Legal Approvals Required to Run a Clinic or Hospital in India

Legal Approvals Required to Run a Clinic or Hospital in India

In today’s legal landscape, commencing a private practice as a health care service provider be it a small Clinic, individual practice, diagnostic services, a single specialty hospital or multi-specialty hospital attracts licensing and compliance requirements.  As a first step, before starting a Clinic/ hospital, it is imperative for you to become aware of the various legal requirement.  You can see below a list of the licenses you need, and the basic compliance’s which you should stick to, so you can stay on the right side of the law.

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 enhances your own licenses.

See the reference below for different health care services/ speciality and the license under relevant laws:

Service License Under:

Ultrasound scanningPre–natal Conception and Pre-natal Diagnostics techniques Act, 1994
Admission of Physicatric CasesMental Health Act, 1987
Selling Medicines/ DrugsDrugs and Cosmetics Act, 1940
Transplantation of Human OrgansTransplantation of Human Organ Act, 1994
Scan centers having X-RAY, CT, PET-CT etcAtomic Energy Regulatory Bord
Blood bank/ Blood Storage CenterDrugs 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 labor laws.

Here is the list of license you will need for the infrastructure you use for the clinic/ hospital:

Approvals relating to the infrastructure:

In order to run a small clinic, you will need a consulting room of a minimum of 100 square feet.  Naturally, depending on the services you render the space requirements also change.  Keep in mind, for each specialty (see the list we have mentioned above) you offer the space requirement will be multiplied and it is governed under the respective laws mentioned against each specialty.

The basic approvals required for the Building, if owned by you, is:

1. Occupancy certificate.
2. Completion certificate.
3. Fire NOC, if the building where the clinic/ hospital is established is more than 15 meters tall.

If the building/ space is taken on lease/ rent, then you will need a Lease deed/ rent agreement, which shall be renewed on expiry of the lease.  Also, ensure that the owner has obtained the above-mentioned approvals for the building.

Clinical Registration:

Irrespective of whether you are a small single practitioner Clinic or a multi-specialty hospital, you need a registration certificate under Clinical Establishments (Registration and Regulation) Act, 2010.  Each state has passed its own rules, and accordingly, the procedure followed for obtaining the license also varies.

Pollution Approvals:

You will need to obtain consent from the State Pollution Control Board for generation of bio-medical waste if your clinic/ hospital generates any waste such as soiled waste, linens, sharp waste, etc. This authorization is given for a non-bedded category if you have only outpatient consulting.  Typically such authorizations are valid until revoked, i.e for a 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. See our article on how to obtain pollution consents.

Approvals related to medical professionals and employees:

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:

1. State Medical Council Registration for doctors.
2. Nursing Council Registration for the nurses employed.
3. Dental Council Registration, for the dentists.
4. Pharmacy Council Registration for Pharmacists.
5. Registration of clinical psychologist, if it is a psychology clinic.

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

1. License for retailing drugs obtained from the Drug Controller under Drugs and Cosmetics Act, 1940.
2. If the clinic/ hospital uses or dispenses narcotics drugs in the form of injection or tablets or patches, then special approval from the district collector has to be obtained.

Here the thumb rule is, when in doubt, just display, and display all the licenses you obtain, specifically, every Clinic/ hospital shall display:

1. The registration certificate under the Clinical Establishments Act.
2. Registration Certificate of the Doctors under the Indian Medical Council.

1. Record of employment of adults, letters of employment issued and hours of work.
2. Records regarding the treatment of patients (IMC Regulations 2002).
3. Register of medico-legal cases (MLCs).
4. Register of Medical certificates issued to patients.
5. Copies of medical certificates issued to the patients.
6. Registration certificates of doctors/nurses/pharmacists with the Indian Medical Councils (IMCs).
7. Professional qualification certificates (degrees/diplomas) of the staff.
8. Record of consumption of Morphine, Vermin other narcotic drugs (if applicable) (Narcotic Drugs Rules, 2002).
9. Account of money receipts and expenses (Income Tax Act, 1961).

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