Q.

Write in detail about the various approvals and licences required for
setting up a Hospital facility.
India as a developing nation is in a dire need of medical and healthcare centers. Well qualified senior doctors
or businessmen thinking to invest in the medical industry should come forward to build more hospitals in
India. However, there are certain licenses and permits required to open a hospital in India. However, a hospital
isn’t a simple building with physicians, nurses, medical devices, operation theatres, and intensive care units,
but it requires basic legal obligations while installing this system. Thus, doctors planning to open a hospital
should follow the legal protocols and register their business via a dedicated platform. The different licenses
and permits required to open a hospital in India. It is better to adhere to the governing laws in order to avoid
legal complications in the future.

We need 7 types of licenses/permit.

1. Building Plan Approval

2. NBC/State Fire & Rescue Department NOC
3. CPCB/PCB NOC
4. Environmental Clearance Certificate – EC from SEIAA/MoE&F
5. Building Permit
6. Occupancy Certificate
7. Others – Drug Control, Electrical, Water Authority

There is the brief discussion about all the permits/licenses.

1. BUILDING PLAN APPROVAL

▪ Architectural Plan as per NBC/ State Building Rule Signed by Registered

Architect/Engineer/ Town Planner - The municipal regulations that come hand in hand with
every plot of land will permit the desired usage are a very important site attribute, they differ
considerably from city to city, and even with in cities from site to site, and a detailed discussion
on them is beyond the scope of this book. The National Building Code of India, however, specifies
that the maximum height a hospital building can go up to is 30.00. This height is usually measured
from the centerline of the access road to the site.
▪ Structural Plan + Stability Certificate issued by a registered Structural Engineer - The
structural engineers’ role is that of providing the optimum support for the building. Structural work
needs to be coordinated with the architect and the other engineering consultants; this coordination
is absolutely essential in hospital projects. He will decide in consultation with the architect the
structural system to be used. Structural engineers are more generically called civil engineers. The
civil engineer is responsible for inspection and testing of the materials used in construction, to
 make certain the owner gets the quality and quantity specified. He designs the columns, the beams
(or how to work without them), the slabs, the retaining walls; in other words, he designs the
framework and the structure on the strength of which the edifice stands. He also happens to give
you the structural stability certificate.
▪ Application from Building Owner – The building owner have to apply for different
building planning approval.
▪ Declaration certificate from Architect /Engineer, that the plan is made according to
concerned building rule – The planner may well be the bridge between the owners’ aspirations
and the architect’s pencil, providing a brief that captures the essence of the owners’ requirements
in a language that the architect understands. A good planner should have an understanding of
finance, medical practice, architectural and engineering practices too. He also gives a declaration
certificate, that the plan is made according to concerned building rule.

2. NBC/ STATE FIRE & RESCUE DEPARTMENT NOC – Compliances:- Fires can be
devastating, especially in a hospital where a large number of people who need to be evacuated may be
vulnerable – immuno compromised, on life support, and incapable of moving on their own. There are
special requirements that must be met with while evacuating such people in case of fire emergencies.
But before that – “fires must be prevented”. A no objection certificate shall be obtained from the local
chief fire officer before the building can be used. The NOC implies that the building is constructed
taking into consideration fire safety requirements. The NOC is valid for a given period, generally 3 to
5 years, depending upon the local rules and must be renewed on time.
There are 2 stages:
❖ Initial Site NOC – For Building Permit
❖ Final Site NOC – For Occupancy Certificate
Hospital having 10 or more Inpatient beds must go for sprinkler system with fire alarm system as
per NBC Part –IV. This is applied with check list as per NBC Part –IV.

3. CPCB /Population Control Board NOC – Compliances:- This NOC must be obtained from
the state’s pollution control board, under Water Act, Air Act and Hazardous waste act. The NOC is
required before commencing the work in hospital and then renewed periodically for operating the
patient care activities. The certificate is given if the effluent/sewerage from hospital, air pollution
emission and is within the limit defined by the pollution control board.
There are two stages:
❖ Initial Site NOC – Consent to Establish COE
❖ Final Site NOC – Consent to Operate COD
Hospital having 10 or more Inpatient beds must go for consent to operate from State Pollution Control
Board. It will be applied on online with check list as per

❖ Water (Prevention and Control of Pollution) Act, 1974.

❖ Air (Prevention and Control of Pollution) Act, 1981.
4. Environmental Clearance Certificate – Compliances:- Environmental clearance is a
procedure to get clearance from the government for certain projects which cause environmental
pollution. Government has made a list of projects which need an environmental clearance like
mining, thermal power plants, infrastructure etc. From State Environmental Impact Assessment
Authority or from Ministry of Environment, Forest and Climate Change EC for Hospitals and
Medical Colleges – under Category A Buildings Total Built-up Area Exceeding 20000 m2 and 50
Hectare Land area.
The Major Assessment Criteria are-

❖ Waste water Management - ETP/STP

❖ Solid waste Management – IMAGE (Indian Medical Association Goes Eco Friendly)
❖ Energy consumption – Any Renewable Energy used for the projects
❖ Power requirements for the Project
❖ Green Plan & Parking Management Plan
❖ Ecology Biodiversity Study
❖ Climatic Study for the project for min 2 months period includes Air, Sound & Water

5. Building Permit - Hospital building must be built as per National building code (NBC). This is
a comprehensive building standard, issued by Bureau of Indian Standards, that is used for regulating
construction of buildings across India. The above licenses and permits largely depends upon whether
or not the building is as per NBC. Development/building approval committee comprises a team of
representatives of building officials to verify and issue the building permit. After submitting the
application form with relevant documents, Officials will verify and issue first response/invalid
notice/non-compliance intimation notification within 30 days. Building plans shall be prepared duly
signed by Registered Architect/engineer/Supervisor and other registered professionals. Plans must
contain name, address, qualification and registration number of the professional. All plans should
have Name, address and signature of the owner. Structural plans shall be prepared and duly signed
by the registered engineer/structural engineer.
6. Occupancy Certificate - This certificate must be obtained from the local municipal
corporation. Some documents need to submit there.
❖ Final Completion Plan duly signed by Architect/Engineer.
❖ Fire NOC for Completion
 ❖ PCB NOC – Consent to Operate for Completion
The certificate implies that the building is fit to be occupied by people. Building cannot be used for
hospital or for any other purpose unless occupancy certificate is obtained.
7. Other Statutory Requirements – There are many other requirements of Statutory. Like,
❖ Drug License for Pharmacy - For each pharmacy in the hospital, which is involved in
selling of medicine to OPD, IPD or outside patient, a separate license must be obtained from
Drug Standard Control Organization. This license is required to ensure that regulations
under Drugs and Cosmetics act is being fulfilled, specifically the area, storage, technical
staff and compliance to drug schedules.
❖ Electrical inspectorate approval for Electric Systems and Lift - This is required as a
compliance to Indian electrical rules, 1956 and electricity act, 2014. This is given after
satisfactory inspection of electrical installation and sub-station, by the chief electrical office
of the district. This is required one time initially. If the hospital’s building has lifts installed
in it, it must be obtained for operating the same. This is issued after inspection by Lift safety
inspector, who assess if the requirements stated under Lifts and Escalator acts act has been
fulfilled. The license generally is given for one year and must be renewed annually.
❖ AERB Approvals for Radiology & Nuclear Medicine Departments - If the hospital
uses radiology or radiation therapy departments the layout and design of the area w must be
approved by AERB. The approval depends upon whether or not the layout has been designed
as per the radiation safety criteria set by AERB. If the hospital uses radioactive substances
such as Iodine-125, Fluorine-18 etc., for treatment, it will need a license from AERB to
procure and store the same. The license is given for specific radioactive substances for a
specific quantity and license must be renewed periodically.
❖ PNDT Certificate for Diagnosis - Under this act every ultrasound machine or any other
machine that can be used for pre-natal sex determination must be registered under PNDT
act. It also requires that every radiologist who will be using ultrasound or similar equipment
for diagnosis also be registered.
❖ Blood Bank Storage Approval by State Licensing Agency - If the hospital has a blood
bank, it shall comply to the space, manpower and equipment requirements specified under
Drugs and Cosmetics act. A license to operate blood bank must be obtained from Drug
Standard Control Organization or state licensing agency.
❖ Ground Water Authority clearance for water supply
❖ DMO approval for registering with shops & establishment act etc.

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