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Bengaluru, <keyword id="350365" type="DOMAIN" weightage="20" keywordseo="AstraZeneca-India">AstraZeneca India</keyword> on Tuesday said it has received marketing authorisation from <keyword id="2906413" type="COMPANY" weightage="20" keywordseo="The-Drugs-Controller-General-of-India">the Drugs Controller General of India</keyword> (DCGI) for use of <keyword id="8033475" type="PERSON" weightage="20" keywordseo="fasenra">Fasenra</keyword> for the management of patients with <keyword id="5305913" type="UNKNOWN" weightage="20" keywordseo="Severe-Asthma">severe asthma</keyword>. Fasenra is not an inhaler or a steroid and is administered once in eight weeks under the skin via injection as maintenance therapy. It is an add-on maintenance treatment for patients with severe eosinophilic asthma. It is designed to target cells in the body called eosinophils, which are a key cause of the eosinophilic subtype of asthma. Studies have also shown that patients on Fasenra could reduce their oral steroid intake significantly, thereby reducing the potential steroid-related side-effects. The marketing authorisation from DCGI paves the way for the launch of Fasenra in India subject to other requisite regulatory approvals, AstraZeneca India said. "AstraZeneca has always been at the forefront of innovative solutions for non-communicable diseases. Despite currently available therapies, a significant unmet need for effective management of severe asthma continues to exist globally as well as in India," Gagandeep Singh Bedi, <keyword id="24973" type="PERSON" weightage="20" keywordseo="managing-director">Managing Director</keyword>, AstraZeneca India, said in a statement. "The regulatory approval of Fasenra in India will provide better medicine for the management of eosinophilic asthma and support patients to attain a <keyword id="7631990" type="UNKNOWN" weightage="20" keywordseo="better-quality">better quality</keyword> of life". Asthma is a common, heterogeneous, chronic inflammatory disease of the airways that affects people of all ages and imposes a substantial burden on patients, their families, and the community. It causes respiratory symptoms that are interspersed with attacks of breathlessness, which may require urgent health care and may result in emergency admission in hospital or sometimes be fatal. The burden of asthma is immense as it causes limitations in daily activities, loss of school and work days, lung function impairment, reduced quality of life, and an adverse socioeconomic burden. SEE ALSO: <a href="https://www.businessinsider.in/stock-market/news/top-stocks-to-watch-spicejet-interglobe-aviation-tata-motors-pfizer-asian-paints-niit-lupin-and-others/articleshow/79849749.cms">Top stocks to watch – SpiceJet, InterGlobe Aviation, Tata Motors, Pfizer, Asian Paints, NIIT, Lupin, and others</a> <a href="https://www.businessinsider.in/stock-market/news/how-to-check-mrs-bectors-food-specialities-ipo-allotment-status-online/articleshow/79808672.cms?upcache=2">Mrs Bectors Food Specialities IPO allotment today: Here’s how to check share allotment status</a> <a href="https://www.businessinsider.in/business/startups/news/google-microsoft-invest-in-dailyhunt-for-its-short-video-platform-josh-making-it-the-latest-unicorn-in-india/articleshow/79850804.cms">Google, Microsoft invest in DailyHunt for its short video platform Josh – making it the latest unicorn in India</a>

AstraZeneca's Fasenra gets regulator nod for launch in India for asthma treatment

<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

New Delhi, Feb 3 () Drug firm Zydus Cadila on Monday said that it has received approval from Drug Controller General of India (DGCI) for Saroglitazar Magnesium used in treatment of diabetes.
 "Zydus Cadila has received the approval from the Drug Controller General of India for use of Saroglitazar Mg in the treatment of type II diabetes mellitus as an add-on therapy with Metformin," the drug firm said in a filing to BSE.
 Type II diabetes is a condition in which cells cannot use blood sugar (glucose) efficiently for energy.
 In India, the drug was previously approved in 2013 for the treatment of hypertriglyceridemia and diabetic dyslipidemia .
 More than one million patients are being treated with Saroglitazar (Lipaglyn).
 "Insulin resistance is one of the primary causes of diabetes and there is a huge unmet medical need for a safe and effective insulin sensitizer. Saroglitazar is an important scientific and medical breakthrough in our effort to develop medicines for patients suffering from type 2 diabetes mellitus," Zydus Group Chairman Pankaj Patel said.
 With increasing cases of diabetes in India, the need to strengthen diabetes management and help patients control their blood sugar levels is of critical importance, he said. SID ANS
ANS

Zydus Cadila gets DGCI nod for diabetes treatment drug

The <keyword id="682334" type="General" weightage="20" keywordseo="Drugs-Controller-General-of-India" source="Orion">Drugs Controller General of India</keyword> (DCGI) has granted permission for the conducting of the Phase III bridging trials of Sputnik Light on the Indian population. The Sputnik Light is a single-dose <keyword id="8904563" type="General" weightage="20" keywordseo="COVID-19-vaccine" source="Orion">Covid-19 vaccine</keyword> of the <keyword id="9340724" type="General" weightage="20" keywordseo="Russian-vaccine" source="Orion">Russian vaccine</keyword> Sputnik. The nod comes after a recent study published in the medical journal The Lancet said that Sputnik Light showed 78.6 to 83.7 per cent efficacy against Covid-19, significantly higher than most two-shot vaccines. The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) in July had refused to grant emergency-use authorisation to Sputnik-Light, ruling out the need for the conduct of the <keyword id="9915130" type="General" weightage="20" keywordseo="phase-III-trial" source="Orion">phase III trial</keyword> of the Russian vaccine in the country. The committee had noted that Sputnik Light was the same as component-1 of <keyword id="9739267" type="General" weightage="20" keywordseo="Sputnik-V" source="Orion">Sputnik V</keyword> and its safety and immunogenicity data in the Indian population was already generated in a trial. The study was conducted on at least 40,000 elderly people in Argentina. Sputnik Light also reduced hospitalizations among the target population at 82.1-87.6 per cent, the study said. The Russian Direct Investment Fund (RDIF) last year partnered with Dr Reddy's Laboratories to conduct the phase III trials of Sputnik V vaccine in India. In April, Sputnik V received an emergency use authorisation in India. Reddy's administered the first dose of the vaccine in Hyderabad under a limited pilot on May 14. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/tech/news/ios-15-will-be-released-for-all-compatible-iphones-on-september-20/articleshow/86223330.cms">Everything you need to know about iOS 15: Release date, new features, supported devices</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/stock-market/news/analysts-recommend-buying-zee-entertainment-on-end-to-concerns-over-corporate-governance/articleshow/86222841.cms">Zee Entertainment good to buy as concerns over corporate governance will be put to bed after management change, say analysts</a>

DCGI permits to conduct the third phase trials of Sputnik V COVID-19 vaccine in India

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>

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

New Delhi, Dec 5 () Drug firm Zydus Cadila on Thursday said it has filed New Drug Application (NDA) with the Drug Controller General of India (DCGI) for Saroglitazar Mg, used in treatment of liver disease.
 "Zydus Cadila...has filed the NDA of Saroglitazar Mg in non-alcoholic Steatohepatitis (NASH) with the Drug Controller General of India (DCGI)," the drug firm said in a regulatory filing.
 NASH is a progressive disease of the liver and a significant unmet medical need. There are currently no treatments available for the treatment of NASH.
 Saroglitazar Magnesium was launched in India during September 2013, for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients with type-2 diabetes not controlled by statins.
 "There is a significant need for new therapies for patients with NASH, who have no treatment options as their liver disease progresses, other than opting for eventual liver transplants to survive," Zydus Group Chairman said Pankaj R Patel said.
 Saroglitazar Mg has demonstrated beneficial effects in NASH animal models, the filing said adding that Saroglitazar Mg favourably affects all components of NASH including steatosis, ballooning, inflammation and fibrosis in NASH models.
 "We are very pleased that our NDA filing has been accepted for review which we believe represents an important step towards providing an innovative treatment option for millions of patients suffering from this devastating liver disease," Patel said.
 Saroglitazar Mg has previously demonstrated improvement in both liver enzymes along with favorable effects on lipid and glycemic indices in patients with nonalcoholic fatty liver disease in Phase II clinical trials. SID DRR

Zydus Cadila files NDA for Saroglitazar Magnesium

New Delhi, Jan 16 () Drug firm Wockhardt on Thursday said that it has received approval from the Drug Controller General of India for its two new antibiotics.
 "DCGI (Drug Controller General of India) has approved Wockhardt's two new antibiotics, EMROK (IV) and EMROK 0 (Oral), for acute bacterial skin and skin structure infections including diabetic foot infections and concurrent bacteraemia...," the drug firm said in a regulatory filing.
 The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).
 "By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety over currently available anti-MRSA agents and its unique properties, I believe EMROK/EMROK-O has a strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping to reduce the morbidity and mortality," Wockhardt Group founder chairman Habil Khorakiwala said.
 The size of Indian antibiotic market is around Rs 16,000 crore.
 AMR is a major public health problem globally. India carries one of the largest burdens of drug-resistant pathogens worldwide.
 Infections caused by drug-resistant organisms could lead to increased mortality and prolonged duration of hospitalisation, causing a huge financial burden to the affected persons, health-care systems, and hinder the goals of sustainable development.
 Two million deaths are projected to occur in India due to AMR by the year 2050, the company said.
 Currently available anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet cell counts and muscle pain, which limits their use for a longer period and compromise the safety of critically ill patients in the ICU. SID DRR

Wockhardt gets DGCI approval for 2 new antibiotics

The first batch of DRDO-developed anti-Covid drug 2-DG (2-deoxy-D-glucose) was launched on Monday to treat patients suffering from the deadly disease. The medicine comes in powder form and can be taken with water. Defence Minister Rajnath Singh and Health Minister Harsh Vardhan released the first batch of the 2-DG, an anti-Covid-19 therapeutic application of the drug developed by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of <keyword id="152819" type="COMPANY" weightage="20" keywordseo="Defence-Research-and-Development-Organisation">Defence Research and Development Organisation</keyword> (DRDO) in collaboration with Dr Reddy's Laboratories (DRL). Rajnath Singh handed over the anti-Covid drug to his cabinet colleague Harsh Vardhan who handed over it to Delhi All India Institute of Medical Sciences (AIIMS) director Randeep Guleria at an event here. The Defence Minister would be later distributing around 10,000 doses of the drug to a few hospitals in the national capital. The Drugs Controller General of India (<keyword id="172241" type="COMPANY" weightage="20" keywordseo="DCGI">DCGI</keyword>) granted emergency use nod for the drug last week. The drug could be a game-changer in the battle against pandemic as it helps in faster recovery of hospitalised patients and reduces <keyword id="11257268" type="UNKNOWN" weightage="20" keywordseo="oxygen-dependence">oxygen dependence</keyword>. Clinical trial results have shown that the drug helps in faster recovery of hospitalised patients and reduces supplemental oxygen dependence. Higher proportion of patients treated with 2-DG showed <keyword id="9043621" type="COMPANY" weightage="20" keywordseo="RT-PCR">RT-PCR</keyword> negative conversion in Covid patients. The medicine was found to be safe for Covid-19 patients in phase 2 trials, conducted between May and October last year. It was found to be effective in cutting short the hospital stays of Covid patients and reducing their supplemental oxygen dependence. During the first wave of the pandemic in April last year, INMAS-DRDO scientists conducted laboratory experiments with the help of <keyword id="395778" type="COMPANY" weightage="20" keywordseo="Centre-for-Cellular-and-Molecular-Biology">Centre for Cellular and Molecular Biology</keyword> (CCMB), Hyderabad, and found that this molecule works effectively against SARS-CoV-2 virus and inhibits the viral growth. Based on these results, the Drugs Controller General of India (DCGI) <keyword id="170943" type="COMPANY" weightage="20" keywordseo="Central-Drugs-Standard-Control-Organisation">Central Drugs Standard Control Organisation</keyword> (CDSCO) permitted Phase-II clinical trial of 2- DG in Covid-19 patients in May 2020. The DRDO, along with its industry partner DRL, Hyderabad, started the clinical trials to test the safety and efficacy of the drug in Covid-19 patients. In Phase-II trials (including dose ranging) conducted during May-October 2020, the drug was found to be safe in Covid-19 patients and showed significant improvement in their recovery. Phase-II was conducted in six hospitals and Phase IIb (dose ranging) clinical trial was conducted at 11 hospitals all over the country. Phase-II trial was conducted on 110 patients. SEE ALSO: <a href="https://www.businessinsider.in/cryptocurrency/news/after-ditching-bitcoin-elon-musk-is-now-working-on-making-dogecoin-efficient/articleshow/82628521.cms">After ditching Bitcoin, Elon Musk is now working on making Dogecoin efficient</a> <a href="https://www.businessinsider.in/cryptocurrency/news/four-reasons-why-cryptocurrency-ethereum-has-been-on-a-bull-run/articleshow/82606761.cms">Four reasons why cryptocurrency Ethereum has been on a bull run</a>

DRDO launches a new anti-COVID drug called 2-DG that has helped patients recover faster during trials

<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

New Delhi, Mar 5 () Pharmaceutical major Zydus Cadila on Thurday said it has received Drug Controller General of India (DCGI) approval for its new drug application for Saroglitazar to treat a particular condition of liver, commonly known as NASH in India.Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) is a progressive disease of the liver, which starts with fat accumulation in the liver known as non-alcoholic fatty liver disease. This condition could progress to cirrhosis and liver failure, the company said in a statement.Commenting on the approval, Zydus Group Chairman Pankaj Patel said, "We are happy that our efforts to discover and develop a novel drug for patients living with NASH, an unmet healthcare need globally, have been successful. Saroglitazar will provide hope and new lease of life for millions of patients in India suffering from NASH".The company had launched Saroglitazar in India in September 2013 for treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with Type-2 diabetes not controlled by statins alone.In January this year, Saroglitazar received an approval for the treatment of Type-2 diabetes Mellitus. In the last seven years, over a million patients have benefitted from this drug, Zydua Cadila said.The drug has been found to reduce significantly liver fat, liver enzymes and disease activity during trials in India, the company said, adding it has also met primary and secondary endpoints during trials in the US. RKL BAL

Zydus Cadila gets DCGI nod for Saroglitazar to treat liver disease

Union Health Minister <keyword id="196226" type="PERSON" weightage="20" keywordseo="Harsh-Vardhan">Harsh Vardhan</keyword> clarified on Sunday that the government is yet to take a final decision on phase-3 trials of the Russian COVID-19 vaccine candidate Sputnik V. "This issue is still under consideration and no final decision on Sputnik V vaccine developed by Russia has been taken as yet," he stated while addressing his social media audience during his weekly programme 'Sunday Samvaad'. The clarification by the minister has come after a pharmaceutical giant, which partnered with Russia's sovereign wealth fund in September to conduct final trials and distribution of the Sputnik V, sought permission for the same from <keyword id="682334" type="COMPANY" weightage="20" keywordseo="Drugs-Controller-General-of-India">Drugs Controller General of India</keyword> (DCGI) on Friday. Hyderabad-based drugmaker Dr Reddy's Laboratories (DRL) had partnered the <keyword id="1397612" type="COMPANY" weightage="20" keywordseo="Russian-Direct-Investment-Fund">Russian Direct Investment Fund</keyword> (RDIF) last month to conduct final-stage human trials and distribution of Russia's Sputnik V Covid-19 vaccine in India. Two days ago, the DRL had applied to the DCGI for permission to conduct the phase-3 human clinical trials of Sputnik. Upon regulatory approval in India, RDIF will supply Dr Reddy's 100 million doses of the vaccine, the firm had said last month. The trials of Sputnik V are mired in controversy. The Russian government registered Sputnik V as a COVID-19 vaccine without conducting final clinical trials. Besides, the phase I and II of the trials involved merely 76 participants. The Indian scientists and medical experts are also of the opinion that the Indian government should conduct phase-2 trials of the vaccine to prove its safety and efficacy. Russia, had announced in August that it has developed the world's first <keyword id="1754604" type="PERSON" weightage="20" keywordseo="coronavirus">coronavirus</keyword> vaccine. However, the country had made the announcement before completion of phase-3 trials. A vaccine is deemed safe to be commercially available only after a larger efficacy trial which involves thousands of participants in the phase-3. However, the study of Sputnik trials published in The Lancet declared the vaccine as "Safe, well-tolerated, and does not cause serious adverse events in <keyword id="10049599" type="UNKNOWN" weightage="20" keywordseo="healthy-adult-volunteers">healthy adult volunteers</keyword>." As per the study, two small trials were conducted on two groups involving 38 healthy adults between the ages of 18 and 60, each. They were given a two-part immunisation. Each participant was given a dose of the first part of the vaccine, and then a booster with the second part, 21 days later. These volunteers were monitored over 42 days, and it was found that all of them developed antibodies against the virus within three weeks. After widespread criticism of conducting relatively small and early trials before registering Sputnik V as a COVID-19 vaccine, Russia said that a more rigorous phase-3 <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> has been planned with the involvement of 40,000 volunteers "from different age and risk groups". SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/latest-update-on-covid-19-vaccine-in-india/articleshow/78422652.cms" data-type="tilCustomLink">India COVID-19 vaccine updates — Zydus, Biotech enter clinical trials, Dr Reddy’s yet to apply for Sputnik V phase-III trials</a> <a href="https://www.businessinsider.in/stock-market/news/investors-must-brace-for-a-turbulent-october-in-the-stock-market-but-they-should-hold-on-for-a-strong-4th-quarter-finish-a-senior-wall-street-strategist-says/articleshow/78477243.cms" data-type="tilCustomLink">Investors must brace for a turbulent October in the stock market — but they should hold on for a strong 4th-quarter finish, a senior Wall Street strategist says</a>

Centre yet to decide on phase-3 trials of Russian COVID-19 vaccine Sputnik V, says Health Minister Harsh Vardhan

<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>

You Searched For "Drugs Controller General of India" and got 12 results

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Wockhardt gets DGCI approval for 2 new antibiotics

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

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Centre yet to decide on phase-3 trials of Russian COVID-19 vaccine Sputnik V, says Health Minister Harsh Vardhan

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

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