Simplifying Compliance Management For Hospitals

Simplifying Compliance
Management
for Hospitals
www.teamleaseregtech.com
Table of Contents
Executive Summary 03
Overview of the Healthcare Sector 04
Types of Healthcare Institutions 05
Regulatory Framework for Hospitals 07
Types of Compliances 27
Instances of Non-Compliance 31
State of Criminalisation 32
Compliance Challenges for Hospitals 33
Recommendations for Enabling Ease of Compliance 37

Executive Summary 3
EXECUTIVE
SUMMARY
This report examines the complexities Hospitals must navigate a labyrinth of 37 one-time
registrations and approvals and numerous ongoing
and challenges of compliance
compliances across seven categories: Labour,
management in Indian hospitals. It Finance & Taxation, Environment Health & Safety
provides an in-depth analysis of the (EHS), Secretarial, Commercial, Industry-Specific, and
General. Further compliance requirements include
regulatory framework, types of
over 100 certificates, licenses, permissions, and
healthcare institutions, and the approvals under various acts. Fire Safety
compliance landscape, offering compliances are also an important concern for
hospitals and require adherence to National Building
actionable recommendations to
Code (NBC) standards and NABH recommendations.
streamline processes and enhance
regulatory adherence. Hospitals face a wide range of challenges in their
compliance functions, including:
The Indian healthcare sector has seen remarkable
growth, with public expenditure rising to 2.2% of GDP in Lack of Accurate Compliance Lists: Managing
FY23 from 1.6% in FY21. Valued at US$ 372 billion in 2023,
623 unique compliances for a single 50-bed
the market is projected to reach US$ 638 billion by
hospital.
2025. Key growth drivers include the burgeoning
Fluid Regulatory Environment: Frequent
medical tourism market, valued at over $7 billion and
updates across 2,233 government websites.
expected to double by 2029, and the expanding e-
health market, projected to reach US$ 10.6 billion by Strict Liability Implications: High standards of
2025. The sector employs 7.5 million people, and the care required to avoid legal penalties.
integration of Artificial Intelligence (AI) is anticipated Poor Tracking of Licenses: Managing numerous
to create 3 million new jobs by 2028. Government licenses with different renewal timelines.
support is significant, with a $10.93 billion allocation in Event-Based Compliances: Tracking specific
the Interim Union Budget 2024-25 and a $6.8 billion events that trigger additional compliance
credit incentive program to boost healthcare
requirements.
infrastructure.
Manual Processes: Reliance on paper-based
systems and manual tracking.
The regulatory landscape for hospitals in India is
complex, involving numerous central and state-level Lack of Awareness: Poor understanding of
regulations. Key regulatory bodies include the compliance obligations at the management
National Accreditation Board for Hospitals & level.
Healthcare Providers (NABH), the Central Drugs
Standard Control Organisation (CDSCO), and the The report also prescribes recommendations for
Atomic Energy Regulatory Board (AERB). Hospitals enabling Ease of Compliance. These action items
must comply with regulations covering patient rights, include the creation of a Culture of Compliance and
infection control, record maintenance, professional adopting Digital Solutions. Effective compliance
training, and various acts like the Drugs and management is critical for hospitals to ensure quality
Cosmetics Act, Telemedicine Practice Guidelines, and care and regulatory adherence. By implementing the
the New Drugs and Clinical Trials Rules. recommended strategies, hospitals can streamline
compliance processes, reduce the risk of non-
compliance, and focus on delivering better
healthcare services.
Overview of the Healthcare Sector 4
Overview of the Healthcare Sector
The Indian healthcare sector has Policy and government support

witnessed remarkable growth and have played a pivotal role in the
development in recent years. As per sectoral growth. In the Interim Union
the Economic Survey 2022-23, India's Budget 2024-25, the government
public expenditure on healthcare allocated Rs. 90,659 crore ($10.93
increased to 2.1% of GDP in FY23 and billion) to the Ministry of Health and
2.2% in FY22, a notable rise from 1.6% Family Welfare (MoHFW).
in FY21. This surge underscores the Additionally, the government plans
government's commitment to to introduce a credit incentive
enhancing healthcare infrastructure program worth Rs. 50,000 crore
and services across the country. ($6.8 billion) to enhance healthcare
infrastructure.
The Indian healthcare market, valued
at US$ 372 billion, is projected to Investment inflows have also been
reach US$ 638 billion by 2025. The robust. Between April 2000 and
$7+ billion medical tourism market is December 2023, the drugs and
also projected to double by 2029. pharmaceuticals sector received
With around 630,000 international $22.37 billion in Foreign Direct
patients in 2023 alone, India has Investment (FDI), while hospitals,
established itself as a global leader diagnostic centres, and medical &
in advanced medical treatment. The surgical appliances sectors
sector is a major employer, with 7.5 attracted $9.81 billion and $3.26
million people employed as of 2024. billion, respectively. During FY2022-
The integration of Artificial 23 (up to December 2022), FDI
Intelligence (AI) within the sector is inflows in India stood at $36,746
expected to create nearly 3 million million.
new jobs by 2028, further bolstering
employment. This report delves into the
compliance landscape for hospitals
The e-health market is also poised in India, examining the regulatory
for significant growth, with an frameworks, standards, and
estimated market size of US$ 10.6 practices that govern healthcare
billion by 2025. The doctor-to- delivery. It aims to provide an insight
population ratio in India stands at into the challenges and complexities
1:854, assuming 80% availability of faced by healthcare institutions
the 12.68 lac registered allopathic such as hospitals in compliance
doctors and 5.65 lakh AYUSH doctors, management. It then provides
as reported by Dr Bharati Pravin actionable recommendations to
Pawar, Minister of Health & Family help organisations transform their
Welfare. This ratio highlights the compliance culture and workflows.
availability of a large pool of well-
trained medical professionals in the
country.
Types of Healthcare Institutions
Hospitals Hospice Homes
These are healthcare institutions with organised Hospice care facilities aim to improve the quality of
medical and other professional staff, and inpatient life for people with advanced and end-stage
facilities deliver medical, nursing and related services illnesses, their families and their caregivers. Hospice
24 hours per day, 7 days per week. Hospitals offer a centres differ from traditional health care settings
varying range of acute, convalescent and terminal because the goal of providers isn't to cure a patient's
care using diagnostic and curative services in condition but to maximise their comfort through a
response to acute and chronic conditions arising variety of palliative care options, which help relieve
from diseases, injuries, and genetic anomalies. pain. Additionally, hospice centres emphasise the role
of family members by offering them support during
the last stages of their loved one's life, including
Clinics and Medical Offices medical, psychological and spiritual support.
Clinics and medical offices usually specialise in one

or more areas of medicine and offer outpatient Dialysis Centers
treatment that doesn't require an overnight stay for
patients. Clinics and medical offices vary in size and Additionally, hospice centres emphasise the role of
staff and are either privately owned or part of a family members by offering them support during the
hospital or a larger healthcare network. These last stages of their loved one's life, including medical,
affiliations can affect the number of patients and the psychological and spiritual support.
rules for referrals to other specialists. Some common
clinics and medical offices are dental clinics, mental
health clinics, community health clinics and physical Mobile Clinics
therapy clinics.
There are fully-equipped mobile health centres that
deliver health care to impoverished families in dozens
of locations. Hundreds of patients daily benefit from
Community Health Centres
on-site services and free medicines these mobile
Community health centres (CHCs) are established vans provide. This is the only time for the residents to
and maintained by the State Government under the see a doctor in remote areas. Immediate needs are
MNP/BMS program in an area with a population of met, referrals are made when necessary, and chronic
120,000 people and in hilly/difficult-to-reach/tribal diseases are identified and treated on an ongoing
areas with a population of 80,000. As per minimum basis.
norms, a CHC is required to be staffed by four
medical specialists, that is, surgeon, physician,
gynaecologist/obstetrician and paediatrician, Nursing Homes
supported by 21 paramedical and other staff. It has
These are residential facilities that provide 24-hour
30 beds with an operating theatre, X-ray, labour
care for older adults or people with disabilities. These
room and laboratory facilities. It serves as a referral
facilities provide generalised or specialised care for
centre for PHCs within the block and also provides
patients with physical or mental health needs.
facilities for obstetric care and specialist
Generally, the illnesses and injuries treated in nursing
consultations.
homes aren't serious enough to require
hospitalisation but are too severe for home care.
Some facilities specialise in different levels of
treatment and care.
Blood Banks Addiction Treatment Centres
Only licensed blood banks are permitted to collect, These centres typically handle issues with alcohol and
process, store, and transport blood and blood drugs. Professionals can also treat other types of
components. The safety and quality of blood and addictions, like gambling, video game and shopping
blood components is ensured by the State Drugs addictions.
Control (Licensing Authority), the Drugs Controller
General (India) and the Central Drugs Standard
Control Organization (CDSCO) through licensing and Birth Centers
periodic inspections.
Birth centres are healthcare facilities that
specialise in childbirth. They aim to offer the
Mental Healthcare Institutions mother and family a comfortable birth

environment. Unlike hospitals, birthing centres don't
Mental health treatment facilities offer general usually have staff that readily provide obstetrics or
psychiatric and psychological care or specialise in one neonatal care.
area of psychiatry. These institutions provide inpatient
and outpatient care, depending on the severity of
patients' mental health needs. Rehabilitation Centres
Rehabilitation is care that can help you get back,

keep, or improve your daily life abilities. These
Imaging and Radiology Centers
abilities may be physical, mental, and/or cognitive
These types of facilities offer diagnostic imaging (thinking and learning). You may have lost them
services, such as ultrasounds, computerised because of a disease or injury or as a side effect of
tomography (CT) scans, magnetic resonance imaging a medical treatment. Rehabilitation can improve
(MRIs), X-rays and other specialised imaging tests. your daily life and functioning.
Many hospitals and clinics have this imaging AYUSH

equipment, but imaging and radiology centres offer a
variety of tests and imaging services that doctor's The Ayush system of medicine refers to India's
offices may not. The availability of these centres can traditional medicine system. It includes Ayurveda,
allow patients greater flexibility in scheduling their Yoga & Naturopathy, Unani, Siddha, Sowa Rigpa
imaging appointments. and Homoeopathy. While Ayurveda has a history of

over 5,000, the other systems covered under this
system all have a long history of being used for
Diagnostic Centres medical treatment.
These stand-alone organised facilities provide simple

to critical diagnostic procedures such as radiological
investigation supervised by a radiologist and clinical
laboratory services by laboratory specialists, usually
performed through referrals from physicians and other
health care facilities.
Regulatory Framework for Hospitals

In India, the regulatory framework for hospitals is complex and multifaceted, involving regulations at
both the central and state levels. The regulatory landscape encompasses various authorities,
standards, and compliance requirements, making it essential for healthcare entities to navigate
multiple layers of regulations to ensure adherence and quality care delivery. For instance, the
National Accreditation Board for Hospitals & Healthcare Providers (NABH) has developed
comprehensive accreditation standards for hospitals covering various aspects of healthcare
delivery, including patient care, clinical services, infrastructure, and management systems. These
include:
On the regulatory front, hospitals are subject to two

Ensuring patient rights, informed consent,
kinds of compliances: one-time and ongoing. A single
confidentiality, and provision of information to entity hospital operating in a single state is required
patients. to comply with 37 one-time registrations and
Implementing infection prevention and control approvals. These typically include incorporation of
measures to minimise healthcare-associated the entity, land allotment, approvals related to the
infections. project, construction, labour, environment, health and
Healthcare organisations are required to safety, tax-related registrations, and industry-specific

approvals, among others.
maintain comprehensive records of patient
care, treatment protocols, adverse events, and
Besides these one-time compliances, hospitals are
quality improvement activities.
subject to a variety of ongoing compliances at the
Healthcare professionals must undergo regular central, state and local levels, given the
training and competency assessments to decentralisation of power that characterises the
maintain high standards of clinical practice Indian polity. For instance, labour laws fall in the
and patient care. concurrent list, wherein the Centre and States are
entitled to legislate. Similarly, taxation and tax-
related regulations are split between the Centre and
States. Land is a state subject, but property transfer
In addition, there are compliances under the Drugs
(including registration of deeds and documents) falls
and Cosmetics Act, 1940, and Rules, 1945, Indian
in the concurrent list. Electricity is again a subject on
Council of Medical Research (ICMR) Guidelines,
the concurrent list with laws at both the central and
Telemedicine Practice Guidelines issued by the
state levels. Additionally, hospitals must ensure
Ministry of Health and Family Welfare, and New Drugs
compliance with local/municipal laws.
and Clinical Trials Rules, 2019, to name a few. In
addition, the corporate side of the industry is
The regulatory requirements of hospitals can be
regulated by the MCA and other departmental-
classified into 7 broad categories:
specific regulations.
In cases of professional negligence, patients are

empowered to take legal action against the Labour Industry-Specific
healthcare professional and, in some instances, the
Finance & Taxation General
hospital. Liability arises from the criminal law system,
consumer laws, and National Medical Commission Environment, Health & Safety
regulations. Patients can simultaneously approach the
Secretarial
criminal court, the consumer court, and the medical
commission. Consequently, all of these authorities can Commercial
penalise a medical professional/ hospital.
While the requirements under most of these categories remain consistent and constant across industries and
sectors, there are vast deviations regarding industry-specific requirements.
Table 1: List of Reporting Authorities for a Hospital*
Level of Governance Reporting Authority
Central Central Drugs Standard Control Organisation
Chief Labour Commissioner
Department of Atomic Energy
Department of Consumer Affairs
Department of Health and Family Welfare - Ministry of Health and Family Welfare
Department of Pharmaceuticals
Department of Revenue, Government of India
Employees' State Insurance Corporation
Food Safety and Standards Authority of India
Ministry of Corporate Affairs
Ministry of Electronics & Information Technology
Ministry of Road Transport and Highways
Ministry of Statistics and Programme Implementation
Ministry of Women and Child Development
National Medical Commission
State Department of Goods an Service Tax, Govt. of Maharashtra
(Maharashtra)
Electrical Inspectorate, Industries, Energy and Labour Department, Govt. of Maharashtra
Home Department of State of Maharashtra
Labour Department, Govt. of Maharashtra
Legal Metrology Organization, Govt. of Maharashtra
Maharashtra Fire Services, Govt. of Maharashtra
Maharashtra Labour Welfare Board, Labour Department, Govt. of Maharashtra

Maharashtra Nursing Council
Maharashtra Pollution Control Board
Maharashtra Right to Public Service Commission
Maharashtra State Pharmacy Council
Public Health Department, Govt. Of Maharashtra
Social Justice and Special Assistance Department, Govt. Of Maharashtra
Welfare Commissioner, Labour Department, Govt. of Maharashtra
Municipal Mumbai Municipal Corporation
*Single entity, 50-bed hospital with a diagnostic centre, radiology, pathology lab, and pharmacy with a
corporate office operating in the Greater Mumbai
APPROVALS Furthermore, approval of a Radiological Safety Officer
Every hospital must obtain close to 100 certificates, is necessary for procuring any new radiotherapy
licenses, permissions, and approvals under at least equipment.
58 acts and rules at various stages of business from

Central and State authorities. These stages can be Hospitals must also register under the Pre-
classified as follows: Conception and Pre-Natal Diagnostic Techniques

(Prohibition of Sex Selection) Act, 1994, and
pharmacists must be registered under the Indian
Setting Up Pharmacy Act, 1948. The Narcotic Drugs and
Pre-Commissioning Stage Psychotropic Substances (NDPS) Act, 1985, requires a
Post-Commissioning Stage certificate of recognition for storing and using these
Post-Establishment substances. Under the Drugs and Cosmetics Act,
1940, and its associated rules, hospitals must obtain
licenses for operating blood banks, retail and
Hospitals must adhere to numerous registration and
wholesale drug licenses, approval as a blood storage
approval requirements to ensure compliance with
center, and an NOC from the State Blood Transfusion
relevant regulations. These include obtaining a No
Council (SBTC). For organ transplantation, hospitals
Objection Certificate (NOC) for radiotherapy
must register under the Transplantation of Human
equipment and commissioning approval before
Organs Act, 1994, for both the transplantation of
energizing such equipment under the Atomic Energy
human organs and the registration of tissue banks.
(Radiation Protection) Rules, 2004. Additionally,
Finally, hospitals must secure licenses for establishing
hospitals must secure licenses for the commissioning
or maintaining psychiatric hospitals or nursing
and operation of medical diagnostic X-ray
homes in accordance with the Mental Healthcare Act,
equipment. They also need authorisation from the
2017, and the Mental Healthcare (State Mental Health
Atomic Energy Regulatory Board (AERB) for procuring
Authority) Rules, 2018.
radiotherapy equipment like teletherapy machines,
brachytherapy devices, simulators, CT simulators,
and kV imaging systems.
Figure 1: Distribution of Approvals, Permissions, etc. on the basis of Acts
60
52 No. of Acts
50 No. of Approvals/
Permissions
40
32
31
30 25
20 16
10
2
0
Central State Municipal
Figure 2: Approvals across the stage of business
120
100
52 3
100
80
60
42
40
20
0
Pre Post Post
Setting Up Total
Commissioning Commissioning Establishment
Furthermore, these approvals can also be classified based on the 7

categories of compliance.
Figure 3: Approvals to Establish, Start, and Continue Operations

across Compliance Categories
Finance & Taxation 5%

Secretarial 3%
22% General 5 3
22
15 Commercial 15%
11% Labour 11
26
18
Industry-Specific 26%
18% EHS
Table 2: An illustrative list of licenses, permissions etc., has been presented below
Name of Legislation Approvals / Registrations / Permissions
Air (Prevention & Control of Pollution) Act,

1981, Water (Prevention & Control of Pollution) Consent to Establish & Consent to Operate
Act, 1974, Environment Protection Act, 1986
Ancient Monuments and Archaeological Sites

NOC from the Department of Cultural Affairs, Directorate of Archaeology, if the
and Remains (Amendment and Validation)
project site is near the monuments
Act, 2010
The Apprentices Act, 1961 & Apprenticeship

Registration of Establishment
Rules, 1992
Arms Act, 1959 & Arms Rules, 2016 Licence for acquisition and possession of firearms and ammunition
Atomic Energy (Radiation Protection) Rules, Approval of the Radiological Safety Officer for obtaining procurement
2004 permission for any Radiotherapy equipment in the new Radiotherapy facility
Approval of survey report
Authorisation from AERB for procurement of equipment (e.g. Teletherapy

equipment, Brachytherapy equipment, Simulator, CT-Simulator and kV imaging
system) and radioactive sources to be used in Radiotherapy equipment
Commissioning approval before energising equipment for radiation
Licence/Registration for Commissioning / Operation of Medical Diagnostic X-

Ray Equipment
Registration for operation of Medical Diagnostic X-ray Equipment
Type approval certificate or NOC for Radiotherapy equipment
Bombay Prohibition Act, 1949 & Bombay

Permission to use spirit
Rectified Spirit Rules, 1951
Building and Other Construction Workers

(Regulation of Employment and Conditions of
Service) Act, 1996 and Maharashtra Building
and Other Construction Workers (Regulation
of Employment and Conditions of Service)
Rules, 2007
Coastal Regulation Zone Notification, 2011 Coastal Regulation Zone Clearance
Companies Act, 2013 & Companies Private Limited Company - Digital Signature Certificate (DSC) & Director
(Incorporation) Rules, 2014 Companies Act, Identification Number (DIN)
2013
Approval for Name & Certificate of Incorporation
Contract Labour (Regulation & Abolition) Act,

1970 & Maharashtra Contract Labour Registration of Principal Employer
(Regulation & Abolition) Rules, 1971
Registration of dentists in the State Register or the Indian Dentist

Dentists Act, 1948
Register (To be done by dentists but checked by Hospital)
Drugs and Cosmetics Act, 1940 & Drugs and Cosmetics Personnel Approval of Blood Storage Centre (To be done by
Rules, 1945 Technician and medical oflicer)
Approval as Blood Storage Centre in Annexure C
License for operating blood bank
Retail Drug License
Wholesale Drug License
NOC by State Blood Transfusion Council (SBTC)
EIA Notification, 2006 Environment Clearance
Electricity Act, 2003 & Central Electricity Authority

(Measures Relating To Safety and Electric Supply) Consent for setting up captive power plant
Regulations, 2023
Final Electrical Installation Certificate
Permission for charging of MSEDCL line for more than 650 Volts
Employees' State Insurance Act, 1948 Registration of Establishment
Maharashtra Electricity Duty Act, 2016 and Maharashtra

Layout Approvals for DG sets
Electricity Duty Rules, 1962
Permission for charging Diesel
Generator Sets for more than 250 KV
Registration of Diesel Generator Sets
Employee Provident Funds and Miscellaneous Provisions

Act, 1952 and Employees Provident Fund Scheme, 1952
(EPFS), Employees Pension Scheme, 1995 (EPS), Registration of Establishment
Employees Deposit-linked Insurance Scheme, 1976
(EPLIS)
Environment Protection Act, 1986 & Bio-Medical Waste

Authorisation for handling bio-medical waste
Management Rules, 2016
Explosives Act, 1884 NOC for controlled Blasting for Excavation
Food Safety and Standards (Licensing and Registration FSSAI license for operating a kitchen(License for food
of Food Businesses) Regulations, 2011 business)
Gas Cylinder Rules, 2016 License for storage of LPG
Guidelines to regulate and control Ground Water Permission/ Clearance for abstraction of groundwater/ drilling for
Extraction in India (With effect from 01.06.2019) Industrial purposes
Income Tax Act, 1961 Obtaining PAN
Obtaining TAN
Income tax exemption Certificate
Indian Boilers Act, 1923 Registration of Boiler Indian Boilers Act, 1923 Registration of Boiler
Indian Forest Act, 1927 & Maharashtra Forest Rules, 2014 Tree Transit Pass
Registration of doctors in State Medical Register or the Indian

Indian Medical Council Act, 1956 Medical Register (To be done by doctors but checked by the
Hospital)
Indian Nursing Council Act, 1947

Registration of nurses in the State Medical Register or the Indian
Maharashtra Nurses Act, 1966
Medical Register (To be done by nurses but checked by the
Maharashtra Nursing Council Rules, 1971
Hospital)
Maharashtra Nursing Council By-Laws, 1973
Indian Pharmacy Act, 1948 Registration of Pharmacists
Inter-State Migrant Workmen (Regulation of

Employment and Conditions of Service) Act, 1979 and
Inter-State Migrant Workmen (Regulation of Registration of the establishment
Employment and Conditions of Service) (Maharashtra)
Rules, 1985
Legal Metrology Act, 2009 & Maharashtra Legal

Verification of weight or measure before putting into use
Metrology (Enforcement) Rules, 2010
Maharashtra (Mumbai) Nursing Homes Registration Act,

1949 & Maharashtra Nursing Homes Registration Rules, Registration of Nursing Homes
1973
Maharashtra Electricity Regulatory Commission

(Standards of Performance of Distribution Licensees,
Power Connection for Construction
Period for Giving Supply and Determination of
Compensation) Regulations, 2014
Maharashtra Fire Prevention and Life Safety Measures

Final Fire NOC
Act, 2006
Fire Safety Certificate
Provisional Fire NOC
Maharashtra Goods and Services Tax Act, 2017 Obtaining GSTN
Maharashtra Labour Welfare Fund Act, 1953 & Bombay

Labour Welfare Fund Rules, 1953
Maharashtra Land Revenue Code, 1966 & Maharashtra

NOC for Excavation/Royalty Payment
Land Revenue (Restriction on use of Land) Rules, 1968
Approval for Lift / Elevator for Plant (Passenger Lifts)

Maharashtra Lifts, Escalators & Moving Walks Act, 2017
License to Operate Lifts
Maharashtra Mathadi, Hamal and other manual Workers

Registration of Employer
(Regulation of Employment and Welfare) Act, 1969
Maharashtra Private Security Guards (Regulation of

Employment and Welfare) Act, 1981 & Maharastra Private
Registration of Principal Employer
Security Guards (Regulation of Employment and
Welfare) Scheme, 2002
Maharashtra Regional Town Planning Act, 1966 Health License
Maharashtra Shops and Establishments (Regulation of

Employment and Conditions of Service) Act, 2017 &
Registration of Hospital / Clinical Establishment
Maharashtra Shops and Establishments (Regulation of
Employment and Conditions of Service) Rules, 2018
Maharashtra State Tax on Professions, Trades, Callings

PTEC / PTRC
and Employments Act, 1975
Medical Termination Of Pregnancy Act, 1971 & Medical Certificate of Approval in Form B(Registration under Medical
Termination of Pregnancy Rules, 2003 Termination Of Pregnancy Act, 1971)
Mental Healthcare Act, 2017 & Mental Healthcare (State License for establishment or maintenance of psychiatric hospitals or
Mental Health Authority) Rules, 2018 psychiatric nursing homes
Micro, Small and Medium Enterprises Entrepreneurship Memorandum Part-1 Under MSME Act, 2006
Development Act, 2006
Entrepreneurship Memorandum Part-2 Under MSME Act, 2006
Udyam Registration Certificate (e-Certificate)
Udyam Registration Number
Motor Vehicles Act, 1988 & Maharashtra Motor Vehicles

Vehicle Registration Certificate (For all hospital vehicles)
Rules, 1989
Mumbai Municipal Corporation Act, 1888 Issue of No Due Certificate
Building Completion Certificate
Building Layout Approval
Commencement Certificate / Construction Permit
Intimation of disapproval (Building Permit)
NOC for Storm Water and Drain
NOC from Sewarage Department

NOC from the Traffic and Co-ordination Department
Non-Agriculture Permission
Occupancy Certificate
Ownership Certificate / Extract
Permanent Water Connection
Plinth Completion Certificate
Water Connection for Construction
Maharashtra Felling of Trees (Regulation) Act, 1964 Permission for Felling / Trimming / Re-plantation of trees
Certificate of Recognition for storing and usage of Narcotic Drugs

Narcotic Drugs and Psychotropic Substances Act, 1985
and Psychotropic Substances (NDPS)
National Accreditation Board for Testing and Calibration Accreditation from the National Accreditation Board for Testing and
Laboratories (NABL) Calibration Laboratories
No Objection Certificate (NOC) for height clearances -

Air Traffic Management Circular No. 6 of 2017Guidelines
NOC from Airport Authority
for Filing Online Application for NOC (Height Clearance)
Through NOCAS, NOC Revalidation and Appeal to the
Appellate Committee (MoCA)
Payment of Gratuity Act, 1972 and Payment of Gratuity

Registration of the establishment(Notice of Opening)
(Maharashtra) Rules, 1972
Petroleum Act, 1934 License for storage of Petroleum products (Class B)
Poisons Act, 1919 & Maharashtra Poisons Rules, 1972 License for storage and usage of Acid / Poisons
Pre-Conception and Pre-Natal Diagnostic Techniques

Certificate of registration
(Prohibition of Sex Selection) Act, 1994
Registration Act, 1908 Registration of Land with the Department of Registration & Stamps
The Control of National Highways (Land & Traffic) Act,

2002 Guidelines / Norms for Grant of permissions for
Permission for Highway Crossing, access road through highway,
construction of access to Fuel Stations, Wayside
right of way etc.
amenities, connecting roads, other properties, rest area
complexes & such other facilities dated 26th June 2020
Certification of Registration of hospital for transplantation of human

organs
Transplantation of Human Organs Act, 1994
Certification of Registration of Tissue Bank

Table 3: Illustrative list of authorities responsible for multiple approvals
Number of Approvals/
Issuing Authority
Registrations/ Permissions
Municipal Corporation of Greater Mumbai 12
Atomic Energy Regulatory Board (AERB) 7
However, the complexities do not

Labour Commissioner 5
end there. These registrations,
Maharashtra Pollution Control Board (MPCB) 4 licenses, permissions, etc., all
have different timelines for their
Department for Micro, Small and Medium approval. This affects the
4
Enterprises (MSME)
hospital's business planning and
operations as some approvals
Registrar of the Companies (ROC) 3
take much longer than others.
Maharashtra State Electricity Distribution Co.

3
Ltd.
Director Maharashtra Fire & Emergency

3
Services Chief Fire Officer (CFO)
Public Works Department (Electrical) 3
Table 4: Timeline for obtaining Approvals, Registrations & Permissions
Timeline for Approval, Number of Approvals, Registrations, Additionally, each license/

Registration, Permission Permissions
permission/ registration/ approval
requires hospitals to pay a different
1 to 15 Days 18
fee. This can be either a fixed fee or
calculated based on several factors,
15 to 30 Days 22
such as the project's total area, total
30 to 90 Days 13
investment, and number of
employees. Furthermore, there are
90 to 196 Days 7 additional registrations,
certifications, approvals etc., that
No timeline 2 become applicable once the
hospital starts operations,
Issued on the Same Day 2 increasing the complexity of
compliance. The very nature of
Others 34
compliances also differs based on
their level (Governance level),
category, and type.
*Single entity, 50-bed hospital with a diagnostic centre, radiology, pathology lab, and pharmacy with a corporate office operating in the
Greater Mumbai
LEVELS OF COMPLIANCE
The overlapping of legislative powers among the
union and the state governments adds another layer
of complexity to the regulatory framework. For
instance, ‘labour’ and ‘electricity’ fall under the
concurrent list of the seventh schedule of the
Constitution of India, empowering both the union and
state governments to legislate on it. As a result, a
company must comply with not only Union laws but
also the laws of the state in which it operates. A
particularly complex situation is that of ‘Land’ as it is
a state subject, but ‘transfer of property excluding
agricultural land’ falls under the concurrent list.
Yet another example is ‘taxation’. The power to

impose and collect taxes on different matters has
been spread across the union, state and concurrent
lists. Thus, some taxes (such as corporate tax) are
payable to the union government, while others (such
as stamp duty) are payable to the state government.
Some taxation powers (such as property tax) have
also been devolved to municipal bodies.
This division of law-making authority across various

levels of government has created three levels of Figure 4: Compliances at Central, State, and
compliance - union, state and municipal. Municipal Levels for a Hospital*
On average, a single entity, 50-bed hospital with a 500
diagnostic centre, radiology, pathology lab, and 421

400
pharmacy with a corporate office operating in the
Greater Mumbai area in the state of Maharashtra
300
faces 623 unique obligations, of which 421 (67.5%) are
at the union level, 192 (31%) are at the state level, and 200 192
10 (1.5%) are at the municipal level. In terms of
frequency of these compliances, there are 27 100
monthly, 12 quarterly, 11 half-yearly and 47 annual 10

0
compliances. Ongoing, checklisted, event-based and
Central State Municipal
other compliances account for 523 obligations.
Greater Mumbai
3.3 CATEGORIES OF COMPLIANCES

The compliance requirements for a hospital can be
broadly classified across seven categories. Each of
these categories contains several laws, rules and
regulations with varying degrees of applicability
depending on the company's size, nature and
operations. A typical single-entity 50-bed hospital
with a diagnostic centre, radiology, pathology lab,
and pharmacy with a corporate office in a single
state needs to deal with 623 unique compliances.
However, this figure inflates to 967 once we factor in
the annual frequency of these obligations. This
figure can go even higher given the nature of
ongoing and event-based compliances that do not
have a fixed frequency.
Table 5: Category-wise frequency of compliances for a hospital* in a single state
Frequency
Category Others
Seven Five Two Half (Event-
Annual Quarterly Monthly Total
Yearly Yearly Yearly Yearly Based, One-
Time)
Labour 1 - - 14 6 4 12 154 191
Finance and
- - - 10 - 5 11 17 43
Taxation
Environment,
Health and - - - 4 2 - 2 115 123
Safety (EHS)
General - - - 2 - - - 16 18
Commercial 1 - - 3 2 1 2 17 26
Secretarial - 1 - 12 1 1 - 36 51
Industry Specific - - - 2 - 1 - 168 171
Total 2 1 - 47 11 12 27 523 623
Total Annual
Obligations
(annual freq. X 2 1 - 47 22 48 324 523 967
no. of
compliances)
Source: TeamLease RegTech
Greater Mumbai
Labour Maharashtra Workmen's Minimum House-Rent

This category includes 29 union laws that have now Allowance Act, 1983 & Maharashtra Workmen's
been consolidated into four labour codes. Since Minimum House-Rent Allowance Rules, 1990
labour is a subject in the concurrent list, it is Maternity Benefit Act, 1961 and Maharashtra
legislated by the union government, and each of Maternity Benefit Rules, 1965
these laws is accompanied by a host of state
Minimum Wages Act, 1948 & Maharashtra
legislations. There are also various delegated
Minimum Wages Rules, 1963
legislations, such as rules and regulations, both at
Payment of Bonus Act,1965 & Payment of Bonus
the union and state levels. As such, hospitals must
Rules, 1975
create a list of applicable acts, rules and regulations
to understand their obligations better. Payment of Gratuity Act, 1972 and Payment of
Gratuity (Maharashtra) Rules, 1972
Presented below is an illustrative list of applicable Rights of Persons with Disabilities Act, 2016 and
regulations under labour compliance: Rights of Persons with Disabilities Rules, 2017
Sexual Harassment of Women at Workplace
Contract Labour (Regulation & Abolition) Act, (Prevention, Prohibition & Redressal) Act, 2013 &
1970 & Maharashtra Contract Labour Sexual Harassment of Women at Workplace
(Regulation & Abolition) Rules, 1971 (Prevention, Prohibition & Redressal) Rules 2013
Employees Compensation Act, 1923 &
Maharashtra Employees’s Compensation Rules,
1934 Hospitals must adhere to several labour
Employees State Insurance Act, 1948 & regulations to ensure the welfare and rights of their
Employees State Insurance (General) employees. For instance, they are required to
maintain a Register of Contractors in Form VIII
Regulations, 1950 & Employees State Insurance
under the Contract Labour (Regulation & Abolition)
(Central) Rules, 1950
Act, 1970, and the Maharashtra Contract Labour
Employment Exchange (Compulsory
(Regulation & Abolition) Rules, 1971. Additionally,
Notification of Vacancies) Act, 1959 &
they must keep a Register of Employees in Form 6
Employment Exchange (Compulsory as mandated by the Employees State Insurance
Notification of Vacancies) Rules, 1960 Act, 1948, and its associated regulations and rules.
Equal Remuneration Act, 1976 and Equal Hospitals are also responsible for providing and
Remuneration Rules, 1976 maintaining first aid facilities for their workers and
Maharashtra Labour Welfare Fund Act, 1953 & providing identity cards to its workers in
Bombay Labour Welfare Fund Rules, 1953 accordance with the Maharashtra Shops and
Establishments (Regulation of Employment and
Maharashtra Private Security Guards
Conditions of Service) Act, 2017, and its rules.
(Regulation of Employment and Welfare) Act,
Furthermore, they must also maintain a Muster Roll
1981 & Maharashtra Private Security Guards
cum Wage Register in Form II as stipulated by the
(Regulation of Employment and Welfare) Minimum Wages Act, 1948, and the Maharashtra
Scheme, 2002 Minimum Wages Rules, 1963. In addition, they are
Maharashtra Shops and Establishments required to frame and publish an equal opportunity
(Regulation of Employment and Conditions of policy for disabled persons under the Rights of
Service) Act, 2017 and Maharashtra Shops and Persons with Disabilities Act, 2016, and the Rights of
Establishments (Regulation of Employment and Persons with Disabilities Rules, 2017. These are some
of the several labour compliance obligations that
Conditions of Service) Rules, 2018
compliance teams must manage.
Secretarial Under the secretarial category, hospitals are required

to maintain a register of significant beneficial owners
Secretarial compliances comprise legislation related in Form No. BEN-3 as per the Companies (Significant
to corporate governance and risk management. Beneficial Owners) Rules, 2018. Additionally, hospitals
While the union government enacts the laws, the must keep detailed cost records in Form CRA-1 under
rules and regulations are issued by the Ministry of the Companies (Cost Records and Audit) Rules, 2014.
Corporate Affairs (MCA), Securities and Exchange The Companies Act, 2013, and the Companies
Board of India (SEBI), etc. There are several rules and (Accounts) Rules, 2014 calls for the preparation and
regulations under the overarching Companies Act, maintenance of book of accounts and maintenance
2013. of financial statements as per the outlined
accounting standards.
Presented below is an illustrative list of applicable
regulations under secretarial compliance:
Finance and Taxation
Companies Act, 2013 and Companies
This category includes laws on direct taxes (Income
(Acceptance of Deposits) Rules, 2014 Tax, Property Tax and Corporate Tax) and on indirect
Companies Act, 2013 and Companies taxes (GST, Excise Duty, and Customs Duty).
(Accounts) Rules, 2014
Companies Act, 2013 and Companies Presented below is an illustrative list of applicable
(Appointment and Qualification of Directors) regulations under finance and taxation compliance:
Rules, 2014
Companies Act, 2013 and Companies (Audit Income Tax Act, 1961 and Income Tax Rules, 1962
and Auditors) Rules, 2014 Central GST Act, 2017 and Central GST Rules,
Companies Act, 2013 and Companies 2017
(Incorporation) Rules, 2014 Maharashtra GST Act, 2017 and Maharashtra
Companies Act, 2013 and Companies GST Rules, 2017
(Corporate Social Responsibility) Rules, 2014 Maharashtra State Tax on Professions, Trades,
Companies Act, 2013 and Companies Callings and Employments Act,1975 and
(Management and Administration) Rules, 2014 Maharashtra State tax on Professions, Trades,
Companies Act, 2013 and Companies Callings and Employments Rules, 1975
(Meetings of Board and its Powers) Rules, 2014 State-specific laws for taxes on professions,
Companies Act, 2013 and Companies trades, callings and employment
(Registration of Charges) Rules, 2014
Companies Act, 2013 and Companies
Under the Maharashtra State Tax on Professions,
(Significant Beneficial Owners) Rules, 2018
Trades, Callings, and Employments Act, 1975, and its
Companies Act, 2013 & Companies (Share
subordinate rules, hospitals are required to maintain
Capital and Debentures) Rules, 2014
a register of salaries, wages, and deductions and
Companies Act, 2013 and Companies (Cost furnish a monthly return in Form IIIB (PTRC), detailing
Records and Audit) Rules, 2014 the same. The Income Tax Act, 1961, and Income Tax
SS-1 Secretarial Standard on Meetings of the Rules, 1962, mandate that hospitals to submit their
Board of Directors audit report in Form 3CD and submit quarterly TDS
SS-2 Secretarial Standard On General Meetings returns for foreign payments.
Under the Central Goods and Services Tax Act, 2017,

Environment (Protection) Act, 1986 and Plastic
and the Maharashtra Goods and Services Tax Act,
2017, along with their respective rules, hospitals are Waste Management Rules 2016
required to furnish an annual return in Form GSTR-9. Environment (Protection) Act, 1986 and Solid
They must also maintain and preserve backups for Waste Management Rules, 2016
electronic records of documents to ensure Maharashtra Fire Prevention and Life Safety
compliance with GST regulations. These requirements Measures Act, 2006 and Maharashtra Fire
are crucial for maintaining transparency, ensuring Prevention and Life safety Measures Rules, 2009
accurate financial reporting, and adhering to tax
Patient's Rights and Responsibilities in all
obligations, thus upholding legal and fiscal
Clinical Establishment vide D.O. No.
accountability. These are some of the several finance
Z.28015/09/2018-MH-II/MS dated June 02, 2019
& taxation related compliance obligations that
compliance teams must manage.
EHS compliances also constitute an integral part of

Environment, Health and Safety (EHS) the regulatory framework for hospitals. For instance,
they must adhere to the Indian Standard for the
This category covers all environmental issues, such Selection, Installation, and Maintenance of First-Aid
as pollution, waste management, and hazardous Fire Extinguishers under the Bureau of Indian
substance discharge. It comprises regulations Standards Act, 2016. This includes regular inspection
related to Air, Water and Noise Pollution and Waste and maintenance of fire extinguishers, keeping
Management (Bio-Medical, Solid Waste, E-Waste, records, placing extinguishers in conspicuous places,
Plastic Waste, and Hazardous Waste), among others. maintaining at least 10% of spare refills in stock, and
conducting annual inspections.
regulations under EHS compliance: Compliance with the Solid Waste Management Rules,
2016, mandates the segregation of dry and non-
Atomic Energy Act, 1962 and Atomic Energy biodegradable waste. Under the Atomic Energy Act,
(Radiation Protection) Rules, 2004 1962, and Atomic Energy (Radiation Protection) Rules,
Bureau of Indian Standards Act, 2016 read with 2004, hospitals must conduct health surveillance of
workers every three years, display radiation symbols
Indian Standard - Selection, Installation and
or warning signs, and establish written procedures for
Maintenance of First-Aid Fire Extinguishers -
controlling and monitoring exposure to ensure
Code of Practice
adequate protection. This includes maintaining
Constructional and Functional Requirements
records of workers, ensuring preventive maintenance
for Road Ambulances (National Ambulance of radiation protection equipment, periodic
Code) verification of radioactive material, and conducting
Environment (Protection) Act, 1986 & quality assurance tests. Records of radiation doses
Environment (Protection) Rules, 1986 received by therapy patients and other relevant
Environment (Protection) Act, 1986 and Battery parameters must be maintained, and the
Waste Management Rules, 2022 radiological safety officer must submit periodic
safety reports to the competent authority.
Environment (Protection) Act, 1986 and Bio-
Medical Waste Management Rules, 2016
Environment (Protection) Act, 1986 and E-
Waste (Management) Rules, 2022
Environment (Protection) Act, 1986 and Noise
Pollution (Regulation And Control) Rules, 2000
The Bio-Medical Waste Management Rules, 2016, Hospitals need to adhere to certain commercial
require hospitals to submit an annual report in Form- obligations, stemming from food business operations
IV, establish a bar-code system for bio-medical on its premises and the usage of electricity, motor
waste bags or containers, maintain a daily updated vehicles, and weights and scales. Under the Food
bio-medical waste management register, and Safety & Standards Act, 2006, and the Food Safety
display monthly records of waste generated on the and Standards (Licensing and Registration of Food
hospital’s website. Records for the operation of Businesses) Regulations, 2011, they must provide an
incineration, hydro, or autoclaving must be adequate supply of potable water to meet
maintained for five years, along with records related operational and cleanup needs. Additionally, the
to the generation, collection, reception, storage, maintenance of floors and ceilings is required to
transportation, treatment, and disposal of bio- maintain hygiene.
medical waste. Annual reports and minutes of
committee meetings must be submitted to the In case the hospital is also a captive generator of
prescribed authority, such as the State Pollution electricity, the Maharashtra Electricity Duty Act, 2016,
Control Committee. These are some of the several and Maharashtra Electricity Duty Rules, 1962,
EHS compliance obligations that compliance teams mandate the submission of a quarterly return in Form
must manage. B. Furthermore, under the Legal Metrology Act, 2009,
and the Maharashtra Legal Metrology (Enforcement)
Rules, 2011, weights, capacity measures, length
Commercial measures, tape measures, beam scales, and counter
machines must be re-verified every two years.
This category includes all laws overseeing the
production and trade of goods and services.
General
regulations under Commercial compliance:
All legislations that are not under any of the other six
categories are categorised as general laws.
Collection of Statistics Act, 2008 and Collection

Presented below is an illustrative list of regulations
of Statistics (Central) Rules, 1959 under General compliance:
Motor Vehicles Act, 1988 and Central Motor
Vehicle Rules, 1989
Cigarette and Other Tobacco Products
Food Safety & Standards Act, 2006 & Food
(Prohibition of Advertisement and the
Safety and Standards (Licensing and
Regulation of Trade and Commerce,Production,
Registration of Food Businesses) Regulations,
Supply and Distribution) Act, 2003 & Prohibition
2011
of Smoking in Public Places Rules, 2008
Legal Metrology Act, 2009 and Maharashtra
Information Technology Act, 2000 and
Legal Metrology (Enforcement) Rules, 2011
Information Technology (Reasonable Security
Maharashtra Electricity Duty Act, 2016 and
Practices and Procedures and Sensitive
Maharashtra Electricity Duty Rules, 1962
Personal Data or Information) Rules, 2011
Disaster Management Act, 2005 and underlying
directions
Information Technology Act, 2000 and
Information Technology (The Indian Computer
Emergency Response Team and Manner of
Performing Functions and Duties) Rules, 2013
Mumbai Municipal Corporation Act, 1888
Hospitals must comply with regulations under the However, the number of compliance obligations can
Information Technology Act 2000 and the Information vary depending on the state.
Technology (Reasonable Security Practices and
Procedures and Sensitive Personal Data or Presented below is an illustrative list of regulations
Information) Rules, 2011. They are required to maintain under industry-specific compliance:
reasonable security practices for data protection.
This includes conducting annual audits to ensure
Atomic Energy Act, 1962 and Radiation Safety in
these security practices and procedures are
Manufacture, Supply and Use of Medical
adequately implemented and maintained.
Additionally, hospitals must comply with the Diagnostic X-Ray Equipment
Cigarette and Other Tobacco Products (Prohibition of Atomic Energy Act, 1962 and Radiation
Advertisement and the Regulation of Trade and Surveillance Procedures for Medical Application
Commerce, Production, Supply, and Distribution) Act, of Radiation, 1989
2003, and the Prohibition of Smoking in Public Places Clinical Establishments (Registration and
Rules, 2008, by displaying "NO SMOKING AREA" signs at Regulation) Act, 2010 and Clinical
the entrances.
Establishment (Central Government) Rules,
2012
Industry Specific Drugs and Cosmetics Act, 1940 and Drugs and
Cosmetics Rules, 1945
Apart from the above mentioned several different
Drugs and Cosmetics Act, 1940 and Schedule N
types of compliances, hospitals must also manage a
- List of minimum equipment for the efficient
variety of industry-specific compliances. As indicated
runninig of a pharmacy
earlier, hospitals are often involved in bio-hazardous
Drugs and Magic Remedies (Objectionable
processes and therefore, the risk stemming from
non-compliance is concomitantly high. Many of the Advertisement) Act, 1954 and Drugs and Magic
compliances that compliance officers are required to Remedies (Objectionable Advertisements)
manage to find their roots in international Rules, 1955
conventions. This subsection will elaborate on the Essential Commodities Act, 1955 and Drugs
applicable industry-specific compliances: (Price Control) Order, 2013
Figure 5: Category-Wise Compliances for a Guidelines for Protection of Good Samaritans -
Hospital* in a single state Notification No. 25035/101/2014-RS. dated May

12, 2015
Indian Medical Council Act, 1956 and Indian
Labour
Industry-Specific Medical Council (Professional conduct,
27.4%
Secretarial 191 Labour Etiquette and Ethics) Regulations, 2002
30.7%
171 Indian Medical Council Act, 1956 and Integrated
Finance and
Taxation Total Disease Surveillance Project, 2004
Compliances
Indian Medical Council Act, 1956 and Maternal
EHS 18 623
General
26 Death Review Guidelines
2.9% 51
Commercial Commercial
123 43 Indian Medical Council Act, 1956 and Medical
4.2% Secretarial
8.2% Council of India Regulations, 2000
General EHS
19.7%
Finance and Taxation Indian Medical Council Act, 1956 and TB
6.9%
Industry-Specific Notification Guidance, 2012
Maharashtra Nurses Act, 1966 and Maharashtra
Nursing Council Rules, 1971
Greater Mumbai
The Indian Medical Council Act, 1956, and the Indian

Maharashtra Nursing Homes Registration Act,
Medical Council (Professional Conduct, Etiquette and
1949 and Maharashtra Nursing Homes Ethics) Regulations, 2002, require physicians to
Registration Rules, 1973 maintain medical records for indoor patients for
Medical Termination of Pregnancy Act, 1971 and three years, keep a register of medical certificates
Medical Termination of Pregnancy Rules, 2003 issued, notify public health authorities of
Narcotic Drugs and Psychotropic Substances communicable diseases, and maintain
Act, 1985 and Maharashtra Narcotic Drugs and comprehensive patient records, including case
histories, investigation reports, images, and
Psychotropic Substances Rules, 1985.
prescription records for in-person consultations.
Narcotic Drugs and Psychotropic Substances
Act, 1985 and Narcotic Drugs and Psychotropic
Substances (Regulation of Controlled FIRE SAFETY COMPLIANCES
Substances) Order, 2013
Pharmacy Act, 1948 and Maharashtra State In recent years, fire-related incidents in hospitals
have been on a rise. According to the National Crime
Pharmacy Council Rules, 1969
Records Bureau (NCRB), Maharashtra and Gujarat
Pharmacy Act, 1948 and Pharmacy Practice
together accounted for 30 percent of fire-related
Regulations, 2015
fatalities last year. Electrical faults and human
Pre-conception and Pre-natal Diagnostic negligence were cited as primary causes. Delhi has
Techniques (Prohibition of Sex Selection) Act, also reported numerous hospital fires in the past few
1994 and Pre-conception and Pre-natal years. In most instances of fires, local authorities
Diagnostic Techniques (Prohibition of Sex have been found negligent in conducting routine fire
Selection) Rules, 1996 safety audits. Fire services in India fall under state
Registration of Births and Deaths Act, 1969 and jurisdiction and are considered a municipal function.
However, statutory bodies issue guidelines and
Maharashtra Registration of Births and Deaths
recommendations that prescribe the regulatory
Rules, 1976
framework for fire safety. Fire safety regulations in
India are published by the Bureau of Indian
Standards (BIS) under the National Building Code
Hospitals must adhere to various regulatory (NBC). The National Disaster Management Authority
requirements to ensure compliance with the Narcotic (NDMA) also mandates specific fire safety criteria for
Drugs and Psychotropic Substances Act, 1985, and public structures such as hospitals, including
the Maharashtra Narcotic Drugs and Psychotropic provisions for open safety spaces, evacuation
Substances Rules, 1985. This includes making annual procedures, dedicated staircases, and evacuation
disclosures to the licensing authority regarding the drills.
purchase and consumption of manufactured drugs
and maintaining detailed accounts of drugs received, The most common causes of fires in hospitals include
used, and held in stock. the presence of combustible materials like cotton
beddings, sanitizers, oxygen pipeline connections in
Under the Pharmacy Act, 1948, and the Pharmacy patient rooms and operation theatres, and chemicals
Practice Regulations, 2015, hospitals are required to in laboratories. Faulty electrical wiring or frayed wires
maintain patient records for five years, along with often cause electrical short circuits in hospitals. In
proper documentation of compounding, labeling, modern constructions, these wires are concealed,
dispensing of drugs, and prescription records. making it difficult to track the source of the fire.
Additionally, hospitals must document and maintain
records of drugs administered to patients and inform
authorities about any cases of communicable
diseases. The Pre-Conception and Pre-Natal
Diagnostic Techniques (Prohibition of Sex Selection)
Act, 1994, mandates that hospitals preserve the
names of individuals who have received genetic
counseling for two years.
Fire Prevention Standards National Accreditation Board for Hospitals &

Healthcare Providers (NABH) Recommendations
National Building Code
The NABH has also published recommendations for

The NBC outlines several fire prevention standards.
fire safety. These include:
Some of them are enlisted below:
Conducting regular fire risk assessments and

Buildings with a total covered area of 500 m²
audits to identify vulnerabilities and ensure
and above must protect load-bearing steel
compliance with fire safety regulations.
beams and columns against failure or collapse
Implementing robust fire prevention measures,
in case of fire.
including properly storing flammable materials,
An emergency power distribution system is
maintaining electrical systems, and installing
necessary for fire and life safety systems and
fire detection and suppression systems.
equipment, including fire pumps, pressurisation
Providing regular training to staff members on
and smoke venting systems, fireman’s lifts, exit
fire evacuation procedures, including the safe
signage lighting, emergency lighting, fire alarm
evacuation of patients with special needs.
systems, public address (PA) systems,
Periodically reviewing and updating fire safety
magnetic door hold/open devices, and lighting
policies and procedures to address emerging
in the fire command centre and security room.
risks and incorporate best practices.
Air conditioning and ventilating systems must
Hospitals must regularly conduct electrical
be installed and maintained to minimize the
load audits, particularly when adding new
danger of spreading fire, smoke, or fumes from
equipment or converting spaces into ICUs.
one floor to another or from outside to any
They must strictly adhere to regulatory
occupied building.
requirements and obtain valid fire No-
Fire doors with a 120-minute fire-resistance
Objection Certificates (NOCs) from their
rating are required for non-naturally ventilated
respective state fire departments.
areas, and all exits and exit passageways must
Implementing strict no-smoking policies and
have a clear ceiling height of at least 2.4
controls on heat sources in areas with oxygen
meters.
tanks or piped oxygen. Signage should clearly
Additionally, gas pipes should be run on
mark these areas, and staff should be trained
external walls in separate shafts away from
on the risks associated with high-oxygen
staircases, and pump houses should be
environments.
separated by firewalls, with doors protected by
fire doors with a 120-minute rating. The
pressure in the sprinkler system should not
exceed 12 bar; if higher pressure is required,
high-pressure sprinklers must be installed.
Ministry of Housing and Urban Affairs (MOHUA) Fire Safety Recommendations

Recommendations
The NABH has also published recommendations for

The MOHUA has also issued recommendations for
fire safety. These include:
fire safety during the construction of hospitals.
These include:
Periodic fire drills and training to help the
hospital staff to understand their roles and
Prohibition on the usage of
responsibilities during a fire emergency
combustible/flammable material for
Regular inspection of fire exits
partitioning, wall panelling, false ceiling etc. In
The location of the firefighting equipment
addition, any material that releases toxic
should be identified, and the building
gases/smoke must also not be used if involved
occupants should be aware of the location of
in the fire.
the fire protection equipment, manual call
All hospital buildings of 15 m. and above or
points, smoke detectors
having a number of beds exceeding 100 need
An assembly point should be designated
to appoint a qualified fire officer
outside the hospital building with a clear path
Electric distribution cables/wiring must be laid
to reach the assembly point.
in a separate duct and should be sealed on
Regular inspection of the Firefighting system
every floor with non-combustible material. The
and the fire alarm system
fire resistance of the duct must be similar to
Laboratory experiments or pressure vessels
that of the material.
should not be left unattended
The ducting should be constructed of metal in
Adequate housekeeping should be ensured in
accordance with BIS 655:1963
the pharmacy and fire extinguishers should be
The material used for insulating the duct
provided to deal with a fire eventuality
system (inside or outside) should be flame
Fire retardant material must be used for the
resistant (IS 4355: 1977) and non-conductor of
curtains, bedsheets, ceiling and wall claddings
heat
Regular third-party fire safety audits must be
Boilers must be installed in a fire-resistant
conducted for the hospital buildings
room of 4 hours fire resistance rating
Regular inspection of electrical points, circuit
Welding or use of a blow torch must only be
boards, and wiring
done under strict supervision. It must be in full
conformity with the requirements laid down in
IS: 3016-1966 code of practice for fire
precautions in welding and cutting operations.
Types of Compliances 27
Types of Compliances
Having looked at the different categories of compliances, this section will look at the broad types in which such
compliances are typically classified.
Figure 6: Type-wise Compliances for a AUDIT AND ACCOUNTS

hospital*
Different auditing requirements are required for
hospitals under different laws. For instance, under
Appointments 8
Information Technology Act 2000 and Information
Audit and Accounts 5 Technology (Reasonable Security Practices and
Certificates and Licenses 53 Procedures and Sensitive Personal Data or
Committees and Meetings 12 Information) Rules, 2011, the hospital must conduct an
Display Requirements 69 annual audit of reasonable security practices and
Employee Safety and Welfare 33 procedures. The Maharashtra Fire Prevention and Life
Examination, Inspection &Testing 32 Safety Measures (Amendment) Act, 2023, added
Register and Records 112 Section 45A which added the obligation for a Fire &
Return Filing & Disclosures 65 Life safety audit of buildings once in two years.
Statutory Payments 41
Others 193 As per the Secretarial Standard on General Meetings

0 50 100 150 200 (SS-2) approved by the Central Government, any
adverse qualifications, observations or comments on
the financial transactions that are mentioned in the
APPOINTMENTS
auditor’s report must be read out at the Annual
Under the Companies Act, 2013, and the Companies General Meeting.
(Audit and Auditors) Rules, 2014, hospitals must file a
Notice of Appointment of Auditor in Form ADT-1.
Additionally, eligible companies must appoint a Cost CERTIFICATES AND LICENSES
Auditor as stipulated by the Companies (Cost
The Maharashtra Nursing Homes Registration Act,
Records and Audit) Rules, 2014, and file a notice of this
1949, and Maharashtra Nursing Homes Registration
appointment with the Central Government in Form
Rules, 1973, require hospitals to obtain a renewed
CRA2. They are also required to appoint a
certificate of registration in Form C from the local
Radiological Safety Officer to ensure compliance with
supervising authority. Additionally, hospitals must
radiation safety standards under the Atomic Energy
obtain a certificate of registration in Form B from the
Act, 1962, and the Atomic Energy (Radiation
appropriate authority under the Pre-conception and
Protection) Rules, 2004.
Pre-natal Diagnostic Techniques (Prohibition of Sex
Selection) Act, 1994, and its rules.
Furthermore, they are mandated under the Pharmacy
Act, 1948, and the Pharmacy Practice Regulations,
Under the Indian Medical Council Act, 1956, and TB
2015, to appoint registered pharmacists to oversee
Notification Guidance, 2012, hospitals must register
the dispensing of medications and ensure adherence
for TB notification in Form Annexure I with the Nodal
to pharmaceutical standards.
Officer for TB Notification in the district. Furthermore,
under the Drugs and Cosmetics Act, 1940, and Drugs
and Cosmetics Rules, 1945, hospitals must renew their
license to sell, stock, exhibit, offer for sale, or distribute
drugs other than those specified in Schedule C, C1,
and X. Compliance with these regulations ensures
proper management of controlled substances,
registration of medical facilities, notification of
communicable diseases, and adherence to
pharmaceutical distribution standards.
Greater Mumbai
Types of Compliances/ 9 28
COMMITTEES AND MEETINGS Furthermore, under the Indian Medical Council Act,
1956, and the Indian Medical Council (Professional
Hospitals must institute committees and ensure that Conduct, Etiquette, and Ethics) Regulations, 2002,
mandatory meetings are being convened. Under the physicians are required to display their registration
Maharashtra Shops and Establishments (Regulation numbers in their clinics and on all prescriptions,
of Employment and Conditions of Service) Act, 2017, certificates, and money receipts.
and its rules, they must constitute a Health, Safety,
and Welfare Committee to oversee and ensure the A significant number of display requirements are
well-being of employees. The Sexual Harassment of contained under labour laws. For example, laws such
Women at Workplace (Prevention, Prohibition & as the Child and Adolescent Labour (Prohibition and
Redressal) Act, 2013, mandates the reconstitution of Regulation) Act, 1986, Employees Compensation Act,
the internal committee every three years to address 1923, Maternity Benefit Act, 1961, Minimum Wages Act,
and prevent sexual harassment. 1948 and Payment of Gratuity Act, 1972 make it
mandatory for an employer to display an abstract of
Under the Environment (Protection) Act, 1986, and the the Act and Rules within the establishment. The
Bio-Medical Waste Management Rules, 2016, Minimum Wages Act, 1948 and Contract Labour
hospitals are required to hold meetings of a (Regulation and Abolition) Act, 1970 impose additional
dedicated committee to review activities related to requirements such as displaying notice regarding the
bio-medical waste management. The Companies rates of wages, dates of payment of wages and rest
Act, 2013, along with the Companies (Management days.
and Administration) Rules, 2014, requires holding an
Annual General Meeting to discuss and review the The Rights of Persons with Disabilities Act, 2016
company's annual performance and strategies. requires employers to display an equal opportunity
Additionally, under the Companies (Meetings of policy for disabled persons. The Sexual Harassment of
Board and its Powers) Rules, 2014, regular meetings of Women at Workplace (Prevention, Prohibition and
the Board of Directors must be conducted to oversee Redressal) Act, 2013 mandates the display of a flow
and guide the company’s operations and decision- chart of the sexual harassment complaint redressal
making processes. process and the names and contact details of the
members of the Internal Committee. Under the
DISPLAY REQUIREMENTS Cigarette and Other Tobacco Products (Prohibition of

Advertisement and the Regulation of Trade and
Hospitals are required to adhere to several display Commerce, Production, Supply and Distribution) Act,
requirements. Under the Atomic Energy Act, 1962, and 2003 & Prohibition of Smoking in Public Places Rules,
the Atomic Energy (Radiation Protection) Rules, 2004, 2008, stores are required to display a “No Smoking
they are required to display radiation symbols or Area” sign at the public entrance.
warning signs to indicate areas where radiation is
used, ensuring safety and awareness among staff
and patients. Under the Medical Termination of
Pregnancy Act, 1971, and the Medical Termination of
Pregnancy Rules, 2003, hospitals must display the
certificate of approval for conducting medical
terminations of pregnancy, confirming that they are
authorized to perform such procedures. Additionally,
under the Pre-conception and Pre-natal Diagnostic
Techniques (Prohibition of Sex Selection) Act, 1994,
and its rules, hospitals must display notices
prohibiting the disclosure of the sex of the fetus to
prevent sex-selective practices.
EMPLOYEE SAFETY AND WELFARE Hospitals are required to conduct general medical
examination for its workers every 3 years and maintain
Several provisions have been made under the surveillance of its workers involved with radioactive
Minimum Wages Act, 1948 such as providing substances under the Atomic Energy Act, 1962 and
explanations about proposed fines or deductions, Atomic Energy (Radiation Protection) Rules, 2004.
intimating the amount of fines or deductions and
giving wages for rest days in case the employee was
given a substituted rest day. REGISTER AND RECORDS
There are a variety of compliances for registers and
Under the Maternity Benefit Act, 1961, a hospital
records under various laws. The Contract Labour
employing 50 or more employees must provide
(Regulation and Abolition) Act, 1970 requires employers
crèche facilities with all necessary arrangements and
to maintain a register of contractors. The Payment of
supplies and allow 4 crèche visits per day to women
Bonus Act, 1965 requires maintaining a register showing
employees. It must also permit 2 nursing breaks of 5-
the computation of allocable surplus, set-on and set-off
15 minutes until the child attains the age of 15 months.
of allocable surplus and bonus payable. The Minimum
Wages Act, 1948 lays down compliances for maintaining
The Sexual Harassment of Women at Workplace
an inspection book and a register of wages, fines and
(Prevention, Prohibition & Redressal) Act, 2013 makes
overtime. Under the Environment (Protection) Act, 1986
provisions regarding skill-building programmes and
and Bio-Medical Waste Management Rules, 2016, every
seminars for the Internal Committee members,
occupier is required to maintain and update on a day-
dissemination of internal policy for promoting
to-day basis the bio-medical waste management
gender-sensitive safe spaces and awareness
register.
workshops for employees.
Under the Medical Termination of Pregnancy Act, 1971,

and the Medical Termination of Pregnancy Rules, 2003,
EXAMINATION, INSPECTION AND
TESTING they are required to maintain an Admission Register in
Form III. This register is crucial for documenting all
Certain requirements for examination, inspection and medical terminations of pregnancy performed within
testing have been prescribed under the Bureau of the facility. Additionally, under the Indian Medical
Indian Standards Act, 2016. These include monthly Council Act, 1956, and the Indian Medical Council
inspections and testing of all mechanical parts, (Professional Conduct, Etiquette, and Ethics)
extinguishing media and expelling means of fire Regulations, 2002, hospitals must maintain
extinguishers to be carried out by properly trained comprehensive patient records. These records include
and competent personnel. In premises where Diesel case histories, investigation reports, images, and other
Generator (DG) sets are used, the Environment relevant medical documentation. The regulations also
(Protection) Act, 1986 mandates a proper routine to mandate the maintenance of prescription records for
be set to prevent the deterioration of noise levels. in-person consultations, ensuring that all medical
advice and treatments are accurately recorded.
Under labour laws such as the Minimum Wages Act, Compliance with these regulations ensures that
1948 and Employees State Insurance Act, 1948, every hospitals maintain high standards of patient care, legal
employer is required to maintain an inspection book. accountability, and ethical medical practice.
Under EHS-related compliances such as the Bureau
of Indian Standards Act, 2016 read with Indian
Standard - Selection, Installation and Maintenance of
First-Aid Fire Extinguishers - Code of Practice, a
company is required to paste inspection cards on the
body of fire extinguishers and maintain records of
inspection and testing of the fire extinguishers
RETURN FILING AND DISCLOSURES

The compliances for return filing, disclosures and
intimations are primarily contained in the labour laws.
For instance, annual returns must be filed under the
Employees’ Compensation Act, 1923, Maternity Benefit
Act, 1961, Minimum Wages Act, 1948 Payment of Bonus
Act, 1965, Contract Labour (Regulation and Abolition)
Act, 1970 and quarterly returns under the Employment
Exchange (Compulsory Notification of Vacancies) Act,
1959.
Additionally, under the Indian Medical Council Act,

1956, and the Maternal Death Review Guidelines,
facilities are required to file Annexure 1 in the case of
maternal deaths. This ensures proper documentation
and review of such incidents to improve maternal
health outcomes. Under the Narcotic Drugs and
Psychotropic Substances Act, 1985, and the
Maharashtra Narcotic Drugs and Psychotropic
Substances Rules, 1985, hospitals must annually
furnish information regarding the purchase and
consumption of manufactured drugs to the licensing
authority.
Under the Environment (Protection) Act, 1986, and the

Bio-Medical Waste Management Rules, 2016, hospitals
are also required to provide information about all
accidents and the remedial steps taken in their
Annual Report. As per the Sexual Harassment of
Women at Workplace (Prevention, Prohibition and
Redressal) Act, 2013, the Internal Committee must
prepare and submit a report to the employer and
district officer. The Collection of Statistics Act, 2008
and Collection of Statistics (Central) Rules, 1959
mandate furnishing returns in the prescribed format
to the Statistics Authority.
STATUTORY PAYMENTS
Under the Employees’ State Insurance Act, 1948, an
employer must make monthly contributions in
respect of an employee to the Employees’ State
Insurance Corporation via electronic mode. Certain
statutory payments are also prescribed under the
Minimum Wages Act, 1948, Payments of Bonus Act,
1965 and Apprentices Act, 1961.
Various municipal and state laws also prescribe
statutory payments to be made for property tax,
advertising permit fees, Labour Welfare Board
contributions and electricity consumption tax, among
others.
Instances of Non-Compliance 31
Instances of Non-Compliance
Major instances of non-compliance in healthcare
institutions revolve around contravention of standards
of care, requirement of appropriate approvals, disposal
of bio-medical waste and fire prevention.
A number of hospitals have been fined for non-display

of hospital charges to the public. They have indulged in
unregistered usage of medical devices such as
ultrasound machines along with improper storage.
There have been instances of improper registration of
pregnant women before conducting sonography and
not maintaining proper records of tests. Hospitals have
also been found to violate procedures related to
disposal of bio-medical waste. These actions violate
the regulations laid down under Pre-Conception and
Pre-Natal Diagnostic Techniques Act, 1994, Assisted
Reproductive Technology (Regulation) Act, 2021, the
Surrogacy (Regulation) Act, 2021, and Bio-Medical
Waste Management Rules, 2016.
There are also violations related to Maharashtra

Nursing Homes Registration Act 1949 and Medical
Termination of Pregnancy (MTP) Act, 2021. Violations
include employing unregistered nurses, non-
maintenance of proper medical records, non-display of
shift times, to name a few. Furthermore, several
hospitals have been also found to have not maintained
grievance redressal records and not even appointed a
grievance redressal officer. Other violations relate to
maintaining a hygienic environment within the hospital
premises. A significant number of instances involved
non-display of qualification certificates of doctors and
healthcare professionals.
State of Criminalisation 32
State of Criminalisation
A thorough review of India’s business laws reveals that Classifying these across the seven categories of
imprisonment has been used as a tool of control against compliance, we find that EHS laws account for
entrepreneurs over the years. The report titled Jailed for one-third of all the obligations prescribing jail
Doing Business, co-authored by Gautam Chikermane terms.
and Rishi Agrawal, uncovers the nature and extent of the
risks of imprisonment faced by entrepreneurs in the Figure 8: Imprisonment Clauses across
country. Of the 1,536 laws that govern doing business in Levels of Compliance
India, more than half (54.9%) carry imprisonment
clauses. Among the 69,233 compliances contained in
these laws, two out of every five (37.7%) prescribe jail
terms for non-compliance. The monogram highlights
that a sizable portion of these clauses criminalises
73% 27%
procedural violations and technical lapses rather than
serious offences involving willful harm. It illustrates that
in many cases, there is an equivalence between
punishment for minor errors by entrepreneurs and for Central State
death due to negligence under the Indian Penal Code,
1860. Resultantly, the current business environment
reflects a sense of distrust and hostility towards Figure 9: Distribution of imprisonment
companies and raises barriers to the seamless flow of clauses across compliance categories
innovation, wealth and jobs in the economy.
Finance & Taxation 9

Figure 7: Imprisonment clauses as a share of
Secretarial 21
total compliances for a Hospital*
Commercial 6
Compliance EHS 94
Prescribing
Imprisonment
Industry Specific 66
45.3%
282 Labour 82
General 4
341 0 20 40 60 80 100
Compliance
Prescribing
Monetary Penalties
54.7% As evidenced by the data, the implications of
non-compliance can be severe. Hence, hospitals
must focus on establishing strong control over
With this basic premise of the monograph, Teamlease
their compliance obligations. Staying on top of the
Regtech has compiled data on the imprisonment
regulatory changes, filings, permissions, and
clauses facing hospitals. A single entity, 50-bed hospital
approvals, among others, must assume priority
with a diagnostic centre, radiology, pathology lab, and
for the institution.
pharmacy with a corporate office in a single state deals
with 623 compliances in a year. Among them, 282 (~45%)
compliances contain imprisonment clauses. 73% (206)
of these clauses are contained in Union laws while the
rest are within State laws.
Greater Mumbai
Compliance Challenges for Hospitals

Between the Indian Medical Council Act, 1956 and its Apart from these, hospitals are also expected to
subordinate regulations, and the Atomic Energy Act, adhere to the BIS and ISO Standards. On top of this,
1962 and Radiation Surveillance Procedures for laws and rules constantly undergo amendments,
Medical Application of Radiation, 1989, compliance leading to periodic changes in applicability and
officers in hospitals need to comply with tens of acts compliance obligations. The lack of an accurate list
and hundreds of rules, depending on the size of the of this diverse range of laws, rules and regulations
hospital. Depending on the nature of care provided by can make compliance an extremely challenging
the institution, there is also requirement to adhere by task for hospitals.
the compliances under Indian Medical Council Act,
1956, Pharmacy Act, 1948 etc.and their subordinate
regulations. FLUID REGULATORY ENVIRONMENT
India’s regulatory environment is fluid. Just in
Given below are some of the major compliance
FY2023-24, there were close to 8,000 regulatory
challenges faced by the healthcare sector. Many of
updates published on the 2,233 websites of union,
these are in congruence with a larger survey of clients
state and local government websites via
conducted by TeamLease Regtech on regulatory
notifications, gazettes, circulars, ordinances,
complexity and the Ease of Doing Business in India.
master circulars, and press releases, among others.
These updates typically lead to changes in forms,
LACK OF AN ACCURATE LIST OF dates, timelines, frequencies, fines, interest rate
APPLICABLE COMPLIANCES calculations, applicability threshold values, and

letters of the law, among others. Since these
A single-entity 50-bed hospital with a diagnostic changes are often applicable almost immediately,
centre, radiology, pathology lab, and pharmacy with a they require a time-sensitive interpretation and
corporate office in a single state needs to deal with implementation. There were over 4,000 regulatory
623 unique compliances in a year. As the hospital updates that affected in the healthcare industry in
increases its size, scale, and geographical footprint, the last financial year. Among these, more than
the number of compliances multiply. These 2,200 were issued by Central level authorities.
compliances are at three levels - centre, state and
local. In addition, they are spread across seven Unfortunately, there is no centralised repository of
compliance categories - labour, environment, health regulatory updates that provides national, real-
and safety (EHS), finance and taxation, commercial, time, comprehensive and personalised information
secretarial, industry-specific and general. on all changes that affect the compliance burden.
Identification of the applicable compliances for a As a result, the compliance officers are often
healthcare institution requires deep expertise. expected to periodically visit literally hundreds of
websites to ensure that they are not missing any
The applicability of compliance also varies based on critical updates.
the location of the hospital, no. of beds, nature of
medical care provided by it, diagnostic and laboratory
facilities available and use of specific equipment (such
as boilers, pressure vessels, weights and measures,
heat exchangers, fire extinguishers, centrifuges, etc.). In
addition, there are challenges pertaining to the ever-
changing threshold quantities and its notification to
the concerned authority. Most hospitals in India find it
highly challenging to track compliance for such a
broad spectrum of regulations.
STRICT LIABILITY IMPLICATIONS

Healthcare is a critical sector that involves the health
and safety of patients. As such, the doctrine of strict
liability becomes applicable to healthcare institutions
to ensure a high standard of care and safety of the
patients. Under the Medical Termination of Pregnancy
Act, 1971, and the Medical Termination of Pregnancy
Rules, 2003, they must submit an application for
approval of the place for medical termination of
pregnancy in Form A.
Additionally, under the Atomic Energy Act, 1962, and
the guidelines for Radiation Safety in the Manufacture,
Supply, and Use of Medical Diagnostic X-Ray
Equipment, hospitals must provide structural shielding
in X-ray rooms to prevent radiation exposure.
Servicing of X-ray equipment must be carried out by
agencies authorized by the regulatory body to ensure
safety and compliance with radiation standards. The
Pharmacy Act, 1948, and the Pharmacy Practice
Regulations, 2015, prohibit the appointment of
unregistered or unlisted attendants, ensuring that only
qualified personnel handle pharmaceutical tasks.
Furthermore, hospitals must maintain records of drugs
administered to patients under the same act and
regulations.
Considering the diverse range of these compliance
requirements and the lack of any comprehensive
checklist in this regard, hospitals must always be alert
as to their compliance with these requirements. In
cases of poor compliance, strict liability can be
imposed on hospitals by the relevant authorities,
which can likely result in both criminal as well as
financial penalties.
POOR TRACKING AND

MANAGEMENT OF APPLICABLE
LICENCES
A typical healthcare institution in India deals with
tens if not hundreds of licenses. These include
medical licenses, shop and establishment
registrations, certification and standardisation
requirements by Atomic Energy Regulatory Board
(AERB), gas cylinder and boiler authorisations,
consent to operate, fire safety NOCs, hazardous and
biomedical waste authorisations, among many
others. An illustrative list of licenses has been
provided in Table 2.
POOR TRACKING OF ONGOING

Issue Date COMPLIANCES
Expiry Date
A typical hospital deals with a large number of
Categorisation of Industry (Red, Orange, Green, compliances that are ongoing in nature. These
White) include displays (licenses, registrations, abstracts of
Conditions of License (Client Specific) legislations, employee-related social security-based
Days for application for next renewal displays, labelling, storage conditions, emergency
planning, no smoking, fire exits, danger signs, GST
Number, abstract for the prohibition of employment of
child labour, etc.), maintenance of registers & records,
Licences, registrations, permissions, consent orders
and ensuring hygienic and sanitary conditions. These
and NOCs need to be tracked meticulously to
ongoing compliances when not adhered can result in
ensure that they are in good order, failing which,
a high cost of poor compliance.
there are serious business consequences. Most
organisations lack robust processes that provide
For instance, the company must maintain a variety of
adequate assurance for statutory licence
registers that must be current at all points of time.
management.
These include leave and attendance, wage registers,
temperature registers, records of disposal of waste,
admission registers, patient records, prescription
POOR TRACKING OF EVENT-BASED
records, and records of disposal of bio-medical waste,
COMPLIANCES
among at least 40 other unique registers in various
There are many instances where the applicability of formats.
licenses and compliances changes based on the
occurrence of specific business events. As a result, Creating, maintaining, reviewing and certifying that
the compliance officer needs to keep his eyes these registers are in compliance with the law of the
peeled to identify such occurrences, be ready to land is the responsibility of different people across the
interpret their impact on the organisation’s organisation. Unfortunately, there are no enterprise
compliance obligations and implement a quick and processes to track and maintain the digital copies of
comprehensive response. A hospital also deals with these registers and obtain periodic self-certification
various kinds of audits such as safety audits, from the relevant stakeholders.
environmental audits, and fire drills. Furthermore,
compliance teams must keep track of periodic
medical examinations of its workers involved with
radioactive machinery and maintain relevant
medical records. Hospitals are also required to
conduct committee meetings to review waste
management activities. For instance, bio-hazardous
waste is constantly generated in hospitals. This
waste needs to be disposed off with a significant
amount of paperwork and processes involved.
Employers often struggle to keep up with these
requirements, leading to lapses, delays and
defaults.
LACK OF AWARENESS AT MANAGEMENT ANECDOTAL COMPLIANCE

LEVEL CERTIFICATION
Based on a recent survey conducted by TeamLease
The Companies Act, 2013 mandates the issuance of
RegTech, it was discovered that the key managerial
compliance certificates to the Board. Since the
personnel (KMP) in Indian hospitals have a poor
organisation is lacking in technology-based tracking
understanding of compliance obligations in over 75%
systems, the compliance officer has no choice but to
of the instances.
prepare the statutory compliance certificates
manually.
As a result, they are often unpleasantly surprised in
instances of show cause notices, financial penalties,
These certificates often miss key information such as
cancelled licences, revoked permissions and leaked
the specific data on an instance of non-compliance,
revenue. Under the survey, most executives were
delayed filings and the residual risk of poor
found to have a very poor handle on the status of key
compliance. In such instances, the board is often
compliances, dates, documentation and residual risk
flying blind as they do not have any framework to
of non-compliance.
establish the level of compliance in the company.
MANUAL, PAPER BASED AND PEOPLE

DEPENDENT COMPLIANCE
A typical mid-sized hospital deals with a few

thousand compliances in a year. There are at least
50-100 people in different departments (human
resources, finance and taxation, company
secretarial, administration, environment, health and
safety, warehouse, research and development, etc.)
directly involved in day-to-day compliance
functions.
Unfortunately, while compliance is a key binding

constraint in an organisation’s growth, a number of
Indian organisations are yet to adopt technology
platforms for transparent and accountable
compliance programs. The compliance officers
often use spreadsheets to track status manually.
Resultantly, there can be many instances involving
inadvertent misses, delays, lapses, defaults, expired
licences and missed legal updates. Hence, it is not
uncommon to see them firefighting and highly
stressed during regulatory audits.
Recommendations for Enabling Ease of

Compliance
In India, employer compliance requires a complete overhaul. With the regulatory framework of the 19th and 20th
centuries, entrepreneurs have been unable to compete in the 21st century. Businesses can take a number of
actions to improve compliance management within their establishments. Some of the low-hanging fruits are
briefly highlighted below:
CREATING A CULTURE OF COMPLIANCES
The primary factor influencing any organisation is the "Tone at the Top." A
"Zero Tolerance" policy on compliance from the top management needs to
be evident at all organisational levels. A strong compliance management
programme is also implemented at the organisational level by the
compliance officers with the assistance of top management, which is
involved in the review of compliance statuses.
ADOPTING DIGITAL SOLUTIONS
Technology is the key to most of the problem statements, and compliance is not untouched. Several
RegTech players have emerged who have invested heavily in technology solutions to support
organisations in effectively tracking and managing their compliance programs. Additionally, a few
RegTech players have also introduced automation layers to reduce manual dependency and
intervention and reduce the overall cost of compliance for any organisation. Enterprises must consider
adopting solutions that can either automate the process of overall management or can also automate
the compliance document generation process as well.
Rationalisation Decriminalisation
There is a lot of duplication, redundancy and Criminal penalties in business laws should be
overlap across compliances. It is recommended used with extreme restraint. Misdemeanours
that a detailed analysis of such opportunities be such as procedural lapses and technical non-
conducted. The list should be classified into items compliances should be punished with financial
that can be executed by executive order and those penalties only whereas criminal penalties should
requiring legislative change. Based on an initial be retained only for serious crimes involving
assessment, at least 20 to 30% of the compliances intentional harm.
can be reduced without affecting the outcomes
A general and indicative set of standards should
The current process of inspections is ad-hoc, be adopted to guide lawmakers, executive
manual, paper-based and people-dependent. authorities and regulators in making laws, rules
There is limited transparency and accountability. and regulations. Such standards should include
The inspection process should be reviewed and a principles of necessity and proportionality.
risk-based, faceless, presence-less, cashless
inspection process should be implemented. All imprisonment clauses must go through
legislative scrutiny at least once in five years. For
Opportunities for self-certification and third-party this, sunset clauses can be introduced in the
inspections should be rolled out. legislative process to ensure either the renewal
or termination of imprisonment clauses
Digital interfaces (new license applications/ depending on their need and relevance in light
renewals/ return filings/ requests for inspection of the evolving business climate.
etc) should be identified and developed.
Digitisation
There should be a single digital portal for
centralised publishing of all regulatory updates
across various departments and ministries and
at all governance levels. The portal should be a
technology utility that should be extended to all
relevant stakeholders. It should provide the
capability to subscribe to automated alerts
based on filters such as type, industry, location
and compliance category, among others.
A digital platform to automate the creation of

all regulatory records for compliance should be
created. It should also facilitate the safe storage
and authentication of such records.
CONTACT US
TeamLease Regtech Pvt. Ltd.
Awfis Space Solutions Pvt Ltd, Opposite Commissioner Office,

1 Church road, Camp, Pune, Maharashtra 411001, India.
Bangalore, Mumbai, Kolkata, Hyderabad, Delhi, Chennai, Ahmedabad
9899245318
[email protected]
www.teamleaseregtech.com

Simplifying Compliance Management For Hospitals

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Simplifying Compliance

Overview of the Healthcare Sector 04

Types of Healthcare Institutions 05

Regulatory Framework for Hospitals 07

Compliance Challenges for Hospitals 33

Recommendations for Enabling Ease of Compliance 37

Overview of the Healthcare Sector

The Indian healthcare sector has Policy and government support

Types of Healthcare Institutions

Hospitals Hospice Homes

Clinics and medical offices usually specialise in one

Blood Banks Addiction Treatment Centres

Mental Healthcare Institutions mother and family a comfortable birth

Rehabilitation is care that can help you get back,

Many hospitals and clinics have this imaging AYUSH

imaging appointments. and Homoeopathy. While Ayurveda has a history of

These stand-alone organised facilities provide simple

Regulatory Framework for Hospitals

On the regulatory front, hospitals are subject to two

Healthcare organisations are required to safety, tax-related registrations, and industry-specific

In cases of professional negligence, patients are

Table 1: List of Reporting Authorities for a Hospital*

Level of Governance Reporting Authority

Central Central Drugs Standard Control Organisation

Chief Labour Commissioner

Department of Atomic Energy

Department of Consumer Affairs

Department of Revenue, Government of India

Employees' State Insurance Corporation

Food Safety and Standards Authority of India

Ministry of Corporate Affairs

Ministry of Electronics & Information Technology

Ministry of Road Transport and Highways

Ministry of Statistics and Programme Implementation

Ministry of Women and Child Development

National Medical Commission

State Department of Goods an Service Tax, Govt. of Maharashtra

Home Department of State of Maharashtra

Labour Department, Govt. of Maharashtra

Legal Metrology Organization, Govt. of Maharashtra

Maharashtra Fire Services, Govt. of Maharashtra

Maharashtra Labour Welfare Board, Labour Department, Govt. of Maharashtra

Maharashtra Nursing Council

Maharashtra Pollution Control Board

Maharashtra Right to Public Service Commission

Maharashtra State Pharmacy Council

Public Health Department, Govt. Of Maharashtra

Social Justice and Special Assistance Department, Govt. Of Maharashtra

Welfare Commissioner, Labour Department, Govt. of Maharashtra

Municipal Mumbai Municipal Corporation

APPROVALS Fu﻿rthermore, approval of a Radiological Safety Officer

licenses, permissions, and approvals under at least equipment.

58 acts and rules at various stages of business from

classified as follows: Conception and Pre-Natal Diagnostic Techniques

Figure 1: Distribution of Approvals, Permissions, etc. on the basis of Acts

Figure 2: Approvals across the stage of business

Furthermore, these approvals can also be classified based on the 7

Figure 3: Approvals to Establish, Start, and Continue Operations

Finance & Taxation 5%

APPROVALS Furthermore, approval of a Radiological Safety Officer