Business Medical Dialogues
    • facebook
    • twitter
    Login Register
    • facebook
    • twitter
    Login Register
    • Medical Dialogues
    • Speciality Dialogues
    • Education Dialogues
    • Medical Jobs
    • Medical Matrimony
    • MD Brand Connect
    Business Medical Dialogues
    • News
        • Financial Results
        • Hospitals & Diagnostics
        • IT / Health Venture
        • Implants / Devices
        • Insurance
        • Key Movement
        • Pharmaceuticals
        • Policy
        • Technology
        • pharma-news
    • blog
    LoginRegister
    Business Medical Dialogues
    LoginRegister
    • Home
    • News
      • Financial Results
      • Hospitals & Diagnostics
      • IT / Health Venture
      • Implants / Devices
      • Insurance
      • Key Movement
      • Pharmaceuticals
      • Policy
      • Technology
      • pharma-news
    • blog
    • Home
    • News
    • pharma-news
    • CDSCO issues...

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

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2020-03-21T12:00:30+05:30  |  Updated On 21 March 2020 12:00 PM IST
    CDSCO issues clarification on the requirement of process validation report for permission to conduct Clinical trial/BA-BE studies

    New Delhi: Through a recent notice Central Drugs Standard Control Organization (CDSC0), Directorate General of Health Services has clarified the requirement for process validation report for permission to conduct Clinical trial/BA-BE studies.

    The notice for the same was issued by Dr V G Somani, Drugs Controller General (India) (DCGI) to all the stakeholders.

    Under the New Drugs and Clinical Trials Rules, 2019, CDSCO grants permission for import/manufacture of new drugs for sale and distribution.BA/BE study are mandatory to be submitted by pharma companies to the CDSCO for its approval.

    Bioavailability (BA) refers to the relative amount of drug from an administered dosage from which enters the systemic circulation and the rate at which the drug appears in the systemic circulation.

    Bioequivalence (BE) of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.

    Concerns have been raised regarding the requirement of process validation report for permission to conduct clinical trial/BA-BE studies.

    In this regard, the notice mentioned that data to be submitted along with the application to conduct clinical trials or import or manufacture of new drugs (new molecule) for sale in the country are specified in Table 1 of Second Schedule of New Drugs and Clinical Trials Rules, 2019.

    As per the said table when the application is for clinical trials only, the international non-proprietary name (INN) or generic name, drug category, dosage form and data supporting stability in the intended container-closure system for the duration of the clinical trial (information covered in item numbers 2.1, 2.3, 2.6, 2.7 of the table) are required.

    " Process validation as required for commercial batches may not be required for Phase I, Phase II studies, However, the proof of process standardization may be required. Further, for the phase III clinical trial batches, the requirements of the process validation though may not be required as per commercial batches, however, it will vary depending on the complexity of the product ( biological, high tech etc)," the DCGI clarified.

    For full details click on the link given below:

    https://business.medicaldialogues.in/pdf_upload/pdf_upload-125586.pdf


    cdscodcgidr-vg-somaniba/be study

    Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2020 Minerva Medical Treatment Pvt Ltd

    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

      Show Full Article
      Next Story
      Similar Posts
      NO DATA FOUND

      Popular Stories

      • Email: info@medicaldialogues.in
      • Phone: 011 - 4372 0751

      Website Last Updated On : 13 Oct 2022 5:14 AM GMT
      Company
      • About Us
      • Contact Us
      • Our Team
      • Reach our Editor
      • Feedback
      • Submit Article
      Ads & Legal
      • Advertise
      • Advertise Policy
      • Terms and Conditions
      • Privacy Policy
      • Editorial Policy
      • Comments Policy
      • Disclamier
      Medical Dialogues is health news portal designed to update medical and healthcare professionals but does not limit/block other interested parties from accessing our general health content. The health content on Medical Dialogues and its subdomains is created and/or edited by our expert team, that includes doctors, healthcare researchers and scientific writers, who review all medical information to keep them in line with the latest evidence-based medical information and accepted health guidelines by established medical organisations of the world.

      Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement or prescription.Use of this site is subject to our terms of use, privacy policy, advertisement policy. You can check out disclaimers here. © 2025 Minerva Medical Treatment Pvt Ltd

      © 2025 - Medical Dialogues. All Rights Reserved.
      Powered By: Hocalwire
      X
      We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok