In today’s legal landscape, commencing a private practice as a healthcare service provider — be it a small clinic, individual practice, diagnostic services, a single speciality hospital or a multi-speciality hospital — attracts licensing and compliance requirements. As a first step, before starting a clinic/hospital, it is imperative for you to be aware of the various legal requirements. You can see below a list of the licenses you need, and a few guidelines one must comply to, so you can stay on the right side of the law.
That’s why, before starting any business, one may consider Legal Compliance Management Company. They give proper guidance, legal and compliance auditing services, and handle everything through a legal and regulatory compliance software.
These compliance requirements may vary depending on the services you offer. Say, for example, if you are a dentist with an X-ray machine, then you will need to obtain a registration for using the X-Ray. Similarly, the type of services you deliver typically enhance your various licenses.
The reference below mentions licenses for different health care services/speciality under relevant laws:
|Ultrasound scanning||Prenatal Conception and Pre-natal Diagnostics Techniques Act, 1994|
|Admission of Physicatric Cases||Mental Health Act, 1987|
|Selling Medicines/ Drugs||Drugs and Cosmetics Act, 1940|
|Transplantation of Human Organs||Transplantation of Human Organ Act, 1994|
|Scan centres having X-RAY, CT, PET-CT etc||Atomic Energy Regulatory Board|
|Blood bank/ Blood Storage Center||Drugs and Cosmetics Act, 1940|
Besides the above laws, your clinic/hospital will also need to adhere to the Clinical Establishment Act, pollution control norms, fire safety norms, and other central and state-specific labour laws. Here is a list of licenses you will need for the infrastructure you use for the clinic/hospital:
In order to run a small clinic, you will need a consulting room of a minimum 100 square feet. Naturally, depending on the services you render, the space requirements will also change. Keep in mind, for each speciality you offer, the space requirement will be multiplied and governed under the respective laws as aforementioned.
The basic approvals required for the building, if owned by you, is:
If the building/space is taken on lease/rent, then you will need a lease deed/rent agreement, which shall be renewed on the expiry of the lease. Also, ensure that the owner has obtained the above-mentioned approvals for the building.
Irrespective of whether you are a small single practitioner clinic or a multi-speciality hospital, you need a registration certificate under Clinical Establishments (Registration and Regulation) Act, 2010. Each state passes its own rules, and accordingly, the procedure followed for obtaining the license also varies.
You will need to obtain consent from the State Pollution Control Board for the generation of bio-medical waste, if your clinic/ hospital generates any waste such as soiled waste, linens, sharp waste, etc. This authorisation is given for a non-bedded category i.e if you only offer outpatient consulting. Typically, such authorisations are valid until revoked, i.e for lifetime. However, if there is any change in the quantum of waste being generated, then a revised approval has to be obtained. Apart from this, you will need consent to establish and consent to operate the hospital from the Pollution Control Board depending on the bed size.
Besides approvals and licenses for the clinic, the doctor, nurses and other medical professionals you employ also need to have the right registration, such as:
If your clinic/hospital has an attached pharmacy, or you dispense drugs to your patients from your clinic/hospital, then you need:
Above all, if you have put in the work, and obtained the licenses, display them.
Here the thumb rule is, when in doubt, just display. You may display all the licenses you obtain. Every clinic/hospital must display:
Apart from obtaining the approval, you will need to maintain some mandatory records under the law, such as: