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<ul><li>DCGI has approved market authorisation for the COVID-19 vaccine <keyword id="10678894" type="General" weightage="100" keywordseo="covovax" source="Orion">Covovax</keyword> as a heterologous booster dose for adults.</li><li>The DCGI's approval came following recommendations by the <keyword id="3923779" type="General" weightage="50" keywordseo="subject-expert-committee" source="Orion">Subject Expert Committee</keyword> of the Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="50" keywordseo="cdsco" source="Orion">CDSCO</keyword>).</li></ul>The <keyword id="6386816" type="General" weightage="50" keywordseo="drug-controller-general-of-india" source="Orion">Drug Controller General of India</keyword> (DCGI ) has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of <keyword id="9617748" type="General" weightage="50" keywordseo="covishield" source="Orion">Covishield</keyword> or <keyword id="9485939" type="General" weightage="50" keywordseo="covaxin" source="Orion">Covaxin</keyword>, official sources said on Monday. The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO). Prakash Kumar Singh, Director of Government and Regulatory Affairs at the <keyword id="95879" type="General" weightage="50" keywordseo="serum-institute-of-india" source="Orion">Serum Institute of India</keyword> (<keyword id="52604" type="General" weightage="80" keywordseo="sii" source="Orion">SII</keyword>), had recently written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating COVID-19 pandemic situation in some countries, an official source had said. "The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin," an official source said. The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and in children aged 7- 11 years on June 28 last year subject to certain conditions. Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation. It was granted emergency-use listing by the <keyword id="43588" type="General" weightage="50" keywordseo="world-health-organization" source="Orion">World Health Organization</keyword> (WHO) on December 17, 2021. In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in <keyword id="3658" type="General" weightage="50" keywordseo="india" source="Orion">India</keyword> and low-and-middle-income countries. SEE ALSO: <a href="https://www.businessinsider.in/tech/news/amazon-great-republic-day-sale-2023-best-deals-and-offers-on-tvs/articleshow/96987966.cms">Amazon Great Republic Day Sale 2023 – Best deals and offers on TVs</a> <a href="https://www.businessinsider.in/tech/apps/news/these-audio-setting-tweaks-can-make-music-sound-better-on-spotify/articleshow/96876010.cms">These audio setting tweaks can make music sound better on Spotify</a>

Serum Institute's Covovax gets DCGI approval as a heterologous booster dose

<ul><li>Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the <keyword id="46985" type="COMPANY" weightage="20" keywordseo="Oxford">Oxford</keyword> COVID-19 vaccine candidate in the country</li><li>SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events. </li><li>The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders. </li></ul>Drugs Controller General of India (DCGI) Dr V G Somani on Tuesday gave permission to Serum Institute of India to resume clinical trial of the Oxford COVID-19 vaccine candidate in the country while revoking its earlier order of suspending any new recruitment for phase two and three trial. The DCGI, however, put certain conditions like taking extra care during screening, providing additional information in informed consent and close monitoring for adverse events during follow-up of the study which have to be "scrupulously" followed by Serum Institute of India (SII). SII has also been asked to submit to the DCGI's office details of medication used in accordance with the protocol for management of adverse events. The DCGI had on September 11 directed Serum Institute of India to suspend any new recruitment in the phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of ''an unexplained illness'' in a participant in the study. On Saturday, British-Swedish biopharmaceutical giant AstraZeneca and the University of Oxford said clinical trials for their coronavirus vaccine have resumed in the UK after the Medicines Health Regulatory Authority's (MHRA) confirmed that the trials were safe. SII, which has partnered with AstraZeneca for manufacturing the vaccine candidate for COVID-19, on Tuesday submitted the recommendations of the Data and Safety Monitoring Board (DSMB), UK and DSMB, India, and requested for permission to restart enrolment in the clinical trial. According to Tuesday's order issued by DCGI, the DSMB, UK, recommended that the investigators recommence all immunization in their clinical trials subject to certain conditions. DSMB, India, also has recommended to continue the study and enroll the remaining participants in the clinical trial as per protocol subject to certain conditions. According to the order, SII has submitted revised participant information sheet, revised informed consent form and additional safety monitoring plan for the evolved participants. The Pune-based firm has also submitted a summary of safety follow up of seven days post first vaccination, stating that no serious adverse events were experienced by any of the subjects till the date of the reporting, and the reported adverse events were stated to be mild, resolved on their own and did not have any sequale. "In view of the above, I Dr V G Somani, Drugs Controller General of India, Central Licensing Authority, after careful examination of your reply and the recommendations of the DSMB in India and in UK revoke herewith the order dated September 11 issued under Rule 30 of the New Drugs and Clinical Trials Rules, 2019. "You may recommence the clinical trial as recommended by DSMB, India, as per already approved protocol and the provisions laid down under the New Drugs and Clinical Trial Rules, 2019, subject to the conditions mentioned," the order said. SEE ALSO: <a href="https://www.businessinsider.in/science/news/bill-gates-says-the-pandemic-wiped-out-25-years-of-vaccine-progress-in-25-weeks/articleshow/78117898.cms">Bill Gates says the pandemic wiped out 25 years of vaccine progress in 25 weeks</a> <a href="https://www.businessinsider.in/education/news/uks-new-visa-rules-make-it-easier-for-international-students-to-study-and-work-now/articleshow/78127748.cms">UK’s new visa rules make it easier for international students to study and work now</a>

Serum Institute of India can resume clinical trial of Oxford COVID-19 vaccine, says DCGI

New Delhi, Apr 30 () Shares of Glenmark Pharmaceuticals on Thursday gained nearly 9 per cent after the company said it has received approval from DCGI to conduct clinical trials of tablets used for the treatment of COVID-19 patients.The company said it is the first firm in India to receive such an approval from the Drug Controller General of India (DCGI).The scrip jumped 8.88 per cent to Rs 359 on the BSE.On the NSE, it zoomed 8.88 per cent to Rs 359.Having internally developed the active pharmaceutical ingredients (API) and the formulations for the product, the company filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients, Glenmark Pharmaceuticals said in a statement.The company is the first pharmaceutical firm in India to be given an approval by the DCGI to start the trial on COVID-19 patients, it added.Favipiravir antiviral tablet has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections, it added. SUM RUJRUJ

Glenmark Pharma shares jump nearly 9 pc on DCGI nod for clinical trials of COVID-19 tablets

The <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> (<keyword id="52604" type="COMPANY" weightage="20" keywordseo="SII">SII</keyword>) has applied to the Drug Controller General of India (<keyword id="172241" type="COMPANY" weightage="20" keywordseo="DCGI">DCGI</keyword>) seeking permission to manufacture COVID-19 vaccine <keyword id="9739267" type="PERSON" weightage="20" keywordseo="Sputnik-V">Sputnik V</keyword> in the country, sources said on Thursday. The Pune-based firm has also sought approval for test analysis and examination. Russia's Sputnik V vaccine is currently being manufactured in India by Dr Reddy's Laboratories. "The <keyword id="242973" type="COMPANY" weightage="20" keywordseo="Serum-Institute">Serum Institute</keyword> of India (SII) put up an application to the <keyword id="282629" type="COMPANY" weightage="20" keywordseo="Drugs-Controller">Drugs Controller</keyword> General of India (DCGI) on Wednesday seeking permission to manufacture the COVID-19 vaccine, Sputnik V, in India," a source said. The SII has already told the government that it will be able to manufacture and supply 10 crore Covishield doses in June, while it is also manufacturing the Novavax vaccine, the regulatory clearance for which is awaited from the United States. The vaccine was given emergency use authorisation (<keyword id="2503801" type="COMPANY" weightage="20" keywordseo="EUA">EUA</keyword>) by the DCGI in April. A consignment of 30 lakh doses of Sputnik V landed in Hyderabad on Tuesday. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/the-indian-government-is-doling-out-1500-crore-to-reserve-300-million-of-biological-es-covid-19-vaccine-doses/articleshow/83196362.cms">The Indian government is doling out ₹1500 crore to reserve 300 million of Biological-E’s COVID-19 vaccine doses</a> <a href="https://www.businessinsider.in/tech/news/huawei-announces-first-devices-with-harmonyos-set-to-take-on-apple-and-google-with-its-in-house-operating-system/articleshow/83195689.cms">Huawei announces first devices with HarmonyOS — set to take on Apple and Google with its in-house operating system</a> <a href="https://www.businessinsider.in/tech/mobile/news/oneplus-nord-ce-5g-mobile-phone-full-specifications-leaked-days-ahead-of-launch/articleshow/83195375.cms">OnePlus Nord CE 5G full specifications leaked days ahead of launch – heavily inspired by the original Nord</a> <a href="https://www.businessinsider.in/business/startups/news/top-five-fintech-ideas-that-are-drawing-the-most-amount-of-money/slidelist/83194276.cms">Five fintech ideas that are raking in the most amount of money</a>

Serum Institute of India seeks permission from DCGI to manufacture 'Sputnik V' COVID-19 vaccine in the country

New Delhi, Jun 21 () Drug firm Hetero on Sunday said it has received approval from regulator DCGI to launch investigational antiviral drug Remdesivir for the treatment of COVID-19 after getting The company has received the manufacturing and marketing approval for Remdesivir from the Drug Controller General of India (DCGI) for the treatment of COVID-19, it said in a statement. The company's generic version of Remdesivir will be marketed under the brand name 'Covifor' in India. The drug has been granted approval by DCGI for the treatment of suspected or laboratory-confirmed cases of COVID-19 in adults and children, hospitalised with severe symptoms of the disease, it added. "In the light of increasing COVID-19 cases in India, the approval of 'Covifor' (remdesivir) can prove to be a game-changer given its positive clinical outcomes. "Backed by strong backward integration capabilities, we can ensure that the product is immediately made available to patients across the country," Hetero Group of Companies Chairman B Partha Saradhi Reddy said. The company is prepared for ensuring enough stock to cater to the present needs, he added. The drug will be available in 100 mg vial (injectable) which has to be administered intravenously in a hospital setting under the supervision of a healthcare practitioner, Hetero said. The product is being launched under a licensing agreement with Gilead Sciences Inc to expand access to COVID-19 treatment in low and middle-income countries, it added. AKT ABM ABM

Hetero gets DCGI nod to launch COVID-19 drug

New Delhi, Jul 11 () Biotechnology major Biocon on Saturday said it has received approval from the Drugs Controller General of India (DCGI) for use of its biologic drug Itolizumab for the treatment of moderate to severe COVID-19 patients. The company has received the DCGI approval to market Itolizumab injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome in moderate to severe acute respiratory distress syndrome (ARDS) patients due to COVID-19, Biocon said in a BSE filing. Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications, it added. The company, however, did not disclose the price at which it will be selling the drug. The firm has repurposed the drug, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as Alzumab for treating chronic plaque psoriasis, Biocon said. The drug will be manufactured and formulated as an intravenous injection at the company's bio-manufacturing facility at Biocon Park, Bengaluru. DCGI's approval for Itolizumab is based on the results from the successful conclusion of a randomised, controlled clinical trial at multiple hospitals in Mumbai and New Delhi, Biocon said. "As an innovation-led biopharmaceuticals company, I am proud of the successful outcome of the pivotal study we conducted with our novel immuno-modulating anti-CD6 monoclonal antibody, Itolizumab, which has proven to be an efficacious intervention in treating the serious hyper immune response seen with COVID-19," Biocon Executive Chairperson Kiran Mazumdar-Shaw said. This positions India among the leading global innovators in their effort to overcome the COVID-19 pandemic, she added. "We plan to take this therapy to other parts of the world impacted by the pandemic," Mazumdar-Shaw said. India's coronavirus caseload zoomed past the eight-lakh mark on Saturday with a record single day increase of 27,114 cases.The death toll climbed to 22,123 with 519 people succumbing to the disease in 24 hours, according to health ministry data. AKT ABM ABM

Biocon gets DCGI nod for use of Itolizumab for treatment of COVID-19 patients

If all goes well, Phase-II clinical trials of Russian vaccine Sputnik V will commence at state government-run College of Medicine and Sagore Dutta Hospital by the end of this month, a senior official of the health department said on Tuesday. The necessary surveys -- which include visiting the hospital to check its infrastructure and cold storage facilities -- have been carried out by a site management organisation before starting the process, he stated. Snehendu Koner, the head of business development at site management organisation CliniMed LifeSciences, said a report on survey findings has been sent to the Drug Control General of India (DCGI) for approval. "We have visited the site, conducted checks on its infrastructure as well as facilities for storing vaccines and immunogenicity samples. "We have also gone through the hospital's records and found it has experiences of conducting clinical trials. Our findings are quite satisfactory and we have sent it to the DCGI for approval," Koner told when contacted. Once the DCGI gives green signal, the hospital's ethics committee will issue a clearance to start the Phase-II clinical trials there, he said "We have also identified the principal investigator as well the co-investigator for the process," he said. The clinical trial of Sputnik V, scheduled to be held throughout the country, will be conducted by pharma company Dr Reddy's Lab, which has joined hands with the Russian Direct Investment Fund (RDIF). According to a health department official, the RDIF will be supplying 100 million doses of its potential COVID-19 vaccine to Dr Reddy's Lab. Hundred volunteers will be chosen all over the country, and out of them 75 will be administered the vaccine. Twenty five others will be given placebo -- a substance or treatment which is designed to have no therapeutic value. SEE ALSO: <a href="https://www.businessinsider.in/careers/news/tcs-infosys-hcl-tech-and-others-to-see-more-freshers-than-lateral-hires-in-the-next-six-months/articleshow/79014794.cms">TCS, Infosys, HCL Tech, and others to see more freshers than lateral hires in the next six months</a> <a href="https://www.businessinsider.in/thelife/personalities/news/prajakta-koli-aka-mostlysane-advice-for-content-creators-on-the-fine-line-between-brand-collaborations-and-staying-honest-on-social-media/articleshow/79013162.cms">Prajakta Koli aka MostlySane’s advice for content creators on the fine line between brand collaborations and staying honest on social media</a> <a href="https://www.businessinsider.in/business/ecommerce/news/flipkart-acquires-gaming-startup-mech-mocha-as-it-looks-to-tap-the-social-gaming-space-for-more-consumers/articleshow/79014466.cms">Flipkart acquires gaming startup Mech Mocha as it looks to tap the social gaming space for more consumers</a>

Phase-II trial of Russia's COVID-19 vaccine awaits DCGI nod in India

<ul><li>The <keyword id="95879" type="ORGANIZATION" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> has paused the Phase II/Phase III human trials of Oxford’s coronavirus vaccine candidate across all 17 locations. </li><li>The Drug Control General of India (DCGI) issued a show-cause notice, seeking an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear. </li><li>The notice was issued after <keyword id="6409874" type="COMPANY" weightage="20" keywordseo="astrazeneca">AstraZeneca</keyword> halted the late-trials of its coronavirus vaccine over safety concerns. </li></ul>The Serum Institute of India has paused 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. SII<a href="https://twitter.com/CNBCTV18Live/status/1303981172200882176"> says</a> there have been no issues in India. It is a precautionary measure, and it will restart the trial as soon as AstraZeneca does. "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials. You can connect with DCGI for more updates on this front," SII said. The Drug Control General of India (DCGI), VG Somani, issued a show-cause notice to it asking for an explanation as to why the institute decided to go ahead with the clinical trial of COVID-19 vaccine when doubts about patient safety were yet unclear. "The Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns," <a href="https://www.deccanchronicle.com/nation/in-other-news/100920/dcgi-issues-notice-to-serum-institute-over-astrazenecas-trial-suspens.html">the notice by DGCI read.</a> The DGCI further asked the institute as to why the authority did not suspend the permission given to SII for the clinical trials of Covishield. The notice was issued after AstraZeneca halted the late-trials of its coronavirus vaccine over safety concerns. According to<a href="https://www.businessinsider.com/astrazeneca-covid-19-vaccine-trial-paused-after-potential-adverse-reaction-2020-9?IR=T"> reports</a>, one of the participants in the United Kingdom reported a severe adverse reaction after being administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and the University of Oxford, on Tuesday. AstraZeneca was conducting human trials at over 60 locations including the US, Brazil and South Africa. SII is the partner of the University of Oxford's Jenner Institute to conduct vaccine trials. Last month, the DGCI had granted permission to SII for the second and third phase study of the vaccine at 17 trial sites across India. SEE ALSO: <a href="https://www.businessinsider.com/astrazeneca-covid-19-vaccine-trial-paused-after-potential-adverse-reaction-2020-9?IR=T">AstraZeneca's phase 3 coronavirus vaccine trial was just put on pause because a participant may have had an adverse reaction</a>

Oxford COVID-19 vaccine: SII pauses trials in India following show-cause notice

An expert panel of India's central drug authority has recommended granting approval to Russian COVID-19 vaccine Sputnik V for emergency use in the country with certain conditions, sources said. The Subject Expert Committee (<keyword id="6362470" type="COMPANY" weightage="20" keywordseo="sec">SEC</keyword>) of the <keyword id="589469" type="COMPANY" weightage="20" keywordseo="Central-Drugs-Standard-Control-Organization">Central Drugs Standard Control Organization</keyword> (CDSCO) on Monday took up the application of Dr Reddy's Laboratories seeking emergency use authorisation for Sputnik V. The Drugs Controller General of India (<keyword id="172241" type="COMPANY" weightage="20" keywordseo="DCGI">DCGI</keyword>) will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India. The vaccine would be imported from Russia for emergency use in the country, they said. In September last year, Dr Reddy's partnered with the <keyword id="1397612" type="COMPANY" weightage="20" keywordseo="Russian-Direct-Investment-Fund">Russian Direct Investment Fund</keyword> (RDIF) to conduct clinical trials of Sputnik V and for its distribution rights in India. The Drugs Controller General of India (DCGI) has already given the emergency use authorisation for two COVID-19 vaccines -- Covaxin of <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> and Covishield of Oxford-AstraZeneca, being manufactured by <keyword id="95879" type="COMPANY" weightage="20" keywordseo="Serum-Institute-of-India">Serum Institute of India</keyword> in Pune. Sputnik V has demonstrated an efficacy rate of 91.6 per cent in the interim analysis of phase 3 clinical trial, which included data on 19,866 volunteers in Russia. SEE ALSO: <a href="https://www.businessinsider.in/tech/news/aadhaar-pan-and-bank-account-numbers-leaked-in-upstox-data-breach/articleshow/82025949.cms">Discount broker Upstox suffers data breach – Aadhaar, PAN and bank account numbers leaked</a> <a href="https://www.businessinsider.in/science/environment/news/how-ash-from-st-vincents-volcano-is-covering-the-caribbeans-largest-island-nation/slidelist/82025420.cms">Devastating images show how ash from St Vincent’s volcano is covering the Caribbean's largest island nation</a> <a href="https://www.businessinsider.in/tech/mobile/news/lg-wing-gets-a-40000-price-cut-a-week-after-the-company-shuts-its-smartphone-business/articleshow/82027401.cms">LG Wing gets a ₹40,000 price cut a week after the company shuts its smartphone business</a>

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Serum Institute's Covovax gets DCGI approval as a heterologous booster dose

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Serum Institute of India can resume clinical trial of Oxford COVID-19 vaccine, says DCGI

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Glenmark Pharma shares jump nearly 9 pc on DCGI nod for clinical trials of COVID-19 tablets

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Serum Institute of India seeks permission from DCGI to manufacture 'Sputnik V' COVID-19 vaccine in the country

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Hetero gets DCGI nod to launch COVID-19 drug

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Biocon gets DCGI nod for use of Itolizumab for treatment of COVID-19 patients

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Phase-II trial of Russia's COVID-19 vaccine awaits DCGI nod in India

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Oxford COVID-19 vaccine: SII pauses trials in India following show-cause notice

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Russia’s Sputnik V COVID-19 vaccine recommended for emergency use in India

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