1. The Clinical Establishments Act provides for registration and regulation of clinical establishments in the country with a view to prescribe basic minimum standards of facilities and services of particular type being provided by the clinical establishment.
2. A clinical establishment means a hospital, maternity home, nursing home, dispensary, clinic, sanatorium, or any other institution that offers services, facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognized system of medicine. It also includes laboratory and diagnostic centre or any other place where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other services with aid of laboratory or other medical equipment are carried out. (Please refer to the Definition in the CEA 2010.)
3. All clinical establishments across all recognized systems of medicine (i.e. Allopathy, Ayurveda, Yoga, Naturopathy, Homoeopathy, Siddha, Unani and Sowa Rigpa) in both public and private sector are covered under this Act. This includes, all establishments owned, controlled or managed by the Government, a trust (public or private), a corporation registered under a Central, Provincial or State Act (whether or not owned by the Government), a local authority and a single doctor.
4. The clinical establishments owned, controlled or managed by the Armed Forces are not covered under this Act. Also those categories of Clinical Establishment exempted by the state Government and Clinical Establishments located in the States/UTs mentioned in the schedule to the Act; unless these States/UTs repeal their existing Act and adopt Clinical Establishments Act.
5. No. This Act has come into force in the States of Arunachal Pradesh, Sikkim, Mizoram, Himachal Pradesh and all Union Territories (namely Andaman & Nicobar Islands, Chandigarh, Dadra & Nagar Haveli, Daman & Diu, Lakshadweep and Puducherry) except Delhi from 01 March 2012. The States of Uttar Pradesh, Bihar, Rajasthan, Jharkhand and Uttarakhand have adopted the Act by passing resolution in their respective State assemblies. All clinical establishments in above mentioned States and Union Territories will need to register under this Act. Other states may adopt the law by passing a resolution in their state assemblies under clause (I) of Article 252 of the Constitution.
6.(i) The Act: (a) Assists in generation of reliable and comprehensive database (or registry) for all types of clinical establishments in the country at district, state and national level. (b) Helps classify various types of clinical establishments into categories & determine category wise basic minimum standards. (c) Defines basic minimum standards for operation, using participatory and consultative approach to ensure uniformity across all establishments. The minimum standards indicate basic standards which are mandatory and certain standards which are desirable. (d) Assists Government in obtaining information and data required from clinical establishments for public health interventions including outbreak and disaster management 3 (ii) It establishes the multi-stakeholder bodies namely National Council for Clinical Establishments at National level, State Council for clinical establishments at State level & District Registration Authority at each district. Implementation of the Act is by respective state through State council and District Registration Authority. (iii) The Act allows for two-step process of registration – provisional and permanent registration. Provisional registration is done through a process of self-declaration, without any inquiry or inspection. Permanent registration would be undertaken after categorization, classification and notification of category wise minimum standards. (iv) The Act places the entire process of registration and the data of clinical establishments in the public domain which ensures transparency. (v) Details of charges, facilities available would be prominently displayed at a conspicuous place at each establishment (vi) Registry of clinical establishments would aid in policy formulation and resource allocation. (vii) Cancellation of registration would occur at any time, if conditions for registration are not complied with. (viii) Clinical Establishment to provide emergency medical treatment within staff and facilities available. (ix) The Act may control or act as deterrent against quackery by introducing registration which is applicable only to clinical establishments of recognized systems of medicine and no one can run a clinical establishment without registration. (x) It lays down provisions for healthcare providers to maintain records and reporting as prescribed and provide information and statistics that may be asked for by the authority.
7. It is true Health is a state subject and in the same so the Act is not enforced on any state. State has to adopt the Act by passing a resolution in the legislature assembly of state. The Bill was passed by Parliament after 4 states agreed to enforce the Act after notification. 4 As per the provisions of the Act,
The Central Government is responsible for:
- Notification of the Act (Completed)
- Notification of the National Council and Rules for the functioning (Completed)
- Classification & Categorization of the Clinical Establishments by Central Government based on the recommendations of the National Council. (Completed)
- Establish Minimum Standards for the different categories of Clinical Establishments based on the recommendations of the National Council.
- Develop and prescribe the form and manner in which the registry (National, State & District level) is to be maintained.
- Provide oversight and assistance to the States and UT’s for the implementation of the CEA 2010 including capacity building.
- Assistance for the drafting of Rules under Section 54 of the Act. Draft of Model Rules circulated to all implementing States/UTs.
- Assist States & UT’s in adoption of the proposed web based registration system and offline registration systems. Assistance to the State & UT’s Councils for any other matter that may be required.
The State Governments would be responsible for:
- Notification of State Rules under Section 54 of the Act
- Constitute & notify the State / Union Territory Council of Clinical Establishments
- Constitute & notify District Registration Authorities in all districts
- Begin the process of provisional registration
- Identification and notification of Registrars of Clinical Establishment at State Level (Director of Health Services) and District level (District Health Officer)
- Disseminate information about the Act and Rules at various levels and among stakeholders
8. The purpose of Clinical Establishment Act is to make available a database of Clinical Establishments which are authorized to function. Therefore the overall objective is improvement in public health quality by eliminating quacks.
Other objectives are:
- To prescribe basic minimum standards for different categories of clinical establishments for ensuring provision of proper healthcare by the clinical establishments.
- To collect the required statistics from clinical establishments for policy formulations, planning, implementation, response and evaluation.