Legal Requirements For

Setting Up A Hospital
 Registration Procedure
● The Uttarakhand Health Care Establishment 2018.
● As per Section 10: State government may set up an authority in the district level for clinical establishment
● As per Section 10A: It states that the authority may grant, renew or cancel the registration of any clinical establishment

Registration Procedure For Issuance Of License

1. By Offline/Physical Mode:-
● To apply for registration of Hospital License, the national authority must be contacted
● Then an application, which is firmly proved is attested by the Concerned Officer
● Application has to fill all the necessary requirements mentioned in the form
● Make sure all the necessary documents are attached with the form
● Applicant has to decide the type of hospital like general, speciality, super speciality along with their size and
location
● The Application will proceed further then the concerned officer will undergo with his/her inspection regarding the
safety measures
● If everything is correct, then the concerned officer will issue the license for the hospital
● This entire procedure could be completed within 30-40 days or as per timeline
 2. By Online Mode
● To apply for hospital in Uttarakhand, the applicant has to make the application online
● The Applicant has to upload all the required documents
● Applicant has to select the facilities available in the hospital along with insurance facility.
● Applicant has to pay a required fees after completion of filing of application.
● The Concerned Officer will conduct inspection and only after which the concerned officer shall issue a license
● The entire procedure takes 30-40 days for completion
3. Required Documents

● Application form
● Proof of registration of the hospital (under the Companies Act or the Trusts Act or the Societies Registration Act)
● Building plan approved by the local municipal corporation or town planning department
● No Objection Certificate (NOC) from the fire department
● Environmental clearance certificate from the State Pollution Control Board (SPCB)
● Medical equipment list and their source
● List of doctors and their qualifications
● List of other medical and non-medical staff and their qualifications
● Details of Sewage lines, fire extinguishing systems, lifts, emergency alarms, well-equipped ICU, pathological labs, OPDs, and
general and emergency wards.
● Any other documents if required
 Eligibility
● The applicant has to be a qualified Medical staff.
● The applicant needs to either own or lease the land where they plan to build the hospital.
● The applicant needs to have sufficient financial resources to set up and run the hospital.
● The applicant must have Indian Citizenship.
Validity

With the approval and consent of the local authority the license needs to be renewed periodically keeping in consonance
with the rules and regulations set up by the local authority.
Permits

● Land & Construction

Hospital could be set up in a land which is considered to be ‘no agricultural land’.

● Electricity & Water

The concerned municipal authority’s consent must be obtained in order to avail the benefits of electricity as well as
water supply facilities.

● Sewage
Well planned sanitary measures for disposal of waste as well as drainage system which includes tanks, pipelines, etc.
and permission from the local authorities should be obtained.
 ● Biomedical Waste
The Municipal corporation permission would also be required for such disposal of waste and it must not be harmful to the people living
at a nearby location.

● Fire & Health License

Approval of Fire Department is required for a large hospital as well as a health certificate from the local authority after installation of all
the beds and equipment within the Hospital.
 Miscellaneous Licenses

● Permit to store LPG Cylinder

● Pharmacy registration for medical store
● Trademark Registration
● Vehicle Registration For Ambulance
● Arms Licenses Under Arms Act 1959
● FSSAI (License for operating a kitchen
Planning The Infrastructure Of Hospital

There are certain essentials which one must keep into consideration while planning the infrastructure of a hospital and
these are:-

● Qualifications of Doctors as well as their registration numbers

● Working hours for Nurses as well as their shift timings
● Medical equipment as well as instruments purchased
● Computers as well as other hardware devices set up
● Engineers as well as staffs required for maintenance, plumbing, medical gas pipelines, air conditioning, etc.
Other Licenses

● Regulations Building Permit and Licenses (From the Municipality)

● No objection certificate from the Chief Fire Officer "License under Bio-Medical Management and Handling
Rules, 1998.
● No objection certificate under Pollution Control Act.
● Narcotics and Psychotropic substances Act, 1985
● Vehicle Registration Certificates (For all hospital vehicles.)
● Atomic energy regulatory body approvals (For the structural facility of radiology dept, TLD badges, etc)
● Boilers Act, 1923(If applicable)
● MTP Act, 1971 (MTP stands for Medical termination of pregnancy. To be displayed in the Gynaec and Obs
department)
● License for the Blood Bank (To be displayed in the Blood Bank)
● Transplantation of Human Organs Act 1994(If applicable)
● PNDT Act, 1996 (PNDT stands for Prenatal diagnostics test. To be displayed in the Radiology department that this is followed. )
● Dentist Regulations, 1976
● Drugs & Cosmetics Act, 1940
● Electricity Act, 1998
● ESI Act, 1948 (For contract employees)
● Environment Protection Act, 1986
● Fatal Accidents Act 1855
● Guardians and Wards Act, 1890
● Indian Lunacy Act, 1912 (Applicable only if a Psychiatry dept is there in the hospital)
● Indian Nursing Council Act 1947 (Whether nurses are registered with NCI).
● Also one must check whether pharmacists are registered with Pharmacy Council of India.)
● Lepers Act Maternity Benefit Act, 1961
● Minimum wages act, 1948 (For contract employees)
● Pharmacy Act, 1948
● SC and ST Act, 1989
● Protection of Human Rights Act, 1993
● Registration of Births and Deaths Act, 1969
● Urban Land Act, 1976
● Right to Information Act 2005r
 Rights of a Medical Practitioner
● Right to choose his/her patients
● Right to use their title as well as qualifications
● Right to receive fees and recover expenditures
● Right to be appointed in Hospitals as well as medical institutions
● Right to practice medicines along with dispensing it
● Right to issuance of medical certificates
● Right to give evidence
● Right to remove organs as well as tissues from a dead body
● Right to perform medical termination of pregnancy
● Right to disclose confidential information in exceptional circumstances.
● Right to be exempted to be serving as a member of jury
● Right to use the red cross emblem
● Right to access information
● Right not to be unfairly discriminated
● Right to refuse to conduct un-bodily search and seizure
Rights of Patients

● Right to accessibility
● Right to dignity and privacy of patients
● Right to ensure safety
● Right to confidentiality of information
● Right to refusal of treatment
● Right to give informed consent
● Right to complain and redressal
● Right to have second opinion
● Right to be aware of the hospital’s rules and regulations
● Right to have access to their clinical records
Liabilities of Medical Professionals For Negligence

● It is a legal duty of the doctor to exercise due care toward his patient,
● That the doctor by an act of commission or omission breach that duty
● There shall be a relationship between the breach of duty and the damage suffered to the patient,
● The patient due to breach of such duty consequential suffers damage or harm.
Case Laws

● Dr. Balram Prasad v. Dr. Kunal Shah & Ors.

● Mr. M Ramesh Reddy v. State of Andhra Pradesh
● Hunter v. Hanley
● Indian Medical Association v. P Santha
● Gian Chand v. Vinod Kumar Sharma
● State Of Haryana v. Shreemati Santra
● Jacob Mathew v. State of Punjab