Module III

Module III
 Building Regulations
 Development Authority
 Regulations, Rules & Bye-Laws
 Land within Jurisdiction of Panchayat,
Nagar Palika / Notified Area
 Cantonment
 Power and Water Connections
 Liability to local and other Taxes,
Charges etc.
Rules, Regulations, Bye-
Laws for Starting a
Hospital / Clinic in India
The necessary steps & legal requirements to be taken to set up
hospitals in India.
 Hospitals can primarily be of two types- government or private.
 Further, they can be General, Speciality or Multispecialty
hospitals.
Following are the pointers one needs to keep in mind and set in
place for setting up a private hospital in India:
 1. Location of the Hospital
 Thishas to be chosen well, because if there are already some
hospitals in the locality, then it will be difficult to pool in patients.
 Also,the hospital needs to be set up in an area which has good
transportation facility or is close to a railway station.
 Considering the cost of real estate, a huge financial investment is
required.
2.Facilities the Hospital offers
One has to be sure what set-up is planned
and what infrastructure is required.
A pediatric, orthopedic, gynecologic,
oncology, pathology, imaging, etc facility in
the hospital all require different facilities.
3. Permits for the Hospital
A. Land and construction
Land allotted for agriculture cannot be used. To start building the hospital wing, several
permissions from local authorities need to be taken. Numerous documents need to be approved,
like land deed, architect’s plan, etc. An occupation certificate is to be obtained after clearing all
formalities.
B. Electricity and water
As per the requirements of the hospital, permission has to be taken from the local governing body
to obtain electric meters and water supply. Water requirement has to be calculated, which for any
setup is approx 100 litres per day.
C. Sewage
Proper disposal of waste requires a well planned sewage and drainage system, which is done after
permission is sought from the local board.
D. Biomedical waste
This is very vital aspect and permission of Municipal Corporation is required for installing
incinerators required to dispose of medical waste and body parts.
E. Fire and Health Licence
A Fire licence is necessary to prove that the hospital will not cause any damage or loss of life and
needs to be procured from the local municipal council.  Procuring a health licence is vital to
provide health care to the patients.
 4. Planning the Hospital Infrastructure
 Take care of all these:
1. Doctors, their qualifications and registration numbers recorded
2. Nurses and working shifts
3. Medical equipment and instruments
4. Computers and other hardware devices
5. Engineers and staff required for maintenance, plumbing, medical gas pipelines, air
conditioning, etc.
 Multiple medical laws and ethics must be followed at every step. A set of
guidelines and eligibility criteria have been put forth by the government for
hospitals, which provide services to central government health scheme
beneficiaries.
 A tremendous amount of planning, large finances, approvals, certifications,
licences and guidelines need to be followed while setting up a hospital in India. It
needs ample time and mammoth effort to pool together the resources in place.
 Registration & Legal
Requirements for Starting a
Hospital / Clinic in India
 Setting up a hospital / Clinic in India isn’t a smooth sail.
 The complex course of regulatory approvals and associated
paperwork is undoubtedly cumbersome to deal with
 However, more daunting is the cost constraint. Not only
establishing a health care facility but its on-going maintenance
demands full-fledged financial planning for hospital set-up.
 1. Registration under the Clinical Establishment Act, 2017
 This Act was enacted by the central government and is being
adopted by States in India.
 It needs a one-time registration for a premise towards being
operated as a hospital.
 The registration must be done by the respective state government
that has adopted this Act
 2. Registration under companies Act, 2013
 This Act is applicable when the hospital established it under the
ownership of a Corporation.
 The Act needs that the corporation is registered and fulfills the
requirement of incorporation like memorandum of association,
articles of association, capital structure formation, securities
allotment, account audits, etc.

 3. Director Index No (DIN NO) for each Director

 This comes under the Ministry of Corporate Affairs, Government of
India. It is a compulsory registration required for each director who
wants to be a part of a corporation. It is a onetime registration for
directors.
 4. Registration under Societies Registration Act, 2001
 In case the hospital is being established under the ownership of society,
the Society Registration Act is applicable
 See the reference below for different health care services/ Speciality
and the license under relevant laws:
 The other important license required is:
1. Regulations Building Permit and Licenses (From the Municipality)
2. No objection certificate from the Chief Fire Officer "License under Bio-
Medical Management and Handling Rules, 1998.
3. No objection certificate under the Pollution Control Act.
4. Narcotics and Psychotropic Substances Act, 1985
5. Vehicle Registration Certificates (For all hospital vehicles.)
6. Atomic energy regulatory body approvals (For the structural facility of
radiology dept, TLD badges, etc)
7. Boilers Act, 1923 (If applicable)
8. MTP Act, 1971 (MTP stands for Medical termination of pregnancy. To
be displayed in the Gynaec and Obs department)
9. License for the Blood Bank (To be displayed in the Blood Bank)
10.Transplantation of Human Organs Act 1994 (If applicable)
11. PNDT Act, 1996
12. Dentist Regulations, 1976
13. Drugs & Cosmetics Act, 1940
14. Electricity Act, 1998
15. ESI Act, 1948 (For contract employees)
16. Environment Protection Act, 1986
17. Fatal Accidents Act of 1855
18. Guardians and Wards Act, 1890
19. Indian Lunacy Act, 1912 (Applicable only if a Psychiatry
dept is there in the hospital)
20. Indian Nursing Council Act 1947 (Whether nurses are
registered with NCI).
21. Also one must check whether pharmacists are registered with the
Pharmacy Council of India
22. Insecticides Act, 1968
23. Lepers Act Maternity Benefit Act, 1961
24. Minimum Wages Act, 1948 (For contract employees)
25. Pharmacy Act, 1948
26. SC and ST Act, 1989
27. Protection of Human Rights Act, 1993
28. Registration of Births and Deaths Act, 1969
29. Urban Land Act, 1976
30. Right to Information Act 2005
31. Registration of Medico-Legal Cases
32. Accounts of Money Receipts and Expenses for the purposes of Income
Tax
• Recognizing the nature of the hospital: whether government or private
• Hospital Registration Certificate, Form C to be filled
• Approval by the competent authorities
• FSSAI license for operating a kitchen
• Pharmacy registration for medical shops within the hospital premises
• Certificate of registration of hospital with municipal corporations
• IMC/SMC registration certificate under the Indian Medical Council
Act, 2002
• Trademark registration
• Licensing of arms under the Arms Act, 1959.
• Registration for Transplantation under Transplantation of Human
Organ Act, 1994
• Excise permit to store spirits
 How much does it Cost to Setup a Hospital in India
 The cost to set up a hospital in India depends on two per-determinants:
1. The intended capacity of the health care facility.
2. The level of health care the facility intends to offers.
 The land and construction cumulatively require 50-60% of the total
capital cost. Once you’re sorted with finances for the land or
construction project, the entire set-up that follows to get the health
care facility fully functional comes down to roughly one half of what’s
already spent in acquiring or building the premises from the facility.
 The medical equipment, consumables, and ambulatory services though
doesn’t claim the lion’s share in setting up a small hospital in India, it’s a
recurrent cost.
 Implementing cost-effective procurement is an indispensable long-term
benefit to the organization and best to be also the part of initial
financial planning for hospital set-up.
• 1. Location of the hospital
• 2. Facilities the hospital offers
• 3. Necessary Permits for the hospital
• 3.1 A. Land and construction
• 3.2 B. Electricity and water
• 3.3 C. Sewage
• 3.4 D. Biomedical waste
• 3.5 E. Fire and Health Licence
• 4. Planning the hospital infrastructure
Essential Permits for Running the Hospital
 Permit procurement is one of the most important and decisive factors in
installing and running any hospital in India. Individuals or companies
planning to invest in this cause must ensure to acquire all legal permits
before its actual set up.
 Some of the mandatory permits needed for hospital set up are:
• Land and Construction
• Sewage and Sanitation
• Water
• Electricity
• Biomedical Waste
• Fire
• Health permits
Plan the Infrastructure
 Next in the process, one requires expert civil engineers and architects to construct the
actual hospital building. This step entails the presence of both physical and human
resources. The physical infrastructure includes:
• The hospital building and the concrete material used for its dynamic construction
• Installation of sewage lines, fire extinguishing system, lifts, emergency alarms, well-
furnished ICU, pathological labs, OPDs, general and emergency wards.
• Purchasing suitable medical machines and surgical tools and instruments
• Setting up of computer and other hardware systems including security devices and CCTV
cameras; Hospital Apps.
 In addition to the above, proper human resource planning for a successful hospital
comprises:
• Employment of educated and qualified doctors, nurses, and other working staff for the
smooth running of a hospital.
• Other significant labor includes ward boys, watchmen, cleaners, and maintenance staff
(engineers, legal, insurance and accounts officers, fire extinguishers, air-conditioning and
gas pipeline operators, etc. )
 Building Regulations & Bye-Laws

The Town & Country Planning Organization under the

Ministry of Urban Development has made efforts to
prepare “Model Building Bye-Laws- 2016” for the
guidance of the State Governments, Urban Local Bodies,
Urban Development Authorities, etc. which is an
improvement over the previous Model Building Bye Laws
brought out in 2004.
 Building Regulations & Bye-Laws
 In 2003, the Ministry of Urban Development desired that
Model Building Bye-Laws be prepared in view of Bhuj
Earthquake that occurred in 2001.
 This was to lay focus on structural safety of buildings
and to provide specific guidelines to the State Govts.
Accordingly, provisions were made for structural safety
and rainwater harvesting, waste water recycling, solar
assisted heating, barrier free public buildings and fire
safety.
These Bye-laws were circulated to all the State Govts.,
Uts. 5
 THE BUILDING AND OTHER CONSTRUCTION WORKERS
(REGULATION OF EMPLOYMENT AND CONDITIONS OF
SERVICE) ACT, 1996
An Act to regulate the employment and conditions of
service of building and other construction workers and to
provide for their safety, health and welfare measures and
for other matters connected therewith or incidental thereto
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