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 13,2024

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New Delhi: The Supreme Court took a firm stance on ‘bulldozer justice’ today, affirming that the Executive cannot bypass the Judiciary and that the legal process must not prejudge the guilt of an accused. In a significant judgment, the bench led by Justices BR Gavai and KV Viswanathan set new guidelines for demolition practices, responding to petitions challenging the controversial bulldozer actions taken against individuals accused of crimes.

The rise of this practice, termed 'bulldozer justice,' has seen authorities in various states demolish what they claim to be illegal structures belonging to accused individuals. However, multiple petitions questioned the legality and fairness of this approach, bringing the matter before the court.

Justice Gavai highlighted that owning a home is a cherished goal for many families, and an essential question was whether the Executive should have the authority to strip individuals of their shelter. “In a democracy, the rule of law protects citizens from arbitrary actions by the state. The criminal justice system must not assume guilt,” stated the bench, underscoring that due process is a fundamental right under the Constitution.

On the principle of separation of powers, the bench reinforced that the Judiciary alone holds adjudicatory powers and that the Executive cannot overstep these boundaries. Justice Gavai remarked, “When the state demolishes a home purely because its resident is accused of a crime, it violates the doctrine of separation of powers.”

The court issued a strong warning about accountability, stating that public officials who misuse their power or act arbitrarily must face consequences. Justice Gavai observed that selectively demolishing one property while ignoring similar cases suggests that the aim might be to penalize rather than enforce legality. “For most citizens, a house is the product of years of labor and dreams. Taking it away must be an action of last resort, thoroughly justified,” he said.

In its directives under Article 142 of the Constitution, the Supreme Court established new demolition guidelines. These include:

Mandatory Show-Cause Notice: No demolition should occur without first issuing a show-cause notice. The person served has a minimum of 15 days or the duration stated in local laws to respond.

Transparency of Notice Content: The notice must include specifics about the alleged unauthorized construction, the nature of the violation, and the rationale for demolition.

Hearing and Final Order: Authorities are required to hear the response of the affected individual before issuing a final order. The homeowner will have 15 days to address the issue, with demolition proceeding only if no stay order is obtained from an appellate authority.

Contempt Proceedings: Any breach of these guidelines would lead to contempt proceedings. Officials who disregard these norms will be personally accountable for restitution, with costs deducted from their salaries.

Additionally, the court mandated that all municipal bodies establish digital portals within three months, displaying show-cause notices and final orders on unauthorized structures to ensure public transparency and accountability.

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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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News Network
November 12,2024

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The Taliban regime has appointed Ikramuddin Kamil as the acting consul in the Afghan mission in Mumbai, Afghan media has reported.

It is the first such appointment made by the Taliban set up to any Afghan mission in India.

There was no immediate comment from the Indian side on the appointment that came.

The Ministry of Foreign Affairs of Afghanistan has announced the appointment of Kamil as the acting consul in Mumbai, the Taliban-controlled Bakhtar News Agency reported on Monday, citing unnamed sources.

"He is currently in Mumbai, where he is fulfilling his duties as a diplomat representing the Islamic Emirate," it said.

The appointment is part of Kabul's efforts to strengthen diplomatic ties with India and enhance its presence abroad, the media outlet said

Kamil holds a PhD degree in international law and previously served as the deputy director in the department of security cooperation and border affairs in the foreign ministry, it said.

He is expected to facilitate consular services and represent the interests of Afghanistan in India, the report added.

Kamil's appointment comes days after the external affairs ministry's point-person for Afghanistan held talks with the Taliban's acting defence minister, Mullah Mohammad Yaqoob, in Kabul.

Sher Mohammad Abbas Stanikzai, the Taliban's deputy foreign minister for political affairs, also posted on X about Kamil's appointment.

The appointment of Kamil is seen as part of efforts to facilitate consular services to the Afghan population in Mumbai.

There has been almost negligible presence of diplomatic staff at the Afghan missions in India.

Most of the diplomats appointed by the Ashraf Ghani government have already left India.

In May, Zakia Wardak, the seniormost Afghan diplomat in India, resigned from her position after reports emerged that she was caught at the Mumbai airport for allegedly trying to smuggle 25 kg of gold worth Rs 18.6 crore from Dubai.

Wardak had taken charge as the acting ambassador of Afghanistan to New Delhi late last year, after working as the Afghan consul general in Mumbai for more than two years.

She took charge of the Afghan embassy in New Delhi last November, after the mission helmed by then ambassador Farid Mamundzay announced its closure.

Mamundzay, who was an appointee of the Ghani government, had moved to the United Kingdom.

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