The Drugs Controller General of India (DCGI) on Wednesday issued a showcause notice to pharma giant Serum Institute of India (SII) seeking an explanation as to why it did not suspend the ongoing clinical trial of Covishield vaccine candidate till doubts about patient safety are cleared.
The drug regulator’s move comes after AstraZeneca, which is developing the vaccine candidate against Covid-19 with researchers of Oxford University, paused its trial as a volunteer developed an unexplained illness. The clinical trial has been put on hold in the US, UK, Brazil and South Africa. Referring to reports of AstraZeneca halting the trials in the UK, SII, which is conducting the trials in India, said that the UK trials have been paused for further review.
“We can’t comment much on the UK trials but they have been paused for further review and hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all,” it said.
The notice to the SII has been issued by DCGI Dr V.G. Somani.
“In view of the above Drugs Controller General of India and Central Licensing Authority hereby allow you to showcause as provided under rule 30 of the New Drugs and Clinical Trials Rules 2019 — why the permission granted to you on 2 August shall not be suspended till patient safety is established,” said the notice as per an ANI report.
It said that SII “up till has not informed” the central licensing authority regarding pausing of clinical trials carried out by AstraZeneca in other countries and has “also not submitted a casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase II/III clinical trial of the subject vaccine in the country in light of the safety concerns”.
“Your reply shall reach undersign immediately, else it shall be construed that you have no explanation to offer and action deemed fit will be taken against you,” it added.
The country’s apex drugs regulator had on 2 August granted permission to SII to conduct a phase II/III clinical trial of ChAdOx1 nCoV-19 coronavirus vaccine (recombinant) at various clinical trial sites in the country to determine its safety and immunogenicity. The vaccine will be manufactured by SII under technical collaboration with Oxford University/ AstraZeneca and is called Covishield (SII-ChAdOx1 nCoV-19).
Covishield vaccine contains replication-deficient simian adenovirus vector ChAdOx1 containing structural surface glycoprotein (spike protein) antigens of SARS-CoV-2.
With inputs from ANI
The Daily Guardian is now on Telegram. Click here to join our channel (@thedailyguardian) and stay updated with the latest headlines.
For the latest news Download The Daily Guardian App.
VOKKALIGAS VS VOKKALIGAS: DK SHIVAKUMAR HAS GOWDAS WORRYING
It was Kempe Gowda Day on Monday. Prominent Vokkaliga leaders occupied the dais including Deve Gowda, HD Kumaraswamy, Sadananda Gowda and Vokkaliga seer Nirmalananda Swami. As DK Shivakumar started to speak, he got stupendous response from the crowd. DK, as he is popularly known, though appreciated his political bête noire too, drove home the point that three Ks built Bengaluru – Kempe Gowda, Kengal Hanumanthaiah and SM Krishna. Deve Gowda and son Kumaraswamy were left red faced.
Those who know Vokkaliga politics in the state knew the import of DK’s address. There is a tug of war going on among the leaders of the community and DK made it clear that day.
In 2018, when the Karnataka electorate threw a fractured mandate, the political drama that played out in the state for over a fortnight had everyone cued in – midnight hearing in SC, resort politics, resignation of BS Yediyurappa and formation of JDS–Congress coalition government. Something impossible was achieved and on the steps of Vidhana Soudha the coronation HD Kumaraswamy took place, with a galaxy of Indian politics – from Mamata Banerjee to Mayavati, from Sonia Gandhi to MK Stalin, from Sharad Pawar to KCR, from Arvind Kejriwal to Kamal Hassan – in attendance. This picture was a direct message to the BJP that it has a formidable force to contend with, but what happened in 2019 Lok Sabha elections was an anti-climax.
It was nothing short of a miracle then as the BJP lost in the numbers game by a whisker, and it was achieved as two Vokkaliga leaders Kumaraswamy and DK, who were sworn enemies, joined hands. The biggest losers were Lingayat strongman BS Yediyurappa and Kuruba leader Siddaramaiah.
It has been four years since, and Karnataka has seen four chief ministers in the interregnum – Siddaramaiah, Kumaraswamy, Yediyurappa and now Basavaraj Bommai – and a lot of water has flown under the bridge. Today the very same leaders DK and HDK, as they are popularly known, are at each other’s throat. The reason is that both are vying with each other to get the mantle of undisputed Vokkaliga leader.
For decades the Gowdas – Deve Gowda and clan – have been the first political family of the Vokkaligas. SM Krishna, though a Vokkaliga from Mandya heartland and Deve Gowda’s contemporary, was edged out.
The battle for the Vokkaliga mantle has passed on to the second generation – between DK and HDK. While HDK is Deve Gowda’s son, DK, who is Kirshna’s protégé, became family through his daughter’s was marriage to Krishna’s grandson Amarthya (Cafe Coffee Day Siddharth’s son).
An apparent result of dynastic politics is that the JDS is losing support especially in the Cauvery basin, their bastion. The loss of then sitting Chief Minister’s son Nikhil Kumaraswamy in 2019 Lok Sabha is a case in point. All seven assembly constituencies in Mandya were with JDS, yet the party failed to ensure his victory.
JDS has since then rapidly declined, while DK’s popularity has steadily grown.
DK’s jail time proved counterproductive for the BJP and the Congress Party finally made him the state president despite resistance from the Siddaramaiah faction.
The Gowdas have been critical of him, for they know DK’s organisational and resource mobilization skills. DK has in the past couple of years consolidated his position in Vokkaliga-dominated districts of Mysore, Mandya, Hassan, Ramanagara, Tumkur, Kolar, Bengaluru Urban and Rural, Chikkaballapur, Chikkamagalur and parts of Shimoga much to Gowdas’ discomfiture.
The open revolt in JDS in recently concluded Rajya Sabha elections can be seen in this backdrop. JDS MLAs like AT Ramaswamy and Shivlinge Gowda of Hassan, Srinivas of Tumkur, Shrinivasa Gowda of Kolar and GT Deve Gowda of Mysore have rallied behind DK.
There is a general sentiment among the Vokkaligas that DK should ascend the CM throne given the current political scenario. The BJP is going to the hustings sans Yediyurappa, the JDS is getting weaker because of exodus of their legislators. The big question is will this sentiment convert to vote? And will DK replace the Gowdas as their numero uno leader?
Tourism has a value beyond lifestyle and economic factors
Going on a holiday can have a positive impact on an individual’s mental health and well-being, according to a new study. A new cross-disciplinary paper from Edith Cowan University (ECU) has proposed a change in the way we view tourism, seeing it not just as a recreational experience, but also as an industry that can provide real health benefits.
The collaboration between ECU’s Centre for Precision Health and the School of Business and Law found many aspects of going on holiday could have a positive impact on those with mental health issues or conditions.
Lead researcher Dr. Jun Wen said the diverse team of tourism, public health and marketing experts investigated how tourism could benefit those living with dementia.
“Medical experts can recommend dementia treatments such as music therapy, exercise, cognitive stimulation, reminiscence therapy, sensory stimulation, and adaptations to a patient’s mealtimes and environment,” Dr. Wen said, adding “These are all also often found on holidays.” This research is among the first to conceptually discuss how these tourism experiences could potentially work as dementia interventions.”
HOLIDAY FUN OR TREATMENT?
Dr Wen said the varied nature of tourism meant there were many opportunities to incorporate treatments for conditions such as dementia.
For example, being in new environments and having new experiences could provide cognitive and sensory stimulation.
“Exercise has been linked to mental wellbeing and travelling often involves enhanced physical activity, such as more walking. Mealtimes are often different on holidays: they’re usually more social affairs with multiple people, and family-style meals have been found to positively influence dementia patients’ eating behavior and then there’s the basics, like fresh air and sunshine, increasing vitamin D and serotonin levels,” he said.
“Everything that comes together to represent a holistic tourism experience, makes it easy to see how patients with dementia may benefit from tourism as an intervention,” he further expressed.
A SHIFT IN THINKING
Covid-19’s impact on travel in recent years has raised questions about tourism’s value beyond lifestyle and economic factors.
“Tourism has been found to boost physical and psychological well being, so, after Covid-19, it’s a good time to identify tourism’s place in public health and not just for healthy tourists, but vulnerable groups,” he said.
He hoped a new line of collaborative research could begin to examine how tourism can enhance the lives of people with various conditions and expressed, “We’re trying to do something new in bridging tourism and health science,” he said, adding, “There will have to be more empirical research and evidence to see if tourism can become one of the medical interventions for different diseases like dementia or depression; so, tourism is not just about travelling and having fun; we need to rethink the role tourism plays in modern society.”
‘OVERNIGHT SUCCESSES’ CANNOT BE ATTRIBUTED TO PROVIDENCE
Everybody wants to hop onto a bandwagon that is taking off, yet few of us are prepared for the toil that paves the way for it.
“There are decades where nothing happens, and there are weeks where decades happen,” goes a quote attributed to Lenin. For Eric Yuan and the team at Zoom, those weeks were in March and April 2020. That was when the world was reeling under the twin impact of the pandemic and the lockdowns; and voila, Zoom was the savior. From work meetings to birthday parties, everything started happening online. Usage of Zoom ‘zoomed’ thirty-fold in just four months, surpassing three hundred million daily participants. The company’s market capitalization smashed past the hundred-billion-dollar mark, rising eightfold over the ten months to October 2020.
‘Overnight successes’ are not confined to the world of business. In 1976, an unknown, out-of-work actor named Sylvester Stallone approached a movie studio with a script. The studio offered him over three hundred thousand dollars, but he opted to take a much lower sum if they agreed to his demand to play the lead role. The studio finally relented, and the rest is history. The movie, ‘Rocky’, smashed box-office records, was nominated for ten Oscars, and spawned multiple sequels. It left behind an enduring legacy based on its theme of the power of the human will.
One might be tempted to attribute such successes to providence. Yet, nothing could be farther from the truth. As entertainer Eddie Cantor said, “It takes twenty years to make an overnight success.” Many processes in life follow the pattern of the Chinese bamboo tree, a seed that needs to be watered and cared for over four full years before it even begins to sprout. Yet, in the fifth year, it suddenly shoots up, growing over fifty feet in just a few weeks. Plodding over those dreary four years lays the foundation for what follows.
Before 2020, the team at Zoom had spent nine years obsessing over the customer experience, product architecture and technical standards, with the founder Eric personally responding to customer complaints. Eric’s own story is testament to his persistence, of how he found his feet in the US after eight visa rejections and despite his patchy English.
Sylvester Stallone’s story is no different. To realize his Hollywood dreams, he went through many rough years, with only two pairs of clothes, sleeping in a bus station, and even having to sell his dog. To quote him, “Life is an opponent that never stops punching, so you better never stop punching back.”
In the world of business today, it has become commonplace to talk about the ‘hockey-stick’ curve, an initial period of learning followed by supposedly meteoric growth. Yet, few founders and investors have the patience to last it through the initial curve of the ‘hockey stick’. This is where setbacks happen, mistakes are made, business models come apart, and often, startups flounder and die. Eventually, this trial by fire culminates in a better product and a wiser management team. Everybody wants to hop on to a bandwagon that is taking off, yet few of us are prepared for the toil that paves the way for it.
I have also seen this dynamic in the stock markets. Whenever we hear of someone making a ‘multi-bagger’ return on a stock, it is tempting to attribute it either to luck or to spotting an attractive company early. Yet, neither of these explanations conveys the full story. The real secret of bagging a multi-bagger is often in being able to retain conviction and hold it through periods of gut-churning volatility, when the stock might be down over 50%.
This pattern is mirrored in the world of books too. Writing my first book, KaalKoot, took many years. This was a period where I had to keep at it without any external validation, and with pangs of self-doubt gnawing away at my mind. After the success of KaalKoot, writing my second book was much faster and easier. Yet, it was those difficult early years that laid the foundation for what followed.
The US Airways pilot ‘Sully’ Sullenberger, who saved hundreds of lives in January 2009 by successfully landing the plane over the Hudson river after an engine failure, garnered widespread applause for his presence of mind during those critical moments. Yet, to quote him, the secret lay elsewhere. “For 42 years, I’ve been making small, regular deposits in this bank of experience, education, and training. On January 15, the balance was sufficient so that I could make a very large withdrawal.”
That, then, is the secret of becoming an ‘overnight success’, i.e making regular deposits in the bank of experience, being consistent with it, and persisting despite obstacles.
S. Venkatesh is the author of AgniBaan and KaalKoot, a leadership coach and an investor who has held key positions with JP Morgan, Credit Suisse and Macquarie. He writes about mindfulness and its link to creativity, business and wealth.
ARTIST’S SEARCH FOR ROOTS AMONG UTTARAKHAND HILLS
Yatin Kandpal makes a mark though his solo exhibition ‘Emotional Rescue’
After his four-day solo exhibition, “Emotional Rescue”, ended on Sunday June 19, Yatin Kandpal returned to his studio that late evening more than contented. For the 37-year-old painter, who left a well-paid job in 2016 to pursue his passion, never knew his work would create so much enthusiasm among the seekers of art. “The reception my open-air exhibition got from both the connoisseurs of art and the customers visiting was more than expected,” said Yatin basking radiantly in the stupendous success his exhibition had.
Yatin (right), in conversation with fellow artist Asha Sharma
The four-day long exhibition, organised at iHeart Café at the sleepy village of Mehragaon on way to Bhimtal – about 15 km from district headquarters – saw a footfall of about 2000 visitors. Children, wannabe and accomplished artists, actors, senior bureaucrats, police officials, teachers and students, tourists and locals all came in droves to see the two-hour-long evening exhibition, keeping Yatin on his toes, discussing at length about each painting, with the artist giving live demos especially to children, even inviting them to give a shot at it.
“It was wonderful to see Yatin engage children showing them hands on how they can express how they view the world around them with the stroke of a brush,” said Asha Sharma, an artist herself.
Among a surprise visitor to his exhibition was none another than his teacher, Professor Zahoor Ahmed Zergar, former Head of the Department of Applied Art at Jamia Milia Islamia University. It was under Professor Zergar’s tutelage that Yatin grew from a raw hand, who could barely drew some sketches on art paper, to an accomplished artist that he is now. It was, in fact, Professor Zergar who discovered Yatin way back in 2005 when he had gone to Almora to attend a 10-day-long camp organized by Lalit Kala Academy where artistes from various parts of the country had come to participate.
The camp he attended at the prodding of one of his arts teacher proved a turning point, as it created an everlasting bonding both with the professor and with the brush. After doing Masters in Fine Arts, he followed Professor Zergar to Delhi in 2008 where he learnt the nuances of painting while watching closely his Guru working on canvas strung on the easel in his studio even while pursuing another Masters. After his stints with Prime Focus and the Central Institute of Educational Technology in Delhi, he packed his bags in 2016 to settle down in Bhimtal. “It is these mountains where I chose to put down my roots in the midst of nature which is my muse,” said Yatin waving his hands without any cares about the world at large.
“It needs a lot of courage to stay through what you believe is your calling. Yatin has done exactly that. In other words, he has rescued himself through his paintings,” said Professor Anne Feenstra, who curated the exhibition. “I will put his work in the realm of super-reality as he interprets realities of life through his paintings,” added the recipient of Global Award for Sustainable Architecture.
Take, for instance, the self-portrait he drew on canvas after his dog died a couple of years back, the centrepiece of the exhibition. He threw in some paws all over his face to express his loss. When you look at a landscape, a person, or a mountain, for instance, you interpret those elements of nature or objects through your work adding your own perspective to what you observe, using imagination.
So when he saw Nainital with its daunting mountain tops on three sides, half cut by forces of nature and half denuded by human intervention, he drew a painting that says all about it. We see the beautiful lake in its quaint pristine form with a solitary row boat in the middle and with no human intervention. The rich yet sauve colour tones he used to express his interpretation of the city he was born and brought up in forces you to take notice and brood over it.
“Yatin’s paintings reflect his emotional response to life around him. In some of his works, his brush strokes reflect expressionism and in others the dark shadows in portraits appear mysterious and loaded,” said Anupama Sharma, an artist from Rajasthan settled in Bhimtal, who had an exhibition with Yatin some years back in Mumbai.
His signature style is visible in the portrait of a girl venturing out of her home. She is cautious as she steps out. The use of a darker tone over her eyelashes and eyelids enhances the expression on those kohled eyes and face wear, conveying her fears, her wonderment, to the beholder. Those intense black eyes catch and transfix us.
The exhibition was part of a collective effort that Professor Anne, who is working on sustainable mountain architecture there, has put together with the help of Padmini Smetacek and some other local enthusiasts to promote local talent by helping them showcase their works, with iHeart Cafe providing a perfect setting. “It is all about giving value to our immediate community. We are trying to help artists like Yatin to showcase their talent,” said Tim Sebastian, owner of iHeart Cafe, visibly happy at the turnout during the exhibition. And it makes a lot of business sense as well for him.
POLICE ARREST GANGSTER JAGGU BHAGWANPURIA
In a latest development in the Sidhu Moosewala muder probe, the Mansa Police have arrested Jaggu Bhagwanpuria after getting a permit from Patiala House Court for his arrest and transit remand. Jaggu, who was lodged in Delhi Jail, would soon be brought to Punjab for further interrogation. It is reported that police have an input on his involvement in the Sidhu Moosewala murder case.
Out of the four shooters involved in the murder of Sidhu Moosewala, two are related to Jaggu, told the Mansa Police to court in order to get his transit remand. Meanwhile, Jaggu’s mother had alleged in court that her son was being tortured in jail.
Prior to Jaggu, Gangster Lawrence Bishnoi was taken to Punjab from Delhi for interrogationin connection with Sidhu Moosewala’s murder.
A special cell of Delhi Police recently arrested a total of four shooters, including the main shooter Priyavrat Fauji, from near Mundra Port in Gujarat. It is further said that Priyavrat Fauji was leading the shooters, who shot the singer.
A total of 150 cases, including murder, are registered against the notorious gangster. His gang is considered to be the richest and most active in Amritsar and Gurdaspur and is said to be involved in all kinds of crimes, including kidnapping, extortion, and dacoits.
Jaggu’s name is also associated with a drug syndicate. It is being said that he is related to many big leaders and names in the criminal world.
PM MODI’S ‘SAHAKAR SE SAMRIDHI’ NOT JUST A SLOGAN: SHAH
After the union cabinet approved the computerization of Primary Agricultural Credit Societies (PACS) on Wednesday,Union Home Minister and Minister of Cooperation Amit Shah said that Prime Minister Narendra Modi’s ‘Sahakar Se Samridhi’ is not just a slogan but his unwavering resolve to bring positive change in the lives of those associated with the cooperative sector.Shah’s remarks came while showing regard by thanking the Prime Minister for the major decision on PACS. In a series of tweets, Shah said “Whether it is the creation of the Ministry of Cooperation or decisions taken thereafter in the direction of empowering this sector, they show that Prime Minister Modi’s ‘Sahakar Se Samridhi’ is not just a slogan, rather that the Prime Minister has an unwavering resolve to bring positive change to lives of those associated with the cooperative sector”.Further in this series of decisions, the Cabinet chaired by PM Modi has taken a very important decision today to computerize PACS, which are the smallest unit in the cooperative sector and their computerization will prove to be a boon for the sector.The Minister highlighted that 63 thousand PACS will be computerized at a cost of Rs 2,516 crore, which will benefit about 13 crore small and marginal farmers.“In this digital age, the decision of computerization of PACS will increase their transparency, reliability and efficiency and will also facilitate the accounting of multipurpose PACS,” he added.Shah also informed that software will be made available in local languages for the convenience of the people.“Along with this, it will also help PACS to become a nodal center for providing various services such as Direct Benefit Transfer (DBT), Interest Subvention Scheme (ISS), Crop Insurance Scheme (PMFBY) and inputs like fertilizers and seeds,” he concluded.
Opinion2 years ago
South Block’s mistakes will now be corrected by Army
Sports2 years ago
When a bodybuilder breaks Shoaib’s record
News2 years ago
PM Modi must take governance back from babus
Spiritually Speaking2 years ago
Spiritual beings having a human experience
News2 years ago
Chinese general ordered attack on Indian troops: US intel report
Legally Speaking2 years ago
Law relating to grant, rejection and cancellation of bail
Royally Speaking2 years ago
The young royal dedicated to the heritage of Jaipur
Sports2 years ago
West Indies avoid follow-on, England increase lead to 219