INTRODUCTION
Post operationalisation of the National Accreditation Board for Hospitals and Healthcare Providers (NABH) in the year 20061, Indian healthcare sector witnessed regulatory evolution in the country. Establishment of the board under the aegis of Quality Council of India2 is certainly a landmark beginning, which seeks to benchmark quality standards in the healthcare sector in line with international norms.
Though voluntary in nature, to begin with, accreditation is getting much sought after by well-off players of the sector, more so to seek its alignment with government sponsored health insurance schemes and even private insurance companies.
Some 12 years later, in 2018, Maharashtra, the second most populous state of the country, opted to join the Accreditation that led to formalization of Maharashtra Nursing Homes Registration (Amendment) rules-2021, in a bid to exhort healthcare facilities in the state seeking accreditation to urgently go in for quality control standards that the revised rules need them to.
Ofcourse, the implementation of guidelines as enumerated in the NABH programme, coupled with enhanced enforcement of existing rules under the Bombay Nursing Homes Regulation act 19493, is a welcome step on grounds of quality control and patient safety. But the call for strict adherence to the revised rules, as envisaged in the NABH programme, has a telling effect on the healthcare sector of the state, for the implementation is proving challenging, particularly for small level nursing homes which operate with limited financial and human resources.
The early stage of the implementation, in the state of Maharashtra, of quality control standards as envisaged in the NABH programme, is characterized by opting out of many a small-level healthcare providers in the system. While the period 2018-2021 was a period of mustering strength by bigger healthcare providers on the one side, and of hesitation and uncertainty on the other, the period post of amendment rules 2021 saw an outflux from the healthcare sector. Given the official data from Pune Muncipal Corporation more than seventy small and medium level private nursing homes and hospitals have shut their shutters during the period 2022-2024 alone. The position is no better in other parts of the state. Though no real time data of the state as a whole has been released by authorities, but averaging out the available statistics from Pune City alone speaks volume of the state- wide trend, leading to diminishing accessibility, particularly in semi-urban and rural areas of the state, where position was otherwise not so satisfactory even prior to the implementation of revised quality control standards
LITERATURE REVIEW
Establishment of the National Accreditation Board for Hospitals and Healthcare Providers
Indian Standard Institute was established in the year 19474 to oversee quality control standards of industrial products. Services were out of its purview. To align healthcare services in the country with international standards NABH came to be operationalised in the year 2006 to represent a systematic approach to quality assurance in the field against existing and not so coded quality standards. The board operates under the aegis of Quality Council of India, which aims to draw upon international standards to adapt them to the Indian healthcare context. The board has developed a comprehensive accreditation programs for various healthcare facilities which include; full-service hospitals, small healthcare facilities, blood banks, diagnostic centres and care homes.
The Small Healthcare Organisation (SHCO) accreditation program, it being one of many, is specifically designed for healthcare facilities with 50 or fewer beds. Introduced to provide tailor-made framework for smaller players in the field of healthcare, SHCO standards were operationalised in the year 2022. Broadly it includes objective elements, commitment elements, achievements, and excellence category. Over all there are 408 elements of SHCO programme5, with sub-head categorisation being 100+257+35+16 in the above given order. Ultimate aim of the programme is to facilitate steady and progressive quality improvement of the healthcare system at the grass root level.
A. Regulatory Framework in the State Prior to the Healthcare Accreditation Program
Since 1949 healthcare facilities in the state of Maharashtra were being governed under The Bombay Nursing Homes Registration Act-1949, extended to all parts of the state in the year 19596. The legislation spoke of elementary requirements, such as registration, inspection, and basic standards of services provided, healthcare facilities being defined as any premises used or intended to be used for the reception of persons suffering for many ailments, injury, infirmity, and which is providing treatment and or nursing for them, and includes a nursing home.
The act of 1949 and the codes of statutory governance of healthcare facilities in the state remained unchanged thereafter, till 2021 when the accreditation programme under NABH was adopted by the state in the year 2021, requiring healthcare facilities in the state to conform to the following:
• Nursing homes with 10 bed facility mandatorily need one duty officer, two midwifes, and one qualified nurse, across three shifts.
• Minimum of 140 sq. ft waiting room with examination room of similar area.
• Beds need to six feet apart.
• A nursing station after every five beds
• Mandatory certification for all nursing staff.7
• Upward revision of fee structure and compliance documentation.
B. Healthcare Scenario of the State of Maharashtra
Maharashtra is the second largest state of the country, spread over around 3.07 lakh sq. kms, with an estimated population of 13 crore8, 55 percent of which resides in rural areas. As per latest report, the state has a little more than 20000 healthcare facilities registered9 under the Nursing Homes Registration Act, more than 50 percent of which are classified as small and medium sized. The role of small level facilities in the system of healthcare delivery, thus, is critical, in as much as these being more and easily accessible, and provide affordability as compared to big establishments.
With ever increasing population numbers and limited public resources, the role of private participation in the system of health delivery can never be overstated. Currently, around 70 percent of healthcare establishments10 in the state are family owned or operated by individual medical practitioners. At local levels the system is more amenable in terms of proximity, cost, and personalized care.
ACCREDITATION FRAMEWORK FOR SMALL HEALTHCARE ESTABLISHMENTS (SHCO) ACCREDITATION
It contains ten patient centred standards11, major thrust areas being:
• (AAC) Assessment and continuity
• (COP) Care of patients
• (MDM) Management of medication
• (PRE) Patients-rights and education
• (HIC) Hospital infection control.
• (CQI) Continuous quality improvement.
Apart from the above, there are organisational level standards, such as:
• (ROM) Responsibility of Management
• (FMS) Facility management and safety
• (HRN) Human resource management
• (IMS) Information management system.
There are many conditions to be eligible for seeking accreditation, these being
a) sanctioned capacity of 50 or less beds12,
b) submitting operational data of at least past six months during which time occupancy must be of 30 beds or more,
c) facility is maintaining SHCO standards for three months prior to submitting application for accreditation, and
d) finally, to commit to applicable legal/statutory/regulatory compliance.
A. NABH Accreditation and Financial Challenges
To be a certified member of NABH accreditation is, of course, a matter of pride for any healthcare facility, for the certification speaks of international level standards in the delivery of healthcare services. But the process entails substantial outflow of funds, which include; fee towards application and documentation, consultant fee, staff training, infrastructure expenses, and assessment fee.
While big and corporate healthcare centres and hospitals can easily manage the investment, it does prove a burden on smaller healthcare facilities which generally operate on annual turnover of around one crore or even less. The NABH board further revised the fee structure from 1st April 202413, adding further to financial woes of smaller players in the field of healthcare services.
Though the Accreditation Board tries to lend a helping hand through Programmes on Implement sessions and regular monthly masterclasses etc, but hardly lessens the burden of accreditation outlay.
In addition, NABH healthcare standards are being revised periodically in line with international norms. 6th edition of NABH quality standards became operative from 1st April 202514.
B. NABH Accreditation: The Up Side
The state of Maharashtra is reported to top the list of healthcare facilities seeking full Accreditation or accreditation at the entry level.
Most of top healthcare facilities in Mumbai, Pune15, Nagpur had gone for the certification. To name a few, the list includes;
Mumbai- Kokilaben Ambani Hospital, Lilavati, Hinduja, Jupiter, D.Y. Patil, Beach Candy, Sahyadri, Jaslok, Saifee, and Fortis.
Pune- Deendayal Memorial, Sanjeevni, Ranka, Sadhu Vaswani Mission, Sahyadri Pune
Nasik and others- Sujata Burla Hospital, Sahyadri Nasik, and various specialised centres across Thane, Aurangabad, and Nagpur.
Of late even public sector healthcare facilities16 has started joining the BSVH accreditation. The list includes KEM, Sion Hospital, Nair Hospital, Cooper, Tata Memorial, JJ Hospital, Cana & Albless, GT hospital, Bhabha hospital, and Rajawadi.
C. The Conundrum
As the matter stands presently, participation in NABH accreditation programme is voluntary. But does it really help smaller healthcare facilities with limited resources. The answer is big no. Contrarily, non-participation has come to pinch them even more. With Information system updating on daily basis, every new development in the society, or a happening, spreads from one corner to the other in no time, the world, both at global and local levels, becoming, in the process, a competitive lot. In the face of accreditational upgradation of services by a part of the healthcare system puts the left of part at great disadvantage. In addition, governments, be it at the National or the provincial level, prefer NABH Accreditation healthcare facilities for empanelment under their public healthcare schemes: such as Ayushman Arogya Yojna of Government of India17 and the Mahatma Jyotiba Phule Han Arogya Yojna of the state of Maharashtra18. Such an unfavourable situation has resulted in the closure of many a small level healthcare facility in the state of Maharashtra which could not provide for necessitated financial resources for NABH accreditation.
GROUND LEVEL SITUATION IN THE AFTERMATH OF NABH ACCREDITATION PROGRAMME
The term quality of a product is the biggest pitch of sales management. Quality of healthcare services ranks even higher in the minds of end users. Quality control through NABH certification of quality standards of a healthcare facility, in line with international norms, thus, is a welcome development. But, as stated herein above, NABH certification has a cost to it, which, sometimes, does not fit in structural feasibility or financial viability of a healthcare facility. Getting put in a disadvantageous position for long as compared to NABH accredited facility, the end result is shutting down shutters. This is true of many a small level nursing homes which had to ultimately opt out of the list of healthcare providers. These, in fact, find themselves in a catch 22 position, economically damned if they go in for NABH accreditation and equally damned if they do not.
A. Reasons which Adversely Affect Nursing Homes with Fewer Bed Capacity
1. The Pandemic
Corona pandemic, under which world economy reeled during the period starting from late 2019 to mid- 202119 had been the culprit that destroyed many a business enterprises world over. Healthcare facilities too got affected. While high end hospitals and nursing homes, given their financial strength, could withstand the ill, it was smaller facilities with meagre resources which did find the going difficult. Onset of NABH accreditation programme and strict enforceability of rules with 2021 amendment by the Maharashtra government, immediately in the aftermath of the pandemic, has unmanageable affect both on the psychology and finances of not so well-of healthcare providers.
2. The Process Compliance
NABH accreditation coupled with 2021 amendments to 1949, rules significantly added to process compliance requirements. NABH accreditation standards require a facility to maintain standard operating procedures, which include: protocols, quality indicators, policies, audit, and reporting. In addition to extra manpower needed, every step of process compliance has a cost. Smaller healthcare providers with limited resources find it difficult to cope up with the added burden.
3. Infrastructure Cost
NABH accreditation require a healthcare facility to have
a) 140 sq. ft waiting room,
b) examination room of similar dimensions,
c) minimum 6 ft distance between two beds,
d) nursing station after 5 beds,
e) medicine storage space,
f) infection control measures,
g) fire safety,
h) biomedical waste management.
All these conditionalities require more space and structural changes. Most of the smaller healthcare facilities are family owned, running business for decades. Given paucity of space they are unable to immediately match required standards. Again, given the scale of business the extra cost of infrastructure changes is often uneconomical. Further, in case a healthcare facility is run from a rented premises the provider would think many a times before deciding to heavily invest in a premise, which is owned by some else one.
4. Staffing Requirement
2021 Amendment to the rules of 1949 require a 10-bed healthcare facility in the state of Maharashtra to must have one medical officer, two qualified midwifes, and one qualified nurse across all three shifts. It translates into a condition of employing minimum of 12 medical persons. For a small nursing home, of 10 beds, with average occupancy rate of 70 to 80 percent, the cost of running the facility often becomes unbearable.
EMPIRICAL SURVEY: METHODOLOGY AND FINDINGS
In order to ground the observations of this paper in primary field data, a structured empirical survey was conducted across 50 small healthcare units (up to 30 beds) located in urban, semi-urban, and peri-urban areas of Maharashtra. The survey was administered to administrative staff of each unit and covered ten questions mapping directly to the key challenges identified in the literature review and documentary analysis.
A. Survey Instrument
The ten questions posed to administrative staff were as follows:
1. No of Beds in the unit
2. Ownership of the Unit
3. Since the amendment Rules of 2021, do you feel there is an increase in your monthly administrative costs/compliance costs?
4. Have you been able to meet the mandatory staffing requirement (one medical officer, two midwives, and one qualified nurse per shift)?
5. Has your facility made the structural changes requirements as mentioned in the Rules in your owned/ rented premises? If yes, what was the approximate increase in the cost?
6. Is your facility currently registered under any of the government health insurance scheme (Ayushman Bharat/MJPJAY)? Has not having NABH accreditation played a role into it?
7. Have your staff members gone thru the mandatory NABH training and if yes who bore the cost?
8. On a scale of 1-5, what do you feel about the documentation and other processes according to the employee strength as specified in the rules?
9. Were you operational during COVID-19 (2019–2021)? Did the disruptions cause any effect to subsequently invest in NABH compliance?
10. Has your facility’s patient footfall increased, decreased, or stayed the same since larger NABH-accredited facilities operate in your area?
11. Have you ever considered shutting down or downsizing the facility due to regulatory or financial pressure?
12. Are you aware of the proposed relaxations being considered by the state government for 10-bed and day-care facilities? Would those relaxations make compliance feasible?
KEY FINDINGS- QUESTION-WISE ANALYSIS
Q1. No of beds in the facility
In the survey we covered 50 Facilities, which were relatively small in terms of bed capacity. Most of the facilities approached during the survey were 30 bedded or less, out of 50 only 2 facilities were 50 bedded.
Q2, Ownership of the facility
During the survey the facilities approached were small Healthcare facilities, which either self-owned, family owned or in partnership. This ownership pattern is typical of grassroots healthcare delivery, where local practitioners play a central role in serving their immediate communities, often with limited external funding or institutional support.
Q3: Monthly Compliance Cost Increase
The survey recorded an average monthly cost increase of approximately ₹20,350 per unit following the 2021 amendments. Units in the 20-30 bed range reported higher incremental costs (₹30,000-₹40,000 per month), while the smallest units (5-8 beds) reported increases in the range of ₹8,000-₹12,000. This finding adds to the facts that compliance expenditure, while proportionally smaller for large facilities, constitutes a disproportionate burden on small units operating on thin margins.
| Bed Category | No. of Units | Avg. Monthly Cost Increase (₹) | Range (₹) |
|---|---|---|---|
| 5–10 beds | 24 | 11,500 | 8,000 – 15,000 |
| 11–20 beds | 16 | 22,000 | 15,000 – 30,000 |
| 21–30 beds | 10 | 35,000 | 30,000 – 40,000 |
| All Units | 50 | 20,350 | 8,000 – 40,000 |
Table 1: Monthly compliance cost increase by bed category (Survey, 2024–25)
Q4: Staffing Requirement Compliance
Only 14 out of 50 units (28%) reported fully meeting the mandatory staffing requirement of one medical officer, two midwives, and one qualified nurse across all three shifts. Twenty-two units (44%) reported partial compliance (covering one or two shifts), while 14 units (28%) stated they were unable to meet the requirement at all. This finding starkly highlights the human resource challenge that the 2021 amendment imposed on smaller facilities, for whom employing 12 or more qualified medical staff is often economically untenable.
| Staffing Status | No. of Units | Percentage (%) |
|---|---|---|
| Fully met | 14 | 28% |
| Partially met (1–2 shifts) | 22 | 44% |
| Not met | 10 | 20% |
| In progress / under recruitment | 4 | 8% |
Table 2: Staffing compliance status across 50 surveyed units
Q5: Structural Changes and Infrastructure Cost
Of the 50 units surveyed, 21 (42%) reported having completed the required structural changes to meet the 140 sq. ft. room norms; 16 (32%) had made partial changes; and 13 (26%) had made no changes, citing lack of space or unaffordable renovation costs. Among those who had completed changes, the average infrastructure expenditure was approximately ₹1,47,000. Notably, 58% of the units in the sample operated from rented premises, and most of these units either had not undertaken changes or had done so only partially, underscoring the reluctance to invest heavily in non-owned property.
| Structural Change Status | No. of Units | % | Avg. Cost (₹) | Premises: Rented (%) |
|---|---|---|---|---|
| Completed | 21 | 42% | 1,47,000 | 38% |
| Partial | 16 | 32% | 72,000 | 62% |
| Not undertaken | 13 | 26% | — | 77% |
Table 3: Structural compliance and infrastructure cost by premises type
Q 6: Government Scheme Enrolment and NABH as a Barrier
Only 18 of the 50 surveyed units (36%) were enrolled under any government health insurance scheme (Ayushman Bharat or MJPJAY). Of the 32 non-enrolled units, 19 (59%) explicitly identified the lack of NABH accreditation as the primary barrier to enrolment. This empirically validates the theoretical concern raised in Section 4.3, that non-accreditation has a direct, tangible cost in terms of exclusion from publicly funded healthcare delivery mechanisms.
| Scheme Enrolment | Count | % of Total |
|---|---|---|
| Enrolled (any scheme) | 18 | 36% |
| Not enrolled – NABH cited as barrier | 19 | 38% |
| Not enrolled – other reasons | 13 | 26% |
Table 4: Government scheme enrolment and NABH as a barrier to enrolment
Q 7: Staff Training
The average number of staff members trained per unit in the past two years was 2.7 persons. In 31 of the 50 units (62%), the training cost was borne entirely by the facility. In 10 units (20%), staff bore the cost themselves, and only 4 units (8%) reported availing a government subsidy. This reflects the limited reach of training support mechanisms and the additional financial pressure that skills upgradation creates for small units.
Q 8: Process Compliance Manageability (Scale 1–5)
The average score as reported by the facilities came out to be 2.6 out of 5. Majority of the units, 34 of 50 (68%), scored 3 or below, signifying that process compliance documentation (SOPs, quality indicators, audit trails, reporting) is perceived as difficult to manage with existing staff levels. Only 6 units (12%) rated compliance manageability at 4 or 5. These finding directly supported the argument that rules laid down for the documentation requirements, is in line with the well-staffed corporate facilities, but are a significant operational strain on small units.
| Score (1–5) | No. of Units | % of Total | Interpretation |
|---|---|---|---|
| 1 | 8 | 16% | Very difficult |
| 2 | 13 | 26% | Difficult |
| 3 | 13 | 26% | Manageable with effort |
| 4 | 10 | 20% | Largely manageable |
| 5 | 6 | 12% | Easily managed |
Table 5: Self-rated process compliance manageability (Q6)
Q 9: COVID-19 Impact on NABH Readiness
Of the 50 units, 32 (64%) reported having been operational during the COVID-19 period (2019–2021), 9 operated on an emergency-only basis, and 9 remained closed. Among those that were operational, 26 (81%) reported that pandemic-related disruptions caused a moderate to severe delay, ranging from 1 to over 2 years, in their ability to invest in NABH compliance thereafter. This finding empirically establishes the sequential burden: pandemic-induced financial depletion, followed immediately by the imposition of the 2021 amendment standards, created a compounding effect on smaller facilities that larger establishments were better positioned to absorb.
Q 10: Patient Footfall Trend
As many as 30 of the 50 surveyed units (60%) reported a decrease in patient footfall, with 10 units (20%) describing the decline as significant. Only 7 units (14%) reported an increase. Qualitative responses indicated that proximity of a larger NABH-accredited facility, combined with the growing public awareness of accreditation status, was a key driver of the patient shift. This finding has a direct social ramification, discussed further in Section 7.0.
| Footfall Trend | No. of Units | % of Total |
|---|---|---|
| Increased | 7 | 14% |
| No change | 13 | 26% |
| Decreased | 20 | 40% |
| Significantly decreased | 10 | 20% |
Table 6: Patient footfall changes reported by surveyed units
Q 11: Consideration of Closure or Downsizing
A striking 34 of the 50 units (68%) indicated that they had either already considered closure or downsizing, or were currently under consideration. Amongst these, the primary reasons that were mostly cited were: financial unviability (cited by 13 units), inability to meet staffing norms (9 units), infrastructure compliance costs (7 units), and competitive pressure from nearby NABH-accredited facilities (5 units). Only 16 units (32%) had not considered closure. This finding constitutes one of the most significant empirical outcomes of the survey, validating the macro-level closure trend observable in official data from Pune Municipal Corporation.
| Considered Closure? | Count | % |
|---|---|---|
| Yes | 20 | 40% |
| Under consideration | 14 | 28% |
| No | 16 | 32% |
Table 7: Units that have considered closure or downsizing (Q9)
Q 12: Awareness of Proposed Relaxations
Of the 50 units, 27 (54%) were aware of the proposed regulatory relaxations under consideration by the state government for 10-bed and day-care facilities. Of those aware, and of all units surveyed, 36 (72%) indicated that such relaxations would be helpful, with 18 stating the relaxations would prevent their closure, and 8 stating they would resume or expand operations if the relaxations were implemented. Only 5 units felt the proposed measures would be too little, too late. These findings lend strong empirical support to the conclusion that targeted, stratified regulatory reform has broad acceptance among small healthcare providers, and that the demand for such reform is genuine and widespread.
| Response to Proposed Relaxations | Count | % |
|---|---|---|
| Would prevent closure | 18 | 36% |
| Would resume / expand | 8 | 16% |
| Partially helpful | 10 | 20% |
| Too little, too late | 5 | 10% |
| Not applicable / not aware | 9 | 18% |
Table 8: Utility of proposed relaxations as perceived by surveyed units (Q10)
C. Cross-tabulated Outcomes and Overall Survey Findings
A cross-analysis of survey responses reveals consistent and reinforcing patterns:
• Units with rented premises were significantly more likely to have not undertaken structural changes (77% rented vs. 38% owned), and were also more likely to have considered closure.
• Units that were fully operational during COVID-19 but reported severe pandemic impact were nearly three times more likely to score compliance manageability at 1 or 2 compared to units that reported mild or no COVID impact.
• All 19 units citing NABH as a barrier to government scheme enrolment also reported a decrease in patient footfall, confirming a compounding exclusionary effect, these units are simultaneously losing private patients to accredited competitors and being locked out of the publicly-funded patient base.
• Of the 34 units that have thought about closing, 31 (91%) said that their compliance manageability score was 3 or lower. This suggests that the daily costs of compliance, not just the one-time costs of capital, are what is making them decide to leave.
The survey paints a picture of a small healthcare sector that is under a lot of pressure from many different directions. This includes a lack of money after the pandemic, rising costs of following rules, a shrinking patient base, being left out of government programs, and not having enough support infrastructure to build capacity. The survey results thus furnish an empirical foundation for the regulatory reform proposals delineated in Section 9.2.
SOCIAL RAMIFICATION OF THE CLOSURE OF SOME OF EXISTING HEALTHCARE FACILITIES
Small nursing homes and hospitals generally offer community based cheaper healthcare services. As the circumstantial closure is a concentrated more in the case of low-end healthcare facilities, the incidence negatively affects the vulnerable class of the society, which is already at a disadvantageous position, more than the well-off, for varied reasons. Cost-effective availability of healthcare per thousand of persons becomes less with the closure of some of the available economical healthcare services. Distance for the end users to travel increases as the next healthcare centre may be situated far off. In rural areas of the state closure of just one hospital or a nursing home can affect many villages in the periphery because of existing area wise abnormalities which point to concentration of health services in urban and semi-urban areas.
Studies point out that even in an advanced country closure of one healthcare facility in rural part of the country 20significantly Increases travel time of patients seeking treatment.
Judicial Review of Healthcare Accreditation Program: The Constitutional Mandate and Case Law Analysis.
Constitutionally healthcare in India comes under provincial control, falling under List-II of Seventh Schedule21. Though the quality control standards have been adopted, in principle, by Central authorities through the establishment of National Accreditation Board of Healthcare providers (NABH) in the year 2006, given the constitutional provisions, individual states of the union are free to subscribe or not to subscribe to the adoption. Maharashtra state provisionally endorsed the accreditation in the year 2018, officially joining the programme, in the year 2021 through amendment to the existing healthcare law of 1949.
Healthcare is not literally defined as a fundamental right under the constitution, but judicial reviews by different constitutional courts, during last couple of decades, have interpreted fundamental rights to include the right to healthcare, as well, thereby widening the scope of Article 21 of the constitution of India22. In addition, reviews embarked upon some other provisions of the constitution, these being; Article 38, 39, 41, 42, and Article 4723. Which require the state to promote welfare, protection of the health of workers, right to public assistance, and the state’s duty to raise level of nutrition and to improve public health.
REVIEW OF HEALTHCARE STANDARDS IN LIGHT OF CASE LAWS
A. Delhi High Court (2020)24
Hon’ble court, in response to a petitioner Ms. Jyoti Nambiar, while acknowledging the need for regulatory evolution, advised her to take up the matter of healthcare deficiencies, with concerned authorities. But the court did not agree to direct the government to mandate specific amendments to the existing Delhi Nursing Homes Registration Act-1953.
The Judgement does recognise dynamic nature of the subject of public healthcare governing rules of which need to keep evolving.
B. Bombay High Court
2020- No closure of a healthcare facility without due process. Regulators and the owner of healthcare facility to first embark upon all possible remedial measures.25
2025- BMC to take strict action against unregistered hospitals and nursing homes.26
Taking note of a fire incident, it mandates BMC to check and ensure adherence to fire safety norms by healthcare facilities.
2024- Following reports of high death rate at a public owned hospital, the Court slammed state government for poor conditions including lack of staff and medicines.
C. Delhi High Court -2006
The Judgement emphasized on proportionality in regulatory enforcement and the need to balance quality requirements with practical operational considerations.
OPPOSITION TO AMENDMENTS (2021) TO BOMBAY NURSING HOMES REGISTRATION ACT OF 1949
Small level healthcare providers in the state of Maharashtra and the Maharashtra Chapter of Indian Medical Association opposed the amendments27, calling some of its provisions being draconian and infeasible, Government authorities has taken note of the opposition, and the Healthcare-Minister off the state, following meetings with IMA representatives during last 2 years, has agreed to some relaxations for day care centres and nursing homes with 10 bed capacity. Proposed amendments are likely to be presented in the state assembly soon.
MAJOR AMENDMENTS IN THE 2021 RULES
1. Updated Registration Records & Transparency
• Local supervising authorities must maintain the nursing home register manually and electronically.
• All registration certificates must be uploaded on official municipal / corporation / zilla parishad websites, enhancing transparency about which facilities are registered.
2. Advance Renewal Filing
• Nursing homes must apply for renewal in advance in January of the year the existing registration expires, using the prescribed Form ‘B’ and fees.
3. Revised Fees for Registration & Renewal
• New fees slabs were introduced based on number of beds and classification of
municipal areas (e.g., Grade A+, B, C, etc.).
• For small facilities (1-5 beds), registration fees range from approx. ₹3,000-₹5,000 depending on municipal grade.
4. Infrastructure and Staffing Standards (most debated part)
As interpreted from media reporting (and opposed by some medical bodies), the amendment introduced minimum facility and staffing norms for nursing homes with 10 or more beds, including:
• A duty medical officer (MBBS) on site.
• Two qualified midwives and one qualified nurse per shift (i.e., three doctors and nine nurses for three shifts).
• Dedicated spaces such as a 140 sq ft waiting room and 140 sq ft examination room.
• Six feet distance between beds, and a nursing station after every five beds.
These norms aim to raise minimum standards of care but have been criticized by associations like the IMA as impractical for many small hospitals due to cost and space constraints.
5. Patient Rights and Transparency Requirements (via Implementation)
Though not always explicitly in the rules text, implementation discussions refer to allied patient protections such as:
• Display of treatment tariff / price lists (itemized rates) in nursing homes.
• Active patient rights charter and a grievance redressal mechanism, often with a toll-free number linked to local authority complaint units.
A. Maharashtra Healthcare Regulations viz-a-viz Other States of the Union
After independence every state enacted a set of rules for the registration of healthcare facilities operating under its domain. Practically, rules governing healthcare of different states were more or less same of the gist.
Andhra Pradesh became the first state in the country to enact Clinical Establishments Act in the year 200228, with an approach to comprehensive quality regulation. In bespoke of both; improved quality standards and patient’s rights awareness. The act, however, invited challenges in regard to implementation in rural areas and resistance from small healthcare providers. Kerala’s approach to healthcare, contrarily, emphasizes on public-private partnership, thereby aiming at collaborative quality improvement.
Central Clinical Establishment (Registration and Regulation) Act 201029 serves as a model framework for different states to adapt with state specific changes. Indian Medical Association did lend a helping hand in advocating and suggesting Maharashtra specific modifications to this framework that resulted in the enactment of amended rules and regulations in the year 2021.
Apart from Maharashtra, states of Delhi, Punjab, Telangana, and U.P have since adopted NABH accreditation quality standards. However, Maharashtra remains at the top with adoption of 597 quality standards30 of the given list under NABH healthcare program.
Other states with significant progress towards the goal are Gujrat, Tamil Nadu, Bihar, and Chhattisgarh.
B. The Giide-Post
As stated herein above, India has attempted to formulate a set of quality standards for healthcare delivery on the basis of best practices prevalent in developed nations. But economically and demographically the country is on a different footing as compared to advanced economies. Again, the size of the populace it serves is an added drawback.
Thus, it is necessary to be flexible in approach in the implementation of NABH accreditation norms across the country.
First and foremost is the adoption of given quality standards to be in phases, with a timeline for capacity building, process compliance, infrastructure build-up, before full compliance.
Financial and advisory support is another area for the regulators to take care of.
More than structural standards the program must emphasise on outcome, based quality standards. Taking stakeholders in confidence and evolving a consultation process would go a long way to minimize doubts and differences.
Regular impact assessment should be the rule to corrective steps. There ought to be a stratified regulatory reform, that is, differentiated set of regulatory norms for small 1 to 10 bed facility, 11 to 25 beds, 26 to 50 beds, and so on.
Last but not the least, emphasise needs to give in providing quality healthcare services in rural areas, which is, otherwise, has always been a neglected domain.
CONCLUSION
The objective of the Government of Maharashtra has been the improvement of quality standards of healthcare delivery in the state, coupled with patient safety concerns. This objective gets manifested in the adoption of the NABH accreditation programme in the year 2018, and the strengthening of existing rules by amending the 1949 rulebook in the year 2021.
While the objectives as stated above are well-intentioned and necessary for a healthy society, the process of achieving these objectives must be in line with the ground realities of the area. The empirical survey conducted for this paper across 50 small healthcare units in Maharashtra provides a concrete, data-backed picture of those ground realities. The findings, an average monthly compliance cost increase of ₹20,350, only 28% of units meeting staffing norms, 60% reporting a fall in patient footfall, and 68% having considered closure, collectively present a healthcare subsector under serious and compounding stress.
The closure, subsequent to NABH accreditation adoption and the 2021 amendment, of approximately 18% of existing healthcare facilities in the state rang an alarming bell. Most of these closed or closing healthcare facilities cater to the healthcare needs of the rural and semi-urban populace, which is otherwise already at a disadvantage. The government of Maharashtra has acknowledged such social challenges, committing to regulatory relaxations wherever needed.
The survey finding that 72% of responding units believe proposed relaxations would be helpful with 36% stating such relaxations would directly prevent their closure is perhaps the most significant empirical conclusion of this paper. It affirms that the sector is not opposed to quality regulation per se, but is seeking a more measured, phased, and financially supported pathway to compliance.
While emphasis on quality standards in the delivery of healthcare services is non-negotiable, the path forward needs to be smooth-sailing for all existing as well as upcoming healthcare providers through balancing competing imperatives, ensuring economic viability, and demographic feasibility. With policy makers and regulators being thoughtful of the approach and supportive of means, maintaining such a balance is not only desirable but achievable.
WAY FORWARD: SUGGESTIONS AND THE PATH AHEAD
Establishment of NABH, and standardising smaller healthcare facilities under Small Health Care Organisation {SHCO), is, of-course s well needed development to attune healthcare in the country to international standards, safety, quality and efficiency being it’s three Pillars.
Yet, implementation of regulatory framework of the scheme did cause inconvenience and resentment, particularly amongst smaller healthcare facilities, leading to around 16 to 20 percent close downs. As we all know, suchlike smaller healthcare facilities cater to around 70 percent of the total populace of the country, their role in the healthcare field cannot be overlooked.
Regulatory framework, in the implementation of schematic necessities, these being ‘Safety-Quality-Efficiency’, needs to be such that it embraces in itself limitations being experienced by small level healthcare providers.
A multi-pronged stance that cares for reasonable restrictive constraints of smaller players in the field must be a part of the structural rule book, as a solace to ward-off compulsive closures of healthcare facilities.
1. A small 5 bed hospital can certainly not vie with a 50 beds facility. ‘Risk Model’ of the two, therefore, cannot be the same, and nor can be the standard of efficacious requirement for maintenance of quality of services. In line with ‘The UK Care Quality Commission’, risk-based model within overall NABH accreditation program, thereby quantifying risk to the size of healthcare facilities, can, to some extent, obviate the incidence of close downs.
2. Financial comparability between the two, the small level healthcare facilities and bigger hospitals is a burdensome inequality. Facilitating long term soft financial assistance to small level facilities to upgrade structural necessities would go a long way in helping them to keep footed in the system.
3. In the given scheme of SHCO, regulatory paperwork and reporting is same for a 5 bed and 50 beds facilities, as both need to regularly report on 408 compliance elements. Viability and feasibility of maintaining records for smaller units, thus, proves burdensome as compared to bigger hospitals. Some kind of abridged reporting framework, covering basic reporting elements, given the low risk attenuated, is needed for smaller facilities within the SHCO program.
In addition, availability of a common and simple digital platform for reporting would lesson the pressure on not so viable small healthcare units
4. Strict adherence to required staffing pattern is again an unsustainable exercise for smaller facilities. A 12 member staff team for five bed facilities adds enormously to its bottom line, which, otherwise, given the low strata of society it generally caters to, is meagre in comparison to bigger hospitals. Accreditation must review the scope of staffing pattern for all such healthcare facilities to make them sustainable, immediately, and in the long run.
5. India lives in villages, it is said, population in villages accounting for more than half of the total. Per village population of most of these 6.65 lakh villages is lesser than 10000. Owing to the size they lac immediate availability of even elementary healthcare facilities, some random healthcare unit functioning at centrally located convenience place. Burdening such small level facility with unviable rigors of accreditational implementation would further lead to inaccessibility of healthcare to this critical poverty-stricken populace of the country.
Given paucity of infrastructural build-up in remote rural sides on the one hand, and shortage of funds in the hands of healthcare providers on the other, coupled with the fact that trained healthcare professionals generally avoid postings in rural areas, there ought to be a separate set of regulatory frame work, within overall quality standard marks.
The author believes that taking care of above listed need-based adjustments in implementation of NABH accreditation would go a long way in sustaining healthcare to the deprived, the so-called ‘lesser mortal’.
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Footnotes
1. NABH, “History and Milestones,” Quality Council of India (2006)
2. The Quality Council of India was established jointly by the Government of India and Indian Industry represented by the three premier industry associations: Associated Chambers of Commerce and Industry of India (ASSOCHAM), Confederation of Indian Industry (CII), and Federation of Indian Chambers of Commerce and Industry (FICCI)
3. The Bombay Nursing Homes Registration Act, 1949 (Bombay Act No. XXXV of 1949), extended to all parts of Maharashtra in 1959
4. Bureau of Indian Standards (formerly Indian Standards Institution), established under the Bureau of Indian Standards Act, 1986
5. NABH, “Small Healthcare Organization (SHCO) Standards, 6th Edition” (2022), Quality Council of India
6. Maharashtra Adaptation of Laws Order, 1959
7. Maharashtra Nursing Homes Registration (Amendment) Rules, 2021, Rule 4(2)(c)
8. Census of India 2021, Provisional Population Totals for Maharashtra
9. Directorate of Health Services, Government of Maharashtra, Annual Report 2023-24
10. Indian Medical Association, Maharashtra Chapter, Survey Report on Private Healthcare Facilities (2022)
11. NABH, “SHCO Standards Manual,” 6th Edition (2025), pp. 15-28
12. NABH Eligibility Criteria for Small Healthcare Organizations, available at https://www.nabh.co/eligibility.aspx
13. NABH Circular No. NABH/FEE/2024/01, dated March 15, 2024
14. NABH, “Standards for Small Healthcare Organizations,” 6th Edition, effective April 1, 2025
15. NABH, “List of Accredited Healthcare Organizations,” updated as of January 2026, available at https://www.nabh.co/accredited.aspx
16. Brihanmumbai Municipal Corporation, Health Department, “NABH Accreditation Status of Municipal Hospitals” (2024)
17. National Health Authority, “Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB PM-JAY): Empanelment Guidelines,” Government of India (2023)
18. Government of Maharashtra, “Mahatma Jyotiba Phule Jan Arogya Yojana Guidelines,” Department of Public Health (2023)
19. World Health Organization, “COVID-19 Pandemic Timeline,” WHO Coronavirus Disease Dashboard
20. See generally, K. J. Kaufman et al., “The Rising Rate of Rural Hospital Closures,” Journal of Rural Health, Vol. 32, No. 1 (2016), pp. 35-43
21. Constitution of India, Seventh Schedule, List II (State List), Entry 6: Public health and sanitation; hospitals and dispensaries
22. Article 21 states: “No person shall be deprived of his life or personal liberty except according to procedure established by law”
23. Constitution of India, Part IV: Directive Principles of State Policy, Articles 38-47
24. Jyoti Nambiar v. Union of India & Ors, W.P.(C) 7735/2020, Delhi High Court (2020)
25. Hospitals Association, Nagpur v. Government of Maharashtra (Bombay HC, 2020) – regarding COVID-19 regulations and nursing home operations
26. Shakeel Shaikh v. Brihanmumbai Municipal Corporation & Ors, Public Interest Litigation before the Bombay High Court (2022)
27. Indian Medical Association, Maharashtra Chapter, “Memorandum to Health Minister on 2021 Amendment Rules,” dated June 2021
28. The Andhra Pradesh Clinical Establishments (Registration and Regulation) Act, 2002 (A.P. Act No. 16 of 2002)
29. The Clinical Establishments (Registration and Regulation) Act, 2010 (Act No. 23 of 2010)
30. NABH State-wise Accreditation Statistics, Quality Council of India (2024)