Health Sector – UHC, National Health Policy, Family Planning, Health Insurance, etc.

Diagnostic sector requires Regulations

Note4Students

From UPSC perspective, the following things are important :

Mains level: Health Sector;

Why in the News?

India has around 3,00,000 diagnostic labs, and the number is increasing. However, the sector is largely unregulated, scattered, and concentrated in urban areas.

What is the significance of India’s Diagnostics Sector?

  • Market Size and Growth: The Indian diagnostics market was valued at approximately US$13 billion in 2023 and is projected to reach US$25 billion by FY28. It is expected to grow at a CAGR of around 14%. Some projections estimate the market could reach US$40 billion by 2034.
  • Essential Component of Healthcare: Diagnostics play a crucial role in disease prevention, early detection, and effective management, making them an essential part of modern healthcare. Doctor recommendations drive a major part of the diagnostic business, with tests being conducted for most patients before prescribing medication.
  • Key Market Segments: The sector is primarily divided into pathology (60%) and radiology (40%). Pathology is further broken down into illness (acute and chronic) and wellness segments.
  • Drivers of Growth: Several factors contribute to the sector’s growth, including increasing life expectancy, a growing middle class, higher penetration of government insurance schemes, rising income levels, and increasing awareness of preventive testing. An aging population and the rise in chronic diseases also fuel the demand for diagnostic services.

What are the challenges faced by the Diagnostics Sector?

  • Urban-Rural Divide: A significant portion of diagnostics revenue (76%) comes from urban areas, even though 70% of India’s population resides in rural areas.
  • Disparities in Infrastructure: Rural areas have fewer healthcare facilities, with only about 36.5% of the total hospital beds, leading to delayed treatments and poorer health outcomes
  • Regulatory Issues: The Kerala State Clinical Establishments Act faces resistance due to stringent space (300 sq. ft. in rural areas, 500-700 sq. ft. in urban areas) and educational requirements, making compliance unviable for many small labs.
  • Standardization Needs: Lack of uniform testing protocols leads to errors. Example: A government lab in Karnataka reported a platelet count of 0.47 lakh/cmm, but a private lab retest showed 2.2 lakh/cmm, highlighting the need for mandatory NABL accreditation and standard SOPs to ensure diagnostic accuracy.
  • Infrastructure Gaps in Public Sector: Lack of essential upgrades in government labs (e.g., Osmania and Gandhi Hospitals in Hyderabad). Limited operational hours and unavailability of specialists in government hospitals force patients to private facilities.

What are the present Regulations implemented by the govt for this Sector?

  • Clinical Establishments Act, 2010: This act aims to regulate diagnostic centers but has been adopted by only 12 states and Union Territories, leading to inconsistent regulations across the country.  
  • Medical Devices Rules, 2017: These rules govern medical devices, an integral part of the diagnostics framework, focusing on manufacturing, import, sale, distribution, and quality and safety control. They provide risk-based categorization, establish product standards, and set timelines for obtaining licenses.
  • State-Specific Regulations: Some states like Karnataka and Kerala have separate regulatory frameworks, but enforcement remains inconsistent. Tamil Nadu’s Clinical Establishments (Regulations) Rules, 2018, mandate minimum space requirements for labs.
  • Pricing Regulations for Government-Led Diagnostic Schemes: Limits test costs to reduce out-of-pocket expenses for patients. Example: Telangana’s T-Diagnostics Programme has conducted 18.10 crore tests at subsidized rates, saving ₹1,100 crore for patients.
  • Mandatory Quality Control & External Audits: Enforces periodic inspections to maintain test accuracy. Example: Karnataka’s KPME Act mandates SOPs for sample collection, testing, and reporting, with penalties for non-compliance.

 

Way forward: 

  • Expand Rural Diagnostic Infrastructure: Strengthen public-private partnerships (PPPs) to enhance diagnostic services in rural areas, improve affordability, and ensure equitable access through mobile labs and telemedicine integration.
  • Enforce Uniform Regulatory Standards: Implement a nationwide mandatory NABL accreditation and standard operating procedures (SOPs) for all diagnostic centers to ensure quality, accuracy, and compliance across states.

Mains PYQ:

Q What do you understand by nanotechnology and how is it helping in health sector? (UPSC IAS/2020)

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