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 services have already turned
themselves into an ever expanding industry contributing substantially to the
gross national product.

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.
Indian cabinet has recently cleared a proposal to add 10,000 more medical
seats in government colleges and aims to reduce the doctor to patient ratio
in the country from current 2000 to 1000 with the help of private medical
colleges. Natural outcome of these factors are proliferation 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. Medicine no longer remains a patient centric
activity where patients welfare is the prime objective. All aspects of medical
services today are driven by the motive of profit like any other profit making
activity in the economy. This is a dangerous trend and a great hazard to the
public health.

Under the above circumstances, it becomes incumbent upon the government

to ensure that all aspects of public health are protected and regulated by
stringent and thorough legal framework which is sophisticated and refined
enough to adapt itself to the rapid improvement in technology and
innovation that is so characteristic of modern medicine. 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 and the threat that it poses to public health in India.

Sweeping changes in medical services outlined above has affected the

doctor patient relationship as well. Lucky were the doctors of the past who
were treated like Gods and revered without questioning. Today the doctorpatient 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. Litigation against doctors under this act has
since been on a steady rise. 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 the
ministry of health. Health Ministry opposed it as it felt that government
hospitals were not prepared for such a law. They lacked infrastructure,
resources and drugs to withstand the demands of this act. The Consumer
Protection (Amendment) Act, 1993 was later passed by the Parliament,
without bringing into its ambit Govt. health services.

The main issue concerning public health in the world of medicine is the
medical negligence. The concept of negligence is a tort in civil law. It is an
act or omission that causes harm to an individuals property, reputation or
interests. Tort imposes a duty of care where one party could reasonably
foresee that his or her conduct may cause harm to another. 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 evolution of the legal 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 what is called the Bolam test, which has underpinned the UKs
arrangements for more than half a century. The test forms the basis of
defense for medical professionals when they have acted in accordance with
1 [1932] AC 562

a practice accepted as proper by a responsible body of medical opinion. In

practice, this makes proving a negligence claim very difficult. The Bolam test
was amended by a judgment 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 Department of Health, in UK acknowledged the high level
of adverse incidents in NHS hospitals, revealing that 10 per cent of in-patient
admissions resulted in some form of adverse outcome, and five per cent of
the general population report suffering some injury or other adverse effects
of medical care. The factors cited in explanation include underfunding, staff
shortages and overwork and conflicting priorities. However, it is also
accepted that risk management and the avoidance of clinical error has not
received the focus that it deserves in the past.

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). Hence the necessity to provide for an alternate system
which would be easily accessible, speed and cheap, gave birth to the
Consumer Protection Act. This Act was made applicable to the doctors
because there are no provisions in the Indian Medical Council Act, 1956;

15th March is celebrated as World Consumer Rights Day. On this day in 1962,
President J.F. Kennedy declared four basic consumer rights in the special
message to the American Congress, i.e. (a) and other rights were added to it
by IOCU.
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.
A number of Acts specific to certain aspects of public health is also passed by
the parliament. 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

REGULATION) BILL, 2007

(REGISTRATION

AND

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.
At a time when the meaning of the fundamental right to life has been
expanded and would even in minimalist terms include the right to health and
nutrition, the National Health Policy 2002 expresses concern that the
existing public health infrastructure is far from satisfactory, and locates the
problem in insufficient funding and trained personnel, gross inadequacy of
consumables, obsolescent equipment, dilapidated buildings, non-availability
of essential drugs, low quality of services, and overcrowding of poor
facilities.

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 higher technologies, and wasting of scarce
resources, to serious 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, 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
(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,
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 includes clinical
establishments owned, controlled or managed by the Government, a Trust, a
Corporation, a local authority and a single doctor establishment, but does not
include the clinical establishments 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)
Elected Members
Dental Council of India
Medical Council of India
Nursing Council of India
Pharmacy Council of India
Central Council of Indian Medicine (Ayurveda, Siddha & Unani)
Central Council of Indian Medicine (Homoeopathy)
Central Council of the Indian Medical Association
Bureau of Indian Standards
Zonal Councils
North-Eastern Council
Paramedical System

1
1
1
1
1
3
1
1
1
2
2
1

Nominated Members (represent any system of medicine

without statutory authority)
Total

3
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 performance of functions of
classification, review and compilation of records at the state level, 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.

2 Chairperson: Shri Amar Singh

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.

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 regulator for all clinical establishments (including government
establishments) at the district level is also the administrator for
government health services. This could lead to conflict of interest.
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 cover all the different 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 has to be registered to admit patients for

providing treatment. 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 prescribe different minimum standards 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 shall notify standards 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 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 establishment shall have the
right to be represented during the inspection or inquiry. The authority
shall convey its views and may advise the establishment on the action
to 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
establishments 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 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
REGULATION) ACT, 2010

(REGISTRATION

AND

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 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
3 http://clinicalestablishments.nic.in/

would be undertaken after 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. Compliance to Standard
Treatment guidelines as may be issued by Central/State Govt. to be ensured
by CEs.

The Clinical Establishments (Registration and Regulation) Bill, 2010 was introduced in
the Lok Sabha on April 15, 2010 by the Minister of Health and Family Welfare, 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 hospitals and clinics and similar facilities that offer treatment for illness in
any recognised 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
the government, a trust, and a single doctor establishment. The Bill does not apply to
any clinical establishment owned or managed by the Armed Forces.

The central government shall establish a National Council of Clinical Establishments to

(a) determine the minimum standards of health care by a clinical establishment; (b)
classify them into categories; and (c) maintain a national register of clinical
establishments. The Council shall be chaired by the Director General of Health Services

(DGHS) and 22 other members (includes consumer groups and Associations of Indian
Systems of Medicine).

Every clinical establishment has to be registered to admit patients for providing

treatment. Norms required to be met prior to registration include (a) minimum standards
of facilities; and (b) minimum qualifications for the personnel. It may prescribe different
minimum standards for each category of clinical establishment.

National Register shall be 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 Secretary, Health; Director of Health Services;
elected representatives 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. However, the District Health Officer and Chief Medical Officer shall act as
registering authority for 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 standards for each type of clinical establishment.
The Bill provides for a system of provisional and permanent registration. Provision
registration may be granted for a year. For clinical establishment whose minimum
standards have been notified, provisional registration will only be granted for a specified
time-limit. Permanent registration shall be valid for five years and application for
renewal should be made six 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.

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 percentage of the population, in rural as well as urban areas, is

dependent on private clinics and, therefore, the quality of healthcare
services provided by them is very important. At present there is no system of
registration of private clinics by health authorities in India. The Clinical
Establishments (Registration and Regulation) Bill, 2007 is still pending in the
parliament.

Presently, the operation of private clinics is being governed by the Indian

Medical Council (Professional Conduct, Etiquette and Ethics) 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

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

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);

1954).

Clinic timings, closed days (Delhi Shops and Establishments Act,

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;

Record of consumption of Morphine (if applicable)9

Account of money receipts and expenses10

7 IMC Regulations, 2002

8 Delhi Shops and Establishments Act, 1954
9 Delhi Narcotic Drugs Rules, 2002
10 Income Tax Act, 1961


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 Euthanasia 12 , 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 amount 13

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


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,
13 Insurance Regulatory and Development Authority Act, 1999
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

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.

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 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.
IMAs refusal to accept this is contrary to the interests of patient care and
public health. The IMAs 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
18 Parmanand Katara v. Union of India AIR 1989 SC 2039

representation from consumer groups and professional medical association

or bodies.

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.