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<keyword id="6359469" type="CITY" weightage="100" keywordseo="Ranbaxy">Ranbaxy</keyword> has filed a complaint against the US Food and Drug Administration (<keyword id="6354656" type="ORGANIZATION" weightage="100" keywordseo="FDA">FDA</keyword>) in an American federal court for revoking approvals to market generic versions of patented drugs — Astra Zeneca's anti-ulcer pill Nexium and Roche's anti-viral Valcyte. 
 
In its petition, Ranbaxy said that the FDA had exceeded its jurisdiction by revoking the approvals which were granted a few years ago. Ranbaxy called the FDA's decision "arbitrary, capricious and contrary to law." It added, "FDA has no power to correct an alleged 'mistake' it made six years ago". 
 FDA had withdrawn its approvals, saying it had made a mistake in granting them. Ranbaxy had sought FDA’s approval for the drugs manufactured at its <keyword id="203483" type="CITY" weightage="100" keywordseo="Paonta-Sahib">Paonta Sahib</keyword> plant, which the FDA had blacklisted in 2008. 
 
The FDA, while revoking its approvals, said, “Ranbaxy forfeited its eligibility for 180-day exclusivity for generic Valcyte but was silent on whether the company had also surrendered its exclusivity rights for generic Nexium. Ranbaxy in its plea has assumed that its exclusivity for Nexium is most likely to meet a similar fate.”

Ranbaxy Sues US FDA For Withdrawing Approval For Its Drugs

<keyword id="6354504" type="General" weightage="80" keywordseo="reliance-jio" source="Orion">Reliance Jio</keyword> on Tuesday said that its True 5G services have gone live in 406 cities, thus becoming the first and only telecom operator to reach such a wide network in a short span of time. The company announced the launch of its True 5G services in 41 new cities in 16 states/union territories - Adoni, Badvel, Chilakaluripet, Gudivada, Kadiri, Narsapur, Rayachoti, Srikalahasti, Tadepalligudem (Andhra Pradesh), Margao (Goa), Fatehabad, Gohana, Hansi, Narnaul, Palwal (Haryana), Paonta Sahib (Himachal Pradesh), Rajouri (Jammu &amp; Kashmir) Dumka (Jharkhand), Robertsonpet (Karnataka). Other cities include - Kanhangad, Nedumangad, <keyword id="870168" type="General" weightage="50" keywordseo="taliparamba" source="Orion">Taliparamba</keyword>, Thalassery, Thiruvalla (Kerala), Betul, Dewas, Vidisha (Madhya Pradesh) Bhandara, Wardha (Maharashtra), Lunglei (Mizoram), Byasanagar, Rayagada (Odisha), Hoshiarpur (Punjab), Tonk (Rajasthan), Karaikudi, Krishnagiri, Ranipet, Theni Allinagaram, Udhagamandalam, <keyword id="595772" type="General" weightage="50" keywordseo="vaniyambadi" source="Orion">Vaniyambadi</keyword> (<keyword id="20154" type="General" weightage="50" keywordseo="tamil-nadu" source="Orion">Tamil Nadu</keyword>) and Kumarghat (Tripura). "<keyword id="2003276" type="General" weightage="100" keywordseo="jio" source="Orion">Jio</keyword> is expanding its True-5G reach at a rapid pace and has already rolled out a large portion of the planned True-5G network in this country. Covering majority of the nation is a matter of immense pride for us," a company spokesperson said. Starting Tuesday, Jio users in these 41 cities will be invited to try the Jio Welcome Offer, to experience unlimited data at up to 1 Gbps+ speeds, at no additional cost. Meanwhile, the Chairman of Reliance Jio Infocomm Ltd, Akash Ambani, has said that Reliance Jio is on the path to achieving the declared goal to increase the Jio 5G footprint to cover every town, taluka and tehsil across the country by December this year. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/news/youtube-premium-price-plans-benefits/articleshow/98862188.cms">Ad-free videos to background play, here’s everything you get with YouTube Premium</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/finance/news/brent-crude-oil-prices-remain-under-pressure-on-tensions-that-risks-in-global-banking-sector-may-spark-a-recession-worldwide/articleshow/98862335.cms">Brent crude oil prices remain under pressure on tensions that risks in global banking sector may spark a recession worldwide</a>

Reliance Jio's True 5G now available in over 406 cities

(Eds: Updating with details) Shimla, May 14 () A seven-year-old girl and two women have tested positive for coronavirus in Himachal Pradesh, taking the total number of COVID-19 cases in the state to 71, officials said on Thursday. The three fresh cases were reported from Sirmaur and Kangra districts in the state, they said. A 24-year-old woman who recently returned to Himachal Pradesh from Mumbai tested positive for the dreaded virus at Dr Rajendra Prasad Government Medical College (RPGMC) in Kangra on Thursday, the officials said. On Wednesday night, a 30-year-old woman and her daughter from Sirmaur's Paonta Sahib tested positive for COVID-19, Special Secretary (Health) Nipun Jindal said. The two had returned from Delhi on May 4. The woman and her daughter were quarantined after they had returned to Paonta Sahib on May 4 and their samples were taken for testing on May 12, Sirmaur Deputy Commissioner R K Pruthi said, adding that both of them were asymptomatic. A total of 706 people returned to Sirmaur district from various red zones, Pruthi said. Out of these 706 people, samples of 541 were taken for tests, he said. With the three new cases, the COVID-19 tally in the state rose to 71. Three people have lost their lives due to the disease. There are 29 active cases in the state, while 39 people have recovered. Twelve active cases are in Kangra, six in Chamba, four in Hamirpur, two each in Sirmaur and Bilaspur, and one each in Mandi, Una and Shimla. DJI SNESNE

7-year-old girl, two women test positive for COVID-19 in HP; tally rises to 71

(Eds: adding another case) Shimla, May 14 () A seven-year-old girl and three women tested positive for coronavirus in Himachal Pradesh, taking the number of COVID-19 cases in the state to 72, officials said on Thursday.Two new cases each were reported in Sirmaur and Kangra districts, they said.A woman from Sheela Chowk in Kangra's Dharamshala tested positive for the dreaded virus at the Dr Rajendra Prasad Government Medical College in Kangra on Thursday evening, Kangra Superintendent of Police Vimukt Ranjan said.Earlier, a 24-year-old woman, who recently returned to Himachal Pradesh from Mumbai, tested positive for the virus at the same hospital. She had returned to the hill state with her two family members and a Nadaun resident.On Wednesday night, a 30-year-old woman and her daughter from Sirmaur's Paonta Sahib tested positive for COVID-19, Special Secretary (Health) Nipun Jindal said. The two had returned from Delhi on May 4.They were quarantined after they arrived in Paonta Sahib and their samples were taken for testing on May 12, Sirmaur Deputy Commissioner R K Pruthi said, adding that both of them were asymptomatic.A total of 706 people returned to Sirmaur district from various red zones, Pruthi said.Out of these 706 people, samples of 541 were taken for tests, he said.With the four new cases, the COVID-19 tally in the state rose to 72. Three people have lost their lives due to the disease so far.There are 30 active cases in the state, while 39 people have recovered.Thirteen active cases are in Kangra, six in Chamba, four in Hamirpur, two each in Sirmaur and Bilaspur, and one each in Mandi, Una and Shimla. DJI IJT

7-year-old girl, three women test positive for COVID-19 in HP; tally rises to 72

(Eds: Adds one more case) Shimla, May 14 () Five more persons, including a seven-year-old girl, confirmed positive for coronavirus in Himachal Pradesh on Thursday, taking the number of cases in the state to 73, officials said.Besides the minor girl, the fresh cases include three women and a man, they added. The cases were reported two each from Sirmaur and Kangra districts and one from Bilaspur district, the officials said. A youth, who had returned from Delhi and quarantined at Bilaspur's Swarghat area on the HP-Punjab border, tested positive for the novel coronavirus, Bilaspur Deputy Commissioner Rajeshwar Goyal said. A 57-year-old woman from Sheela Chowk in Kangra's Dharamshala tested positive for the dreaded virus at Dr Rajendra Prasad Government Medical College (RPGMC) Thursday evening, a district official said. She had come with three other people from Delhi two days ago, he said. Besides, a 24-year-old woman who recently returned to Himachal Pradesh from Mumbai tested positive for the virus at RPGMC. She had returned to the hill state with her two family members and a Nadaun resident from Mumbai, the officials said. On Wednesday night, a 30-year-old woman and her daughter from Sirmaur's Paonta Sahib tested positive for COVID-19, Special Secretary (Health) Nipun Jindal said on Thursday. The two had returned from Delhi on May 4, he added. The woman and her daughter were quarantined after they had returned to Paonta Sahib on May 4 and their samples were taken for testing on May 12, Sirmaur Deputy Commissioner R K Pruthi said, adding both of them were asymptomatic. A total of 706 people have returned to Sirmaur district from various red zones, Pruthi said. Of these 706 people, samples of 541 were taken for tests, he added. With the five new cases, the COVID-19 tally in the state rose to 73. Three people have lost their lives due to the disease. There are 31 active cases in the state, while 39 people have recovered. Thirteen active cases are in Kangra, six in Chamba, four in Hamirpur, three in Bilaspur, two in Sirmaur, one each in Mandi, Una and Shimla. DJI AQSAQS

Seven-yr-old girl among 5 new COVID-19 cases in HP; tally rises to 73

(Eds: Adds two fresh cases) Shimla, May 14 () Seven more persons, including a minor girl, confirmed positive for coronavirus in Himachal Pradesh on Thursday, taking the number of cases in the state to 75, officials said.Besides the seven-year-old girl, the fresh cases include three women and as many men, Special Secretary (Health) Nipun Jindal said. The cases were reported two each from Sirmaur, Kangra and Bilaspur districts and one from Hamirpur district, he said. A 39-year-old man who was quarantined at Bilaspur's Swarghat area on the HP-Punjab border has tested positive for the novel coronavirus, Jindal said. A resident of Karohta village in Hamirpur's Bhoranj tehsil, the man had come from Ahmedabad and was quarantined in a relief camp at Hill Top Hotel of Tourism at Swarghat, he added. Similarly, a 43-year-old man quarantined at PWD rest house at Bilaspur's Naina Devi has tested positive. He is a primary contact of a Delhi driver who had been earlier tested positive and was admitted at Covid Hospital Medical College in Mandi, Jindal said. Besides, a 55-year-old man from Hamirpur's Tauni Devi has tested positive. He is a primary contact of his 50-year-old brother-in-law from Bajrol area, who is under treatment at RCH, Bhota, he said. A 57-year-old woman from Sheela Chowk in Kangra's Dharamshala tested positive for the dreaded virus at Dr Rajendra Prasad Government Medical College (RPGMC) Thursday evening, Jindal said. She had come with three other people from Delhi two days ago and was admitted to a hospital with severe acute respiratory illness, he said. A 24-year-old woman who recently returned to Himachal Pradesh from Mumbai tested positive for the virus at RPGMC. She had returned to the hill state with her two family members and a Nadaun resident from Mumbai, the officials said. On Wednesday night, a 30-year-old woman and her daughter from Sirmaur's Paonta Sahib tested positive for COVID-19, Special Secretary (Health) Nipun Jindal said on Thursday. The two had returned from Delhi on May 4, he added. The woman and her daughter were quarantined after they had returned to Paonta Sahib on May 4 and their samples were taken for testing on May 12, Sirmaur Deputy Commissioner R K Pruthi said, adding both of them were asymptomatic. A total of 706 people have returned to Sirmaur district from various red zones, Pruthi said. Of these 706 people, samples of 541 were taken for tests, he added. With the new seven cases, the COVID-19 tally in the state rose to 75. Three people have lost their lives due to the disease. There are 33 active cases in the state, while 39 people have recovered. Thirteen active cases are in Kangra, six in Chamba, five in Hamirpur, four in Bilaspur, two in Sirmaur and one each in Mandi, Una and Shimla. DJI AQSAQS

Seven-yr-old girl among 7 new COVID-19 cases in HP; tally rises to 75

Shimla, May 14 () A 30-year-old woman and her 7-year-old daughter have tested positive for COVID-19 in Himachal Pradesh's Sirmaur district, taking the total number of cases in the state to 70, a state health official said on Thursday. The two had returned from Delhi on May 4. Sirmaur deputy commissioner RK Pruthi said the two were quarantined after they had returned to Hari Om Colony in Paonta Sahib on May 4 and their samples were randomly taken for testing on May 12. Both of them were asymptomatic.The two tested positive for COVID-19 at Central Research Institute, Kasauli, on Wednesday night, Special Secretary, Health, Nipun Jindal said.A total of 706 people have returned to Sirmaur district from various red zones, Pruthi said, adding that samples of 541 people out of them had been taken and the two tested positive.With this, the number of positive cases in Sirmaur district has risen to four. Two people have been cured in the district. The total number of COVID-19 cases in the state has now climbed to 70 and three people have died due to the virus so far.Thirty-nine people in the state have so far recovered from the infection.Himachal Pradesh now has 28 active COVID-19 cases -- 11 in Kangra, six in Chamba, four in Hamirpur, two each in Sirmaur, Bilaspur and one each in Mandi, Una and Shimla. DJI DVDV

Coronavirus cases in Himachal climb to 70 HP-VIRUS-CAS'

<ul class="summary-list"><li>With 24 hours notice, I flew from New York to New Delhi to help my father care for sick family members. </li><li>My grandmother's condition began to worsen and we had to find an available hospital bed, but there were very few options. </li><li>In the week since I arrived in <keyword id="3658" type="COUNTRY" weightage="60" keywordseo="India">India</keyword>, I lost friends and family members - all I could do was write condolence messages. </li><li>Amitoj Singh is a New York-based journalist who has previously been principal anchor and <keyword id="6355005" type="UNKNOWN" weightage="60" keywordseo="news">news</keyword> editor at India's New Delhi Television. </li><li>This is an <keyword id="6356002" type="UNKNOWN" weightage="100" keywordseo="opinion">opinion</keyword> column. The thoughts expressed are those of the author. </li></ul>In the span of 24 hours, two of my friends lost their fathers to India's COVID crisis.It was that fear for my father's life that made me pack my bags and leave New York within a day's notice.It was April 24 and New York was coming back - you could feel it. The sun was shining that glorious Saturday. I woke up, donned my running shoes, grabbed my headphones, and without checking my overnight messages, took off for a run around the Central Park reservoir. Midway through the run, I got a rare call from my dad's sister. I would call her back. But then a feeling nagged me so I called my dad. He answered like he always did whatever the situation."Ya Johnny," as he calls me. Not waiting to hear my reply, I heard him ask my 93-year-old grandmother to keep her mask on. "Don't you want to get well?" I stayed quiet for a moment. "Dad, do you have COVID?" I interrupted."I may have. I don't know. I haven't been able to get a test yet. I've been kind of sick for the past few days. But everyone here is sick. I'll call you back." He needed to give someone medicine. He was taking care of his cousin and mother at their house in a town called Paonta Sahib, a five-hour drive from New Delhi, India.Over the next half hour, I learned that COVID had hit my family in three separate households. I knew I needed to help my father, and since I was fully vaccinated, I decided to fly back to India. <h2>From a city that survived to a country in crisis</h2>As a breaking news journalist for the past 10 years, I'm used to packing my bags quickly and leaving for a new destination. But, this time was different. I was leaving New York after having survived the worst of the city's crisis, after avoiding getting the virus for more than a year. It felt like the <keyword id="43587" type="ORGANIZATION" weightage="60" keywordseo="pandemic">pandemic</keyword> was over. But now I was travelling to the world's second-most populous country where the virus was uncontrollable."What will you be able to do? You don't understand. The moment you exit the airport, you will get the virus. It's in the air. It's everywhere," warned my brother-in-law urging me to not come. His mother and grandmother had been infected in the same house.On the plane, I overheard a number of my fellow double-masked passengers asking about the health of loved ones back home."What are the oxygen levels?""I should be home in about 15 hours. Do we need a hospital bed yet?"After landing in India, I entered our family home. My father spoke to my grandmother, "Look who has come. He's come from America to be with you." Even the oxygen mask couldn't hide her happiness at seeing me. But for me, there was no time to feel joy, relief, or family warmth, only the slow build-up of shock - an unbelievable realization that a crisis I thought was over, was very much alive.My family house looked like a hospital. Medicine, defibrillators, an IV line set up, an oxygen concentrator, and medical supplies crowded the rooms. My father was performing a non-stop schedule of cooking, measuring oxygen and blood pressure levels, seeking the advice of doctors, giving medicine, updating the rest of the family, and constantly planning the next move - which hospital has a bed we can take her too?Three other members of the family had COVID too. Still jet-lagged, I settled into the night shift to look after my grandmother. She would unknowingly take off her oxygen mask and I would put it back on to keep her blood oxygen levels stable. When she took it off, her oxygen levels shot down. So far, I was winning. I just had to gently hold her hand through the night. <h2>"It's in the air. It's everywhere."</h2>By now, COVID had brutalized India.Horror stories were emerging. A <a href="https://www.ndtv.com/india-news/baby-starved-for-2-days-as-mother-lay-dead-no-one-helped-fearing-covid-2425451">baby had starved for two days</a>, while his mother lay dead from COVID beside him. <a href="https://www.thesun.co.uk/news/14915417/covid-bodies-loating-ganges-river-india/">Bodies washed up</a> on the banks of India's most holy river, the Ganges. <a href="https://factly.in/this-video-showing-a-long-queue-of-dead-bodies-awaiting-cremation-is-from-delhi-not-bhopal/">Snake-shaped queues of bodies waiting outside cremation sites</a> sent a chill down the spine. India had become the only nation to pass 400,000 cases and 3,500 deaths in one day. Experts believed, in reality, <a href="https://edition.cnn.com/2021/04/27/india/india-covid-underreporting-intl-hnk-dst/index.html">deaths and infections were likely three to five times more</a>.<div type="image" title="Cows feast on fruits left as offerings at the cremation site of a COVID victim" height="2688" width="3583" msid="82859013" hostid="261"></div>News of the death of a family elder, a loving grand-uncle, rocked us. He had been as close to me as a grandfather. Speaking to friends and family, I learned COVID was in every household. A former colleague, in his 30s, dead.A friend's grandfather, dead.A friend's wife, a mother to two young kids, dead.<h2>Chasing hospital beds</h2>In all of this, my grandmother's condition was worsening. My father decided it was time to get her to a hospital bed. One was available three hours away in a small town in the hills of the North Indian state of Himachal Pradesh. The ambulance arrived, but the medical staff refused to touch my grandmother for fear of contracting the virus. We had to transport her to the ambulance ourselves. Midway to the hospital, the oxygen supply malfunctioned temporarily.Upon arrival, two doctors outside the COVID-dedicated facility spoke to my father. They were impatient, frustrated, and immediately cited their doubts. They didn't think a 93-year-old could survive. They didn't want to take responsibility for another death. They said maybe it's better if we took her back home. Moments before our arrival, a 38-year-old man had died within seconds of entering the premises. They hadn't even been able to take him out of the ambulance. My father assured the doctor, my grandmother was a fighter. She had no comorbidities at 93 - we expected she would live past 100 easily. They allowed her to be admitted. But their frustration was justified. The hospital itself was inadequate; it didn't have ventilators, a laboratory for basic diagnostic tests, a CAT scan, resuscitation equipment, or an ICU. Even oxygen was rationed between 32 patients as there were only nine regulators. Two of the four government-appointed attendants had not been paid in five months.<div type="image" title="The writer’s grandmother, Harjit Kaur, being treated by the doctors at a Covid facility in North India" height="1040" width="584" msid="82859016" hostid="261"></div>We had to recalibrate. We couldn't take my grandmother to Delhi or any other nearby town. We couldn't take her back home because my father had given our oxygen concentrator to a friend in an emergency, thinking there would be oxygen at the hospital. We tried to find an open hotel for the night. We found one, but they required negative COVID tests and we didn't have any.They allowed us to sit in their restaurant to have tea. Eventually the owner came out. He happened to know my grandmother from her work as a social worker in the area. He explained the situation."It's horrible. I suggest you drive back. You can't do anything. You can keep track of what's happening by video-calling the doctor regularly."On our drive back, my father made dozens of calls to find a bed in a better medical facility. We had no luck; there were no beds anywhere. The next day we were able to find accommodation near the hospital, so we drove back to be near my grandmother. The rest of my family scrambled to find oxygen in case she needed to come home.<div type="image" title="The ambulance that came at 8 PM on May 4 to take Harjit Kaur, the writer’s grandmother back home." height="2476" width="3302" msid="82859018" hostid="261"></div>After three days, the doctor was prepared to discharge my grandmother. She was heard mumbling "take me back home." Her oxygen levels were stable, and we were told she was "COVID-free." The doctor even posted a picture with her on social media, proud of having treated a 93-year-old patient. She was looking better.<h2>The crisis is not over</h2>Despite the positive signs, 24 hours later, after an irregular heartbeat sent us to a local hospital and home again since we couldn't find space in an ICU, my grandmother died as she passed over the threshold into her house. She had died the way she wanted, in her own home.In the week since I arrived in India, I lost friends and family members. I tried to help with oxygen and finding hospital beds, but in the end, all I could do was write out condolence messages.<div type="image" title="A pyre burns at the banks of India’s Yamuna river, Paonta Sahib, a designated cremation site for COVID related deaths" height="3024" width="4032" msid="82859022" hostid="261"></div>Back in the US, I saw friends moving on from the pandemic - most of them had been vaccinated, extra doses were everywhere, New York was opening up, and selfies of joyful reunions adorned my media platforms.In India, I was under lockdown. I couldn't step outside. I was still trying to get my parents fully vaccinated, still trying to help friends and acquaintances get beds, oxygen, and vaccines. I was reliving the pandemic.While the US is moving on, the pandemic still rages in India. Four days ago, on May 18, India recorded 4,529 COVID deaths, the pandemic's highest single daily death toll in any country so far.

Several members of my family in India got COVID, so I flew home to help. While the US reopens, India is still deep in crisis.

New Delhi, Nov 12 (IANS) The key vaccines India is banking on are from Oxford/AstraZeneca, Novavax and J&amp;J and the earliest efficacy data is expected by the end of November-December 2020 and in the best case, vaccines can be rolled out in January 2021. According to a research by Credit Suisse, India needs about 1.7 billion Covid-19 vaccine doses to vaccinate majority of its adult population. It targets to administer 400-500 million doses by July 2021. "The key vaccines India is banking on are from Oxford/AstraZeneca, Novavax and J&amp;J (temperature range is 2-8-degree Celsius) and the earliest efficacy data is expected by the end of November-December and in the best case, vaccines can be rolled out in January 2021," the report said. Credit Suisse said there is sufficient capacity for vaccine manufacturing (more than 2.4 billion doses) and various components like vials, stoppers, syringes, gauze, alcohol swabs, etc. The bottleneck is cold storage infrastructure (especially refrigerated vans) and by using a part of the capacity of current immunisation programme (600 million doses) and the cold chain infrastructure of the private sector (250-300 million doses), potential vaccinations can reach 550-600 million doses annually. Manpower required for administering the vaccine will be less than 1 lakh. Aurobindo's large viral vector vaccine facility (300 million doses) should be ready by March-April 2021. The pricing in export markets could be higher than in India and profitability could be at Rs 20-25 per dose and, therefore, on a 300 million dose capacity, Aurobindo could benefit from a potential EBITDA of Rs 6-7.5 billion (or 12-15 per cent of FY22E EBITDA). Cadila also has facility for 100 million doses but it is for DNA vaccine and, therefore, would not be able to manufacture vaccine from global players in the near term, the report said. Apollo Hospitals has infrastructure to administer 100 million doses annually and this can add Rs 2.5 billion EBITDA. Diagnostic companies (Metropolis) should also benefit from an increase in demand for antibody tests (both before and after vaccination) but their pricing can sharply come down. Higher vaccination will impact volumes of Covid-19 treatment drugs. Cipla and Cadila have benefited the most from the sale of Covid-19 treatment drugs (especially Remdesivir) in 2Q FY21 and the volume should substantially reduce in FY22 on increasing vaccination. The key vaccines India is banking on are from Oxford/AstraZeneca, Novavax, and J&amp;J as the temperature range of these vaccines is about 2-8-degree Celsius (vs -20-degree Celsius for Moderna and -70-degree Celsius for Pfizer). The key bottleneck is likely to be cold storage capacity. The Covid-19 vaccination will have to use a part of the infrastructure of the current immunisation programme (27,000 cold chain points catering to 600 million doses) and would need support of the private sector too. Organised private cold chain companies can at best handle 250-300 million doses (bottleneck is refrigerated vans rather than storage). Further, the reach of private sector cold storage doesn't extend to the hinterland and for that another solution needs to be devised. "Overall, with bottleneck on cold chain infrastructure, we estimate annual vaccinations may be just around 550-600 million doses. Skilled manpower required to administer 550-600 million doses is less than 1 lakh which should not prove to be a bottleneck," the report said. "Our demand estimate for population to be vaccinated assumes 25 per cent of the population already being infected by March 2021 (most sero-studies already pointing to 20 per cent plus positive infection rate). Most of the global vaccines have done trials only on population set of above 12-15 years, as per current protocols, and requirement of two doses per person (the exception is J&amp;J vaccine which is a single dose vaccine). These assumptions lead to requirement of 1.7 billion doses, assuming that no repeat vaccinations are needed," the report added. The government has already started preparing the database of priority beneficiaries. It has issued an advisory at district and state levels to prepare a database of both public and private healthcare workers, and subsequently upload it to the Covid-19 Vaccine Beneficiary Management System, which is currently under works. The database of healthcare workers is expected to be finalised shortly, whereas the database of people above 50 years and frontline workers is already in place. However, the key challenge would be to prepare the database of people with comorbidities, where the data is currently limited to screening of people at 48,000 health centers. The number of Covid-19 cases in India currently stands at 8.6 million, but the growth in new cases has considerably slowed down to 0.6 per cent 5-day CDGR. The average number of daily cases in the trailing week has dropped to 46,000 (vs 92,000 at peak), the report said. The recovery rate has also increased to 93 per cent, and the total number of active cases is less than half of the peak. These metrics point to a moderation in pandemic severity. However, this may not reflect the actual underlying disease burden given that the latest nationwide sero-prevalence study, conducted between August 17 and September 22 in 70 districts across 21 states, found that 6.6 per cent of the total participants were exposed to SARSCoV-2, while reported cases then were 0.3 per cent (of total population). This indicates that the actual infections could be 25 times the reported cases. However, from India's perspective, the success of mRNA candidates would have little impact since they have more stringent cold chain requirements, with the Pfizer candidate requiring cold chain to operate at as low as -70-degree Celsius. The Serum Institute of India has mentioned that it has already been producing about 40-50 million doses per month and, therefore, it has stockpiled initial inventory for Oxford/AstraZeneca vaccine. Hence, this should be the first vaccine available in 1Q CY21 in India (unless Indian government provides an Emergency Use Authorisation to any other company). Thereafter, 2QCY21 onwards, multiple plants are expected to come online and Serum's manufacturing capacity could also get augmented to 100 million doses per month by around June 2021. In terms of availability, Serum said that Oxford/AstraZeneca's ChAdOx1 nCoV-19 vaccine candidate, named Covishield in India, can be provided regulatory go-ahead as early as December 2020 provided the trial results are successful. Serum is currently conducting Phase II/III trials of Covishield among 1,600 participants across 17 sites in India, aged 18 to 55. Biological E is working on capacity to manufacture 1. 4 billion vaccine doses annually, comprising 400 million doses for J&amp;J and 1 billion doses for its vaccine developed with US-based Baylor College of Medicine (BCM). In addition, Biological E has signed a licensing agreement with BCM under which the latter would facilitate technology transfer for recombinant protein-based Covid-19 vaccine. Biological E would undertake further development, conduct clinical trials and manufacture 1 billion doses annually. In order to augment its capacity, it had recently acquired Akorn India's facility in Paonta Sahib in Himachal Pradesh, which has capacity to produce 135 million doses annually. Biological E has received approval for conducting Phase I/II clinical trials among 400 participants in India. Bharat Biotech has developed Covaxin  India's first vaccine candidate for Covid-19  in collaboration with the Indian Council of Medical Research, and the National Institute of Virology (NIV), Pune. The Covid-19 strain was isolated by NIV and transferred to Bharat Biotech. It received go-ahead for Phase I trials in July, which was subsequently conducted among 375 volunteers across 12 sites. After assessing the safety data, the company initiated Phase II trials among 380 volunteers. Post assessing safety and immunogenicity data from the two trials, the company is progressing with Phase III trials, which will involve 28,500 subjects across 19 sites in 10 states. The report said that the private players, in anticipation of possible demand, have begun ramping up capacity to distribute Covid-19 vaccines en masse when ready. The largest private player  Snowman Logistics  has capacity to store 650 million doses. However, this assumes that all of the capacity is used only for vaccine storage. Practically, capacity available for vaccine distribution will be only 10-15 per cent of this or about 100 million doses for Snowman. For the organised private cold chain storage industry, total vaccine storage capacity would be 250-300 million doses. "Our interaction with the industry suggests that bottleneck is not in the storage but in the number of refrigerated vans. The organised sector does not have reach extending to the hinterlands in the country and for those regions, it is likely that the government may utilise existing fruit and vegetable cold storage to achieve the purpose," the report said. The key domestic logistics players with substantial cold storage business are Snowman Logistics, Gati Kausar, Transport Corporation of India, Mahindra Logistics and Future Supply Chain Solutions. (Sanjeev Sharma can be reached at Sanjeev.s@ians.in) --IANS san/arm

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