Clinic and Hospital Registration in Kerala: Licences and Approvals

A clinic, diagnostic centre, laboratory or hospital in Kerala must be registered under the Kerala Clinical Establishments (Registration and Regulation) Act, 2018, in addition to the business registrations and the specific approvals that its services require. These approvals depend on what the establishment does: a consultation clinic needs far fewer than a hospital with a laboratory, imaging and a pharmacy.

This article lists the registrations that usually apply when setting up a healthcare establishment in Kerala.

Choosing the structure

A clinic can be run as a proprietorship of the doctor, a partnership, an LLP or a company. Group practices, multi-speciality centres and establishments that will take investors usually choose an LLP or a private limited company. A Section 8 company or a trust is used where the establishment is run on a not-for-profit basis. See LLP registration in Kerala and company registration in Kerala.

Registrations and approvals

Approval	When it applies	Authority
Registration under the Kerala Clinical Establishments Act, 2018	All clinical establishments covered by the Act; provisional registration first, followed by permanent registration on meeting the standards	Kerala State Council for Clinical Establishments, through the district registering authority
Local body licence	For running the establishment within the local body area	Panchayat, municipality or corporation
Authorisation under the Bio-Medical Waste Management Rules, 2016	Any establishment generating bio-medical waste	Kerala State Pollution Control Board
Consent to establish and operate	Depending on the size and category of the establishment	Kerala State Pollution Control Board
Fire safety approval	Depending on the height, area and occupancy of the building	Kerala Fire and Rescue Services
Drug licence	Where a pharmacy is run or medicines are stocked for sale	Drugs Control Department, Kerala
AERB licence	Where X-ray or other radiation equipment is installed	Atomic Energy Regulatory Board
PCPNDT registration	Where ultrasound or similar diagnostic equipment is used	Appropriate authority under the PCPNDT Act

Every doctor and nurse practising in the establishment must hold a valid registration with the appropriate council.

Tax points

• Healthcare services by a clinical establishment or a registered medical practitioner are generally exempt from GST. Other supplies, such as the sale of medicines to outpatients, cosmetic procedures and rent, may be taxable.
• Income tax applies as for any business or profession, according to the structure chosen.

Practical points

• Check building suitability and approvals before taking premises on lease, since several approvals depend on the building.
• Plan bio-medical waste handling with an authorised common treatment facility from the start.
• Keep registrations displayed and renewals tracked; inspections under the Clinical Establishments Act check display and records.
• Where doctors join as partners or shareholders, put the arrangement in writing. See shareholders’ agreements.

Frequently asked questions

Does a single-doctor consultation clinic need registration?

Clinical establishments covered by the Kerala Act, including many single-doctor clinics, need registration. The categories and standards notified under the Act should be checked for the specific establishment.

Can a company own a hospital if the directors are not doctors?

Yes. A company or LLP can own and run a clinical establishment, but the clinical services must be provided by qualified, registered professionals.

Is there a separate registration for a laboratory?

A laboratory is itself a clinical establishment under the Act and needs registration, with standards specific to laboratories.

ചുരുക്കം (Summary in Malayalam)

കേരളത്തിൽ ക്ലിനിക്, ഡയഗ്നോസ്റ്റിക് സെന്റർ, ലാബ്, ആശുപത്രി എന്നിവ കേരള ക്ലിനിക്കൽ എസ്റ്റാബ്ലിഷ്മെന്റ്സ് (രജിസ്ട്രേഷൻ ആൻഡ് റെഗുലേഷൻ) ആക്ട്, 2018 പ്രകാരം രജിസ്റ്റർ ചെയ്യണം. ഇതിനു പുറമേ തദ്ദേശ സ്ഥാപനത്തിന്റെ ലൈസൻസ്, ബയോ-മെഡിക്കൽ മാലിന്യത്തിന് മലിനീകരണ നിയന്ത്രണ ബോർഡിന്റെ അനുമതി, ഫയർ NOC, ഫാർമസിക്ക് ഡ്രഗ് ലൈസൻസ്, എക്സ്-റേയ്ക്ക് AERB, അൾട്രാസൗണ്ടിന് PCPNDT രജിസ്ട്രേഷൻ എന്നിവ ആവശ്യാനുസരണം വേണം. ആരോഗ്യ സേവനങ്ങൾക്ക് സാധാരണ GST ഇല്ല.

This article gives a general overview of registrations for healthcare establishments in Kerala. Standards, categories and procedures are revised from time to time; for accurate and current requirements, check with the Kerala State Council for Clinical Establishments and the authorities concerned. The article is not advice on any particular case.