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Jamia Millia Islamia: Health Law Assignment
Jamia Millia Islamia: Health Law Assignment
Submitted by – Submitted
to-
Shahbaz Khan Mehar Dr. Ghulam
Yazdani
Semester – VIII
Section – B
Roll No – 29
Table Of Contents
Acknowledgement
Introduction
Objective of the Act
Implementation of the act
Work done by National Council for Clinical Establishment
An overview of the Clinical establishment (regulation and registration) act, 2010.
The National Council for Clinical establishment.
Clinical establishment and procedure for registration of clinical establishment.
Minimum Standard to be followed by the clinical establishment.
Template for display of rates.
Conclusion
Bibliography
Acknowledgement
I have taken efforts in this project but it wouldn’t have been possible without the support of
many individuals. I would like to extend my sincere thanks to all of them. I am highly
indebted to Prof. (Dr.) Ghulam Yazdani for his guidance and constant supervision as well as
for providing necessary information regarding the project and also for his support in
completing the project. My thanks and appreciations are also due to my friends who helped
me a lot in developing the project and people who have willingly helped me out with their
abilities.
REGARDS
Shahbaz Khan Mehar.
Introduction
The Clinical Establishments (Registration and Regulation) Act, 2010 ("Act") has been enacted
by the Central Government to provide for registration and regulation of all clinical
establishments in the country with a view to prescribing the minimum standards of facilities
and services 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,1Health regulation in India encompasses a variety
of factors and issues. These include promulgation of legislation for health facilities &
services, disease control & medical care, human power (Education, Licensing & Professional
Responsibility), Ethics and Patients Rights, 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. Hence, the report highlighted for the need for a central legislation for registration
of clinical establishments in the country and uniform standards need to be developed for
the entire country.
Objective of the Act
The Act makes it mandatory for registration of all clinical establishments, including
diagnostic centres and single-doctor clinics across all recognized systems of medicine both in
the public and private sector except those run by the defence forces. The registering
authority facilitates policy formulation, resource allocation and determines standards of
treatment. It can impose fines for non-compliance of the provision of the Act. The Act 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
provide medical care and treatment necessary 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.
According to Chapter 1, a clinical establishment may be a hospital, maternity home, nursing
home, dispensary, clinic, sanatorium or any other institution that offer services for
diagnosis, care or treatment of patients.1
The Chapter 2 details the formation of a National Council. 2 The Chapter 3 details the
formation of State and Union Territory Councils. It also requires formation of district
registering authorities.3 The Chapter 4 details the registration procedure. A provisional
registration shall be valid for 1 year and must be renewed.4 An establishment may apply for
a permanent registration.5 The registration certificate must be prominently displayed. The
Chapter 5 details the creation of state and national level Register of Medical Establishment
in digital form.6
The registering authority may authorise an inspection or an inquiry of any clinical
establishment through a multi-member inspection team to be prescribed. A show cause
notice may be issued if the authority feels that a clinical establishment is not complying with
the conditions of its registration. It may also cancel the registration. The authority may
enter and search in the prescribed manner after giving notice of its intention to the clinical
establishment, if it suspects that an establishment is operating without registration.
The Chapter 6 details various offences and penalties. For example, running an unregistered
establishment carries a fine up to ₹50,000 on the first offence. 7 A person knowingly working
in an unregistered establishment will be fined up to ₹25,000.8 There is also a fine of up to 5
lakh rupees for obstructing investigations, withholding information or giving false
1
Section 2(c).
2
Section 3.
3
Section 8.
4
Section 14.
5
Section 30.
6
Section 37.
7
Section 41.
8
Section 41.
information. In case of violation by a corporate body, the management shall be held
responsible.9
9
Section 42.
Work done by National Council for Clinical Establishments
8 meetings of National Council for Clinical Establishments have been held and
minutes of which are available on the website.
Five subcommittee of National Council were constituted to carry out different work
as per the Act.
Categorization of Clinical Establishments has been finalized and approved.
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.
Minimum Standards for 35 specialty/super-specialty wise departments/clinical
establishments has been finalized and approved by National Council.
Minimum Standards for all systems of medicine under AYUSH have been finalized
and approved by National Council.
Application Form for Provisional and Permanent Registration finalized and approved.
Certificate of Provisional and Permanent Registration finalized and approved.
Formats for collection of Information & Statistics from OPD, IPD, Lab and Imaging
Clinical Establishments have been finalized and approved.
List of Recognised Qualifications of person incharge of Clinical Establishments has
been finalized and approved by National Council.
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.
Draft Operational Guidelines have been developed for implementation of the Act by
the State Authorities.
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.
An overview of the Clinical Establishments (Registration and Regulation) Act
public health and shall consider this responsibility as among its primary duties in particular,
the State shall endeavour to bring about prohibition of the consumption except for
medicinal purposes of intoxicating drinks and of drugs which are injurious to health.
Hence, with the Article 47 of the Constitution lays down a responsibility upon the State for
aiming at improvement in objective to strive at fulfil this responsibility, the Government of
India enacted the Act with the objective to provide for the registration and regulation of
clinical establishments in India and for matters connected therewith or incidental thereto.
The Act defines "Clinical Establishment" and bring under the ambit of clinical establishment
all hospitals, maternity home, nursing home, dispensary, clinic, etc or an institution by
whatever name called that offers services, facilities requiring diagnosis, treatment or care
for illness, injury, etc or a place established as an independent entity or part of an
establishment in connection with the diagnosis or treatment of certain diseases. It also
includes a clinical establishment which is owned, controlled and managed by government or
a department of the Government, a trust, a corporation registered under a Central,
Provincial or State Act, a local authority and a single doctor.
Books referred
An introduction to health law, Dr. Jyoti Bhakare. 124( Swanand, Pune) 2015.
HWV Cox Medical Jurisprudence and Toxicology; P.C.Dixit; 7th edn.; 2002.
Articles referred