Brazil’s health regulator scraps Bharat Biotech’s EUA application of Covaxin

Brazil’s health regulator, ANVISA has scrapped Bharat Biotech’s application seeking emergency use authorisation (EUA) of Covaxin.

“The Collegiate Board of the National Health Surveillance Agency unanimously decided to close the process that dealt with the temporary authorization of emergency use, on an experimental basis, of the Covaxin vaccine,” it said in a statement.

It said that the process will be closed without evaluating the merits of the request for temporary authorization for emergency use, on an experimental basis, filed by the company Necessidade Comercialização de Medicamentos Ltda. on June 29 this year.

The move comes after Anvisa was informed by Bharat Biotech that it’s Brazilian partner-Necessidade no longer has authorization to represent them in Brazil.

Director Meiruze Freitas, rapporteur of the process, highlighted that “the disruption of the commercial relationship between the companies, as well as the decay of a fundamental requirement for the Authorization of Emergency Use, implies impediment to the maintenance and continuity of the evaluation of the request.

The directors thought that evaluating the application would imply a significant waste of the administration’s efforts and resources.

On Friday, Anvisa had suspended the clinical studies of the Covaxin vaccine in Brazil.

  • Related Posts

    • Pharma
    • July 24, 2025
    • 161 views
    Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram

    Natco Pharma shares slipped 2.5% to Rs 1,009 apiece on the BSE in Thursday’s trade after the company announced its plan to acquire a 35.75% stake in South Africa-based Adcock…

    • Pharma
    • July 22, 2025
    • 250 views
    DGFT Extends Deadline on Application for Export of Pharma Grade Sugar

    The Directorate General of Foreign Trade ( DGFT ) has notified an extension in the deadline for submitting applications for the export of Pharma Grade Sugar. This was communicated through Trade Notice…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram

    Natco Pharma shares dip over 2% after Rs 2,000-crore stake buy in South Africa’s Adcock Ingram

    10, 000 Km is just a Number for Intercontinental Tele Surgery by SSIMantra

    10, 000 Km is just a Number for Intercontinental Tele Surgery by SSIMantra

    DGFT Extends Deadline on Application for Export of Pharma Grade Sugar

    DGFT Extends Deadline on Application for Export of Pharma Grade Sugar

    Bihar Healthcare is poised to be embraced by Robotic Surgery Mantra

    Bihar Healthcare is poised to be embraced by Robotic Surgery Mantra