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Mahesh

16/09/22 04:42 AM IST

CDSCO falling short in effectively regulating the medical devices industry: Parliamentary panel

In News 
  • The Central Drugs Standard Control Organisation (CDSCO) is falling short in effectively regulating the medical devices industry.
  • Committee presented Report on the subject “Medical Devices: Regulations and Control” to Rajya Sabha.
Major recommendations 
  • New legislation should set up a new set of regulators at different levels for regulating the medical devices industry.
  • New regulator to involve institutions such as IISC, CSIR, DRDO and network of IITs to test medical devices for safety and efficacy.
  • Ministry to work in synergy with State governments to impart the necessary skills to the local medical device officers.
  • Mechanism to regularly designate State Medical personnel: Designate them as Medical Device/Medical Device Testing Officers so that the mandate of the legislation can be implemented effectively.
  • Department to start a Research Linked Incentive (RLI) Scheme: In Line with the PLI scheme.
  • The Department should facilitate academia-industry partnerships for undertaking research projects.
  • More certified medical devices testing laboratories
  • Robust IT enabled feedback driven post-market surveillance system
  • Medical device registry, particularly for implants
  • Need for developing a robust IT enabled feedback driven post-market surveillance system: For Medical Devices to evaluate the efficiency of specific Medical Devices.
  • Medical device registry: Particularly for implants should also be made to ensure traceability of patient who has received the implant in order to assess the performance of the implant
  • Single window clearing platform: For the application of the license for manufacturing, export, and import shall also integrate all these bodies involved in the regulation of medical devices.
Targets by 2047
  • Set up National Institutes of Medical Devices Education and Research (NIMERs) along the lines of the National Institute of Pharmaceutical Education & Research (NIPERs).
  • India will be the home & originator of 25 high-end futuristic technologies in MedTech (Medical Technology).
  • Will have a MedTech Industry of USD100-300 Bn size with 10-12% of Global Market Share
Source- The Hindu 

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