Law and Medicine


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Q. Doctor and Patient relationship is based on Implied Contract. Explain. Is the law of negligence applicable to Doctors? How are the duties of a doctor controlled by Consumer Protection Act, 1986? Discuss with the help of decided cases.  / Explain the obligations of a doctor towards a patient. What should be the standard of care? What are the recent trends in Consumer Protection law with reference to Liability of Doctors. Describe the criminal liability arising out of professional negligence.

The profession of a doctor is considered to be the most pious profession and a doctor is respected in the society as no other professional. A doctor commands immense trust of his patients because of his ability to cure the patients. Patients literally put their lives in the hands of a doctor. It is imperative for a doctor that when he holds such a huge influence over his patient, he must not let him down and give his patient due care and attention. It is the responsibility of the doctor to follow standard procedures and precautions while treating his patient. Negligence on the part of a doctor can cause severe hardship for the patient and can even lead to the patients death.  

Negligence is a subject of Torts as well as Crime and the law of negligence is certainly applicable to doctors. In fact, for a long time, until 1992 (when due to a judgment by SC, medical profession was brought within the ambit of Consumer Protection laws), the law of negligence was the only remedy for compensation against negligence by a medical professional.  A doctor is liable to Civil as well as Criminal Negligence depending on the situation.

Implied Contract between a Doctor and a Patient
Contract is defined as an agreement between two or more persons which creates an obligation to do or not to do a particular thing. Contract may be implied or express.  An implied contract is one inferred from conduct of parties and arises where one person renders services under circumstances indicating that he expects to be paid therefor, and the other person knowing such circumstances, avails himself of benefit of those services. An express contract is an actual agreement of the parties, the terms of which are openly uttered or declared at the time of making it, being stated in distinct and explicit language, either orally (oral agreement ) or in writing (written agreement).

The doctor-patient contract is almost always of the implied type, except where a written informed consent is obtained because no formal contract is usually written when a patient visits a doctor. Thus, it can be said that the relationship between a doctor and his patient is of an implied contract. Although there is no written or oral explicit contract between them, it is implied that the doctor is expected to cure the patient and the patient pays fees in consideration. Thus, persons who offer medical advice and treatment implicitly state that they have the skill and knowledge to do so, that they have the skill to decide whether to take a case, to decide the treatment, and to administer that treatment. This is known as an “implied undertaking” on the part of a medical professional. In case of Dr Laxman Balkrishna Joshi vs Dr Trimbak Bapu Godbole, AIR 1969, the Supreme Court held that a doctor who holds himself ready to give medical advice and treatment impliedly undertakes that he is possessed of skill and knowledge for the purpose.  Such a person when consulted by a patient, owes him certain duties, viz., a duty of care in deciding whether to take the case, a duty of care to decide the treatment, and a duty of care while administering the treatment. A breach of these duties gives a right of action of negligence to the patient.

When a doctor accepts a patient, he has certain responsibilities towards that patient. It is an implied contract. A doctor-patient contract requires that the doctor must treat such a person with reasonable care, reasonable skill. He must not undertake any procedure/ treatment beyond his skill.

As held in Dr P Luthra vs Iftekhar, while a doctor does not guarantee that he will cure the patient, he is expected to provide a treatment that is considered apt by medical professionals in similar situation. If there are multiple opinions about the treatment in given situation, and all are accepted by various groups of medical professionals, a doctor cannot be said to have erred in following one of such opinions.

Implied contract is not established when :
(i) the doctor renders first-aid in an emergency ;
(ii) he makes a pre-employment medical examination for a prospective employer;
(iii) he performs an examination for life insurance purpose ;
(iv) he is appointed by the trial court to examine the accused for any reason ; and
(v) when he makes an examination at the request of an attorney for last suit purposes.


Reasonable Care
A doctor must use clean and proper instruments, and provide his patients with proper and suitable medicines if he dispenses them himself. If not, he should write the prescriptions legibly,using standard abbreviations and mention instructions for the pharmacist in full. He should give full directions to his patients as regards administration of drugs and other measures,preferably in local written language. He must suggest / insist on consultation with a specialist in the following circumstances :
1. When the case is complicated.
2. When the question arises about performing an operation which may be dangerous to life or requiring amputation.
3. Operating on a case in which there has been a criminal assault.
4. Performing an operation which may affect the intellectual or reproductive functions of a patient.
5. In cases where there is suspicion of poisoning or other criminal act.
6. When desired by the patient / attendants.
7. When it appears that the quality of medical service is required to be enhanced.
8. When there is no one from whom informed consent can be obtained.

Reasonable Skill
The degree of skill a doctor undertakes is the average degree of skill possessed by his professional brethren of the same standing as himself. The best form of treatment may differ when different choices are available. There is an implied contract between the doctor and the patient when the patient is told in effect : "Medicine is not an exact science. I shall use my experience and best judgment and you take the risk that I may be wrong. I guarantee nothing."

Not to undertake any procedure beyond his skill - This depends upon his qualifications, special training and experience. The doctor must always ensure that he is reasonably skilled before undertaking any special procedure / treating a complicated case. To quote an example, a doctor who is not sufficiently trained or qualified should not administer anesthesia.

Professional Secrets
A professional secret is one which a doctor comes to learn in confidence from his patients, on examination, investigations or which is noticed in the ordinary privacies of domestic life. A doctor is under a moral and legal obligation not to divulge any such secret except under certain circumstances. This is known as privileged communication which is defined as a communication made by a doctor to a proper authority who has corresponding legal, social and moral duties to protect the public. In must be bona fide and without malice, e.g., as a witness in a court of law; warning partners or spouses of AIDS patients and those found infected with HIV; informing public health authorities of food poisoning from a hotel etc; assisting apprehension of a person who has committed a serious crime ;informing law enforcers about medico-legal cases, etc.


Civil Negligence
Since it is established that there exists an implied contract between a doctor and a patient, a medical practioner is obligated to fulfill his part of the contract. A question of civil negligence arises when a patient dies or is injured while in care of a doctor and the patient or his representative sue the doctor for compensation. In such cases, it is up to the plaintiff to prove that -
1. The defendant owed him a duty to a particular standard of conduct.
2. The defendant was derelict and failed to perform that duty.
3. The plaintiff suffered actual damage.
4. The conduct of the defendant was the direct or proximate cause of the damage.

In certain cases,  the principle of Res ipsa loquitor i.e. situation speaks for  itself, applies. For example, in several cases that involved articles left in the body of the patient after a surgery, it has been held that it cannot happen without the doctor being negligent. In such cases, it is not necessary for the plaintiff to prove the negligence of the doctor. The applicability of this principle rests on three conditions -
1. The situation must be such that it cannot happen without negligence.
2. The plaintiff must not have added to his own injury.
3. The defendant must have been in total and exclusive control of the situation.

Criminal Negligence
The question of criminal negligence arises in case death or serious injury to a patient caused by criminal negligence. In case of a death, a doctor may be charged under Section 304-A of IPC, which makes it an offence to cause death of  any person by doing any rash or negligent act. In case of serious injury, he may also be charged under Section 336 - Act  endangering life or personal safety of others, Section 337 - Causing  hurt by act endangering life or personal safety of others
and Section 338 - Causing grievous hurt by act endangering life or personal safety of others.

For the above to happen, the degree of negligence has to be so grave as to go beyond compensation and must be penalized because it causes harm not just to the victim but to the society as well. Conduct that disregards the life and safety of the patient deserves punishment.

SC, in the case of Dr. Suresh Gupta, Aug 2004, gave guidelines on when a doctor may be held as criminally liable. It held that the standard of negligence that had to be proved to fix a doctor’s or surgeon’s criminal liability was set at “gross negligence” or “recklessness.”  It distinguished between an error of judgment 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.

However, 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 AIR 2004. In this case, 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.

Thus, the negligence is so great as to go beyond matter of mere compensation. Not only has the doctor made a wrong diagnosis and treatment, but also that he has shown such gross ignorance, gross carelessness or gross neglect for the life and safety of the patient that a criminal charge is brought against him. For this he may be prosecuted in a criminal court for having caused injury to or the death of his patient by a rash and negligent act amounting to culpable homicide under Section 304-A of the Indian Penal Code. Some examples are as follows:

1. Injecting anesthetic in fatal dosage or in wrong tissues.
2. Amputation of wrong finger, operation on wrong limb,removal of wrong organ, or errors in ligation of ducts.
3. Operation on wrong patient.
4. Leaving instruments or sponges inside the part of body operated upon.
5. Leaving tourniquets too long, resulting in gangrene.
6. Transfusing wrong blood.
7. Applying too tight plaster or splints which may cause gangrene or paralysis.
8. Performing a criminal abortion.


Patient as a Consumer

In the past two decades, medical field has seen tremendous rise in terms of doctors, nursing homes, hospitals, and also the patients because of population explosion. With the rise of commercialization of medical services, the society has witnessed a sharp rise in cases of negligence by medical professionals.  Although medical professionals are governed by Medical Councils, who have the power to suspend or revoke the license of a medical practioner upon such negligence, the medical councils do not have any power to provide any compensation to the victim of a doctor's negligence.  Since negligence is generally covered under Law of Torts, this necessitated the aggrieved parties to approach Civil Courts for damages. This is a time consuming and expensive process, which very few had the ability to avail.  Thus, there was an urgent need to curb the irresponsible attitude of the medical professionals as well as to provide faster relief to victims of medical negligence.

Consumer Protection Act, 1986, was a landmark act that gave power to the consumers in cases of being cheated by businesses providing any kind of services. However, this act did not explicitly include Medical services. It must be noted that a doctor does not perform out of altruism. He charges fees for his services and in this respect, a patient is a consumer of his services. This is the basic premise which was observed by the Supreme Court of India in the case of Indian Medical Association vs V P Shantha, AIR 1995.  In this case, SC held that doctors, hospitals, and nursing homes who render service as medical practitioner are accountable for any act of medical neglect and they can be sued for compensation under Consumer Protection Act, 1986. As a result of this judgment, medical profession was brought under the Section 2(1) (o) of CPA, 1986. It has included the following categories of doctors/hospitals under this Section:
  1. All medical/dental practitioners doing independent medical/dental practice unless rendering only free service.
  2. Private hospitals charging all patients.
  3. All hospitals having free as well as paying patients and all the paying and free category patients receiving treatment in such hospitals.
  4. Medical / dental practitioners and hospitals paid by an insurance firm for the treatment of a client or an employment for that of an employee.
It exempts only those hospitals and the medical / dental practitioners of such hospitals which offer free service to all patients. Further, this judgment concedes that the summary procedure prescribed by the CPA would suit only glaring cases of negligence and in complaints involving complicated issues requiring recording of the evidence of experts, the complainant can be asked to approach the civil courts. Also, this judgment says that the deficiency in service means only negligence in a medical negligence case and it would be determined under CPA by applying the same test as is applied in an action for damages for negligence in a civil court. As a result of this judgment, virtually all private and government hospitals and the doctors employed by them and the independent medical / dental practitioners except primary health centers, birth control measures, anti malaria drive and other such welfare activities can be sued under the CPA.

Duties/Obligations of a Doctor

Duties and obligations of doctors are enlisted in ordinary laws of the land and various Codes of Medical Ethics and Declarations - Indian and International, which are :
(i) Code of Medical Ethics of Medical Council of India ;
(ii) Hippocratic Oath ;
(iii) Declaration of Geneva ;
(iv) Declaration of Helsinki;
(v) International Code of Medical Ethics ;
(vi) Government of India Guidelines for Sterilization.

On the basis of these various Codes of Ethics and Declarations, the duties can be summarized as under -

1. Duties to Patient.
2. Duties to Public.
3. Duties towards Law Enforcers.
4. Duties not to violate Professional Ethics.
5. Duties not to do anything illegal or hide illegal acts.
6. Duties to each other.

1. Duties to Patient - These are : Standard Care, Providing Information to the Patient /Attendant , Consent for Treatment, and Emergency Care. The first duty of a doctor towards his patient is to provide the patient with due skill, care, and attention.  In the case of the State of Haryana vs Smt Santra, AIR 2000, the Supreme Court held that every doctor “has a duty to act with a reasonable degree of care and skill”. While it is not possible to lay down precise standards of medical skill and care, it can be reasonably said that the skill and care that is provided by an average doctor is what any doctor can be expected to provide to his patients.


(A) Standard Care - This means application of the principles of standard care which an average person takes while doing similar job in a similar situation :

1. Due care and diligence of a prudent Doctor.
2. Standard, suitable, equipment in good repair.
3. Standard assistants : Where a senior doctor delegates a task to a junior doctor or paramedical staff, he must assure himself that the assistant is sufficiently competent and experienced to do the job, and fulfills the prescribed qualifications.
4. Non-standard drug is a poison by definition.
5. Standard procedure and indicated treatment and surgery.
6. Standard premises, e.g. Nursing Home, Hospital , must comply with all laws applicable as imposed by the State and these must be registered wherever required.
7. Standard proper reference to appropriate specialist.
8. Standard proper record keeping for treatment given,surgery done, X-ray and pathological reports.
9. Standard of not to experiment with patient ( See Declaration of Helsinki in Appendix IV).
10. Anticipation of standard risks of complications and preventive actions taken in time.
11. Observe punctuality in consultation.

(B) Duty to provide information to patient / attendant

1. Regarding necessity of treatment.
2. Alternative modalities of treatment.
3. Risks of pursuing the treatment, including inherent complications of drugs, investigations, procedure,surgery etc.
4. Regarding duration of treatment.
5. Regarding prognosis. Do not exaggerate nor minimize the gravity of patient’s condition.
6. Regarding expenses and break-up thereof.


(C) Consent for treatment - Must obtain consent before any operation.

(D) Emergency Care - A doctor is bound to provide emergency care on humanitarian grounds, unless he is assured that others are willing and able to give such care. It may be noted that prior consent is not necessary for giving emergency / first-aid treatment. In emergency medico-legal cases, condition of first being seen by medical jurist is not essential.

(E) Duty to warn -  The doctor must warn the patient of any known or possible side effects of a drug, device, or operation. Failure to do so renders the doctor liable for the harm suffered by the patient.

2. Duties to the Public -

1. Health Education
2. Medical help when natural calamities like drought,flood, earth-quakes, etc. occur.
3. Medical help during train accidents.
4. Compulsory notification of births, deaths, infectious diseases, food poisoning etc.
5. To help victims of house collapse, road accidents, fire,etc.

3. Duty towards Law Enforcers, Police, Courts, etc.

1. To inform the police all cases of poisoning, burns,injury, illegal abortion, suicide, homicide,manslaughter, grievous hurt and its natural complications like tetanus, gas-gangrene , etc. This includes vehicular accidents, fractures, etc.
2. To call a Magistrate for recording dying declaration.
3. To inform about bride burning and battered child cases.

4. Duty not to violate Professional Ethics

1. Not to associate with unregistered medical practitioner and not allow him to practice what he is not qualified for.
2. Not to indulge in self-advertisement except such as is expressly authorized by the M.C.I. Code of Medical Ethics.
3. Not to issue false certificates and bills.
4. Not to run a medical store / open shop for sale of medical and surgical instruments.
5. Not to write secret formulations.
6. Not to refuse professional service on grounds of religion, nationality, race,party politics or social status.
7. Not to attend patient when under the effect of alcohol
8. No fee sharing ( Dichotomy).
9. Not to talk loose about colleagues.
10. Information given by patient /attendant to be kept as secret. Not to be divulged to employer, insurance company, parents of major son/daughter without consent of patient. Even in court this information is given only if ordered by the Court.
11. Recovering any money ( in cash or kind) in connection with services rendered to a patient other than a proper professional fee, even with the knowledge of the patient.

5. Duty not to do anything illegal or hide illegal acts

1. Perform illegal abortions / sterilization’s
2. Issue death certificates where cause of death is not known.
3. Not informing police a case of accident, burns,poisoning, suicide, grievous hurt, gas gangrene.
4. Not calling Magistrate for recording dying declaration.
5. Unauthorized, unnecessary , uninformed treatment and surgery or procedure.
6. Sex determination (in certain States).

6. Duty to other Doctors

1. A doctor must give to his teachers respect and gratitude.
2. A doctor ought to behave to his colleagues as he would like them to behave to him.
3. A doctor must not entice patients from his colleagues,even when he has been called as a specialist.
4. When a patient is referred to another doctor, a statement of the case should be given. The second doctor should communicate his opinion in writing /over telephone/fax direct to the first doctor.
5. Differences of opinion should not be divulged in public.
6. A doctor must observe the principles enunciated in ‘The Declaration of Geneva’ approved by the World Medical Association.

Duties of the Patient / Attendant
When a patient ( consumer ) hires or avails of services of a doctor for treatment, he has the following duties :-

1. He must disclose all information that may be necessary for proper diagnosis and treatment.
2. He must co-operate with the doctor for any relevant investigations required to diagnose and treat him.
3. He must carry out all the instructions as regards drugs,food, rest, exercise or any other relevant /necessary aspect.
4. In the case of a private medical practitioner he must compensate the doctor in terms of money and money alone. Moral considerations apart, failure on the part of the patient / attendant to do his duty :
(a) will enable the doctor to terminate patient -physician contract and that would free him from his legal responsibilities,
(b) will be construed as contributory negligence, and weaken the case of the patient for compensation.



Q. What defenses are available to a doctor in a suit for negligence under tort?

That the treatment that he gave was reasonably accepted among other professionals in similar situations.
That there was no negligence on his part.
That the patient added to his own injury.
That the patient did not follow his directions properly.
That the patient was not exclusively in his care.

The most important thing is to maintain proper record of the patient that can prove that appropriate medical care and treatment was give. The following information may be maintained in this regard -

  1. In complicated cases record precisely history of illness and substantial physical findings about the patient on your prescription.
  2. If the patient/attendants are erring on any count ( history not reliable, refusing investigations, refusing admission ) make a note of it or seek written refusal preferably in local language with proper witness.
  3. Mention the condition of patient in specific /objective terms. Avoid vague / non-specific terminology.
  4. Record history of drug allergy.
  5. If a drug is a poison ( e.g., certain local applications ), warn in writing.
  6. Mention additional precautions e.g., food, rest, avoidance of certain drugs, allergens, alcohol, smoking etc. if indicated.
  7. Mention whether prognosis explained. If necessary take a signature of patient /attendant, after explaining the prognosis in written local language.
  8. In case of any deviation from standard care, mention reasons .
  9. Specifically mention review, SOS/or follow-up schedule.
  10. Mention if patient /attendant are/is under effect of alcohol/drugs.
  11. In case a particular drug/equipment is not available, make a note.
  12. Mention where the patient should contact in case of your non-availability /emergency.
  13. Keep updating your knowledge. Read again what you think you already know. You will be in for surprises.
  14. Routinely advise X-rays in injury to bones /joints.


Q. What are the difficulties encountered in collecting evidence in such cases and how can they be overcome?
Commonsense.




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Q. Discuss the organization and regulation of Medical Education and Profession in India. Enumerate the regulatory authorities governing the Medical and Paramedical Professions. Explain their powers. "Indeed, a large number of medical areas are not at all regulated by Indian Legal order." Explain critically.  

Organization of Medical Education and Profession
Medical Profession in India is consists of four different types of streams -  Allopahy, Ayurvedic, Homeopathic, and Unani. While Allopathy, which is also known as the western medical system, is the most popular, other streams are also widely used. There are govt. approved colleges for all the three streams. The admission to the undergraduate and graduate level of  these colleges is through competitive exams.  Graduates can also go for higher degrees such as MD, MS, FRCS, MRCP.

Besides the physicians, there are various kinds of paramedical staff such as Radiologists, Anesthist, Pathologist, and of course the Nursing. There are diploma and degree courses for these professions as well.

Regulatory Authorities
The expansion of the private sector in India has forced the passages of a number of regulations to promote quality of care and to protect consumers. This has expanded the role of government in developing and enforcing regulations in three areas of the health sector: drugs, medical practice, and health care facilities. These regulations have been promulgated by both national and state governments.  

The Medical Council of India
The most important act that regulates this field is the Medical Council Act 2001, which paved the way for the formation of The Medical Council of India as well as State Medical Councils. The Medical Council of India was established in 1934 under the Indian Medical Council Act, 1933, now repealed, with the main function of establishing uniform standards of higher qualifications in medicine and recognition of medical qualifications in India and abroad. The number of medical colleges had increased steadily during the years after Independence. It was felt that the provisions of Indian Medical Council Act were not adequate to meet with the challenges posed by the very fast development and the progress of medical education in the country. As a result, in 1956, the old Act was repealed and a new one was enacted. This was further modified in 1964, 1993 and 2001. The objectives of the Council are as follows.
  1. Maintenance of uniform standards of medical education, both undergraduate and postgraduate.
  2. Recommendation for recognition/de-recognition of medical qualifications of medical institutions of India or foreign countries.
  3. Permanent registration/provisional registration of doctors with recognised medical qualifications,
  4. Reciprocity with foreign countries in the matter of mutual recognition of medical qualifications.
Besides the formation of The Medical Council of India, the Medical Council Act, 2001 also allows the Central Govt. to make important regulations in the medical profession. These are:

Graduate Medical Education Regulations, 1997:  These regulations define the general consideration and teaching approach of Medical Students. Graduate  medical curriculum is  oriented  towards  training students  to  undertake the responsibilities of  a  physician  of  first  contact  who is capable of looking after the preventive, promotive, curative & rehabilitative aspect of medicine. It also describes the eligibility and process for admission into medical colleges in India.

P.G. Medical Education Regulations, 2000:  The goal of postgraduate medical education shall be to produce competent specialists and/or Medical teachers,
   1. who shall recognize the health needs of the community, and carry out professional obligations ethically and in keeping with the objectives of the national health policy
   2. who shall have mastered most of the competencies, pertaining to the speciality, that are required to be practiced at the secondary and the tertiary levels of the health care delivery system;
   3. who shall be aware of the contemporary advance and developments in the discipline concerned;
   4. who shall have acquired a spirit of scientific inquiry and is oriented to the principles of research methodology and epidemiology; and
   5. who shall have acquired the basic skills in teaching of the medical and paramedical professionals;

It also defines the nomenclature and major components of the post graduate curriculam.

Minimum Qualifications for Teachers in Medical Institutions Regulations, 1998 :  These regulations define the minimum qualification for teachers in medical institutions. All Medical teachers must possess a basic University or equivalent qualification included in any one of the Schedules to the Indian Medical Council Act, 1956 (102 of 1956). They must also be registered in a State Medical Register or Indian Medical Register.

Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002: This is by far the most important regulation that governs the conduct of medical professionals. It specifies the duties and responsibilities of physcians in general. It formulates the guidelines for good medical practice such as - mainatenance of patient records, display of registration numbers, payment for services.

Eligibility Certificate Regulations, 2002 : These regulations establish the Eligibility Requirement for taking admission in an undergraduate medical course in a Foreign Medical Institution.

Screening Test Regulations, 2002 : An Indian citizen possessing a primary medical qualification awarded by any medical institution outside India who is desirous of getting provisional or permanent registration with the Medical Council of India or any State Medical Council on or after 15.03.2002 shall have to qualify a screening test conducted by the prescribed authority for that purpose

The State Councils maintains the register of medical professionals in the state.

The Pharmacy Council of India
It is the job of the Pharmacist to correctly dispense medicines prescribed by the doctor. This field is governed by The Pharmancy Act, 1948. The act constitutes Pharmacy Council of India and as well as State Pharmacy Councils, which in turn formulate and execute the policies governing this profession. The State councils maintains the register of pharmacists in the state.


Indian Nursing Council
Nurses are one of the key elements of the medical fraternity. This profession is governed by Indian Nursing Council Act, 1947, which constitues Indian Nursing Council. Indian Nursing Council is responsible to ensure a uniform standard of Nursing in India. To be a nurse, one has to pass Higher Secondary Examination and get admitted in a nursing college for four years and obtain a degree in Nursing.


Testing Laboratories and Experimental Institutions
Testing laboratories are required for doing analysis of various kinds of samples such as blood, urine, and stool. They also do procedures such as XRay, CT Scan, MRI, ECG, etc. Most of these procedures are done by paramedics and the results are certified by a pathologist.
Similarly, for launching new drugs, testing and clinical trials need to be performed. Such tasks are governed by Drugs and Cosmetics Act, 1940.


Other Regulatory Mechanisms
The other important acts that govern the medical profession are Nursing Home Act, Private Hospitals and Medical Clinics (PHMC) Act, and Consumer Protection Act, 1987. Most of the States have also enacts provisions for building and running private hospitals and nursing homes.  A physician should observe the provision of the state Acts such as Drugs and Cosmatic Act 1947, Pharmacy Act 1948, Narcotic Drugs and Psychotropic Substance 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 Disabilties (Equal Opportunities and Full Participation) Act 1995, and Biomedical Waste (Management ad Handling) Rules 1998.


While, these Acts have provided basic guidelines for regulation of certain aspects of the health sector, they have also created new challenges, as consumers have become more involved in monitoring health service delivery. The challenge for the future will be to ensure the quality and efficiency of health services in both the public and private sectors through these regulatory mechanisms while seeking to promote national health objectives

Powers of the MCI
MCI Regulations, 2000, Section 34 specifiesPowers and Duties of the President of MCI.  The President shall subject to the provision of the Act, rules, regulations and Standing Orders of the Council do such acts as he considers necessary for the furtherance of the objectives for which the Council is established.  Similarly, Section 35 specifies the powers and duties of the Vice President. If the office of the President is vacant or if the President for any reason is unable to exercise the powers or perform the duties of his office, the Vice-President shall act in his place and shall exercise the power and perform the duties of the President.

Power to take cognizance - State Medical Councils have the power to take cognizance of any offence of misconduct committed by a Registered Medical Practitioner during the practice of his profession only when a written complaint in this respect received by the council or when the practioner is convicted in the court of law. The gravity of the offence determines the scale of disciplinary action.

The following are some of the offences that can entail disciplinary action -
  1. Association with unqualified persons
  2. Illegal Advertising
  3. Adultery
  4. Illegal Abortion
  5. Rendering improper services such as using unsterile equipment.

Unethical Acts & Misconducts
Any violation of code of conduct, unethical act or misconduct shall lead to removal of his/her name from the register permanently or temporarily and shall publicize the name of physician in local press as well in the publications of different medical associations/societies/bodies.

PUNISHMENT AND DISCIPLINARY ACTION

8.1 It must be clearly understood that the instances of offences and of Professional misconduct which are given above do not constitute and are not intended to constitute a complete list of the infamous acts which calls for disciplinary action, and that by issuing this notice the Medical Council of India and or State Medical Councils are in no way precluded from considering and dealing with any other form of professional misconduct on the part of a registered practitioner. Circumstances may and do arise from time to time in relation to which there may occur questions of professional misconduct which do not come within any of these categories. Every care should be taken that the code is not violated in letter or spirit. In such instances as in all others, the Medical Council of India and/or State Medical Councils have to consider and decide upon the facts brought before the Medical Council of India and/or State Medical Councils.

8.2 It is made clear that any complaint with regard to professional misconduct can be brought before the appropriate Medical Council for Disciplinary action. Upon receipt of any complaint of professional misconduct, the appropriate Medical Council would hold an enquiry and give opportunity to the registered medical practitioner to be heard in person or by pleader. If the medical practitioner is found to be guilty of committing professional misconduct, the appropriate Medical Council may award such punishment as deemed necessary or may direct the removal altogether or for a specified period, from the register of the name of the delinquent registered practitioner. Deletion from the Register shall be widely publicized in local press as well as in the publications of different Medical Associations/ Societies/Bodies.

8.3 In case the punishment of removal from the register is for a limited period, the appropriate Council may also direct that the name so removed shall be restored in the register after the expiry of the period for which the name was ordered to be removed.

8.4 Decision on complaint against delinquent physician shall be taken within a time limit of 6 months.

8.5 During the pendency of the complaint the appropriate Council may restrain the physician from performing the procedure or practice which is under scrutiny.

8.6 Professional incompetence shall be judged by peer group as per guidelines prescribed by Medical Council of India.


In spite of several regulations and act, there are several areas that are not regulated. For example, new technological frontier has opened immense possibilities in medical field such as surrogate mother hood, artifical limbs, stem cell research. However, there are no regulation on these activities. Foreign drug companies routinely perform human trials of their experimental drugs in India specially because there are very strict laws for such tests in their own countries and there are not strict laws in India. Poor people are made guinea pigs because of this.

The recent canse of Manji Yamada, the Japanese baby born to a surrogate mother in India, highlights the lack of proper laws for treating infertility.

Activities which are not under the purview of MCI

   1. Questions pertaining to drugs, reactions, nonscheduled drugs etc.
   2. Paramedical personnel- Registration , duties ,responsibilities of nurses, Pharmacists , Laboratory Technicians etc.
   3. Dental Surgeons – Registration / Practice etc.
   4. Matters relating to Registration and practice of Indian systems of Medicine like Ayurveda , Siddha , Unani and Homeopathy.
   5. Queries pertaining to Diplomats of National Board of Examinations and other related matters.
   6. Screening test – Scheme of Examination including syllabus, dates of examinations , No of Attempts etc.
   7. Matters relating to Nursing Homes and Hospitals .
   8. All India Entrance Examinations for Admission to MBBS courses.
   9. All India Entrance Examinations for Admission to PG courses.






READ DISCLAIMER



Q. Explain - Surrogate Motherhood. Who is the legal parent? What are the rights of surrogate mother and parents of the child? Explain the contractual aspect and enforceability. What are the issues with Surrogacy?

Surrogacy
As per National Guidelines for Accreditation, Supervision & Regulation of ART Clinics in India published by Ministry of Health and Family Welfare, Surrogacy is defined as follows - Surrogacy is an arrangement in which a woman agrees to carry a pregnancy that is genetically unrelated to her and her husband, with the intention to carry it to term and hand over the child to the genetic parents for whom she is acting as a surrogate.

The basic idea is that in Surrogate Motherhood, a woman gives birth to a child for someone else. The intention of the birth mother is to give up the child to the party who has commissioned her to deliver the baby. A surrogate mother is the woman who is pregnant with the child and intends to relinquish it after birth. The word surrogate, from Latin subrŏgare (to substitute), means appointed to act in the place of. The intended parent(s) is the individual or couple who intends to rear the child after its birth.

Intended parents may arrange a surrogate pregnancy because of female infertility, or other medical issues which may make the pregnancy or the delivery risky. A female intending parent may also be fertile and healthy, but unwilling to undergo pregnancy. Alternatively, the intended parent may be a single male, a male homosexual couple or a single woman who is unable to bring a pregnancy to full term.\

There are several kinds of Surrogate Motherhood -

In traditional surrogacy (aka the Straight method) the surrogate is pregnant with her own biological child, but this child was conceived with the intention of relinquishing the child to be raised by others such as the biological father and possibly his spouse or partner, either male or female. The child may be conceived via home artificial insemination using fresh or frozen sperm or impregnated via IUI (intrauterine insemination), or ICI (intra cervical insemination) which is performed at a fertility clinic. Sperm from the male partner of the 'commissioning couple' may be used, or alternatively, sperm from a sperm donor can be used. Donor sperm will, for example, be used if the 'commissioning couple' are both female and where the child is commissioned by a single woman.

In gestational surrogacy (aka the Host method) the surrogate becomes pregnant via embryo transfer with a child of which she is not the biological mother. She may have made an arrangement to relinquish it to the biological mother or father to raise, or to a parent who is unrelated to the child (e. g. because the child was conceived using egg donation, sperm donation or is the result of a donated embryo). The surrogate mother may be called the gestational carrier.

Altruistic surrogacy is a situation where the surrogate receives no financial reward for her pregnancy or the relinquishment of the child (although usually all expenses related to the pregnancy and birth are paid by the intended parents such as medical expenses, maternity clothing, and other related expenses).

Commercial surrogacy is a form of surrogacy in which a gestational carrier is paid to carry a child to maturity in her womb and is usually resorted to by well off infertile couples who can afford the cost involved or people who save and borrow in order to complete their dream of being parents. This procedure is legal in several countries including in India where due to excellent medical infrastructure, high international demand and ready availability of poor surrogates it is reaching industry proportions. Commercial surrogacy is sometimes referred to by the emotionally charged and potentially offensive terms "wombs for rent", "outsourced pregnancies" or "baby farms".

Contractual Aspects of Surrogacy

There has been a major change in Indian surrogacy laws. The law regarding Surrogacy is governed by Assisted Reproductive Technology (Regulation) Bill & Rules, 2008. India is now the only country in the world to legalise commercial surrogacy. Unlike in other countries, including the UK, USA and France, in India the surrogacy agreements between the two parties are legally enforceable. The new law will protect all parties — the genetic parents, surrogate mother and the child.

The following are its salient features -
1. The new Assisted Reproductive Technology (Regulation) Bill & Rules, 2008, legalises commercial surrogacy, stating that the surrogate mother may receive monetary compensation for carrying the child in addition to health-care and treatment expenses during pregnancy. It further, states that the surrogate mother can receive monetary compensation for carrying the child in addition to health-care and treatment expenses during pregnancy. But the surrogate mother has to relinquish all parental rights over the child once the amount is transferred and birth certificates will be in the name of genetic parents.

2. Single parents can also have children using a surrogate mother

3. The prescribed age-limit for a surrogate mother is between 21- 45 years. The proposed Bill also states that no surrogate mother can undergo an embryo transfer more than three times for the same couple.

4. All foreigners seeking infertility treatment in India will first have to register with their embassy. Their notarised statement will then have be handed over to the treating doctor. The foreign couple will also state whom the child should be entrusted to in case of an eventuality such as a genetic parent’s death.

Who are the Legal Parents of a Surrogate Child
The new Assisted Reproductive Technology (Regulation) Bill & Rules, 2008, states that the surrogate mother has to relinquish all parental rights over the child once the amount is transferred and birth certificates will be in the name of genetic parents. Thus, the birth mother does not have any rights on the child.  

A child born through ART shall be presumed to be the legitimate child of the couple, born within wedlock, with consent of both the spouses, and with all the attendant rights of parentage, support and inheritance. Sperm/oocyte donors
shall have no parental right or duties in relation to the child, and their anonymity shall be protected.

Determination of status of the child –
  1. A child born to a married couple through the use of assisted reproductive technology shall be presumed to be the legitimate child of the couple, having been born in wedlock and with the consent of both spouses, and shall have identical legal rights as a legitimate child born through sexual intercourse.
  2. A child born to an unmarried couple through the use of assisted reproductive technology, with the consent of both the parties, shall be the legitimate child of both parties.
  3. In the case of a single woman the child will be the legitimate child of the woman, and in the case of a single man the child will be the legitimate child of the man.
  4. In case a married or unmarried couple separates or gets divorced, as the case may be, after both parties consented to the assisted reproductive technology treatment but before the child is born, the child shall be the legitimate child of the couple.
  5. A child born to a woman artificially inseminated with the stored sperm of her dead husband shall be considered as the legitimate child of the couple.
  6. The birth certificate of a child born through the use of assisted reproductive technology shall contain the name or names of the parent or parents, as the case may be, who sought such use.


Rights of a Surrogate Child
  1. A child born through ART shall be presumed to be the legitimate child of the couple, having been born in wedlock and with the consent of both the spouses. Therefore, the child shall have a legal right to parental support, inheritance, and all other privileges of a child born to a couple through sexual intercourse.
  2. Children born through the use of donor gametes, and their "adopted" parents shall have a right to available medical or genetic information about the genetic parents that may be relevant to the child’s health.
  3. Children born through the use of donor gametes shall not have any right whatsoever to know the identity (such as name, address, parentage, etc.) of their genetic parent(s). A child thus born will, however, be provided all other information about the donor as and when desired by the child, when the child becomes an adult. While the couple will not be obliged to provide the above “other” information to the child on their own, no deliberate attempt will be made by the couple or others concerned to hide this information from the child as and when asked for by the child.
  4. In the case of a divorce during the gestation period, if the offspring is of a donor program – be it sperm or ova – the law of the land as pertaining to a normal conception would apply.
  5. To make the couple aware, if relevant, that a child born through ART has a right to seek information (including a copy of the DNA fingerprint, if available) about his genetic parent/surrogate mother on reaching years, excepting information on the name and address – that is, the individual’s personal identity – of the gamete donor or the surrogate mother. The couple is not obliged to provide the information to which the child has a right, on their own to the child when he/ she reaches the age of 18, but no attempt must be made by the couple to hide this information from the child should an occasion arise when this issue becomes important for the child.
  6. The birth certificate issued in respect of a baby born through surrogacy shall bear the name or names of the parent or parents, as the case may be, who sought such use.

Rights of a Surrogate Mother
  1. A surrogate mother signs a contract with the the parents for whom she is supposed to carry the child to term. The surrogate mother has the right to enforce the contract and avail the benefits that the contract provides.
  2. All expenses, including those related to insurance, of the surrogate related to a pregnancy achieved in furtherance of assisted reproductive technology shall, during the period of pregnancy and after delivery as per medical advice, and till the child is ready to be delivered as per medical advice, to the biological parent or parents, shall be borne by the couple or individual seeking surrogacy.
  3. Subject to the surrogacy agreement, the surrogate mother may also receive monetary compensation from the couple or individual, as the case may be, for agreeing to act as such surrogate.
  4. If the first embryo transfer has failed in a surrogate mother, she may, if she wishes, decide to accept on mutually agreed financial terms, at most two more successful embryo transfers for the same couple that had engaged her services in the first instance. No surrogate mother shall undergo embryo transfer more than three times for the same couple.
  5. A surrogate mother shall be given a certificate by the person or persons who have availed of her services, stating unambiguously that she has acted as a surrogate for them.
Duties of a Surrogate Mother
  1. A surrogate mother shall relinquish all parental rights over the child. 
  2. No woman under twenty one years of age and over forty five years of age shall be eligible to act as a surrogate mother under this Act. 
  3. No woman shall act as a surrogate for more than three successful live births in her life. 
  4. Any woman seeking or agreeing to act as a surrogate mother shall be medically tested for such diseases, sexually transmitted or otherwise, as may be prescribed, and all other communicable diseases which may endanger the health of the child, and must declare in writing that she has not undergone intravenous medical treatment or received a blood transfusion.
  5. A surrogate mother shall, in respect of all medical treatments or procedures in relation to the concerned child, register at the hospital or such medical facility in her own name, clearly declare herself to be a surrogate mother, and provide the name or names and addresses of the person or persons, as the case may be, for whom she is acting as a surrogate.
  6. A surrogate mother shall not act as an oocyte donor for the couple or individual, as the case may be, seeking surrogacy.
  7. In the event that the woman intending to be a surrogate is married, the consent of her spouse shall be required before she may act as such surrogate. 
  8. A relative, a known person, as well as a person unknown to the couple may act as a surrogate mother for the couple. In the case of a relative acting as a surrogate, the relative should belong to the same generation as the women desiring the surrogate.

Rights of a the patients (i.e. the couple who wants the child)
  1. ART shall be available to all persons including single persons, married couples and unmarried couples. In case ART is used by a married or unmarried couple, there must be informed consent from both the parties.
  2. The parents of a minor child have the right to access information about the donor, other than the name, identity or address of the donor, or the surrogate mother, when and to the extent necessary for the welfare of the child.
  3. All information about the patients shall be kept confidential and information about ART procedures done on them shall not be disclosed to anyone other than the central depository of the ICMR, except with the consent of the person or persons to whom the information relates,or by a court order.
Duties of the patients
  1. The person or persons who have availed of the services of a surrogate mother shall be legally bound to accept the custody of the child / children irrespective of any abnormality that the child / children may have, and the refusal to do so shall constitute an offence under this Act.
  2. A foreigner or foreign couple not resident in India, or a non-resident Indian individual or couple, seeking surrogacy in India shall appoint a local guardian who will be legally responsible for taking care of the surrogate during and after the pregnancy, till the child / children are delivered to the foreigner or foreign couple or the local guardian. Further, the party seeking the surrogacy must ensure and establish to the ART clinic through proper documentation that the party would be able to take the child / children born through surrogacy, including where the embryo was a consequence of donation of an Oocyte or sperm, outside of India to the country of the party’s origin or residence as the case may be.
  3. A couple or an individual shall not have the service of more than one surrogate at any given time. 
  4. A couple shall not have simultaneous transfer of embryos in the woman and in a surrogate.


Rights of a Donor
  1. All information about the donors shall be kept confidential and information about gamete donation shall not be disclosed to anyone other than the central database of the Indian Council of Medical Research, except with the consent of the person or persons to whom the information relates, or by an order of a court of competent jurisdiction. 
  2. Subject to the other provisions of this Act, the donor shall have the right to decide what information may be passed on and to whom, except in the case of an order of a court of competent jurisdiction.
Duties of a Donor
  1. A donor shall relinquish all parental rights over the child which may be conceived from his or her gamete.
  2. No assisted reproductive technology procedure shall be conducted on or in relation to any gamete of a donor under this Act unless such donor has obtained the consent in writing of his or her spouse, if there, to such procedure.

Issues with Surrogacy
The basic tenets of any medical treatment mentioned in the Helsinki Declaration of 1964 and reiterated in October 2000 in Scotland (information available on the Internet) clearly spell out the ethical concerns of treating patients. These basic tenets are also applicable to ART. The clinic must ensure that a particular ART being offered is fully in consonance with the diagnosis made of the cause of infertility. More particularly, the clinic must make sure that patients are well informed about the treatment being offered to them, the reasons of suggesting a particular form of treatment, and alternative therapies available if any.

Possible misuse of ART – sale of embryos and stem cells
There is a growing interest in embryonic stem cells because of their potential use for developing spare organs or replacing defective tissues such as parts of the brain destroyed due to Alzheimer’s disease, or pancreatic cells in diabetic patients. The range of their potential use is limited only by one’s imagination. ART clinics are the only source of embryonic stem cells. Spare embryos are either frozen or returned to the infertile couple for replacement during a later cycle, or donated to another infertile couple, or discarded after five years using a suitable protocol (Section 3.11).

Recently, the USA banned all federal support for embryonic stem cell researches unless the laboratories could demonstrate that they had developed embryonic stem lines before August 10, 2001. However, private funding is allowed which encourages scientists in the USA to procure stem cells from abroad. Germany has banned all research on embryos produced in that country but permits the use of embryos brought from abroad. The stand taken by the foreign governments on embryo research opens up the possibility of embryos from developing countries that do not have appropriate national guidelines in this area, being commercially exploited and sold to foreign countries. Therefore sale or transfer of human embryos or any part thereof, or of gametes in any form and in any way – that is, directly or indirectly – to any party outside the country must be prohibited. Within the country, such embryos or gametes could be made available to bonafide researchers only as a gift, with both parties (the donor and the donee) having no commercial transaction, interest or intent.

Exploitation of Surrogate Mother because of Poverty

Underdevelopment of fetus due to lack of  proper care of surrogate mother

Complex legal issues - Example of Japanese baby Manji Yamada