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  • AstraZeneca Pharma India gets DCGI nod to import, market Selumetinib capsules Sep 27, 2021 08:24 AM IST

    AstraZeneca Pharma India gets DCGI nod to import, market Selumetinib capsules

    The company has received the import and market permission in Form CT-20 from the Drugs Controller General of India for Selumetinib 10 mg & 25 mg capsules, AstraZeneca Pharma India said in a regulatory filing.

  • Mixing of vaccines | Studies initiated, need more scientific data for clarity, says Dept of Biotechnology Secy Sep 14, 2021 10:03 PM IST

    Mixing of vaccines | Studies initiated, need more scientific data for clarity, says Dept of Biotechnology Secy

    On August 11, the Drug Controller General of India issued its nod to the Christian Medical College in Vellore to conduct the trials on mixing of Covishield and Covaxin vaccines.

  • Biological E's COVID-19 vaccine Corbevax gets DCGI's approval for two clinical trials: Govt Sep 03, 2021 03:44 PM IST

    Biological E's COVID-19 vaccine Corbevax gets DCGI's approval for two clinical trials: Govt

    It also received approval for the Phase 2/3 study to evaluate the “safety, reactogenicity, tolerability and immunogenicity” of Corbevax in children and adolescents.

  • Sanofi, GSK get approval to conduct phase 3 trial of COVID-19 vaccine in India Jul 09, 2021 09:00 AM IST

    Sanofi, GSK get approval to conduct phase 3 trial of COVID-19 vaccine in India

    In a two-stage approach, the phase 3 clinical study will initially investigate the efficacy of the COVID-19 vaccine formulation targeting the original novel coronavirus strain.

  • 2-DG | DRDO shares directions to administer the drug to COVID-19 patients Jun 01, 2021 04:45 PM IST

    2-DG | DRDO shares directions to administer the drug to COVID-19 patients

    DRDO stated that the medicine can be given to Covid patients under the care and prescription of doctors.

  • Zydus gets DCGI nod for emergency use of 'Virafin' in treating moderate COVID-19 cases Apr 23, 2021 03:17 PM IST

    Zydus gets DCGI nod for emergency use of 'Virafin' in treating moderate COVID-19 cases

    The company has claimed that 91.15 percent of COVID-19 patients treated with Virafin were RT-PCR negative by day 7.

  • Bharat Biotech ties up with CSIR-IICT to locally make vaccine raw materials Mar 29, 2021 09:14 PM IST

    Bharat Biotech ties up with CSIR-IICT to locally make vaccine raw materials

    Bharat Biotech signed a master collaborative agreement with Biovet and Sapigen Biologix. Under the agreement all the firms would provide necessary financial support to CSIR-IICT for developing key raw materials.

  • COVID-19 vaccine | Patanjali’s Coronil GMP certification doesn’t guarantee efficacy in coronavirus cure: Centre Feb 22, 2021 09:27 PM IST

    COVID-19 vaccine | Patanjali’s Coronil GMP certification doesn’t guarantee efficacy in coronavirus cure: Centre

    Baba Ramdev-promoted company launched the medicine at an event where Dr Harsh Vardhan and Nitin Gadkari were present. WHO issued a clarification stating that no traditional medicine for COVID-19 had been reviewed or certified.

  • Pfizer says ‘engaging with government’, compiling answers to DCGI queries on vaccine: Report Jan 12, 2021 09:09 AM IST

    Pfizer says ‘engaging with government’, compiling answers to DCGI queries on vaccine: Report

    Pfizer failed to present before the Subject Expert Committee (SEC) on vaccines in India on three occasions

  • Bharat Biotech to begin Phase-1 trials of its intranasal vaccine for COVID-19 in February-March Jan 08, 2021 11:28 AM IST

    Bharat Biotech to begin Phase-1 trials of its intranasal vaccine for COVID-19 in February-March

    Besides Covaxin, Bharat Biotech has been actively working on developing another vaccine, for which it tied up with Washington University School of Medicine in St Louis for the novel "chimp-adenovirus" (Chimpanzee adenovirus), a single dose in tranasal vaccine for COVID-19.

  • DCGI grants Bharat Biotech permission to conduct vaccine trials on children above 12: Report Jan 04, 2021 05:10 PM IST

    DCGI grants Bharat Biotech permission to conduct vaccine trials on children above 12: Report

    The Hyderabad-based firm is conducting Phase III trials. Covaxin is yet to complete late-stage human clinical trials in India.

  • Zydus Cadila gets DCGI nod to initiate Phase-3 clinical trials for COVID-19 vaccine Jan 03, 2021 05:46 PM IST

    Zydus Cadila gets DCGI nod to initiate Phase-3 clinical trials for COVID-19 vaccine

    The company will now be initiating Phase III clinical trial in around 30,000 volunteers, Zydus Cadila said in a statement.

  • Congress leaders raise concern over grant of permission for restricted use of COVID-19 vaccine Jan 03, 2021 12:54 PM IST

    Congress leaders raise concern over grant of permission for restricted use of COVID-19 vaccine

    India's drugs regulator DCGI on Sunday approved Oxford's COVID-19 vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use.

  • AstraZeneca Pharma gets DCGI nod to market asthma drug Dec 21, 2020 11:16 AM IST

    AstraZeneca Pharma gets DCGI nod to market asthma drug

    AstraZeneca Pharma said the receipt of this permission paves way for the launch of Benralizumab (Fasenra) in India, subject to the receipt of related statutory approvals and licenses.

  • India reviewing Pfizer’s emergency use application, detailed plans in place for vaccination programme: Health Minister Harsh Vardhan Dec 21, 2020 11:00 AM IST

    India reviewing Pfizer’s emergency use application, detailed plans in place for vaccination programme: Health Minister Harsh Vardhan

    Emphasising “atmanirbharta” or self-reliance, the minister said India’s focus is on developing an indigenous vaccine, adding that our vaccine manufacturing capacities “are not less than anyone.”

  • COVID-19 update | Gennova's indigenous mRNA vaccine HGCO19 gets nod for Phase I, II human trials Dec 11, 2020 07:30 PM IST

    COVID-19 update | Gennova's indigenous mRNA vaccine HGCO19 gets nod for Phase I, II human trials

    The firm has received conditional permission for Phases 1 and 2 human clinical trials. The subject expert committee has reviewed its proposal before giving the conditional nod.

  • COVID-19 update | DCGI finds no link between vaccine shot and 'adverse' reaction in Chennai volunteer during trial: Report Dec 02, 2020 10:12 PM IST

    COVID-19 update | DCGI finds no link between vaccine shot and 'adverse' reaction in Chennai volunteer during trial: Report

    ICMR Director General Dr Balram Bhargava had on Tuesday said adverse events do occur with drugs or vaccines or any other health intervention.

  • COVID-19 treatment | DGCI rejects Dr Reddy’s application for full market authorisation for remdesivir: Report Nov 03, 2020 09:28 AM IST

    COVID-19 treatment | DGCI rejects Dr Reddy’s application for full market authorisation for remdesivir: Report

    Dr Reddy’s proposal comes after the USFDA granted remdesivir full regulatory status – making it the first COVID-19 drug to receive full approval

  • Coronavirus update | Feluda COVID-19 test expected to be released in few weeks, says Harsh Vardhan Oct 12, 2020 09:02 AM IST

    Coronavirus update | Feluda COVID-19 test expected to be released in few weeks, says Harsh Vardhan

    The Feluda paper strip test for SARS-CoV-2 diagnosis has been developed by CSIR-IGIB and was earlier approved by the Drug Controller General of India for a commercial launch.

  • DCGI orders Serum Institute of India to suspend recruitment for Oxford COVID-19 vaccine trials Sep 12, 2020 01:01 PM IST

    DCGI orders Serum Institute of India to suspend recruitment for Oxford COVID-19 vaccine trials

    DCGI Dr V G Somani on Friday also directed Serum Institute of India (SII) to increase the safety monitoring of the subjects already vaccinated as part of the trial, and submit the plan and report.

  • DCGI asks Serum Institute to revise protocol for phase 2, 3 trials of Oxford COVID-19 vaccine Jul 30, 2020 08:10 AM IST

    DCGI asks Serum Institute to revise protocol for phase 2, 3 trials of Oxford COVID-19 vaccine

    The Serum Institute of India had submitted its application to the DCGI on July 24, seeking permission for conducting the phase 2 and 3 trials of the potential vaccine 'Covidshield'.

  • Human clinical trial of COVID-19 vaccine 'Covaxin' begins at Odisha hospital Jul 27, 2020 07:25 PM IST

    Human clinical trial of COVID-19 vaccine 'Covaxin' begins at Odisha hospital

    The much-awaited trial of BBV152 COVID-19 vaccine or Covaxin commenced at the Institute of Medical Sciences and SUM Hospital, one of the 12 centres selected by Indian Council of Medical Research (ICMR) for conducting phase one and two of the process, the official at the facility said.

  • Biophore India gets DCGI nod to manufacture COVID-19 drug Favipiravir Jul 14, 2020 01:45 PM IST

    Biophore India gets DCGI nod to manufacture COVID-19 drug Favipiravir

    Besides DCGI's nod to produce the active pharmaceutical ingredient in India, it has been cleared for exports as well.

  • COVID-19 treatment | Drug regulator warns of black marketing as Remdesivir sells for Rs 60,000 Jul 08, 2020 12:52 PM IST

    COVID-19 treatment | Drug regulator warns of black marketing as Remdesivir sells for Rs 60,000

    Remdesivir with MRP of Rs 5,400 is reportedly being sold for even Rs 60,000 with medical shops telling customers the drug is in short supply and can be made available at an inflated price.

  • AstraZeneca's Dapagliflozin gets DCGI nod for treatment of heart failure patients Jul 04, 2020 07:00 PM IST

    AstraZeneca's Dapagliflozin gets DCGI nod for treatment of heart failure patients

    The company has received import and market permission from DCGI in Form CT-20 (Marketing Authorisation- Additional Indication).

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