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The <keyword id="83655" type="General" weightage="50" keywordseo="union-health-ministry" source="Orion">Union Health Ministry</keyword> on Thursday rejected media reports that <keyword id="9485939" type="General" weightage="100" keywordseo="covaxin" source="Orion">Covaxin</keyword> manufacturer <keyword id="149108" type="General" weightage="80" keywordseo="bharat-biotech" source="Orion">Bharat Biotech</keyword> skipped certain processes and accelerated clinical trials due to political pressure, calling them "completely misleading, fallacious and ill-informed". "The government of India and the national regulator Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="80" keywordseo="cdsco" source="Orion">CDSCO</keyword>) have followed a scientific approach and prescribed norms in approving the Covid-19 vaccines for emergency use authorization," the Ministry said. The media reports had claimed that Bharat Biotech, manufacturer of the indigenous Covaxin, "had to skip certain processes" and "speed" up clinical trials due to political pressure. They also alleged that there were several irregularities in the three phases of the clinical trials. The Ministry said that the Subject Expert Committee (<keyword id="6362470" type="General" weightage="80" keywordseo="sec" source="Orion">SEC</keyword>) of CDSCO met on January 1-2, 2021 and after due deliberations, made the recommendations in respect of the proposal for Restricted Emergency Approval of the vaccine. "Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains," it added. The SEC's approval for the commencement of phase 3 clinical trial of the proposed dose of Covaxin was based on scientific data and established practices in this regard. "Moreover, the purported unscientific changes' in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI." The Ministry added that based on the further submission made by Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of the vaccine in 'clinical trial mode' was removed on March 11, 2021. "Authorisation of Covid-19 vaccines, including Covaxin, for restricted use in an emergency situation with various conditions and restrictions was granted by the national regulator only on the recommendations of the SEC. "The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, and internal medicine," it added. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/novel-artificial-enzymes-could-help-kill-covid-virus-study/articleshow/95575741.cms">Novel artificial enzymes could help 'kill' Covid virus: Study</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/eating-disorders-can-be-detected-earlier-using-electrolytes-as-diagnostic-tool/articleshow/95573008.cms">Eating disorders can be detected earlier using electrolytes as diagnostic tool</a>

Health Ministry rejects claim 'Covaxin was rushed due to political pressure'

All the manufacturing activities at the Indian Pharma company, Marion Biotech Pvt Ltd, have been stopped following allegations by Uzbekistan that at least 18 children died in the country after consuming the medicine. The manufacturing activities have been stopped after the inspection by the Central Drugs Standard Control Organisation (<keyword id="6375144" type="General" weightage="80" keywordseo="cdsco" source="Orion">CDSCO</keyword>). A joint inspection of the manufacturer's Noida facility was carried out by the teams of the <keyword id="15923942" type="General" weightage="50" keywordseo="uttar-pradesh-drug-control-department" source="Orion">Uttar Pradesh Drug Control Department</keyword> and CDSCO. "Following inspection by @CDSCO_INDIA_INF team in view of reports of contamination in cough syrup Dok1 Max, all manufacturing activities of Marion Biotech at NOIDA unit have been stopped yesterday night, while further investigation is ongoing", said <keyword id="700200" type="General" weightage="50" keywordseo="union-health" source="Orion">Union Health</keyword> Minister <keyword id="2607815" type="General" weightage="80" keywordseo="mansukh-mandaviya" source="Orion">Mansukh Mandaviya</keyword> in a tweet on Friday. However, further investigation is in progress by government agencies. The samples of the cough syrup have been taken from the manufacturing premises and sent to the Regional Drugs Testing Laboratory (RDTL), <keyword id="6360078" type="General" weightage="80" keywordseo="chandigarh" source="Orion">Chandigarh</keyword> for testing. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/leaders-condole-death-of-pms-mother-recall-her-simplicity-high-values/articleshow/96616064.cms">Leaders condole death of PM's mother, recall her simplicity, high values</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/urgent-need-to-develop-antibiotics-for-newborns-say-global-experts/articleshow/96618564.cms">Urgent need to develop antibiotics for newborns say global experts</a>

Uzbekistan cough syrup issue: Manufacturing at Marion Biotech stopped after probe

<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>Maiden Pharmaceutical Limited is the manufacturer licensed by the state drug controller for the products under reference. </li><li>It is a practice that the importing country tests the products for quality before sanctioning their usage there.</li><li>Four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated.</li></ul> A probe has been initiated by India's drug regulator after the <keyword id="6366244" type="General" weightage="20" keywordseo="who" source="Orion">WHO</keyword> issued an alert saying cough syrups manufactured by an Indian firm could potentially be linked to the death of children in The <keyword id="162357" type="General" weightage="20" keywordseo="Gambia" source="Orion">Gambia</keyword>, official sources said. The World Health Organisation (WHO) on Wednesday warned that four "contaminated" and "substandard" cough syrups allegedly produced by <keyword id="15173890" type="General" weightage="20" keywordseo="Maiden-Pharmaceuticals-Limited" source="Orion">Maiden Pharmaceuticals Limited</keyword> based in Haryana's Sonepat could be the reason for the deaths in the West African nation. The sources said the exact "one-to-one causal relation of death" has neither been provided by the <keyword id="10118578" type="General" weightage="20" keywordseo="United-Nations-Health-Agency" source="Orion">United Nations Health Agency</keyword> nor the details of labels and products been shared by it with the <keyword id="170943" type="General" weightage="20" keywordseo="Central-Drugs-Standard-Control-Organisation" source="Orion">Central Drugs Standard Control Organisation</keyword> (CDSCO), enabling it to confirm the identity or source of the manufacturing of the products. "Based on available information, the CDSCO has already taken up an urgent investigation into the matter with regulatory authorities in Haryana. "While all required steps will be taken, as a robust regulatory authority, the WHO has been requested to share with CDSCO at the earliest the report on the establishment of a causal relation to the deaths with the medical products in question, photographs of labels/products etc," the sources said. According to the sources, the WHO had on September 29 informed the Drugs Controller General of India that it was providing technical assistance and advice to The Gambia. It had highlighted that a significant contributing factor to the deaths was suspected to be the use of medicines which may have been contaminated with Diethylene Glycol/Ethylene Glycol, and said its presence had been confirmed in some of the samples it tested. The CDSCO said it responded to the WHO within an hour-and-a-half after receiving intimation, by taking up the matter with the state regulatory authority. A detailed investigation was launched to ascertain the facts and details into the matter in collaboration with Haryana State Drugs Controller, the source explained. From the preliminary inquiry, it has been made out that Maiden Pharmaceutical Limited is the manufacturer licensed by the state drug controller for the products under reference, and holds manufacturing permission for these products. "The company has manufactured and exported these products only to The Gambia so far," the source said. It is a practice that the importing country tests the products for quality before sanctioning their usage there. As per the tentative results received by WHO out of the 23 samples tested, four samples have been found to contain Diethylene Glycol/ Ethylene Glycol as indicated. It has also been informed by WHO that the certificate of analysis will be made available to it in near future and WHO will share it with India. "At the same time, the exact one-to-one causal relation of death has not yet been provided by WHO, nor have the details of labels/ products been shared by WHO with CDSCO enabling it to confirm the identity/ source of the manufacturing of the products," the official source stated. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/news/indias-service-sector-activity-falls-to-6-month-low-in-sep-amid-inflation-competition-pmi/articleshow/94675187.cms">India's service sector activity falls to 6-month low in Sep amid inflation, competition: PMI</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/taj-mahal-will-be-open-for-night-viewing-during-sharad-purnima-for-four-nights/articleshow/94672935.cms">Taj Mahal will be open for night viewing during 'Sharad Purnima' for four nights</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/news/rupee-falls-4-paise-to-81-66-against-us-dollar-in-early-trade/articleshow/94672726.cms">Rupee falls 4 paise to 81.66 against US dollar in early trade</a>

Indian drug regulator kicks off probe on cough syrup linked to deaths of Gambian children

The Central Drug Standard Control Organisation's (CDSCO)Subject Expert Committee has asked Dr Reddy's Laboratories to present additional data of immunogenicity while reviewing its <keyword id="6355821" type="UNKNOWN" weightage="20" keywordseo="application">application</keyword> for Emergency Use Authorisation (EUA) of Russian Covid vaccine <keyword id="9739267" type="PERSON" weightage="20" keywordseo="Sputnik-V">Sputnik V</keyword> in India, sources said. Dr Reddy's had applied for EUA before the CDSCO, and its application was reviewed by the SEC on Wednesday, a source told. Meanwhile, the committee has also asked Hyderabad-based <keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword> to submit efficacy data of <keyword id="9485939" type="LOCATION" weightage="20" keywordseo="covaxin">Covaxin</keyword> before seeking its <keyword id="42907" type="PERSON" weightage="20" keywordseo="trial">trial</keyword> on children. The firm had sought permission from the Drug Controller General of India to conduct vaccine's trial on the children. In September 2020, 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 the clinical trials of the Sputnik V and for its distribution rights in India. The vaccine is currently undergoing the Phase 3 clinical trial in India. SEE ALSO: <a href="https://www.businessinsider.in/defense/news/dassault-aviation-has-an-india-it-services-unit-offering-defence-msmes-a-digital-trial-room-where-they-can-test-their-products-to-bag-more-contracts/articleshow/81183313.cms">INTERVIEW: Dassault Aviation has an India IT services unit offering defence MSMEs a digital ‘trial room’ where they can test their products to bag more contracts</a> <a href="https://www.businessinsider.in/india/news/these-indian-states-now-require-you-to-carry-a-covid-19-negative-test-report-for-entry-after-rising-coronavirus-cases/slidelist/81185478.cms">These Indian states now require you to carry a COVID-19 negative test report for entry</a> <a href="https://www.businessinsider.in/stock-market/news/vested-finance-ceo-shares-his-guide-to-us-stock-investing-for-indians/articleshow/81185944.cms">Vested Finance CEO shares his guide to US stock investing for Indians</a> <a href="https://www.businessinsider.in/careers/news/global-consulting-firm-zs-says-it-plans-to-hire-3000-employees-in-india-this-year/articleshow/81188160.cms">Global consulting firm ZS says it plans to hire 3000 employees in India this year</a>

India's drug regulator asks Dr Reddy's for more data, as it reviews emergency use of Covid-19 vaccine Sputnik V

Indian Pharma company <keyword id="15908017" type="General" weightage="100" keywordseo="marion-biotech" source="Orion">Marion Biotech</keyword> Pvt Ltd has halted the production of cough syrup following allegations by Uzbekistan that at least 18 children died in the country after consuming the medicine. A joint inspection of the manufacturer's Noida facility was carried out by the teams of the Uttar Pradesh Drug Control Department and CDSCO. The Central Drugs Standard Control Organisation (CDSCO) is in contact with the national drug regulator of Uzbekistan regarding the matter. "Immediately on receipt of the information, joint inspection of the NOIDA facility of the manufacturer, Marion Biotech, was carried out by UP Drug Control and CDSCO team and further action as appropriate would be initiated based on the inspection report," said the Union health ministry on Thursday. The samples of the cough syrup have been taken from the manufacturing premises and sent to Regional Drugs Testing Laboratory (RDTL), Chandigarh for testing. Meanwhile, Marion Biotech Pharma company has said that it has sent samples of the said cough syrup for testing and has also halted the production of the product. Hasan, the Legal Head of Marion Biotech, expressed grief over the deaths on behalf of the company and said that an inquiry into the matter was being conducted by the government. He added that samples were collected and action would be taken on the basis of the report. Marion Biotech is a licensed manufacturer and holds a license for manufacturing Dok1 <keyword id="26842" type="General" weightage="50" keywordseo="max" source="Orion">Max</keyword> syrup and <keyword id="50839" type="General" weightage="50" keywordseo="tablet" source="Orion">Tablet</keyword> for export purposes granted by <keyword id="282629" type="General" weightage="50" keywordseo="drugs-controller" source="Orion">Drugs Controller</keyword>, Uttar Pradesh. Uzbekistan's health ministry, on Tuesday, said that 18 children suffering from an acute respiratory disease died after taking excessive doses of cough syrup Dok 1 Max, manufactured by Marion Biotech. Experts say that cough syrups sometimes contain "unacceptable levels" of Di<keyword id="7488410" type="General" weightage="50" keywordseo="ethylene-glycol" source="Orion">ethylene Glycol</keyword> and Ethylene Glycol. The syrup becomes harmful if there is even a slight difference in their quantity. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/science/health/news/urgent-need-to-develop-antibiotics-for-newborns-say-global-experts/articleshow/96592721.cms">Urgent need to develop antibiotics for newborns say global experts</a> <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/india/news/nirmala-sitharaman-discharged-from-aiims/articleshow/96598659.cms">Nirmala Sitharaman discharged from AIIMS</a>

Indian drugmaker Marion Biotech halts manufacture of cough syrup, probe underway

<keyword id="242973" type="General" weightage="20" keywordseo="serum-institute" source="Orion">Serum Institute</keyword> of India (<keyword id="52604" type="General" weightage="20" keywordseo="sii" source="Orion">SII</keyword>) CEO <keyword id="201929" type="General" weightage="20" keywordseo="adar-poonawala" source="Orion">Adar Poonawala</keyword> on Friday said it has applied to Indian authorities for full market authorisation of <keyword id="9617748" type="General" weightage="100" keywordseo="covishield" source="Orion">Covishield</keyword>, stating supplies of the COVID-19 vaccine have exceeded 125 crore doses. SII had partnered with the developer of Covishield, AstraZeneca, for the supply of the vaccine to the Indian government, which had in January this year granted emergency use authorisation in the country. "Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (<keyword id="172241" type="General" weightage="20" keywordseo="dcgi" source="Orion">DCGI</keyword>) and @MoHFW_INDIA for this permission," Poonawala said in a tweet tagging the Central Drugs Standard Control Organisation (CDSCO) and <keyword id="191419" type="General" weightage="20" keywordseo="ministry-of-health-and-family-welfare" source="Orion">Ministry of Health and Family Welfare</keyword>. SEE ALSO: <a target="_blank" class="c-link c-message_attachment__title_link" href="https://www.businessinsider.in/business/auto/news/tech-mahindra-buys-us-based-allyis-india-green-investments-for-125-million/articleshow/88611295.cms">Tech Mahindra buys US-based Allyis India, Green Investments for $125 million</a>

Serum Institute applies to Indian authorities for full market authorisation of Covishield

<keyword id="149108" type="PERSON" weightage="20" keywordseo="Bharat-Biotech">Bharat Biotech</keyword>'s COVID-19 vaccine <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword> was on Tuesday recommended by an expert panel for <keyword id="6393270" type="UNKNOWN" weightage="20" keywordseo="phase">phase</keyword> II/III <keyword id="122283" type="PERSON" weightage="20" keywordseo="Clinical-trial">clinical trial</keyword> on those aged between two to 18 years, official sources said. The trial will take place in 525 subjects at various sites, including <keyword id="40458" type="COMPANY" weightage="20" keywordseo="AIIMS">AIIMS</keyword>, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur. The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (<keyword id="6375144" type="COMPANY" weightage="20" keywordseo="cdsco">CDSCO</keyword>) on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years. "After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source said. Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol. Covaxin, indigenously developed by Bharat Biotech in collaboration with the <keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>n Council of Medical Research (ICMR), is being used in adults in India's ongoing COVID-19 vaccination drive. SEE ALSO: <a href="https://www.businessinsider.in/tech/apps/news/whatsapp-responds-to-privacy-criticism-by-alleging-other-apps-like-zomato-ola-aarogya-setu-zoom-google-and-other-apps/articleshow/82570897.cms">WhatsApp responds to privacy criticism by alleging that other apps and tech companies also show disdain for user privacy</a> <a href="https://www.businessinsider.in/business/telecom/news/vodafone-idea-adds-subscribers-for-the-first-time-in-15-months/articleshow/82568343.cms">Vodafone Idea shares up by 10% as it adds subscribers for the first time in 15 months – Airtel, Reliance Jio expand their user base</a>

Bharat Biotech's COVAXIN reportedly recommended by expert panel for phase 2 and 3 clinical trials on 2-18 year-olds

<keyword id="3658" type="LOCATION" weightage="20" keywordseo="India">India</keyword>'s drug regulator may soon grant restricted emergency use authorisation for <keyword id="4912868" type="PERSON" weightage="20" keywordseo="moderna">Moderna</keyword>'s <keyword id="8904563" type="UNKNOWN" weightage="20" keywordseo="covid-19-vaccine">COVID-19 vaccine</keyword>, official sources said on Tuesday. In a separate communication, Moderna has informed that the US has agreed to donate a certain number of doses of its COVID-19 vaccine through COVAX to the Government of India for use here and has sought approval from the Central Drugs Standard Control Organisation (CDSCO), while <keyword id="6357157" type="COMPANY" weightage="20" keywordseo="cipla">Cipla</keyword>, on behalf of the US pharma major, has requested for import and marketing authorization of these jabs. According to the sources, an approval is likely anytime as the CDSCO is in favour of granting permission to Cipla for import of Moderna's COVID-19 vaccine for restricted emergency use in India considering the pandemic situation in the country and in public interest. Cipla filed an application on Monday seeking permission for import of Moderna's COVID-19 vaccine referring to DCGI notices dated April 15 and June 1 as per which if the vaccine is approved by the <keyword id="44669" type="COMPANY" weightage="20" keywordseo="USFDA">USFDA</keyword> for EUA, the vaccine can be granted marketing authorisation without bridging trial and assessment of safety data of first 100 beneficiaries of vaccines shall be submitted before rolling out in immunization programme. Also, the requirement of testing of every batch by the Central Drugs Laboratory (CDL), Kasauli can be exempted if the batch/lot is released by the CDL of country of origin. However, summary lot protocol review and scrutiny of documents shall be undertaken by the laboratory for batch release as per standard procedures, Cipla said referring to the DCGI's new revised rules. Moderna through a separate communication has informed that the <keyword id="48028" type="COMPANY" weightage="20" keywordseo="US-government">US Government</keyword> has agreed to donate a certain number of doses of the <keyword id="9708420" type="UNKNOWN" weightage="20" keywordseo="moderna-covid-19-vaccine">Moderna COVID-19 Vaccine</keyword>, mRNA-1273, through COVAX to the Government of India for use in India and has submitted the dossiers through e-mail. "This correspondence is to request the CDSCO to open a file for approval of these urgently needed vaccines," Moderna said. In a bid to expedite the roll out of vaccines, the DCGI on June 1 decided to waive off testing of batches at CDL for foreign-manufactured vaccines that have been approved by international drug regulators such as the US FDA, the UK's MHRA or the WHO. The Centre had in April issued detailed guidelines and proactively eased entry of foreign made COVID-19 vaccines approved by the US FDA, EMA, UK's MHRA and Japan's PMDA, and WHO's Emergency Use Listing into India. According to the guidelines, these vaccines will not need to undergo prior bridging trials. The provision was further amended to waive off the trial requirement altogether for the well-established vaccines manufactured in other countries.

COVID-19: India's drug regulator may soon give restricted emergency use authorisation to American vaccine Moderna

An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of <keyword id="44612" type="COMPANY" weightage="20" keywordseo="Pfizer">Pfizer</keyword>, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 <keyword id="24209" type="PERSON" weightage="20" keywordseo="vaccine">vaccine</keyword> candidates, official sources said on Monday night. The decision was taken late on Monday evening after the Hyderabad-based Bharat Biotech became the <keyword id="10394896" type="UNKNOWN" weightage="20" keywordseo="third-pharmaceutical-firm">third pharmaceutical firm</keyword> to apply to the Drugs Controller General of India (DCGI) for emergency use authorisation for its indigenously developed COVID-19 vaccine <keyword id="9485939" type="PERSON" weightage="20" keywordseo="covaxin">Covaxin</keyword>. The Indian arm of US pharmaceutical giant Pfizer had on December 4 sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain. The Pune-based Serum Institute of India sought such a nod for the Oxford COVID-19 vaccine, <keyword id="9617748" type="COMPANY" weightage="20" keywordseo="covishield">Covishield</keyword>, on December 6. "DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said. At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks. SEE ALSO: <a href="https://www.businessinsider.in/science/health/news/oxford-covid-19-vaccine-serum-institute-seeks-emergency-use-nod-for-covishield-vaccine-in-india/articleshow/79600349.cms" data-type="tilCustomLink">Oxford COVID-19 vaccine: Serum Institute seeks emergency use nod for Covishield vaccine in India</a> <a href="https://www.businessinsider.in/india/news/section-144-extended-across-noida-and-greater-noida-till-january-2/articleshow/79600323.cms" data-type="tilCustomLink">Section 144 extended across Noida and Greater Noida till January 2</a>

COVID-19 vaccine in India: Expert panel to review Pfizer, Serum and Bharat Biotech's emergency use application tomorrow

New Delhi, Feb 11 () The quantity of raw materials imported for the formulation of antibiotic medicines was reduced to 11,230.50 metric tonne in 2019, as the government has undertaken various steps to promote the production in the country, the Lok Sabha was informed on Tuesday.As per the information received from the port offices of the Central Drugs Standard Control Organisation (CDSCO), it stood at 12,006.11 metric tonne (MT) for 2018 and 5,591.44 MT in 2017, Minister of Chemicals &amp; Fertilizers D V Sadananda Gowda said in a reply in the House."The policies formulated by Government from time to time are designed to minimize country's dependence on imports and to give fillip to indigenous manufacturing," he added.In this direction, the government has withdrawn exemption of customs duty on certain categories of bulk drugs/ APIs, which are used in the manufacturing of some of the antibiotics, to provide a level-playing field to domestic manufacturers, Gowda said.The Department of Pharmaceuticals has formulated a scheme, namely 'Assistance to bulk drug industry for common facility centre', for providing assistance to bulk drug segment in any upcoming bulk drug park promoted by state governments/ state corporations, he added."An inter-ministerial task force was also constituted under the chairmanship of the Minister of State of Chemicals and Fertilizers on April 18, 2018 to formulate a roadmap for enhanced production of active pharmaceutical ingredients (APIs) in the country," Gowda said.Ministry of health and family welfare and CDSCO have also various measures to encourage indigenous manufacturing of drugs, he added. AKT BAL

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