India’s Diagnostics Sector

Syllabus: GS3/ S&T

Context

• India’s diagnostics sector plays a crucial role in the healthcare industry, facilitating early disease detection and treatment planning. 
• The tragic case of Shankar Dhange, whose sister lost her life due to incorrect diagnostic test results, underscores the serious risks posed by inadequate regulation and oversight.

India’s Diagnostics Sector: Growth and Importance

• The diagnostics sector contributes 9% of the total healthcare industry and plays a crucial role in disease management and medical decision-making.
• The Indian diagnostics industry is expanding at a rapid pace, with an estimated value of ₹1,275 billion by 2028.
• There are approximately 300,000 labs across India, serving a growing population.
• The early disease detection  with the rise of digital health platforms and AI-driven diagnostics is shaping the future of medical testing in India.

Challenges Facing the Diagnostics Sector

• Weak Regulatory Oversight: Only 12 states and Union Territories have adopted the Clinical Establishments Act, leading to inconsistent regulations across the country.
  • No mandatory accreditation for labs, allowing many to operate without standardized quality control.
•  Shortage of Skilled Personnel: Lack of trained pathologists, microbiologists, and lab technicians affects diagnostic accuracy.
• Urban-Rural Divide: Only 24% of diagnostics revenue comes from rural areas, despite 70% of India’s population residing there.
  • Government-run labs lack proper infrastructure, funding, and trained staff.
• High Cost of Private Diagnostics: No standardized pricing for tests, leading to disparities in cost.
  • Private labs often charge exorbitant fees, making diagnostic services inaccessible to low-income groups.
  • Initiatives like Telangana’s ‘T-Diagnostics’ and Kerala’s ‘Aardram Mission’ aim to provide affordable diagnostics but face logistical challenges.
• Fraudulent Practices: Fake pathologists and unauthorized technicians are common, compromising patient safety.
  • Some labs use “bought signatures” of pathologists to issue reports without proper review.

Regulations of the Sector

• Clinical Establishments (Registration and Regulation) Act, 2010: Aims to regulate diagnostic centers and set minimum standards for services.
  • Adopted by only 12 states and Union Territories, with poor implementation.
• NABL Accreditation: The National Accreditation Board for Testing and Calibration Laboratories (NABL) provides voluntary accreditation.
  • Large diagnostic chains follow NABL guidelines, but many small labs operate without accreditation.
• State-Specific Regulations:Karnataka and Kerala have separate regulatory frameworks, but enforcement remains inconsistent.
  • Tamil Nadu’s new Clinical Establishments (Regulations) Rules, 2018, mandate minimum space requirements for labs.

Way Ahead: Reforming India’s Diagnostics Sector

• Strengthening Regulations and Compliance:Make NABL accreditation mandatory for all diagnostic centers.
  • Ensure uniform implementation of the Clinical Establishments Act across all states.
  • Establish a central regulatory body for consistent oversight.
• Expanding Workforce and Training Programs: Increase medical education seats and training programs for microbiologists, pathologists, and lab technicians.
  • Mandate regular upskilling and certification for lab technicians.
  • Set a cap on the number of labs a pathologist can be associated with to curb ghost pathologists.
• Eliminating Fraudulent Practices: Implement digital tracking of lab reports to prevent misuse of pathologists’ credentials.
  • Enforce strict penalties for ghost pathologists and unqualified technicians.
  • Conduct regular audits and surprise inspections to ensure compliance.
• Bridging the Urban-Rural Divide: Increase government investment in rural diagnostic centers.
  • Expand public-private partnerships (PPPs) to improve access to diagnostics in remote areas.
  • Extend successful state-funded diagnostic initiatives like ‘T-Diagnostics’ and ‘Aardram Mission’ to other regions.
• Standardizing Pricing and Quality Control: Introduce price caps for essential diagnostic tests.
  • Mandate Standard Operating Procedures (SOPs) for sample collection, testing, and reporting.
  • Enforce external and internal quality control measures.

Source: TH