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
    • AYUSH
    • No clinical trials...

    No clinical trials need for Ayurveda, Unani, Siddha Medicines: Government of India

    Written by Ruby Khatun Khatun Published On 2018-07-11T16:26:50+05:30  |  Updated On 11 July 2018 4:26 PM IST
    No clinical trials need for Ayurveda, Unani, Siddha Medicines: Government of India

    New Delhi: Through a recent notification, the Government of India has clarified that no clinical trials are required for issuing licenses patented or proprietary Ayurvedic, Siddha and Unani (ASU) products


    In a letter to All-State Licensing Authorities and Drug Controllers for ASU Drugs, Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), Under-Secretary, Ministry of AYUSH issued new directives to to issue licences for patented or proprietary Ayurvedic, Siddha and Unani (ASU) products without insisting on clinical trial or safety study reports.


    The step was taken after it has come to the notice of Central Government that the provisions of Rule 158-B of the Drugs & Cosmetics Rules, 1945 pertaining to the requirements for issue of manufacturing license for Ayurvedic, Siddha or Unani drugs are being interpreted differently and clinical trial reports are reported to be sought from the manufacturers particularly for Patent or Proprietary category of such medicines, resulting in inordinate delay in granting license or renewal of license.


    Providing clarification on the requirement of pilot study/clinical trial for the license of Ayurvedic, Siddha or Unani drugs under the provisions of Rule 158B of the Drugs and Cosmetics Rules, 1945 the ministry has issued a new directive and has advised all the State Licensing Authorities and Drug Controllers for ASU Drugs to comply that:




    1. The term 'clinical trial' as such is not mentioned in the context of ASU drugs-related provisions of Drugs & Cosmetics Rules, 1945. However, experience or evidence of effectiveness of the ASU drug based on textual rationale, published literature and pilot study is required in support of the claim of indication or use for issue of license in accordance with the provisions of Rule 158(b). Proof of effectiveness in the form of Pilot Study may be required for intended ASU drug, if the textual rationale, published literature and textual (authoritative book-based) indications are not furnished to support the claim of use or indication;

    2. there is no provision to designate, authorize or notify any particular institution or center for conducting such pilot studies on ASU drugs; and

    3. license applications for ASU drugs may accordingly be disposed of in a time bound manner within a period of three months provided under Rule 154 (i) of the Drugs & Cosmetics Rules, 1945.


    Below is the attachment of the same
    All-State Licensing AuthoritiesASU DrugsASU productsayurvedicAyushClinical Trialclinical trialsDrug controllersDrugs and Cosmetics RulesGovernment of IndiaMinistry of AyurvedaMinistry of AyushNo Clinical trialsproductsSiddhaUnani
    Source : with inputs

    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

    Ruby Khatun Khatun
    Ruby Khatun Khatun
      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