University of Kashmir

Department of law

Semester 8th

Roll no. 41

Health Care Law

Topic:- Legal requirements for establishing a hospital.

Submitted by :- Merjaan Tahir

 LEGAL REQUIREMENTS FOR ESTABLISHING PRIVATE
HOSPITALS IN INDIA
Establishing a private hospital in India involves compliance with various legal
requirements. Here are the key steps and legal aspects involved:

➔ Business Structure and Registration: Select a business structure (such as

a partnership, private limited company, or LLP) and register the entity as per the
Companies Act, 2013 or relevant laws.
➔ Land and Building Compliance: Ensure the land and building conform to local
zoning and land use regulations. This might involve obtaining necessary
clearances from local municipal bodies.
➔ Obtaining Licenses and Registrations:
◆ Clinical Establishment Act: Under this act, specific states in India might
require registration for clinical establishments, including hospitals.
Registration processes can vary by state.
◆ Medical Council of India (MCI): Ensure compliance with MCI guidelines for
infrastructure, equipment, and staff requirements.

The Medical Council of India (MCI) was a statutory body responsible for establishing
and maintaining high standards in medical education in India. However, the MCI was
replaced by the National Medical Commission (NMC). The NMC has taken over the
functions of the MCI and oversees the regulation and standardization of medical
education and related aspects in India.

While the MCI no longer exists, the guidelines set by the NMC may include certain
regulations for establishing private hospitals or medical colleges in India. Here are
some of the general guidelines and requirements that were traditionally set forth by the
predecessor, the MCI, and may still be applicable under the NMC:

Infrastructure Requirements: Hospitals must adhere to specific infrastructure

guidelines such as the size of the building, availability of necessary departments
(emergency, inpatient, outpatient, etc.), and facilities.

Qualified Staff: The hospital should employ qualified medical professionals,

including doctors, nurses, and other healthcare staff. The number of staff
required might depend on the hospital's size and services provided.
Equipment and Facilities: Guidelines regarding the availability of medical equipment
and facilities based on the services the hospital intends to offer.
Patient Care Standards: Hospitals must meet certain standards of patient care,
safety, and hygiene.
Teaching Hospitals (if applicable): If the hospital is associated with a medical
college, it might have additional criteria related to teaching facilities and
requirements for medical education.
 Regulatory Compliance: Adherence to the laws and regulations of the Clinical
Establishments Act, Bio-Medical Waste Management Rules, and other relevant
healthcare laws.

As the guidelines and regulations might change and evolve over time, it's important to
refer to the current directives and standards set by the National Medical Commission
(NMC) for the most up-to-date requirements. You may visit the NMC website or contact
them directly for specific and current guidelines related to establishing private hospitals
in India.

◆ NABH/NABL Accreditation: National Accreditation Board for Hospitals &

Healthcare Providers (NABH) and National Accreditation Board for Testing
and Calibration Laboratories (NABL) accreditations are not mandatory but
highly recommended for quality assurance. In India, obtaining
accreditation from the National Accreditation Board for Hospitals &
Healthcare Providers (NABH) and the National Accreditation Board for
Testing and Calibration Laboratories (NABL) is not mandatory but highly
recommended for ensuring quality healthcare services and facilities.

● NABH Accreditation (National Accreditation Board for Hospitals &

Healthcare Providers):

Purpose: NABH accreditation focuses on setting benchmarks and

standards to ensure quality and patient safety in healthcare organizations.

Benefits: Accreditation from NABH signifies that a hospital meets specific

quality standards in patient care, infrastructure, and management
systems. It enhances the hospital's credibility and patient trust.

Process: Hospitals need to comply with various standards, including

patient rights, patient care, medication management, infection control,
infrastructure, and more. The hospital undergoes an assessment by NABH
assessors, and if it meets the standards, it receives accreditation.

● NABL Accreditation (National Accreditation Board for Testing and

Calibration Laboratories):

Purpose: NABL accreditation is specifically for testing and calibration

laboratories.
 Benefits: It ensures that laboratories maintain high standards in testing
and calibration procedures, thereby increasing confidence in their test
results.

Process: Laboratories need to comply with various technical and

management system requirements for accreditation. An evaluation by
NABL assessors is conducted, and if the lab meets the criteria, it receives
accreditation. For establishing private hospitals in India, while NABH and
NABL accreditations are not legally required, they significantly contribute
to the credibility and quality of healthcare services. Many stakeholders,
including patients, insurance companies, and government bodies,
consider accreditation as an essential benchmark for quality healthcare
delivery. It is highly recommended to seek NABH accreditation for
hospitals and NABL accreditation for laboratories within the hospital
premises to ensure high standards of quality and patient care. The
process for obtaining NABH or NABL accreditation involves meeting
specific standards and undergoing an evaluation by qualified assessors.
Detailed information on the standards and the accreditation process can
be obtained from the official websites of NABH and NABL. It's crucial for
hospitals aspiring to attain accreditation to thoroughly understand and
implement the required standards and processes.

● Fire Department Clearance: Obtain a No Objection Certificate

(NOC) from the fire department after meeting fire safety standards.

➔ Regulatory Compliances:
◆ Drug Control Department: Register the hospital's pharmacy under the
Drugs and Cosmetics Act, 1940.
◆ Biomedical Waste Management: Adhere to rules laid down by the Bio-
Medical Waste Management Rules, 2016. The Bio-Medical Waste
Management Rules, 2016 in India are crucial guidelines that apply to
healthcare facilities, including private hospitals. These rules are designed
to regulate the proper management and disposal of bio-medical waste to
prevent health and environmental hazards. Compliance with these rules is
essential for establishing and operating private hospitals in India. Here are
some key points from the Bio-Medical Waste Management Rules, 2016:

● Categorization of Bio-Medical Waste: The rules categorize bio-

medical waste into different types (like human anatomical waste,
expired or unused medicines, soiled waste, etc.), and each category
has its disposal requirements.
 ● Segregation and Collection: Hospitals are required to segregate
bio-medical waste at the point of generation. They should use
color-coded bins or bags for different categories of waste. Proper
collection and storage methods are specified for each category.
● Transportation: Bio-medical waste must be collected and
transported by authorized personnel using vehicles designed and
equipped for safe transport. These vehicles should comply with the
norms for waste transportation.
● Treatment and Disposal: Private hospitals must have tie-ups or
arrangements with common bio-medical waste treatment facilities
(CBWTFs) for the treatment and disposal of bio-medical waste.
These facilities should have the necessary infrastructure for the
appropriate treatment of bio-medical waste.
● Training and Awareness: Staff handling bio-medical waste should
receive training in waste management and the use of personal
protective equipment. Hospitals are required to conduct regular
awareness programs among their staff.
● Record-Keeping and Reporting: Maintaining records related to the
generation, collection, transportation, treatment, and disposal of
bio-medical waste is mandatory. Regular reporting to the State
Pollution Control Boards or Pollution Control Committees is also
required.
● Inspections and Compliance: Authorities may conduct periodic
inspections of healthcare facilities to ensure compliance with the
rules. Non-compliance can lead to penalties or closure.

For a private hospital in India to comply with the Bio-Medical Waste Management Rules,
it's essential to implement proper segregation, storage, transportation, treatment, and
disposal procedures for bio-medical waste. Hospitals need to ensure that staff is
adequately trained, proper documentation is maintained, and the waste is treated
through authorized facilities.

Non-compliance with these rules can lead to legal repercussions and affect the
hospital's functioning and reputation. It's important for hospitals to be well-versed with
these rules and implement them effectively to ensure the safe and responsible
management of bio-medical waste.

◆ Clinical Waste Disposal: Comply with guidelines for clinical waste

disposal to ensure environmental safety.
➔ Staffing Requirements:
◆ Staff Licensing: Ensure that all medical professionals (doctors, nurses,
paramedical staff) possess the required licenses.
 ◆ Employment Laws: Comply with labor laws for employee contracts,
benefits, and working conditions.
➔ Tax and Financial Compliances:
◆ Register for Goods and Services Tax (GST) and obtain necessary tax
registrations.
◆ Maintain proper financial records and comply with accounting standards.
➔ Insurance Requirements:
◆ Obtain liability insurance, malpractice insurance, and insurance for the
hospital's assets.
➔ Patient Data Protection:
◆ Comply with data protection laws and patient confidentiality regulations.
➔ Environmental Regulations:
◆ Ensure adherence to environmental regulations related to waste disposal,
energy consumption, and pollution control.

➔ Continuous Compliance:
● Regularly update and comply with changes in regulations and laws.

It’s essential to consult legal advisors, healthcare consultants, and professionals

experienced in setting up hospitals in India to ensure compliance with all legal
requirements. Regulations may vary by state and can be subject to updates, so staying
informed and seeking legal counsel is crucial.