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DIRECTORATE GENERAL OF HEALTH SERVICES

Ministry of Health & Family Welfare
Government of India

National Council for Clinical Establishments

Clinical Establishments Act, 2010 And National Council for Clinical Establishments

A. Background

The purpose of the act is to prescribe minimum standards of facilities and services provided by the clinical establishments so that mandate of article 47 of the Constitution for improvement in public health may be achieved. A copy of the Clinical Establishments (Registration & Regulation) Act (CEA) 2010 and Central Government rules 2012 may be seen on the website of the Act, www.clinicalestablishments.nic.inClinical Establishments Act 2010 after passage by the Parliament came into force on 1-3-2012 came into force in the States of Arunachal Pradesh, Himachal Pradesh, Sikkim and Mizoram and all union territories except Delhi. Subsequently 6 more States have namely Bihar, Jharkhand, Rajasthan, Uttar Pradesh, Uttarakhand and Assam have adopted the Act. Thus the Act as on date is applicable in 10 States and 6 UTs. Rest of the States and Government of Delhi have not taken any action so far for adoption of the Act.

The Act was passed by Parliament in August 2010 and notified on 1st March, 2012

  • National Council for Clinical Establishments notified on 19th March, 2012 and Rules by Centre notified on 23rd May, 2012 (Section 52)
  • Model State Rules under (Section 54) of the Act have been circulated among the States/UT’s
  • The implementation of this Act is being monitored by the PMO
  • Hon’ble Health Minister has requested the Chief Ministers to adopt and implement the Act.

B. Applicability (Present Status)

Clinical Establishments Act 2010 after passage by the Parliament came into force on 1-3-2012 came into force in the States of Arunachal Pradesh, Himachal Pradesh, Sikkim and Mizoram and all union territories except Delhi. Subsequently 6 more States have namely Bihar, Jharkhand, Rajasthan, Uttar Pradesh, Uttarakhand and Assam have adopted the Act. Thus the Act as on date is applicable in 10 States and 6 UTs. Rest of the States and Government of Delhi have not taken any action so far for adoption of the Act.

C. Salient Features & Benefits of the CEA 2010

  • All clinical establishments - including diagnostic centres and single doctor clinics, across all recognized systems of medicine in both public and private sector. (exception: establishments of the Armed Forces) are covered.
  • The Act shall assist in compilation of reliable digital registry of all types of clinical establishments at National, State and District level available in public domain.
  • Standard application form for registration of clinical establishments to ensure uniformity in information being collected.
  • Assist government in obtaining information and data required from clinical establishments for public health interventions including outbreak and disaster management
  • Provisional registration, through a process of self-declaration, without any inspection.
  • Permanent registration would be undertaken after categorization, classification and development of minimum standards
  • Application for registration by post, in person or online
  • Mandatory for every clinical establishment to provide treatment to stabilize the emergency medical condition of any individual brought to such establishment.
  • Establishment of multi stakeholder institutional bodies

a. National Council of Clinical Establishments

b. State Council / Union Territory Council of Clinical Establishments

c. District Registering Authority: Implementing Authority with powers to register and cancel registration

  • Contravenes of any provisions shall be punished with monetary penalties
  • Every clinical establishment has to be registered. Norms required to be met prior to registration include

                       minimum standards of facilities and services; and minimum requirement of personnel.

                       Provision and maintenance of records and reports such other condition as may be prescribed

  • As per the Clinical Establishments (Central Government) Rules 2012, under the abovementioned Act,
  • The clinical establishments shall display the rates charged for each type of services provided and facilities available at a conspicous place in the local as well as English language.
  • the clinical establishments shall charge the rates for each type of procedures and services with in the range of rates determined and issued by the Central Government from time to time in consultation with the State Governments.
  • The Clinical Establishments shall ensure compliance of the Standard Treatment Guidelines (STG) as may be determined and issued by Central Government or State Government from time to time. Compliance to STG shall ensure that unnecessary operations are avoided.
  • Cancellation of registration, would occur at any time, if conditions for registration are not compiled

D. Status of Implementation of Clinical Establishments Act (CEA) and Work Done By National Council for Clinical Establishments till Date (22-4-2016)

  1. At present provisional registration is going on in the implementing States/UTs except U.P., Bihar and Uttarakhand who have not started provisional registration.

  2. A dedicated website www.clinicalestablsihments.nic.in has been operationalized for online registration of clinical establishments and providing information related to Act.

  3. Online registration has been made functional through aforesaid website of the Act in the 7 States/UTs of Himachal Pradesh, Rajasthan, Jharkhand, Chandigarh, Daman and Diu, Dadra and Nagar Haveli and Andaman and Nicobar.
  4. State/UT  Allopathy  Ayurveda  Unani  Siddha  Homoeo -pathy  Yoga Natura -pathy  Sowa -Rigpa  Total 
     ANDAMAN & NICOBAR ISLANDS (UT)  193  22  1  2  26  6  2  0  212
    CHANDIGARH (UT)  281  18  1  1  9  3  4  1  301
    DADRA & NAGAR HAVELI (UT)  1  8  0 14 
    DAMAN & DIU (UT)  100  22  1  0  41  2  0  0  138
    HIMACHAL PRADESH  3689 1712  134  26  152  40  52  9  5035
     Jharkhand  2668  97  26  1  61  9  5  0  2735
     RAJASTHAN  68  13  3  0  9  2  0  0  71
     Total  7000  1892  166  30  303 62   63  10   8506
  5. So far, 8506 Clinical Establishments have registered on line forming the part of digital National register. No. of clinical establishments registered offline as per information received is around 1260.
  6. Steps taken for implementation of the Act:

                       5.1 Dedicated website (www.clinicalestablishments.nic.in) has been made operational.

                       5.2 Online registration facility for clinical establishments is available through website.

                       5.3 Designated Nodal Officers and provision of posts of coordinators at states and district level for                                         implementation of this Act.

                       5.4 Secretariat for National Council has been set up for coordinating the work of national council.

                       5.5 Budget for implementation is provided through state PIP through National Heath Mission (NHM).

                       5.6 Major preparatory work for starting permanent registration has been completed and has been                                          approved by National Council

                       5.7 Operational Guidelines for implementation of the Clinical Establishments Act have been drafted and                           are available on the website of the Act.

                      5.8 Provision of budget to States/UT is made through Programme Implementation Plan for implementation                         of the Act

                      5.9 Other Technical Supports Provided

  •  Advocacy cum training workshops are regularly conducted regarding implementation of the Act and training in online registration. In this year the workshops have been conducted in Rajasthan, Sikkim, Puducherry and Dadra and Nagar Haveli.
  • Training Web Site for practice of online registration 
  • User Manual for online registration 
  • Web based training Module 
  • Frequently asked Questions 
  • Help Email for responding to queries: Help.ceact2010@nic.in 
  • Assistance is provided through telephone 
  • Receiving Feedback online 
  • Suggested terms of Reference for Coordinators and Data Entry Operators for implementation of the Act

6. Work done by National Council for Clinical Establishments:

6.1 8 meetings of National Council for Clinical Establishments have been held and minutes of which are available on the website
6.2 Five subcommittee of National Council were constituted to carry out different work as per the Act.
6.3 Categorization of Clinical Establishments has been finalized and approved
6.4 Minimum Standards of major general categories of clinical establishments namely Clinics, Polyclinics, Mobile Clinics, Hospitals, Physiotherapy Centre, Health Check-up Centre, Dental Lab, Physiotherapy, Dietetics, Integrated Counselling Centre
6.5 Minimum Standards for 35 specialty/super-specialty wise departments/clinical establishments has been finalized and approved by National Council
6.6 Minimum Standards for all systems of medicine under AYUSH have been finalized and approved by National Council
6.7 Application Form for Provisional and Permanent Registration finalized and approved
6.8 Certificate of Provisional and Permanent Registration finalized and approved
6.9 Formats for collection of Information & Statistics from OPD, IPD, Lab and Imaging Clinical Establishments have been finalized and approved
6.10 List of Recognised Qualifications of person incharge of Clinical Establishments has been finalized and approved by National Council
6.11 The National Council for Clinical Establishments has approved a list of medical treatment procedures and a standard template of costing of procedures and services. State/UT Governments have been advised to use these for determining the standard cost of any procedure taking into consideration all pertinent factors.
6.12 Draft Operational Guidelines have been developed for implementaion of the Act by the State Authorities
6.13 All the States that have completed provisional registration of majority of clinical establishments within their States may start permanent registration immediately as the minimum standards have already been approved by the National Council.
 

7. Documents available on the website of the clinical establishments Act namely, www. clinicalestablishments.nic.in:

7.1 Act, Central Govt. and State Rules and Notifications
7.2 Application Form for provisional and permanent registration
7.3 Dashboard of National Register
7.4 Categorization of Clinical Establishments
7.5 Minimum Standards

  • Indian Public Health Standards
  • Minimum standards in respect of major General categories of clinical establishments and 35 specialty/super-specialty categories of allopathic clinical establishments 
  • Minimum Standards for all 7 recognised systems of medicine under AYUSH 

7.6 Standard Treatment Guidelines:

  •  STGs for proper health care for 215 conditions belonging to 21 clinical specialties and Ayurveda out of AYUSH have been uploaded on the website of the CEA.
  •  Standard Treatment Guidelines prescribed under National Health Programmes have been compiled and uploaded.
  • Draft STG for Snake Bite and Diabetic Foot, Management of Alcohol Dependence and Hypertension have been prepared and same has been put up in public domain for comments.  

7.7 Formats for collection of Information & Statistics from Clinical Establishments
7.8 User Manual
7.9 Web based training Module
7.10 Frequently asked Questions
7.11 Help Email for responding to queries: help.ceact2010@nic.in
7.12 Contact List of all nodal officers
7.13 Assistance through telephone
7.14 Feedback Form
7.15 IMA- QCI Survey Report
7.16 Minutes of Meetings of National Council and Report/Minutes of Subcommittees
7.17 Draft operation guideline for Clinical Establishments Act
7.18 list of medical treatment procedures
7.19 standard template of costing of procedures
7.20 Template for Display for Rates
7.21 List of Recognised Qualifications of person incharge of Clinical Establishments
 

Annexure


The Summary of Health Regulations in States/UTs

States / UTs which do not have Clinical Establishments Act (CEA)

Parameter States/UT’s
States repealing existing legislations and enacting own acts on lines of CEA, 2010 (3) Maharashtra, Goa & Delhi (?) are in the process of repealing existing legislation & enacting one on the lines of CEA with modifications.
States enacting legislations where there was no legislations (4) Kerala, Gujarat, Haryana & Meghalaya are in the process of enacting legislation on the lines of central act with modifications
Other States which have own Act (5) ; J&K, Andhra Pradesh (erstwhile), Chhattisgarh, Tamil Nadu (not implemented), Assam (Not implemented)
States which have their own legislations, listed in schedule to CEA and exempted from CE Act. (9) Andhra Pradesh (erstwhile) Maharashtra Delhi Madhya Pradesh Manipur Nagaland Punjab Orissa West Bengal


 States/UTs (16) where the Clinical Establishments Act (CEA) is applicable

 

States: Arunachal Pradesh, Himachal Pradesh, Sikkim, Mizoram, Bihar, Jharkhand, U.P., Uttarakhand, Rajasthan and Assam

UTs: Andaman & Nicobar Islands, Daman & Diu, Dadra & Nagar Haveli, Puducherry, Chandigarh and Lakshadweep

Status of notifications in 16 States/UTs where the Clinical Establishments Act (CEA) is applicable

 

Parameter States/UT’s
Notification of State rules Notified by – Arunachal Pradesh, Himachal Pradesh, Bihar, Jharkhand, Sikkim, Uttarakhand, Rajasthan, Andaman & Nicobar Islands, Daman & Diu, Dadra & Nagar Haveli, Puducherry, Mizoram, Chandigarh Not notified – Assam, Lakshadweep, U.P.
Notification of State / UT council Notified by – Arunachal Pradesh, Himachal Pradesh, Sikkim, Bihar, Uttarakhand, Jharkhand, Rajasthan, Andaman & Nicobar Islands, Lakshadweep, Daman, Diu, Dadra and Nagar Haveli, Puducherry, Mizoram Not notified: -- U.P., Assam, Chandigarh
Notification of District Registration Authorities Notified by - Arunachal Pradesh, Himachal Pradesh, Bihar, Uttarakhand, Jharkhand, Sikkim, Andaman & Nicobar Islands, Daman, Diu, Dadar Nagar Haveli, Puducherry (2/4). Rajasthan, Chandigarh, Mizoram Not notified: -- U.P. and Assam
Act not implemented and provisional registration not started • Uttarakhand: (rethinking on changing rules) • Bihar: (Court cases) • UP: (PIL filed in high court) • Assam

 

This Act is a guiding mechanism for providing an overall improvement in the quality of health care sector in the country. All State Governments are expected to adopt this Act gradually, including the States having similar legislation, have been requested to repeal the same for adopting this Act.

For further information please visit website www.clinicalestablishments.nic.in

Last Updated On 06/03/2017