There are many regulatory clearances required to establish and operate a hospital. The management of hospital must be aware about all such legal documents, requirements and process to obtain the same. Here is a comprehensive list of applicable legal documents with their brief description and relevant links. Some of these may not be applicable to specific hospitals, depending upon the scope of service, type of infrastructure, location etc.
1. Legal documents required for establishing the business of hospital
1.1. Registration under the clinical establishment act (Registration and Regulation) act, 2017 – This act has been enacted by central government and is being adopted by states of India. It requires a one-time registration for a premise to be operated as hospital. The registration shall be done by the respective state government that has adopted the said act. For registration, hospitals must fulfill the minimum requirement under the category which it falls. Each state has described the process of registration of the hospitals that falls within their territory. More information about the act can be found on this link http://dghs.gov.in/content/1361_3_NationalCouncilClinicalEstablishments.aspx
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1.2. Registration under companies’ act, 2013 – This act is applicable If the hospital is being established under the ownership of a company. The act requires that the company is registered and fulfils the requirement of incorporation such as memorandum of association, articles of association, capital structure formation, securities allotment, account audits etc. Complete information about the companies’ act can be downloaded from this link. http://www.mca.gov.in/Ministry/pdf/CompaniesAct2013.pdf
1.3. Registration under societies registration act, 2001 – If the hospital is being established under the ownership of a society, societies registration act is required. Like companies act, under societies act also several requirements has to be complied with. More details can be downloaded from this link. http://www.mca.gov.in/Ministry/actsbills/pdf/Societies_Registration_Act_1860.pdf
1.4. Registration of nursing home under ‘Delhi Nursing Home Registration Act, 1953’: This is applicable to nursing homes in Delhi. It provides minimum requirement for the building, staff, equipment and certain policies to be fulfilled by the nursing home. A snapshot of the requirements can be downloaded here. http://it.delhigovt.nic.in/writereaddata/egaz201151.pdf
1.5. Registration of nursing home under ‘The Bombay Nursing Home Registration Act, 1941’: Similar to Delhi nursing home, nursing homes in Mumbai must be registered under this act, after fulfilling the minimum basic requirements. The process of registration is described in this link http://imapcb.org/images/lectures/hospital%20reg.pdf
2. Legal documents required for the hospital’s building and its installations
2.1. NOC from fire safety – 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. This link describe the process for getting NOC in state of Maharashtra http://mahafireservice.gov.in/site/Information/eApproval.aspx
2.2. Electrical installation certificate – This certificate is required as a compliance to Indian electrical rules, 1956 and electricity act, 2014. The certificate is given after satisfactory inspection of electrical installation and sub-station, by the chief electrical office of the district. This certificate is required one time initially. The electricity rules can be checked on this link http://www.dgms.net/IErules1956.pdf
2.3. License for operating lift – If the hospital’s building has lifts installed in it, a certificate must be obtained for operating the same. The certificate 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. Check this link for application and renewal https://www.india.gov.in/application-renewal-licence-working-lift
2.4. Building occupancy certificate – This certificate must be obtained from the local municipal corporation. 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. Check this link for the process https://lawrato.com/indian-kanoon/property-law/how-to-apply-for-completion-certificate-and-occupancy-certificate-590
Note: Hospital building must be built as per National building code (NBC). This is a comprehensive building standards, 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. The NBC can be obtained through this link http://bis.org.in/sf/nbc.htm
2.5. Layout approval for radiation departments area – 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. Check www.aerb.gov.in
3. Legal documents required for the equipment, machines, vehicles etc.
3.1. Type approval certificate of radiation emitting equipment – Each radiation emitting equipment that are installed in the hospital must have a type approval certificate from AERB. This is for prevention of excessive scattered radiation which can be hazardous to people. Check www.aerb.gov.in
3.2. Certificate for using Boilers under the Indian Boilers act, 1923 – If the hospital uses large Boilers, a certificate for its use must be obtained under Indian Boiler’s act from Boiler inspectors. The certificate is generally issued for a period of 3 years and must be renewed in a timely manner. A copy of the act can be obtained here http://labour.bih.nic.in/Acts/The-Indian-Boilers-Act-1923.pdf
3.3. Ambulance vehicle registration – The ambulances that are used in hospital must be registered as Ambulance with the road transport department. The process and rule of registering Ambulances in Delhi is given in this link http://www.delhi.gov.in/DoIT/Health/cat.pdf
3.4. PNDT registration of Ultrasound machines under PCPNDT act, 2015 – 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 also be registered. This handbook provides much needed details on this https://www.iria.in/pndt/Handbook%20on%20PNDT%20Act.pdf
3.5. Arms licenses under arms act 1959 – If arms are possessed by hospital or its staff (such as by security guards), a license for the same must be available. The process of obtaining arms license is described here https://indiansforguns.com/viewtopic.php?t=504
4. Legal documents related to medical professionals and employees
4.1. Qualification certificates of doctors – The doctors who practice in the hospital must have necessary qualification certificates as per Indian Medical Degree act. https://www.mciindia.org/CMS/acts-amendments/the-indian-medical-degree-act-1916
4.2. Registration of doctors – The doctors practicing in hospital must be registered with medical council of India, in Indian Medical Register. The registration must be valid. https://www.mciindia.org/CMS/information-desk/indian-medical-register
4.3. Qualification certificates of nurses – The nurses working in the hospital must possess necessary qualification certificate as per the Indian Nursing Council act. https://www.indiannursingcouncil.org/pdf/inc-act-1947.pdf
4.4. Qualification and registration of Dentists – The dentists working in the hospital must be qualified as per the Dentists act, 1948 and registered under the Dental Council. www.dciindia.org.in
4.5. Qualification and licenses of clinical psychologist – The clinical psychologists qualification is regulated by Rehabilitation Council of India (RCI). To practice clinical psychology a license is required from RCI. www.rehabcouncil.nic.in
4.6. Qualification certificates of therapists – Some states have specific councils that regulates the professional practices of therapists such as Physiotherapists, Occupational Therapists. For example, Delhi has The Delhi Council for Physiotherapy and Occupational Therapy, Maharashtra has state council for physio and occupational therapy. The hospital must check if their state has relevant councils and regulations for therapists and accordingly ascertain that they possess necessary qualification certificates and registration. www.msotptcouncil.com ; www.dcptot.com
4.7. Technicians qualification certificate - Various technicians in hospitals such as Lab technician, OT technician, radiology technician, physicists etc. must possess necessary qualification certificate as per AICTE rules for technician, 1987. https://www.aicte-india.org/downloads/aicteact.pdf
4.8. Registration for EPF: This one time registration is required for hospitals to eomply with Employee Provident Fund Requirements. This link can be accessed for registration https://epfindia.gov.in/site_en/OLRE.php
5. Legal documents for environment protection
5.1. NOC from pollution control board – 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. This link explains the process of obtaining NOC in Maharashtra. http://mpcb.gov.in/faq/faq.php
5.2. Authorization for generation of Bio-medical waste – The authorization is required on a yearly basis from pollution control board of the state. The authorization is given if the hospital complies with the rules and regulations of Biomedical Waste (Management and Handling) rules, 1989 and amendments thereafter. The rules and process for the same is given in this link http://mpcb.gov.in/biomedical/pdf/BMW_Rules_2016.pdf
5.3. Radiation protection certificate – This certificate must be obtained which requires periodic inspection of radiation areas. The certificate is issued by AERB through its approved agencies. www.aerb.gov.in
6. Legal documents for storing and usage of medical and non-medical products
6.1. Drug sale license for medical store: 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. Refer this link for details on how to obtain a drug license https://enterslice.com/learning/procedure-for-drug-license-in-india/
6.2. License for storing and usage of Narcotic Drugs and Psychotropic Substances (NDPS): The hospitals that uses NDPS for patient care, must obtain license under NDPS act, 1985 from Food and Drug Administration of the state. The license specifies the quantity and type of NDPS allowed and need to be renewed from time to time. Check this link for the process in Maharashtra state. https://fda.maharashtra.gov.in/grantndps.aspx
6.3. Excise permit to store spirit: To store spirit beyond a certain quantity, the hospital is required to obtain a permit from state excise department. This is done to ensure that the facility is safe for storing spirit, which is combustible in nature and also that it is not sold illicitly as liquor. Check this link for the process of obtaining permit. http://164.100.150.10/jelons/uploaddocumentview.aspx?svid=6512bd43d9caa6e02c990b0a82652dca
6.4. License for radioactive substances: 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. The detailes requirement for this license is given in this link http://dae.nic.in/writereaddata/lssq404_250810.pdf
6.5. Permit for storing Diesel – If the hospital stores large quantity of petroleum product such as Diesel for using in Diesel generator a permit must be obtained from Controller of explosives, under Petroleum act 1934. The permit is required generally if the storage required is in excess of 30 litres. The rules given under the act must be complied with and the permit must be renewed from time to time. Check this link for rules of storing Diesel under this act. http://www.peso.gov.in/Work_Mannual/wmchap10wo.pdf
6.6. Permit to store LPG cylinder – If the hospital stores large quantity of LPG cylinder for use in hospital’s kitchen or any other purpose, it shall take a permit from Controller of Explosives under Petroleum act, 1934. The rules for storing LPG cylinder are given in this link http://peso.gov.in/Work_Mannual/Gas_cylinder_Rule_WM.pdf
7. Legal documents related to other specific services offered by the hospital
7.1. Registration under MTP act – If the hospital performs ‘Medical Termination of Pregnancy’, they must be registered with their respective state under the MTP act, 1971. Only after registration the place will be approved for carrying out MTP. The approval for MTP is given under 2 categories, category A (without operation theatre facility) and category B (with operation theatre facility). The rules under MTP act, 1971 must be adhered to for carrying out MTP. Check this link for MTP regulations https://mohfw.gov.in/acts-rules-and-standards-health-sector/acts/mtp-regulations
7.2. License for operating blood bank – 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. http://www.cdsco.nic.in/forms/list.aspx?lid=1642&Id=1
7.3. Registration for transplantation of human organ – If the hospital conducts human organ transplantation or organ harvesting, it shall be registered by the appropriate authority under Transplantation of Human Organs Act, 1994. The registration is given on the basis of availability of infrastructure required for conduction of transplant. Check this link for procedure and rules for transplantation http://www.organindia.org/laws-made-easy/
7.4. License for provision of Psychiatric services – Hospitals providing certain type of services such as de-addiction, treatment of psychiatric disorders, child/adolescent psychiatric clinic etc. are required to register with their state government. The Mental Health act of India becomes applicable on them. Check this link for guidelines of obtaining license in Kerala state. http://www.ksmha.org/Guide%20lines%20for%20license.pdf
Besides the licenses described above, there are several laws that are relevant to hospital, however no legal document need to be obtained for them.
Did I miss any important legal document? Do let me know in comments.
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