Opposition concerned over DCGI approval to indigenous covid-19 vaccine

Agencies
January 3, 2021

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New Delhi, Jan 3: Some Congress leaders on Sunday raised serious concern over the grant of approval to Bharat Biotech's Covid-19 vaccine for restricted use, saying it is "premature" and can prove dangerous.

However, there were different voices within the party as its chief spokesperson Randeep Surjewala lauded scientists and researchers of Bharat Biotech for the indigenous vaccine.

Leaders like Anand Sharma, Jairam Ramesh and Shashi Tharoor asked the health minister to explain why mandatory protocols and verification of data "had been dispensed with", prompting a sharp retort from Union Minister Hardeep Puri who said the Congress leaders were behaving "true to their form" and were on a "quest for permanent political marginalisation".

Sharma, who heads the Parliamentary panel on Home Affairs which dealt with the issue at length, said the matter of granting authorisation for vaccine use needs to be taken up carefully as no country has dispensed with the mandatory phase 3 trials and verification of data.

India's drugs regulator DCGI on Sunday approved Oxford's Covid-19 vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use.            

As per submissions made before the expert panel, phase 3 trials have not been completed and therefore, the data on safety and efficacy has not been reviewed, which is a mandatory requirement, Sharma said referring to Covaxin.

"The health ministry needs to give cogent reasons for dispensing with the mandatory protocols and requirements in this case, since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category," Sharma told PTI.

"The restricted use emergency authorisation for the Bharat Biotech vaccine presently undergoing Phase 3 trials raises bonafide concerns.

"Standard protocols and mandatory requirement of publication of data on safety and efficacy which is reviewed and verifiable is important for the integrity of the process," he said.

Congress leader Shashi Tharoor said the approval is premature and Covaxin's use should be avoided as it could be dangerous.

"The Covaxin has not yet had Phase 3 trials. Approval was premature and could be dangerous. Dr Harsh Vardhan should please clarify. Its use should be avoided till full trials are over. India can start with the AstraZeneca vaccine in the meantime," he tweeted.

Another senior Congress leader Jairam Ramesh asked Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on phase 3 trials "are being modified".

"Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister Harsh Vardhan should clarify," he said on Twitter.

However, Surjewala tweeted, "Kudos to our scientists and researchers of Bharat Biotech on approval of the indigenously developed Corona vaccine and Serum Institute and its scientists too. India has always led the way in path-breaking innovations in the past and will continue to do the same. Great start for New Year."

Hitting out at the Congress leaders for their scepticism, Puri tweeted, "Our in-house cynics M/s Jairam, Tharoor and Akhilesh are behaving true to form. They first questioned the valour of our soldiers and are now unhappy that the two vaccines to get DCGI nod are made in India. Clearly, they are on a quest for permanent political marginalization."

Samajwadi Party leader Akhilesh Yadav had on Saturday termed the anti-Covid vaccine to be rolled out in the country as a "vaccine of the BJP" and said he would not take the shot.

On Sunday, the former Uttar Pradesh chief minister said the Covid-19 vaccination programme is a "sensitive process", and the government should not treat it as a "cosmetic" event as it is a matter of lives.

Sharma said the news of the imminent arrival and rollout of the nation-wide vaccination drive is "truly uplifting and reassuring" for a country paralysed by the pandemic and is a tribute to India's scientists, researchers and institutions that have made India the largest vaccine manufacturer of the world.

"The DCGI statement is puzzling and the government must reveal the final data of global efficacy trials and the final trials in the UK which has been shared officially by the UK's MHRA (Medicines and Healthcare Products Regulatory Agency) following a government-to-government agreement signed between the two countries.

"This should be put in the public domain to avoid any confusion on the proven efficacy of the vaccine," Sharma also said.

The Drugs Controller General of India (DCGI) granted the approval on the basis of recommendations by a Covid-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

This paves the way for the roll-out of at least two vaccines in India in the coming days, while two more are in advanced stages of development.

The issue was earlier dealt with by the Parliamentary Standing Committee on Home Affairs. The panel has recommended to the government that any vaccine against Covid-19 should be granted emergency use authorisation only after proper consideration and conducting its trials on sufficient sample size.

In its report submitted on December 21 to Rajya Sabha chairman and Vice President M Venkaiah Naidu, the committee noted that the CDSCO has given no emergency use authorisation in the past and suggested that all necessary and mandatory requirements must be duly fulfilled and all trial phases completed.

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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 14,2024

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The UN special rapporteur for Palestine has slammed Israel’s parliament for passing a law authorizing the detention of Palestinian children, who are “tormented often beyond the breaking point” in Israeli custody.

Francesca Albanese, the UN special rapporteur on the rights situation in the Occupied Palestinian Territory, in a Thursday post on X, characterized the experiences of Palestinian minors in Israeli detention as extreme and often inhumane.

The UN expert highlighted the grave impact of this policy, noting that up to 700 Palestinian minors are taken into custody each year, a practice she described as part of an unlawful occupation that views these children as potential threats.

Albanese said Palestinian minors in Israeli custody are “tormented often beyond the breaking point” and that “generations of Palestinians will carry the scars and trauma from the Israeli mass incarceration system.”

She further criticized the international community for its inaction, suggesting that ongoing diplomatic efforts, which often rely on the idea of resuming negotiations for peace, have contributed to normalizing such human rights violations against Palestinian children and the broader population.

The comments by Albanese came in response to Israel’s parliament (Knesset) passing a law on November 7 that authorizes the detention of Palestinian children under the age of 14 for “terrorism or terrorist activities.”

Under the legislation, a temporary five-year measure, once the individuals turn 14, they will be transferred to adult prison to continue serving their sentences.

Additionally, the law allows for a three-year clause that enables courts to incarcerate minors in adult prisons for up to 10 days if they are considered dangerous. Courts have the authority to extend this duration if necessary, according to the Knesset.

The legislation underscores a shift in the treatment of minors and raises alarms among human rights advocates regarding the legal and ethical ramifications of detaining children and the conditions under which they may be held.

Thousands of Palestinians, including hundreds of children and women, are currently in Israeli jails—around one-third without charge or trial. Also, an unknown number are arbitrarily held following a wave of arrests in the wake of the regime's genocidal war on Gaza.

Since the onset of the Gaza war, the Israeli regime, under the supervision of extremist minister Itamar Ben-Gvir, has turned prisons and detention centers into “death chambers,” the ministry of detainees and ex-detainees’ affairs in Gaza says.

Violence, extreme hunger, humiliation, and other forms of abuse of Palestinian prisoners have been normalized across Israel’s jail system, reports indicate.

Over 270 Palestinian minors are being detained by Israeli authorities, in violation of UN resolutions and international treaties that forbid the incarceration of children, as reported by Palestinian rights organizations.

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News Network
November 27,2024

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Mangaluru: Dakshina Kannada MP Captain Brijesh Chowta recently met with Union Minister for Railways Ashwini Vaishnav to discuss urgent concerns regarding the region's railway infrastructure development. Key issues raised during the meeting included the long-pending Mangaluru-Bengaluru connectivity, the Shiradi Ghat stretch, and other vital railway concerns impacting the region.

In addition to discussing these issues, Captain Chowta submitted a letter requesting the Union Minister's intervention and support. The letter emphasized the need to merge Konkan Railway with Indian Railways and called for the doubling of railway tracks between Bengaluru and Mangaluru, which would significantly improve rail connectivity between the state capital and Mangaluru.

Further, Captain Chowta raised concerns about enhancing passenger facilities along the region's rail routes, particularly the need for better services between Subrahmanya and Mangaluru.

To bring more attention to these pressing issues, Captain Chowta took to social media, urging the state government’s support. In a tweet on his official X handle, he requested Chief Minister Siddaramaiah to expedite the resolution of these concerns. “In this direction, I request our Karnataka government led by CM Shri @siddaramaiah to kindly provide the necessary state support for the swift redressal of various concerns pertaining to both Konkan Railways as well as HMRDC to ease movement of both people and cargo in this important stretch between Mangalore and Bangalore,” he posted.

The meeting with the Union Minister was attended by Bengaluru Rural MP Dr. CN Manjunath, Udupi-Chikmagalur MP Kota Srinivas Poojary, and Uttara Karnataka MP Vishweshwara Hegde Kageri, all of whom supported the discussion on enhancing railway infrastructure in the region.

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