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    Tag: DCGI

    You Searched For "dcgi"
    With DCGI Nod in hand, Roche launches Breast Cancer Drug Atezolizumab in India

    With DCGI Nod in hand, Roche launches Breast Cancer Drug Atezolizumab in India

    Medical Dialogues Bureau9 April 2020 12:30 PM IST
    New Delhi: Drug firm Roche India on Wednesday said it has launched immunotherapy drug Atezolizumab for the treatment of metastatic triple-negative...
    Coronavirus Outbreak: Govt to grant licence to industrial manufacturers to produce oxygen for medical use

    Coronavirus Outbreak: Govt to grant licence to industrial manufacturers to produce oxygen for medical use

    Medical Dialogues Bureau8 April 2020 10:00 AM IST
    New Delhi: The Drug Controller General of India (DCGI) has decided to grant a licence to manufacturers of industrial oxygen to produce oxygen for...
    BAN on export of anti-malarial drug hydroxycloroquine with immediate effect: Govt

    BAN on export of anti-malarial drug hydroxycloroquine with immediate effect: Govt

    Medical Dialogues Bureau26 March 2020 12:27 PM IST
    "The export of hydroxycloroquine and formulations made from hydroxycloroquine is prohibited with immediate effect".
    CDSCO issues regulatory pathway for R&D of IVD kit for diagnosis of COVID-19

    CDSCO issues regulatory pathway for R&D of IVD kit for diagnosis of COVID-19

    Medical Dialogues Bureau24 March 2020 11:45 AM IST
    Delhi: Through the recent notice Central Drugs Standard Control Organization(CDSCO), Directorate General of Health Services as apprised about the...
    CDSCO to fast-track applications, issues regulatory pathway for R & D of drugs for COVID-19

    CDSCO to fast-track applications, issues regulatory pathway for R & D of drugs for COVID-19

    Medical Dialogues Bureau22 March 2020 12:15 PM IST
    Delhi: Through a recent notice Central Drugs Standard Control Organization(CDSCO) , Directorate General of Health Services has released the regulatory...
    CDSCO issues clarification on the requirement of process validation report for permission to conduct Clinical trial/BA-BE studies

    CDSCO issues clarification on the requirement of process validation report for permission to conduct Clinical trial/BA-BE studies

    Medical Dialogues Bureau21 March 2020 12:00 PM IST
    New Delhi: Through a recent notice Central Drugs Standard Control Organization (CDSC0), Directorate General of Health Services has clarified the...
    Roche Diagnostics India first private firm to get COVID-19 test approval

    Roche Diagnostics India first private firm to get COVID-19 test approval

    Medical Dialogues Bureau20 March 2020 10:00 AM IST
    New Delhi: Roche Diagnostics India has received the license from the country's drug regulator DCGI for its ''Cobas SARS CoV-2'' diagnostic test kit,...
    CDSCO updates procedure for issuance of WHO GMP

    CDSCO updates procedure for issuance of WHO GMP

    Medical Dialogues Bureau15 March 2020 12:45 PM IST
    New Delhi: Through a recent notice Central Drugs Standard Control Organization (CDSC0), Directorate General of Health Services, has laid...
    AstraZeneca Pharma India gets DCGI nod for Calquence-Acalabrutinib 100mg capsules

    AstraZeneca Pharma India gets DCGI nod for Calquence-Acalabrutinib 100mg capsules

    Medical Dialogues Bureau14 March 2020 12:03 PM IST
    Acalabrutinib 100mg capsules are indicated for the treatment of patients with chronic lymphocytic leukaemia (CLL)/ small lymphocytic lymphoma (SLL).
    CDSCO updates FAQs Drugs & Clinical Trial Rules 2019

    CDSCO updates FAQs Drugs & Clinical Trial Rules 2019

    MD bureau10 March 2020 1:50 PM IST
    New Delhi: Aimed at promoting clinical research in the country. Union Health Ministry notified the Drugs and Clinical Trials Rules, 2019 in the month...
    Worlds first drug for treatment of Non-Cirrhotic NASH approved: Zydus

    World's first drug for treatment of Non-Cirrhotic NASH approved: Zydus

    Medical Dialogues Bureau6 March 2020 2:26 PM IST
    Saroglitazar is uniquely poised with its dual PPAR alpha and gamma properties – reducing the comorbidities (dyslipidemia, hypertriglyceridemia,...
    CDSCO pulls manufacturers for failing to submit application for category d FDCs; Details

    CDSCO pulls manufacturers for failing to submit application for category d FDCs; Details

    Farhat Nasim14 Feb 2020 12:31 PM IST
    New Delhi: Through a recent notification, the Central Drugs Standard Control Organization (CDSCO) has pulled up the Fixed-Dose Combination (FDCs)...
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