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
    • Editors Pick
    • CDSCO expert committee...

    CDSCO expert committee suggests ban of yet another 324 FDCs

    Meghna A SinghaniaWritten by Meghna A Singhania Published On 2019-04-15T11:49:55+05:30  |  Updated On 16 Aug 2021 3:05 PM IST

    New Delhi: Domestic drugmakers are likely to face a blow as 324 Fixed Dose Combination (FDCs) drugs have been recommended to be banned by an expert panel under the Central Drugs Standard Control Organization (CDSCO). Probing the efficacy of the FDCs, the committee has found the FDCs "irrational" and has suggested that the manufacture and marketing of the same should be prohibited in India.


    The proposal came to light following the submission of the assessment report by the Kokate Committee to the Drugs Technical Advisory Board (DTAB), the highest decision-making body on technical matters related to drugs, on 2 April.


    The Committee was headed by Prof. C. K. Kokate, Former Vice-Chancellor, KLE University, Belgaum, Karnataka for examining the Safety and Efficacy of unapproved FDCs which were licensed by State Licensing Authorities without due approval of DCGI.


    The Committee examined 418 applications of FDCs and found 324 FDCs as irrational while only 28 FDCs as rational. The panel further said that they require more data for two FDCs and 4 FDCs require further deliberation. It was also observed that out of the remaining 60 FDCs, 48 FDCs have already been prohibited, 11 have been declared rational and one FDC is sub judice.


    Also Read: HC reserves verdict on pleas against ban on 344 FDC drugs


    The Committee in its report said, "these FDCs wherever recommended as "irrational (category 'a')" should not be allowed for their continued manufacturing and marketing in the country. The FDCs which have been declared as irrational needs to be prohibited under the Drugs and Cosmetics Act, 1940 as other safer alternatives to those combinations are available."


    The report of the Kokate Committee has been placed before the DTAB for deliberation.


    To evaluate the report, the DTAB has also constituted a sub-committee of eight members under the chairmanship of Dr Nilima Kshirsagar, chair of clinical pharmacology at the Indian Council of Medical Research.


    Besides the chairperson, the sub-committee members include dr T V Narayana, President, IPA, Bengaluru; Dr. Sandeep Bavdekar, Former Prof. Head Pediatrics, T.N Medical College & BYL Nair Ch. Hospital, Mumbai; Dr. Nirmala Rege, Former Prof. & HOD Pharmacology Seth G S Medical College & KEM Hospital, Mumbai; Dr. R.N.Tandon, Immediate Past Honorary Secretary General, IMA, New Delhi; Dr. B. Gupta, Professor & Head, Dept. of Medicine, NDMC Medical College & Hindu Rao Hospital, New Delhi; Shri H.Mahapatra, Former Drugs Controller, Odisha, Shri. Sanjeev Kumar Convener DDC(I), CDSCO (HQ), New Delhi.


    Prior to this, in December 2018, the Government had banned 328 FDCs after. The Drugs Technical Advisory Board (DTAB ) in public interest had recommended that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Therefore, the only prohibition under Section 26A is recommended."





    Also Read: FDC Ban: Avoid These Combinations of Paracetamol


    Fixed-dose combination(FDC), includes two or more active pharmaceutical ingredients (APIs) combined in a single dosage form, which is manufactured and distributed in fixed doses.





    CDSCOCentral Drugs Standard Control OrganizationCiplacombination drugsDrugs Technical Advisory BoardDTABFDCFDC banfdc drugFDCsFixed Dose Combinationfixed dose combinationsPfizerSanofiSun Pharmatherapeutic justification

    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

    Meghna A Singhania
    Meghna A Singhania

      Meghna A Singhania is the founder and Editor-in-Chief at Medical Dialogues. An Economics graduate from Delhi University and a post graduate from London School of Economics and Political Science, her key research interest lies in health economics, and policy making in health and medical sector in the country. She can be contacted at editorial@medicaldialogues.in. Contact no. 011-43720751

      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