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:
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
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;
Clinical Registration certificate under Clinical Establishments (Registration and Regulation) Act, 2010. The rules and regulations under this act have been different states accordingly.
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for permitted bio-medical waste generation if your hospital does so.Such permits are usually valid until they have been revoked.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.
The staff including doctor, nurses and other medical must be registered under their respective codes/acts such as;
If you have an annexed pharmacy in your clinic / hospital or dispense your patients with medicine from the clinic / hospital, you need:
Technically all the obtained licenses must be displayed in such way, which can be seen by the public, specifically, every Clinic/ hospital shall display:
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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