United States Food and Drugs Administration (FDA) has declined the emergency use of Covaxin developed by Bharat Biotech. Covaxin is an India-made vaccine developed by Bharat Biotech against the Coronavirus disease. The vaccine has been developed by using ‘whole-Virion Inactivated Vero Cell’.
The decision to reject the emergency use of Covaxin has been taken due to the limited amount of data and information provided by Bharat Biotech. FDA requires extra clinical test data for supporting the marketing application submission for Covaxin. Additional information and data from human clinical trials, the vaccine’s safety, and acceptable efficacy must be provided to the FDA. US FDA said that the corporate would need to follow the biological license application process for vaccines. Ocugen, Bharat Biotech’s US partner, said they would pursue to urge complete approval of Covaxin. The FDA has asked Ocugen to start with their additional vaccine trial so that the corporate can file for a Biologics Licence Application (BLA). The BLA grants complete approval to the vaccine. Ocugen, as per the instructions given by FDA, will file a BLA to urge complete approval for Covaxin. Ocugen said on 10 June, the corporate won’t attempt to get the emergency approval for Covaxin. Instead, it will try to provide all the knowledge and data asked by US FDA. The information from the Phase-3 trial of Covaxin is going to be released publicly in July. Bharat Biotech will apply for complete approval of Covaxin only after releasing the entire data and knowledge. ” While this may extend our timelines, we are committed to bringing Covaxin to the US,” Dr Shankar Musunuri, Chairman of the Board, CEO and co-founder of Ocugen, said.
What does it mean for India?
The US FDA has directed Bharat Biotech to apply for a BLA for a full licence for Covaxin. The corporate has responded positively and agreed to provide complete information and data about the vaccine. But this will create a sort of hesitation among people. Already, nearly 70 per cent of Indians are unwilling to get the COVID-19 vaccine due to misconceptions created by oppositions. However, the Centre has said that the FDA turning down Covaxin isn’t going to disturb India’s vaccination drive. VK Paul, a member of NITI Aayog, said that “Certain vaccines vary as per scientific consideration like nutrition, genetic dynamic consideration. We respect FDA’s decision and we expect that our manufacturers will comply with whatever it requires to be done. Each country has its own regulatory system, some parameters could be common, some could be different. We are satisfied our regulator approved it”, he further added. He said that the Phase-3 trial data of the vaccine is going to be published in a peer-reviewed journal.
Bharat Biotech said, “With good heard immunity and significant percentage of the population vaccinated, the pandemic in US is reducing. Our US partner, Ocugen has received a recommendation from the FDA to pursue Biologics License Applications path for Covaxin, which is full approval instead of EUA.” Responding to FDA’s denial of emergency Covaxin use, the government said that America’s decision won’t affect India. India will still use the vaccine.
The most immediate impact of the decline in emergency use of Covaxin will be that it will delay plans of rolling out the vaccine in the US. The method of application for BLA and additional clinical test of the vaccine will be time-consuming. FDA’s decision of declining the emergency use of Covaxin may delay the target of vaccinating the entirety of India as early as possible.
Vaccine certificates or passports are becoming a reality as countries are opening their borders only for fully vaccinated individuals. It’s crucial to supply all the extra data and knowledge to FDA to urge complete approval for Covaxin.
Ram Mandir Opening For “Darshan” In 2023
The Ram Mandir in Ayodhya is expected to allow visitors by December 2023, with the completion of construction only in 2025.
Sources in the Shri Ram Janmabhoomi Teerth Kshetra have revealed that the colossal project of building the Ram Mandir in Ayodhya, Uttar Pradesh, will be opening for devotees towards the end of 2023. In contrast, the project’s entire construction completion is expected towards the end of 2025. The sanctum sanctorum (Garbha Griha), along with the mandir’s first floor, will be ready by December 2023. Devotees will be allowed to visit the long-awaited mandir soon after the construction is completed.
An ANI report said, “The grand Ram Mandir being constructed in Ayodhya will be opened for devotees from December 2023. Sources told ANI that Garbhagriha, all five mandaps and the first floor will be ready by December 2023 and the mandir will be opened for devotees”.
Completion of entire Ram Temple complex in Ayodhya is expected by the year 2025; A museum, digital archives and a research centre also to come up in the temple complex: Sources
— ANI UP (@ANINewsUP) August 4, 2021
The sanctum sanctorum will be as high as 161 feet and built using Rajasthani marble and stones. Engineers and architects are taking all measures to ensure the longevity of this enormous project. The second stage of construction is expected to begin in December this year. Currently, the structure is at a standstill as a result of monsoons. Another reason for the delay is the coronavirus pandemic that depleted the force with which the mandir’s construction was expected to go on.
Ram Temple in Ayodhya will be ready in a year or two. Delhi government has decided to take senior citizens to Ayodhya for Ram Lalla's darshan with travel, accommodation, and food expenses to be borne by us: Delhi CM Arvind Kejriwal pic.twitter.com/MDGeP0k613
— ANI (@ANI) March 14, 2021
The announcement of the mandir being opened to visitors in 2023 has brought up questions about the political agenda. It is believed that the Bharatiya Janata Party (BJP) aims to use the mandir to catapult themselves into a position of advantage during the 2024 Lok Sabha elections. Opening the mandir to devotees in December 2023 will give the BJP an easy 6-month gap to the general elections in 2024.
The opening of the long-awaited Ram Mandir in Ayodhya could be the factor that diverts the public, at least the Hindu’s in favour of BJP. Thus, securing them a vote bank based on religious sentiments upheld by the party in their previous tenure as the ruling party.
The Ram Janmabhoomi Mandir will be 360 feet long, 235 feet wide, and 20 feet high mandir will be completely ready by the end of 2025. The project will include amenities and structures like museums, archives, research centre, Sant Niwas, gau and Yagya shala, Etc. The main attraction is the Ram Mandir.
Centre to SC: Shreya Singhal Judgement- States Also Have Liability To Guarantee Individuals Not Troubled Utilizing Scrapped Section 66A
The Center has submitted to the Supreme Court that police and police requests being state subjects, the obligation to ensure the execution of the pronouncement that annuls Section 66A of the Information Technology Act belongs to the states. Further, the law requires organizations to share equivalent obligations to hold out the judgment.
On July 5, 2021, a Bench drove by Justice Rohinton F. Nariman said it was “upsetting,” “shocking” and “terrible” that individuals are as yet reserved and tried under Section 66A even six years after the apex court struck down the arrangement as unlawful and an infringement of free speech. The NGO People’s Union of Civil Liberties, represented by senior lawyer Sanjay Parikh and advocate Aparna Bhat, had made the court take notice of the contempt.
Undead segment: About Section 66A of the IT Act
In its reaction, the Centre said the police and public request were “State subjects” under the Constitution. “Counteraction, location, examination and arraignment of wrongdoings and limit the working of the police are essentially the obligation of the States,” the Centre submitted in the affidavit. It said law requirement organizations share equivalent obligation to agree with the apex court judgment. They make a move against cybercrime offenders according to the law.
The Centre said the Ministries of Information and Technology and Home Affairs gave a valiant effort to disperse information about the Supreme Court judgment in the Shreya Singhal case. Section 66A had suggested three years of imprisonment if an online media message caused “disturbance” or was found “terribly antagonistic”. Mr Parikh had welcomed the court intervention to work out a system to disperse the Shreya Singhal judgment to each police headquarters and preliminary court in the country.
“Section 66A of the IT Act has continued being utilized inside police base camp just as in cases under the attentive gaze of primer courts across India. This data was accessible on the Zombie Tracker site, created by a group of independent researchers. The discoveries of the site uncover that as of March 10, 2021, upwards of 745 cases are as yet forthcoming and dynamic under the steady gaze of region courts in 11 States, wherein the denounced are being indicted for offences of the IT Act under Section 66A.” the PUCL has acquiesced.
The accommodation has been in the rejoinder affidavit filed by PUCL in the apex court. This response was because of the Centre’s counter-affidavit in a petition filed by PUCL looking for different bearings and rules against the FIRs scraped under the struck-down Section 66A.
PUCL in, its rejoinder affidavit through Advocate Aparna Bhat, has contended that the Union of India should not have avoided its commitment by arguing that the obligation of execution lies with the States just as with the law enforcement agencies. It mentioned alluding to Union’s accommodation in its affirmation that ‘Police’ and ‘Public Order’ are state subjects. Accordingly, the obligation rests with the State.
Alluding to the Centre’s accommodation that they had mentioned Chief Secretaries, all things considered, and Administers of Union Territories to outfit information for arraignments summoning Section 66A get-togethers, PUCL has contended that the reaction to the said letters have ‘nor set on record nor unveiled.’ PUCL has been tending that looking for removal of its application mentioning the execution of the judgment downplays the enormous scope infringement of the right to freedom of speech and expression and the right to fair trials of citizens.
The applicant has proposed the additional directions to be given by the Court in the matter:
Directions to High Courts:
The applicant has looked for specific bearings to every one of the High Courts through Registrar Generals. The proposed headings ought to impart to every one of the District Courts and Magistrates that forthwith there ought to be no cognizance taken under the revoked Section 66A of the IT Act. It had been expressed that the High Courts be permitted to start Suo Motu contempt procedures against those liable for enlisting a case under Section 66A or for examining it or for indicting it.
Directions to DGPs:
The applicant has recommended that bearings are given to the Director-General of Police and Union Territories to convey to all police headquarters inside their separate locales to show a notification that Section 66A of the IT Act has been scrapped. Also, no case can be enrolled under the cancelled Section 66A of the IT Act.
Directions to Respondents:
Decisions have looked to the Respondents, Union of India, to accumulate the nuances of the cases enrolled by the Police or Law Enforcement Agencies under Section 66A of IT Act since the judgment of Shreya Singhal revealed by coordination with the chief secretaries of the DGP of the States and Union territories.
As per the applicant, Respondents can coordinate to guarantee that Doordarshan and All India Radio make quarterly declarations in significant vernacular dialects advising the public that Section 66A of the IT Act is presently not in power. The applicant has looked for bearings to guarantee that all authority and business forms of the IT Act that are here in after distributed (on the web or disconnected) do exclude the total content of Section 66A and educate the per user that said arrangement stands revoked.
The Shreya Singhal judgment had delivered by the seat which, lifted Section 66A by Judge J Chelameswar and RF Nariman for a violation of Articles 14 and 19(1)(a) of the Constitution. The judgment wrote by Justice Nariman held the arrangement to be obscure, over the edge, and making an alarming impact on free discourse.
SC/ST Act Misuse: Alleged Fraudulence Of The Atrocities Act?
The Government of India, recently, claimed in an answer to the MPs of Rajya Sabha, that according to research, many states have conviction rates that are even lower than 1%.
In the year 2019, there were a total of 41,793 incidences of crime or atrocities against Dalits and 7815 cases of crime against tribal people. According to the report, only 44 out of 6540 cases of crimes or atrocities against Dalits in Bihar have been proven factual in trial courts. The STs filed a total of 97 cases under the SC-ST Act, but only two were judged to be true.
The conviction rate was 0.67 percent for men and 2.06 percent for women. It also stipulates the state with the most cases of crime against SCs is Uttar Pradesh, with 9451 cases, or 22.61 percent of all such cases in the country. Rajasthan comes in second with 6659 cases (15.9% of total cases), followed by Bihar (15.6%), and Madhya Pradesh (12.6 percent). In the last year, the number of ST cases filed in UP has increased by 600 percent.
According to the information, 705 cases were filed, however just one case was found to be true during the trials. The conviction rate in Kerala and Karnataka is slightly more than 1%. The SC-ST Act has been used in 1,733 cases in Karnataka. The conviction rate, on the other hand, was only 1.67%. In Kerala, the average conviction rate for atrocities against Dalits and Adivasis under the PoA Act remained at 1.76%. These claims sure put the concerned legislation on spot for being exploited.
The Scheduled Castes and Scheduled Tribes (Prevention of Atrocities) Act, 1989, aimed to prohibit the atrocities committed against members of the Scheduled Castes and Scheduled Tribes, to establish Special Courts for the trial of such offences and the relief and rehabilitation of victims of such acts, and to provide for matters connected with or incidental thereto.
The number of complaints against the misuse of the same has arisen in the last few years. The apex court has had stated in the past, that the Act has been misused to submit bogus complaints to foster caste animosity, rather than blurring caste barriers, adding that, if the Atrocities Act is not brought into line, it may even “perpetuate casteism,” and the court will have to act to prevent “false implication of innocent persons along caste lines.”
However, when seen through the lens of why the Act was necessary and how well it was administered, a different image emerges. The court’s stated goal in a 2018 ruling for the Prevention of Atrocities Act, was to safeguard officers from “arbitrary arrest” and “innocent civilians” from being falsely accused in cases. But according to data from the National Crime Records Bureau (NCRB) and the Ministry of Home Affairs, low conviction rates under the Act may be due to the misuse of the provision as much as the way investigations and cases are pursued in the courts.
Those who have pushed for stricter rules under the Act argue that the low conviction rate is due to the way cases are registered and prosecuted. “Dalits are frequently the victims of discriminatory treatment in the administration of justice,” according to a Human Rights Watch report.
According to a report published in the Economic & Political Weekly, approximately half of the cases brought under the Act do not get to court and are closed by the police. It had also hinted at a “caste bias among the investigating officers.” Sthabir Khora, an assistant professor, alleges that compounding, compensation inducement, and criminal intimidation are some of the practices that tend to prevail when the complainant is from the SC/ST category.
In October 2019, the top court observed the National Crime Records Bureau, where over 47,000 cases were reported in 2016 under the Scheduled Castes and Scheduled Tribes (Prevention of Atrocities) Act. “It would be against the basic human dignity to treat all of them (SC/ST members) as a liar or as a crook person and cannot look at every complaint by such complainant with a doubt,” remarked justices Arun Mishra, M R Shah and B R Gavai.
The bench stated that if a case filed under the SC/ST Act is determined to be false or baseless, many a time. It could be due to poor investigation or other factors such as human failures, regardless of caste. Therefore, all such accounts must be taken into consideration before making an informed decision to serve justice.
The bench had also added, “All humans are equal including in their failings. To treat SCs and STs as persons who are prone to lodge false reports under the provisions of the Scheduled Castes and Scheduled Tribes Act for taking revenge or otherwise as monetary benefits made available to them in the case of their being subjected to such offence, would be against fundamental human equality.”
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