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Press Release

FICCI launches Self-Regulatory Code of Conduct for e-Diagnostics sector in the interest of consumers

May 07, 2022

NEW DELHI, 07 May 2022: The Federation of Indian Chambers of Commerce and Industry (FICCI) announced the launch of Self-Regulatory Code of Conduct for e-Diagnostics in India yesterday through a virtual event. The code of conduct was launched in the esteemed presence of Ms Manmeet K Nanda, Joint Secretary, Department for Promotion of Industry and Internal Trade, Government of India. The virtual event was also attended by representatives of health-tech companies, start-ups, non-profits, public -policy scholars, and media professionals.   

Self-Regulatory Code of Conduct for e-Diagnostics - prepared after several rounds of industry consultations by FICCI's e-Pharmacy working Group aims to ensure adherence to the highest professional standards while delivering quality e-Diagnostic services till last mile in a safe and compliant manner.  

In recent times, the country has seen rapid strengthening of the healthcare network, active participation from all the concerned stakeholders with adequate handholding driven by optimistic policy making with programs like Ayushman Bharat Digital Mission (ABDM). This model fits well with the 'Ayushman Bharat Digital Mission' and 'Atmanirbhar Bharat Abhiyaan' and encompasses the vision of 'Digital India'. 

Tech-enabled platforms are playing a significant role in enhancing access to quality healthcare services including diagnostic services by bringing these services to the doorstep furthering the patient centric approach and at home care. The also provide for tracking and traceability of the services aimed to be provisioned from over their platforms. 

To ensure standardization of services along with quality maintenance the industry has taken a welcome step to adhere to the FICCI Self-Regulatory Code of Conduct for e-Diagnostics. FICCI believes that the industry submitting itself to self-regulation, would achieve the dual purpose of structured growth and consumer protection.   

Some of the key components of the Code of Conduct includes: 

  • Responsibilities of the Technology Platform listing Medical Laboratories 

Members shall provide details of the laboratories on behalf of which they are listing services and various test details to support informed decision making by the consumer. It also covers procedure for evaluation and selection criteria before listing laboratories 

  • Requirements for Safe Sample Collection and Transportation 

    In addition to adherence to all exiting norms of safe sample collection and transportation, members shall put in place a regular training program for phlebotomists, ensure traceability of samples, and provisions to handle urgent requests 
  • Requirements for Clinical Sample Processing & Reporting 

    Members shall ensure that a physical medical laboratory processes the sample within the stipulated time frame and generates the report. In addition to the standards of reporting, the report shall mention the identification of the laboratory and requester, and date and time of sample collection, sample receipt, report generation 
  • Requirements for Report delivery to consumer 

    Reports of the user shall be provided in a secured manner within the committed time frame and members shall put systems in place to monitor TAT and act on any breach 
  • Customer grievances 

    Members must ensure that there is a proper mechanism in place to address any queries or grievances the end user may have. Members should also be registered with the National Consumer helpline  
  • Adherence to applicable regulatory requirements and technical specifications 

    Members shall adhere to all regulatory norms, standards, and guidelines applicable in their respective State(s) of operations, process the data as per the applicable laws, and meet required technical specifications of the equipment used 
  • Public Health Initiatives of Government of India 

Members shall support Government's various public health initiatives coming into effect from time to time. 

Speaking on occasion, Ms Manmeet K Nanda, Joint Secretary, Department for Promotion of Industry and Internal Trade, congratulated the industry for launching the Self-Regulatory Code of Conduct for e-Diagnostics in India. She further invited the industry for input to address any compliance issues with respect to ease of doing business.    

"Industry members can sit with the FICCI and identify specific issues they face in terms of compliance and how these could be simplified", she said, adding, "we will be happy to take in your input in this regard".   

Speaking on occasion, Mr Tanmay Saksena, Chief Operating Officer, TATA 1mg, averred that the technological value chain in the healthcare sector helps save costs and ensures zero disruption in the care rendered to the patients, especially those with limited mobility, elderly and bedridden.   

He said that FICCI's group of progressive Health-Tech platforms have come up with a Self-Regulatory Code of Conduct for e-Diagnostics and added that "we look forward to productive engagement with the regulators to strengthen healthcare access in the country further", he said.  

Dr. Prashant Nag, Assistant Vice President, TATA 1mg said "Technology is the key answer towards the goal of developing affordable, accessible, and quality diagnostics value chain. India having a huge demographic dividend has operational labs with figures around one lakh; approx. 40 labs per million population which is a bit constrained as compared to developed economies with approx. 400 labs per one million population. Technology plays an important role here in improving access by bridging the gap between the patient and quality diagnostic infrastructure." 

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