HEALTH LAW-

LEGAL REGULATION
OF
MEDICAL ESTABLISHMENTS

SUBMITTED TO - SUBMITTED BY -

Prof. GULAM YAZDANI NAME – SAMEERA HASAN,

ROLL NO. – 27, Sec - B

CLASS – VIIITH SEMESTER, IV YEAR

1|Page
CONTENTS
S.NO. PARTICULARS PAGE NO.

1. ACKNOWLEDGEMENT 3

2. INTRODUCTION 4

3. THE CLINICAL ESTABLISHMENTS (REGISTRATION AND 7

REGULATION) BILL, 2007
4. CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) 13
ACT, 2010
5. SALIENT FEATURES 17

6. CRITIQUE 24

8. CONCLUSION 26

9. BIBLIOGRAPHY 27

2|Page
ACKNOWLEDGEMENT

I extend my heartfelt gratitude and sincere thanks to my Health Law law teacher
Prof. Gulam Yazdani for his encouragement and full cooperation throughout the
completion of this assignment. Without her guidance and support this assignment
would never have been possible.

THANK YOU SIR

3|Page
INTRODUCTION
India has been an underdeveloped country throughout the last century. However, it embarked
upon the 21st century, as the fastest growing economy of the world. According to certain
reports, this nation of 1.27 billion people is poised to become the third largest economy of the
world much before the end of this century. With its ever expanding economic base, improved
literacy rate, living standards, longevity and purchasing power, India is in the process of putting
in place the largest health infrastructure the world has ever seen. Medicine and medical sector
have already tuned themselves into an ever expanding industry contributing significantly to the
nation’s economy.

While in most developed countries, doctor to patient ratio is in the range of 200 to 500 patients
per doctor, in India it is over 2000 patients per doctor. There are only 50,000 medical college
seats registered with the Medical Council of India today which includes government as well as
private colleges. The Natural result of these shortcomings are escalation in number of private
medical colleges and private hospitals all over the country. While some of them match the
world standards, producing good doctors and good quality medical services, a great majority of
them remain barely equipped and with questionable quality. Notwithstanding above,
entrepreneurs today see medical services and pharmaceutical industry as one of the most
rewarding business models in the country. The medical sector no longer remains a patient
centric area but has turned into a booming profit making industry where patient’s welfare is the
last objective.

Under such conditions and circumstances, it becomes necessary on the part of the
government to make sure that all aspects of public health are protected and regulated through
strict legal regiments and controls. Unfortunately, such a framework does not exist in India and
howsoever little laws are there, they are insufficient to handle the dangers of rapid
commercialization of medical services.

The Far flung changes taking place in the medical sector as described above has also changed
the relationship as well as approach of Doctors towards patients. Lucky were the doctors of the
past who were treated like Gods and revered without questioning. Today the doctor-patient
relationship has transformed to such an extent that hospitals and doctors have started viewing
their patients as customers and patients have started viewing their doctors as service providers.
Even though the services of doctors attracted laws such as the Law of Torts, IPC etc. In the past
also, however, after passing of the Consumer Protection Act in 1986, medical services legally
came under it.

The Central Consumer Protection Council in 1993 tried to bring government medical and health
services within the ambit of the Consumer Protection Act, but met with strong resistance from

4|Page
the ministry of health. The Consumer Protection (Amendment) Act, 1993 was later passed by
the Parliament, without bringing into its ambit Govt. health services.

The central issue in regard to public health in the sector of medicine is the concept of “medical
negligence”. The concept of ‘negligence’ is a tort in civil law. It is an act or omission that causes
harm to an individual’s property, reputation or interests. Therefore, in cases of medical
negligence, the claimant has to prove that he or she has suffered injury or harm because of the
negligence of the medical practitioner. The advancement of the concept of medical negligence
is a rather recent development. The tort of negligence itself was founded in the UK with the
case of Donoghue v. Stevenson1, when commercial liability for defective produce was
established. The key ingredient in the establishment of medical negligence was provided by the
Bolam proceedings of 1950. This case introduced a test known the ‘Bolam test’, which has
underpinned the UK’s arrangements for more than half a century. The test forms the basis of
defense for medical professionals when they have “acted in accordance with a practice
accepted as proper by a responsible body of medical opinion. In practice, this makes proving a
negligence claim very difficult. This test was amended by a decision of apex Court in the late
1990s to permit a judge to conclude that a medical decision that is not capable of withstanding
logical analysis is unreasonable and the treatment therefore negligent.

In the UK, to deal with clinical negligence in the National Health Scheme (NHS), the
Government created a centrally funded pool of resources to meet the costs of any claims
brought against the NHS. The NHS Litigation Authority (NHSLA) was set up in 1995 to contest
law suits on behalf of the Secretary of State. Contributions were extracted from NHS Trusts on
the basis of assessments of their risk management procedures. Suits against general
practitioners (GPs) and other primary care professionals are not dealt with by the NHSLA, but
are defended by a number of other medical defense organizations. The various reasons cited in
report include multiple factors such as underfunding, shortage of staff and conflicting priorities.

In India too, lack of alternatives to legal redress had made it very difficult for the victims of
medical accidents or negligence to secure compensations / apologies from the erring medical
practitioner .This is because the laws of the land that provided relief in cases of medical
negligence under the Law of Tort and Indian Penal Code had some well documented problems.
These included the following: (i) Inordinate delay in the legal system, which in medical
negligence cases, tends to be greater; (ii) the cost of bringing an action, is notoriously high in
relation to the sums recovered in damages; (iii) limited access to the courts; (iv) success
depends on proof of both negligence and causation (which can be particularly difficult in cases
of medical negligence).

1
[1932] AC 562

5|Page
Therefore, the need to provide for an alternative mechanism which would be easily accessible,
and affordable, gave birth to the Consumer Protection Act of 1986. The present Act was also
applied to the doctors because no provisions are provided for it in the Indian Medical Council
Act, 1956.

In India also, these rights are enshrined in our Consumer Protection Act, 1986. In addition,
Indian Penal Code, 1860 sections 52, 80, 81, 83, 88, 90, 91, 92 304-A, 337 and 338 contain the
law of medical malpractices in India. These are – The medical termination of pregnancy Act, The
Pre-Natal Diagnostic Techniques (PNDT) Act, Acts in Disability, Insecticide Act, Maternity Benefit
Act, Narcotic Drugs and Psychotropic Substances Act, Prevention of Food Adulteration Act,
Drugs and Cosmetic Act, Bio-medical Waste Act 1988, The Pharmacy Act, 1948, The
transplantation of Human Organs Act, Environment Act, Food Safety and Standard regulation
Act, Food Safety and Standards (Prohibition and Restriction on Sales) Regulation Act, 2011 are
some of the ad hoc measures taken by the government to protect the public health.

THE CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) BILL, 2007

Article 47 of the Constitution of India says:

The state shall regard the raising of the level of nutrition and the standard of living of its people,
and the improvement of public health, as among its primary duties and, in particular, the state
shall endeavour to bring about prohibition of the consumption except for medicinal purposes of
intoxicating drinks and drugs which are injurious to health.

In the present times when the concept and idea of the fundamental right to life has been so
expanded and liberalized, it would even in minimalist terms include the right to nutrition and
health, the National Health Policy of 2002 expresses its concern “the present public health
infrastructure is not satisfactory”, and places the problem of insufficient funds and trained
staffs, gross unhealthy consumables, obsolescent equipment, dilapidated buildings, non-
availability of essential drugs, low quality of service provided, and overcrowding of poor
facilities.

6|Page
The Working Group on Clinical Establishments, Professional Services Regulation and
Accreditation of Health Care Infrastructure, constituted by the Planning Commission for the
11th Five-Year Plan, points out in its report that although the “for-profit private sector
accounts for...50% of inpatient care and 60-70% of outpatient care...[it] has...remained largely
fragmented and uncontrolled”, with problems ranging from “inadequate and inappropriate
treatments, excessive use of technologies, and wastage of limited resources, to heinous
problems of medical malpractice and negligence"

. The Clinical Establishments (Registration and Regulation) Bill 2007 reiterates the concerns
of the Working Group in its statement of objects and reasons.

This is an Act that is proposed to be brought into force to streamline the functioning and
provision of services by clinical establishments. Importantly, it is a matter that regulates
not just allopathic facilities, but also clinical establishments that provide services in a
range of Indian systems of medicine. The relevance of this enactment lies in the fact that
there has been an increasing concern about the gross inadequacy of public health facilities on
the one side and the lack of any standards to regulate the existing facilities both public and
private on the other. The virtual collapse of the public health system, particularly in rural and
remote tribal areas, has rendered already marginalised communities totally vulnerable to
unregulated, unmonitored health care providers. In the cities there has been a takeover
of health services by corporate health care, without any transparent processes of
accountability being put in place.

With the recent discovery of the theft of kidneys from unsuspecting poor people and the
offer of huge sums of money in return for kidneys to people on the brink of survival by a
“homoeopathic” doctor who ran a hospital that specialised in kidney transplants near Delhi,
the question of regulation of clinical establishments is an urgent one.

Main Features

The Bill defines a “clinical establishment” as:

(a) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution
by whatever name called that offers services, facilities with beds requiring diagnosis, treatment
or care for illness, injury, deformity, insanity or pregnancy in any known medical system
established, administered or maintained by any person or body of person,or

(b) a place established as an independent entity or part of an establishment referred to in sub-

clause (i), in connection with the diagnosis or treatment of diseases where pathological,

7|Page
bacteriological, genetic, radiological, chemical, biological inspections or other diagnostic or
inspection services with the aid of laboratory or other medical appliances, are usually carried
on, administered and established or maintained by any person or body of person, whether
mentioned or not, and includes clinical establishments that are controlled, owned or managed
by the Government, a Trust, a Corporation, a local authority and a single doctor establishment,
but does not include the clinical establishments that are owned, controlled or managed by the
Armed Forces.

Recognised systems of medicine include allopathy, yoga, naturopathy, ayurveda, homoeopathy,

siddha and unani, or any other system of medicine as may be recognised by the central
government. The Bill envisages the constitution of a “National Council” that will draw
representatives from professional bodies in the fields of dentistry, nursing, associations of the
different systems of medicine, etc.

Composition of the National Council

Chairperson (DGHS) 1
Elected Members
Dental Council of India 1
Medical Council of India 1
Nursing Council of India 1
Pharmacy Council of India 1
Central Council of Indian Medicine (Ayurveda, Siddha & Unani) 3
Central Council of Indian Medicine (Homoeopathy) 1
Central Council of the Indian Medical Association 1
Bureau of Indian Standards 1
Zonal Councils 2
North-Eastern Council 2
Paramedical System 1
Nominated Members (represent any system of medicine 3
without statutory authority)
Total 19

The function of this council will be to determine standards for clinical establishments, prescribe
minimum standards, develop classifications of these establishments, and take responsibility for
periodic review and maintenance of a national register of clinical establishments. The state
director of health services or any officer subordinate to him will be designated state registrar of
clinical establishments, and will be responsible under the proposed legislation for the

8|Page
performance of functions of classification, analysis and issues of records at the state level, has
to be sent to the national council periodically.

Registration, under the proposed legislation is mandatory; the Bill provides for provisional
registration for a period not exceeding three years for establishments already in existence
without prior inquiry. Permanent registration will be granted only to those establishments that
are found to fulfill the standards set by the central government. The proposed legislation
envisages a pyramidal structure for the registering authorities from the district to the national
level, with the authorities both at the state and district level being personnel of the department
of health services. The legislation will not apply in the states of Andhra Pradesh, Maharashtra,
Madhya Pradesh, Manipur, Nagaland, Orissa, Punjab and West Bengal. Of these states West
Bengal and Maharashtra have in place Acts that came into force in 1950 and 1949 respectively,
Madhya Pradesh in 1973, the other states relatively recently between 1991 and 2002.

The Bill was introduced in the Lok Sabha on August 30, 2007. The Bill has been referred to the
Standing Committee on Health and Family Welfare2.

Highlights of the Bill

 The Clinical Establishments (Registration and Regulation) Bill, 2007 seeks to register and
regulate, and set standards for clinical establishments. It shall be applicable to all union
territories and four states. Other states may adopt the Bill.
 A clinical establishment is defined as a hospital, maternity home, nursing home and any
similar facility with beds. The definition also includes a laboratory that carries out
pathological, bacteriological and other diagnostic services.
 The central government shall establish a National Council. Its main functions include
prescribing standards for clinical establishments and maintaining a register of clinical
establishments.
 Every clinical establishment will need to register. The Bill provides for both provisional
registration and permanent registration upon satisfaction of prescribed conditions.
 The district registering authority is responsible for registering clinical establishments,
inspecting such establishments and cancelling registrations in case of non-compliance
with prescribed standards.

2
Chairperson: Shri Amar Singh

9|Page
Key Issues and Analysis (Part-A)

 The definition of “clinical establishment” refers to dispensaries and clinics; however it

also states that the facilities should have beds. This would arguably exclude clinics
which only provide out-patient services.
 In case of change of ownership or management, the clinical establishment will need a
new registration. This requirement differs from other sectors in which the registering
authority is informed and the transfer is recorded in the register.
 The Bill stipulates that a register has to be maintained in digital format. This could
prevent the use of new technologies which might not be digital in nature.
 The Bill is not applicable in areas where eight state Acts have jurisdiction. These Acts do
not engulf all types of clinical establishments listed in the Bill.

Applicability

 The Bill shall be applicable to all union territories and four states (Arunachal Pradesh,
Himachal Pradesh, Mizoram, and Sikkim). Other states may adopt the law by passing a
resolution in the state legislatures.

Registration of Clinical Establishments

 Every clinical establishment should be registered to admit and provide treatment to

patients. Norms required to be met prior to registration include (a) minimum standards
of facilities; (b) minimum qualifications for the personnel; and (c) provisions for
maintenance of records. The National Council may authorise minimum standards of
registration for each category of clinical establishment.
 Every state government shall designate the Director of Health Services or any other
subordinate officer as the Registrar of clinical establishments. The Registrar shall
compile the state register and monthly returns in digital format for updating the
national register (maintained by the National Council). The state government shall
designate the District Health Officer or the Chief Medical Officer as the district
registering authority for clinical establishments.
 The central government must notify different standards of registration for each type of
clinical establishment. The Bill provides for a system of provisional and permanent
registration. The provisional registration is valid for a period of one year. These may be

10 | P a g e
 granted till three years after the central government notifies minimum standards for
that type of establishment. After that period, only permanent registration may be
granted.
 Existing clinical establishments have to apply for registration within one year from the
date of commencement of the Act. Irrespective of registration under any existing law,
every clinical establishment has to register under the Act. The registering authority is
required to grant provisional registration within 10 days of receiving the application. No
inquiry is required before granting of such provisional registration.
 A clinical establishment, applying for permanent registration, has to submit evidence of
it having complied with the prescribed minimum standard. The information shall be
displayed for 30 days for any objection to be filed. Permanent registration shall be
granted only when a clinical establishment fulfils the prescribed standards for
registration. A clinical establishment can reapply even if its application has been
rejected.

Inspection of Clinical Establishments

 The registering authority may authorise an inspection or an inquiry of any clinical

establishment. The clinical establishments should endure right to be represented during
any inspection or inquiry. The authority shall convey its opinion and may advise the
establishment on which action should be taken.
 A show cause notice may be issued if the authority feels that a clinical establishment is
not complying with the conditions of its registration or the person managing the
establishment has been convicted of an offence punishable under the Act. The
authority may cancel the establishment’s registration if it feels there is a breach of the
law. 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.

Penalties

 If anyone operates a clinical establishment without registration, he shall on first

conviction be punishable with fine up to Rs 50,000, on second offence with fine up to Rs
2 lakh and for any subsequent offence with fine up to Rs 5 lakh. If someone knowingly
serves in a clinical establishment which is not registered he shall be punishable with fine

11 | P a g e
 up to Rs 25,000. If any person violates the provisions of the Act and no penalty is
provided elsewhere, he shall bepunishable with fine up to Rs 10,000 for the first
offence. For a second offence, the fine may extend to Rs 50,000 and for any subsequent
offence it may extend to Rs 5 lakh.

Key Issues and Analysis (Part-B)

1) Exclusion of Out-Patient Clinics:

The definition of a clinical establishment appears to exclude dispensaries, clinics etc without
beds, i.e., those that deal only with out-patients. Since private out-patient facilities constitute
60-70 per cent of the private sector health care in India, the purpose of the Bill to register and
regulate all clinical establishments might not be served if such establishments are excluded
from its purview.

2) Transfer of Ownership:

The Bill requires a clinical establishment to apply for fresh registration in case of transfer of
ownership or management. This requirement differs from the case of transfer of ownership in
several other cases, in which the registering authority is informed and the transfer is recorded
in the register. (For example, if A sells a car to B, the registration number remains the same,
but the ownership is changed by informing the registration office). Furthermore, in case of a
clinical establishment which is registered as a company and trades on the stock exchanges, the
ownership structure changes every time the stock trades. This provision would imply that a
new registration is required on each such instance.

CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010

Preamble

An Act to provide for the registration and regulation of clinical establishments in the country
and for matters connected therewith or incidental therto.

An Act Whereas, it is considered expedient to provide for the registration and regulation of
clinical establishments with a view to prescribe minimum standards of facilities and services

12 | P a g e
which may be provided by them so that mandate of article 47 of the Constitution for
improvement in public health may be achieved.

And whereas, Parliament has no power to make laws for the States with respect to any of the
matters aforesaid except as provided in articles 249 and 250 of the Constitution;

And whereas, in pursuance of clause (1) of article 252 of the Constitution, resolutions have
been passed by all the Houses of the Legislatures of the States of Arunachal Pradesh, Himachal
Pradesh, Mizoram and Sikkim to the effect that the matters aforesaid should be regulated in
those States by Parliament by law;

Be it enacted by Parliament in the Sixty-first Year of the Republic of India as follows:--

Preliminary

1. Short title, application and commencement.--

(1) This Act may be called the Clinical Establishments (Registration and Regulation) Act, 2010.

(2) It applies, in the first instance, to the whole of the States of Arunachal Pradesh, Himachal
Pradesh, Mizoram and Sikkim and the Union territories; and it shall apply to such other State
which adopts this Act by resolution passed in that behalf under clause (1) of article 252 of the
Constitution.

(3) It shall come into force at once in the States of Arunachal Pradesh, Himachal Pradesh,
Mizoram and Sikkim and the Union territories, on such date as the Central Government may, by
notification, appoint and in any other State which adopts this Act under clause (1) of article 252
of the Constitution, on the date of such adoption; and any reference in this Act to the
commencement of this Act shall, in relation to any State or Union territory, mean the date on
which this Act comes into force in such State or Union territory:

Provided that different dates may be appointed for different categories of clinical
establishments and for different recognised system of medicine.

2. Definitions.--

In this Act, unless the context otherwise requires,--

(a) "authority" means the district registering authority set-up under section 10;

(b) "certificate" means certificate of registration issued under section 30;

(c) "clinical establishment" means--

13 | P a g e
(i) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by
whatever name called that offers services, facilities requiring diagnosis, treatment or care for
illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine
established and administered or maintained by any person or body of persons, whether
incorporated or not; or

(ii) a place established as an independent entity or part of an establishment referred to in sub-

clause (i), in connection with the diagnosis or treatment of diseases where pathological,
bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or
investigative services with the aid of laboratory or other medical equipment, are usually carried
on, established and administered or maintained by any person or body of persons, whether
incorporated or not,

and shall include a clinical establishment owned, controlled or managed by—

(a) the Government or a department of the Government;

(b) a trust, whether public or private;

(c) a corporation (including a society) registered under a Central, Provincial or State Act,
whether or not owned by the Government;

(d) a local authority; and

(e) a single doctor,

but does not include the clinical establishments owned, controlled or managed by the Armed
Forces.

Explanation.-- For the purpose of this clause "Armed Forces" means the forces constituted
under the Army Act, 1950 (46 of 1950), the Air Force Act, 1950 (45 of 1950) and the Navy Act,
1957 (62 of 1957);

(d) "emergency medical condition" means a medical condition manifesting itself by acute
symptoms of sufficient severity (including severe pain) of such a nature that the absence of
immediate medical attention could reasonably be expected to result in--

(i) placing the health of the individual or, with respect to a pregnant women, the health of the
woman or her unborn child, in serious jeopardy; or

(ii) serious impairtment to bodily functions; or

(iii) serious dysfunction of any organ or part of a body;

14 | P a g e
(e) "National Council" means the National Council for clinical establishments established under
section 3;

(f) "notification" means a notification published in the Official Gazette;

(g) "prescribed" means prescribed by rules made under this Act by the Central Government or,
as the case may be, the State Government;

(h) "recognised system of medicine" means Allopathy, Yoga, Naturopathy, Ayurveda,

Homoeopathy, Siddha and Unani System of medicines or any other system of medicine as may
be recognised by the Central Government;

(i) "register" means the register maintained by the authority, State Government and the Central
Government under sections 37, 38 and 39 respectively of this Act containing the number of
clinical establishments registered;

(j) "registration" means to register under section 11 and the expression registration or
registered shall be construed accordingly;

k) "rules" means rules made under this Act;

(l) "Schedule" means the Schedule appended to this Act;

(m) "standards" means the conditions that the Central Government may prescribe under
section 12, for the registration of clinical establishments;

(n) "State Government", in relation to a Union territory, means the Administrator thereof
appointed under article 239 of the Constitution; and

(o) "to stabilise (with its grammatical variations and cognate expressions)" means, with respect
to an emergency medical condition specified in clause (d), to provide such medical treatment of
the condition as may be necessary to assure, within reasonable medical probability, that no
material deterioration of the condition is likely to result from or occur during the transfer of the
individual from a clinical establishment.

In August 2010, the Parliament of India passed the ‘Clinical Establishments (Registration and
Regulation) Act, 2010’, which came into force in March 2012. Through the CEA 2010, all private
and public (excluding the armed forces) medical facilities (called clinical establishments), which
cover all systems of medicine, laboratories & diagnostic centres and single doctor
establishments, need to be registered. It is applicable in the States of Arunachal Pradesh,
Sikkim, Mizoram, Himachal Pradesh and all Union Territories. The States that have adopted this
act are Uttar Pradesh, Rajasthan, Bihar and Jharkhand. Maharashtra and other states are keen
on adopting the CEA 2010. The central government is keen on pushing the State governments

15 | P a g e
to adopt the central Act. Kerala & Tamil Nadu are keen on having their own Act in line with the
CEA 2010. In Punjab and Gujarat, there is massive opposition for adopting or enacting similar
legislations. Among the States & UTs the CEA 2010 is applicable and adopted the progress has
been slow due to various reasons. In Himachal Pradesh and Sikkim the offline registration of
clinical establishments is in progress. In the other States and UTs the governments are in the
process of notifying the State / UT councils, the District Registration Authorities and the Rules
under section 54 of the act. The National Informatics Centre has developed a web-based
software for the implementation of the CEA 20103. The copies of the Act, Rules are available on
this site.

Firstly it is necessary to note that the framing of the Clinical Establishments (Registration and
Regulation Act, 2010 (CEA 2010) was necessitated since there has been practically no regulation
for private clinical establishments in the country. This has been due to the opposition by certain
sections of the medical profession and owners of clinical establishments for any kind of
accountability or transparency.

Many state governments were not able to push for enacting legislation regulating private
clinical establishments. In Maharashtra, the Bombay Medico- Friends- Circle group which took
the lead 15 years back by filing a PIL in the Bombay High court, not much progress has been
achieved in the State. In the above context it was felt that having a central act, would put
pressure on those state governments that do not have any legislation to adopt a central act and
those States to modify their outdated & deficient existing acts regulating private providers. This
seems to have been achieved to an extent.

The National Council, through multi stakeholder participation and a consultative process is
presently in the process of categorization and classification of clinical establishments,
determination of minimum standards, information to be collected from clinical establishments,
determining the rates and charges to be charged among other aspects.

SALIENT FEATURES
The salient features of the CEA 2010 are that there would be digital registry of all types of
Clinical Establishments at National, State & District level. All information provided by the clinical
establishment would be available in the public domain. It would assist government in obtaining
data from clinical establishments required for public health interventions including outbreak
and disaster management among others. The provisional registration would be through self
declaration, without any inspection. Permanent registration would be undertaken after

3
http://clinicalestablishments.nic.in/

16 | P a g e
categorization and determination of minimum standards within two years from the date of
notification. Every clinical establishment needs to provide treatment “within the staff and
facilities available” to stabilize the emergency medical condition of any individual brought to
such establishment. Details of charges, facilities available should be prominently displayed at a
conspicuous place by each establishment. Clinical Establishments shall charge the rates for
procedures and services within the range of rates determined by the Central Government from
time to time in consultation with the State Governments. Assurance to the Standard Treatment
guidelines as may be issued by Central/State Govt. to be ensured by the CEs.

 The Clinical Establishments Bill of 2010 was introduced in the Lok Sabha on April 15,
2010 by the Health and Family Welfare Minister, Shri Ghulam Nabi Azad. The Bill was
passed by the Lok Sabha on May 3, 2010 and is pending in Rajya Sabha.

 The Bill shall be applicable to all union territories and four states (Arunachal Pradesh,
Himachal Pradesh, Mizoram, and Sikkim). Other states may adopt the law by passing a
resolution in the state legislatures.

 The Bill seeks to register and regulate clinical establishments. “Clinical establishment” is
defined as the hospitals, dispensaries, clinics and similar facilities that offer treatment for
any kind of illness in any known system of medicine (allopathy, yoga, naturopathy,
ayurveda, homoeopathy, siddha and unani). It also includes any laboratory which offers
pathological, chemical and other diagnostic services. An establishment can be owned by
any of the following, a trust, the government, and a single doctor establishment. The Bill
does not apply to any clinical establishment owned or managed by the Armed Forces.

 National Council of Clinical Establishments by the central government shall be establish

to (a) determine the minimum standards of health care help by any clinical establishment;
(b) classify them into various categories; and (c) maintain a national register of all the
clinical establishments. The Director General of Health Services (DGHS) and 22 other
members (includes consumer groups and Associations of Indian Systems of
Medicine)shall chair the counsil.

 Every clinical establishment should be registered to admit and provide treatment to the
patients. Norms required to be met prior to registration include (a) minimum standards of
facilities; and (b) minimum qualifications for the personnel. National Register shall be

17 | P a g e
 compiled within two years from the date of commencement of the law and determine the
first set of standards for clinical establishments within two years of setting up the
Council.

 Every state government shall establish a State/Union Territory Council for clinical
establishments. Members shall include all the following mentioned: Secretary, Director
of Health Services; representatives elected from state Medical Council, Nursing Council
and Pharmacy Council, and state-level consumer groups or reputed NGOs etc.

 The state government shall set up a district registering authority for registering clinical
establishments at district level. Members shall be the District Collector, the District
Health Officer and 3 members with such qualifications to be prescribed by central
government. The District Health Officer and Chief Medical Officer shall act as the
authority to register for the provisional registration.

 The functions of the Council include compiling state registers and hearing appeals against
orders of the authority for registration.

 The central government shall notify all the standards for every type of clinical
establishments. The Bill provides for a system of provisional and permanent
registration. Provision registration may be granted for a year. For clinical establishment
in whose case the minimum standards have been notified, provisional registration shall
only be granted for a particular time-limit. Permanent registration shall only be valid for
5 years and renewal application should be made 6 months before expiry of registration.

 A clinical establishment, applying for permanent registration, has to submit evidence of it

having complied with the prescribed minimum standard.

 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.

18 | P a g e
Regulatory requirements for private clinics

A clinic may be defined as a place of professional practice with facilities for outdoor
consultation and treatment during scheduled hours by one or more physicians and staff and
equipment essential for the services provided. It may or may not have the facilities for limited
investigations specific to the scope of services provided.

A large percent of the population, is dependent on private clinics and, therefore, the quality of
services for health benefit provided by them is of very importance. This time there is no
provision of registration of private clinics by health authorities in India. The Clinical
Establishments Bill, 2007 is still pending in the parliament.

Presently, the inpection of private clinics is being governed by the Indian Medical Council
Regulations 2002 and certain other legislations as outlined below.

1. Registration/Requirement of Licenses

• Registration with health authorities is not mandatory for private clinics but the clinic will
be subject to inspections in case of any complaints. If and whenever the Clinical Establishments
(Registration and Regulation) Bill, 2007 is passed by the parliament and implemented by the
states, registration of all clinics (Private/Public) of all systems of medicine will become
mandatory;

• Registration with the municipal authorities (Delhi Shops and Establishments Act, 1954);

• Recognition for usage of narcotic drugs (Delhi Narcotic Drugs (Amendment) Rules, 2002;

• Authorisation for generation of Bio-Medical Waste, if treating 1,000 or more patients per
month;

• Permit for procurement/usage of spirit;

• Registration under the Medical Termination of Pregnancy (MTP) Act 1971, the Pre-Natal
Diagnostic Techniques (PNDT) Act, 1994, as applicable.

2. Regulations Related to Employment of Staff

• Employment of staff (Doctors, Nurses, Pharmacists) only after proper credentialing;

• Prevention of sexual harassment of women at work place4

4
Judgment of the Supreme Court of India (SCI) in Sakshi Vs the Union of India and Others 2004 Supp(2) SCR 723

19 | P a g e
• Responsibility of employer for safety of employees5

• Rules governing the employment of staff6

• Immunisation / other measures for protection of staff from Occupational Health hazards.

3. Sign Boards
• Rules for the size, contents and correct place for sign boards (IMC Regulations 2002).

4. Information to be displayed at the Clinic

• Certificate of registration of clinic with the municipal authorities;

• IMC/SMC registration certificate7

• Charges for consultation and other procedures/services (IMC Regulations 2002);

• Clinic timings, closed days (Delhi Shops and Establishments Act, 1954).

5. Documents to be maintained by the Clinic

• Registration of the clinic with the municipal authorities8

• Record of employment of adults, letters of employment issued and hours of work;

• Maintenance of record of patients treated (IMC Regulations 2002) and a register of

medico-legal cases (MLCs);

• Maintenance of a register of medical certificates issued;

• Copies of medical certificates issued;

• Registration certificates of doctors/nurses/pharmacists with the State Medical Councils

(SMCs);

• Professional qualifications (degrees/diplomas) of the staff;

5
Delhi High Court Judgment in Ms XYZ Vs Shanti Mukund Hospital, Delhi and Punjab & Haryana High Court
Judgment in Jasbir Kaur Vs the state of Punjab CWP No.25449 of 2012
6
Delhi Shops and Establishments Act, 1954
7
IMC Regulations, 2002
8
Delhi Shops and Establishments Act, 1954

20 | P a g e
• Record of consumption of Morphine (if applicable)9

• Account of money receipts and expenses10

• Authorisation for generation of Bio-Medical Waste and record of category wise waste
generated (BMW Management Rules, 1998);

6. Issue of any medical certificate, notification, document or report, which is untrue,

misleading or improper is a misconduct and punishable offence (IMC Regulations 2002, Section
197 of Indian Penal Code);

7. Regulations Related to Treatment of Patients

• Valid consent for examination/investigation/treatment/research procedure (or informed
refusal of consent), as applicable (IMC Regulations, 2002);

• Confidentiality of privileged communication, as far as permitted under the law;

• Life saving treatment of emergency cases11

• PNDT Act 1994, Conduct of Euthanasia12 , MTP Act 1971 and IPC sections 312-315, 318;

• Rules for issue of prescriptions (IMC Regulations, 2002);

• Maintenance of Medical Records of the patients treated for a period of three years and
as per the format vide Appendix 3 to the IMC Regulations, 2002;

• Reporting of Medico-Legal cases to the police;

• Reporting of occurrence of occupational diseases;

• Responsibility for ensuring safety of patients

• Rights of patients;

• Privacy of patients during consultation, examination and treatment;

• Professional indemnity insurance cover of an appropriate amount13

9
Delhi Narcotic Drugs Rules, 2002
10
Income Tax Act, 1961
11
SCI Judgment in Parmanand Katara Vs Union of India, AIR 1989 SC 2039 and The Delhi State CDRC (Consumer
Disputes Redressal Commission) Judgment in the case of death of NB Sub K L Guliani
12
SCI Judgment in Aruna R Shanbaug Vs Union of India & Others, (2011) 4 SCC 454
13
Insurance Regulatory and Development Authority Act, 1999

21 | P a g e
• Laws applicable to medical negligence — Vicarious Liability, Respondeat Superior, Indian
Contract Law, Tort law, Consumer Protection Act, 1986, Indian Penal Code sections14.

8. Drug and Cosmetics Act 1940, Drugs (Control) Act 1950, Narcotic Drugs and Psychotropic
Substances Act 1985, Drugs and Magic remedies (Objectionable Advertisements) Act, 1954,
Pharmacy Act, 1948.

9. Submission of Reports/Returns to Health Authorities

• Cases of notifiable diseases as applicable in the state15

• Report of cases of food poisoning, if required by Municipal Health Authorities16

• Incidence of needle stick injuries;

• Annual report under BM Waste Management Rules, 1998 (if applicable);

• Reports on the MTPs carried out;

• Reports on the USG abdomen (abdominal ultrasonography) done on the pregnant women.

10. Safe disposal of infectious/hazardous waste generated at the clinic17.

11. Prohibition of unethical activities, such as soliciting patients directly or indirectly, by a

physician, a group of physicians, or by institutions or organisations by advertising, self-
promotion or self-aggrandizement; use of touts for procuring patients; giving/offering or
receiving rebates, gifts, commissions, cutbacks or kickbacks in return for referral or
procurement of patients etc (IMC Regulations, 2002).

12. Prohibition of Smoking in Public Places Rules, 2008, Fire Safety Regulations, Financial
Regulations: Income Tax Act, Value Added Tax (VAT) Act, Central Sales Tax Act, etc.

13. State laws for prevention of vandalism/violence against medical service staff and
institutions.

14
52, 80, 88, 89, 92, 93, 274-276, 284, 304-A, 336, 337, 338 and 376-D
15
Section 371, Delhi Municipal Corporation Act
16
Prevention of Food Adulteration Act, 1954
17
BMW Management Rules, Environment Protection Act 1986, IPC Section 269, 270

22 | P a g e
CRITIQUE
There has been opposition and resistance from private providers, owners and the IMA for any
efforts to adopt the CEA 2010 or enact similar legislations.

The Act will lead to “license and inspector raj”; it is anti-people and curtails freedom of medical
practice, and the penalties are harsh. Another reservation expressed is that the Act makes it
obligatory for clinical establishments to provide treatment and stabilize patients who are
brought in an “emergency medical condition. The standards prescribed are harsh and would
lead to closure of single doctor clinics and small medical establishments and this will raise the
costs of treatment for the general public.

The apprehensions and reservations voiced by them are unfounded and not based on clear
reading of the provisions of the Act.

Firstly it needs to be stated that the registration of establishments is a process of applying to

the District Registration Authority by providing details either by post, online or in-person. There
is no inspection and the grant of registration to the establishment is time bound, so that no
application remains unattended. There are provisions for appeal before the State /UT Council of
Clinical Establishments. Regarding penalties the act has consciously not kept any provision for
imprisonment, only monetary penalties, as the intention is to seek compliance with the
provisions rather than taking punitive action. With regard to Standards being harsh it needs to
be noted that presently there are no standards prescribed. As mentioned earlier the National
Council is presently in the process of categorization of different types of clinical establishments
and determining uniform minimum standards. It is ironic that IMA, which is represented in the
National Council, should make statements that the standards are harsh.

IMA along with the Quality Council of India has been engaged by the Union Ministry of Health
and Family Welfare to survey existing standards in clinical establishments in states where it is
applicable. IMA would need to support its argument that minimum standards would lead to

23 | P a g e
closure of clinical establishment and increase costs with evidence. The premise of the Act is
that there are few clinical establishments that operate using standards of care, guidelines and
protocols and monitoring of these in the country is deficient.

IMA’s refusal to accept this is contrary to the interests of patient care and public health. The
IMA’s reservation that the medical profession is already governed by number of Acts through
multiple regulating bodies is baseless. The CEA 2010 was passed by the parliament on the
request of many state governments that did not have legislation for clinical establishments. The
provision of the Act, which mandates that every clinic must provide basic emergency care, is
being opposed by the IMA. It is well known that private hospitals and clinics do not admit
accident victims who require critical emergency care because it can lead to a medico-legal case,
or the patient or their families will be unable to pay for the treatment costs or are uninsured.
This malaise is widely prevalent.

Taking note of this, the Supreme Court of India as long back as 1989 passed a ruling18 that made
it obligatory for all practitioners to provide emergency medical care. The Act reemphasizes the
judgment. It states: clinical establishment shall undertake to provide within the staff and
facilities available such medical examination and treatment as may be required to stabilise the
emergency medical condition of any individual who comes or is brought to such clinical
establishment.

Further there are concerns being voiced that concerned stakeholders (including consumer
groups) have not been represented in the various bodies of the CEA 2010. It needs to be noted
that the CEA 2010 has 3 institutional mechanisms ie: The National Council, State / UT council
and the District Registration Authority and in each of the bodies there is representation from
consumer groups and professional medical association or bodies.

18
Parmanand Katara v. Union of India AIR 1989 SC 2039
24 | P a g e
CONCLUSION
Health and human rights activists have for at least two decades now demanded a closer
scrutiny of medical establishments and health care systems. This demand has focused on a
range of specific concerns −mental health care, primary health care and sex-selective abortions,
to randomly name a few −alongside a more general demand for more effective public health
services. There has also been a growing acknowledgement among practitioners of allopathy of
possible conversations between it and other systems of Indian medicine. At the same time
there has been a resistance to controls by medical professionals across the board, the most
telling example being the case of regulation under the Pre-conception and Pre-Natal Diagnostic
Techniques (Prohibition of Sex Selection) Act (PCPNDT Act) 1994.

This Bill comes as a response to the demand for greater scrutiny in the wake of spiralling
malpractices and gross negligence. In terms of its objects and reasons, therefore, it is a
welcome move. In terms of its operational elements, however, there are too many gaps, which
might well mean that we have one more legislative response to a public demand that is a mere
“action taken report” that cannot be implemented. Finally, the question of self-regulation,
transparency and its prospects where clinical establishments are concerned is one that must be
revisited time and again by professional bodies and individual practitioners. The resistance to
the commodification of health services, and unethical, illegal practices need to come as much
from within as without.

The CEA 2010 is not a perfect act, it has many problems and issues that have not been covered.
However one needs to remember that when enacting an act there are various pressures from
various stakeholders. Secondly is there a perfect legislation that meets the needs of all
interested stakeholders involved and finally do we keep debating and discussing and wait for a
perfect legislation. It is crucial that the clinical establishments in the country are accountable
and transparent which would greatly improve the quality of health care in our country.

While the above effort is by all means laudable, yet it is not adequate to deal with the
challenges confronting the field of medicine. A much larger and comprehensive view is required
to be taken on the subject. Prevailing consumer protection rules which are basically designed to
protect the interest of consumers in respect of goods and services are barely adequate to
handle the complex medical negligence cases and cases of medical malpractices. The need of
the hour is to formulate a comprehensive action dedicated to medical negligence and medical
malpractices to regulate all aspects of the conduct of doctors and hospitals providing health
services to the citizens of India.

25 | P a g e
BIBLIOGRAPHY:

 Robert D. Miller and Rebecca C. Hutton, Problems in Health Care

Law,[2000], Apen Publication, Maryland.
 Bakshi P.M.,Law and Medicine, [1993], UP Institute of Judicial Training
and Research, Lucknow.
 J.V.N Jaiswal, Legal Aspects of Pregnancy, Delivery and Abortion [2009],
Eastern Book Company, Lucknow.
 Annop K. Kaushal, Medical Negligence And Legal Remedies with special
Reference to Consumer Protection Law, [1998], Universal Law Publishing
Co. PVT. LTD.

26 | P a g e