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 21,2024

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Prominent NRI community leader SM Syed Khalilur Rehman, fondly known as CA Khalil, passed away in Dubai on Thursday at the age of 86 after a brief illness.

Khalil had been admitted to Aster Hospital in Mankhool on Tuesday after experiencing severe leg weakness. Despite the best efforts of the medical team, he succumbed to a double heart attack that worsened his condition, his son Rais Ahmed confirmed.

The news of his passing has sent waves of grief across communities, particularly in his hometown of Bhatkal, Karnataka, where he was a celebrated figure. Tributes have been pouring in on social media, highlighting his significant contributions to international trade, social service, and education.

A Legacy of Leadership and Service

A chartered accountant by profession, Khalil was a founding member of the Dubai chapter of the Institute of Chartered Accountants of India (ICAI), where he served as chairman from 1987 to 1994. His illustrious career included key leadership roles, such as general manager of Khaleej Times, group executive director of the Ilyas and Mustafa Galadari Group, and vice-chairman of the Jashanmal Group of Companies.

He also chaired Maadhyama Communications and Sahil Online, a web-based news platform, and was a director and trustee of several media companies and charitable organisations in Dubai and India.

A Champion for Education and Philanthropy

Khalil’s impact extended far beyond his professional achievements. As president and general secretary of Anjuman Hami-e-Muslimeen, he played a pivotal role in the development of educational institutions, including schools and colleges in Bhatkal and surrounding areas. His dedication to social upliftment earned him recognition from the Government of Karnataka, which honoured him with a prestigious award for his philanthropic contributions.

A Life Celebrated

The Bhatkal Muslim Khaleej Council (BMKC) recently released a documentary celebrating Khalil’s remarkable life and service to the community—a testament to his enduring legacy.

CA Khalil is survived by his family and countless admirers across the globe. His passing marks the end of an era for Indian expatriates in the UAE and beyond, leaving behind a legacy of leadership, generosity, and commitment to community service.

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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 23,2024

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Bengaluru: In a boost to the ruling Congress in Karnataka, the party on Saturday swept the by-polls to three Assembly segments, causing a major setback to the BJP-JD(S) alliance in the state.

The Congress has retained Sandur, the seat considered to be its strong hold, and has also bagged Shiggaon and Channapatna segments, which were earlier held by BJP and JD(S) respectively.

The November 13 by-polls to Sandur, Shiggaon and Channapatna Assembly segments had witnessed a fierce fight between the ruling Congress and a combative BJP-JD(S) alliance.

The by-polls to Sandur, Shiggaon and Channapatna were necessitated as the seats fell vacant following the election of their respective representatives -- E Tukaram of Congress, former CM Basavaraj Bommai of BJP, and Union Minister Kumaraswamy of JD(S) to Lok Sabha in May elections.

The by-polls witnessed a straight fight between the ruling Congress and BJP in Sandur and Shiggaon segments, while in Channapatna, JD(S) which is part of the NDA alliance took on the grand old party.

Congress' C P Yogeeshwara won the Channapatna segment, defeating JD(S) candidate and Kumaraswamy's son Nikhil Kumaraswamy, by a margin of 25,413 votes.

Former CM Basavaraj Bommai's son Bharath Bommai of BJP faced defeat against Congress' Yasir Ahmed Khan Pathan in Shiggaon Assembly segment by a margin of 13,448 votes.

In Sandur, Congress candidate E Annapoorna, the wife of Bellary MP E Tukaram, won the seat vacated by her husband, by a margin of 9,649 votes.

Congress' win in the by-poll is seen as an endorsement of both Chief Minister Siddaramaiah and his deputy D K Shivakumar's leadership, and the government's programmes, especially the five guarantee schemes.

Nikhil Kumaraswamy and Bharath Bommai, the third generation of Gowda and Bommai family respectively, who contested this bypolls, have lost. Their fathers and grandfathers had served as Karnataka's Chief Ministers in the past.

While for Bharath Bommai this was his electoral debut, for Nikhil it was his third electoral loss.

Among the three segments, Channapatna was considered to be a high profile battle, where the contest was between C P Yogeeshwara and actor-turned-politician Nikhil Kumaraswamy.

A five-time MLA from the segment and a former Minister, Yogeeshwara had joined the Congress after quitting BJP ahead of nomination.

There were plans to field Yogeeshwara on a JD(S) ticket, but he was not interested in it, and instead wanted Kumaraswamy to support him as BJP candidate. This was not acceptable to Kumaraswamy and his party, following which Yogeeshwara jumped ship.

However, Kumaraswamy had subsequently said he had agreed to Yogeeshwara contesting from BJP, and despite that he jumped ship to Congress, under the influence of Deputy Chief Minister D K Shivakumar and his brother and former MP D K Suresh.

Nikhil had faced defeat in 2019 Lok Sabha and 2023 Assembly polls. It is seen as a setback for Kumaraswamy too, as he could not ensure son's win from the Channapatna, the seat he had twice represented in the past.

Congress' win is crucial for Shivakumar, who is also the state Congress chief and his brother Suresh to strengthen their position in their home district of Ramanagara, a Vokkaliga heartland.

In Shiggaon, BJP's Bharath Bommai, son of Basavaraj Bommai lost against Congress' Yasir Ahmed Khan Pathan, who had faced defeat against the former Chief Minister in the 2023 Assembly polls.

Initially, former MLA Syed Azeempeer Khadri, a Congress' ticket aspirant, had raised a banner of revolt in Shiggaon, by filing his nomination as an independent, but later withdrew after intervention by party leadership.

In Sandur, Bellary MP Tukaram's wife E Annapurna of Congress won from the seat vacated by her husband, against BJP ST Morcha president Bangaru Hanumanthu, who is considered close to party leader and former mining barron G Janardhan Reddy.

Sandur is a Congress' bastion, and Tukaram had represented it four times.

Congress winning the by-polls is seen as "crucial" for Chief Minister Siddaramaiah to assert himself , amid demands for his resignation following charges against him in the MUDA site allotment case.

There were also behind-the-scenes political activities within the ruling Congress earlier this year, with a few ministers in his Cabinet holding closed door meetings, fueling speculation about leadership change. But such activities came to a halt following instructions from the party high command.

It is equally important for Shivakumar, who has not shied away from openly expressing his Chief Ministerial ambitions, amid speculations over "rotational Chief Minister formula," according to which he will become CM after two-and-half years (in this govt's five years tenure), but they have not been officially confirmed by the party.

The defeat in this by-poll is seen as a setback for state BJP President Vijayendra, who has been facing intense criticism and opposition from a section within the party, who have raised a banner of revolt against his leadership accusing him and his father, veteran leader B S Yediyurappa of "adjustment politics".

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