The Clinical Establishments Act was passed by Parliament of India on 17th August 2010, to provide for registration and regulation of all clinical establishments in the country with a view to prescribe minimum standards of facilities and services which may be provided by them so that mandate of Article 47 of the Constitution for improvement in public health may be achieved. The Act was notified vide Gazette notification dated 28th February 2012 and initially came into force on 1st March 2012 in the four states namely: Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and all Union Territories except Delhi. Further the states of Uttar Pradesh, Rajasthan, Bihar, Jharkhand, Uttarakhand and Assam adopted the Act under clause (1) of article 252 of the Constitution. At present, the Act is applicable in aforesaid 10 states and 6 Union Territories.
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.
The Act is applicable to all kinds of clinical establishments from public and private sectors, of all recognized systems of medicine including single doctor clinics. The only exception is establishments run by the Armed forces which will not be regulated under this Act.
Clinical Establishments covered under this Act
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.
Clinical Establishments not covered under the Act
- Clinical establishments owned, controlled or managed by the Armed Forces.
- Clinical Establishment in the States /UTs mentioned in the schedule of the Act; unless they repeal existing Act and adopt Clinical Establishments Act.
- Also, Clinical Establishments of those categories and of those recognized systems of medicine for which date has not been appointed by the State Government, who has otherwise adopted the Act.
Types of Clinical Establishments (Registration and Regulation) Act Registration:
There are two types of registration: -
- Provisional Registration: No enquiry is to be done prior to grant of certificate of provisional registration, which is granted for one year at a time.
- Permanent registration: Permanent registration is to be considered after notification of Minimum Standards. Clinical Establishments will be required to meet Minimum Standards before grant of Permanent Registration. The provisional registration shall not be renewed after a period of two years from the date of notification of Minimum Standards, in case of existing Clinical Establishments and the same shall not be renewed after a period of six months in case of new Clinical Establishments (i.e. which come into existence after date of notification of Minimum Standards). Certificate of permanent registration is granted for five years at a time.
The Objectives of Clinical Establishments Act are:
- It aims to register and regulate clinical establishments based on minimum standards in order to improve quality of public health care sector in the country.
- To establish digital registration 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 (except teaching hospitals,) and ensuring compliance of other conditions of registration like compliance to standard treatment guidelines, stabilization of emergency medical condition, display of range of rates to be charged, maintenance of records etc.