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Centre of excellence for biomedical instrumentation metrology for healthcare sector

Status: New

Lab/Organization
Name & address of the Laboratory/Organization CSIR - National Physical Laboratory (NPL)
Website address https://www.nplindia.org
Affiliated to which Department/Ministry Council of Scientific and Industrial Research (CSIR)
CSR Registration Number CSR00017422
Registration under 12A
Registration under 80G
Name of the CSR Nodal Dr Neeraj Bhanot
Contact information of CSR Nodal 011-45608350, neeraj.bhanot@nplindia.org
Principal Investigator Dr Rajesh, rajesh@nplindia.org
Co- Principal Investigator (Co-PI) Dr. Ved Varun Agrawal, vedvarun@nplindia.org
Project Detail
Objective on the basis of need

1. To establish and realise National Standards of measurements compatible to International standards in biomedical instrumentation through continuous research and development.

2. To provide Apex level calibration and dissemination of standards in the area of biomedical instruments as per ISO17025:2017 at one place.

3. Establishment of medical equipment standards in India

4. Calibration and testing

5. Research and development

6. To provide the above facility to various hospitals, clinical labs, industries, institutes and other stake holders.

7. Training on biomedical calibration and testing

8. Preparation of standard documents to be used by regulatory bodies such as care NABH, NABL , CENTRAL DRUGS STANDARD CONTROL ORGANIZATION (CDSCO) and BIS at National level.

9. Promote importance of standards in health care.

Executive summary of the proposed project (In 250 words)

In medical equipment market, the quality control becomes a challenging issue. We propose to create and maintain national standards in biomedical instrumentation with traceability to physical parameters and formulation of proper documentation with specific regulatory bodies to maintain the quality service in biomedical instrumentation. This will improve the revenue generation as the medical tourism is expected to increase when the quality control increases and the medical disputes in the country will reduce significantly which ultimately contribute to the cause of “Swasthya Bharat” mission immensely. Given such a huge market, and millions of instruments being used in hospitals setting for diagnosis, surgery, sterilization and many other purposes, it becomes imperative to ensure the proper functioning of those instruments. Calibrating Medical Instruments ensure their accuracy and precision. Thus such establishment of a ‘centre for testing and calibration of biomedical equipments’ would improve the health of public; support Indian industries to export their equipment with globally accepted norms, growth in medical tourism, job creation and revenue generation through above mentioned means. The major focus of the project proposal is to establish and develop the biomedical standards, at CSIR-NPL, for testing and calibration facilities pertaining to medical devices. The CSIR-National Physical Laboratory is the National Metrology Institute (NMI) of India and it is bestowed with the responsibility of providing apex level international traceability to measurements by the act of Indian Parliament. Currently, CSIR-NPL provides apex calibration of equipment to various industries, strategic, academia and government agencies. Such calibrations at CSIR-NPL are keys to drive the growth engine of industries and assume greater significance for the success of “Make in India” & “Swastha Bharat” missions. Accurate and precise measurements would also support Indian industry and business to innovate. CSIR-NPL is uniquely positioned to cater to emerging needs of calibration in medical devices because of the availability of relevant expertise and mandate of the laboratory.This will be a national facility for catering the national needs. Creation of such an apex level calibration facility will help in restricting the several unproven biomedical practices in healthcare sectors.

Technology Readiness Level (If not a new project but an advancement of existing know how) New Project
Outomes or Deliverables

1. Excellence, accountability and uniformity in medical facilities throughout the country.

2. Trust building on medical health-care industry, resulting in India as major hub in international market for medical tourism.

3. Restriction on non quality controlled equipments from grey market.

4. Such establishment would improve the health of public, support Indian industries to export their equipment with globally accepted norms, creation of jobs and startups.

5. Providing high quality control regulation through standardization of biomedical equipments in health sectors, which in turn would contribute to healthy, risk free and dispute free treatments to society.

Project aligned with which most relevant UN SDGs Goal 3 - Good Health & Well-Being
Duration (In years) 03 Years
Expected Impact

1. Excellence, accountability and uniformity in medical facilities throughout the country.

2. Trust building on medical health-care industry, resulting in India as major hub in international market for medical tourism.

3. Restriction on non quality controlled equipments from grey market.

4. Such establishment would improve the health of public, support Indian industries to export their equipment with globally accepted norms, creation of jobs and startups.

5. Providing high quality control regulation through standardization of biomedical equipments in health sectors, which in turn would contribute to healthy, risk free and dispute free treatments to society.

Implementation model (self- implemented/ outsourced partnership) Self-implemented
Total Budget (Recurring +Non-Recurring Expenses) Rs. 210 Lakhs