are proving to be a hit with visitors. Additionally, three more shelters are expected to be ready by November 20.

Shetty mentioned that the beach can now accommodate between 2,500 and 3,000 visitors daily, although footfall remains lower than other district beaches due to user fees and activity restrictions. “Initially, most visitors were from Mangaluru, but now nearly 40% come from other districts, showing a shift in the visitor demographics,” Shetty noted.

To further boost tourism and promote a healthy lifestyle, a Beach Carnival is set to take place on November 23-24, featuring the National Sea Swimming Championship and a sea marathon in collaboration with the Padubidri JCI, which is celebrating its golden jubilee. Cultural events will be held at the main beach, with some sports events taking place at the Blue Flag beach. Emphasis will be placed on making all activities environmentally friendly.

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