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PM Modi visits vaccine plants in 3 cities, reviews progress | India News – Times of India

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PUNE/AHMEDABAD/HYDERABAD: Prime Minister Narendra Modi on Saturday visited the units of three vaccine manufacturers in India to review the progress of vaccine development and manufacturing process — Zydus Biotech Park in Ahmedabad, Bharat Biotech in Hyderabad and Serum Institute of India (SII) in Pune.
Modi’s first stop was Ahmedabad where he reviewed the vaccine development and manufacturing process of Zydus Group’s indigenous plasmid DNA vaccine – ZyCov-D.
“What struck me and left me impressed was PM @narendramodi’s emphasis on science and vision for global good,” Zydus group chairman Pankaj Patel tweeted after PM’s visit.
The company has completed the phase-II human clinical trials of ZyCov-D and the results are currently being analysed. “Soon, the data will be presented (to the regulator) and the third phase will be kicked off. The phase-III trial is expected to begin in December and we hope to complete the third phase trials by March,” Patel told TOI.
“The vaccine is likely to come to market after March next year, subject to regulatory approvals. The production capacity is now being ramped up and the expansion will be over by January. With this, Zydus Cadila’s vaccine capacity will increase to 100 to 150 million doses per annum,” added Patel.
Later, Modi visited Bharat Biotech’s facility at Genome Valley in Hyderabad as part of his three-city tour.
The PM interacted with the company’s brass, including its chairman and managing director Dr Krishna Ella, as well as scientists involved with the development of Covaxin, India’s first indigenous Covid-19 vaccine that is being developed by the Hyderabad-based vaccine maker.
The Phase III trials of Covaxin, involving over 26,000 volunteers at 25 sites across the country, kicked off earlier this month. The first and second phase of human trials at Covaxin involved around 1,000 volunteers. Bharat Biotech had earlier indicated that going by the results of Phase I and II trials, Covaxin’s efficacy is expected to be well over 60%.
His last stop was at the vaccine major Serum Institute of India’s new plant at Manjari and interacted with its team about the manufacturing, logistics and distribution of its Covid-19 vaccine — Covishield.
In a tweet, the Prime Minister said, “Had a good interaction with the team at Serum Institute of India. They shared details about their progress so far on how they plan to further ramp up vaccine manufacturing. Also, took a look at their manufacturing facility.”
Serum Institute of India (SII) has partnered with the University of Oxford and AstraZeneca for the manufacture and distribution of the vaccine.
Its owner and chief executive officer (CEO) Adar Poonawalla said there was a discussion with the Prime Minister regarding the implementation plan of vaccine rollout. The new facility which will ramp up the capacity to 2 billion doses from 1.5 billion a year was also showcased to the PM, he said. At present, the company has stockpiled about 40 million doses, and will ramp up to 100 million doses per month after January.
Worldwide, everyone is dependent and looking forward to vaccines coming out of India which will be in large volumes and at an affordable price, as the country has about 50-60% global capacity, he said, adding India and Covax countries will be our priority.
A release by the PMO later said Modi stressed on that fact that “India considers vaccines as not only vital to good health but also as a global good and that it is India’s duty to assist other countries, including the nations in India’s neighbourhood, in the collective fight against Covid-19.”
He also asked scientists for their suggestions on how the country could improve its regulatory processes further, the PMO release said.



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Covid-19: Authorities still mum on month-old adverse event during vaccine trial | India News – Times of India

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More than a month and a half after an adverse event occurred in a clinical trial in India of the AstraZeneca vaccine, the Central Drug Standard Control Organisation (CDSCO), the regulator for vaccine trials, has not issued any statement on the occurrence. It also did not respond to queries about whether it has completed its investigation to determine if the trial participant’s illness was related to the vaccine. Serum Institute, which is partnering the pharma MNC and Oxford University for producing the vaccine in India, has also refused to comment.
This is in sharp contrast to AstraZeneca and Oxford University going public when one of the trial participants in the vaccine trial in the UK fell ill and halting the trial till an independent safety monitoring board and UK’s regulatory authority gave safety clearance.
Information about the occurrence of the serious adverse event (SAE) during the vaccine trial in India came from the family of the trial participant, which has sent the company and the regulators a legal notice.
Serum Institute merely stated that it would issue an official statement next week. AstraZeneca had issued a statement within days of the trial participant in UK falling ill and halted the trials across the world in the UK, Brazil and South Africa. The trial was resumed within a week after the independent safety review committee and national regulators gave clearance.
The Indian Council of Medical Research is a co-sponsor of the trial along with Serum Institute. Dr Samiran Panda, who heads the Epidemiology and Communicable Diseases (ECD) division of the ICMR, stated that the protocol was for the principal investigator at the trial site to first investigate why the adverse event had occurred followed by an enquiry by the Institutional Ethics Committee of the trial site, Sri Ramachandra Medical College (SRMC), Chennai.
“We cannot intervene as we are one of the sponsors of the trial and it should not seem like we are trying to influence the process, which would be inappropriate. We have informed the drug controller general of India (DCGI) about the development and the DCGI’s report on whether the adverse event was related to the vaccine is awaited,” explained Dr Panda. According to the ICMR, it is for the DCGI to take a call on whether or not to halt the trial. The DCGI heads the CDSCO.
The 40-year-old trial participant, a business consultant with an MBA from New Zealand who says he took part in the trial deeming it his duty to help such an important venture, was administered the vaccine at SRMC on October 1. Eleven days later, he woke up with a severe headache, and progressively lost his memory, showed behaviour changes, became disoriented and was unable to talk or recognise his family members, according to the legal notice.
As soon as he fell ill he was admitted to the ICU in SRMC. “We did a battery of tests to find if there was any linkage to the vaccine, but we did not find any. We provided all medical care free of cost till October 26 when the family said they were dissatisfied with the treatment and got him discharged and took him home. They brought him back a couple of times for follow up but have not been in touch after that,” said Dr S R Ramakrishnan, the principal investigator at the trial site. He added that the institutional ethics committee also did not find any connection to the vaccine, but admitted that they were unable to determine why he had become so seriously ill. The family has questioned how a healthy person declared fit enough to take part in the trial could become so severely ill if it was not due to the vaccine.
“Though the legal notice we have served talks of a compensation of Rs 5 crore, our focus is not on monetary compensation. It was sent just last week, more than a month after the occurrence when we saw that none of the authorities was making the adverse event public. They ought to have warned other participants so that they could watch out for similar symptoms. We want to know why the occurrence of the adverse event has been kept under wraps and why the trial was not halted like it was done in the UK. Is an Indian life of less value than that of an UK citizen?” asked a close family friend who has been helping the family cope with the illness.
In India, the trial for the study to check the safety and immune response of the Covishield vaccine is happening across 17 sites. It enrolls only healthy volunteers and enrolment started in the last week of August.



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Mamata Banerjee plans holding op on Suvendu’s turf | India News – Times of India

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KOLKATA: As Trinamool Congress rebel Suvendu Adhikari quietly prepared for his first political rally since resigning from the Mamata Banerjee cabinet on Friday, almost the entire party machinery got cracking to arrange a December 7 roadshow planned by the CM in his pocket borough Midnapore. Mamata’s primary objective is to quickly quarantine her party ranks from the “rebel” bug as she focuses on taking on BJP and CPM in the battle for the Bengal assembly, sources said.
The flurry of activity in the Trinamool camp included party seniors meeting representatives of West Midnapore, Malda and Murshidabad ahead of the CM’s meet with the party’s district heads on December 4. While TMC described the meetings as “routine”, the buzz was that the party has been shaken and stirred by Adhikari’s resignation as transport and irrigation minister, although he remains a Trinamool member for now. All three districts where TMC is trying to set its house in order are those where Adhikari was the party observer. Trinamool state president and MP Subrata Bakshi was in Midnapore on Saturday to take stock and oversee arrangements for the CM’s rally. Bakshi and other TMC seniors didn’t utter a word against Adhikari, who is being wooed by BJP and cheered by Congress.
At least four senior Adhikari loyalists from Midnapore were conspicuous by their absence at the meetings. Trinamool MP Abhishek Banerjee on Saturday held talks with the party’s Malda district leadership at his south Kolkata office. At Mahishadal in Nandigram, decorators were busy giving finishing touches to the dais from which Adhikari will address a crowd on Sunday.
(With inputs from Sujoy Khanra, Suman Mandal, Sukumar Mahato and Subhro Maitra)



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NGOs must meet 3 terms for FCRA nod: Home ministry | India News – Times of India

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NEW DELHI: The home ministry, in a bid to ease the transition of NGOs and associations to the new FCRA regime following recent amendments to the Foreign Contribution Regulation Act (FCRA) and rules, has put out an advisory for compliance depending on whether an NGO has already applied for FCRA registration, prior permission or renewal or is yet to submit the application.
As per the advisory issued on Friday, the three basic compliances that the NGOs and associations must meet following the latest changes in FCRA, 2010 and Foreign Contribution Regulation Rules (FCRR), 2011 relate to obtaining a DARPAN ID from Niti Aayog portal; opening the main FCRA account in SBI Parliament Street branch, New Delhi; and seeding Aadhaar details of all office-bearers or key functionaries.
Only last week, the home ministry had extended the deadline for NGOs/associations to upload annual returns for 2019-20 up to June 30, 2021, acknowledging that meeting the new conditions under amended provisions of FCRA and FCRR “may require some additional time”.
In a table put on the FCRA website on Friday, the ministry spelt out the requirements needed to be fulfilled under the amended Act and rules for four different categories of NGOs and associations; ones that have already submitted renewal application; those which have already submitted application for FCRA registration or prior permission; those which are yet to submit application for renewal of FCRA registration; and ones that are yet to submit application for FCRA registration or prior permission.



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Covid-19: Cheaper, faster test from CCMB set to hit market | India News – Times of India

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HYDERABAD: Even as clinical trials on Covid-19 vaccine have reached the final stage, city-based Centre for Cellular and Molecular Biology (CCMB) has developed an RT-PCR-based test to detect the pandemic virus easily and effectively.
The new method, which got the final approval of the Indian Council of Medical Research (ICMR) and is ready for release in the market, is simple and fast. Instead of the “wet” method now used for RT-PCR tests, the CCMB model is Dry Swab-Direct RT-PCR. This brings down not only the cost of the RT-PCR test, but also reduces the time taken for the result.
The Dry Swab-Direct RT-PCR method involves collecting and transporting the nasal swab in dry state (as opposed to using the viral transport medium) which makes transportation and handling of the samples easy and less prone to spillage.
CSIR director-general Dr Shekhar C Mande said that the Dry-Swab method is easy to implement with existing kits and current manpower can perform this with no additional training and hence could make a significant contribution to ramping up the testing capacity.



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Goswami case: Maharashtra home minister vows a ‘strong chargesheet’ | India News – Times of India

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NAGPUR: Maharashtra home minister Anil Deshmukh said on Saturday that he wanted to give the late architect Anway Naik and his family justice by filing a “strong chargesheet” in the abetment to suicide case that was “wrongly closed by the previous government.” Republic TV’s editor-in-chief Arnab Goswami is one of the three persons named as accused in the case.
NCP’s Deshmukh said the case against Goswami and two others was reopened following a court order. “Our investigation into Goswami’s and other accused’s roles in the case is underway. The deceased had left behind a suicide note saying the reason for taking the extreme step was non-payment of Rs 80 lakh by Goswami towards the construction of a studio,” the minister said. “The reason behind our taking the case to its logical end and filing the chargesheet is that we are trying to help the Naik family get justice,” Deshmukh added.



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Khattar links Punjab CM’s office to farmers’ agitation | India News – Times of India

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CHANDIGARH: The relationship between Punjab and Haryana has touched new lows over the ongoing farmers’ protest against the Union government’s three contentious agri-marketing laws. The already tense ties worsened on Saturday when Haryana chief minister Manohar Lal Khattar claimed in Gurgaon that the farmer protests were sponsored by political parties in Punjab and that they were led by office-bearers of the Punjab chief minister’s office.
Khattar also alleged that some unwanted elements had raised pro-Khalistan slogans during the farmer protests. “We’ve reports and will disclose (them) once it’s concrete. They raised such slogans,” he said. The Punjab CM, Captain Amarinder Singh, in turn, demanded an unequivocal apology from his Haryana counterpart for inflicting brutality on farmers. He also accused Khattar of spreading lies and sticking his nose into a matter in which his state had no role to play.
“Khattar is lying that he tried calling me earlier and I did not respond. But now, after what he has done to my farmers, I will not speak to him even if he calls me 10 times. Unless he apologises and admits that he did wrong with Punjab’s farmers, I will not forgive him,” said Amarinder.
Criticising Khattar for making allegations that he was instigating the farmers and provoking them to agitate, Amarinder said: “I am a nationalist to the core, I run a border state and will never do anything to create a law and order problem.” He added that for 60 days the farmers had been blocking Punjab’s railway tracks, causing more than Rs 43,000 crore in losses to the state. “I will not take this nonsense from Khattar. Don’t I have better things to do than to incite farmers,” he said, adding that “sometimes they say it’s Khalistanis who’re managing the protests and sometimes they accuse me of doing it… let them make up their minds.”
Amarinder declared that no political party was involved in the farm protests. Terming as ludicrous Khattar’s claim that Haryana farmers were not part of the “Delhi Chalo” agitation, Amarinder said Punjab’s intelligence department had showed that 40,000-50,000 farmers from Haryana had joined the march.



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Covid-19: Delhi, northern states see a dip in fresh cases | India News – Times of India

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NEW DELHI: The country reported around the same number of fresh Covid-19 cases as the previous day, even as several states in north and central India where the pandemic had surged in recent weeks showed signs of the virus receding.
India reported 41,927 new infections on Saturday, a slight increase from the 41,504 cases recorded the previous day, as per data collated from state governments. Daily cases have decreased marginally in the past two days, with no signs yet of the feared second wave in the country following the festive season.
Daily cases were dropping gradually in several states across north and central India. These states — Delhi, Rajasthan, Haryana, Madhya Pradesh, Uttar Pradesh and Himachal Pradesh — were among those that appeared to be leading the surge in the pandemic in the past two-three weeks.
In Delhi, fresh cases had decreased to 4,998 from a high of 8,593 recorded on November 11. Rajasthan reported 2,765 new cases on Saturday, down from a peak of 3,314 four days earlier. Similarly, Madhya Pradesh’s daily count had dropped to 1,634 from 1,798 on November 22 while the number dropped to under 2,000 in Haryana (1,967) after 12 days. The state had logged a peak of 3,104 on November 20.
Likewise, Uttar Pradesh registered 2,170 new infections on Saturday, down from a November peak of 2,858 recorded eight days ago. Himachal Pradesh too reported a drop from a high of 948 cases recorded on November 24 to 650 on Saturday.
However, the infection appeared to be still surging in Gujarat. The state recorded 1,598 cases on Saturday, close to its peak of 1,607 reported just a day earlier.
After three days of recording 6,000-plus new Covid-19 positive cases, Maharashtra witnessed a marginal dip with 5,965 cases on Saturday. Mumbai, however, continued with its seemingly new stable number of little over 1,000 cases (1,063) for the fourth consecutive day.
While state officials added 75 deaths to the state toll, which is now 46,986, BMC officials said 17 deaths were reported in Mumbai in a 24-hour period. The toll in Mumbai since March is 10,847 deaths so far.
The post-Diwali impact due to intermingling was also apparent in the rising number of active cases, both in the state and city. The active cases in the state increased by 10,000 plus from 79,873 (November 21) to 89,905 on Saturday. In Mumbai, the corresponding rise has been 2,500 – from 12,397 on November 21 to 14,979 now.



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