1194199

article-commentary2023
MLI0010.1177/09685332231194199Medical Law InternationalGupta and Nandraj

Case commentary

Medical Law International

Challenges and gaps

2023, Vol. 23(4) 351­–367
© The Author(s) 2023

in regulating medical Article reuse guidelines:

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DOI: 10.1177/09685332231194199
https://doi.org/10.1177/09685332231194199
journals.sagepub.com/home/mli

Pallavi Gupta and Sunil Nandraj

Health Systems Transformation Platform (HSTP), India

Abstract
Accurate diagnosis is an essential component of healthcare delivery. However, research on the
delivery of diagnostic services is lacking in low- and middle-income countries. This article examines
the issues related to the provision of medical laboratory services in India, including licencing,
geographic distribution, charging practices, quality, personnel requirements, information sharing,
and newer technologies that impact the sector. The challenges and gaps in regulatory mechanisms
governing these services are discussed, highlighting the need for improvements. Legislation to
regulate medical laboratories in many Indian states is either outdated or non-existent, with
some states recently updating or enacting their laws. A registry of medical laboratories in the
country will assist in assessing and meeting the shortfall. Universal adoption of external and inter-
laboratory quality control mechanisms will help in standardization and ensuring quality. Clarity
and consensus on who can operate medical laboratories and the responsibility of different cadres
of technical staff are required. The provision for making information on registered laboratories
publicly available under the Central and some state legislations can be very useful to the users
in choosing laboratories. Mandatory reporting to the government by both public- and private-
sector laboratories will help in maintaining data on disease burden and in planning health services.
However, the lack of data protection laws in the country creates the potential for violation of
the users’ privacy when laboratories store data digitally and report it online on government web
portals. Caution is warranted in the use of newer technologies until the regulations governing
these matters are strengthened. A combination of voluntary and statutory mechanisms such
as accreditation and regulation would be useful instruments for ensuring quality in diagnostic
services. Research on the effectiveness of existing provisions at the state level would help in
understanding their impact and suggest ways of further improvement.

Keywords
Diagnostic services, healthcare delivery, India, medical laboratories, regulation

Received 19 April 2023; Accepted 26 July 2023

Corresponding author:
Pallavi Gupta, Health Systems Transformation Platform (HSTP), C1 Block, Institute for Studies in Industrial
Development, Plot No. 4, Institutional Area, Phase II, Vasant Kunj, New Delhi 110070, India.
Email: [email protected]
352 Medical Law International 23(4)

Introduction
‘Test, Test, Test’ was the key message from the World Health Organization in March
2020 on the premise that trying to control the pandemic without accurate and timely test-
ing for COVID-19 infection would be like fighting a fire blindfolded.1 India increased its
testing capacity from 2,000 tests a day in March 20202 to almost 2 million tests a day in
May 2021.3 However, as the pandemic progressed, a number of issues emerged, such as
the non-availability of test kits, lack of trained staff, frequent changes in testing norms,
variable testing costs, lack of transparency, large-scale buying of test kits by the state –
without regulatory approval – and fake COVID-19 test reports.4 Testing in rural areas
was particularly inadequate due to a lack of test kits and laboratories.5 Although these
issues came to the fore in the context of the pandemic, many of them are not new to the
provision of diagnostic services in India.
A physical examination and symptomatic diagnosis may not always provide precise
information to make a prognosis and to guide treatment,6 thereby making diagnostic
investigations crucial. It is believed that 60%–70% of the clinical decisions are based on
diagnostic investigations,7 which can be divided into two categories: laboratory medi-
cine, which deals with the examination of body tissues and body fluids,8 and imaging
technology, which involves the use of techniques such as X-rays, magnetic resonance

1. World Health Organization, ‘WHO Director-General’s Opening Remarks at the Media Briefing on
COVID-19 - 16 March 2020’, available at https://www.who.int/director-general/speeches/detail/
who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---16-march-2020.
2. A. Saikia, ‘India’s Covid-19 Testing Is Falling Short – Again. How Big Is the
Problem?’, Scroll.In, 11 May 2021, available at https://scroll.in/article/994426/
indias-covid-19-testing-is-falling-short-again-how-big-is-the-problem
3. N. C. Sharma, ‘India Fails to Ramp Up Covid-19 Testing to Targeted 4.5-5 Million Per Day’,
Mint, 30 September 2021, available at https://www.livemint.com/news/india/india-fails-to-
ramp-up-covid-19-testing-to-targeted-4-5-5-million-per-day-11632946253796.html
4. M. Krishnan, ‘COVID: How Is India Tackling a Surge in Fake Test Reports?’, DW, 17 September
2021, available at https://p.dw.com/p/40SR7; S. Sharma, ‘Why Were Coronavirus Testing Kit
Approvals Hidden From Public View?’, Scroll.In, 7 April 2020, available at https://scroll.
in/article/958397/why-was-the-list-of-approved-zcoronavirus-testing-kits-kept-hidden-
from-public-view
5. A. Saikia, ‘As Coronavirus Reaches Rural India, Three Cases Reflect the Steep
Challenge Ahead’, Scroll.In, 5 April 2020, available at https://scroll.in/article/958151/
as-coronavirus-reaches-rural-india-three-cases-reflect-the-steep-challenge-ahead
6. F. A. Delwiche, ‘Mapping the Literature of Clinical Laboratory Science’, Journal of the
Medical Library Association 91(3) (2003), p. 303–310; M. L. Wilson, K. A. Fleming, M.
A. Kuti, L. M. Looi, N. Lago, and K. Ru, ‘Access to Pathology and Laboratory Medicine
Services: A Crucial Gap’, The Lancet 391(10133) (2018), pp. 1927–1938.
7. U. P. Rohr, C. Binder, T. Dieterle, F. Giusti, C. G. M. Messina, E. Toerien, H. Moch, and H.
H. Schäfer, ‘The Value of In Vitro Diagnostic Testing in Medical Practice: A Status Report’,
PLoS ONE 11(3) (2016), e0149856.
8. Allied Health Section, ‘Ministry of Health and Family Welfare, “Model Curriculum Handbook,
Medical Laboratory Science”’, Government of India (2015–2016), p. 162, available at https://
main.mohfw.gov.in/sites/default/files/Model%20Curriculum%20Handbook-Medical%20
lab%20sciences.pdf; M. L. Bayot, G. D. Brannan, P. Naidoo, Clinical Laboratory, StatPearls
[Internet]. Treasure Island (FL), (StatPearls Publishing LLC, 2022), available at https://www.
ncbi.nlm.nih.gov/books/NBK535358/
Gupta and Nandraj 353

imaging, and ultrasound to view the interior of the body not visible to the naked eye.9
The two categories differ in their requirements in terms of personnel, infrastructure,
equipment, and the regulations that govern them.
Research on the delivery of diagnostic services is scarce, compared with that on other
aspects of healthcare delivery in low and middle-income countries. The article discusses
the concerns related to medical laboratories in the context of healthcare delivery in India,
including the regulatory environment in which they operate.
The way medical laboratories in India provide services raises many concerns regard-
ing their licencing, geographic distribution, access, charging practices, quality, human
resources, information sharing, reporting, and the technologies used. How these con-
cerns affect service delivery and the pertinent regulations – with their strengths and inad-
equacies – is discussed below.

Licencing and registration

For 7 years in the city of Delhi, a ‘laboratory’ – operated by someone with a graduate
degree in the arts – continued to generate reports without testing the samples.10 A similar
‘laboratory’ in the same city produced 30,000 fake reports within 1 year.11 Many states in
India have had no entry barriers or minimum requirements to set up medical laboratories.
Given such a lack of regulation, the industry has flourished, recording rapid growth,12
along with the spread of several substandard and fake laboratories.
The Clinical Establishments (Registration and Regulation) Act, 2010 – hereafter
referred to as the CEA – was enacted by India’s central (federal) government to correct
this anomaly. The Act provides for the registration of state-run and private health facili-
ties, including medical laboratories,13 and prescribes minimum standards for regulating

9. T. Meštrović, ‘What Is Radiology?’, News Medical, 2018, available at https://www.news-

medical.net/health/What-is-Radiology.aspx#:~:text=. Radiology represents a branch of,in
radiology is called radiologist.
10. A. Bhardwaj, ‘Fake Path Lab Near AIIMS Forged Signs, Made Reports Out of Thin Air’,
Hindustan Times, 24 November 2015, available at https://www.hindustantimes.com/delhi/
fake-path-lab-near-aiims-forged-signs-made-reports-out-of-thin-air/story-pzCQFI0CZg-
GFQ0nUftWcbN.html
11. P. Yadav, ‘Kidnap Call Exposed Fake Path Lab’, The Times of India, 5 May 2018, available
at https://timesofindia.indiatimes.com/city/delhi/kidnap-call-exposed-fake-path-lab/article-
show/64035657.cms
12. K. Kahol, ‘India’s Diagnostics Industry: Opportunity or Challenge?’, CNBCTV18.Com,
17 June 2021, available at https://www.cnbctv18.com/healthcare/indias-diagnostics-indus-
try-opportunity-or-challenge-9694131.htm; NATHEALTH, ‘An Assessment of India’s
Laboratory Diagnostic Industry’, 2022, available at https://aspirecircle.org/wp-content/
uploads/2022/01/Diagnostic-report-HLTH.pdf
13. The CEA, 2010, section 2, c (ii) defines laboratories as places connected ‘with the diagnosis
or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical,
biological investigations or other diagnostic or investigative services with the aid of labora-
tory or other medical equipment, are usually carried on’. Medical laboratories run by India’s
armed forces are exempt.
354 Medical Law International 23(4)

Table 1. Regulation of clinical establishments in states and UTs: March 2023.

States and UTs where CEA, 2010, is States of Arunachal Pradesh, Himachal
applicable from its date of notification, Pradesh, Sikkim, Mizoram, and UTs of
namely, 1 March 2012 Andaman and Nicobar Islands; Dadra
and Nagar Haveli and Daman and Diu;
Lakshadweep; Chandigarh; Puducherry; Jammu
and Kashmir
States that adopted CEA, 2010 Assam, Bihar, Haryana, Jharkhand, Rajasthan,
Telangana, Uttarakhand, Uttar Pradesh
States or UTs that have enacted their States of Andhra Pradesh, Chhattisgarh, Goa,
own legislation Gujarat, Karnataka, Kerala, Madhya Pradesh,
Maharashtra, Manipur, Meghalaya, Nagaland,
Odisha, Punjab, Tamil Nadu, Tripura, and
West Bengal, and one UT, namely, Delhi

CEA: Clinical Establishments (Registration and Regulation) Act.

such entities. As can be seen in Table 1, the Act is in force in 12 states and 6 union ter-
ritories (UTs, which are administrative units typically smaller than a state).14 However,
the implementation of the Act has been sluggish.
Many states have neither adopted the CEA nor updated their own state legislation.
Legislation in Delhi and Maharashtra does not include laboratories within its ambit.15 A
similar situation prevailed in Gujarat, Kerala, and Punjab until recently.16 In Andhra
Pradesh, Karnataka, Madhya Pradesh, Manipur, Meghalaya, Nagaland, Odisha, and
West Bengal, the relevant regulations are applicable only to private laboratories: state-
run laboratories are exempt.17

14. Ministry of Health and Family Welfare, The CEA, 2010, Government of India. Available
at http://www.clinicalestablishments.gov.in/cms/Home.aspx; Gazette notification issued by
government of Telangana state, ‘G.O. Ms.No.64, Health, Medical & Family Welfare (D),14th
June, 2022’.
15. Delhi Nursing Homes Registration Act, 1953; Bombay Act No. XV of 1949 (Maharashtra
Nursing Homes Registration Act) as amended by Mah. 24 of 2012, s. 2, Sch, entry no. 36,
with effect from 1 May 1960.
16. Gujarat Clinical Establishments (Registration and Regulation) Act, 2021, replaced the Gujarat
Nursing Homes Registration Act, 1949; newly enacted Kerala Clinical Establishments
(Registration and Regulation) Act, 2018, and Punjab Clinical Establishments (Registration
and Regulation) Act, 2020.
17. Andhra Pradesh Allopathic Private Medical Care Establishments (Registration and
Regulation) Rules, 2007; Karnataka Private Medical Establishments (Amendment) Rules,
2018; Madhya Pradesh Upcharyagriha Tatha Rujopchar Sambandhi Sthapanaye (Registrikaran
Tatha Anugyapan) Rules, 1997; Manipur Nursing Home and Clinics Registration Act 1992;
Meghalaya Nursing Home (Licensing and Registration) Rules, 2010; Nagaland Health Care
Establishments Rules, 2002; Odisha Clinical Establishments (Control and Regulation) Rules,
2018; West Bengal Clinical Establishment (Registration, Regulation and Transparency),
Rules, 2017.
Gupta and Nandraj 355

Collection centres
Several laboratories rely on collection centres that operate on the franchise model to
achieve high business volumes and economies of scale.18 For instance, Metropolis
Healthcare and SRL Diagnostics (two among the top five diagnostic companies in revenue
terms), respectively, plan to add 1,800 and 1,500 collection centres through franchisees to
their existing 3,006 and 2,400 collection centres in the country.19 However, collection cen-
tres are regulated differently across states. For instance, Chhattisgarh and West Bengal
require the centres to be registered independently of the parent laboratory, whereas Goa
does not. Similarly, under the CEA, collection centres are part of the parent laboratory,
which is held responsible for their compliance with the minimum standards.20

Online health service aggregators and collection of

samples from home
Online health service aggregators21 act like franchisees without physical collection cen-
tres.22 However, they have no legal standing and public-interest litigation was filed in the
Delhi High Court in August 2020 to ban them.23 The Ministry of Health and Family
Welfare (MoHFW), Government of India (GoI), directed states in January 2021 to take
action against online aggregators that offer laboratory facilities.24 Nevertheless, they
continue to function, and concerns have been raised about the quality of their services.25

18. A. Vir, ‘The Business of Diagnostics and the Opportunity for Indian Startups’, Tigerfeathers,
2 October 2020, available at https://tigerfeathers.substack.com/p/the-business-of-diagnostics
-and-the.
19. V. Pilla, ‘Diagnostic Chain Metropolis Says Ramping Up Labs, Collection Centres’, The
Economic Times, 25 November 2021, available at https://economictimes.indiatimes.com/
industry/healthcare/biotech/healthcare/diagnostic-chain-metropolis-says-ramping-up-labs-
collection-centres/articleshow/87912061.cms?from=mdr; PTI, ‘SRL Diagnostics Allocates
Rs 300-500 cr to Expand Lab, Collection Centres Network’, BusinessToday.In, 5 September
2021, available at https://www.businesstoday.in/industry/pharma/story/srl-diagnostics-allo-
cates-rs-300-500-cr-to-expand-lab-collection-centres-network-305964-2021-09-05
20. Directorate General of Health Services (DGHS), Minutes of 11th Meeting of the National
Council for Clinical Establishments, 2018.
21. Technology platforms that facilitate collection of samples from users and transport them to
the collaborating laboratories.
22. N. R. Kumar, ‘Diagnostic Labs Aggregator Gearing for Launch’, The Hindu, 1 February 2016,
available at https://www.thehindu.com/business/diagnostic-labs-aggregator-gearing-for-
launch/article8179209.ece
23. S. Batra, ‘Ban Unregistered Online Health Service Aggregators From Collecting Samples:
PIL In Delhi HC’, Business World, 4 August 2020, available at https://www.businessworld.
in/article/Ban-unregistered-online-health-service-aggregators-from-collecting-samples-PIL-
in-Delhi-HC/04-08-2020-304819/
24. R. Bhushan, ‘Department of Health & Family Welfare Order No. D.O. No.-C.18018/12/
2020-MS dated 19 January 2021’, MoHFW, GoI (2021).
25. A. Mathew, ‘Unregulated Operations by Unscrupulous Online Health Service Aggregators
Pose Grave Risk to Public Health’, National Herald, 10 February 2022, available at https://
www.nationalheraldindia.com/india/unregulated-operations-by-unscrupulous-online-health-
service-aggregators-pose-grave-risk-to-public-health
356 Medical Law International 23(4)

Collection of samples from home is not explicitly mentioned in either the central or any
state legislation except in the West Bengal Rules that provide for it, in case the person is
‘unable or unwilling to attend the clinical establishment’.26

Distribution of and access to medical laboratories

A comprehensive database of medical laboratories in India is not available: different
sources provide different numbers and distribution across the country and are incomplete
(Table 2). Although the number of medical laboratories in India is estimated at 100,000,27
the largest available database, the National Health Resource Repository (NHRR)28 fea-
tures 38,738 entries, nearly one-third of the estimated number.29 The National Register
of Clinical Establishments maintained under the CEA does not specifically mention how
many of the registered 34,337 allopathic clinical establishments are medical laboratories
across the states and UTs in which the Act is in force.30 A third source is the National
Accreditation Board for Testing and Calibration Laboratories (NABL), which puts the
number at 2,374 nationally.31 A more recent database of laboratories that report COVID-
19 test results to the Indian Council of Medical Research (ICMR) lists 3,388
laboratories.32
It is estimated that 65%–75% of laboratory services are located in urban areas,33
although around 65% of the country’s population resides in rural areas.34 According to
the NHRR data, nearly 80% (33,829 out of 42,105) of the enumerated laboratories are in

26. West Bengal Clinical Establishment (Registration, Regulation and Transparency), Rules,
2017.
27. R. Kambli, ‘No Rules to the Game’, Express Healthcare, 10 August 2015, available at https://
www.expresshealthcare.in/lab-diagnostics/no-rules-to-the-game/116862/
28. A joint project of the Central Bureau of Health Intelligence, DGHS, MoHFW, and the National
Remote Sensing Centre, Indian Space Research Organisation, initiated in 2017.
29. MoHFW, NHRR, GoI, 2023, available at https://bhuvan-nhrr.nrsc.gov.in/nhrr/docs/state-
wise_he_report.pdf
30. MoHFW, National Register of Clinical Establishments, GoI, 2023, available at http://clinical
establishments.gov.in/AuthenticatedPages/cms/Views/national_register_of_clinical_estab-
lishments.aspx (accessed 12 March 2023).
31. NABL, ‘Directory of Accredited Medical Laboratories’, NABL 600 (2023).
32. ICMR, Total Operational (initiated independent testing) Laboratories reporting to ICMR,
2023, available at https://www.icmr.gov.in/pdf/covid/labs/archive/COVID_Testing_
Labs_07032023.pdf
33. R. RamPrakash and J. Arun, ‘Access to Diagnostic Services Through Health Insurance
Schemes: Lessons from a Southern Indian State for Post-COVID Era’, Journal of Health
Management 24(3) (2022), pp. 347–355; ReportLinker, ‘India Diagnostic Labs Market, By
Provider Type, By Test Type, By Sector, By End User, By Region, Competition Forecast
& Opportunities, 2027’, 2022, available at https://www.reportlinker.com/p06128276/
India-Diagnostic-Labs-Market-By-Provider-Type-By-Test-Type-By-Sector-By-End-User-
By-Region-Competition-Forecast-Opportunities-FY.html?utm_source=GNW; A. Misra,
‘Diagnostic Industry in India’, Digital First Magazine, 25 October 2021, available at https://
www.digitalfirstmagazine.com/diagnostic-industry-in-india/
34. World Bank, ‘Rural Population (% of Total Population) – India’, 2021, available at https://
data.worldbank.org/indicator/SP.RUR.TOTL.ZS?locations=IN
Gupta and Nandraj 357

Table 2. Distribution of medical laboratories in India, by state.

State or UT NHRR) National NABL- Laboratories

(as on 12 Register accredited reporting
March 2023) of Clinical medical COVID-19
(MoHFW, Establishments laboratories test results
NHRR, (Allopathy) (as (as on 28 to ICMR (as
2023) on 12 March February on 7 March
2023) (MoHFW, 2023) (NABL, 2023) (ICMR,
2023) 2023 2023)
Andaman and Nicobar (UT) 05 95 Not available 05
Andhra Pradesh 2,705 Not applicable 101 165
Arunachal Pradesh 42 287 03 27
Assam 457 6274 45 55
Bihar 3661 Not available 34 92
Chandigarh (UT) 98 699 09 13
Chhattisgarh 386 Not applicable 13 63
Dadra and Nagar Haveli (UT) 08 317 Not available 01
Daman and Diu (UT) 12 223 Not available Not available
Delhi 1,482 Not applicable 207 156
Goa 67 Not applicable 09 14
Gujarat 1,235 Not applicable 143 206
Haryana 1,071 1,818 94 92
Himachal Pradesh 343 5,343 01 37
Jammu and Kashmir 597 1,720 12 41
Jharkhand 610 11,247 24 57
Karnataka 1,236 Not applicable 185 238
Kerala 2,499 Not applicable 104 197
Lakshadweep (UT) 02 Not available Not available 10
Leh-Ladakh Not available Not available Not available 4
Madhya Pradesh 1,961 Not applicable 57 138
Maharashtra 5,956 Not applicable 325 363
Manipur 80 Not applicable 08 18
Meghalaya 13 Not applicable 04 22
Mizoram 27 18 03 14
Nagaland 34 Not applicable 02 15
Odisha 636 Not applicable 26 69
Puducherry (UT) 112 906 08 17
Punjab 2,573 Not applicable 54 80
Rajasthan 1,620 3175 80 88
Sikkim 24 Not available 02 04
Tamil Nadu 2,571 Not applicable 230 346
Telangana Not available Not available 161 161
Tripura 173 Not applicable 02 06
Uttar Pradesh 6,077 778 196 324
Uttarakhand 365 1,437 26 69
West Bengal Not available Not applicable 206 181
Total 38,738 34,337 2,374 3,388

MoHFW: Ministry of Health and Family Welfare; NHRR: National Health Resource Repository; NABL: Na-
tional Accreditation Board for Testing and Calibration Laboratories; ICMR: Indian Council of Medical Research.
358 Medical Law International 23(4)

urban areas with a few being in rural areas.35 Such disproportionate distribution limits
access and leads to a significant proportion of illnesses remaining undetected and
untreated.36
The large number of medical laboratories in urban areas leads to their excessive use.
The ‘preventive or wellness packages’ offered as routine health check-ups comprise
nearly 90 tests,37 many of which are not recommended by any guidelines and have lit-
tle impact on morbidity and mortality. Besides the unnecessary financial burdens on
customers and the waste of resources, such overuse may lead to over-diagnosis and
over-treatment. For instance, there is an increased diagnosis of small thyroid nodules,
which are otherwise harmless, but once detected are treated for papillary carcinoma.38
Another reason for overuse is greater reliance on laboratory results by clinicians to
reassure and protect themselves from legal liability.39

Quality and accuracy of results

Lack of standardization, with different laboratories adopting different standards, and
supplier-induced demand fuelling the industry,40 raises concerns regarding the reliability
of test results. Unqualified professionals, proxy signatories, and use of substandard
equipment, consumables, and reagents are some other reasons for the questionable qual-
ity of laboratory services.41 Such shortcomings can have serious consequences, such as
false positives (e.g., misdiagnosis of breast cancer or a life-threatening condition when

35. The NHRR database has internal inconsistency. However, it is the only source that gives
break-up of urban and rural services, available at https://bhuvan-nhrr.nrsc.gov.in/nhrr/
36. D. Barik and A. Thorat, ‘Issues of Unequal Access to Public Health in India’, Frontiers in Public
Health, 3 (2015), p. 245; V. Yellapa, N. Devadasan, A. Krumeich, N. Pant Pai, C. Vadnais, M.
Pai, and N. Engel, ‘How Patients Navigate the Diagnostic Ecosystem in a Fragmented Health
System: A Qualitative Study From India’, Global Health Action 10(1), (2017), p. 1350452.
37. Dr. Dangs Lab, ‘Towards Better Health -Test Packages’, available at https://www.drdangslab.
com/Packages.aspx; Dr. Lal PathLabs, ‘Test List’, 2018, available at https://www.lalpathlabs.
com/tests-list.aspx
38. S. Bhagwat and S. A. Pai, ‘Medical Ethics in Laboratory Medicine: A Review, With an Oath
for Pathologists’, Indian Journal of Medical Ethics 5(1), (2020), pp. 39–44; B. Honnekeri,
A. Vyas, D. Lokhandwala, A. Vaishnav, A. Vaishnav, M. Singhal, P. Barwad, G. K. Panicker,
and Y. Lokhandwala, ‘Routine Health Check-Ups: A Boon or a Burden?’, National Medical
Journal of India 29(1), (2016), pp. 18–21.
39. S. Dudeja and N. Dhirar, ‘Defensive Medicine: Sword of Damocles’, The National Medical
Journal of India 31(6), (2018), pp. 364–365.
40. Competition Commission of India, ‘Policy Note: Making Markets Work for Affordable
Healthcare’, 2018, available at https://cci.gov.in/public/events/All/details/33
41. Express News Service, ‘Diagnostic Reports “Have No Signature of Authorised Pathologist”;
Police Case Against Lab’, The Indian Express, 2 November 2018, available at https://indi-
anexpress.com/article/cities/mumbai/diagnostic-reports-have-no-signature-of-authorised-
pathologist-police-case-against-lab-5430262/#:~:text=In 2017%2C the Supreme Court,is
signed by a technician.&text=Pant Nagar police in Ghatkopar,signature o; Kambli, ‘No Rules
to the Game’.
Gupta and Nandraj 359

none exists) and false negatives (e.g., missed diagnosis of leukaemia).42 A couple in
Bangalore would have put the life of their newborn at risk had they not taken a repeat test
for thalassemia.43
The data on quality and accreditation of medical laboratories in India are inadequate.44
Accreditation, which involves periodic third-party audits, is a voluntary mechanism to
attain pre-defined standards that ensure the reliability of results.45 Participating in exter-
nal quality assurance schemes (EQAS)46, a measure of quality control, is mandatory for
accreditation by NABL.47 However, very few laboratories in India are thus accredited.48
During the COVID-19 pandemic, inter-laboratory quality control mechanism was used
by the ICMR to ensure the reliability of COVID-19 tests.49
The CEA makes it mandatory to adopt minimum standards for the calibration of
equipment and reagents and standard operating procedures. However, quality control
mechanisms such as EQAS and inter-laboratory comparison are listed as desirable rather
than essential.50 Some states such as Tamil Nadu51 and West Bengal prescribe more strin-
gent quality standards than the central Act, whereas others such as Delhi, Gujarat,
Madhya Pradesh, Maharashtra, Meghalaya, Nagaland, Odisha, and Punjab are less strict.

42. S. S. Dutta, ‘How Diagnostic Labs Are Failing Patients in India in Terms of Poor Standards’, The
New Indian Express, 2 March 2020, available at https://www.newindianexpress.com/thesunday-
standard/2020/mar/01/how-diagnostic-labs-are-failing-patients-in-india-in-terms-of-poor-
standards-2110382.html; P. Raju, ‘Illegal Path Labs: India’s Open Secret’, Express Healthcare,
30 July 2019, available at https://www.expresshealthcare.in/lab-diagnostics/illegal-path-labs-
indias-open-secret/413141/; A. S. Rozario, ‘Pathless Pathology: Why Delhi’s “Unethical”
Labs Love Lawlessness’, The Quint, 2 October 2019, available at https://www.thequint.com/
news/india/pathless-path-labs-why-delhis-unethical-labs-love-lawlessness#read-more
43. P. Kulkarni, ‘How to Deal With Faulty Test Reports From Medical Labs’, Citizen Matters, 25
February 2015, available at https://bengaluru.citizenmatters.in/how-to-deal-with-faulty-test-
reports-from-medical-labs-7170
44. Ministry of Finance, Economic Survey 2017-18 (GoI, 2018), II, p. 177.
45. The NABL, an autonomous body under the Quality Council of India, offers a voluntary
accreditation system for laboratories in accordance with the International Organization
for Standardization, ISO 15189:2012: Medical laboratories: Requirements for quality and
competence.
46. EQAS involves evaluation of laboratories by an outside agency based on their analytical
performance of tests on samples supplied by the external agency.
47. S. Yerram, D. V. Sripad, and V.S. Prabodh, ‘External Quality Assurance Scheme (EQAS):
Criteria for Evaluating Performance of a Laboratory’, IOSR Journal of Biotechnology and
Biochemistry 4 (4) (2018), pp. 16–20; NABL, ‘NABL 112: Specific Criteria for Accreditation
of Medical Laboratories’, Issue No. 4, Issue date: 11-Feb-2019 Amendment No. 01,
Amendment date: 26-Apr-2019.
48. NABL, ‘Directory of Accredited Medical Laboratories’, NABL 600 (2023).
49. H. Kaur, L. Mukhopadhyay, N. Gupta, N. Aggarwal, L. Sangal, V. Potdar, F. Y. Inbanathan, J.
Narayan, S. Gupta, S. Rana, N. Vijay, H. Singh, J. Kaur, V. Kumar, N. Kaundal, P. Abraham,
and V. Ravi, ‘External Quality Assessment of COVID-19 Real Time Reverse Transcription
PCR Laboratories in India’, PLoS ONE 17(2) (2022), p. e0263736.
50. Clinical Establishments (Central Government) Amendment Rules, 2018.
51. Tamil Nadu Clinical Establishments (Regulation) Rules, 2018.
360 Medical Law International 23(4)

In a national-level survey of 29,000 people, only 20% fully trusted the laboratories
they used, and 32% reported receiving one or more incorrect laboratory reports.52 The
health minister of Uttar Pradesh acknowledged that the state was unable to ensure quality
in over 90% of the laboratory services that were in the private sector.53

Human resources
Numerous cases have been reported from across the country in which unauthorized per-
sonnel generate reports, sometimes without performing the tests – a practice known as
‘sink tests’.54 The issue of who can operate medical laboratories is a grey area in several
states. Pathologists55 and laboratory technicians56 have been embroiled in a legal battle
claiming their authority to operate medical laboratories.57 A 2010 Gujarat High Court
ruling, upheld by a 2017 Supreme Court ruling, barred technicians from operating labo-
ratories independently and mandated them to work under the supervision of patholo-
gists.58 However, many laboratories that operate only with technicians circumvent this,
by ‘purchasing’ signatures from qualified professionals for INR 15,000–20,000 a month.
The signature of a pathologist employed with the government of Gujarat was used by
nine private laboratories.59
In states such as Tamil Nadu, West Bengal, and those where the CEA is in force,
requirements for personnel along with their minimum qualification are prescribed.
However, the regulations in Andhra Pradesh, Madhya Pradesh, Meghalaya, Nagaland,
and Odisha are ambiguous and inadequate in this regard. The Directorate of Medical
Education and Research in Maharashtra cited a shortage of qualified pathologists as the
reason to permit technicians to operate laboratories by themselves, particularly in rural

52. LocalCircles, ‘Majority Say a Corrupt Nexus Exists Between Many Pathology Labs and
Doctors’, LocalCircles, 22 November 2017, available at https://www.localcircles.com/a/
press/page/survey-corruption-in-pathology-labs#.Yq4GzXZBy5d
53. Dutta, ‘How Diagnostic Labs Are Failing Patients in India’.
54. C. Belagere, ‘Path Labs May Not Even Be Testing Your Blood Samples’, The New Indian
Express, 5 February 2020, available at https://www.newindianexpress.com/states/karna-
taka/2020/feb/05/path-labs-may-not-even-be-testing-your-blood-samples-2099100.html
55. Doctor of Medicine or Diplomate of the National Board in Pathology or related field or
MBBS with PhD in pathology or a related field.
56. Diploma or bachelor’s in science with specialization in medical laboratory technology or a
postgraduate in related fields.
57. S. J. Mukhopadhyay and K. M. Thaker, Association of Pathologist of Bhavnagar & 17 -
petitioner(s) vs Secretary Health Department and eight other respondent(s), High Court of
Gujarat judgement dated September 17, 2010 (Application No. 7999 of 1998, 2010).
58. TNN, ‘Technicians can’t run path labs, SC upholds HC order’, The Times of India, 31
December 2017, available at https://timesofindia.indiatimes.com/city/ahmedabad/techni-
cians-cant-run-path-labs-sc-upholds-hc-order/articleshow/62311382.cms
59. B. Yagnik, ‘Path Labs Run by Unqualified Persons’, The Times of India, 21 December 2021,
available at https://timesofindia.indiatimes.com/city/ahmedabad/despite-sc-order-pathology-
reports-being-generated-by-unqualified-persons/articleshow/88399102.cms
Gupta and Nandraj 361

areas.60 Taking cognisance of the short supply of pathologists,61 the CEA, in contrast to
the Supreme Court ruling, permitted those with an MSc or PhD in pathology or a related
field to sign the test reports with a mandatory disclaimer ‘reports are for the use of
medical practitioners and are not medical diagnoses as such’.62 However, a pathologist
filed a petition in the Delhi High Court seeking abrogation of these rules.63

Cost and charging practices

The cost of diagnostic investigations comprises a significant proportion of the total
healthcare cost, a reason why people may forego necessary investigations.64 In the
National Sample Survey 75th Round (2017/18), the average out-of-pocket expenditure
on diagnostics is reported to be 12.6% of the total healthcare cost for outpatient care.65 In
cases of hospitalization, the cost ranges from 9.5% in the private sector to 17.7% in the
public sector.66 There is little or no cost control on diagnostics in India. Although the
CEA prescribes the fixing of rates, none of the states or UTs where the Act is in force has
done so. In states such as Andhra Pradesh and Madhya Pradesh, charges must be dis-
closed to the registering authority and cannot be revised more than once a year. In
Meghalaya, the charges need to conform to the norms prescribed by the state govern-
ment. In addition to the provisions of the CEA, the legislation in some states such as
Karnataka, Kerala, and West Bengal mandate that the rates be publicly displayed.
However, the diagnostic industry has been pushing back the government’s attempt to
regulate charges and to bring in greater transparency. The industry contends that some
laboratories offer cheaper services by compromising on quality standards. That argu-
ment, however, does not explain the wide variation in costs of the same investigations by
different laboratories. For instance, an MRI scan can cost from INR 1,000 to INR 6,000,67

60. A. Warren, ‘Shortage of Registered Pathologists in India Continues to Put Patients at Risk in
Illegal Labs That Defy Bombay Court Orders’, Dark Daily, 12 April 2017, available at https://
www.darkdaily.com/2017/04/12/shortage-of-registered-pathologists-in-india-continues-to-
put-patients-at-risk-in-illegal-labs-that-defy-bombay-court-orders-412/
61. Dutta, ‘How Diagnostic Labs Are Failing Patients in India’.
62. Clinical Establishments (Central Government) Amendment Rules, 2020.
63. PharmaBiz Bureau, ‘HC Seeks Responses of Govt & NMC on Repeal of CEA Rules, Allowing
Non-Pathologists to Certify Medical Reports’, PharmaBiz.Com, 22 December 2020, avail-
able at http://www.pharmabiz.com/NewsDetails.aspx?aid=134289&sid=1
64. Yellapa et al., ‘How Patients Navigate the Diagnostic Ecosystem’.
65. National Statistics Office, Ministry of Statistics and Programme Implementation, Key
Indicators of Social Consumption in India: Health, NSS 75th Round (New Delhi, GoI,
November 2019). p. 23 (Statement 3.22).
66. Op. cit., p. A-21 (Table A19). The total cost of care in private sector (INR 31,845) is nearly
seven times that in the public sector (INR 4,452) and the cost of diagnostics (INR 3,038) is
nearly four times that in the public sector (INR 791).
67. S. Dey, ‘Lack of Regulation Haunts India’s Test Labs’, Business Standard, 20 April 2014,
available at https://www.business-standard.com/article/companies/lack-of-regulation-haunts-
india-s-test-labs-114041400536_1.html; L. Yadav, ‘Diagnostic Chains, Pathologists Hail
Govt Move to Regulate Diagnostic Sector’, Pharmabiz.Com, 22 May 2017, available at
http://www.pharmabiz.com/NewsDetails.aspx?aid=102081&sid=1
362 Medical Law International 23(4)

and a thyroid profile test can cost from INR 100 to INR 3,100.68 Such wide disparity
makes it difficult to ascertain whether the differences in cost are on account of quality or
a lack of price control. Taking cognizance of the inflated charges, the West Bengal
Clinical Establishment Regulatory Commission ordered two private hospitals to refund
the excess amount to the patients, including the inflated charges for liver function
tests.69 Although the cost of Real-time reverse transcriptase-polymerase chain resction
(RT-PCR) and rapid antigen tests was regulated during the COVID-19 pandemic in sev-
eral states under the Epidemics Diseases Act 1897,70 under routine circumstances the
costs remain unregulated.
What adds to the cost of diagnostics is the practice of a ‘cut’, or commission, offered
by laboratories to referring clinicians, which can account for nearly 40%–50% of the
cost.71 This is despite the Indian Medical Council (Professional Conduct, Etiquette, and
Ethics) Regulations, 2002, prohibiting such practices by doctors.72 In the Local Circles
survey mentioned above, the majority of the 29,000 people suspected a corrupt nexus
between laboratories and doctors and 59% believed that their doctors had ordered more
tests than were needed.73
The legislation in some states such as Meghalaya and West Bengal provides for ‘poor
and indigent people’ to have access to free investigations. The central and state govern-
ments have been taking measures to provide free diagnostic services.74 However, no
definitive data are available on the utilization of the central government’s Free Essential
Diagnostics Service Initiative or state-specific initiatives and their impact on out-of-
pocket expenditure.75

68. Ministry of Finance, Economic Survey 2017-18 (GoI, 2018), II, p. 176.
69. S. Roy, ‘Panel Censures 2 Hospitals for Overbilling, Orders Refund’, The Telegraph Online,
26 September 2020, available at https://www.telegraphindia.com/west-bengal/calcutta/
panel-censures-2-hospitals-for-overbilling-orders-refund/cid/1793065
70. T. Barnagarwala, ‘Maharashtra: Govt Caps Rates for HRCTTest’, The Indian Express, 25 September
2020, available at https://indianexpress.com/article/india/maharashtra-govt-caps-rates-for-hrct-
test-6609772/; Times Now Digital, ‘COVID-19: How Much Does RT-PCR Test Cost? Find State-
Wise Price Here’, Times Now Digital, 2 December 2020, available at https://www.timesnownews.
com/india/article/covid-19-how-much-does-rt-pcr-test-cost-find-state-wise-price-here/686056
71. A. Baheti, ‘Cut Practice in Radiology and Medicine’, Cafe Roentgen, 8 October 2021, available
at https://caferoentgen.com/2021/10/08/cut-practice-in-radiology-and-medicine/ (accessed 29
August 2022); S. Nagral and S. Nundy, ‘We Need to End “Cut” Practice in Indian Healthcare’,
The BMJ Opinion, 7 July 2017, available at https://blogs.bmj.com/bmj/2017/07/07/we-need-
to-end-cut-practice-in-indian-healthcare/ (accessed 29 August 2022).
72. A. Jain, S. Nundy, and K. Abbasi, ‘Corruption: Medicine’s Dirty Open Secret’, BMJ 348
(2014), p. g4184; Department-Related Parliamentary Standing Committee on Health and
Family Welfare, ‘73rd Report on IMC (Amendment) Bill, 2013’, Parliament of India, Rajya
Sabha, 20 November 2013.
73. LocalCircles, ‘Majority Say a Corrupt Nexus Exists Between Many Pathology Labs and
Doctors’, available at https://www.localcircles.com/a/press/page/survey-corruption-in-
pathology-labs
74. National Health Mission, National Health Mission: Free Diagnostics Service Initiative
(New Delhi, MoHFW, GoI, 2015), pp. 1–4.
75. RamPrakash et al., ‘Lessons From a Southern Indian State’, pp. 347–355.
Gupta and Nandraj 363

Information provision and reporting

Medical laboratories are liable to provide information to users and the state to maintain
transparency and accountability. In states or UTs where the CEA is in force, laboratories
need to display their charges publicly, and hospitals need to provide information about
investigations in the discharge summary. In Chhattisgarh and Kerala, inspection reports
of the laboratories need to be placed in the public domain. In West Bengal, information
regarding available services, personnel, mechanism to avail concession, and the charter
of the patient’s rights needs to be displayed. A discharge summary including laboratory
investigations needs to be provided even if the patient leaves against medical advice.
For the benefit of users, the MoHFW is required to publish a list of registered clinical
establishments including medical laboratories for those states and UTs where the CEA
is in force. Among other states, Tamil Nadu and Kerala have similar provisions.
The increasing use of digital reports is convenient and quick, but there are concerns about
the safety of data. In a breach of privacy, data regarding laboratory investigations of millions
of people were freely available in the public domain.76 Similar breaches have occurred
repeatedly.77 Medical data storage does not enjoy adequate legal protection in India.78
All public and private laboratories registered under the CEA must provide monthly
data on all tests performed, sorted by specialty, and those related to the 22 listed commu-
nicable diseases, to the District Registering Authority.79 Similar provisions are prescribed
in states such as Andhra Pradesh, Chhattisgarh, Goa, Karnataka, Kerala, Tamil Nadu, and
West Bengal. Further, a failure to report notifiable diseases is a criminal offence under
Section 188 of Indian Penal Code (45 of 1860).80 During the COVID-19 pandemic, GoI

76. Tech Desk, ‘Dr Lal PathLabs Leaks Millions of Patients Data in Public Domain: Report’, The
Indian Express, 10 October 2020, available at https://indianexpress.com/article/technology/
tech-news-technology/lalpath-labs-leaked-data-millions-patients-in-public-6716966/
77. P. Dixit, ‘A Lab Accidentally Released the Medical Reports of 43,000 People, Including HIV
Patients’, BuzzFeed News, 2 December 2016, available at https://www.buzzfeednews.com/arti-
cle/pranavdixit/the-medical-reports-of-43000-people-including-hiv-patients-w; O. C. Kurien,
‘Data, Privacy, Pandemic: India Just Had the Biggest Medical Records Breach Ever’, Observer
Research Foundation, 12 January 2021, available at https://www.orfonline.org/expert-speak/
data-privacy-pandemic-india-just-had-the-biggest-medical-records-breach-ever/
78. A. Abbas and J. Simte, ‘India: Health Data Under the Data Protection Bill, 2021 and
Recommendations of the Joint Parliamentary Committee on Data Protection’, Mondaq, 14
January 2022, available at https://www.mondaq.com/india/privacy-protection/1150676/
health-data-under-the-data-protection-bill-2021-and-recommendations-of-the-joint-parlia-
mentary-committee-on-data-protection#; V. Lalwani, ‘Explainer: Does India Need Digital
Health Records and Can the Draft Policy Protect Sensitive Data?’, Scroll.In, 6 September
2020, available at https://scroll.in/article/971884/explainer-does-india-need-digital-health-
records-and-can-the-draft-policy-protect-sensitive-data
79. Clinical Establishments (Central Government) Amendment Rules, 2018. C. Information to be
collected Monthly from Diagnostic Medical Laboratory under Clinical Establishment Act, 2018.
80. The Delhi Prevention and Control of Malaria, Dengue, Chikungunya or any Vector
Borne Disease Regulations, 2021, Pub. L. No. No. 6/DGHS/2019/PHW-IV/NVBDCP/
Notification of VBDs/4714; A. Saxena, ‘Explained: What Is a Notifiable Disease?’, The
Indian Express, 15 August 2019, available at https://indianexpress.com/article/explained/
notifiable-disease-malaria-who-notifies-a-disease-and-how-does-it-help-5906376/
364 Medical Law International 23(4)

invoked the Epidemic Diseases Act of 1897 to make the reporting of all positive COVID-
19 cases mandatory.81 At the same time, concerns have been raised that such notifications
can have adverse consequences for patients suffering from diseases that attract a social
stigma.82 Under the Integrated Diseases Surveillance Programme (IDSP), public-sector
laboratories and private-sector laboratories that are part of the IDSP reporting network
provide weekly information on more than 20 epidemic-prone diseases.83

Newer technologies
Simpler tests and a more diverse range of tests are available with the advent of new tech-
nologies, all of which contribute to wider and more frequent testing. Demand for at-
home diagnostics has increased manyfold since the COVID-19 pandemic, including
those for monitoring infections, cholesterol, blood pressure, oxygen, and heart rate,
among others.84 However, neither the accuracy nor the reliability of these test kits is
necessarily assured.85
The situation in India is more alarming because of the country’s weak regulations gov-
erning diagnostic kits and devices. Medical devices were minimally regulated as drugs
under the Drugs and Cosmetics Act 1940, until the Medical Devices Rules 2017 and 2020
were notified to bring all medical devices under regulation by October 2023.86 Hence,
several diagnostic kits and devices entered the Indian market without regulation.87
Another aspect of concern is the increasing use of artificial intelligence (AI) in medi-
cal diagnosis and how it may impact the structure and functioning of the sector by virtue

81. B. S. Perappadan, ‘Coronavirus | States to Be Asked to Invoke Epidemic Disease Act:

Centre’, The Hindu, 12 March 2020, available at https://www.thehindu.com/news/national/
coronavirus-states-to-be-asked-to-invoke-epidemic-disease-act-centre/article31043653.ece
82. S. Bhaumik and T. Biswas, ‘India Makes Tuberculosis a Notifiable Disease’, Canadian
Medical Association Journal 184(10) (2012), pp. E519–E520; K. Kundlani, ‘Confidentiality
and Privacy in Healthcare’, IPleaders, 23 February 2020, available at https://blog.ipleaders.
in/confidentiality-privacy-healthcare/ (accessed 20 October 2022).
83. Central Surveillance Unit, IDSP, ToT Training Manuals for State/District Surveillance
Officers, State RRTs & Nodal Officers from Medical Colleges (New Delhi, MoHFW, GoI,
2020), pp. 78–82.
84. S. Panda, ‘India Witnesses Rise in Popularity of Home-Diagnostic Tests, Experts Say Trend
to Continue’, FinancialExpress.Com, 21 April 2022, available at https://www.financialex-
press.com/healthcare/diagnostic/india-witnesses-rise-in-popularity-of-home-diagnostic-
tests-experts-say-trend-to-continue/2499455/
85. M. L. Millenson, J. L. Baldwin, L. Zipperer, and H. Singh, ‘Beyond Dr. Google: The Evidence
on Consumer-Facing Digital Tools for Diagnosis’, Diagnosis 5(3) (2018), pp. 95–105; E. J.
Tidy, B. Shine, J. Oke, and G. Hayward, ‘Home Self-Testing Kits: Helpful or Harmful?’,
British Journal of General Practice 68(673) (2018), pp. 360–361.
86. Department of Pharmaceuticals, Approach Paper on draft National Medical Devices Policy
2022 for Consultation (New Delhi, Ministry of Chemicals and Fertilisers, GoI, March 10,
2022), pp. 9–10.
87. Central Drugs Standards Control Organization (CDSCO), DGHS, GoI, ‘Issuance of the no
objection certificate of HealthCube-XL & HealthCube-SE in India-Reg’, 10 December 2018,
available at https://healthcubed.com/wp-content/uploads/2021/05/CDSCO-Letter.pdf
Gupta and Nandraj 365

of its level of accuracy, efficiency, and ability to analyse large data sets, among other
factors. The security of patient data is a legitimate concern in the absence of appropriate
regulatory provisions.88 AI-enabled self-testing kits are vulnerable to cybersecurity
breaches. For instance, the communication chain between an automated insulin pump
and the attached blood glucose metre can be hacked, disrupting insulin delivery to the
body and potentially leading to hypoglycaemia or hyperglycaemia.89
In addition, the use of self-test kits, although convenient, may reduce reporting to the
state (as witnessed with home-testing of COVID-19),90 thereby impacting data-based
planning and management.

Discussion and conclusions

Medical laboratory services in India have essentially grown in an unregulated environ-
ment. With no mandatory registration and minimum standards, they have been operat-
ing as any other commercial enterprise with negligible quality control. Consequently,
news reports about fake laboratories and inaccurate test results continue to appear in the
media. It is only in the past few years that regulations pertaining to medical laboratories
have come into existence, though they are still non-existent or outdated in some states.
Whereas legislation in states such as Chhattisgarh, Karnataka, Kerala, Tamil Nadu,
and West Bengal is more comprehensive, Delhi and Maharashtra have made no pro-
gress in this regard, and legislation in other states such as Madhya Pradesh, Meghalaya,
Nagaland, and Odisha is deficient in content. Coverage of state-run laboratories, labo-
ratories within hospitals, collection centres, and home collection services varies across
state regulations. Online health service aggregators continue to provide laboratory ser-
vices illegally despite court orders and GoI directives to discontinue such operations.
The users, oblivious to such breach, are attracted by the convenience and discounts that
such operators offer.
Data on the availability of medical laboratories in the country indicate inequitable
services across regions, although their exact number and distribution remain unknown.
A registry of medical laboratories in the country giving information on their number and
geographical spread will assist in assessing their adequacy and in planning to meet the
shortfall.

88. Y. Kumar, A. Koul, R. Singla, and M. F. Ijaz, ‘Artificial Intelligence in Disease Diagnosis: A
Systematic Literature Review, Synthesizing Framework and Future Research Agenda’, Journal
of Ambient Intelligence and Humanized Computing 14 (2023), pp. 8459–8486; Meticulous
Research, ‘Artificial Intelligence in Medical Diagnostics Market’, Globe Newswire, 7 July
2022, available at https://www.globenewswire.com/en/news-release/2022/07/07/2475999/0/
en/Artificial-Intelligence-in-Medical-Diagnostics-Market-Worth-9-38-Billion-by-2029-
Exclusive-Report-by-Meticulous-Research.html
89. CDSCO, DGHS, GoI, ‘Medical Device Alert’, 2 July 2019, available at https://cdsco.gov.
in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.
jsp?num_id=NDU0MA==
90. S. Roy, ‘Rapid Surge in Sale of Covid Self-Test Kits’, The Hindu Business Line, 20 January
2022, available at https://www.thehindubusinessline.com/news/huge-surge-in-sale-of-self-
test-kits-for-covid-reporting-of-numbers-remain-a-challenge/article64926523.ece
366 Medical Law International 23(4)

Due to the lack of a quality control mechanism, there is no assurance that the
results of a sample tested in two laboratories would be the same. Universal adoption
of external and inter-laboratory quality control mechanisms that are mandatory for
accreditation by NABL, but not a statutory requirement, in all states will help in
standardization and ensuring quality, make the reports generated by different labora-
tories more credible, and reduce the burden of repeat tests on users in cases of referrals
or a second opinion.
Ambiguity about who can operate medical laboratories and the responsibility of
different cadres of technical staff remains unresolved. The insistence on pathologists
operating medical laboratories restricts access in under-served areas. The graded level
of human resources prescribed in the CEA (Amendment) Rules, 2020, depending on
the scope of services offered by a laboratory is practical and realistic.
There are few studies on the costing of diagnostic services in India. However, media
reports, including those during the COVID-19 period, are indicative of the inexplicably
high costs.91 The Economic Survey 2017–18 reveals disparity in the average cost of
diagnostic tests and the wide range of costs across various cities in the country. Unethical
practices and resistance by the industry to submit to price control contribute to the high
costs of diagnostics. It is necessary to maintain transparency in the costs charged to gain
the users’ trust and confidence. The action taken by the West Bengal Clinical Establishment
Regulatory Commission on overcharging by hospitals is noteworthy and needs to con-
tinue and be consistent.
The provision for making information on registered laboratories publicly available
under the CEA 2010, the Kerala Clinical Establishments (Registration and Regulation)
Act 2018, and the Tamil Nadu Clinical Establishments (Regulation) Rules 2018 can be
very useful to the users in choosing laboratories.
Reporting to the government by both public- and private-sector laboratories will help
in maintaining data on disease burden and in planning health services. However, given
that regulations across states differ in their reporting requirements, it is not comprehen-
sive. The increasing emergence of new diseases makes data sharing with the authorities
imperative in the detection of outbreaks and taking necessary control measures in a
timely fashion. It is recommended that reporting under IDSP, which is currently optional
for private laboratories, should be made mandatory.
While harnessing technological advancements is to be welcomed, caution is war-
ranted in the use of newer technologies such as self-testing tools, AI-assisted testing,
point-of-care testing, and digitization of data until the regulations governing these mat-
ters are strengthened. The Medical Devices Rules 2017 and 2020 do not regulate all
diagnostic kits and devices currently. The lack of data protection laws in the country also
creates the potential for the violation of users’ privacy when laboratories digitally store
data and report it online on government web portals.
The Indian diagnostic market is expected to witness a compound annual growth rate
of nearly 12% and offer substantial financial returns to investors in the next 10 years and

91. A. Saikia, ‘Special Report: Why Does the Coronavirus Test Cost Rs 4,500 in India?’, Scroll.in, 5 May
2020, available at https://scroll.in/article/961002/why-does-the-coronavirus-test-cost-rs-4500-in-india
Gupta and Nandraj 367

is attracting both established and new investors.92 Considering the industry’s keen inter-
est in expanding markets, the need for effective regulation of medical laboratories to
protect the users’ interests and promote rational medicine cannot be overemphasized. A
combination of voluntary and statutory mechanisms such as accreditation and regula-
tions would be useful instruments for ensuring quality in diagnostic services. A greater
push towards updating outdated legislation and their implementation in letter and spirit
is warranted. Research on their effectiveness at the state level would help in understand-
ing the impact and suggest ways of further improvement.

Acknowledgements
The authors would like to thank the following colleagues at Health Systems Transformation
Platform, Mr. Rajeev Sadanandan, Dr. Kumaravel Ilangovan, and Dr. Pratheeba John for their
valuable comments on the earlier drafts of the article.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship,
and/or publication of this article.

Funding
The author(s) received no financial support for the research, authorship, and/or publication of this
article.

ORCID iD
Pallavi Gupta https://orcid.org/0009-0008-2925-0499

92. R. V. Vora, ‘Diagnostics, a Test Indian Corporates Take Hoping for Positive Results’,
The Hindu Business Line, 21 August 2022, available at https://www.thehindubusi-
nessline.com/specials/pulse/diagnostics-a-test-indian-corporates-take-hoping-for-pos-
itive-results/article65726528.ece; P. Vardhan and T. Mukherjee, ‘India’s $9 Billion
Diagnostics Industry: A Midsummer Private Equity’s Dream’, ETHealthWorld, 15
October 2022, available at https://health.economictimes.indiatimes.com/news/diagnostics/
indias-9-billion-diagnostics-industry-a-midsummer-private-equitys-dream/94884091