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    • Govt still mulling to...

    Govt still mulling to bring medical devices under CDSCO: Minister tells parliament

    Farhat NasimWritten by Farhat Nasim Published On 2019-11-20T14:36:36+05:30  |  Updated On 20 Nov 2019 2:36 PM IST
    Govt still mulling to bring medical devices under CDSCO: Minister tells parliament

    New Delhi: The NITI Aayog has not rejected the proposal to bring medical devices under the Central Drugs Standard Control Organisation (CDSCO), the government informed Parliament on Tuesday. The CDSCO under the Ministry of Health regulates the safety, efficacy and quality of notified medical devices under the provisions of Drugs and Cosmetics Act, 1940 and Rules made thereunder.


    Responding to a question in the Rajya Sabha, Minister of State for Health Ashwini Choubey also said that no proposal has been approved regarding the establishment of a separate statutory body on the lines of the Food Safety and Standards Authority of India (FSSAI) for the regulation of medical devices.

    In order to bring all the non-notified medical devices under the regulation, the ministry has prepared a roadmap and published draft rule dated October 18.

    Further, a notice has been issued seeking the comments of the stakeholders on a proposal to notify all the medical devices under the sub-section (b) of section (3) of the Drugs and Cosmetics Act, 1940 to regulate them as per the provisions of the said Act and the Medical Devices Rules, 2017 framed thereunder, Choubey said.

    The Centre's response comes in the backdrop of the NITI Aayog proposing a new framework for regulating all locally-made and imported medical devices.

    Also Read: SOON, Up to Rs 1 crore penalty for unsafe medical device, Niti Ayog drafts bill


    The draft legislation, titled Medical Devices (Safety, Effectiveness and Innovation) Bill, 2019 proposes a separate regulator under the Directorate General of Health Services to monitor the medical devices sector.


    It also proposes a penalty of up to Rs 1 crore on the manufacturers or importers for faulty medical devices having adverse impacts on patients.


    It has suggested a jail term extending up to three years or fine up to Rs 50 lakh or both for placing a medical device in the market without a valid certificate of conformity, obtaining registration and without complying with conditions as may be specified under the proposed Act.

    Also, under the draft law, patients suffering from adverse effects of faulty medical devices and implants will soon be able to demand compensation from the manufacturer or the firm importing them.

    At present, there are no legal provisions to compensate patients facing health problems due to faulty implants or medical devices.

    Also Read: How to Rationalise trade margins in medical devices: NITI Ayog asks public for comments

    Ashwini ChoubeyCDSCOClinical Trialcompensationdrug regulationFSSAIHealth Ministermedical devicemedical device manufacturersmedical device regulationMedical DevicesMedical Devices Bill 2019Niti AyogRajya Sabha
    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

    Farhat Nasim
    Farhat Nasim

      Farhat Nasim joined Medical Dialogue an Editor for the Business Section in 2017. She Covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She is a graduate of St.Xavier’s College Ranchi. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751 To know about our editorial team click here

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