Formulated by National and State Medical Councils and the World Medical Association.
The enforcement of these ethics is carried out by Medical Councils.
Purpose: To regulate the granting of titles in Western Medical Science.
Authorities: Certain designated authorities have the right to grant medical degrees, diplomas, and licenses, qualifying recipients to practice Western Medical Science.
Objective: To regulate the profession of dentistry in general.
Establishment: Constituted the Dental Council of India.
Repeal: The Act of 1933 was repealed, and the 1956 Act was established.
Modifications: This Act was modified in the years 1964, 1993, and 2001.
Recent Changes: The MCI Amendment Act 2010 was approved and superseded previous councils.
Repeal by NMC: The Indian Medical Council Act was ultimately repealed by the National Medical Commission Act of 2019.
Head office is located in New Delhi.
Chairperson: A medical professional with outstanding ability and integrity, possessing a postgraduate degree in modern medicine, and over 20 years of experience in the medical field, including 10 years as a leader.
Ex-officio Members: Includes presidents of various medical boards:
Undergraduate Medical Education Board
Post-graduate Medical Education Board
Medical Assessment and Rating Board
Ethics and Medical Registration Board
Director General of Health Services, New Delhi
Director General of Indian Council of Medical Research (ICMR)
Director of All India Institutes of Medical Science (AIIMS), nominated by the Central Government.
Two individuals from directors of high institutions of medical education and research centers in India.
One person from the Ministry of Health and Family Welfare, at least at the rank of Additional Secretary.
22 part-time members selected from state and union territory nominees, including representatives from disciplines related to Law, Ethics, Health Research, Science and Technology, and Economics.
Tenure: 4 years for members and 2 years for part time members.
Meetings: The commission must hold meetings at least once every quarter.
Search Committee: A Search Committee will be formed for the nominations of the chairperson and members of NMC, led by the cabinet secretary.
Removal of Members: The Central Government has the authority to remove the chairperson or any member for reasons including actions prejudicial to public interest or any abuse of position that affects functioning.
Establish high-quality standards in medical education and regulations.
Lay down policies for medical institutions, researchers, and professionals.
Assess healthcare requirements (human resources and infrastructure).
Coordinate policies for effective functioning of NMC, Autonomous Boards, and State Medical Councils.
Regulate State Medical Councils.
Exercise appellate jurisdiction over autonomous boards' decisions.
Develop policies and codes for professional ethics in medicine.
Frame guidelines for fees related to 50% of seats in private medical institutions.
Chaired by NMC Chairperson.
Includes NMC members and representatives from:
Vice Chancellors of health universities.
Home Ministry and state medical councils.
Eminent individuals from science and technology fields.
Address medical education, training, and research standards.
Meet at least twice a year to advise NMC.
Formed by the Central Government under NMC supervision.
Under-graduate Medical education board
Post-graduate Medical Education Board
Medical Assessment and Rating Board
Ethics and Medical Registration Board
Each board has a President, two whole-time members, and two part-time members.
Includes an elected representative from State Medical Councils.
Members appointed by Central Government for four years.
Boards meet at least once a month for decisions.
Voting based decisions with appeal options to NMC.
Advisory Committees assist boards except the Ethics and Medical Registration Board, which has an Ethics Committee.
Determine education standards across states and union territories.
Develop a competency-based curriculum.
Frame guidelines for under-graduate institutions.
Define course requirements and standards.
Ensure quality of medical education.
Facilitate research and exchange programs.
Specify norms for electronic disclosure of functions to NMC and Central Government.
Grant recognition to a medical qualification.
Determine standards of medical education at post-graduate level
Develop competency-based dynamic curriculum at post-graduate and super-speciality levels
Frame guidelines for setting up medical institutions for post-graduate and super-speciality courses
Determine minimum standards and faculty requirements for these courses
Facilitate research and exchange programmes for international students and faculty
Annual disclosure of institution functions to NMC and Central Government
Grant recognition to medical qualifications at post-graduate and super-speciality levels
Assessment Procedures
Determine procedure for assessing and rating medical institutions
Grant permission for establishing new institutions and starting post-graduate courses
Conduct inspections for assessment and rating; may hire third parties for inspections
Rating of medical institutions
Take measures such as stoppage of admissions; reduce the seats, recommending the withdrawal of recognition to maintain minimum standards of medical education.
Maintain a National Register of all licensed medical practitioners
Regulate professional conduct and promote medical ethics
Develop interaction mechanisms with state medical councils
Exercise appellate jurisdiction regarding State Medical Council actions
No new medical college or post-graduate course without Board's permission
Maintain a separate national register for Community Health Provider (CHP)
Entry Exam
National Eligibility Entrance Test (NEET) for MBBS admissions
Selection based on NEET rank list for medical institutions
Exit Exam
National Exit Test (NEXT) for licensing and enrollment in registers
Common exit exam for Indian and foreign medical graduates
Institution Rating
Medical institutions' ratings available online
Measures to maintain standards include stoppage of admissions and seat reduction
Interdisciplinary Meetings
Annual meeting with Central Council of Homeopathy and Central Council of Indian Medicine
Approve specific education modules or programs to promote medical pluralism across courses
Defined as individuals licensed to practice medicine at the mid-level.
Eligibility framed by the Nursing and Midwifery Council (NMC).
Number of CHPs should not exceed one-third of the total number of licensed medical practitioners.
Composition:
Medical teachers from different universities elected by peers.
Elected members from registered medical practitioners.
Members nominated by the state government.
Leadership:
President and Vice-President elected by members.
Members typically serve a 5-year term.
Medical Register
Maintains a register of medical practitioners.
Any individual with a recognized medical qualification can register.
Requires a 1-year internship post-medical degree in an MCI-recognized institute.
Provisional registration allowed for practice in approved institutions.
Permanent registration follows the internship on application and fee payment.
Registrar informs the Indian Medical Council about additions/deletions in the register.
Disciplinary Control
Power to remove names from the register for serious professional misconduct.
Judicial Procedure of SMC:
Action initiated upon conviction or complaints against practitioners.
Council has powers akin to civil courts under the Code of Civil Procedure 1908.
Complaints processed by subcommittees after submission by the Registrar.
Practitioners are notified of charges and must respond in writing.
Hearings include the complainant and the practitioner, followed by evidence presentation.
Voting process dictates outcomes regarding penalties (temporary suspension/removal/warning).
Requires a two-thirds majority for disciplinary decisions.
Decisions to be made within 6 months of the complaint receipt.
Practitioners can appeal to the Central Government post-disciplinary action, which consults the MCI before deciding.
Definition: Removal of the name of a medical practitioner from the medical register due to serious professional misconduct.
Types: There are temporary removal and permanent removal (also called penal erasure or "professional death sentence").
Definition: Actions by a medical practitioner that are considered disgraceful or dishonorable within the medical profession.
Code of Medical Ethics: Medical practitioners must adhere to rules of conduct outlined by the Indian Medical Council.
Examples of Serious Professional Misconduct: The Indian Medical Council provides examples but notes that it is not an exhaustive list; each case is evaluated individually.
Key Ingredients of Professional Misconduct (6A's):
Advertising:
Medical practitioners may not advertise their services directly in media or report cases treated.
Institutions can advertise, but names of individual doctors must not be mentioned.
Improper to use signboards with anything besides name, qualifications, and specialty.
Prescription papers can include registration number, address, and phone number.
Cannot advertise through manufacturing firms or appoint agents for canvassing patients (called touting).
Association:
Medical practitioners should not:
Associate with unqualified persons in professional matters.
Run open medical shops selling medicines prescribed by others.
Refer patients for a share of fees (known as dichotomy or fee splitting).
Associate with drug companies for commissions or promotions.
Endorse any drugs or medical equipment
Doctors must not seek assistance from unqualified individuals for treatment or operations (referred to as "covering").
Adultery:
Sexual relationships between doctors and their patients or the patients' relatives are prohibited.
Improper conduct with patients or their families is not acceptable.
Abortion
Criminal abortion is forbidden; procedures must adhere to the guidelines set by the MTP Act 1972.
Alcohol Consumption
Doctors should not be alcoholics.
They must not perform examinations or surgeries while under the influence of alcohol.
Addiction
Doctors must not have addictions to drugs (e.g., morphine, tranquilizers).
Selling drugs of addiction for non-medical reasons is prohibited.
Additional Ethical Standards
A physician might face erasure from the medical register for the following actions:
Criminal Convictions: Being convicted of a crime or under military law.
Refusal of Treatment: Not providing treatment based on personal beliefs regarding sterilization, birth control, etc.
Secret Prescriptions: Writing prescriptions using unverifiable formats.
False Certifications: Providing untruthful certificates pertaining to fitness or health.
Sex Determination Tests: Conducting such tests intending termination of a female fetus.
Drug Selling: Selling Schedule H and L drugs to the public beyond his patients and operating open medical shops.
IVF/Artificial Insemination: Performing these procedures without ensured consent from all parties involved.
Patient Privacy: Publishing photographs of patients without their consent.
Research Guidelines: Clinical research should follow Indian Council of Medical Research (ICMR) protocols; violations are misconduct.
Torture Aiding: Physicians must not participate in torture or concealment of trauma inflicted by others.
Improper Use of Emblems: Unauthorized use of the Red Cross emblem is punishable by fine and forfeiture of goods.
According to the Medical Council of India, published guidelines outline:
High-quality assurance in patient care.
Specific unethical practices to avoid.
Obligations to patients, confidentiality, and collaboration among medical professionals.
Responsibilities to paramedical staff and the public.
Disciplinary actions for professional misconduct include potential expulsion from the medical register.
Every registered practitioner must acknowledge and agree to the physician's oath.
A medical practitioner should uphold the dignity and honor of his profession.
Doctors must execute skill and care in all aspects of professional practice including:
Attending to patients
Treating patients
Performing operations
Conducting investigations
Informed Consent
Doctors must obtain informed consent from patients or their relatives prior to any surgery.
Consent includes explaining all procedures and risks involved.
Emergency Situations
In emergencies, physicians have a moral and humanitarian duty to save the patient's life.
Medicolegal Cases
Inform police in cases of homicide.
Refrain from issuing death certificates for suicidal, homicidal, or accidental deaths.
Arrange for recording dying declarations, which must be recorded in presence of two witnesses if a magistrate is not available.
Physicians must issue medical and medico-legal certificates such as:
Wound certificates
Potency certificates
Drunkenness certificates
Postmortem certificates
Doctors are required to testify in court when necessary.
Maintain medical records of indoor patients for at least 10 years.
Professional secrecy must be upheld by the doctor.
Medical records must be provided within 72 hours upon request by the patient or legal authorities.
A register of medical certificates issued must be maintained.
Keeping of medical and medicolegal records.
Doctors have a duty to act with utmost loyalty and good faith towards patients.
Personal interests should never conflict with professional duties.
Medical records include:
Chronologically written account of patient’s medical history
Patient complaints
Physical findings
Results of diagnostic tests
Medications
Therapeutic procedures
Day-wise progress notes
These records can serve as evidence in:
Medical negligence cases
Third-party insurance claims
Life insurance policies
Accidental death claims
Medical records are the property of the hospital and personal data within them are confidential.
Original MLC records (including X-ray, CT, MRI scans) should not be handed over to police, but photocopies may be provided upon request.
Medical records cannot be used in educational or diagnostic conferences without patient consent.
Hospital records may be utilized for statistical purposes without patient consent.
Medical records must be preserved for a minimum of 10 years.
Original MLRs and PMCs must be sent to the concerned court, with one copy to the police station.
Victims or relatives may obtain copies upon request.
MLRs and PMCs are not public documents and cannot be released to third parties under RTI Act per Section 8(1)(h) which protects privacy.
Right to choose patients
Right to use title and description of qualifications
Right to gain appointment in both government and private sectors
Right to practice medicine anywhere in India
Right to issue medical certificates and reports
Right to receive reasonable fees for professional services
Right to prescribe dangerous drugs
Right to provide evidence in court
Authorization to conduct medicolegal examinations and autopsies
Entitled to remove eyes from the deceased for transplantation.
Medical negligence involves the failure to execute a reasonable degree of skill and care or willful negligence by a medical practitioner causing harm, bodily injury, or death to a patient.
Duty: Medical practitioners have a duty to treat patients with reasonable skill and care.
Dereliction of Duty: Failure to fulfill that duty.
Direct Causation: Connection between the negligence and the injury suffered.
Damage: Harm caused to the patient.
Skill and Care: Duty arises when a patient approaches a doctor for treatment, necessitating proper examination and treatment decisions.
Standard of Care: Defined as the skill and care expected from practitioners of similar caliber at that time.
Ordinary practitioners are not held to the same high standards as specialists.
Continuous Learning: Doctors must stay updated with medical advancements and promptly refer patients when necessary to avoid complications.
Diagnosis and Treatment: Proper use of diagnostic tools like blood tests, X-rays, and scans is essential.
Injury can be temporary, irreversible, or permanent and is typically compensable.
Instance of direct negligence: complications from lack of skill during surgical procedures can lead to significant patient harm.
Intravenous Injection Case:
Injection given improperly leading to recurrent infections; original doctor held liable for leaving a needle fragment inside.
Gynecologist Tubectomy Case:
A patient died due to complications from surgery where the doctor neglected to identify internal bleeding, leading to negligence claims after death was confirmed at another facility.
Competence is gauged by the doctor’s circumstances and available resources at the institution where they practice.
Individual Case Analysis: Each case of negligence is evaluated on its own merits considering specific circumstances and available medical facilities.
Medical practitioners are responsible for timely referral of patients to institutions that possess necessary diagnostic and management facilities.
Failure to properly refer a patient can lead to accusations of negligence.
General practitioners must recognize when a case requires a specialist's skill; otherwise, they may be held liable for inadequate care.
Definition: "The thing speaks for itself"; this doctrine places the burden of proof on the physician instead of the patient.
Examples of negligence under this doctrine include:
Burns from hot water application.
Overdose of incorrect medication leading to adverse effects.
Broken needles during injection.
Mismatched blood transfusions.
Leaving surgical instruments inside a patient post-operation.
Surgery performed on the wrong patient or incorrect body part.
Loss of limb due to improper splint application.
Gangrene resulting from overly tight plaster casts.
Failure to administer anti-tetanus serum resulting in tetanus after injury.
These cases illustrate clear evidence of negligence, liable under both civil and criminal contexts.
Describes circumstances where an incident's outcome changes due to a subsequent act (by the doctor) that introduces new causation.
Example: A patient may receive additional treatment from another doctor without informing the first, affecting their recovery trajectory.
Courts generally do not accept this defense as absolving responsibility.
Civil Negligence: Not specifically defined in Indian Law, yet encompasses failure to provide proper care.
Criminal Negligence: Defined under Section 304A IPC:
Punishable with up to 2 years of imprisonment or fines for causing death through rash and negligent acts not amounting to culpable homicide.
Must demonstrate gross negligence to hold a physician accountable.
Procedural Requirement: Any charge against a doctor must involve an expert panel’s scrutiny. This panel, formed by the District Medical Officer, assesses negligence claims.
Examples of criminal negligence include:
Amputating the wrong limb or removing the wrong eye.
Failing to remove surgical instruments from the body.
Performing an unsafe abortion resulting in death.
Incorrect substances administered during procedures leading to vision loss.
Patient deaths due to mismanagement during childbirth or anesthetic misuse.
The doctor could face prosecution in criminal courts for severe negligence under Section 304A IPC.
In cases lacking criminal negligence, patients may seek redress through consumer protection councils or forums for compensation regarding damages.
All hospital deaths warrant thorough examination for possible instances of negligence by the attending doctor.
Section 304A: Addresses medical negligence under the Indian Penal Code (IPC). Proposal for a separate IPC section for medical negligence has been discussed by various courts.
Civil Negligence | Criminal Negligence |
---|---|
No specific violation of law. | Involves possible violation of law. |
Simple absence of skill and care. | Gross negligence or lack of competency. |
Consent is a valid defense. | Consent is not a defense. |
Trials conducted in civil courts or consumer courts. | Trials conducted in criminal courts. |
Strong evidence is sufficient | Guilt must be proved beyond a reasonable doubt. |
Liability to pay damages. | Imprisonment, fines, or both. |
Contributory negligence is a good defence | Not a defence |
Reparable damage | Irreparable damage or death. |
Suffered party has to file the case | Public prosecutor on behalf of the state |
Onus of proving negligence lies with the patient | Doctor has to prove his innocence |
Medical Negligence | Infamous Conduct |
---|---|
Absence of skill and care | Violation of medical ethics |
Duty of care to patient should be present | Duty need not be present |
Damage to the person should be present | Need not be present |
Trial is conducted in civil or criminal courts | State medical council will deal the case |
Punishment is compensation, fine, or imprisonment | Erasure of name from the medical register or warning |
Appeal may be given to the higher court | Appeal to NMC or the central Government |
All surgical procedures involve some degree of risk.
Surgical injury may occur despite reasonable skill and care.
Example: In heart surgery, a 5-10% risk of death signifies a professional accident rather than negligence.
Defined as unreasonable conduct by the patient contributing to injury alongside the doctor's negligence.
Examples include:
Inaccurate medical history provided by the patient.
Non-cooperation with doctor's instructions.
Refusal to follow suggested treatments.
Leaving the hospital against medical advice.
Not seeking further treatment for persistent symptoms.
The doctor must ensure the patient follows instructions; however, this does not exculpate him from negligence claims.
Typically a partial defence that may reduce awarded damages.
The doctor bears the burden of proof regarding contributory negligence.
Notable scenarios:
If a patient leaves treatment prematurely (gross negligence), the doctor is not liable.
Contributory negligence applies only in civil negligence cases, not in criminal negligence.
Last Clear Chance Doctrine: If a patient negligently places themselves in danger, and the doctor fails to correct it despite having the chance, this doctrine bars the use of contributory negligence as a defence.
Doctrine of Avoidable Consequences Rule: If a patient refuses necessary medical attention causing further injury, they may be held accountable. Example: Amputation resulting from ignoring medical advice post foot injury.
Superior holds responsibility for the negligent actions of subordinates.
Requirements for this principle:
An established employer-employee relationship.
Employee's conduct must occur within the scope of employment.
Negligence must happen while working.
Generally, the primary doctor is responsible for their assistant's negligence, although both can be sued by the patient.
Temporary associations in surgery create employer-employee liability. Example: Assistant during surgery is liable alongside the principal surgeon.
Doctors are not liable for each other's negligence, e.g., surgeons and anesthesiologists.
Healthcare personnel like nurses fall under the doctor's liability in India, unlike in countries like the UK and USA where independent charge can exist.
In a situation where two doctors of equal status are treating a patient, the principle of respondent superior cannot be applied. Each doctor is responsible for their own negligence.
A physician is liable for the acts of interns and residents under their direct supervision and control.
Hospital administrators are not responsible for the acts of doctors or staff if they have appointed qualified individuals and if tasks are appropriately distributed among them.
Nursing superintendents are accountable for the mistakes made by trainee nurses due to inadequate training or supervision.
Physicians are not liable for pharmacists' negligence if they have written prescriptions correctly.
If a prescription is ordered over the phone, resulting in a misunderstanding of the drug or dosage, the physician may be held liable.
Hospitals cannot be held responsible for negligent actions of doctors if the hospital can prove that qualified personnel and equipment were used.
Captain of the Ship Doctrine
Commonly referred to as vicarious liability; this doctrine states that a physician is liable for negligent actions of their employees, similar to how a ship captain is responsible for their crew's mistakes.
Corporate negligence occurs when hospital administrators fail to provide adequate facilities and competent staff.
Includes ensuring standard equipment and personnel are available.
If damage results from hospital administration’s negligence, they are liable for damages.
Manufacturers are responsible for damages resulting from faulty, defective, or negligently designed medical instruments or drugs.
A physician must prove that the manufacturer deviated from safety standards in design, manufacture, assembly, or failed to provide adequate warnings and instructions regarding proper usage.
If an instrument functioned correctly on previous occasions, the manufacturer may not be held liable.
Hospital authorities and doctors have a duty to maintain equipment or discard it if irreparable.
The burden of proof regarding the safety and effectiveness of a new drug or instrument lies with the manufacturer.
Failure to warn about potential side effects or defective aspects of a new product makes the manufacturer liable.
Medical science involves inherent risks. A doctor cannot be blamed for death if they have exercised care and skill in treatment.
Examples of medical occurrences where death may not imply negligence:
Idiosyncratic drug reactions in some patients.
Injury to the recurrent laryngeal nerve during thyroidectomy leading to vocal cord paralysis.
Amniotic fluid embolism after a Cesarean section.
Similar to medical maloccurrence, this can occur during:
Administration of drugs.
Diagnostic procedures using dyes or catheters.
Surgical processes.
Doctors cannot be deemed negligent solely due to an error in judgment if they have demonstrated necessary skill and care.
Each case is assessed individually to evaluate whether appropriate investigations and lab tests were conducted before proceeding with treatment.
Legal concept that prevents a case from being retried once it has been decided between two parties.
Example: A patient cannot sue a doctor again for negligence after the case has been resolved.
Cases of alleged negligence against doctors must be filed within 2 years of the incident.
After this period, the case cannot be filed.
Occurs when a patient's harm results from the negligence of two or more parties.
Compensation for damages is divided among the defendants.
Informed Consent is not a defense in negligence cases.
Obtain informed consent from the patient.
Establish rapport with patients.
Maintain accurate medical records.
Employ ordinary skill and care during treatment.
Conduct necessary tests (blood tests, X-rays) for diagnosis.
Ensure immunizations are administered as necessary (e.g., tetanus).
Perform sensitivity tests before administering injections.
Seek second opinions from other doctors when needed.
Conduct all tests necessary for early detection in suspected malignancies.
Inform patient's relatives of critical condition.
Avoid making excessive promises to the patient.
Do not guarantee a cure.
Communicate treatment steps to the patient and relatives.
Refer patients to facilities with adequate resources when necessary.
Obtain specific consent for each stage in multistage treatments.
Follow guidelines for administering new drugs as per Indian Council of Medical Research (ICMR).
Keep operation theatres sterilized and infection-free.
Document reasons and findings for differential diagnosis carefully.
Ensure medical acts align with prevailing practices in the respective specialty.
Thoroughly record the changing clinical profile of the patient.
A contract between the insurance company and the doctor to cover professional negligence in exchange for premium payments.
Objectives:
Protect the doctor’s professional interests.
Fund the doctor’s defense against negligence claims.
Compensate amounts awarded by the court to the opposing party.
Obligation of doctors to keep patient information confidential.
Disclosure without consent can result in professional misconduct or legal action by the patient.
Important Notes:
Do not discuss a patient’s illness with others without consent.
Respect patient privacy, especially regarding sensitive information (e.g., a diagnosis impacting their profession).
Illness details between spouses should remain confidential unless it's a communicable illness.
Employee health information should not be disclosed to employers without consent unless essential.
Public disclosure of a patient's illness only occurs for communicable diseases.
HIV infection status must remain private.
Medical examinations for insurance are voluntary; findings can be disclosed if consent is provided.
Autopsy findings shouldn't be revealed without consent from close relatives to protect the family reputation.
Government medical officers are bound by codes of professional secrecy even for patients treated free of charge.
In artificial insemination cases, donor and recipient identities must be kept confidential.
Patient identities must be protected in journal publications.
Relevant information about minors, mentally ill, or intoxicated individuals can be shared with proper authorities.
For hostel minors, undertrial prisoners, or convicts, necessary information can be disclosed to appropriate authorities.
Major undertrial prisoners' information doesn't need to be disclosed unless required by law.
Doctors may disclose patient information if it serves the public interest:
Venereal Diseases: If a patient has HIV and is to marry, the doctor may disclose this to the partner or parents if the patient refuses to inform them.
Infectious Diseases: An infectious patient in a hostel not receiving treatment can have their status reported to hostel authorities for the safety of others.
Notifiable Diseases: Mandatory reporting of births, deaths, communicable diseases to health authorities. Medical issues affecting driver safety (e.g., color blindness) should be reported to licensing authorities.
Patient's Benefit: Symptoms like melancholy or suicidal tendencies should be communicated to relatives to help the patient.
Suspected Crimes: Knowledge of serious crimes (e.g., assault) during treatment must be reported to police, with legal penalties for non-disclosure.
Court Orders: Professional secrecy is overruled when a court demands disclosure, although doctors can appeal.
Insurance Reports: Doctors on insurance panels must disclose patients' health information without reservation.
Consent is a voluntary agreement for an action, valid only when the person is informed of the nature and consequences of their consent.
Consent is implied when a patient presents for examination and treatment.
No separate written or verbal consent is needed for physical examinations.
Consent that is explicitly stated, can be written or verbal.
Consent provided after understanding the procedure's nature, risks, benefits, and alternatives.
Aimed at enabling the patient to make a knowledgeable decision.
Written consent is required for surgical procedures for individuals over 18 years (Sec. 87-88, IPC).
A child under 12 years or an insane person cannot give valid consent (Sec. 89, IPC).
Parental or guardian consent is needed for patients under 18.
Doctors must explain the following before obtaining consent:
Condition/nature of illness
Diagnostic tests
Nature of procedure/treatment
Risks and benefits of the procedure/treatment
Success rate
Alternative treatment options and their risks
Prognosis of the treatment
Right to refuse or accept treatment
Consent should be signed and witnessed to prevent allegations of coercion.
Examining a person without consent is considered assault.
Treatment without consent generally counts as negligence.
Doctors may withhold certain information if disclosing it causes psychological harm to the patient (e.g., informing about malignancy).
Relatives must be informed and give written consent before surgery or invasive procedures.
In emergencies, doctors can operate on unconscious patients without consent, protected by Sec. 92 IPC.
Presumed implied consent in emergencies when no guardian is available to consent.
Harm done in good faith does not hold the doctor responsible in emergencies (Sec. 93 IPC).
In emergencies, a competent individual may waive their right to consent, allowing the doctor to perform life-saving procedures.
Consent can be taken from a responsible adult in charge when parents or guardians are not present in emergencies involving children.
Consent Requirement: Consent must be obtained from both the victim and the accused before any examination in medicolegal cases.
A registered medical practitioner can examine an arrested person if requested by a police officer (minimum rank: Sub-Inspector).
Reasonable force may be used if necessary.
Female practitioners must examine females, either directly or under supervision (Sec 53 CrPC).
An arrested person may also request an examination, provided it is not for evasion of justice (Sec 54A CrPC).
Consent is mandatory for examination.
If the victim is under 18, only a female practitioner can perform the examination (POCSO Act 2012).
For those above 18, any registered medical practitioner may perform the examination with consent (Sec 164 CrPC).
Under 12 Years: Parents or guardians must give consent as children cannot grant valid consent (Sec 89 IPC).
Ages 12-18: Individuals can consent to physical examinations.
Above 18: Valid consent can be given for surgical procedures.
Consent is invalid if obtained under coercion or misunderstanding (Sec 90 IPC).
Must be free and voluntary, without undue influence or fraud.
Should be properly documented.
Requires witness for written consent.
Medical purpose and potential outcomes must be explained to the patient.
For minors (under 12), consent is given by the warden for examinations.
Patients' illnesses must remain confidential, except for communicable diseases.
Consent does not defend against claims of medical negligence.
For procedures like sterilization, spouse consent is not needed but is grounds for divorce if done without consent.
In prenatal diagnostics, informed consent from the pregnant woman is required.
Spouse consent is not required for medical treatment.
Each treatment stage requires consent.
Patients cannot be detained against their will.
Consent from spouse or next of kin is needed for post-mortem organ donation or body donation for study.
Pathological autopsies require consent from relatives.
No consent needed for medicolegal autopsies or organ removal for analysis.
No consent is required for government mass immunization programs.
Patients can consent to new life-saving treatments
For MTP, the consent of the pregnant lady alone is enough if she is above 18 years
Sexual intercourse with minors (below 18) is considered statutory rape regardless of consent.
Consent should also be sought for examination in criminal cases.
Consent should be sought to examine an arrested person. Even if he does not give the consent, he can be examined using sufficient force for the purpose of examination (Sec 53 CrPC).
In criminal cases, consent is not a defence.
A person below 18 years or a mentally ill person cannot give valid consent for surgical procedures or examination for medicolegal purpose. Parent or guardian should give consent.
Emergencies (Sec 92 IPC)
Therapeutic privilege
Therapeutic waiver
Examination under arrest (Sec 53 CrPC)
Medicolegal postmortems (Sec 174 CrPC)
Treatment for notifiable diseases for community safety
Court-ordered psychiatric examinations
Getting consent without specifying anything or not giving much information.
Blanket Consent is of questionable legal validity.
Defined as faking illness for personal gain; common disorders feigned include abdominal pain, rheumatism, vertigo, sciatica etc.
To avoid hard duties and business contracts
To claim more compensation
To draw more sympathy
To avoid responsibilities
Provides compensation for work-related injuries and diseases (e.g., poisoning from heavy metals).
Dependents receive compensation if a workman dies in an accident.
Compensation depends on the injury type: death, permanent disablement, or partial disability.
Workmen are ineligible for compensation if under the influence of drugs or alcohol when injured.
Act amended in 2017 as Employee's Compensation (Amendment) Act to increase compensation amounts.
Compensation also covers chronic poisoning (arsenic, lead, mercury, manganese, cadmium)and occupational diseases (bronchiectasis, asbestosis, cataract, lung fibrosis).
Issuance of medical certificates should be:
Impartial
Scientific
Accurate
Free of favoritism
Medical practitioners offer services free of charge when issuing these certificates.
Purpose: To provide benefits to employees in cases of:
Sickness
Maternity
Employment injury
Establishment of the Employees' State Insurance Corporation (ESIC):
Chaired by a chairman and vice-chairman appointed by the Central Government.
Other members involved as well.
Coverage includes:
All employees must be insured.
Various benefits issued including:
Sickness benefits
Maternity benefits
Disablement benefits for injured employees
Dependents benefits in case of employee death
Medical treatment benefits for employees and their families
ESIC hospitals are established across India by the Central Government.
Some function as medical colleges.
Objective: To protect consumer interests.
Establishment of consumer councils or forums for dispute redressal.
Consumer dispute redressal agencies include:
District Forum
Headed by a district judge.
Compensations up to 1 Crore.
State Commission
Headed by a high court judge.
Compensations up to 10 Crore; appellate authority for District Forums.
National Consumer Commission
Apex body, headed by a Supreme Court judge.
Compensations exceeding 10 Crore; appellate authority for State Commissions.
Supreme Court
Final appellate authority.
Complaint procedure:
Complaints to be lodged in the District Forum within 2 years.
No court fees charged to consumers.
Resolution timeframe: 90 days (extendable to 150 days).
Appeals against orders must be filed within 30 days.
District Forums have powers resembling those of a civil court under the Code of Civil Procedure, 1908.
Can issue interim orders if required.
Appeals can be made to State or National Commission, with final recourse to the Supreme Court.
Before appealing, the appellant must deposit 50% of the ordered amount or specified fees in respective commissions.
Rs. 25,000 in State Commission, Rs. 35,000 in National Commission.
No fees required for claims less than Rs. 5 lakhs.
Consumer courts can attach the property of the opposite party for recovery.
District collector plays a crucial role in amount recovery.
Courts can refer settlements through mediation cells attached to district and state commissions.
If a complaint is found to be false, the complainant may pay costs up to Rs. 10,000 to the opposite party.
Doctors and hospitals are subject to the Consumer Protection Act (COPRA).
Medical practitioners are liable for acts of medical negligence.
All hospitals (government and private) and all patients fall under this act.
Compensation is required if negligence results in injury or death.
Covers all goods and services, including provisions for e-commerce.
Aims to protect human rights and prevent violations.
Establishes National Human Rights Commission (NHRC) and State Human Rights Commissions.
NHRC chaired by a retired Chief Justice of India or Supreme Court Judge appointed by the President.
State chairs are appointed by the Governor.
Term duration: 3 years.
Defines human rights related to life, liberty, equality, and dignity.
NHRC can investigate cases of human rights violations on its own accord or upon complaint.
Has power to visit jails and institutions for protection of inmates.
Can seize documents and summon witnesses under oath.
Engages in human rights education.
Police administration: failure to act, unlawful detention, false implication, custodial violations.
Other issues: custodial deaths, encounter deaths, atrocities against SC/ST, child labor, dowry demands, abductions, rape, murder, sexual harassment, and exploitation of women.
Established for speedy trials of human rights violation cases.
District Magistrates and Superintendents of Police must report custodial deaths or torture within 24 hours.
Female detainees must be accompanied by a woman police officer.
Arrestees must be brought before a court within 24 hours and allowed to meet friends or lawyers.
Autopsies of custodial deaths must be video-recorded and reported to NHRC.
Postmortem reports must follow NHRC's prescribed format.
NHRC declared all third-degree investigation methods as human rights violations (1995).
Agencies violating human rights are liable for compensation.
A new All India Jail Manual was created in 2010 to reform the prison system.
Regulation, storage, and transportation of human organs and tissues for therapeutic purposes.
Aim to prevent commercial dealings in human organs.
Donor: Individual aged 18 or older can authorize removal of their organs after death.
Authorization can be granted by the legal possessor of the deceased's body unless it contradicts the donor's prior wishes.
If the deceased did not authorize removal:
Legal possessor may authorize organ removal unless a near relative objects.
Authorization must be provided to a registered medical practitioner.
Certification: Brain-stem death must be confirmed by a board of medical experts before removal.
For minors, parents can give authorization for organ removal upon brain-stem death.
If a dead body in a hospital/prison remains unclaimed for over 48 hours, management can authorize organ removal.
Members Include:
In-charge registered medical practitioner of the hospital.
Independent specialist registered medical practitioner.
Neurologist or neurosurgeon nominated by the medical officer.
Treating medical practitioner (not a member of the transplantation team).
Post-Mortem Cases: Authorization can be given by a competent individual if organs won't be used for post-mortem analysis.
If a donor (not a near relative) has signed a specific authorization form, permission from the authorization committee is necessary before organ removal.
Removal requires prior approval if the donor wishes to donate to a non-relative due to affection.
Authorization: No person may remove human organs except for therapeutic reasons.
Practitioners must inform about possible risks associated with organ removal and transplantation.
Committees constituted by state governments to oversee organ donation applications.
Joint applications from donors and recipients must comply with the rules to obtain approval.
Hospitals must register under the Act for removal or transplantation activities.
State-appointed officers will inspect hospitals for compliance and quality assurance.
Offenders face up to 10 years of imprisonment and fines up to 20 lakh rupees for various offences like illegal transplantation, storage, preservation, and selling of organs.
Submission of false affidavits can result in imprisonment up to 10 years and fines up to 1 crore rupees.
The following acts have been repealed:
Ear Drums and Ear Bones (Authority for Use for Therapeutic Purposes) Act 1989
Eyes (Authority for Use for Therapeutic Purposes) Act 1982
Bone marrow transplantation is not covered under the Organ Transplantation Act.
Eyes and ears can be removed from a deceased donor for therapeutic purposes by a doctor.
In cases of biological incompatibility among relatives, mutual organ transplantation (swap transplantation) is allowed with prior approval from the authorization committee (amendment 2014).
No organs or tissues can be taken from minors or mentally challenged individuals.
If one party is a foreign national, organ transplantation requires prior permission of the authorization committee, provided both parties are relatives.
Caution is needed when an Indian-origin donor is involved and the recipient is not an Indian citizen regarding the NOC for organ transplantation.
HLA matching is required for organ transplantation.
Organs that cannot be transplanted from a deceased body include the brain and urinary bladder.
The risks to the life of a living donor.
Commercialization of organ transplantation.
Organ trafficking and transplant tourism.
Death certification regarding organ transplantation from patients with brain stem death.
Solutions to the above issues necessitate the implementation of legal, ethical, and humanitarian principles in organ transplantation.
Adopted in 1975, amended in 2005 and 2006 during the WMA assembly.
Provides guidelines for doctors concerning torture, degradation, or cruel treatment of prisoners.
Doctors are prohibited from participating in torture.
Human subjects (living individuals) are used for research and clinical trials, particularly for novel vaccines, drugs, and medical devices.
Approval from Health Authority/Ethics committee is mandatory to initiate research.
Protecting the rights, dignity, and safety of participants involves adhering to four basic principles:
Autonomy
Beneficence
Non-maleficence
Justice
Human research subjects must be respected and their rights protected:
Voluntary and informed consent is essential.
Rights include:
Right to safeguard integrity.
Right to withdraw from research at any time.
Protection from physical, mental, and emotional harm.
Access to information regarding research.
Protection of privacy and well-being.
Guidelines established by international communities include:
Nuremberg Code (1949)
Common Rule (1991)
Declaration of Helsinki
Belmont Report
Established in 1964 to regulate international research.
Considered a cornerstone document on human research ethics.
Developed by the World Medical Association (WMA).
Key Principles:
Biomedical research should be conducted by qualified individuals.
Risks of research must be assessed, especially those leading to personality changes.
New life-saving drugs may be used upon obtaining patient consent.
Non-therapeutic drugs can be used if risks are explained and written consent is obtained.
Therapeutic experimentation should benefit the patient and community.
Experimental methods should be used after customary methods fail.
Researchers must understand the success probability and risks before experimentation.
Prior animal experimentation must be successful before human trials.
Issued by WMA in 1970 on therapeutic abortion and revised in 1983 and 2006.
Created in 1978 to protect human subjects in biomedical and behavioral research.
Key concerns: privacy, confidentiality, and informed consent.
Violate principles of medical ethics.
Historical examples include Nazi Germany, Imperial Japan, North Korea, US, and Soviet Union.
Nazi Germany conducted extensive human experimentation in concentration camps.
Focuses on ethical questions arising from life sciences, biotechnology, medicine, and their intersection with ethics, law, theology, and philosophy.
Coined by Fritz Jahr in 1926, originally addressing the use of plants and animals in research.
Current issues addressed include drug experimentation, abortion, euthanasia, surrogacy, organ donation, and genetic research.
Initially focused on ethical evaluation of human experimentation.
The National Commission established in 1974 to promote ethical principles in biomedical research.
Fundamental Principles:
Respect for persons
Beneficence
Justice
Additional principles include non-maleficence, human dignity, and sanctity of life.
Bioethicists come from fields such as philosophy, law, medicine, political science, and theology.
Autonomy is often prioritized by medical scholars.
Gene Therapy Ethics:
Concerns over editing genes in reproductive cells to prevent future genetic disorders.
Potential long-term effects on human development are unknown.
Responsible for ethical review of research proposals prior to initiation.
Continuing responsibility to monitor approved research for ethical compliance.
Members from various disciplines: medicine, law, social science, political science, theology, etc.
Headed by a chairperson and supported by other members.
Purpose: Protect human subjects and ensure high ethical standards in research.
ICMR guidelines (2006): Ensure competent review of all ethical aspects objectively.
Protect and promote the dignity, rights, and well-being of research participants.
Ethical committee clearance required to commence medical research.
Stem cells are the body's basic cells, generating specialized cells under optimal conditions.
Divide to form daughter cells:
Self-renewal: Becoming new stem cells.
Cell differentiation: Becoming specialized cells (e.g., blood, brain, heart muscle, bone).
Potential benefits: Understanding disease conditions, regenerating/repairing damaged tissues (regenerative medicine).
Applicable for conditions such as spinal cord injuries, type I diabetes, Parkinson's disease, etc.
Can be used for drug testing regarding safety and quality.
Embryonic Stem Cells
Derived from 3-5 days old embryos (blastocyst stage).
Pluripotent: capable of differentiating into any body cell.
Used for tissue or organ regeneration.
Adult Stem Cells
Found in small quantities in adult tissues (e.g., bone marrow, fat).
Altered to possess properties of embryonic stem cells.
Ethical concerns arise from embryonic stem cells obtained from early embryos (created during in vitro fertilization).
Guidelines (2009) from the National Institute of Health:
Only use embryos that are no longer needed for stem cell research.
Traditionally taken by medical graduates upon entering the profession.
One of the oldest known Greek medical texts (5th-3rd century BC).
Initially required physicians to swear by healing gods to uphold high ethical standards.
Considered the earliest expression of medical ethics in the Western world.
Modern adaptations have removed and updated several parts over time.
Ancient Indian oath for medical students found in Charaka Samhitha (1st century).
Reflects concepts from ancient non-medical Indian literature, unlike the Hippocratic oath.
Uniquely Hindu elements include:
Requirement to live a celibate life.
Mandatory aspects like growing hair/beard, vegetarianism, and carrying no arms.
The oath is taken in front of sacred fire, Brahmanas, and physicians.
Responsibilities include:
No hatred for the king and avoidance of unrighteous acts.
Respect and serve teachers as if they were fathers.
Pray for all creatures, including Brahmanas and cows.
Prohibition on adultery, excessive pride, and drunkenness.
Understand that knowledge should not lead to boastfulness.
Sushruta, father of plastic surgery, laid down ethical guidelines in Sushruta Samhitha (3rd century).
Emphasizes the importance of responsibility and patient care:
Advisors on personal grooming (trimmed nails, short hair, clean clothing).
Treat patients as if they were their own children.
Avoid greed, anger, pride, and untruthfulness.
Punishment for medical negligence: potential loss of a body part for the physician.
Physicians should also be skilled in cooking for palatability of medicines.
Revision of the Hippocratic Oath, adopted by World Medical Association.
Amended in 1968, 1984, 1994, 2005, and 2006.
Taken by new medical professionals at convocation, includes commitments to:
Dedicate life to serving humanity.
Show respect and gratitude to teachers.
Maintain conscience and dignity in practice.
Prioritize patient health above all.
Keep patient secrets confidential.
Uphold honor of the medical profession.
Treat colleagues as brothers and avoid biases in care.
Respect for human life from conception; uphold laws of humanity.
Make these promises freely and with honor.
HIV patients face marginalization and stigma in society.
Migration and urbanization in India contribute to risks:
Migrant laborers often lack stable housing and family support.
Illiteracy and unawareness lead to high-risk behaviors.
Vulnerable populations include:
Truck drivers, commercial sex workers (CSWs), and intravenous drug users (IDUs).
Economic impact of HIV on families:
Loss of income, increased medical expenses, and negative effects on food, education, and health.
Surviving family members are significantly affected by medical issues.
The social fabric of families may be disrupted.
Vulnerability of women and girls increases where access to education and healthcare is limited.
Ethical Importance: Confidentiality helps prevent discrimination.
Conflicts arise between the individual's right to confidentiality and the partner's right to be protected from infection risk.
National AIDS Control Guidelines promote self-disclosure of HIV status to partners.
Supreme Court decisions: Rights to privacy and confidentiality are not absolute and may be restricted when partner risks are present.
NACO policy mandates voluntary consent for HIV testing.
Ideally, HIV status disclosure should not affect employment or healthcare rights.
Stigma is one of the largest barriers for HIV-positive individuals.
Fear of dealing with HIV-positive patients can hinder testing and lead to transmission.
HIV-positive women should have the ability to make informed choices regarding pregnancy and childbirth.
Counseling is essential to support decisions about continuing or terminating pregnancy.
Higher ethical standards are required for behavioral or biological research on HIV/AIDS due to stigma and human rights concerns.
Protection of human rights is vital for safeguarding dignity in the context of HIV/AIDS.
Proper rights protection can reduce infection rates and improve coping mechanisms for those affected by HIV/AIDS.
Section 269 IPC: Negligently spreading infection liable for 6 months imprisonment and a fine. Example: A doctor using an infected needle.
Section 270 IPC: Malignant acts to spread infection punishable by 2 years imprisonment and a fine.
Engaging the public in health discussions.
Building professional networks.
Facilitating access to health information for patients.
Professional Boundaries: Maintaining separation between personal and professional relationships is crucial.
Breach of Confidentiality: Patient confidentiality must be preserved in social media communications.
Medical Etiquette: Avoid criticism or controversial opinions in public forums to prevent confusion among patients and colleagues.
No bullying or harassment of fellow professionals on social media.
Anonymity: Doctors should refrain from making anonymous opinions on social media to avoid potential problems that may arise from being traced.
Advertising: Doctors should not utilize public media for self-advertisement related to themselves or their institutions.
Medicolegal Issues
Public Comments: avoid posting comments on medicolegal matters that could be under investigation.
Communication: Relevant discussions should occur directly with investigation teams
Emotional Burnout: Increasing reports of burnout among doctors due to:
Long working hours
High patient load
Nature of Stress: It's a result of the interplay between demanding work and insufficient rewards, leading to feelings of lack of control.
Mild Stress Benefits: Low levels of stress can enhance work efficiency, but excessive stress can lead to depression and exhaustion.
Consequences of Poor Stress Management: Affects include higher rates of divorce, substance abuse, and heightened suicide rates compared to other professions.
Exercise Regularly: Maintaining a physical activity routine.
Balanced Diet: Consuming nutritious meals.
Adequate Sleep: Prioritizing restful nights.
Meditation: Engaging in mindfulness practices.
Taking Vacations: Allowing time away from work.
Reading for Pleasure: Engaging with books of personal interest.
Artistic Activities: Participation in music, dance, art, or drawing.
Social Support: Talking to friends, family, or colleagues about stress and burnout.
Patient Autonomy: Patients have the right to make their own medical decisions; healthcare providers should facilitate education without making decisions for them.
Beneficence: Healthcare providers must act in the best interest of patients; conflicts can arise between beneficence and patient autonomy, requiring providers to explain recommendations clearly.
Non-maleficence: This principle emphasizes ensuring that treatment does not cause additional harm.
Justice: Ensures fair treatment and equitable access to care for patients.
Confidentiality: Patients trust healthcare providers to maintain discretion regarding their medical conditions.
Fundamental to Care: A strong relationship based on empathy, honesty, transparency, responsibility, equality, vulnerability, and communication.
Communication Skills: Essential for effective patient interaction and public communication, which are critical for implementing health programs.
Education Goals: Medical education must focus on producing committed and practically experienced doctors with excellent communication skills.
Rating scale from Kalamazoo declaration includes:
Builds relation
Opens discussion
Gathers information
Understands the patient's perspective
Shares information
Manages flow
Definition: Painless death for individuals suffering from hopelessly incurable and painful diseases.
Euthanasia has two types:
Active Euthanasia (Physician-assisted suicide)
Passive Euthanasia
Considered a merciful act to end a person's suffering.
Administering lethal doses (opium, barbiturates, Pentothal sodium) for active euthanasia.
Legally permitted in:
Netherlands
Albania
Luxembourg
Belgium
Voluntary Euthanasia - Individual requests mercy killing to end suffering.
Non-voluntary Euthanasia - Individual is unconscious and unable to request.
Involuntary Euthanasia - Mercy killing without patient consent.
End of unbearable suffering.
High cost of medical treatment.
Individuals should not be forced to live.
"Right to live" includes the right to end life.
No one has the right to take life.
Against medical ethics.
Medical advancements may allow recovery from vegetative states.
Rejects the value of human life.
Few countries have legalized euthanasia.
Risk of misuse if legalized.
Indian nurse in a vegetative state for 42 years after sexual assault.
Supreme Court allowed passive euthanasia in 2011; hospital authorities refused.
Died of pneumonia on May 18, 2015.
March 9, 2018: Supreme Court upheld passive euthanasia.
Right to die with dignity recognized as part of the basic right to life.
Provision for living wills, such as "Do Not Resuscitate" (DNR), exists in many western countries.