The start of a private hospital requires obtaining extensive licensing and authorizations from various regulatory bodies as they offer multispecialty services. Private hospitals must be registered and obtain approvals under several Acts related to clinical establishments, companies, atomic energy, electricity, fire safety, sanitation, biomedical waste, and more. Setting up a private hospital involves obtaining licenses related to the land, construction, equipment, radiology, pharmacy, ambulances, storage of flammables, organ transplants, and compliance with various safety, healthcare, and labor laws.

1. The start of a private hospital is always chaotic as
hospitals require intense licensing and
authorizations from various regulatory and
statutory bodies. Most private hospitals offer
multispecialty services which make it all the more
tedious for them to obtain all their necessary
documents. The legal framework for private
hospitals is covered under several Acts like
the Clinical Establishments Act, 2010, the Atomic
Energy Act, 1962, Companies Act,
2013, Electricity Act, 2003, Indian Electricity
Rules, 1956, National Building Code of India,
2005, etc.

2. Land license
• Title Deeds of the land.
• NOCs from Municipal authorities, Pollution Control
Board, Fire Department, Special Area Development
Authority (if any), and Environment Clearance.
• Land registration documents.
• Floor Area Ratio certificates (FARs) and Ground
Coverage certificates (GC).
• Parking requirement certificates.
• Road licenses to maintain distance from the main road.
• Land mutation, if any.
• Land conversion, if any.

3. Construction and installation-related
approvals/licenses
• structural safety.
• landscape planning.
• asset and facility planning.
• accessibility for the elderly and people with disabilities.
• gas pipelines.
• fire and light safety.
• solar energy.
• provisions on cement and steel masonry.
• industrial wastes.
• air conditioning and ventilation.
• escalators, moving walkway provisions.
• Water supply, drainage, and sanitation provisions.
• Solid waste management etc.

4. • NOC from fire safety.
• Electrical installation certificate.
• Height restriction certificates.
• Equipment licenses.
• Lift usage certificate.
• Radiation department licenses.
• Biohazardous permits.
• Drainage approvals.

5. • Registration under Clinical Establishments Act, 2010
• According to Section 11 of the Clinical Establishments
Act, no person is allowed to run a clinical
establishment without being registered under this Act.
The Act goes on to present conditions that should be
met for registering the establishments under Section
12, which are:
• Minimum standards of facilities and services as may be
prescribed;
• Minimum requirements of personnel as may be
prescribed;
• Maintenance of records and reporting provisions as
may be prescribed;
• Such other conditions as may be prescribed.

6. • Registration under Companies Act, 2013
If the private hospital is established under the
ownership of a corporation, then the hospital
needs to be registered under the Companies
Act, 2013.
If the hospital is under the ownership of a
society, then it has to be registered as a
society under the Society Registration Act,
1960.

7. • Atomic Energy Regulation Board Licenses
• Hospitals need to obtain licenses from the AERB for all
radiation generating equipment and all radiation sources
• Electricity, fire and water licenses
• Sanitation and biomedical waste permits
• Healthcare facility certificate
• FSSAI license
• This license is given by the Food Safety and
Standards Authority of India.

8. • Pharmacy registration for medical shop
• Nowadays, hospitals tend to keep a pharmacy
open 24 hours in their premises for easy
accessibility. Having such a medical shop in
the hospital also requires registration under
the Central Drug Standard Control
Organization and State Drug Standard Control
Organization.

9. • Permit for storage of petrol/diesel under the Petroleum Act, 1934.
• License for operating blood banks from the Drug Standard Control
Organization.
• Registration for organ transplantation under the Human Organs Act,
1934.
• Registration for medical termination of pregnancies under the
Medical Termination of Pregnancy Act, 1971.
• Registration to prohibit sex determination practices under the Pre-
Natal Diagnostic Test Act, 1994.
• Registration of Ambulances and all hospital vehicles in the Motor
Vehicles Act, 1988.
• License for using boilers under the Boilers Act, 1923.
• Licenses under the Drugs & Cosmetics Act, 1940.
• Registration under Births and Deaths Act, 1969.
• Licenses under Environment Protection Act, 1986.

10. • Guardians and Wards Act, 1890;
• The Epidemic Diseases Act, 1897;
• The Mental Health Act, 1987;
• Environment Protection Act and Rules;
• Sale of Goods Act, 1930;
• Labor Laws etc.