By Team Metacorp on 27 Apr 2022
How to apply for Pollution board consent for hospitals & health care establishments?
Access to healthcare is a basic need and right of every citizen. The Healthcare system includes hospitals, clinics, druggists, nursing homes, medical camps, etc., and is assisted by doctors, nurses, and other medical professionals. However, given India’s huge and booming population, there are fewer hospitals available for catering to the need. India has 1 hospital for 879 people which is far below the global average of 30 hospitals per 10,000 population.
As per WHO, India needs 80,000 additional hospital beds annually for dealing with its growing population. This highlights the necessity for additional hospitals in India. However, establishing a hospital/clinic in India is not so easy. Here we will discuss the factors that are to be considered and License & legal requirements necessary for starting a hospital/healthcare in India.
Factors to be considered for Starting Hospital/Healthcare Facility
1. Selecting a location
This is the first step and must be well selected because pooling patients would be difficult if already some hospitals are present in the locality. Moreover, the establishment must be done in an area having a good transportation facility or adjacent to a railroad station.
2. Facilities to be provided
It is necessary to ascertain the nature of the establishment planned and the required infrastructure. Whether it’s a pediatric, orthopedic, imaging, gynecologic, pathology, etc. facility in the hospital all require varying facilities.
3. Necessary Permits
a) Land and construction: Agricultural land should not be used for hospitals and healthcare facilities Hence, for building the hospital wing, multiple permissions must necessarily be taken from local authorities, various documents must be approved, like an architectural plan, land deed, etc.
An occupation certificate must be obtained after performing all formalities.
b) Electricity and water: As per the requirements, permission must be taken from the local authorities for obtaining electric meters and water supply and water requirement should be calculated, which is around 100 liters/day.
c) Sewage: Proper waste disposal necessitates a well-planned sewage and drainage system, to be done after obtaining permission from the local authority.
d) Biomedical waste: This is an important aspect and permission from the local municipality is essential for installing incinerators for disposing of medical waste and body parts.
e) Fire and Health License: A Fire license is essential for proving that no damage or loss of life will result from the establishment and needs to be obtained from the local municipality. Getting a health license is also necessary for providing health care to patients.
4. Infrastructural planning: For setting up a hospital/healthcare facility, the following needs to be cared for:
a) Recording the no. of doctors, their qualifications, and registration numbers.
b) Discussing and setting the working shifts of nurses.
c) Purchasing medical equipment and instruments.
d) Setting up computers and other hardware devices.
e) Requirement of engineers and staff for maintenance, plumbing, medical gas pipelines, air conditioning, etc.
f) Various medical laws and ethics must be abided by at every step. Multiple guidelines and eligibility criteria are presented for hospitals by the government, providing services to the Union Government health scheme beneficiaries.
Registration & legal Requirements
Registration under the Clinical Establishments Act, 2017
This is a one-time registration for operating hospital premises in India and must be performed by the respective State government that has adopted this act
Registration under the Companies Act, 2013
This act becomes applicable when a hospital is established under the ownership of a company. Hence fulfilling the requirement of incorporation like Memorandum of Association (MoA), Articles of Association (AoA), forming capital structure, allotting securities, auditing accounts, etc. must be done
Director Index No (DIN NO)
This is a mandatory one-time registration required for every director desiring to participate in a corporation.
Registration under The Societies Registration Act, 2001
This registration is required if the hospital is established by a society provided under the Societies Registration Act, 2001.
Regulations regarding staff employment
a) Employing doctors, nurses, pharmacists only after proper credentialing
b) Preventing sexual harassment of women employees
c) Liability regarding the employee’s safety
d) Rules governing the staff employment
e) Vaccinating and other measures for protecting the staff from occupational health hazards.
Rules for the size, contents as well as the correct place for signboards under IMC Regulations, 2002 must be followed. Information that requires be displayed at the Hospital are:
a) Registration Certificate of the hospital with the municipal authorities
b) IMC/SMC registration certificate under IMC Regulations, 2002
c) Consultation charges and charges for other procedures/services under IMC Regulations 2002
d) Clinic timings, closed days
This license comes under the Food Safety and Standards Authority of India, a statutory body under the Ministry of Health and Family Welfare, Government of India. This license is required by the hospital if it runs an in-house kitchen for the patients and attendants.
Permit for storing LPG cylinder
If the hospital stores LPG cylinders in large quantities for use in the Kitchen or other hospital purposes, a permit from the Controller of Explosives under the Petroleum Act, 1934 must be obtained.
There are various licenses for medical shops attached to hospitals (IP) and standalone medical stores. Minimum requirements for the registration for the minimum size of the shop ( 250 – 300 ft) and requirements of Air conditioner and Refrigerator. The license is valid for up to 5 years.
Registering under the Indian Trademarks Act 1999 is a non-mandatory activity and is mandatory only if the hospital wants to develop its branding.
The ambulances purchased by a hospital must be registered under RTO, Transport Department, and State government.
Arms licenses under the Arms act, 1959
If arms are possessed by the hospital or its employees (security guards), this license for the same becomes mandatory.
Registration under Transplantation of Human Organs Act, 1994
This registration becomes necessary if the hospital conducts human organ transplantation or organ harvesting.
Also, excise permit for storing spirit beyond a certain quantity must be obtained from the state excise department
Other important 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.)
• Insecticides Act, 1968
• 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 2005
A State Pollution Control license is an official written document through which the State Pollution Control Board consents towards the establishment or operation of any potential business that may generate pollutants or trade effluents. Examples of ‘trade effluents include- chemical wastes, smoke emissions, flying ashes, etc. Usually, in two stages the licenses are obtained, i.e., consent to establish (obtained before the commencement of commercial activities) and consent to operate (obtained after completing the construction after obtaining the COE).
There are 2 consent certificates required for the license. The first one is consent to establish and is issued before the commercial operation begins, i.e. for constructing. The second license is for consent to operate and is issued after the construction work is complete and necessary for starting the commercial operation.
All existing industrial sectors are categorized into 4 groups by the Ministry of Environment Forest and Climate Change, i.e., red, orange, green, and white. carries out this classification.
Hospitals and healthcare facilities usually come under the red or orange category of business activity. The Hospitals with less than50 beds fall under orange category while the hospitals with 100 or more beds come under red category. Hence the State Pollution Control Board license is mandatory and will not be permitted to function in ecologically fragile or protected areas. Sectors with a pollution index above 60 belong to the red category because they generate the highest number of emissions, effluents, and hazardous waste, and are the highest consumer of resources.
The hospitals or other health care institutions also need Bio-medical Waste Management Authorization from the State Pollution Control Board. The Bio-medical waste Management Authorization shows that the Bio-medical waste generated in the institution is handled, disposed off and recycled in a responsible manner.
Following documents are required for obtaining COC/COE:
The entity or ownership details, 2 address proofs, site plan, pollution control equipment detail etc.
Applying for a Pollution Control Board License:
Apply with site details, plans for pollution control, and industry registration certificates to the state pollution control board’s regional officer. NOC may be obtained from regional officers.
Apply online by logging into the respective state’s pollution control board’s website.