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
    • Latest News
    • Licences of 10...

    Licences of 10 Liposomal Amphotericin B Injection Makers Suspended

    Written by savita thakur thakur Published On 2016-05-11T12:32:31+05:30  |  Updated On 18 Aug 2021 3:40 PM IST

    New Delhi : The manufacturing licences of 10 drug manufacturers in six states have been suspended, the government informed the Rajya Sabha.


    "The Central Drugs Standard Control Organisation (CDSCO) asked the State Licencing authorities concerned to suspend the manufacturing licences of 10 manufacturers of Liposomal Amphotericin B Injection on March 11, 2016," the Minister of State for Health and Family Welfare Shripad Yesso Naik said during Question Hour.


    He said the injection is used for treatment of systemic fungal infections and for Vesceral Leishmaniasis (Kala Azar) and the manufacturing licences of such drug makers have been stopped after an expert group of ICMR made recommendations to this effect.


    The Committee had also recommended that Liposomal Amphotericin injection marketed in India may be regulated under Section 26A of the Drugs and Cosmetics Act, 1940 and the manufacturers of the injection were asked to prove the quality, safety and efficacy of their products on the basis of scientific criteria suggested by Expert Committee.


    "We have not terminated their licence, but have asked the manufacturers to fulfil the conditions and then will restore their production. Directions have also been given to states to suspend licences of all such medicines till they fulfil the conditions," the Minister said.


    "Show cause notices were issued to all 10 manufacturers to reply within 3 weeks as to why the manufacturing licences issued to them for their products Liposomal Amphotericin injection should not be suspended.


    "Out of 10 manufacturers, 7 responded and it was found that their responses were not satisfactory to conclude that the products are safe and efficacious. Accordingly, state licencing authorities were requested to suspend manufacturing licences of all the ten manufacturers of the product in public interest," he said in his written reply.


    Asked how many states have implemented the orders, Naik said, out of six states, five states have suspended the licences as directed by the Expert Committee, while the report from Gujarat is yet to come.


    To a question on whether such medicines banned were being sold through CGHS dispensaries, the Minister said he will seek a report and asked the member if he had some information to share for action to be taken.


    In reply to another question on implementation of Cigarettes and other Tobacco Products Act (COP TA) prohibiting the sale/advertisements of smokeless products within 100 yards of schools, the Minister said states are implementing the law.


    "12 states, excluding Lakshwadeep, have implemented the law for displaying tobacco warnings on their products and states are implementing the law," he said.


    On surreptitious advertisements on chewing tobacco in TV, the Minister said the Centre will help implement the law properly.

    CDSCOCentral Drugs Standard Control OrganisationCigarettes and other Tobacco Products ActDrugs and Cosmetics ActICMRLicencesLiposomal Amphotericin BMinister of State for Health and Family Welfare Shripad Yesso Naiksuspended
    Source : PTI

    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

    savita thakur thakur
    savita thakur thakur
      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