Set up a new regulator for medical devices

GS paper 2

Syllabus: Issues related to the development of the social sector involving healthcare etc

 

Directions: Go through it once.

Source: The Hindu

Context:

• • • The Central Drugs Standard Control Organization (CDSCO) is falling short in effectively regulating the medical devices industry, observed the Department-related Parliamentary Standing Committee on Health.
    • Therefore, it recommended a new regulator for Medical Devices in the country

 Report:

• • • Committee presented Report on the subject “Medical Devices: Regulations and Control” to Rajya Sabha.

 

Key Recommendations:

• • • New regulators: 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.
    • Other recommendations:
      • More certified medical devices testing laboratories
      • Robust IT enabled feedback driven post-market surveillance system
      • Medical device registry, particularly for implants

 Measures suggested by the committee:

• • • Having adequate common infrastructure including accredited laboratories: For standard testing in various regions of the country.
      • It would significantly encourage local manufacturers to get their products tested for standards
    • Reducing the cost of production: which ultimately will improve the availability and affordability of medical devices in the domestic market.
    • 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.

Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers in March this year released an Approach Paper for the Draft National Policy for the Medical Devices, 2022.

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

Also, a few months back, Drug, Medical Devices, and Cosmetics Bill-2022’ which separately defines medical devices and regulates online pharma was put for public comments.

Related news: National Medical Devices Promotion Council  (which takes up important issues of the MedTech Industry) was reconstituted recently. It comes under the Department of Pharmaceuticals.

 

Insta Links:

Regulation of medical devices

 

Mains Links:

Q. How is the Government of India protecting traditional knowledge of medicine from patenting by pharmaceutical companies? (UPSC 2019)

 

Prelims Links:

Drugs and Cosmetic Act, 1940

Medical professional board