Legal approval required to open a clinic or hospital In India

Legal Approval Required to Open a Clinic or Hospital in India

Guidelines and Eligibility Requirements to open a clinic or hospital in India

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24 Feb 2021

Starting a private practice as a healthcare service provider in today's environment attracts licensing and regulatory criteria, be it a doctor’s clinic, individual practice, laboratory facilities, a single specialty hospital or a multi-specialty hospital. As a first step, it is imperative for you to be aware of the different legal requirements before starting a clinic/hospital.

That is why the Legal Compliance Management Company should be considered before starting any business. They have adequate auditing advice, legal and enforcement programs, and manage anything through compliance software that is legal and regulatory. Depending on the services that you provide, these enforcement criteria can differ.

Approvals Relating To Infrastructure

You would need a consultation room with a minimum of 100 square feet to operate a small doctor’s clinic. Naturally, the room requirements can also vary depending on the services you offer. Bear in mind, the space requirement will be multiplied for each specialization you give, and regulated as above under the respective laws.

If it is owned by you, the basic approvals needed for the building are:

  • Certificate for occupancy.

  • Certificate of completion.

  • If the building where the clinic/hospital is set up is more than 15 meters tall, the copy of Fire NOC is required.

If the building/space is taken on lease/rent, a lease deed/rent agreement will be required, which will be renewed at the expiry of the lease. And, ensure that the owner has received the aforementioned building permits.

Clinical Registration

You need a registration certificate under the Clinical Establishments (Registration and Regulation) Act, 2010, regardless of whether you are a small single practitioner clinic or a multi-speciality hospital. Each state passes its own rules, and the process followed to obtain the license often varies accordingly.

Pollution Approvals

If your clinic/hospital produces any waste such as soiled waste, linen, sharp waste, etc., you will need to obtain consent from the State Pollution Control Board for the generation of bio-medical waste, This authorisation shall be granted in respect of a non-bedded category, i.e. if only outpatient consultation is offered. Such permissions are typically valid until they are revoked, i.e. for life. Nevertheless, if there is any change in the amount of waste being generated, then a revised consent must be obtained. Besides this, depending on the bed size, you will need permission to establish and consent to operate the hospital from the Pollution Control Board.

Approvals Related To Medical Professionals And Employees

The doctor, nurses and other medical practitioners you hire will need to have the proper registration in addition to permits and licenses for the clinic, such as:

  • Registration for physicians by the State Medical Council.

  • Registration of the Nursing Council for the nurses employed.

  • Registration for the Dental Council, for dentists.

  • Registration from the Pharmacy Board for Pharmacists.

  • Clinical psychologist's enrollment, whether it is a psychiatric facility.

Drug License

If you have an attached pharmacy in your clinic/hospital, or you dispense medications from your clinic/hospital to your patients, then you need:

  • Retail license for drugs acquired under the Drugs and Cosmetics Act, 1940, from the Drug Controller.

  • If narcotic medications are used or sold by the clinic/hospital in the form of injections or tablets or patches, then special permission must be sought from the district collector.

Wrapping it Up

It is necessary to adhere to guidelines set by the government, to open a clinic or hospital in India. With the ever growing Indian population, there is a need for more clinics and hospitals.

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