Health Care Law ( LLB 507 & LLB 509 )

Chanderprabhu Jain College of Higher Studies & School of Law
Plot No. OCF, Sector A-8, Narela, New Delhi – 110040
(Affiliated to Guru Gobind Singh Indraprastha University and Approved by Govt of NCT of Delhi & Bar Council of India)
SEMESTER: NINTH SEMESTER
BA LLB / BBA LLB
NAME OF THE SUBJECT: HEALTH CARE LAW
UNIT – 1 (A)
MEDICINE AND HEALTHCARE
FACULTY NAME:
Ms. Shivali Rawat
Assistant Professor (SOL)

Meaning- Health Care
• Healthcare, health-care, or healthcare is the maintenance or improvement of health
via the prevention, diagnosis, and treatment of disease, illness, injury, and other
physical and mental impairments in people. Health care is delivered by health
professionals in allied health fields. Physicians and physician associates are a part
of these health
• Health care systems are organizations established to meet the health needs of
targeted populations. According to the World Health Organization (WHO), a well-
functioning health care system requires a financing mechanism, a well-trained and
adequately paid workforce, reliable information on which to base decisions and
policies, and well maintained health facilities to deliver quality medicines and
technologies.

Healthcare at National Level
• The Indian healthcare scenario presents a spectrum of contrasting landscapes. At
one end of the spectrum are the glitzy steel and glass structures delivering high tech
medicare to the well-heeled, mostly urban Indian.
• At the other end are the ramshackle outposts in the remote reaches of the “other
India” trying desperately to live up to their identity as health subcenters, waiting to
be transformed to shrines of health and wellness, a story which we will wait to see
unfold. With the rapid pace of change currently being witnessed, this spectrum is
likely to widen further, presenting even more complexity in the future.

Five “A's” for our consideration
• Awareness or the lack of it: How aware is the Indian population about important
issues regarding their own health? Studies on awareness are many and diverse, but
lacunae in awareness appear to cut across the lifespan in our country. Adequate
knowledge regarding breastfeeding practice was found in only one-third of the
antenatal mothers in two studies
• Access or the lack of it: Access (to healthcare) is defined by the Oxford dictionary
as “The right or opportunity to use or benefit from (healthcare)” Again, when we
look beyond the somewhat well-connected urban populations to the urban
underprivileged, and to their rural counterparts, the question “What is the level of
access of our population to healthcare of good quality?” is an extremely relevant
one.

1. Absence or the humanpower crisis in healthcare: Any discussion on healthcare
delivery should include arguably the most central of the characters involved – the
human workforce. Do we have adequate numbers of personnel, are they
appropriately trained, are they equitably deployed and is their morale in delivering
the service reasonably high?
2. Affordability or the cost of healthcare: Quite simply, how costly is healthcare in
India, and more importantly, how many can afford the cost of healthcare?
3. Accountability or the lack of it: Being accountable has been defined as the
procedures and processes by which one party justifies and takes responsibility for
its activities

Healthcare as an issue at International level
• THE RIGHT TO HEALTH has evolved rapidly under international law, and its
normative clarification has significant conceptual and practical implications for
health policy.
• The framework that international human rights offers with respect to health shifts
the analysis of issues such as disparities in treatment in the United States from
questions of quality of care to fundamental matters of democracy and social justice,
as well as suggesting avenues for accountability.
• Under international law, there is a right not merely to health care but to the much
broader concept of health. Because rights must be realized inherently within the
social sphere, this formulation immediately suggests that determinants of health and
ill health are not purely biological or “natural” but are also factors of societal
relations.

• Thus, a rights perspective is entirely compatible with work in epidemiology that has
established social determinants as fundamental causes of disease.
• The first notion of a right to health under international law is found in the 1948
Universal Declaration of Human Rights (hereafter called Declaration), which
was unanimously proclaimed by the UN General Assembly as a common standard
for all humanity.
• India is a party to the International Covenant on Civil and Political Rights and
the International Covenant on Economic, Social and Cultural Rights.
• The Supreme Court held that Article 21 of the Constitution of India in relation to
human rights has to be interpreted in conformity with international law.
• Further, Article 25 [2] of the Universal Declaration of Human Rights and
Article 7 (b) of the International Covenant on Economic, Social and Cultural
Rights have been cited by the Supreme Court while upholding the right to
health by a worker

REMEDIES AVAILABLE UNDER THE INDIAN
CONSTITUTION
• Right to Health is not included as an explicit fundamental right in the Indian
Constitution. Most provisions related to health are in PartIV {Directive Principles}.
• These are: Article 38 says that the state will secure a social order for the promotion
of welfare of the people. Providing affordable healthcare is one of the ways to
promote welfare.
• The right to privacy in India has been a neglected area of study and engagement.
Although sectoral legislation deals with privacy issues, India does not as yet have a
horizontal legislation that deals comprehensively with privacy across all contexts.
• The absence of a minimum guarantee of privacy is felt most heavily by
marginalized communities, including HIV patients, children, women, sexuality
minorities, prisoners, etc.- people who most need to know that sensitive information
is protected.

UNIT – 1 (B)
MEDICINE AND HEALTHCARE

• Health is a vital indicator of human development and human development is the
basic ingredient of economic and social development.
• In India, the right to health care and protection has been recognized, since early
times, Independent India approached the public as the right holder and the state
as the duty-bound primary provider of health for all.
• As our country is a founder member of the United Nations, it has ratified
various international conventions promising to secure health care right of
individuals in society.
• The Constitution incorporates provisions guaranteeing everyone’s right to the
highest attainable standard of physical and mental health. Article 21 of the
Constitution guarantees protection of life and personal liberty to every citizen.
REMEDIES AVAILABLE UNDER THE INDIAN
CONSTITUTION

• Bandhua Mukti Morcha v. Union of India (AIR 1984): The Supreme Court
has held that the right to live with human dignity, enshrined in Article 21,
derives from the directive principles of state policy and therefore includes
protection of health
• State of Punjab v. Mohinder Singh Chawla (1997) : Further, it has also been
held that the right to health is integral to the right to life and the government
has a constitutional obligation to provide health facilities
• Paschim Banga Khet Mazdoor Samity v. State of West Bengal (AIR 1996 ):
Failure of a government hospital to provide a patient timely medical treatment
results in violation of the patient’s right to life
• State of Punjab v. Ram Lubhaya Bagga (1998) : Similarly, the Court has
upheld the state’s obligation to maintain health services

• Sheela Barse v. Union of India (1986) : Public interest petitions have been
filed under Article 21 in response to violations of the right to health.
They have been filed to provide:
• special treatment to children in jail
• on pollution hazards
• against hazardous drugs
• against inhuman conditions in after-care homes
• on the health rights of mentally ill patients
• on the rights of patients in cataract surgery camps
• for immediate medical aid to injured persons
• on conditions in tuberculosis hospitals
• on occupational health hazards
• on the regulation of blood banks and availability of blood products
• on passive smoking in public places
• and in an appeal filed by a person with HIV on the rights of HIV/AIDS
patients.

• Most provisions related to health are in PartIV {Directive Principles}.
• These are: Article 38 says that the state will secure a social order for the
promotion of welfare of the people. Providing affordable healthcare is one of
the ways to promote welfare.
• Article 41 imposes duty on state to provide public assistance in cases of
unemployment, old age, sickness and disablement etc. Article 42 makes
provision to protect the health of infant and mother by maternity benefit.
Article 47 make it duty of the state to improve public health, securing of
justice, human condition of works, extension of sickness, old age, disablement
and maternity benefits and also contemplated. Further, State’s duty includes
prohibition of consumption of intoxicating drinking and drugs are injurious to
health.
• Article 48A ensures that State shall Endeavour to protect and impose the
pollution free environment for good health.

• Confidentiality and privacy are essential to all trusting relationships, such as that
between patients and doctors. Moreover, in a healthcare context, patient
confidentiality and the protection of privacy is the foundation of the doctor-
patient relationship.
• Medical confidentiality is a set of rules that limits access to information discussed
between a person and their healthcare practitioners. With only a few exceptions,
anything we discuss with our doctor must, by law, be kept private between the
two o and the organisation they work for.
Right to health vis-à-vis the Right to Confidentiality

• Medical confidentiality promotes the individual's medical autonomy, by sheltering
those seeking morally controversial medical care from outside criticism and
interference with decisions. Patients must feel comfortable sharing private
information about their bodily functions, physical and sexual activities, and
medical history. This will make them more willing to seek information and support
to fully understand and evaluate their options so that they can make the most
informed medical decisions.

Privacy and confidentiality: A Right
There are so many rights which the patient has and can duly exercise them
whenever they require.
Some of the rights are:
• Right to Appropriate Medical Care and Humane Treatment,
• Right to Information,
• The Right to Choose Health Care Provider and Facility,
• Right to Medical Records, Right to Privacy and Confidentiality etc.
• So, the right to privacy and confidentiality is one of the rights given to the
patient where the patient has the right to be free from public exposure. But are
subject to certain exceptions which are:-
• If the mental or physical condition is in question and the Court orders the
patient to surrender himself to a physical and mental examination by a
physician or;

• When the public health and safety demands or;
• When the patient himself gives up his right in writing or;
• It can be disclosed to the parents or the legal guardian of the patient where the
patient is not of legal age or mentally incapacitated; and if the patient is of legal
age, then, the information can be disclosed with his right to choose the person to
whom the medical information should be communicated.

Laws governing the Confidentiality and Privacy of a patient
in India
• According to the Indian Medical Council (Professional Conduct, Etiquette
and Ethics) Regulations, 2002, it has been stated under chapter 7- (7.14) that
the registered medical practitioner shall not divulge any of the secrets of a
patient that have been acquired in the exercise of his/her professional skill or
while conducting the treatment.
• Chapter 8- (8.2) states about the consequences of the violation. It explains that
if any complaint is made with regards to the professional misconduct of any
registered medical practitioner and the same was brought before the Medical
Council of Disciplinary action, then, upon the receipt of the complaint, the
appropriate medical council will hold an enquiry and will also give the
opportunity to the registered medical practitioner to be heard in person or by a
pleader.

• And if during the course of the enquiry or proceeding, the registered medical
practitioner is found guilty of committing professional misconduct, then he will
be awarded with the punishment as it deems fit with the situation by the Medical
Council or they may also direct the removal of his medical practice altogether or
for only a specified period.
• And under chapter 8- (8.5), if the decision is pending on the complaint
registered against him, then the appropriate Council may restrict the physician
from performing the procedure or practice which is under research/scrutiny.

• Other than the ‘code of ethics’ there are no such specific laws in India which
protect the privacy and confidentiality of the patient’s data but the Health
Ministry has proposed a Digital Information Security in Healthcare Ac (DISHA)
in 2018 which is yet to be finalised.
• It is regarded as likely to provide a complete legal framework to ensure the
privacy of the patients, especially in the era of where more than paper electronic
health records are used. If it gets finalised, then it will give the people complete
ownership of their health data.
Exception
• Absolute privacy and confidentiality is not possible under the healthcare sector
because if the doctors start keeping all health records a secret or confidential,
despite knowing the fact that if such information is not communicated to the
public then it will result in the spread of a dangerous disease from his patient
such as HIV/AIDS, Tuberculosis etc. So, sometimes in the interest for the public
good, the patient’s data has to be communicated.

Surupsingh Hrya Naik v. State of Maharashtra (2007)
• In this case, the Medical Council Code of Ethics and Right to Information Act,
2005 was in conflict. In this case, it was questioned that making the health records
public, under the Right to Information Act would constitute a violation of the right
to privacy. So in this situation, the Bombay High Court held that the Right to
Information will supersede the Right to Privacy and Confidentiality.
Radiological & Imaging Association v. Union of India, 2011
• In this case, the petitioner challenged the circular of the Collector and District
Magistrate, Kohlapur which required that the Radiologist and Sonologist should
submit the on-line form F under the Pre-conception and Pre-natal Diagnostic
Techniques Rules (PNDT) and also to install the SIOB (silent observer) for all the
sonography machines, as a part of `save the baby’ campaign for improving sex ratio
in the district. The petitioner challenged this on the grounds that it violates the
privacy of their patients.

The Bombay High Court held that the images are stored in the silent observer
and are not transmitted online to any server and thus, it remains fixed in the
ultrasound machine and only after the request of the Collector/ the civil surgeon,
in the presence of the concerned radiologist/ sonologist/ doctor in-charge of the
Ultrasound Clinic, the silent observer will be opened.
The use of a silent observer system on a sonography machine has necessary
safeguards or protection and it does not violate any privacy rights as the
declining sex ratio of the country was considered a compelling public interest
that could override the right to privacy.

• The right to privacy in India has been a neglected area of study and engagement.
Although sectoral legislation deals with privacy issues, India does not as yet
have a horizontal legislation that deals comprehensively with privacy across all
contexts.
• The absence of a minimum guarantee of privacy is felt most heavily by
marginalized communities, including HIV patients, children, women, sexuality
minorities, prisoners, etc. - people who most need to know that sensitive
information is protected.

• It is very important for the treating doctor to properly document the
management of a patient under his care. Medical record keeping has evolved
into a science of itself. This will be the only way for the doctor to prove that the
treatment was carried out properly. Moreover, it will also be of immense help in
the scientific evaluation and review of patient management issues. Medical
records form an important part of the management of a patient. It is important
for the doctors and medical establishments to properly maintain the records of
patients for two important reasons.
• The traditional method of keeping records that is followed in most of the
hospitals across India is the manual method involving papers and books. There
are serious limitations of manual record keeping including the need for large
storage areas and difficulties in the retrieval of records. However, it is legally
more acceptable as a documentary evidence as it is difficult to tamper with the
records without detection. The present era has seen the computerization of
medical records that are neat and tidy, and can be easily stored and retrieved
ACCESS TO MEDICAL RECORDS

• Well-maintained medical records unquestionably help doctors and hospitals in
their defence in cases of medical negligence.
• In Md. Aslam v. Ideal Nursing Home , the State Commission made a strong
note of the lack of regulations governing nursing homes and made suggestions
regarding medical record-keeping.
• In Poona Medical Foundation Ruby Hall Clinic v. Marutira L.Titkare, the
National Commission held that not providing medical records did not constitute
negligence or deficiency in service, as there was no legal duty cast to furnish such
documents to a patient. It further held that no material was placed before the
Commission to show that either by law, or by convention or by practice, was
there any obligation on the part of the hospital to furnish to the patient full
particulars of the surgical operation performed on him.

• According to the Data Protection Act, 1984, an individual should be informed
by anyone holding computerised information whether that information includes
his/her personal data and should be supplied with copies of it.
• The Access to Medical Reports Act, 1988 states that insurers and employers
may not be shown a report until the patient has seen and commented on it and
has consented to its disclosure. According to the Access to Health Records Act,
1990 patients have access to their health records.
• The Indian Medical Council (Professional conduct, Etiquette and Ethics)
Regulations, 2002 states that every physician shall maintain the medical records
pertaining to his/her indoor patients for a period of three years from the date of
commencement of the treatment. If any request is made for medical records
either by the patients/authorised attendant or legal authorities involved, the
documents shall be issued within a period of 72 hours and refusal to do so
would be misconduct.

UNIT-2 (A)
PROFESSIONAL OBLIGATIONS OF DOCTORS

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TRANSPLANTATION OF HUMANS ORGAN ACT
Section-2(d,e,f,g,h,i,o,p),3,4,6,9,11,13,14,15,16,18,19&23
•The legislation called the Transplantation of Human Organ Act (THO) was
passed in India in 1994 to streamline organ donation and transplantation
activities.
•Broadly, the act accepted brain death as a form of death and made the sale of
organs a punishable offence. With the acceptance of brain death, it became
possible to not only undertake kidney transplantations but also start other solid
organ transplants like liver, heart, lungs, and pancreas.
•Despite the THO legislation, organ commerce and kidney scandals are
regularly reported in the Indian media.

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• Kidney transplants in India first started in the 1970s and since that time,
India has been a leading country in this field on the Asian sub-
continent. The evolutionary history of transplants in the last four
decades has witnessed a different facet of transplant emerging in each
decade. The first 10 years were spent mastering the surgical techniques
and immune-suppression.
• Its success resulted in a phenomenal rise in the numbers of transplants
in the next 10 years and unrelated kidney donation from economically
weaker sections started taking place with commerce in organ donation
becoming an acceptable integral part of the program. After this was
accepted, the ethics of transplants in India has always been on a
slippery slope and all kinds of nefarious activities were accepted as
normal practice.

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•The general dictum was “when you can buy one why donate?” The next
10 years saw an outcry from the physicians of the western world at the
growing numbers of these exploitative transplants being done in India.
•There were also protests from many sections in India. The pressure on the
Government saw the passing of the Transplantation of Human Organ Act
(THO) legislation that made unrelated transplants illegal and deceased
donation a legal option with the acceptance of brain death.
•Overcoming organ shortage by tapping into the pool of brain-dead
patients was expected to curb the unrelated transplant activity.

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For living donation - it defines who can donate without any legal formalities.
The relatives who are allowed to donate include mother, father, brothers,
sisters, son, daughter, and spouse. Recently, in the new Gazette grandparents
have been included in the list of first relatives. The first relatives are required
to provide proof of their relationship by genetic testing and/or by legal
documents. In the event of there being no first relatives, the recipient and
donor are required to seek special permission from the government appointed
authorization committee and appear for an interview in front of the
committee to prove that the motive of donation is purely out of altruism or
affection for the recipient.
Brain-death and its declaration - brain death is defined by the following
criteria: two certifications are required 6 hours apart from doctors and two of
these have to be doctors nominated by the appropriate authority of the
government with one of the two being an expert in the field of neurology.

)
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•Regulation of transplant activities by forming an Authorization Committee
(AC) and Appropriate Authority (AA.) in each State or Union Territory.
Each has a defined role as follows:
•Role of Authorization Committee (AC) - The purpose of this body is to
regulate the process of authorization to approve or reject transplants
between the recipient and donors other than a first relative. The primary
duty of the committee is to ensure that the donor is not being exploited for
monetary consideration to donate their organ.
•The joint application made by the recipient and donor is scrutinized and a
personal interview is essential to satisfy to the AC the genuine motive of
donation and to ensure that the donor understands the potential risks of the
surgery. Information about approval or rejection is sent by mail to the
concerned hospitals. The decision to accept or reject a donor is governed by
Sub Clause (3), Clause 9 of Chapter II of the THO Act.

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Role of Appropriate Authority (AA):
•The purpose of this body is to regulate the removal, storage, and
transplantation of human organs.
•A hospital is permitted to perform such activities only after being licensed
by the authority. The removal of eyes from a dead body of a donor is not
governed by such an authority and can be done at other premises and does
not require any licensing procedure.
•The powers of the AA include inspecting and granting registration to the
hospitals for transplant surgery, enforcing the required standards for
hospitals, conducting regular inspections of the hospitals to examine the
quality of transplantation.

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•Follow-up medical care of donors and recipients, suspending or canceling the
registrations or erring hospitals, and conducting investigations into complaints
for breach of any provisions of the Act.
•The AA issues a license to a hospital for a period of 5 years at a time and can
renew the license after that period. Each organ requires a separate license.
•In India Transplantation of Human Organs Act was passed in 1994. It
provides a system to regulate removal, storage and transplantation of human
organs for therapeutic purposes and for prevention of commercial dealings
in human organs. Consequently, this act was amended in 2011. In pursuance
to the amendment Act 2011, Transplantation of Human Organs and Tissues
Rules 2014 have been notified in March 2014.

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PRE-CONCEPTION AND PRE-NATAL
DIAGNOSTIC TECHNIQUES ACT, 1994.
Sec 2(bb,bc,c,d,e,i,k,m,o) 3,3A,4,6,7,8,9,16,16A,17,17A&18
•The strong law against female foeticide was enacted and suitably amended.
Over a decade has passed but results are unsatisfactory. Where lies the fault
in the law, its provisions, principles or expectations. Along these questions,
the Act has been analytically studied hereunder.
•Female foeticide is the beginning of the suffering of a woman in the course
of her Long suffering from womb to the tomb. It is a paradox that on the
one hand the Indian culture and tradition consider womanhood as sacred
and sacrosanct and on the other hand Indian women are killed in the
mother’s womb.

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Prohibitory Provisions:
Prohibitory provisions of the Act are contained in 4 Sections.
•First of all there is an express prohibition on the genetic clinics and
counseling centers etc. that they cannot employ not possess the
qualifications prescribed for the same as per the Act.
•No Genetic Counselling Centre or Genetic Laboratory or Genetic Clinic
shall employ or cause to be employed or take services of any person,
whether on honorary basis or on payment who does not possess
qualifications as may be prescribed;

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•The central government and the state governments can appoint
Appropriate Authorities for the Union Territories which investigate
the breaches of this Act, they are the ones which provide the
registration certificates to the genetic lab centres etc.
•Regarding the registration of genetic counseling centre, genetic
laboratory and genetic clinic, an application shall be made to the
appropriate authority, in duplicate in Form A.

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•No medical geneticist, gynaecologist, paediatrician, registered medical
practitioner or any other person shall conduct or cause to be conducted or
aid in conducting by himself or through any other person, any pre-natal
diagnostic techniques at a place other than a place registered under this
Act.
•No person, organization, Genetic Counselling Centre, Genetic Laboratory
or Genetic Clinic, including clinic, laboratory or centre having ultrasound
machine or imaging machine or scanner or any other technology capable of
undertaking determination of sex of foetus or sex selection shall issue,
publish, distribute, communicate or cause to be issued, published,
distributed or communicated any advertisement, in any form, including
Internet, regarding facilities of pre-natal determination of sex or sex
selection before conception available at such centre, laboratory, clinic or at
any other place.

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Preventive-provisions:
•There are 6 provisions in the Act which are preventive in nature. They seek
to prevent the hostile actions of the medical professionals as well as the
society.
•No Genetic Counseling Centre, Genetic Laboratory or Genetic clinic shall
conduct any sex determination test, nor in any manner may disclose the sex
or help the people in sex selection in any manner.
•The private clinicians are prohibited under the Act, the government has
become stringent so the tests have become very experience. With the cameras
recording has rendered these tests very secretive, but the flouters have their
own methods of violating the law.

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Regulatory Provisions:
•As far as this Act is concerned there are 27 regulatory provisions in it.
•Under Section 4 of the Act it is said that the ultra sound tests may be
conducted only for specified purposes.
•A complete record of the ultra sound test has to be kept by the hospital
concerned otherwise it would be assumed that sex determination was
carried out.
•Form G has to be filled by the woman undergoing ultrasound wherein she
has to declare that she is undergoing the test.
•Section 7 talks about a Central Supervisory Board for conducting
various functions under this Act.
•Sections 8, 9, 14, 15 & 16 talk about the conditions of its members’
services, their meetings and the facts about their vacancies, their functions
etc.

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•Every certificate of registration shall be valid for a period of five years from
the date of its issue.
•The certificate of registration is liable to be cancelled if the Appropriate
Authority (section 17 )feels it is essential in public interest. Section 17A
talks about the functions of AA.
•The offences under this Act are cognizable, non-compoundable and non-
bailable.
•Under this Act if the complaint is made by the Appropriate Authority, a
person or a social organization may take an action under the Act but they have
to give a notice to the Appropriate Authority.

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CODE OF MEDICAL ETHICS REGULATIONS, 2002
DUTIES AND RESPONSIBILITIES OF THE PHYSICIAN IN GENERAL:
Character of Physician
A physician shall uphold the dignity and honour of his profession.
The prime object of the medical profession is to render service to humanity; reward
or financial gain is a subordinate consideration. Who- so-ever chooses his
profession, assumes the obligation to conduct himself in accordance with its ideals.
A physician should be an upright man, instructed in the art of healings. He shall
keep himself pure in character and be diligent in caring for the sick; he should be
modest, sober, patient, prompt in discharging his duty without anxiety; conducting
himself with propriety in his profession and in all the actions of his life.
No person other than a doctor having qualification recognised by Medical Council
of India and registered with Medical Council of India/State Medical Council (s) is
allowed to practice Modern system of Medicine or Surgery. A person obtaining
qualification in any other system of Medicine is not allowed to practice Modern
system of Medicine in any form.

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Maintaining good medical practice:
The Principal objective of the medical profession is to render service to
humanity with full respect for the dignity of profession and man. Physicians
should merit the confidence of patients entrusted to their care, rendering to
each a full measure of service and devotion. Physicians should try continuously
to improve medical knowledge and skills and should make available to their
patients and colleagues the benefits of their professional attainments.
The honoured ideals of the medical profession imply that the responsibilities of
the physician extend not only to individuals but also to society.
Membership in Medical Society: For the advancement of his profession, a
physician should affiliate with associations and societies of allopathic medical
professions and involve actively in the functioning bodies.
A Physician should participate in professional meetings as part of Continuing
Medical Education programmes, for at least 30 hours every five years,
organized by reputed professional academic bodies or any other authorized
organisations. The compliance of this requirement shall be informed regularly
to Medical Council of India or the State Medical Councils as the case may be.

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Maintenance of medical records:
Every physician shall maintain the medical records pertaining to his / her
indoor patients for a period of 3 years from the date of commencement of the
treatment in a standard proforma laid down by the Medical Council of India
and attached as Appendix
If any request is made for medical records either by the patients / authorised
attendant or legal authorities involved, the same may be duly acknowledged
and documents shall be issued within the period of 72 hours.
A Registered medical practitioner shall maintain a Register of Medical
Certificates giving full details of certificates issued. When issuing a medical
certificate he / she shall always enter the identification marks of the patient
and keep a copy of the certificate. He / She shall not omit to record the
signature and/or thumb mark, address and at least one identification mark of
the patient on the medical certificates or report. The medical certificate shall
be prepared as in Appendix. Efforts shall be made to computerize medical
records for quick retrieval.

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Display of registration numbers:
Every physician shall display the registration number accorded to him by
the State Medical Council / Medical Council of India in his clinic and in all
his prescriptions, certificates, money receipts given to his patients.
Physicians shall display as suffix to their names only recognized medical
degrees or such certificates/diplomas and memberships/honours which
confer professional knowledge or recognizes any exemplary
qualification/achievements.
Use of Generic names of drugs:
Every physician should, as far as possible, prescribe drugs with generic
names and he / she shall ensure that there is a rational prescription and use
of drugs.

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Highest Quality Assurance in patient care:
Every physician should aid in safeguarding the profession against
admission to it of those who are deficient in moral character or education.
Physician shall not employ in connection with his professional practice any
attendant who is neither registered nor enlisted under the Medical Acts in
force and shall not permit such persons to attend, treat or perform
operations upon patients wherever professional discretion or skill is
required.
Exposure of Unethical Conduct:
A Physician should expose, without fear or favour, incompetent or corrupt,
dishonest or unethical conduct on the part of members of the profession

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Payment of Professional Services:
The physician, engaged in the practice of medicine shall give priority to the
interests of patients. The personal financial interests of a physician should not
conflict with the medical interests of patients. A physician should announce
his fees before rendering service and not after the operation or treatment is
under way. Remuneration received for such services should be in the form and
amount specifically announced to the patient at the time the service is
rendered. It is unethical to enter into a contract of “no cure no payment”.
Physician rendering service on behalf of the state shall refrain from
anticipating or accepting any consideration.

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Evasion of Legal Restrictions:
The physician shall observe the laws of the country in regulating the practice
of medicine and shall also not assist others to evade such laws. He should be
cooperative in observance and enforcement of sanitary laws and regulations in
the interest of public health. A physician should observe the provisions of the
State Acts like Drugs and Cosmetics Act, 1940; Pharmacy Act, 1948;
Narcotic Drugs and Psychotropic substances Act, 1985; Medical
Termination of Pregnancy Act, 1971; Transplantation of Human Organ
Act, 1994; Mental Health Act, 1987; Environmental Protection Act, 1986;
Pre–natal Sex Determination Test Act, 1994; Drugs and Magic Remedies
(Objectionable Advertisement) Act, 1954; Persons with Disabilities (Equal
Opportunities and Full Participation) Act, 1995 and Bio-Medical Waste
(Management and Handling) Rules, 1998 and such other Acts, Rules,
Regulations made by the Central/State Governments or local
Administrative Bodies or any other relevant Act relating to the protection
and promotion of public health.

49
DUTIES OF PHYSICIANS TO THEIR PATIENTS
Obligations to the Sick
Though a physician is not bound to treat each and every person asking his
services, he should not only be ever ready to respond to the calls of the sick and
the injured, but should be mindful of the high character of his mission and the
responsibility he discharges in the course of his professional duties. In his
treatment, he should never forget that the health and the lives of those entrusted to
his care depend on his skill and attention. A physician should endeavour to add to
the comfort of the sick by making his visits at the hour indicated to the patients. A
physician advising a patient to seek service of another physician is acceptable,
however, in case of emergency a physician must treat the patient. No physician
shall arbitrarily refuse treatment to a patient. However for good reason, when a
patient is suffering from an ailment which is not within the range of experience of
the treating physician, the physician may refuse treatment and refer the patient to
another physician.
Medical practitioner having any incapacity detrimental to the patient or which can
affect his performance vis-à-vis the patient is not permitted to practice his
profession

50
Patience, Delicacy and Secrecy :
Patience and delicacy should characterize the physician. Confidences
concerning individual or domestic life entrusted by patients to a physician
and defects in the disposition or character of patients observed during
medical attendance should never be revealed unless their revelation is
required by the laws of the State. Sometimes, however, a physician must
determine whether his duty to society requires him to employ knowledge,
obtained through confidence as a physician, to protect a healthy person
against a communicable disease to which he is about to be exposed. In
such instance, the physician should act as he would wish another to act
toward one of his own family in like circumstances.
Prognosis:
The physician should neither exaggerate nor minimize the gravity of a
patient’s condition. He should ensure himself that the patient, his relatives
or his responsible friends have such knowledge of the patient’s condition
as will serve the best interests of the patient and the family.

51
The Patient must not be neglected:
A physician is free to choose whom he will serve. He should, however,
respond to any request for his assistance in an emergency. Once having
undertaken a case, the physician should not neglect the patient, nor should
he withdraw from the case without giving adequate notice to the patient and
his family. Provisionally or fully registered medical practitioner shall not
willfully commit an act of negligence that may deprive his patient or patients
from necessary medical care.

52
UNETHICALACTS :
Advertising:
• Soliciting of patients directly or indirectly, by a physician.
• A physician shall not make use of him / her (or his / her name) as subject of any
form or manner of advertising or publicity through any mode either alone or in
conjunction with others which is of such a character as to invite attention to him
or to his professional position, skill, qualification, achievements, attainments,
specialities, appointments, associations, affiliations or honours and/or of such
character as would ordinarily result in his self aggrandizement. A medical
practitioner is however permitted to make a formal announcement in press
regarding the following:
1.On starting practice.
2.On change of type of practice.
3.On changing address.
4.On temporary absence from duty.
5.On resumption of another practice.
6.On succeeding to another practice.
7.Public declaration of charges.

53
Printing of self photograph, or any such material of publicity in the letter head or
on sign board of the consulting room or any such clinical establishment shall be
regarded as acts of self advertisement and unethical conduct on the part of the
physician.
Patent and Copy rights:
A physician may patent surgical instruments, appliances and medicine or
Copyright applications, methods and procedures. However, it shall be unethical
if the benefits of such patents or copyrights are not made available in situations
where the interest of large population is involved.
Running an open shop (Dispensing of Drugs and Appliances by Physicians):
A physician should not run an open shop for sale of medicine for dispensing
prescriptions prescribed by doctors other than himself or for sale of medical or
surgical appliances. It is not unethical for a physician to prescribe or supply
drugs, remedies or appliances as long as there is no exploitation of the patient.
Drugs prescribed by a physician or brought from the market for a patient should
explicitly state the proprietary formulae as well as generic name of the drug.

54
Secret Remedies:
The prescribing or dispensing by a physician of secret remedial agents of
which he does not know the composition, or the manufacture or promotion
of their use is unethical and as such prohibited. All the drugs prescribed by
a physician should always carry a proprietary formula and clear name.
Human Rights:
The physician shall not aid or abet torture nor shall he be a party to either
infliction of mental or physical trauma or concealment of torture inflicted
by some other person or agency in clear violation of human rights.

55
Euthanasia:
Practicing euthanasia shall constitute unethical conduct. However on specific
occasion, the question of withdrawing supporting devices to sustain cardio-
pulmonary function even after brain death, shall be decided only by a team of
doctors and not merely by the treating physician alone. A team of doctors shall
declare withdrawal of support system. Such team shall consist of the doctor in
charge of the patient, Chief Medical Officer / Medical Officer in charge of the
hospital and a doctor nominated by the in-charge of the hospital from the
hospital staff or in accordance with the provisions of the Transplantation of
Human Organ Act, 1994.

UNIT-2 (B)
PROFESSIONAL OBLIGATIONS OF DOCTORS

57
International Code of Medical Ethics
The International Code of Medical Ethics was adopted by the General
Assembly of the World Medical Association at London in 1949, amended
in 1968, 1983 and 2006. It is a code based on the Declaration of
Geneva and the main goal is to establish the ethical principles of the
physicians worldwide, based on his duties in general, to his patients and to
his colleagues.
After the approval of the Declaration of Geneva, the II General Assembly of
the World Medical Association analyzed a report on "War Crimes and
Medicine". This prompted the WMA Council to appoint another Study
Committee to prepare an International Code of Medical Ethics, which after
an extensive discussion, was adopted in 1949 by the III General
Assembly.

58
The Declaration of Geneva was adopted by the General Assembly of
the World Medical Association at Geneva in 1948, amended in 1968, 1983,
1994, editorially revised in 2005 and 2006 and amended in 2017.
It is a declaration of a physician's dedication to the humanitarian goals
of medicine, a declaration that was especially important in view of the
medical crimes which had just been committed in German-occupied Europe.
The Declaration of Geneva was intended as a revision of the Hippocratic
Oath to a formulation of that oath's moral truths that could be comprehended
and acknowledged in a modern way. Unlike the case of the Oath of
Hippocrates, the World Medical Association calls the statement a "pledge".

59
INDIAN MEDICAL CENTRAL COUNCIL ACT,
1970
Sec- 2(c,d,e,j) 3,9,13A, 14,17,21,23&26
The Central Council and Its Committees (Section-3)
The Central Government shall, by notification in the Official Gazette
constitute for the purposes of this Act a Central Council consisting of the
following members, namely:-
(a) such number of members not exceeding five as may be determined by the
Central Government in accordance with the provisions of the First Schedule
for each of the Ayurveda, Siddha and Unani systems of medicine from each
State in which a State Register of Indian Medicine is maintained, to be
elected from amongst themselves by persons enrolled on that Register as
practitioners of Ayurveda, Siddha or Unani, as the case may be.

60
(b) one member for each of the Ayurveda, Siddha and Unani systems of
medicine from each University to be elected from amongst themselves by the
members of the Faculty or Department (by whatever name called) of the
respective system of medicine of that University;
(c) such number of members, not exceeding thirty per cent of the total
number of members elected under clauses (a) and (b), as may be nominated
by the Central Government, from amongst persons having special knowledge
or practical experience in respect of Indian medicine:

Provided that until members are elected under clause (a) or clause (b) in
accordance with the provisions of this Act and the rules made thereunder, the
Central Government shall nominate such number of members, being persons
qualified to be chosen as such under the said clause (a) or clause (b), as the case
may be, as that Government thinks fit; and reference to elected members in this
Act shall be construed as including references to members so nominated.
(2) The President of the Central Council shall be elected by the members of the
Central Council from amongst themselves in such manner as may be prescribed.
(3) There shall be a Vice-President for each of the Ayurveda, Siddha [Unani and
Sowa-Rigpa] systems of medicine who shall be elected from amongst
themselves by members representing that system of medicine, elected under
clause (a) or clause (b) of sub-section (1) or nominated under clause (c) of that
sub-section.

Committees for Ayurveda, Siddha and Unani. (Section-9)
(1) The Central Council shall constitute from amongst its members,--
(a) a committee for Ayurveda;
(b) a committee for Siddha;
(c) a committee for Unani; and
(d) a committee for Sowa-Rigpa,
and each such committee shall consist of members elected under clause (a) or
clause (b) or nominated under clause (c) of sub-section (1) of section 3
representing the Ayurveda, Siddha, Unani or Sowa-Rigpa system of medicine,
as the case may be.
Permission for establishment of new medical college, new course of study,
etc. (Section 13A)

Professional conduct. (section-26)
(1) The Central Council may prescribe standards of professional conduct and
etiquette and a code of ethics for practitioners of Indian medicine.
(2) Regulations made by the Central Council under sub-section (1) may
specify which violations thereof shall constitute infamous conduct in any
professional respect, that is to say, professional misconduct, and such
provision shall have effect notwithstanding anything contained in any law for
the time being in force.

64
DENTIST ACT, 1948
•Sec-2(b,d,e.k), 3,4,9,10A,10, 11,12, 13,17A,17,18
•The Dental Council of India was incorporated under The Dentists Act,
1948 to regulate dental education and the profession throughout India.
•It is financed by the Ministry of Health and Family Welfare and through the
local state dental councils. The Dental Council of India is constituted by an
act of parliament ‘The Dentists Act 1948’ with a view to regulate the dental
education, dental profession and dental ethics thereto-which came into
existence in March, 1949.
•The Council is composed of 6 constituencies representing Central
Government, State Government, Universities, Dental Colleges, Medical
Council of India and the Private Practitioners of Dentistry.

65
•The Director-General of Health Services is Ex-Officio Member – both of the
Executive Committee and General Body. The Council elects from themselves
the President, Vice-President and the members of the Executive Committee.
•The elected President and the Vice-President are the Ex-Officio Chairman and
Vice Chairman of the Executive Committee.
•The Executive Committee Section -9 -is the governing body of this
organisation, which deals with all procedural, financial and day-to-day activities
and affairs of the Council.

66
The Council is financed mainly by grants from the Govt. of India, Ministry of
Health & Family Welfare (Department of Health) though the other source of
income of the Council are:
•the 1/4th share of fees realized every year by various State Dental Councils
under section 53 of the Dentists Act,
•Inspection fee from the various Dental Institution for Inspecting under
Section 15 of the Dentists Act, 1948 and
•application fee from the organization to apply for permission to set up new
Dental College, opening of higher Courses of study and increase of admission
capacity in Dental Colleges under section 10A of the Dentists Act, 1948 as
amended by the Dentists (Amendment) Act, 1993.

IDA Code of Ethics
The IDA Code of Ethics is a comprehensive directive on the ethical codes
of conduct an IDA dentist member is expected to follow. The IDA code of
ethics has been formulated keeping in mind the DCI Code of Ethics i.e.
Dentist’s Act amended in 2016 and adopted from various international
Dental Associations promoting high standards of patient care matching
global standards. IDA strives to put India on the global map by holding its
members to a very high standard through the adoption of this Code of
Ethics. These regulations may be called the Revised IDA Code of Ethics,
2014.
Character of Dentist / Dental Surgeon
In view of the important role of a Dentist/ Dental Surgeon as a health
professional educated and trained in surgical and medical treatment of
diseases of the Oral cavity, he shall:

Be mindful of the high character of his mission and the responsibilities he
holds in the discharge of his duties as an independent healthcare professional
and shall always remember that care of the patient and treatment of the disease
depends upon the skill and prompt attention shown by him. Treat the welfare
of the patients as paramount to all other considerations and shall conserve it to
the utmost of his ability.
Maintaining good Clinical Practices:
The Principal objective of the Dental profession is to render service to
humanity with full respect for the dignity of profession and man. Dental
Surgeons should merit the confidence of patients entrusted to their care,
rendering to each a full measure of service and devotion. They should try
continuously to improve medical knowledge and skills and should make
available to their patients and colleagues the benefits of their professional
attainments. The Dentist/ Dental Surgeon should practice methods of healing
founded on scientific basis and should not associate professionally with
anyone who violates this principle.

Maintenance of Dental/Medical records:
Every Dental surgeon shall maintain the relevant records pertaining to his out-
patients and inpatients (wherever applicable). These records must be preserved
for a minimum period of three years from the date of commencement of the
treatment in a format determined by the Council or accepted as a standard mode
of documentation.
If any request is made for medical or dental records either by the
patients/authorized attendant or legal authorities involved, the same may be
issued to the competent authority within 72 hours after having obtained a valid
receipt for all documents. It is prudent to keep certified photocopies / carbon
copies of such submissions.
A Registered Dental practitioner shall maintain a Register of Medical
Certificates giving full details of certificates issued.
Efforts shall be made to digitalize dental/ medical records for quick retrieval.

Display of Registration Numbers:
Every Dental practitioner shall display the registration number accorded to him
by the State Dental Council in his clinic and in all his prescriptions, certificates
and money receipts given to his patients.
Highest Quality Assurance in patient care:
Every Dental practitioner should ensure quality treatment that does not
compromise the outcome of treatment. He must be vigilant about malpractice
by other practitioners that may jeopardize the lives of others and which are
likely to cause harm to the public. All practitioners should be aware of
unethical practices and practices by unqualified persons. Dentists/ Dental
Surgeons shall not employ in connection with their professional practice any
attendant who is neither registered nor enlisted under the Dentists Act and shall
not permit such persons to attend, treat or perform operations upon patients
wherever professional discretion or skill is required.

Exposure of Unethical Conduct:
A Dental Surgeon should expose, without fear or favour, incompetent or
corrupt, dishonest or unethical conduct on the part of members of the
profession. It is the responsibility of the dental surgeon to report to the
competent authorities’ instances of quackery and any kind of abuse including
doctor-patient sexual misconduct, misuse of fiduciary relationship, child abuse
and other social evils that may come to their attention.
Payment of Professional Services:
The Dental Surgeon, engaged in the practice of his profession shall give
priority to the interests of patients. The personal financial interests of a dental
surgeon should not conflict with the medical interests of patients. A dental
practitioner should announce his fees before rendering service and not after the
operation or treatment is under way. Remuneration received for such services
should be in the form and amount specifically announced to the patient at the
time the service is rendered. It is unethical to enter into a contract of “no cure -
no payment”.

Observation of Statutes:
The Dental Surgeon shall observe the laws of the country in regulating the
practice of his profession including the Dentists’ Act 1948 and its amendments
and shall also not assist others to evade such laws. He should be cooperative in
observance and enforcement of sanitary laws and regulations in the interest of
public health.
He should observe the provisions of the State Acts like Drugs and Cosmetics
Act, 1940; Pharmacy Act, 1948; Narcotic Drugs and Psychotropic
substances Act, 1985; Environmental Protection Act, 1986; Drugs and
Magic Remedies (Objectionable Advertisement) Act, 1954; Persons with
Disabilities (Equal Opportunities and Full Participation) Act, 1995 and
Bio-Medical Waste (Management and Handling) Rules, 1998 and such
other Acts, Rules, Regulations made by the Central/State Governments or
local Administrative Bodies, etc.

Signing Professional Certificates, Reports and other Documents:
A Registered Dental Surgeon involved independently in the treatment of
dental and oral surgical problems may be called upon to sign certificates,
notifications, reports etc. He is bound to issue such certificates and to sign
them. Documents relating to disability, injury in the oral and maxillofacial
region and deaths occurring while under the care of such dental surgeons
should be signed by them in their professional capacity for subsequent use in
the courts or for administrative purposes etc. Any registered dental surgeon
who is shown to have signed or given under his name and authority any such
certificate, notification, report or document of a similar character which is
untrue, misleading or improper, is liable to have his name deleted from the
Register.

74
The Homeopathy Central Council Act, 1973
The Central Council of Homoeopathy Act 1973, (Act 59), also called
the Homoeopathy Central Council Act, 1973, is an Act of the Parliament of
India to primarily structure the role of the Central Council of
Homoeopathy and to enable the regularization of the maintenance of a central
register of issues and entities related to the field of homoeopathy.
It included five chapters when it was initially passed.
The Act was amended in 2002, and the amendment—Homoeopathy Central
Council Amendment Act, 2002 (No. 51 of 2002)—was passed in December
2002.

75
Section-3- Central Council of Homeopathy is a statutory apex body under
the Ministry of AYUSH, Government of India. It was set up by
the Government of India in 1973, and is one of the Professional
Councils of University Grants Commission, formed to monitor higher
education in India.
Any institution desiring to grant a qualification in homeopathy is required to
apply to the Council, which prescribes course curriculum and maintains
central registers of homeopaths The institution set up under the Central
Council of Homeopathy Act 1973.
Any university or similar institution in India offering either a degree or a
diploma in homeopathy can do so only if it is approved by CCH, apart from
being listed under the schedules of the above-mentioned act.

Section-9. The Executive Committee and other committees.—
(1) The Central Council shall constitute from amongst its members an
Executive Committee and such other committees for general or special
purposes as the Council deems necessary to carry out the purposes of this
Act.
(2) (i) The Executive Committee (hereafter in this section referred to as the
Committee), shall consist of the President and Vice-President, who shall
be members ex officio, and not less than five and not more than seven
members who shall be elected by the Central Council from amongst its
members.
(ii) The President and the Vice-President shall be the President and Vice-
President respectively of the Committee.
(iii) In addition to the powers and duties conferred and imposed upon it by this
Act, the Committee shall exercise and discharge such powers and duties as the
Central Council may confer or impose upon it by any regulations which may
be made in this behalf.

Section 12A. Permission for establishment of new medical institution, new
course of study, etc.—
(1) Notwithstanding anything contained in this Act or any other law for the time
being in force, — (a) no person shall establish a Homoeopathic Medical
College; or (b) no Homoeopathic Medical College shall— (i) open a new or
higher course of study or training (including post-graduate course of study or
training) which would enable students of each course or training to qualify
himself for the award of any recognized medical qualification; or (ii) increase
its admission capacity in any course of study or training (Including the post-
graduate course of study or training), except with the previous permission of the
Central Government obtained in accordance with the provisions of this section.

Section 15. Rights of persons possessing qualifications included in Second or
the Third Schedule to be enrolled.—
(1) Subject to the other provisions contained in this Act, any medical qualification
included in the Second or the Third Schedule shall be sufficient qualification
for enrolment on any State Register of Homoeopathy.
(2) No person, other than a practitioner of Homoeopathy who possesses a
recognised medical qualification and is enrolled on a State Register or the
Central Register of Homoeopathy, shall hold office as Homoeopathic
physician or any other office (by whatever designation called) in Government
or in any institution maintained by a local or other authority; practise
Homoeopathy in any State; shall be entitled to sign or authenticate a medical or
fitness certificate or any other certificate required by any law to be signed or
authenticated by a duly qualified medical practitioner;

shall be entitled to give any evidence at any inquest or any court of law as an
expert under section 45 of the Indian Evidence Act, 1872 (1 of 1872) on any
matter relating to Homoeopathy. (4) Any person who acts in contravention of
any provision of sub-section (2) shall be punished with imprisonment for a
term which may extend to one year, or with fine which may extend to one
thousand rupees, or with both.
Section 24- Professional conduct.—
(1) The Central Council may prescribe standards of professional conduct and
etiquette and a code of ethics for practitioners of Homoeopathy.
(2) Regulations made by the Central Council under sub-section (1) may specify
which violations thereof shall constitute infamous conduct in any
professional respect, that is to say, professional misconduct, and such
provision shall have effect notwithstanding anything contained in any law
for the time being in force.

CODE OF ETHICS FOR PRACTITIONERS OF HOMOEOPATHY
Obligations to the Sick
Though a practitioner of Homoeopathy is not bound to treat each and every
one asking for his services except in emergencies, he shall, for the sake of
humanity and the noble traditions of the profession, not only be ever ready to
respond to the calls of the sick and the injured, but shall be mindful of the high
character of his mission and the responsibility he incurs in the discharge of his
professional duties.
Patience, Delicacy & Secrecy Patience and delicacy shall characterize the
attitude of a practitioner of Homoeopathy.
Confidences concerning individual or domestic life entrusted by patients to a
practitioner and defects in the disposition or character of patients observed
during the medical attendance shall not be revealed by him to anyone unless
their revelation is required by the laws of the State.

Patient not be Neglected
(1) A practitioner of Homoeopathy is free to choose whom he will serve
provided he shall respond to any request for his assistance in an emergency
or whenever temperate public opinion expects the service.
(2) Once having undertaken a case, a practitioner of Homoeopathy shall not
neglect the patient nor shall he withdraw from the case without giving
notice to the patient, his relatives or his responsible friends sufficiently long
in advance of his withdrawal to allow them time to secure another
practitioner.
Physician to obey law and regulation:-
A physician, -
(a) shall not act contrary to the laws regulating the practice of Homoeopathy;
(b) shall not assist others to disobey the law regulating the practice of
Homoeopathy;
(c) shall act in aid of the enforcement of sanitary laws and regulations in the
interest of public health;

(d) shall comply with the provisions of the Drugs and Cosmetics Act, 1940
(23 of 1940), Drugs and Cosmetics Rules, 1945; the Pharmacy Act, 1948
(8 of 1948); the Narcotic Drugs and Psychotropic Substances Act 1985
(61 of 1985); the Medical Termination of Pregnancy Act, 1971 (34 of
1971), the Transplantation of Human Organ Act, 1994 (42 of 1994); the
Persons with Disabilities (Equal Opportunity and Full Participation)
Act, 1995 (1 of 1996) and Biomedical Waste (Management and
Handling) Rules, 1998 and such other related Acts, Rules, of the Central
Government or the State Government or the Local Administrative
bodies relating to protection and promotion of public health.

Behaviour Towards Patients
The demeanour of a practitioner of Homoeopathy towards his patients shall
always be courteous, sympathetic, friendly and helpful. Every patient shall be
treated with attention and consideration.
Visits
A practitioner of Homoeopathy shall endeavour to add to the comfort of the
sick by making his visits at the hour indicated to the patients.
Prognosis
(1) The practitioner of Homoeopathy shall neither exaggerate nor minimize the
gravity of a patient's condition. He shall ensure that the patient, his
relatives or responsible friends have such knowledge of the patient's
condition as will serve the best interest of the patient and his family.
(2) In cases of dangerous manifestations, he shall not fail to give timely notice
to the family or friends of the patient and also to the patient when
necessary.

Acts of Negligence
(1) No practitioner of Homoeopathy shall wilfully commit an act of
negligence that may deprive his patient of necessary medical care.
(2) A practitioner of Homoeopathy is expected to render that diligence and
skill in services as would be expected of another practitioner of
Homoeopathy with similar qualifications, experience and attainments.
(3) His acts of commission or omission shall not be judged by any non-
Homoeopathic standards of professional service expected of him but by
those standards as are expected from a Homoeopath of his training,
standing and experience.
(4) A practitioner of Homoeopathy shall use any drug prepared according to
Homoeopathic principles and adopt other necessary measures as
required.

Upholding honour of Profession
A practitioner of Homoeopathy shall, at all times, uphold the dignity and
honour of this profession.
Membership of Medical Society
For the advancement of his profession a practitioner of Homoeopathy may
affiliate himself with Medical Societies and contribute his time, energy and
means to their progress so that they may better represent and promote the
ideals of the profession.
Exposure of Unethical Conduct
A practitioner of Homoeopathy shall expose, without fear or favour, the
incompetent, corrupt, dishonest or unethical conduct on the part of any
member of the profession.

86
Drugs and Cosmetics Act, 1940
The Drugs and Cosmetics Act, 1940 is an Act of the Parliament of India which
regulates the import, manufacture and distribution of drugs in India.
•The Act regulates the import, manufacture, and distribution of drugs in India.
•The primary objective of the act is to ensure that the drugs and cosmetics sold
in India are safe, effective and conform to state quality standards.
It was initially known as the Drug Act and was passed in 1940 and after several
amendments is known as the Drugs and Cosmetics Act, 1940.
The related Drugs and Cosmetics Rules, 1945 contains provisions for
classification of drugs under given schedules and there are guidelines for the
storage, sale, display and prescription of each schedule. This act was originally
known as the Drug Act and was passed in 1940.

Background
As per the 7th Schedule of the Indian Constitution, drugs fall under the
Concurrent List and the definition of medical devices was introduced in 1982,
under the definition of drugs under the Drugs and Cosmetics Act,1940.
A majority of medical devices and their sale is unregulated in India. At present,
only 24 high-risk medical devices, including cardiac stents, are regulated as
drugs by the Central Drugs Standards Control Organisation.
The Medical Devices Rules were introduced in 2017, and the Centre has also
formulated a report on a roadmap to medical devices.
It has been formulated in consultation with all the stakeholders, such as
AiMED, NITI Aayog, etc.The AiMeD is an Umbrella Association of Indian
Manufacturers of Medical Devices.

The Central Drugs Standards Control Organisation (CDSCO) is the
apex drug regulator in India.
The Health Ministry notification has said that all medical device
manufacturers will also have to register themselves on a centralized online
portal for the purposes of quality control and assurance.
The decision to include all the medical devices under the ambit of the
Drugs and Cosmetics Act,1940 was taken in consultation with the Drugs
Technical Advisory Board (DTAB).

Classification of medical devices
•The classification of the medical device rules along with the regulatory
approval and registration by the CDSCO is under the control of the Drug
Controller General of India (DCGI).
•All medical devices in India follow a regulatory framework based on the
drug regulations under the Drugs and Cosmetics Act, 1940 and the Drugs and
Cosmetic Rules, 1945.
•The newly notified rules further classify medical devices in four categories,
Class A, Class B, Class C, and Class D.
•Class A and Class B would have 36 months, while Class C and Class D will
have 42 months to subject themselves to strict quality control mechanisms
and come under the compliance regime.
•The regulatory requirements for the approval of the license for drugs and
medical devices are completely different.

Sl. No Classes of Medical
Device
Type of Medical
Device
Examples
1. Class A Low-risk absorbent cotton
balls, alcohol
swabs, etc.
2. Class B Moderate-low
risk
thermometer, BP
monitoring
device, etc.
3. Class C Moderate-high
risk
Implants, etc.
4. Class D High-risk heart valve, etc.

•The term "drug" as defined in the act includes a wide variety of substance,
diagnostic and medical devices.
•The act defines "cosmetic" as any product that is meant to be applied to the
human body for the purpose of beautifying or cleansing. The definition however
excludes soaps.
In 1964, the act was amended to include Ayurveda and Unani drugs.
The Section 16 of the act defines the standards of quality for drugs.
The Section 17 defines "misbranding". A drug is considered misbranded if it
claims to be of more therapeutic value than it actually is.
91

The manufacturer of such a drug may be asked to suspend manufacture of
the drug under Section 18.
Section 27 deals with fake and adulterated drugs. The act requires more of
that ingredients of the drugs should be printed on the label.

UNIT-3 (A)
MEDICAL NEGLIGENCE & INGREDIENTS

94
MEDICAL NEGLIGENCE is a combination of two words. The second word solely
describes the meaning, though the meaning of negligence has not been described in a
proper way but it is an act recklessly done by a person resulting in foreseeable damages
to the other. Negligence is an offense under tort, IPC, Indian Contracts Act, Consumer
Protection Act and many more.
Medical Negligence basically is the misconduct by a medical practitioner or doctor by
not providing enough care resulting in breach of their duties and harming the patients
which are their consumers.
A professional is deemed to be an expert in that field at least; a patient getting treated
under any doctor surely expects to get healed and at least expects the doctor to be careful
while performing his duties. Medical negligence has caused many deaths as well as
adverse results to the patient’s health.

The medical profession is considered a noble profession because it helps in preserving life. We
believe life is God given. Thus, a doctor figures in the scheme of God as he stands to carry out
His command. A patient generally approaches a doctor/hospital based on his/its reputation.
Expectations of a patient are two-fold: doctors and hospitals are expected to provide medical
treatment with all the knowledge and skill at their command and secondly they will not do
anything to harm the patient in any manner either because of their negligence, carelessness, or
reckless attitude of their staff.
Though a doctor may not be in a position to save his patient's life at all times, he is expected to
use his special knowledge and skill in the most appropriate manner keeping in mind the interest of
the patient who has entrusted his life to him. Therefore, it is expected that a doctor carry out
necessary investigation or seeks a report from the patient.

Furthermore, unless it is an emergency, he obtains informed consent of the patient before
proceeding with any major treatment, surgical operation, or even invasive investigation.
Failure of a doctor and hospital to discharge this obligation is essentially a tortious liability.
A tort is a civil wrong (right in rem) as against a contractual obligation (right in personam) – a
breach that attracts judicial intervention by way of awarding damages.
Thus, a patient's right to receive medical attention from doctors and hospitals is essentially a civil
right. The relationship takes the shape of a contract to some extent because of informed consent,
payment of fee, and performance of surgery/providing treatment, etc. while retaining essential
elements of tort.

In the case of Dr. Laxman Balkrishna Joshi vs. Dr. Trimbark Babu Godbole and Anr., AIR
1969 SC 128 and A.S.Mittal v. State of U.P., 1989 it was laid down that when a doctor is consulted
by a patient, the doctor owes to his patient certain duties which are:
(a) duty of care in deciding whether to undertake the case,
(b) duty of care in deciding what treatment to give, and
(c) duty of care in the administration of that treatment.
A breach of any of the above duties may give a cause of action for negligence and the patient may
on that basis recover damages from his doctor. In the aforementioned case, the apex court interalia
observed that negligence has many manifestations – it may be active negligence, collateral
negligence, comparative negligence, concurrent negligence, continued negligence, criminal
negligence, gross negligence, hazardous negligence, active and passive negligence, willful or
reckless negligence, or negligence per se.

Negligence per se
While deliberating on the absence of basic qualifications of a homeopathic doctor to practice
allopathy in Poonam Verma vs. Ashwin Patel and Ors. (1996), the Supreme Court held that a
person who does not have knowledge of a particular system of medicine but practices in that
system is a quack. Where a person is guilty of negligence per se, no further proof is needed
INGREDIENTS OF MEDICAL NEGLIGENCE
1. Doctor’s duty to attend the patient with care
Medicine is such a profession where a practitioner is supposed to have requisite knowledge and
skill needed for the purpose and has a duty to exercise reasonable duty of care while dealing with
the patient. The standard of the care depends upon the nature of the profession. A surgeon or
anaesthetist will be determined by the standard of average practitioner in that field while in case of
specialists, a higher skill is needed.

If the doctor or a specialist doesn’t attend a patient admitted in emergency or under his surveillance
and the patient dies or becomes victim of consequences which could have been avoided with due
care from the doctor, the doctor can be held liable under medical negligence.
This was held in Sishir Rajan Saha v. The state of Tripura that if a doctor did not pay enough
attention to the patients in government hospitals as a result of which the patient suffers, the doctor
can be held liable to pay compensation to the patient.
A doctor or a medical practitioner when attends to his patients, owes him the following duties of
care:
• A duty of care in deciding whether to undertake the case
• A duty of care in deciding what treatment to give
• A duty of care in the administration of the treatment

2. Doctor acting in a negligent manner
It is well accepted that in the cases of gross medical negligence the principle of res ipso loquitur is
to be applied. The principle of res ipso loquitur is said to be essentially an evidential principle and
the said principle is intended to assist the claimant. Res Ipso loquitur means things speaks for
itself; while deciding the liability of the doctor it has to be well established that the negligence
pointed out should be a breach in due care which an ordinary practitioner would have been able to
keep.
Latin for “the thing speaks for itself,” a doctrine of law that one is presumed to be negligent if
he/she/it had exclusive control of whatever caused the injury even though there is no specific
evidence of an act of negligence, and without negligence the accident would not have happened. A
doctor is not an insurer for the patient, inability to cure the patient would not amount to
negligence but carelessness resulting in adverse condition of the patient would.

In Gian chand v. Vinod kumar Sharma
it was held that shifting of the patient from one ward to another in spite of requirement of instant
treatment to be given to the patient resulting in damage to the patient’s heath then the doctor or
administrator of the hospital shall be held liable under negligence.
In Jagdish Ram v. State of H.P.
it was held that before performing any surgery the chart revealing information about the amount
of anaesthesia ad allergies of the patient should be mentioned so that an anaesthetist can provide
ample amount of medicines to the patient. The doctor in above case failed to do so as a result of
the overdose of anaesthesia the patient died and the doctor was held liable for the same.

3. Liability
The liability of the person committing the wrong can be of three types depending on the harm
or the injury suffered by the injured person they are:
1.Civil Liability– Civil liability usually includes the claim for damages suffered in the form of
compensation. If there is any breach of duty of care while operating or while the patient is
under the supervision of the hospital or the medical professional they are held to be vicariously
liable for such wrong committed. And are liable to pay damages in the form of compensation.
At times the senior doctors are even held vicariously liable for the wrongs committed by the
junior doctors.
2.Criminal Liability- There may be an occasion when the patient has died after the treatment
and criminal case is filed under Section 304A of the Indian Penal Code for allegedly causing
death by rash or negligent act. According to S. 304A of the IPC, whoever causes the death of
any person by a rash or negligent act not amounting to culpable homicide shall be punished by
imprisonment for up to two years, or by fine, or both.

UNIT-3 (B)
ROLE OF CONSENT IN MEDICAL
PRACTICE

104
Role of Consent in Medical Practice
Consent is perhaps the only principle that runs through all aspects of health
care provisions today.
It also represents the legal and ethical expression of the basic right to have
one's autonomy and self-determination. If a medical practitioner attempts to
treat a person without valid consent, then he will be liable under both tort and
criminal law.
Tort is a civil wrong for which the aggrieved party may seek compensation
from the wrong doer. The consequences would be payment of compensation
(in civil) and imprisonment (in criminal). To commence, the patient may sue
the medical practitioner in tort for trespass to person.

105
Types of Consent
Implied Consent
Not written, that is, its existence is not expressly asserted, but
nonetheless, it is legally effective. It is the most common type of consent
in both general and hospital practice. It implies consent to medical
examination in a general sense but not to procedures more complex than
inspection, palpation and auscultation.
Implied consent is apparent when a patient comes to hospital or doctor’s
clinic for treatment, it is also apparent in a case of comatose patient
requiring immediate treatment or a mentally incompetent patient
requiring treatment when legal guardian is not available.

106
Expressed Consent
The terms of which are stated in distinct and explicit language. It may be in
oral or written form.
Written should be preferred as it has the advantage of easy proof and
permanent form.
Oral consent is also equally valid if properly witnessed. Oral consent
should be taken in the presence of a disinterested party like any literate
paramedical staff e.g. nurse, pharmacist

107
Informed Consent
Doctor should inform the patient regarding:
- Diagnosis
- Nature of treatment or procedure
- Risks involved
- Prospects of success
- Prognosis if the procedure is not performed
-Alternative methods of treatment.
Informed consent was practically non-existent till the time Consumer
protection act came into existence. This is seen as more of a legal
requirement than the ethical moral obligation on part of the doctor
towards his patient.

108
Duty on the part of a hospital and doctor to obtain prior consent of a
patient
There exists a duty to obtain prior consent (with respect to living patients)
for the purpose of diagnosis, treatment, organ transplant, research purposes,
disclosure of medical records, and teaching and medico-legal purposes.
With respect to the dead in regard to pathological post mortem, medico-
legal post mortem, organ transplant (for legal heirs), and for disclosure of
medical record, it is important that informed consent of the patient’s
relatives should to be obtained.
Consent can be given in the following ways:
Express Consent: It may be oral or in writing. Though both these
categories of consents are of equal value, written consent can be considered
as superior because of its evidential value.
Implied Consent: Implied consent may be implied by patient's conduct.

109
Tacit Consent: Tacit consent means implied consent understood without
being stated.
Surrogate consent: This consent is given by family members. Generally,
courts have held that consent of family members with the written approval
of 2 physicians sufficiently protects a patient's interest.
Advance consent, proxy consent, and presumed consent are also used.
While the term advance consent is the consent given by patient in
advance, proxy consent indicates consent given by an authorized person.
As mentioned earlier, informed consent obtained after explaining all
possible risks and side effects is superior to all other forms of consent.

110
The importance of obtaining informed consent
In the case of Samira Kohli vs. Dr. Prabha Manchanda and Ors.
(2008) the apex court held that consent given for diagnostic and operative
laparoscopy and “laporotomy if needed” does not amount to consent for a
total hysterectomy with bilateral salpingo opherectomy. The appellant was
neither a minor nor mentally challenged or incapacitated. As the patient
was a competent adult, there was no question of someone else giving
consent on her behalf. The appellant was temporarily unconscious under
anesthesia, and as there was no emergency.
The respondent should have waited until the appellant regained
consciousness and gave proper consent. The question of taking the
patient's mother's consent does not arise in the absence of emergency.
Consent given by her mother is not a valid or real consent.

111
The question was not about the correctness of the decision to remove
reproductive organs but failure to obtain consent for removal of the
reproductive organs as performance of surgery without taking consent
amounts to an unauthorized invasion and interference with the appellant's
body. The respondent was denied the entire fee charged for the surgery
and was directed to pay Rs. 25000/- as compensation for the
unauthorized surgery.

112
Often medical practitioners ask for precise prescriptions for the situations
when written consent is needed. It is interesting to note that what law
demands is mere consent and not written consent and does not prescribe
such requirement on a mandatory basis. In fact, the medical practice itself
determines the need for written consent.
Ideally, where the patient is subjected to anesthesia (either local or general)
or where the patient is subjected to severe pain during administration of the
treatment, a written consent would be helpful. There is no mandate that a
doctor should always obtain written consent and failure of which would
hold him liable. However, if there is written consent, the medical
practitioner would have greater ease in proving consent in case of
litigation.

113
To standardize the practice, the Medical Council of India (MCI) has laid
down guidelines that are issued as regulations in which consent is required to
be taken in writing before performing an operation.
The MCI guidelines are applicable to operations and do not cover other
treatments. For other treatments, the following may be noted as general
guidelines:
1.For routine types of treatment, implied consent would suffice
2.For detailed types of treatment, ideally express oral consent may be needed
3.For complex types of treatment, written express consent is required

114
The principle of autonomy is enshrined within Art. 21 of the Indian
Constitution, which deals with the right to life and personal liberty. The
expression personal liberty under Art. 21 is of the widest amplitude and
covers a wide variety of rights, including the right to live with human
dignity and all that goes along with it, and any act which damages,
injures, or interferes with the use of any limb or faculty of a person,
either permanently or temporarily.
However, the common law application of consent is not fully developed
in India, although the Indian courts have often referred to these
principles. In such situations, obviously one has to refer to the principles
of the Indian Contract Act and the Indian Penal Code. The relationship
between a medical professional and his patient is a contract by parties
competent to contract giving rise to contractual obligations.

115
Parties are generally competent (in accordance with the Indian Majority Act)
(i) if they have attained the age of 18,
(ii) are of sound mind, and
(iii) are not disqualified by any law to which they are subject to.
(iv) Furthermore, there is a stipulation in the contract law stating that consent
of any party (in our case it is the patient) that is obtained by coercion,
undue-influence, mistake, misrepresentation or fraud, will render the
agreement invalid.

116
Recently, the apex court gave an impacting judgment in the area. Wherein
the court observed that “where a surgeon is consulted by a patient and
consent of the patient is taken for diagnostic procedure/surgery, such consent
can't be considered as authorization or permission to perform therapeutic
surgery either conservative or radical (except in a life-threatening emergent
situation)”. For the fist time in India, the court ruled that however broad
consent might be for diagnostic procedure, it can not be used for therapeutic
surgery.
Furthermore, the court observed that “where the consent by the patient is for
a particular operative surgery it can't be treated as consent for an
unauthorized additional procedure involving removal of an organ only on the
ground that it is beneficial to the patient or is likely to prevent some danger
developing in the future, where there is no imminent danger to the life or
health of the patient”. This proposition puts fetter upon the role of a “paternal
doctor” in the Indian scenario. In one case, a 44-year-old unmarried female
consulted her doctor and was advised to undergo a laparoscopy. A few
consent forms were taken from her of which one was for admission and
another one was for the surgery.

117
The relevant one among such consent forms gave the doctor an allowance to
carry out a “diagnostic and operative laparoscopy” and there was an
additional endorsement that a “laparotomy may be needed”. When the patient
was in the operation theater (and was unconscious), another proxy consent
was taken from her attending mother for a hysterectomy. Her uterus, ovaries,
and fallopian tubes were removed. Subsequently, when an action was brought,
it was held that the operation was conducted without real consent and the
doctors were held liable.
This decision is of very far reaching consequences, pushing the development
of consent law to new heights. It is contended that it is not only informed
consent which is imperative now, but the same shall be “prior informed
consent” unless there is imminent threat to the patient's life. In addition, this
decision curtails the scope of proxy consent from the person having parental
authority or an attendant.

UNIT-3 (C)
ERROR OF JUDGMENT AND GROSS NEGLIGENCE
&
WRONGFUL DIAGNOSIS AND NEGLIGENT DIAGNOSIS

119
Negligent Diagnosis
Doctors act negligently when they fail to provide the quality of care that other
reasonably competent doctors would have provided under similar circumstances. In
medical malpractice lawsuits, patients have the burden of proving what quality of care
other reasonably competent doctors would have provided in similar circumstances.
This usually requires expert testimony.
The patient (usually through a medical malpractice attorney) hires a doctor that has
experience with the type of medical problem at issue in the case. The doctor provides
an opinion regarding what a reasonably competent doctor would have done under the
circumstances.
Generally, when an improper diagnosis is involved, the expert will opine about the
"differential diagnosis" that a reasonably competent doctor would have conducted.

120
To do this, a doctor makes a list of all of the possible medical problems that could be
causing the patient’s symptoms. The doctor then conducts tests on the patient, ruling out
various possibilities until a definitive diagnosis can be determined.
Doctors might fail to achieve the standard of care in any of the following ways when it
comes to a diagnosis:
- A doctor might fail to include an important potential medical problem on the initial
differential diagnosis list.
-A doctor might improperly conduct or interpret a test that could cause a mistake in
narrowing down the possibilities.
.

121
Wrong Diagnosis or Misdiagnosis
Wrongful or misdiagnosis cases involve a mistaken identification of a medical condition
and are different from failure to diagnose claims. In misdiagnosis cases, the physician has
arrived at an improper medical diagnosis, as opposed to not arriving at a diagnosis at all.
Negligent diagnoses can result in serious heath conditions and sometimes death.
Misdiagnosis claims can also include delayed diagnosis claims, which occurs when the
patient suffers more serious health conditions due to the doctor’s inability to timely
diagnosis the patient’s condition.
Doctors are expected to render a definite diagnosis only after all necessary medical tests
have been conducted. There are a number of illnesses that are commonly diagnosed,
including cancer, heart disease, stroke, blood clots, meningitis and diabetes.

122
The most common misdiagnosis claims are a result of a false position, in which the
doctor diagnoses the patient with a disease that is non-existent; false negative, in
which the doctor fails to diagnose a disease or condition; and, equivocal results, in
which the doctor’s interpretation is not without a definitive diagnosis.
Healthcare providers can avoid a wrongful or misdiagnosis claim by implementing due
diligence and care standards. A physician is expected to correctly administer tests, read
and interpret lab results, consult other doctors when necessary and request further
exams to diagnose conditions

Diagnosis
It is an essential task performed by physicians. To treat a patient of an illness, the first
step of treatment is his diagnosis. A diagnosis is the identification of a condition in the
form of a disease or disorder. It is an examination conducted on the body of the patient
to determine probable causes of his condition.
Misdiagnosis is the primary reason for filing a medical negligence claim. The World
Health Organization (WHO) recently prioritized patient safety areas and included
diagnostic errors as a high-priority problem.
A misdiagnosis may relate to a wrong diagnosis, delayed diagnosis or failure of
diagnosis.
When a doctor's diagnosis leads to an error in treating the illness of the patient, which
results in worsening the situation of the patient, shall amount to medical negligence.
However, not all wrong/delayed diagnosis shall have a basis for a medical negligence
claim.

A patient filing a case for medical negligence based on the misdiagnosis of the doctor has
to establish the following:
1.Doctor-patient relationship
2.Failure of providing standard care in conducting a diagnosis on the patient. (Review to
be based on expert opinion)
3.Misdiagnosis causing an injury
4.The patient must submit proof that the doctor did not correctly diagnose him and that a
competent doctor a doctor of the similar speciality would have diagnosed correctly.
Generally, in case of a death, it is challenging to prove misdiagnosis in India since there
is no proper mechanism to report it except under medical negligence.

Also, to prove misdiagnosis, one would have to request for an autopsy, which is an
expensive affair, and not everyone can afford it. Even if the family of the patient inclines
towards requesting an autopsy, it is difficult for a layman who does not understand
medical terms, to take a wise call.
There are several reasons due to which misdiagnosis takes place. It is for the court to
decide on the merits of each case individually whether it would be regarded as a defence
available to the doctor, or would the doctor be held liable for medical negligence for
misdiagnosis.
Different reasons/causes of misdiagnosis:
 The diagnosis was based on erroneous lab results conducted by a non-interested third
party
 A piece of flawed equipment is used for conducting diagnosis
 A technician who wrongly administers the test

 A secondary who misreads the scan
 Results of tests swapped between patients
 The limited-time associated with each patient
For the above instances, if the concerned or diagnosing doctor is not liable, some other
party will be liable.
For example- the doctor is not responsible in case of 'results of tests being swapped' since
it is the hospital staff who is involved in giving the doctors the test results.

In this recent case the Supreme Court has enumerated the factors to be taken into
consideration while establishing the liability of concerned doctor or hospital in cases of
medical negligence.
Vinod Jain v. Santokba Durlabhji Memorial Hospital & Anr.
In the case, the Appellant has challenged in NCDRC (National Consumer Dispute
Redressal Commission, whereby Commission exonerated the respondents of any medical
negligence. Here it would be relevant to mention that the Appellant was aggrieved by the
demise of his wife which resulted in the present legal proceedings.
The Appellant in the case initiated legal proceedings under the belief that the respondents
were guilty of medical negligence in the manner in which medical treatment was
administered to his wife and her subsequent discharge from respondent hospital.
The Supreme Court in view of the facts and circumstances of the case and principles
governing medical negligence law in the case of Kusum Sharma & ors. v. Batra Hospital
& Medical Research Centre & ors. upheld NCDRC’s order and made the following
observations in the case:

•That a fundamental aspect, which has to be kept in mind is that a doctor cannot be said
to be negligent if he is acting in accordance with a practice accepted as proper by a
reasonable body of medical men skilled in that particular art, merely because there is a
body of such opinion that takes a contrary view.
•That in cases of medical negligence, where a special skill or competence is attributed
to a doctor, a doctor need not possess the highest expert skill, at the risk of being
found negligent, and it would suffice if he exercises the ordinary skill of an ordinary
competent man exercising that particular art.
•That a physician would not assure a full recovery in every case, and the only assurance
given, by implication, is that he possesses the requisite skills in the branch of the
profession, and while undertaking the performance of his task, he would exercise his
skills with reasonable competence.

•When does Liability of Doctor come into play?
A liability would only come, if
(a) either the person (doctor) did not possess the requisite skills which he professed to
have possessed; or
(b) he did not exercise, with reasonable competence in a given case, the skill which he
did possess.
While applying the above stated principles governing the law of medical negligence to
the facts of the present case, In view of the aforesaid, the Supreme Court noted that ththe
Court noted that the respondent Hospital promptly attended the appellant’s wife
and carried out medical procedures based on professional and medical assessment
by respondent Doctor depending upon the medical condition of the patient, and
could not constitute medical negligence.
ough we have sympathy for the appellant, but sympathy cannot translate into a legal
remedy.
It was opined that the case at hand could be termed as a case of wrong diagnosis
and certainly not one of medical negligence.

Wrongful or misdiagnosis cases involve a mistaken identification of a medical condition
and are different from failure to diagnose claims. In misdiagnosis cases, the physician
has arrived at an improper medical diagnosis, as opposed to not arriving at a diagnosis at
all.
Negligent diagnoses can result in serious heath conditions and sometimes death.
Misdiagnosis claims can also include delayed diagnosis claims, which occurs when the
patient suffers more serious health conditions due to the doctor’s inability to timely
diagnosis the patient’s condition.
In order to successfully litigate a wrongful or misdiagnosis claim, an experienced personal
injury lawyer must prove that the doctor failed to provide an adequate standard of care and
had the doctor properly diagnosed the patient’s condition, the patient would have received
proper medical treatment and avoided further injury.
Doctors are expected to render a definite diagnosis only after all necessary medical tests
have been conducted. There are a number of illnesses that are commonly diagnosed,
including cancer, heart disease, stroke, blood clots, meningitis and diabetes.

The most common misdiagnosis claims are a result of a false position, in which the doctor
diagnoses the patient with a disease that is non-existent; false negative, in which the doctor
fails to diagnose a disease or condition; and, equivocal results, in which the doctor’s
interpretation is not without a definitive diagnosis.
Healthcare providers can avoid a wrongful or misdiagnosis claim by implementing due
diligence and care standards. A physician is expected to correctly administer tests, read and
interpret lab results, consult other doctors when necessary and request further exams to
diagnose conditions.

Some of the most common diagnostic errors that patients report include:
•Failure to review medical history. Unfortunately, this is an extremely common
diagnostic error. When a doctor does not evaluate a patient’s medical records, they will
not have a complete picture of the person’s health, history, allergies, and potential
complications.
•Poor patient communication. When a doctor fails to ask the patient thorough questions
or when a patient is unable to communicate their symptoms adequately, misdiagnosis is
more likely to occur. This breakdown in communication is extremely dangerous, so
doctors must make sure to ask the right questions to fully understand what the patient is
experiencing.
•Errors in judgment. Often, diagnostic errors can be attributed to poor decision-making
on the part of the physician. If a doctor ignores a patient’s symptoms or doesn’t conduct
appropriate tests, they may put their patient’s health at serious risk.
•Failure to act on test results. When test results indicate that a patient has a medical
condition, technicians must report the results to the physician. The physician must then
take the appropriate next steps to address the issue. If there is a breakdown in the
procedure, a serious condition may not be properly diagnosed and treated.

133
Error in Judgment
Within each field of medicine there are general rules and guidelines to follow as care is
administered to a patient. Although these guidelines are designed to provide a relatively
uniform level of care and treatment based on current research and best practices,
trained medical professionals must often rely on their own judgment when deciding
both the type of treatment to administer and when to administer it.
Many unique factors present may be weighed by the practitioner as he or she considers the
appropriate course of action. If the medical practitioner ultimately errs in deciding when
and how to act and the patient suffers serious harm as a result, the question becomes:
would another reasonably competent practitioner, possessing the same information
and working under the same circumstances, have come to the same conclusion or
made a similar error?

The error of judgment can be of two types:
•An error of judgment – In such cases, it has been recognized that it doesn’t amount to a
breach of duty. Merely because a doctor’s decision turned out to be wrong, we cannot
make him liable for medical negligence.
•The error of judgment due to negligence – If all the factors were considered before
coming to a decision then it would be called an error of judgment due to negligence. This
amounts to a breach of duty.

In a significant ruling, the National Consumer Disputes Redressal Commission has made
a distinction between medical negligence and “error of judgment” while rejecting a
complaint against a private hospital of Delhi, which was accused of failing to make a
correct diagnosis of cancer in a patient. The patient later died during treatment in
another hospital.
Complainant Kamani Sharma had charged a doctor in Pamposh Medical Care Centre at
Pamposh Enclave here with diagnosing her husband with tuberculosis Rajinder Sharma in
December 1999, while he was actually suffering from cancer.
The patient later approached LNJP Hospital, Rajiv Gandhi Cancer Hospital and Sir
Ganga Ram Hospital, where he was diagnosed as an advanced case of lung cancer and
metastasis.
The patient underwent biopsy at Maulana Azad Medical College and took treatment at Sir
Ganga Ram Hospital. In spite of best efforts, he died on November 19, 2000.
Ms. Sharma alleged that it was the wrong diagnosis of tuberculosis initially made at
Pamposh Medical Care Centre that led to the critical condition of her husband and his
death within a short span of 11 months. She sought a compensation of Rs.65 lakh for
medical negligence and deficiency in service.

A Bench of the Commission, comprising Justice J.M. Malik and S.M. Kantikar, dismissed
the complaint last week, while holding that it was a case of “error of judgment” rather than
medical negligence. The Bench said Rajinder did not turn up at the hospital for eight
months and its doctor never treated him.
The Commission noted that the patient was a heavy smoker and drug addict and had
earlier received anti-tubercular therapy (ATT) for testicular TB. There was a
possibility of healed TB focus or sarcoidosis. “We are of the considered view that it was an
error of judgment that the doctor failed to diagnose cancer at the initial examination of the
patient.”
Applying the principle of “loss of chance” to the instant case, the Bench held that the
failure to diagnose would not matter so much as the patient was suffering from frank
metastasis in brain and liver. There were less than 50 per cent chances of survival, it said
and absolved the doctor of the charge of negligence.
The Commission rejected the complaint and said the advice given at Pamposh Medical
Care Centre for investigations and biopsy of the lesion for proper diagnosis was not
followed. “After the lapse of eight months, the patient went to LNJP Hospital, which
became fatal for him...It was negligence of the patient, for which the doctor is not liable.”

137
Gross Negligence
Negligence, in very general terms, is when someone does something wrong and causes
harm to someone else. Within the context of medical malpractice, "gross negligence" refers
to conduct so reckless or mistaken as to be virtually obvious to a person with no
medical training.
Examples include a surgeon amputating the wrong limb or leaving a surgical
instrument inside a body cavity of the patient.
Some states allow medical malpractice lawsuits grounded in gross negligence without the
need for expert testimony, based on a legal doctrine called res ipsa loquitur, meaning "the
thing speaks for itself."
So if a surgeon fails to obtain informed consent prior to a procedure, and the procedure
results in injuries, a patient may sue for gross negligence, perhaps without the need for
expert testimony (since the negligence would be obvious to a layman).

Gross negligence is the "lack of slight diligence or care" or "a conscious, voluntary act
or omission in reckless disregard of a legal duty and of the consequences to another
party." In some jurisdictions a person injured as a result of gross negligence may be able to
recover punitive damages from the person who caused the injury or loss.
Negligence is the opposite of diligence, or being careful. The standard of ordinary
negligence is what conduct deviates from the proverbial "reasonable person". By
extension, if somebody has been grossly negligent, that means they have fallen so far
below the ordinary standard of care that one can expect, to warrant the label of being
"gross". Gross negligence may thus be described as reflecting "the want of even slight or
scant care", falling below the level of care that even a careless person would be expected to
follow. While some jurisdictions equate the culpability of gross negligence with that
of recklessness, most differentiate it from simple negligence in its degree.
Negligence is an action that causes injury unless preventative measures are put in place.
The standard of ordinary negligence is what conduct one expects from the proverbial
"reasonable person". If the accused is a professional, such as a doctor, the "reasonable
person" is then defined as a doctor of average intelligence in the same field. To put it
another way, negligence is a failure to exercise reasonable care.

Gross negligence is reckless and willful misconduct causing bodily injury. With gross
negligence, the standard of care is ignored to such an extent that the action is almost
intentional. Within the context of medical malpractice, gross negligence is an action that is
obviously an error even to someone without any medical training. A Supreme Court judge
pointed out the extent of gross negligence versus negligence many years ago by saying, "Even
a dog knows the difference between being tripped over and being kicked." For someone to be
accused and found guilty of gross negligence, it must be proven that they had a conscious and
voluntary disregard for your reasonable care, and caused foreseeable grave injury or harm to
you.
Some examples of medical malpractice gross negligence:
•Giving a patient a drug that their chart says they are allergic to
•Amputating the wrong limb
•Leaving a surgical instrument inside a body cavity
Not every situation is so black and white. Determining whether an injury or death is actionable,
and then whether it is an act of negligence or gross negligence can be confusing.

WHAT EXACTLY IS GROSS NEGLIGENCE?
Gross negligence is the extreme indifference to or reckless disregard for the safety of others.
Gross negligence is more than simple carelessness or failure to act. It is willful behavior
done with extreme disregard for the health and safety of others. It is conduct likely to cause
foreseeable harm.
Examples of gross negligence include:
•A driver speeding in an area with heavy pedestrian traffic.
•A doctor prescribing a patient a drug that their medical records clearly list that they are
allergic to.
•Nursing home staff failing to provide water or food to a resident for several days.
Because deliberate actions or extreme carelessness caused the injury or damage to property,
the amount of damages awarded to the injured party may be increased and may include
punitive damages intended to punish the wrongdoer.

BOLAM TEST & MEDICAL PROFESSION
The test for determining the negligence of a medical professional was given by
McNair J. in Bolam’s case to be the standard of the ordinary skilled man exercising
and professing to have that skill. Since 1957, the Bolam test has been the benchmark
by which professional negligence has been assessed. It is based on the direction to the
jury of a high court judge, McNair J, in Bolam v Friern Hospital Management
Committee.
The claimant was undergoing electro convulsive therapy as treatment for his mental
illness. The doctor did not give any relaxant drugs and the claimant suffered a serious
fracture. There was divided opinion amongst professionals as to whether relaxant
drugs should be given. If they are given there is a very small risk of death, if they are
not given there is a small risk of fractures. The claimant argued that the doctor was in
breach of duty by not using the relaxant drug.

The Court Held that doctor was not in breach of duty. The House of Lords formulated
the Bolam test: It is important to remember that the "Bolam test" is just one stage in the
fourfold test to determine negligence. - First, it must be established that there is a duty
of care (between a doctor and patient this can’t be taken for granted). - Second, it must
be shown that the duty of care has been breached. This is where the Bolam test is
relevant, because falling below the standard of a responsible body of medical men
means that person will be considered negligent. Thirdly it must be shown that there
was a causal link between the breach of duty and harm. - And fourth, it must be shown
that the harm was not too remote.
Because of the nature of the relationship between a medical practitioner and a patient, it
is reasonable for the patient to rely on the advice given by the practitioner.
Thus, Bolam test applies to all the acts and omissions constituting diagnosis and
consequential treatment, and applies to all advisory activities involving the
communication of diagnosis and prognosis, giving of advice on both therapeutic and
non-therapeutic options for treatment, and disclosure of relevant information to obtain
informed consent

Test Used To Determine The Liability
Indian courts have conformed to the test aid down in the Bolam case and have
adhered to the same in all medical negligence litigation. It was a test whereby the
defendants conduct is tested against the normal usage of his professional calling. This
test is one that is applied to all kinds of negligence and not only medical negligence.
There are three criteria’s that have to be fulfilled for the test to show a positive result,
they are-
 a. It must be proved that the there is a usual and normal practice
 b. It must be proved that the defender has not adopted that practice
 c. It must be established that the course the doctor adopted is one which no
professional man of ordinary skill would have taken if he had been acting with
ordinary care.[this is the most important criteria of the test out of the other three.]

Indian Cases Where Bolam Test Being Followed:
In India, Bolam test has broadly been accepted as the general rule.
In Achutrao Haribhau Khodwa vs. State of Maharastra, this Court held :
"The skill of medical practitioners differs from doctor to doctor. The nature of the profession
is such that there may be more than one course of treatment which may be advisable for
treating a patient. Courts would indeed be slow in attributing negligence on the part of a
doctor if he has performed his duties to the best of his ability and with due care and caution.
Medical opinion may differ with regard to the course of action to be taken by a doctor treating
a patient, but as long as a doctor acts in a manner which is acceptable to the medical
profession and the Court finds that he has attended on the patient with due care skill and
diligence and if the patient still does not survive or suffers a permanent ailment, it would be
difficult to hold the doctor to be guilty of negligence.
In cases where the doctors act carelessly and in a manner which is not expected of a medical
practitioner, then in such a case an action in torts would be maintainable.“

In Poonam Verma v. Ashwin Patel and Ors., a doctor registered as medical practitioner
and entitled to practice in Homoeopathy only, prescribed an allopathic medicine to the
patient. The patient died. The doctor was held to be negligent and liable to compensate the
wife of the deceased for the death of her husband on the ground that the doctor who was
entitled to practice in homoeopathy only, was under a statutory duty not to enter the field
of any other system of medicine and since he trespassed into a prohibited field and
prescribed the allopathic medicine to the patient causing the death, his conduct amounted
to negligence per se actionable in civil law.
In State of Harvana and Ors. v. Smt. Santra, also Bolam’s test has been approved. This
case too refers to liability for compensation under civil law for failure of sterilization
operation performed by a surgeon.
The Court in Dr. Suresh Gupta Vs. Government of NCT of Delhi held that the test for
determining medical negligence as laid down in Bolam's case holds good in its
applicability in India.

The doctrinal shift
The House of Lords ruling in Bolitho signalled a shift away from Bolam. It was no longer
enough for the standard of care proclaimed by a defendant doctor to be endorsed by
a responsible body of peers. In minority judgment comments in Bolitho, it was
emphasised that the word “responsible” in the traditional formulation of the Bolam test
meant that responsible practice is that which withstands the scrutiny of “logical analysis”
from a judicial perspective.
The clinical practice, however prevalent within the medical profession, would perhaps be
unlikely to withstand logical scrutiny if that practice is contrary to a clear consensus
emerging from the evidence base. In his opinion delivered in the Bolitho case, Lord
Browne-Wilkinson indicated that experts should direct their minds to the question of
comparative risks and benefits in order to reach a defensible conclusion on the matter
in question. A clinical conclusion which does not have risk analysis at its heart is not
likely to be deemed a responsible conclusion.

Bolitho has called attention to this issue and will therefore take effect not only in
determining the logical basis of the course of action offered by the defendant, but also
by engaging more forcefully in assessing risk analysis. Properly considered clinical
guidelines will similarly weigh the risks and benefits. This consonance with doctrinal
changes may be a further factor for evidence-based guidelines to play a greater part in
medical litigation proceedings.
Bolitho in India
The Bolitho test has been mentioned in the Indian Supreme Court on only two occasions.
It was stated in Samira Kohli v Prabha, where the court clearly pointed out that “A
beginning has been made in Bolitho v City and Hackney and Pearce v United Bristol
Healthcare. We have however, consciously preferred the ‘real consent’ concept evolved in
Bolam."
Similar was the case in Binitha v Lakshmi Hospital where the court did not look into the
test at all.

UNIT-4 (A)
NEGLIGENCE AS A TORT

DEFINITION:
• WINFIELD AND JOLOWICZ: According to Winfield and Jolowicz- Negligence is the breach of a
legal duty to take care which results in damage, undesired by the defendant to the plaintiff.
• In Blyth v. Birmingham Water Works Co, (1856) LR 11 Exch. 781; ALDERSON, B. defined negligence
as, negligence is the omission to do something which a reasonable man…….. would do, or doing
something which a prudent or reasonable man would not do.
• In Lochgelly Iron & Coal Co. v. Mc Mullan, 1934 AC 1; LORD WRIGHT said, negligence means
more than headless or careless conduct, whether in commission or omission; it properly connotes the
complex concept of duty, breach and damage thereby suffered by the person to whom the duty was
owing.

ESSENTIALS OF NEGLIGENCE
• In an action for negligence, the plaintiff has to prove the following essentials:
1. DUTY TO TAKE CARE: One of the essential conditions of liability for negligence is that the defendant
owed a legal duty towards the plaintiff. The following case laws will throw some light upon this essential
element.
• In Grant v. Australian Knitting Mills Ltd., 1935 AC 85; the plaintiff purchased two sets of woolen
underwear from a retailer and contacted a skin disease by wearing an underwear. The woolen underwear
contained an excess of sulphates which the manufacturers negligently failed to remove while washing them.
The manufacturers were held liable as they failed to perform their duty to take care.
2. DUTY TO WHOM: Donoghue v. Stevenson, 1932 AC 562 carried the idea further and expanded the
scope of duty saying that the duty so raised extends to your neighbour. Explaining so as to who is my
neighbour LORD ATKIN said that the answer must be “the persons who are so closely and directly affected
by my act that I ought reasonably to have them in contemplation as being so affected when I am directing
my mind to the acts or omissions which are called in question”.

• 3. DUTY MUST BE TOWARDS THE PLAINTIFF- It is not sufficient that the defendant owed a duty to
take care. It must also be established that the defendant owed a duty of care towards the plaintiff.
• In Bourhill v. Young, 1943 AC 92; the plaintiff, a fishwife, alighted from a tram car. While she was being
helped in putting her basket on her back, a motor-cyclist after passing the tram collided with a motor car at
the distance of 15 yards on the other side of the tram and died instantly. The plaintiff could see neither the
deceased nor the accident as the tram was standing between her and the place of accident. She had simply
heard about the collision and after the dead body had been removed she went to the place and saw blood left
on the road. Consequently, she suffered a nervous shock and gave birth to a still-born child of 8 months. She
sued the representatives of the deceased motor-cyclist. It was held that the deceased had no duty of care
towards the plaintiff and hence she could not claim damages.
4. BREACH OF DUTY TO TAKE CARE: Yet another essential condition for the liability in negligence is
that the plaintiff must prove that the defendant committed a breach of duty to take care or he failed to
perform that duty.
• In Municipal Corporation of Delhi v. Subhagwanti, AIR 1966 SC 1750; a clock-tower in the heart of the
Chandni Chowk, Delhi collapsed causing the death of a number of persons. The structure was 80 years old
whereas its normal life was 40-45 years. The Municipal Corporation of Dellhi having the control of the
structure failed to take care and was therefore, liable.
•
·

• 5. CONSEQUENT DAMAGE OR CONSEQUENTIAL HARM TO THE PLAINTIFF: The last
essential requisite for the tort of negligence is that the damage caused to the plaintiff was the result of
the breach of the duty. The harm may fall into following classes:-
• physical harm, i.e. harm to body;
• harm to reputation;
• harm to property, i.e. land and buildings and rights and interests pertaining thereto, and his goods;
• economic loss; and
• mental harm or nervous shock.
• In Achutrao Haribhau Khodwa v. State of Maharashtra (1996) 2 SCC 634; a cotton mop was left
inside the body by the negligence of the doctor. The doctor was held liable.

• DEFENCES FOR NEGLIGENCE:
• In an action for negligence following defences are available:-
• 1. CONTRIBUTORY NEGLIGENCE: It was the Common law rule that anyone who by his own negligence
contributed to the injury of which he complains cannot maintain an action against another in respect of it. Because,
he will be considered in law to be author of his wrong.
• Butterfield v. Forrester, (1809) 11 East 60; the defendant had put a pole across a public thoroughfare in Durby,
which he had no right to do. The plaintiff was riding that way at 8’O clock in the evening in August, when dusk
was coming on, but the obstruction was still visible from a distance of 100 yards, he was riding violently, came
against the pole and fell with the horse. It was held that the plaintiff could not claim damages as he was also
negligent.
• 2. ACT OF GOD OR VIS MAJOR: It is such a direct, violent, sudden and irresistible act of nature as could not,
by any amount of human foresight have been foreseen or if foreseen, could not by any amount of human care and
skill, have been resisted. Such as, storm, extraordinary fall of rain, extraordinary high tide, earth quake etc.

• In Nichols v. Marsland, (1875) LR 10 Ex.255; the defendant had a series of artificial lakes on his land in
the construction or maintenance of which there had been no negligence. Owing to an exceptional heavy
rain, some of the reservoirs burst and carried away four country bridges. It wa held that, the defendant was
not liable as the water escaped by the act of God.
• 3. INEVITABLE ACCIDENT: Inevitable accident also works as a defence of negligence. An inevitable
accident is that which could not possibly, be prevented by the exercise of ordinary care, caution and skill.
it means accident physically unavoidable.
• In Brown v. Kendal, (1859) 6 Cussing 292; the plaintiff’s and defendant’s dogs were fighting, while the
defendant was trying to separate them, he accidentally hit the plaintiff in his eye who was standing nearby.
The injury to the plaintiff was held to be result of inevitable accident and the defendant was not liable.

• In Holmes v. Mather, (1875) LR 10 Ex.261, 267; a pair of horses were being driven by the groom of the
defendant on a public highway. On account of barking of a dog, the horses started running very fast. The
groom made best possible efforts to control them but failed. The horses knocked down the plaintiff who
was seriously injured, it was held to be an inevitable accident and the defendant was not liable.
• In Stanley v. Powell, (1891) 1 QB 86; the plaintiff and the defendant, who were members of a shooting
party, went for pheasant shooting. The defendant fired at a pheasant, but the shot from his gun glanced off
an oak tree and injured the plaintiff. It was held that the accident was an inevitable accident and the
defendant was not liable.

UNIT-4 (B)
NEGLIGENCE AS A CRIME

• The original Indian Penal Code, 1860 had no provision providing punishment for causing death by
negligence. Section 304-A was inserted in the Code in 1870 by the Indian Penal Code (Amendment) Act,
1870. This section did not create a new offence but was directed towards the offences which fall outside
the range of section 299 and 300 of the Indian Penal Code, 1860 (herein after referred as I.P.C.) when
neither intention nor knowledge to cause death is present.
• 304A. Causing death by negligence.--Whoever causes the death of any person by doing any rash or
negligent act not amounting to culpable homicide shall be punished with imprisonment of either
description for a term which may extend to two years, or with fine, or with both.
• The provisions of this section apply to cases where there is no intention to cause death, and no knowledge
that the act done in all probability would cause death. The Supreme Court has clarified that the section
304-A of I.P.C. is applicable only when death is caused due to rash and negligent act of the accused, which
is an essential element to attract said provision. But a colossal group of legal scholars have always
questioned whether this section provides punishment for manslaughter without intention or is it a 'license
to kill' in disguise of a rash and negligent act.

• This section deals with homicide by negligence and covers that class of offences, where death is caused
neither intentionally nor with the knowledge that the act of the offender is likely to cause death, but
because of the rash and negligent act of the offender. This clause limits itself to rash and negligent acts
which cause death, but falls short of culpable homicide of either description. When any of the two
elements, namely, intention or knowledge, is present this section has no application. Intentional shooting
at a fleeing person and hitting someone else to death comes under the section 300 read with section 301 of
the I.P.C. It is not a negligent act so as to come under section 304-A.
• Thus it's clear that the facts which must be proven in order to invoke the applicability of this section are
essentially three folds:
• (1) Death of a human being;
• (2) The accused caused the death;
• (3) The death was caused by the doing of a rash and negligent act, though it did not amount to culpable
homicide.

• Sections 80 and 88 of the Indian Penal Code contain defences for doctors accused of criminal liability.
• Under Section 80 (accident in doing a lawful act) nothing is an offence that is done by accident or
misfortune and without any criminal intention or knowledge in the doing of a lawful act in a lawful
manner by lawful means and with proper care and caution.
• According to Section 88, a person cannot be accused of an offence if she/ he performs an act in good faith
for the other’s benefit, does not intend to cause harm even if there is a risk, and the patient has explicitly or
implicitly given consent.

Burden of proof and chances of error
• The burden of proof of negligence, carelessness, or insufficiency generally lies with the complainant. The
law requires a higher standard of evidence than otherwise, to support an allegation of negligence against a
doctor.
• In cases of medical negligence the patient must establish her/ his claim against the doctor.
• In Calcutta Medical Research Institute vs Bimalesh Chatterjee (1991) it was held that the onus of
proving negligence and the resultant deficiency in service was clearly on the complainant.
• In Kanhaiya Kumar Singh vs Park Medicare & Research Centre (1991) , it was held that negligence has
to be established and cannot be presumed. Even after adopting all medical procedures as prescribed, a
qualified doctor may commit an error. The Supreme Court has held, in several decisions, that a doctor is
not liable for negligence or medical deficiency if some wrong is caused in her/ his treatment or in her/ his
diagnosis if she/ he has acted in accordance with the practice accepted as proper by a reasonable body of
medical professionals skilled in that particular art, though the result may be wrong.

• Before the case of Jacob Mathew vs State of Punjab, the Supreme Court of India delivered two different
opinions on doctors’ liability.
• In Mohanan vs Prabha G Nair and another (2004), it ruled that a doctor’s negligence could be
ascertained only by scanning the material and expert evidence that might be presented during a trial.
• Whereas, in Suresh Gupta’s case in August 2004 the standard of negligence that had to be proved to fix a
doctor’s or surgeons criminal liability was set at “gross negligence” or “recklessness.” The Supreme Court
distinguished between an error of judgement and culpable negligence. It held that criminal prosecution of
doctors without adequate medical opinion pointing to their guilt would do great disservice to the
community. A doctor cannot be tried for culpable or criminal negligence in all cases of medical mishaps or
misfortunes.
• A doctor may be liable in a civil case for negligence but mere carelessness or want of due attention and
skill cannot be described as so reckless or grossly negligent as to make her/ him criminally liable. The
courts held that this distinction was necessary so that the hazards of medical professionals being exposed
to civil liability may not unreasonably extend to criminal liability and expose them to the risk of
imprisonment for alleged criminal negligence.

• Hence the complaint against the doctor must show negligence or rashness of such a degree as to indicate a
mental state that can be described as totally apathetic towards the patient. Such gross negligence alone is
punishable.
• On September 9, 2004, Justices Arijit Pasayat and CK Thakker referred the question of medical negligence to
a larger Bench of the Supreme Court. They observed that words such as “gross”, “reckless”, “competence”,
and “indifference” did not occur anywhere in the definition of “negligence” under Section 304A of the Indian
Penal Code and hence they could not agree with the judgement delivered in the case of Dr Suresh Gupta.

• The issue was decided in the Supreme Court in the case of Jacob Mathew vs State of Punjab (2004). The
court directed the central government to frame guidelines to save doctors from unnecessary harassment and
undue pressure in performing their duties.
• It ruled that until the government framed such guidelines, the following guidelines would prevail:
• A private complaint of rashness or negligence against a doctor may not be entertained without prima facie
evidence in the form of a credible opinion of another competent doctor supporting the charge.
• In addition, the investigating officer should give an independent opinion, preferably of a government
doctor.
• Finally, a doctor may be arrested only if the investigating officer believes that she/ he would not be
available for prosecution unless arrested.

UNIT-4 (C)
NEGLIGENCE UNDER CONSUMER PROTECTION ACT

NEGLIGENCE UNDER CONSUMER PROTECTION LEGISLATIONS
• Under consumer protection laws, medical negligence is another form of deficiency in service. It is most akin
to the liability under the law of torts. But there is stricter and broader liability in this situation as failure to
exercise skill and care as is ordinarily expected of a medical practitioner is the test under consumer protection
laws.
• In India, all medical services fall under the purview of the Consumer Protection Act 1986. The interests of
the consumers are protected against the deficiency of services. As per section 2 (1) of the Consumer
Protection Act, 1986 the deficiency of service means any default, imperfection or inadequacy in the nature,
quality, or manner of performance that should be maintained by any law for the time being in force. It shall
be undertaken to be performed by a person in pursuance of a contract or the service provided. It is
comprehensive legislation implemented to promote and safeguard the concerns of the consumers. To
establish a relation between the CPA and the medical profession, it is essential to understand whether the
patient can be considered a 'consumer' as per the definitions of CPA.
• In order to deal with this uncertainty, the courts clarified that the medical treatment rendered to a patient for a
certain amount of consideration is a service as described under the CPA. Hence it can be stated that medical
professionals who render services are liable to the patient for injury caused due to negligence on his part.

• Negligence is simply the failure to exercise due care. The three ingredients of negligence are as follows:
• The defendant owes a duty of care to the plaintiff.
• The defendant has breached this duty of care.
• The plaintiff has suffered an injury due to this breach.
• Medical negligence is no different. It is only that in a medical negligence case, most often, the doctor is the
defendant.
• When does a duty arise?
• It is well known that a doctor owes a duty of care to his patient. This duty can either be a contractual duty or
a duty arising out of tort law. In some cases, however, though a doctor-patient relationship is not established,
the courts have imposed a duty upon the doctor. In the words of the Supreme Court “every doctor, at the
governmental hospital or elsewhere, has a professional obligation to extend his services with due expertise
for protecting life” (Parmanand Kataria vs. Union of India). These cases are however, clearly restricted to
situations where there is danger to the life of the person. Impliedly, therefore, in other circumstances the
doctor does not owe a duty.

• What is the duty owed?
• The duty owed by a doctor towards his patient, in the words of the Supreme Court is to “bring to his task
a reasonable degree of skill and knowledge” and to exercise “a reasonable degree of care” (Laxman vs.
Trimback). The doctor, in other words, does not have to adhere to the highest or sink to the lowest degree
of care and competence in the light of the circumstance. A doctor, therefore, does not have to ensure that
every patient who comes to him is cured. He has to only ensure that he confers a reasonable degree of
care and competence.
• For instance, in Indrani Bhattacharjee v. Chief Medical Officer and Ors, the doctor failed to advise the
patient to consult cardiologist as the ECG of the patient was not normal. Instead of that doctor gave him
medicines for the gastric problem which amounted to deficiency in service as per the Consumer
Protection Act.
• In the case of Kusum Sharma v. Batra Hospital and Medical Research Center and Ors, the court states
that if the medical practitioner fails to maintain the standards of reasonable care, then they will be held
liable for medical negligence, which gives appearance of deficiency in medical service as per Section 2
(1) (g) of Consumer Protection Act.

• The District Consumer Forum has laid the order to refund the amount with interest in case of Kidney Stone
Center v. Khem Singh, where the patient was suffering from the problem of stone in the urethra. The
defendant promised to remove the stone without surgery by paying ten thousand rupees but failed to do so.
• When doctors do the treatment or give their services without charging the patients, they are not held liable
either individually or vicariously. Therefore, the free treatment at government or non-government hospital,
dispensary or a nursing home, health care centre cannot be considered as service defined under Section 2 (1)
(o) of the Consumer Protection Act, 1986. Therefore, the contract of providing the service is beyond the
ambit of the Consumer Protection Act. The Act cannot rescue the patients, where they take free services or
are paying only a nominal fee for the registration purpose. However, if the medical practitioner or doctors
waive the charges due to the incapability of patients to pay the costs, then they are considered as consumers
and can sue under the Act.
• In Indian Medical Association v. P Santha, it is observed that the doctors or medical practitioners will be held
liable for their services unless the exceptions mentioned in this case are not followed. The court states that
the patients cannot be treated as a contract of personal services.

• The complaints under the Consumer Protection Act can be filed at the District Forum, State Commission
and National Commission.
• If the value of compensation and services claimed is less than 20 lakh rupees, then the matter will be filed
before the District Forum.
• If the value of the goods or services and the compensation claimed is below one crore rupees, then the
matter will be referred to the State Commission.
• And if the value of the goods or services and the compensation exceeds more than one crore rupees, the
matter is referred to the National Commission. There is a minimal fee for filing a complaint before the
District Consumer Redressal Forums, State Commission and National Commission.

• Who can file a complaint?
• A consumer or any recognized consumer association, i.e., voluntary consumer association registered under
the Companies Act, 1956 or any other law for the time being in force, whether the consumer is a member
of such association or not, or the central or state government.
• Who is a consumer?
• A consumer is a person who hires or avails of any services for a consideration that has been paid or
promised or partly paid and partly promised or under any system of deferred payment and includes any
beneficiary of such services other than the person hires or avails of the services for consideration paid or
promised, or under any system of deferred payment, when such services are availed of with the approval of
the first mentioned person. This definition is wide enough to include a patient who merely promises to pay.
• What is a complaint?
• A complaint is an allegation in writing made by a Complainant, i.e., a consumer that he or she has suffered
loss or damage as a result of any deficiency of service.

• What is deficiency of service?
Deficiency of service means any fault, imperfection, shortcoming, or inadequacy in the quality, nature, or
manner of performance that is required to be maintained by or under any law for the time being in force or has
been undertaken to be performed by a person in pursuance of a contract or otherwise in relation to any service.
• Where is a complaint filed?
A complaint can be filed in:
1) the District Forum if the value of services and compensation claimed is less than 20 lakh rupees,
2) before the State Commission, if the value of the goods or services and the compensation claimed does not
exceed more than 1 crore rupees, or
3) in the National Commission, if the value of the goods or services and the compensation exceeds more than 1
crore rupees.
• What is the cost involved in filing a complaint?
There is a minimal fee for filing a complaint before the district consumer redressal forums.

• Is there any provision for appeal?
• An appeal against the decision of the District Forum can be filed before the State Commission. An appeal
will then go from the State Commission to the National Commission and from the National Commission to
the Supreme Court. The time limit within which the appeal should be filed is 30 days from the date of the
decision in all cases.
• What are the powers of the consumer redressal forums?
The forums have a variety of powers. They are
1) the summoning and enforcing of the attendance of any defendant or witness and examining the witness under
oath,
2) the discovery and production of any document or other material object producible as evidence,
3) the reception of evidence on affidavits,
4) the summoning of any expert evidence or testimony,

5) the requisitioning of the report of the concerned analysis or test from the appropriate laboratory or from
any other relevant source,
6) issuing of any commission for the examination of any witness, and
7) any other matter which may be prescribed.
• How does adjudication of liability take place?
The process before the competent forum will be set in motion in the following manner. When the
Complainant files a written complaint, the forum, after admitting the complaint, sends a written notice to the
opposite party asking for a written version to be submitted within 30 days. Thereafter, subsequent to proper
scrutiny, the forum would ask for either filing of an affidavit or production of evidence in the form of
interrogatories, expert evidence, medical literature, and judicial decisions.

• Reasonable Degree Of Care
• Reasonable degree of care and skill means that the degree of care and competence that an “ordinary
competent member of the profession who professes to have those skills would exercise in the
circumstance in question.” At this stage, it may be necessary to note the distinction between the standard
of care and the degree of care. The standard of care is a constant and remains the same in all cases. It is
the requirement that the conduct of the doctor be reasonable and need not necessarily conform to the
highest degree of care or the lowest degree of care possible. The degree of care is a variable and depends
on the circumstance. It is used to refer to what actually amounts to reasonableness in a given situation.
• Thus, though the same standard of care is expected from a generalist and a specialist, the degree of care
would be different. In other words, both are expected to take reasonable care but what amounts to
reasonable care with regard to the specialist differs from what amount of reasonable care is standard for
the generalist. In fact, the law expects the specialist to exercise the ordinary skill of this speciality and not
of any ordinary doctor. Though the courts have accepted the need to impose a higher degree of duty on a
specialist, they have refused to lower it in the case of a novice.

• Another question that arises is with regard to the knowledge that is expected from a doctor. Should it
include the latest developments in the field, hence require constant updating or is it enough to follow
what has been traditionally followed? It has been recognized by the courts that what amounts to
reasonableness changes with time. The standard, as stated clearly herein before requires that the doctor
possess reasonable knowledge. Hence, we can conclude that a doctor has to constantly update his
knowledge to meet the standard expected of him. Furthermore, since only reasonable knowledge is
required, it may not be necessary for him to be aware of all the developments that have taken place.
• When does the liability arise?
• The liability of a doctor arises not when the patient has suffered any injury, but when the injury has
resulted due to the conduct of the doctor, which has fallen below that of reasonable care. In other words,
the doctor is not liable for every injury suffered by a patient. He is liable for only those that are a
consequence of a breach of his duty. Hence, once the existence of a duty has been established, the
plaintiff must still prove the breach of duty and the causation. In case there is no breach or the breach did
not cause the damage, the doctor will not be liable. In order to show the breach of duty, the burden on the
plaintiff would be to first show what is considered as reasonable under those circumstances and then that
the conduct of the doctor was below this degree. It must be noted that it is not sufficient to prove a
breach, to merely show that there exists a body of opinion which goes against the practice/conduct of the
doctor.

• Normally, the liability arises only when the plaintiff is able to discharge the burden on him of proving
negligence. However, in some cases like a swab left over the abdomen of a patient or the leg amputated
instead of being put in a cast to treat the fracture, the principle of ‘res ipsa loquitur’ (meaning thereby ‘the
thing speaks for itself’) might come into play. The following are the necessary conditions of this principle.
• Complete control rests with the doctor.
• It is the general experience of mankind that the accident in question does not happen without negligence.
This principle is often misunderstood as a rule of evidence, which it is not. It is a principle in the law of
torts. When this principle is applied, the burden is on the doctor/defendant to explain how the incident
could have occurred without negligence. In the absence of any such explanation, liability of the doctor
arises.
• Normally, a doctor is held liable for only his acts (other than cases of vicarious liability). However, in some
cases, a doctor can be held liable for the acts of another person which injures the patient. The need for such
a liability may arise when the person committing the act may not owe a duty of care at all to the patient or
that in committing the act he has not breached any duty.

• A typical example of a case where such a situation may arise is in the case of a surgery. If a junior doctor
is involved as part of the team, then his duty, as far as the exercise of the specialist skill is concerned, is to
seek the advice or help of a senior doctor. He will have discharged his duty once he does this and will not
be liable even if he actually commits the act which causes the injury. In such a case, it is the duty of the
senior doctor to have advised him properly. If he did not do so, then he would be the one responsible for
the injury caused to the patient, though he did not commit the act. When there is no liability
• A doctor is not necessarily liable in all cases where a patient has suffered an injury. This may either be due
to the fact that he has a valid defence or that he has not breached the duty of care. Error of judgment can
either be a mere error of judgment or error of judgment due to negligence. Only in the case of the former,
it has been recognized by the courts as not being a breach of the duty of care. It can be described as the
recognition in law of the human fallibility in all spheres of life.
• A mere error of judgment occurs when a doctor makes a decision that turns out to be wrong. It is situation
in which only in retrospect can we say there was an error. At the time when the decision was made, it did
not seem wrong. If, however, due consideration of all the factors was not taken, then it would amount to
an error of judgment due to negligence.

• What Constitutes Medical Negligence?
• Failure of an operation and side effects are not negligence. The term negligence is defined as the absence
or lack of care that a reasonable person should have taken in the circumstances of the case. In the
allegation of negligence in a case of wrist drop, the following observations were made. Nothing has been
mentioned in the complaint or in the grounds of appeal about the type of care desired from the doctor in
which he failed. It is not said anywhere what type of negligence was done during the course of the
operation. Nerves may be cut down at the time of operation and mere cutting of a nerve does not amount
to negligence. It is not said that it has been deliberately done. To the contrary it is also not said that the
nerves were cut in the operation and it was not cut at the time of the accident.
• No expert evidence whatsoever has been produced. Only the report of the Chief Medical Officer of
Haridwar has been produced wherein it said that the patient is a case of post-traumatic wrist drop. It is not
said that it is due to any operation or the negligence of the doctor. The mere allegation will not make out a
case of negligence, unless it is proved by reliable evidence and is supported by expert evidence. It is true
that the operation has been performed. It is also true that the Complainant has many expenses but unless
the negligence of the doctor is proved, she is not entitled to any compensation as held in Smt. Vimlesh
Dixit v. Dr. R.K. Singhal. 2004;(I) CPJ 123 (Uttaranchal)

• What is the Standard of Care?
• It is now a settled principle of law that a medical practitioner will bring to his task a reasonable degree of
skill and knowledge and must exercise a reasonable degree of care. Neither the very highest nor the very
lowest degree of care and competence judged in the light of circumstances in each case is what the law
requires. Judged from this yardstick, post-operative infection or shortening of the leg was not due to any
negligence or deficiency in service on the part of the opposite party Appellant. Deficiency in service thus
cannot be fastened on the opposite party as held in Dr. Kamta Prasad Singh v. Nagina
Prasad. 2000;(III) CPJ 283 (WB)

Health Care Law ( LLB 507 & LLB 509 )

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Health Care Law ( LLB 507 & LLB 509 )