What ails India’s massive diagnostics sector: putting labs under the lens
(Source – The Hindu, International Edition – Page No. – 7)
| Topic: GS2 – Social Justice – Health |
| Context |
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Background and Problem in the Diagnostics Sector
- The diagnostics sector in India is facing a significant crisis due to the rapid expansion of medical laboratories and diagnostic facilities.
- There are approximately 300,000 labs across India, contributing to about 9% of the healthcare industry.
- This sector is estimated to be worth ₹860 billion in 2024 and projected to reach ₹1,275 billion by 2028.
- Despite this growth, the sector remains under-regulated, fragmented, and predominantly biased toward urban areas.
Regulatory Framework and Challenges
- The Clinical Establishments (Registration and Regulation) Act, 2010, aims to regulate diagnostic centers by ensuring registration and setting minimum standards.
- As of now, only 12 states and Union Territories, excluding Delhi, have adopted the Act. Some states like Kerala and Karnataka have their own regulations, but implementation has been poor.
- The sector remains fragmented with many small, unorganised labs that lack accreditation, leading to varying quality standards.
Shortage of Skilled Manpower
- A significant shortage of trained doctors and lab technicians affects the quality of services in diagnostic centers.
- Accredited labs are required to have full-time technicians, but many smaller labs cannot afford such staff, leading to unreliable results.
- Research shows a lack of microbiologists and trained personnel in some areas, exacerbating the problem.
Ghost Pathologists and Fraudulent Practices
- The shortage of qualified pathologists leads to practices where lab reports may be signed off by ghost pathologists or even by unqualified staff, sometimes in exchange for money.
- This is a widespread issue across many states, with “technician-only” labs being run by non-qualified personnel in some places.
Urban-Rural Divide
- A significant disparity exists in the availability of diagnostic facilities between urban and rural areas.
- Despite nearly 70% of the population living in rural areas, only 24% of diagnostics revenue comes from these regions.
- Government-run labs are under-equipped and have limited operational hours, forcing patients to rely on expensive private labs.
Pricing and Affordability
- The private diagnostics sector is also marked by high pricing, though government initiatives in states like Telangana and Kerala are addressing these issues.
- For example, Telangana’s ‘T-Diagnostics’ initiative has saved patients over ₹1,100 crore by providing affordable tests, but logistical challenges persist.
Problems Faced by Smaller Labs
- Many small labs face difficulties due to regulatory requirements regarding space and educational qualifications.
- In states like Kerala and Tamil Nadu, small labs struggle to meet the minimum standards required by law.
- Lab associations are asking for relaxed rules regarding space requirements and better training programs for technicians from outside the state.
Sector’s Desire for Standardization
- While the diagnostics sector is fragmented, there is a strong desire for better regulation and standardization.
- Associations are calling for stricter licensing and accreditation mandates, better supervision by qualified pathologists, and mandatory adherence to quality standards in testing, reporting, and sample collection.
Conclusion
- The diagnostics sector faces major challenges such as under-regulation, a shortage of qualified personnel, and widespread fraudulent practices.
- These issues directly impact patient health and safety by leading to inaccurate diagnoses and improper treatments.
| Practice Question: Unqualified personnel in the diagnostics sector can lead to inaccurate medical test results, affecting patient safety. Discuss the challenges in regulating private diagnostic labs in India and suggest measures to ensure quality control. (250 Words /15 marks) |
