The document defines clinical establishments and classifies them into different levels. It discusses the Clinical Establishments Act passed in 2010 to regulate healthcare facilities in India. The act established authorities at the national, state, and district levels to register clinics and enforce minimum standards. It classifies Tamil Nadu as a state that has its own clinical establishments act. The document also outlines requirements for registering a clinic in Tamil Nadu, including online registration procedures, minimum space, staffing, equipment, and drug requirements.

1. CLINICAL
ESTABLISHMENT ACT
By
Dr. S.Vinodhraja pg

2. Objectives
• Define Clinical Establishments.
• Classify various levels of Clinical
Establishments.
• Elicit the procedure for registering clinics
under Clinical Establishment Act .

3. MCQ
1.Which Clinical establishments not covered
under the Act ?
a) Clinic owned by single doctor.
b) Clinics owned, controlled or managed by the
Armed Forces.
c) Government medical college.
d) Corporation / municipality – dispensaries.

4. MCQ
2.According to National Sample Survey 60th
round % of the private care is likely being
provided by informal unqualified providers?
a) 20%
b) 30%
c) 40%
d) 50%

5. MCQ
3. Tamil Nadu falls under which category of
states of CEA 2010?
a) States/UTs where Clinical Establishments Act
(CEA) 2010 is applicable.
b) States / UTs which do not have Clinical
Establishments Act (CEA) but have their own
Act.
c) States which neither have Clinical
establishments Act nor their own Act.

6. Introduction
• The Clinical Establishments Act was passed by
Parliament of India on 17th August 2010
• The Act was notified vide Gazette notification dated
28th February, 2012.
• The Ministry of Health and Family Welfare has notified
the National Council for Clinical Establishments and the
Clinical Establishments (Central Government) Rules,
2012 under this Act vide Gazette notifications dated
19th March, 2012 and 23rd May, 2012 respectively.
• NSSO estimates, as much as 40% of the private care is
likely being provided by informal unqualified providers.

7. Definition
• Clinical establishments defined as health care establishments by
any name, engaged in diagnosis, treatment or care of injury, illness,
pregnancy, disability, or abnormality.
• a clinical establishment owned, controlled or managed by a
Government or
a) department of the Government;
b) a trust, whether public or private;
c) a corporation (including a society) registered under a Central,
Provincial or State Act, whether or not owned by the Government;
d) a local authority; and
e) a single doctor
(Exception: establishments of the Armed Forces)

8. Objectives of the Act
• To establish digital registry of Clinical Establishments at
National, State and District level.
• To prevent quackery by unqualified practitioners by
introducing registration system, which is mandatory.
• To improve quality of health care through standardization of
healthcare facilities by prescribing minimum standards of
facilities and services for all categories of health care
establishments.

9. States category
CATEGORY STATES
States/UTs* where Clinical Establishments
Act (CEA) is Applicable
Arunachal Pradesh, Assam, Himachal
Pradesh,Bihar, Jharkhand, Sikkim,
Uttarakhand, Rajasthan, Andaman &
Nicobar Islands, Daman & Diu, Dadra &
Nagar Haveli, Puducherry, Mizoram,
Chandigarh, Uttar Pradesh,
Lakshadweep(16)
States / UTs (16) which do not have
Clinical Establishments Act (CEA) but have
their own Act
Andhra Pradesh ,Maharashtra, Delhi,
Madhya Pradesh, Manipur, Nagaland,
Punjab, Odisha, West Bengal, Karnataka,
Jammu&kashmir, Chhattisgarh,Tamil
Nadu, Haryana,Tripura& Meghalaya(16)
States which neither have Clinical
establishments Act nor
their own Act
Kerala, Gujarat, Goa

10. Authority
National Council for clinical establishments
• DGHS, Ex-officio, Chairperson
4 elected representatives, out of which
• Medical Council of India (one representative),
• Dental Council of India (one representative),
• Nursing Council of India (one representative),
• Pharmacy Council of India(one representative),
• Indian Medicines representing the Ayurveda,Siddha,Unani (three elected
representatives),
• Central Council of Homoeopathy (one elected representative) ,
• Indian Medical Association (one elected representative),
• Bureau of Indian Standards (one representative),
• Association of Indian Systems of Medicines relating to Ayurveda,
Siddha,Unani to be nominated by the Central Government (one
representative)
• Secretary General of the Quality Council of India,

11. At State Level
• State Council for Clinical Establishments
• Chairman: Secretary (Health) - IAS
• Member Secretary : Director of Medical and rural Health Services
• Members (14):
a) Directors of different streams of Indian Systems of Medicine (3)
b) Elected Representatives of State Councils: Medical Council, Dental
Council, Nursing Council, Pharmacy Council, State council of Indian
Systems of Medicine (7)
c) Elected representative of State council of IMA, (1)
d) Representative of line of paramedical system (1)
e) State-level consumer groups or reputed Health NGOs (2)

12. AT DISTRICT LEVEL
• District Registering Authority
• Chairman: District collector/District Magistrate
(DM)
• Convener: Joint Director Health Services JDHS
• Three members: to be nominated by DM
a) City Police Commissioner/SSP/SP or nominee
b) Senior officer of local self Government at district
level/ DDHS/MHO/CHO
c) Professional medical Association/body IMA,IAP

13. Powers & Responsibilities: DRA
a) Grant/Renew provisional (within 10 days)/permanent
registration.
b) List expired Registrations.
c) May issue a notice to Clinical Establishment to show cause within
3 months, if condition(s) of registration are not met
d) To enter and search unregistered CE (after due notice), inspection
and inquiry of registered Clinical establishments
e) May cancel registration (after giving reasonable opportunity) and
giving reasons After cancelling registration, immediately restrain
Clinical Establishment if imminent danger to the health and safety
of patients
f) Recover penalties
g) Maintain District register of Clinical establishments

14. Levels of establishments
Levels Clinical establishment
Level 1 (A) General Medical services with indoor
admission facility (PHC, Government and
Private Hospitals and Nursing Homes
run by MBBS /BDS Doctors)
Level 1 (B) level 1(A) above and basic specialist
medical Services General Medicine,
General Surgery, Paediatrics, Obstetrics &
Gynaecology and Dentistry.
Level 2 (Non-Teaching) level 1(A) and 1(B) and services through
other medical specialties
(Orthopaedics,ENT,Ophthalmology,emerg
ency with or without ICU, Anaesthesia
,Psychiatry,Skin,Pulmonary
Medicine,Rehabilitation.

15. Level 3 (Non-Teaching) Super-specialty
services
level1(A), 1(B) and
2 and services of one or more or the
super specialty with distinct
department(Corporate Hospitals,
Referral Hospitals, Regional/State
Hospital,)
Level 4 (Teaching) Tertiary healthcare services

16. Instructions for Creating New
Account for Registration TN
a) http://tnhealth.org/dms/tncea/login.Choose the Correct
Revenue District. The User ID will be tagged to the Competent
Authority of the Concerned District and the Bank Account for
Payment of Registration Fee.
b) Verify the presence of your Taluk name in the dropdown for the
chosen district.
c) Enter the Name of the Clinical Establishment correctly. This name
will appear in the Registration Certificate as it is entered here.
d) Enter Mobile number
e) Enter Valid Email ID. Link for activation of the Login User ID will be
sent to this email.
f) Enter the Password of your Choice

17. Minimum required standards
• Clinic / Polyclinic only Consultation ( level 1A)
space :
Human Resource:
One Doctor – MBBS / BDS registered in any MCI
One Support staff – registered in any nursing council
Common area Consultation area
Reception Waiting Room
35 sqft 35 sqft 70 sqft

18. Furniture/fixtures
S.NO Articles
1 Table
2 Chairs
3 Examination Table/couch
4 Screens
5 Foot Step
6 Stools
7 Storage Cabinet for records
8 BMW storage area

19. Essential Equipment
Equipment Minimum specification Number
Stethoscope 1
Thermometer Digital 1
Torch (flash lights) 1
Sphygmomanometer(B.P.
Apparatus)
Digital 1
Weighing
machine(Optional)
Adult 1

20. Emergency Equipment
Equipment Minimum specification Number
Resuscitation Equipment
Ambu Bag/Air Way
Adult
Pediatric
1
1
Oxygen Concentrator/
Cylinder .
Portable 1
Fire Extinguisher 1

21. Emergency Drugs
Name of the Drug No of ampule
Inj Adrenaline 2 A
Inj Hydrocortisone 1 vial
Inj Atropine 1 Ampoule
Inj Avil 1 Ampoule
Inj Phenargan 1 Ampoule
Inj. Deryphyline 1 Ampoule
Inj. Frusemide 1 Ampoule
Inj. Metoclopramide 1 Ampoule

22. Emergency Drugs
Name of the Drug No of ampule
Inj. Dexamethasone 2 A
Inj. Diazepam 1 vial
Inj. Dicyclomine Hydrochloride 1 Ampoule
Inj. 5% dextrose infusion 1 Vac
Inj. Normal saline 1 Vac

23. Penalties under the Act
Offences penalties
FIRST ATTEMPT SECOND ATTEMPT SUBSEQUENT
ATTEMPT
Running Clinical
Establishment
without registration
50,000 2,00,000 5,00,000
Contravention of
any other provision
of the Act
10,000 50,000 5,00,000
Whoever knowingly
serves in an
unregistered
Clinical
Establishment
25,000
Minor deficiencies
which do not pose
imminent danger
10,000

24. SANITARY AND REGISTRATION CERTIFICATE FROM LOCAL HEALTH AUTHORITY

25. BIO MEDICAL WASTE TREATMENT FACILITY AGREEMENT & AUTHORIZATION

27. Thank you