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Legal Compliances to set up Hospital in India

Every business before starting needs to get done with various legal compliance as per the sector in which they are plying in. Similarly, for commencing a private practice in a healthcare sector as service provider, be it a Small Clinic, Individual Practice, Diagnostic services, a single specialty hospital, multi-speciality hospital attracts licencing and compliance requirements. 

 

Here are some of the quick compliance guides which you must adhere to before starting your journey in the healthcare service sector. These will vary from general to specific according to services provided.

 

These compliance requirements may vary depending on the services you offer.  See the reference below for different health care services/ speciality and the license under relevant laws:

Service

License Under:

Ultrasound scanning

Pre–natal Conception and Prenatal Diagnostics techniques Act, 1994

Admission of Psychiatric Cases

Mental Healthcare Act, 2017

Selling Medicines/ Drugs

Drugs and Cosmetics Act, 1940

Transplantation of Human Organs

Transplantation of Human Organ Act, 1994

Scan centers having X-RAY, CT, PET-CT etc

Atomic Energy Regulatory Board

Blood bank/ Blood Storage Center

Drugs and Cosmetics Act, 1940



Infrastructural Compliance 

 

A necessity for starting any enterprise or business is space occupancy with valid address proof. Although the required area will be determined by the kind of service you are offering. The minimum requirement for a small clinic is a consulting room of minimum of 100 sq. ft. and this will be multiplied for specialty services as per their respective acts.

The basic approval required for occupying a building, which will given by your local authority; 

  1. Occupancy certificate.
  2. Completion certificate.
  3. Fire NOC, if the building where the clinic/ hospital is established is more than 15 meters tall.
  4. Lease deed/ rent agreement, if the space is on lease/rent.

 

Clinical Registration

 

Clinical Registration certificate under Clinical Establishments (Registration and Regulation) Act, 2010. The rules and regulations under this act have been different states accordingly.

 

Environmental Related Approvals

 

A lot of bio-medical waste  infectious waste includes discarded blood, sharps, unwanted microbiological cultures and stocks, identifiable body parts etc which are hazardous for the environment therefore a consent from the State Pollution Control Board for permitted bio-medical waste generation if your hospital does so.Such permits are usually valid until they have been revoked. However, if the quantity of waste generated changes, a revised approval is required.In addition, the hospital will need the consent of the pollution control board to operate depending on the size of the bed and consent.

 

Medical Professionals and Employees Registration 

 

The staff including doctor, nurses and other medical must be registered under their respective codes/acts 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 psychologists, if it is a psychology clinic.

Drug License

 

If you have an annexed pharmacy in your clinic / hospital or dispense your patients with medicine from the clinic / hospital, you need:

  1. License for retailing drugs obtained from the Drug Controller under Drugs and Cosmetics Act, 1940.
  2. If narcotics are used by the clinic or hospital or dispensed in the form of injection or injection pills, then special approval must be obtained from the district collector.

Displaying of Licences 

 

Technically all the obtained licenses must be displayed in such way, which can be seen by the public, 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.

 

Law prescribe certain records to mandatorily maintained 

 
  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).

 

The Legal Compliance Management Company must be considered first if you start any business. They offer proper legal guidance and audits and handle everything simultaneously through software for compliance with laws and legislation. 

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