New Delhi, Jan 14 (IANS) A group of 49 doctors, scientists and medical professionals, led by former AIIMS director Tirath Das Dogra, have come forward in support of the homemade Covid-19 vaccines and slammed those casting aspersions on their efficacy. "We condemn the irresponsible statements made by people with vested interests in print, electronic and social media defaming the Indian scientific community and casting aspersions upon its integrity by making politicised statements doubting the recent research in the field of Covid-19 vaccines," said the statement issued by Dogra. "Though the efficacy data is not available, the safety parameters of Covaxin are very good and there is a robust immune response seen with this vaccine. Further, this vaccine is a whole virus inactivated vaccine which may have better protection even against mutant strains of the virus as the immune response will be against multiple antigens and not only against Spike protein," it added. Dogra said that such reprehensible utterances are causing huge credibility crisis for the Indian scientific community which has devoted its lifetime to make India a name to reckon with in the export of vaccines all over the world. Many political leaders, including those from the Congress, have said that the government should not have allowed the use of Covaxin without conducting Pahse 3 trials. But the former AIIMS director said that there is a vision to make India a global leader in the field of scientific research. "Due to our untiring efforts, India has emerged a global leader in supply of vaccines to the world. Vaccines are exported from India to over 188 countries. Currently, more than two thirds of the total volume of the vaccines manufactured is exported while the rest is utilised domestically. The Indian vaccine market reached a value of Rs 94 billion in 2019, and has still got unused potential for the future," the statement said. It further said that the DGCI has granted the approval after a subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) recommended the two vaccines (Covishield and Covaxin) for emergency use in India. Covishield was recommended for emergency use on January 1, whereas Covaxin was recommended for restricted use on January 2. Though Covishield still needs data from India on immunogenicity and efficacy, it has been given emergency use authorisation keeping in mind the difficult times caused by the Covid-19 pandemic. --IANS miz/arm

Group led by EX-AIIMS director slams people for doubting Covid vaccine

<ul><li>An investigation by the <keyword id="6386816" type="ORGANIZATION" weightage="20" keywordseo="drug-controller-general-of-india">Drug Controller General of India</keyword> (DGCI) e-commerce giants <keyword id="18635" type="CITY" weightage="20" keywordseo="Amazon">Amazon</keyword> and <keyword id="6354742" type="COMPANY" weightage="20" keywordseo="Flipkart">Flipkart</keyword> were allegedly found to be selling ‘adulterated’ and ‘unregulated’ beauty products on their websites, according to a Mint report. </li><li>The DGCI has asked online retailers to stop such sales. The retailers have reportedly committed to removing these products. </li><li>Cosmetics worth ₹40 million were confiscated from around the country during the investigation.</li></ul>E-commerce giants Amazon and Flipkart were recently served notices from India’s drug regulator Drug Controller General of India (DGCI) for allegedly selling certain <keyword id="721787" type="UNKNOWN" weightage="20" keywordseo="Fake-cosmetics">fake cosmetics</keyword>, Mint <a href="https://www.livemint.com/Companies/ecmOFt9kc8RUTRJjQT5TgJ/Amazon-Flipkart-promise-to-stop-sale-of-fake-cosmetics.html">reported</a>. The online retailers have reportedly said that they will stop the sale of adulterated products in question on their websites sold by certain sellers, according to the Mint <a href="https://www.livemint.com/Companies/ecmOFt9kc8RUTRJjQT5TgJ/Amazon-Flipkart-promise-to-stop-sale-of-fake-cosmetics.html">report</a>. Cosmetics <a href="https://www.medianama.com/2018/11/223-amazon-flipkart-fake-cosmetic-sellers-india-dcgi/">worth</a> ₹40 million were confiscated from around the country during the investigation, it added. In the last three years, online retailers Snapdeal and Shopclues have also faced similar issues and were asked to pull off products from their platforms. The beauty products in question include serums, skin-whitening creams, and stem-cell based cosmetics that fall l under the illegal imports category with some products containing ingredients unfit for human use. As per another <a href="https://www.timesnownews.com/business-economy/companies/article/amazon-flipkart-commit-to-stop-sale-on-fake-cosmetics-on-their-websites/312428">study</a> highlighting the problem of fake cosmetics, one out of every five products sold online is fake. About 35% of the online consumers reported receiving fake products under the cosmetics category in the span of six months, according to poll results. Spokespeople at Amazon and Flipkart could not be reached for comment.

Amazon, Flipkart asked to pull fake beauty products from websites in India: Report

Hyderabad, Nov 16 (IANS) Biological E. Ltd (BE), a Hyderabad-based vaccines and pharmaceutical company, on Monday announced that it has initiated clinical trial of its Covid-19 subunit vaccine candidate in the country following approval from the Drugs Controller General of India (DGCI). BE is making the vaccine in collaboration with Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston. The vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialisation team, along with Dynavax's advanced adjuvant CpG 1018, BE said in a statement. BE's Phase 1/2 clinical trials will evaluate the safety and immunogenicity of the vaccine candidate consisting of the receptor binding domain of the spike protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years, it said. The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart. The results of this clinical trial are expected to be available by February 2021. "The transition of our vaccine candidate into human trials is an important milestone, and exemplifies a successful transfer of technology with BE, that could lead to a safe, effective and affordable vaccine," said Dr Maria Elena Bottazzi, associate dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of Texas Children's Hospital Center for Vaccine Development. "This vaccine represents an urgent biotechnology innovation for ensuring health equity and combating the Covid-19 pandemic," said Dr. Peter Hotez, professor and dean of the National School of Tropical Medicine at Baylor and co-director of Texas Children's Hospital Center for Vaccine Development. "We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of Covid-19," said Mahima Datla, Managing Director, Biological E. Ltd. "We are proud to contribute CpG 1018 to support development of an adjuvanted vaccine to prevent Covid-19. CpG 1018's potential to boost the immune response to produce more antibodies and longer lasting immunity may also minimise the dose of antigen needed, enabling vaccination of a greater number of people," said Ryan Spencer, Chief Executive Officer of Dynavax. --IANS ms/vd

Biological E begins clinical trials of Covid-19 vaccine

As the government pushes for self reliance in the mobile phone and electronics industry with the clarion call for 'Atmanirbhar Bharat', data shows that over 45% imports of smartphone components in the last financial year (FY 2019-20) came from China. Citing data from the Directorate General of Commercial Intelligence and Statistics (DGCI&amp;S), the Ministry of Electronics and Information Technology on Thursday said that the total imports of smartphone components in the country in FY2019-20 were worth ₹56,039 crore, out of which imports from China were to the tune of ₹25,441 crore, which amounts to about 45%. In a written reply to a question in the Rajya Sabha, the ministry also said that the total electronic component imports in the country in FY2019-20 was of Rs 1,15,558 crore, out of which the import from China was of ₹42,983 crore, which amounts to about 37 per cent of the total imports. On the impact of the Covid-19 outbreak on the supplies to India, the ministry said that the outbreak in China coincided with the Chinese New Year festivities which extended till mid-February 2020 and Indian electronics companies had already stocked raw material or components till end-February 2020. Though most factories in China were able to resume operations and achieve around 50 per cent capacity utilization by mid-March 2020, the virus had spread in other parts of the world, including India, by such time and a nation-wide lockdown was imposed on March 23, 2020. This led to a complete halt in all production activities, including electronics manufacturing, with the exception of a few companies who were manufacturing electronic components for essential medical equipment such as ventilators, the ministry said. "It was only after the lockdown was lifted that the domestic companies in the electronics sector resumed production and other associated activities. The shutdown of factories for about two months has impacted the domestic electronics manufacturing sector," it added. According to the India Electronics &amp; Semiconductor Association (IESA), there will be production loss of 20-25 per cent in 2020-21, compared to 2019-20, the ministry said in its reply. SEE ALSO: <a href="https://www.businessinsider.in/defense/news/latest-updates-on-india-china-border-issue/articleshow/78162853.cms">India will take necessary steps against China — 'We will not back down,' asserts Rajnath Singh</a>

India imported smartphone components worth ₹25,441 crore from China in FY20

<ul><li>India’s textile industry, which employs 100 million workers is the second largest to generate employment opportunities. </li><li>Roughly a third of spinning mills have shutdown amid slowdown in export and domestic sales — leading to huge job losses </li><li>The cotton yarn export fell by 34.6% at $696 million in the quarter ending in June, shows the Directorate General of Commercial Intelligence and Statistics (DGCI&amp;S).</li></ul>In a bid to boost the textile industry in India, the Ministry of Textiles drafted guidelines in the National Textile Policy to export as much as $300 billion by 2024-25, and hoped it would add 35 million jobs. That has not happened. Over and above, due to slow down as many as <a href="https://www.nationalheraldindia.com/india/economy-in-crisis-over-3-cr-people-face-job-loss-in-textile-industry-representative-body-blames-tax-regimen">30 million </a>jobs in the sector lost their jobs. This will result in a deep job crisis across the country as textiles is the country’s second largest employer. More jobs to go Due to the state of affairs, more job cuts are inevitable. Sluggish exports and reduced consumer demand has resulted in production cuts. Roughly a third of the spinning mills have shutdown. The cotton, jute, fibre and wool industry is facing its worst time in nine years. The textile industry employs over 100 million people across the country. And the mill association is seeking government intervention to prevent job loss and “avoid the spinning industry from becoming a Non-Performing Asset (NPA),” a recent advertisement titled<a href="https://thelogicalindian.com/awareness/textile-industry-advertisement/"> by </a>Northern India Textile Mills Association (NITMA) said. In the spinning sector itself, over 200,000 workers have lost jobs, Sanjay Jain, Chairman, Confederation of Indian <keyword id="753614" type="DOMAIN" weightage="20" keywordseo="textile-industries">Textile Industries</keyword> (CITI), <a href="http://www.newindianexpress.com/states/tamil-nadu/2019/aug/21/12-lakh-textile-jobs-in-tamil-nadu-lost-in-one-year-2021936.html">told</a> BusinessLine. The textile hub of Tamil Nadu is affected as well as nearly 300 spinning mills have shut down. Across the country, as many as 605 have shut operations, according to M Jayabal, president of TN Open-end Spinning Mills Association (OSMA). Expectedly,120,000 turned jobless in the last one year. Taxes and interest rates According to the NITMA, there has been a decline in cotton yarn exports as well. The export fell by 34.6% at $696 million in the quarter ending in June, as per Directorate General of Commercial Intelligence and Statistics (DGCI&amp;S). This slowdown could reach the farms as well. In fact, the cotton association doubts if the 40 million bales of cotton may not even find buyers in India or overseas. And they blame taxes for that. The State and Central level taxes have made the Indian yarn non-competitive globally. <a href="https://www.businessinsider.in/rbi-cut-interest-rates-by-35-basis-points-as-growth-sputters-and-inflation-cools/articleshow/70565859.cms">High interest rates</a> in the current regime which the central bank has been trying to bring down but unable to is affecting a large number of small and medium sized enterprises of the industry. This is combined with the higher cost of raw material is higher in India, as compared to Bangladesh, Sri Lanka and Indonesia. This has led to ₹20 ₹25 loss per kilo. These competing countries have interest rates at <a href="https://www.thehindubusinessline.com/companies/yarn-fabric-exporters-seek-help-from-centre-as-shipments-fall-mills-close-down/article29189506.ece">around 5%</a>, while it more than twice that at 10%-12% in India. See also: <a href="https://www.businessinsider.in/job-cuts-at-parle-and-britannia-sales-show-indian-economy-is-in-dire-straits/articleshow/70766429.cms">India’s biscuit crisis shows slowdown is hurting the poor more — and job losses are making it worse</a> <a href="https://www.businessinsider.in/hero-motocorp-tata-mahindra-and-maruti-suzuki-are-all-cutting-production-as-theres-no-demand/articleshow/70710729.cms">Hero MotoCorp, Tata, Mahindra and Maruti Suzuki are all cutting production as there’s no demand</a> <a href="https://www.businessinsider.in/the-maker-of-general-motors-and-toyotas-parts-in-india-is-folding-up-axing-thousands-of-jobs/articleshow/70603130.cms">The maker of General Motors and Toyota's parts in India is folding up — axing thousands of jobs</a>

A third of India’s textile workers — 30 million— lost their jobs and more could go

<ul><li>Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations.</li><li>On September 10, the Serum Institute of India had to pause the Phase II/Phase III human trials of Oxford’s <keyword id="8624004" type="UNKNOWN" weightage="20" keywordseo="coronavirus-vaccine">coronavirus vaccine</keyword> candidate across all 17 locations as a precaution, following a show-cause notice.</li><li>However, the Drugs Controller General of India, on September 15, asked the SII to resume human trials. </li><li>Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites. </li></ul>Serum Institute of India (SII) is likely to begin the <keyword id="9978218" type="UNKNOWN" weightage="20" keywordseo="Phase-III-human-trials">phase III human trials</keyword> of Oxford’s coronavirus vaccine at Sassoon General Hospital in Maharashtra on September 22, Hindustan Times <a href="https://www.hindustantimes.com/india-news/phase-3-human-clinical-trial-of-oxford-vaccine-begins-in-pune/story-mpfvHoWiH4lh3I452On7UP.html">reported. </a> “We have started the phase-III trials of the vaccine (candidate <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>). We will administer dose to 150 to 200 volunteers,” said Dr Muralidhar Tambe, Dean, Sassoon General Hospital. Serum Institute is likely to conduct the Phase III trials on 1,500 volunteers across 14 locations. On September 10, the Serum Institute of India had to pause the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations as a precaution, following a show-cause notice<a href="https://www.businesstoday.in/coronavirus/breaking-covid-19-trials-paused-till-further-instructions-says-serum-institute/story/415686.html">, reported Business Today.</a> SII <a href="https://twitter.com/CNBCTV18Live/status/1303981172200882176">sai</a>d there have been no issues in India, and this is a precautionary measure, and it will restart the trial as soon as AstraZeneca does. AstraZeneca has resumed trials in the UK but not yet in the US. Drugs Controller General of India, on September 15, asked the SII to resume human trials. Once successfully tested, the vaccine will be launched under the brand name “Covishield” once the trials are successfully completed at all the sites. SII has signed two agreements for the supply of Covid-19 vaccines, the first being AstraZeneca-Oxford's candidate, for which the company has agreed to produce up to 1 billion doses for low and middle-income countries. SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Earlier, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India. The Serum Institute of India would introduce candidate vaccines from AstraZeneca and Novavax for COVID-19 at less than ₹250 per dose in India. The Pune-based institute <a href="https://www.hindustantimes.com/india-news/serum-institute-ties-up-with-bill-gates-foundation-gavi-to-speed-up-covid-19-vaccine-manufacture-process/story-h20YRO9mdooYA8ysqenE9L.html">partnered with </a>Bill &amp; Melinda Gates Foundation to offer up to 100 million doses, with the price capped at $3 for 92 low and middle-income countries (LMIC), including India. There are at least 30 COVID vaccine candidates in preclinical or clinical stages in India. While three of them are in the advanced stage of Phase I/II/III trials and 4 are in the advanced preclinical development stage, Union Health Minister, Dr Harsh Vardhan, told the Parliament. Vardhan believes India <a href="https://www.businessinsider.in/india/news/covid-vaccine-likely-by-early-2021-for-old-high-risk-first-harsh-vardhan/articleshow/78090587.cms">may</a> get a coronavirus vaccine by early 2021. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/lok-sabha-passes-amendments-to-foreign-contribution-regulation-act-makes-aadhaar-mandatory-for-foreign-contribution-towards-ngos/articleshow/78246944.cms">Lok Sabha passes amendments to Foreign Contribution (Regulation) Act — makes Aadhaar mandatory for foreign contribution towards NGOs</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/bhiwandi-building-collapse-death-toll-rises-to-17-including-eight-children/articleshow/78247063.cms">Bhiwandi building collapse: Death toll rises to 17, including eight children</a>

Oxford’s COVID-19 vaccine: Phase III human trials begin in India

(Eds: Adds details about COVID vaccine) New Delhi, Jul 3 () Zydus on Friday said it has received approval from authorities to start human trials for its COVID-19 vaccine contender - the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide. The vaccine, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus, part of Cadila Healthcare Ltd, said in a statement. This comes within days of Bharat Biotech's Covaxin vaccine getting approval of the drug regulator to start clinical trials. Over seven vaccines are being researched in India and two of them have got go-ahead to start human clinical trials just this week. Globally, over 100 candidates are being tested on humans but no vaccine has yet been approved. "Zydus has already manufactured clinical good manufacturing practice (GMP) batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects," the company said. ZyCoV-D, developed at the company's Vaccine Technology Centre in Ahmedabad, has now received permission from the Drug Controller General of India (DGCI) - Central Drugs Standard Control Organisation (CDSCO) to initiate phase I/II human clinical trials in India, Cadila Healthcare said. In animal studies, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralisation assay indicating the protective potential of the vaccine candidate, it said. It further said no safety concerns were observed for the vaccine candidate in repeat-dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well-tolerated and immunogenic. Zydus said, with its ZyCoV-D, it has successfully established the DNA vaccine platform in India using non-replicating and a non-integrating plasmid carrying the gene of interest making it very safe. The company claimed that the vaccine candidate has no vector response and with the absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements. It is also known to show much-improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest parts of the country, it said. "Furthermore, the platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection," it added. The company now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand. RKL MR

Zydus gets nod for human trials of COVID-19 vaccine

Hyderabad, Dec 9 (IANS) Envoys of 64 countries on Wednesday visited the facilities of Bharat Biotech and Biological E, which are developing vaccines for coronavirus. After landing in Hyderabad by a special Air India flight, the Ambassadors and High Commissioners from the countries in Asia, Africa, Europe, North America, South America, and Oceania reached Genome Valley on the city outskirts to visit the two companies. The visit by the heads of foreign missions was organised by the Ministry of External Affairs (MEA) and was part of India's efforts to develop partnerships for the manufacture and delivery of vaccines. Last month, the diplomats were briefed on trials of vaccines underway in the country and efforts to manufacture and deliver the doses. Officials said the diplomats were divided into two batches and they went around the two companies to see for themselves the facilities developed for research and manufacturing of vaccines. Top officials of both the companies briefed the envoys about the progress made so far in the development of the vaccines and the rollout plans by both the companies after their vaccines get the approval from regulators. At Bharat Biotech, the delegation was briefed about company's vaccine development programme by Dr. Krishna Ella, Chairman and Managing Director, spearheading Covaxin research, development, clinical trials and production teams. The delegates were explained about Bharat Biotech's research process, manufacturing capabilities, expertise through virtual and physical tours of the facilities. The envoys voiced their appreciation of the company's work of national and global public health significance. Covaxin, India's indigenous Covid-19 vaccine, is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility. Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses. According to Bharat Biotech, Covaxin has been evaluated in approximately 1000 subjects in Phase 1 and Phase 2 clinical trials, with promising safety and immunogenicity results. The Phase 3 human clinical trials of the vaccine began in November, involving 26,000 volunteers across India. This is India's first and only Phase 3 efficacy study for a Covid-19 vaccine, and the largest phase 3 efficacy trial ever conducted for any vaccine in India. "The development and clinical evaluation of COVAXIN marks a significant milestone for novel vaccinology in India. Covaxin has garnered interest from several countries worldwide for supplies and introduction," said Suchitra Ella, Joint Managing Director of Bharat Biotech while addressing the foreign envoys. Biological E last month initiated clinical trial of its Covid-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI). It is making the vaccine in collaboration with Dynavax Technologies Corporation (Dynavax), a US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston. Telangana Chief Secretary Somesh Kumar also addressed the diplomats and showcased the potential of the state. He said though being the youngest state in the country, Teangana achieved tremendous progress under the dynamic leadership of Chief Minister K. Chandrasekhar Rao. He also informed that the combined value of the pharma sector in the state is around $50 billion. Hyderabad is the vaccine hub of not only India but the entire world with 33 percent of the entire vaccine production being done in Hyderabad. During the last six years, the state has been a front ranker in the ease of doing business in the country. The state is home to some of the top valued companies such as Google, Apple, Facebook, Amazon, Microsoft etc. Most of these companies have their largest establishments outside the US in Hyderabad. The Chief Secretary told the diplomats that the state has formulated a new TSiPASS policy for speedy approvals to the industries. Industries who do not get permission within 15 days are deemed to have been approved. This policy has proved to be a game changer and during the last six years around 14,000 units have been grounded in the state. Principal Secretary Industries and IT, Jayesh Ranjan, also made a power point presentation and showcased the investment potential of the state to the visiting dignitaries. He said that Hyderabad Pharma city will be operational in a couple of months. Similarly a medical devices park is being set up near Outer Ring Road in 500 acres. --IANS ms/vd

Envoys of 64 countries visit Covid vaccine makers in Hyderabad

New Delhi, Jul 10 () Doctors in state hospitals are being advised to use antiviral Remdesivir on COVID-19 patients strictly as per protocol amid some reports of liver damage in such patients treated with the drug, official sources said. While the health ministry is reviewing the guidelines on the usage of the drug following the adverse reports, states and union territories are also being asked to orient doctors on the protocols of Remdesivir use and not to prescribe it indiscriminately. To prevent black-marketing and overcharging of the drug, India's drug regulator Drugs Controller General of India (DCGI) has asked manufacturers to set up a helpline where the patients or their family members can contact in case the drug is not available in the market and also put on their websites details of distributors and supply chain. "AIIMS specialists tasked by the Centre to provide expert guidance are advising doctors in state hospitals to use the drug as mentioned in the protocols stating it has been approved for restricted emergency use purposes in moderate to severe cases of COVID-19 subject to a set of conditions under 'investigational therapies' and not as a mainstream treatment," a source said. Remdesivir has been included as an "investigational therapy" in the clinical management protocols for COVID-19 based on limited available evidence at present. "The drug is being increasingly prescribed in the absence of any proven treatment leading to a rise in demand. But then the data derived from the studies so far suggest that its use can cut down the duration of the hospital stay and does not have any effect on the mortality," an official explained. Responding to a question on whether Remdesivir will be dropped from COVID-19 treatment protocols after its negative impact on liver has been indicated, a senior Union Health Ministry official during a briefing on Thursday had said that they are aware of few studies which have indicated some adverse events. "We are aware of this and within the ministry also there is a technical group of domain knowledge experts headed by DGHS that is looking into the evidence as it comes up. "If there is a requirement to modify or refine our clinical treatment protocols we will definitely do it," Rajesh Bhushan, Officer on Special Duty in the Union Health Ministry, said. He also said that the DCGI has written letters to companies manufacturing them with two specific suggestions to prevent the blackmarketing and overpricing of the drug. "First suggestion was that these companies must put in place a 24x7 helpline where the patients or their family members could contact in case the drug is not available in the market or is being overcharged. "Second suggestion given was that they must proactively put on their website the details of their distributors and their supply lines so that all confusion and anxiety in the market subside," Bhushan elaborated. In addition, he said, the DCGI has also directed state governments to instruct drug inspectors to ensure that there is no black marketing of drugs which is being used in treatment of COVID-19 patients. Three companies, Hetero, Cipla and Mylan have been given permission by India's drug regulator to manufacture and market the anti-viral drug remdesivir for "restricted emergency use" on hospitalised COVID-19 patients. Written informed consent of each patient is required before the use of the drug while active post-marketing surveillance data and reporting of serious adverse events have to be submitted. In the letters, Bhushan mentioned, DCGI told these firms to upload the information on their websites regarding the distributors and supply chain details along with quantities where Remdesivir has been made available, so as to prevent black marketing and overcharging of the drug. Considering the emergency and unmet medical need for COVID-19 disease, the drug controller said, the CDSCO has granted permission to companies to manufacture and market Remdesivir injectable formulation for restricted emergency use for the treatment of patients with severe COVID-19 infection subject to various conditions and restrictions. "This office has received representation raising concerns regarding black-marketing and overcharging of the drug Remdesivir injectable formulation in the country," the DGCI wrote. PLB ZMN

Doctors advised to use Remdesivir on COVID-19 patients strictly under laid-down protocol

<ul><li>The Indian Council of Medical Research (<keyword id="6364396" type="UNKNOWN" weightage="20" keywordseo="ICMR">ICMR</keyword>) has begun clinical trials of convalescent <keyword id="9033779" type="UNKNOWN" weightage="20" keywordseo="plasma-treatment">plasma treatment</keyword>. </li><li>The biomedical research body has shortlisted 21 hospitals across the country to initiate trials on critically-ill COVID-19 patients. </li><li>Plasma treatment involves injecting the Covid-19 patient with the <keyword id="1006961" type="PERSON" weightage="20" keywordseo="blood-plasma">blood plasma</keyword> of people who recovered from the infection. </li><li>Five of these hospitals are in Maharashtra alone, 16 selected hospitals have been finalised from Gujarat, Rajasthan, Tamil Nadu, Madhya Pradesh Uttar Pradesh, Punjab, Karnataka, Telangana and Chandigarh. </li><li>Another 90 hospitals — including AIIMS, Indraprastha Apollo and Max hospital in Delhi are under consideration. </li></ul>As the Indian Council of Medical Research (ICMR) begins clinical trials of convalescent plasma therapy, the biomedical research body has <a href="https://m.economictimes.com/industry/healthcare/biotech/healthcare/icmr-shortlists-21-hospitals-for-plasma-trials/amp_articleshow/75585784.cms">shortlisted 21 hospitals</a> across the country to initiate trials on critically-ill COVID-19 patients. "The ICMR has initiated a multi-centre clinical trial, titled 'A Phase II, Open-Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease (PLACID Trial)'," the apex health research body <a href="https://zeenews.india.com/india/plasma-therapy-icmr-allows-21-institutions-for-participating-in-clinical-trials-to-contain-covid-19-2281670.html">said</a>. Plasma treatment involves injecting the Covid-19 patient with the blood plasma of people who recovered from the infection. Those cured already have antibodies that drive the virus away. They can be used to do the same for another patient. Researches reveal that it can help boost the immune system of the infected. While five of these hospitals are in Maharashtra alone, 16 selected hospitals have been finalised from Gujarat, Rajasthan, Tamil Nadu, Madhya Pradesh Uttar Pradesh, Punjab, Karnataka, Telangana and Chandigarh. <table style="border-width: initial; border-style: none; width: 468pt; table-layout: fixed;"></colgroup></colgroup><tbody><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">States </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Medical institutions </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Gujarat </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Smt. NHL Municipal Medical College, Ahmedabad </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Gujarat </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">B.J. Medical College and Civil hospital, Ahmedabad </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Gujarat </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Government Medical College, Bhavnagar </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Gujarat </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Government Medical College, Surat </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Rajasthan </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Sawai Man Singh Medical College, Jaipur </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Rajasthan </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Mahatma Gandhi Medical College and Hospital, Jaipur </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Punjab </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Satguru Pratap Singh Hospital, Ludhiana </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Maharashtra </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">B.J. Government Medical College, Pune </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Maharashtra </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Poona Hospital and research centre, Pune </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Maharashtra </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Sir H. N. Reliance Foundation Hospital and Research Centre, Mumbai </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Maharashtra </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Rajarshee Chhatrapati Shahu Maharaj Government Medical College and CPR Hospital Kolhapur </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Maharashtra </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Government Medical college, Nagpur </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Tamil Nadu </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Madurai Medical college, Madurai </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Tamil Nadu </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Madras Medical College, Chennai </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Madhya Pradesh </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Gandhi Medical College, Bhopal </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Madhya Pradesh </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Mahatma Gandhi Memorial Medical College, Indore </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Uttar Pradesh </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Government Institute of Medical Sciences, Noida </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Uttar Pradesh </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Karnataka </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Karnataka Institute of Medical Sciences, Hubli </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Telangana </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Gandhi Medical College, Telangana </td></tr><tr><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Chandigarh </td><td style="border-left:solid #000000 1pt;border-right:solid #000000 1pt;border-bottom:solid #000000 1pt;border-top:solid #000000 1pt;vertical-align:top;padding:5pt 5pt 5pt 5pt;overflow:hidden;overflow-wrap:break-word;">Postgraduate Institute of Medical Education and Research </td></tr></tbody></table> Another 90 hospitals — including AIIMS, Indraprastha Apollo, Batra Hospital and <keyword id="212960" type="COMPANY" weightage="20" keywordseo="Medical-Research-Centre">Medical Research Centre</keyword>, Lady Hardinge Medical College, RML Hospital, Max Hospital-Saket and Indian Red Cross Society in Delhi are under consideration. According to the guidelines by the Drug Controller General of India (DGCI), the donors can only be those who have recovered and have had a 28-day symptom-free period. These donors can donate up to 1,000 ml of blood plasma in a month. See also: <a href="https://www.businessinsider.in/india/news/hundreds-of-delhi-hotels-are-turning-into-quarantine-facilities-for-international-passengers/articleshow/75590602.cms">Hundreds of Delhi hotels are turning into quarantine facilities for international passengers</a> <a href="https://www.businessinsider.in/science/health/news/biocon-chairperson-kiran-mazumdar-shaw-says-indias-covid-19-vaccines-will-enter-clinical-trial-in-9-months/articleshow/75591805.cms">Don’t hold your breath ⁠— Biocon founder Kiran Mazumdar Shaw says coronavirus vaccines from India may be ready for clinical trials in 9 months</a>

These are the 21 hospitals approved by ICMR to conduct clinical trials of convalescent plasma on COVID-19 patients

<ul><li>The subject enrolment for Phase-I <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> of India's first indigenous vaccine for COVID-19 began at Nizam's Institute of Medical Science (NIMS).</li><li>On the direction of the Indian Council of Medical Research (ICMR), authorities at NIMS began the process to register 30-60 subjects for the trial.</li><li>Blood and swab samples of the subjects will be collected and if found fit they will be administered the first dose of the vaccine after a week.</li><li>Each subject would be given the second dose of the same vaccine after 14 days.</li></ul>The subject enrolment for Phase-I clinical trial of India's first indigenous vaccine for COVID-19 began at Nizam's Institute of Medical Science (NIMS) here on Tuesday. On the direction of the Indian Council of Medical Research (ICMR), authorities at NIMS began the process to register 30-60 subjects for the trial. Blood and swab samples of the subjects will be collected and if found fit they will be administered the first dose of the vaccine after a week. NIMS Director Dr K. Manohar told reporters that healthy subjects will be screened and their blood and swab samples sent to ICMR-designated lab in New Delhi. After receiving the test reports, the Department of Medicine will analyse the same and issue the fitness certificates to the subjects. The subjects would be administered two doses of the vaccine. There will be two vaccine dosage of three micrograms and six micrograms, and a placebo. Each subject would be given the second dose of the same vaccine after 14 days. For two days after administering the vaccine, the subjects would be monitored for two days in the ICCU at NIMS by a team of doctors, after which they would be sent home and monitored through videoconference or phone. The phase-I clinical trial would go on for 28 days, after which the ICMR and <keyword id="9440959" type="COMPANY" weightage="20" keywordseo="the-drug-controller-general">the Drug Controller General</keyword> of India (DGCI) would accord permission for Phase-II trial with more subjects. Phase-1 would have around 375 subjects across the country and Phase-II 875. NIMS is one of the hospitals selected by the ICMR to undertake clinical trials of Covaxin, which it is developing in partnership with Hyderabad-based Bharat Biotech International Limited (BBIL). Meanwhile, the Ethics Committee at King George Hospital (KGH) in Visakhapatnam will hold a crucial meeting on Tuesday to finalise the preparations for the clinical trials. KGH is also one of the hospitals selected by ICMR for the trials. In a letter to the heads of the selected institutions last week, ICMR Director General Balram Bhargava asked them to fast-track all approvals related to initiation of the clinical trials and ensure that the subject enrollment is initiated no later than July 7. "It is envisaged to launch the vaccine for public health use latest by August 15, 2020 after completion of all clinical trials. BBIL is working expeditiously to meet the target; however, the final outcome will depend on the cooperation of all clinical trial sites involved in this project," reads the letter dated July 2. He noted that this is the first indigenous vaccine being developed by India and is one of the top priority projects that is being monitored at the topmost level of the government. "The vaccine is being derived from a strain of SARS-CoV-2 isolated by <keyword id="9532168" type="COMPANY" weightage="20" keywordseo="icmr-national-institute-of-virology">ICMR-National Institute of Virology</keyword>, Pune. ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine," he wrote. While experts raised doubts on the August 15 target, the ICMR defended it, saying its process is in accordance with the globally accepted norms to fast-track vaccine development for diseases of pandemic potential. The research body said the Director's letter was intended to cut red tape, without bypassing any necessary process, and speed up recruitment of participants for human trials so that these phases can be completed at the earliest. BBIL refused to comment on ICMR's August 15 deadline. The company had announced on June 29 that it had successfully developed Covaxin, India's first vaccine candidate for COVID-19, in collaboration with the ICMR and NIV. The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured in Bharat Biotech's BSL-3(Bio-Safety Level 3) High Containment Facility located in Genome Valley, Hyderabad, the company said. The Drug Controller General of India - <keyword id="589469" type="COMPANY" weightage="20" keywordseo="Central-Drugs-Standard-Control-Organization">Central Drugs Standard Control Organization</keyword> (CDSCO), <keyword id="1388549" type="COMPANY" weightage="20" keywordseo="Ministry-of-Health-Family-Welfare">Ministry of Health &amp; Family Welfare</keyword> granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.

Hyderabad's Nizam's Institute of Medical Science begins the human clinical trial of COVID-19 vaccine

By Payal Banerjee and Rajkumar Leishimba (Eds: Recasts throughout, adds inputs on second vaccine) New Delhi, Jul 3 () India's apex medical body ICMR said Friday that it aims to launch the world's first COVID-19 vaccine, the indigenously developed Covaxin, by August 15, and has told select medical institutions to fast-track its clinical trial approvals. But experts said such a timeline may not be realistic. The Indian Council of Medical Research(ICMR) has identified 12 clinical trial sites, including medical institutions and hospitals, and has asked their principal investigators to ensure that the subject enrolment is initiated no later than July 7. The trial sites included AIIMS, New Delhi, AIIMS, Patna and SRM Medical College Hospital and Research Centre in Tamil Nadu. COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech International Limited(BBIL) in collaboration with the ICMR and the National Institute of Virology (NIV), had recently got the nod for human clinical trials from the Drug Controller General of India(DCGI). Separately, Zydus, which is part of Cadila Healthcare Ltd., said in a statement on Friday that it has received approval from authorities to start human trials for its COVID-19 vaccine contender. The vaccine candidate, ZyCoV-D, showed a "strong immune response" in animal studies, and the antibodies produced were able to completely neutralise the wild type virus, Zydus said. In its letter to principal investigators of the 12 sites, ICMR Director General Dr Balram Bhargava noted that the clinical trial of Covaxin is one of the "top priority projects which is being monitored at the top-most level of the government". "It is envisaged to launch the vaccine for public health use latest by August 15 after completion of all clinical trials. BBIL is working expeditiously to meet the target, however, final outcome will depend on the cooperation of all clinical trial sites involved in this project," Bhargava said in the letter. However, it is not clear how the clinical trials can be completed and the vaccine released on August 15 when the normal period for a vaccine to be approved is 12 to 18 months. Anant Bhan, of the Department of Forensic Medicine at Kasturba Medical College, Manipal, questioned the timeline of the announcement. "To my knowledge, such an accelerated development pathway has not been done EVER for any kind of vaccine, even for the ones being tried out in other countries. Even with accelerated timelines, this seems really rushed, and hence with potential risks, inadequate attention to process," Bhan wrote in a series of tweets. "For a vaccine for which pre-clinical development is still ongoing, as per the letter itself, how can clinical trial recruitment be starting on 07th July? And that the vaccine will be launched on 15th August? A vaccine trial completed in little over a month, efficacy pre-decided?" Virologist Upasana Ray said in a pandemic situation like this we are all waiting for a therapeutic handle to manage COVID-19. She noted while an accelerated launch or promise for launch for a vaccine against this novel coronavirus deserves applause, we also have to think if we are rushing too much. "We must rush albeit carefully. Giving this project high priority is absolutely important. However, excess pressure might not necessarily lead to a positive product for public use," Ray, senior scientist at CSIR-IICB, Kolkata, told . In his letter to the 12 sites, ICMR chief Bhargava said: "You have been chosen as a clinical trial site of the BBV152 COVID vaccine. In view of the public health emergency due to COVID-19 pandemic and urgency to launch the vaccine, you are strictly advised to fast track all approvals related to initiation of the clinical trial and ensure that the subject enrolment is initiated no later than July 7." Following a flurry of queries from the media about the authenticity of the letter dated July 2, ICMR spokesman Rajnikant Srivastava told Friday that "the letter is genuine and a request has been made to fast track the vaccine trials." Even though the letter makes it seem as if the apex health research body plans to launch the vaccine by August 15, a scientist from the ICMR clarified that the aim of the letter is to fast track the human clinical trials of the vaccine so that results can come out early. "Only if the results are satisfactory only then can a vaccine be launched for public. It cannot be otherwise," the scientist, who did not want to be named, said. The vaccine is derived from a strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune. ICMR and BBIL are jointly working for the pre-clinical as well as clinical development of this vaccine, the letter said. The letter warned the 12 institutes that any non-compliance will be "viewed very seriously." "Therefore, you are advised to treat this project on highest priority and meet the given timelines without any lapse," the letter stated. A copy of the letter has been sent to BBIL. India's COVID-19 cases soared by over 20,000 in a day for the first time taking the country's total tally to 6,25,544 on Friday while the death toll climbed to 18,213 with 379 new fatalities, according to the Union Health Ministry data. Over seven vaccines are being researched in India and only Covaxin and Zydus' ZyCoV-D have got the go-ahead to start human clinical trials, just this week. Globally, over 100 candidates are being tested on humans but no vaccine has yet been approved. "Zydus has already manufactured clinical good manufacturing practice (GMP) batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1,000 subjects," the company said. It did not say when the vaccine will be ready for commercial use, unlike Covaxin, which is targeting for release on August 15. ZyCoV-D, developed at the company's Vaccine Technology Centre in Ahmedabad, has now received permission from the DGCI-Central Drugs Standard Control Organisation (CDSCO) to initiate phase I/II human clinical trials in India, Cadila Healthcare said. In animal studies, the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralise the wild type virus in virus neutralisation assay indicating the protective potential of the vaccine candidate, it said. It further said no safety concerns were observed for the vaccine candidate in repeat-dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well-tolerated and immunogenic. Zydus said, with its ZyCoV-D, it has successfully established the DNA vaccine platform in India using non-replicating and a non-integrating plasmid carrying the gene of interest making it very safe. The company claimed that the vaccine candidate has no vector response and with the absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements. It is also known to show much-improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest parts of the country, it said. "Furthermore, the platform can be rapidly used to modify the vaccine in a couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection," it added. The company now intends to rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand. PLB RKL SAR VJ GSN GSN GSN

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