The Clinical Establishment (Registration and Regulation) Act, 2010

The Clinical Establishment (Registration and Regulation) Act, 2010
16 April 2020

The Clinical Establishment (Registration and Regulation) Act, 2010

The Clinical Establishments (Registration and Regulation) Act, 2010 has been enacted by the Central Government to provide for regulation and registration of all clinical establishments in the nation with an opinion to prescribing the minimum standards of services and facilities provided by them.

As per a report submitted by the Government of India, planning commission namely "Clinical Establishments, Professional Services Regulation and Accreditation of Health Care Infrastructure" for the 11th Five-Year Plan,1 Health regulation in India encompasses a diversity of factors and issues. These includes promulgation of legislation for health facilities & services, human power (Education, Licensing & Professional Responsibility), Ethics and Patients Rights, disease control & medical care, Pharmaceuticals & Medical Devices, Radiation Protection, Poisons & Hazardous Substances, Occupational Health and Accident Prevention, Elderly, Disabled & Rehabilitation Family, Women, and Child Health, Mental Health, Smoking/Tobacco Control, Social Security & Health Insurance, Environmental Protection, Nutrition. Thus, the report highlighted the need for a central legislation for registration of clinical establishments in the nation and uniform standards need to be developed for the entire nation.

Objective of the Act

This Act makes it compulsory for registration of all clinical establishments, comprising diagnostic centers and single-doctor clinics across all recognized systems of medicine both in the private and public sectors except those run by the defense forces. The registering authority facilitates resource allocation, policy formulation, and determines standards of treatment. It can inflict fines for non-compliance of the provision of the Act. This Act also lays down Standard Treatment Guidelines for common disease conditions, for which a core committee of experts has been formed. Further, the Act makes all clinical establishments to require medical care and treatment vital to stabilize any individual who comes or is brought to the clinical establishment in an emergency medical condition, particularly women who come for deliveries and accident cases.

Implementation of the Act

Vide the notification dated 28 January 2010 this Act came into force in four states of India, namely Himachal Pradesh, Arunachal Pradesh, Sikkim, Mizoram, and all Union Territories. Later, Uttar Pradesh, Jharkhand, and Rajasthan have adopted this Act under clause (1) of Article 252 of the Constitution. In 2013, the State of Maharashtra planned a multi-stakeholder committee to formulate the Maharashtra Clinical Establishment Act to be a major step towards the standardization of cost and quality in the private medical sector. Further, the Kerala Clinical Establishments (Registration, Accreditation, and Regulation) Bill, 2009 is awaiting a go-ahead from the Government to be enforced.

The National Council for Clinical Establishment

This Act lays down the establishment for a Council Body called The National Council for Clinical Establishment which is responsible primarily for setting up standards for ensuring proper healthcare by the clinical establishment and developing the minimum standards and their periodic review.

Clinical Establishments and procedure for registration of the Clinical Establishment

This Act under section 11 mandates that no person shall run a clinical establishment unless it has been duly registered in accordance with the provisions of the Act. In September 2014, the Government of India, the Ministry of Health and Family Welfare2 issued the Application format for Permanent Registration of Clinical Establishments which requires the applicant to provide information such as, among others, establishment details, types of service, system of medicine, etc.

Minimum Standards to be followed by Clinical Establishments 

Further, Section 12 of the Act lays down that for the continuation and registration of a Clinical Establishment, such clinical establishment shall fulfill the conditions namely,

  1. the minimum standards of facilities and services
  2. the minimum requirement of personnel
  3. provisions for maintenance of records and reporting
  4. such other conditions as may be prescribed

The minimum standards for hospitals are implemented on the basis of the level of care provided by such hospitals.

Recently in September 2014, the National Council for Clinical Establishments under the Chairmanship of Director General of Health Services, Government of India in consultation with various stakeholders has prepared following draft Documents with the objective of implementation of the Clinical Establishments Act:

  1. Application format for Permanent Registration of Clinical Establishments
  2. Minimum Standards
  3. Formats for Collection of information and Statistics
  4. Template for Display of Rates
  5. Standard Treatment Guidelines of Ayurveda

So to conclude, India is already outshining itself in the global strata of the pharmaceutical market. It is evidently a boon above that for the fact that India is expected to witness huge improvement in its public health as the Government is showing an enthusiastic attitude towards striving at the objective of the Clinical Establishments (Registration and Regulation) Act, 2010. With the implementation of the diligently drafted standards through this Act, it is expected that in the future years each and every clinical establishment in India will be systematized and stringently compelled equipped with all the fundamental minimum standard of medical care and thus, the scenario of healthcare division in India is expected to grow through a tremendously considerable revolution.