In India, the patient possesses a legal right to autonomy and self determination as mentioned within Article 21 of the Constitution of India, 1950. The patient has the right to refuse treatment except in case of an emergency situation where the doctor need not get consent for treatment. The provision of Article 21 of the Constitution of India, 1950 is reproduced hereunder:

“Article 21. Protection of life and personal liberty—No person shall be deprived of his life or personal liberty except according to procedure established by law.”

Apart from the requirement of consent being there under law of torts and various laws of the country, there is now specific provision i.e. the Clause 7.16 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 which places the responsibility on the doctor to obtain consent from the patient or his guardian in case of minor before performing operation and if the doctor fails to obtain consent, then the same amounts to professional misconduct rendering the doctor for disciplinary action. The relevant provision of Clause 7.16 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 is reproduced hereunder:

“Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed.”

The 3 Judges Constitution Bench of Hon’ble Supreme Court of India in the landmark judgment titled as “Samira Kohli versus Prabha Manchanda, AIR 2008 SC 1385 has held that:

“18. We may also refer to the code of medical ethics laid down by the Medical Council of India (approved by the Central Government under section 33 of Indian Medical Council Act, 1956). It contains a chapter relating to disciplinary action which enumerates a list of responsibilities, violation of which will be professional misconduct. Clause 13 of the said chapter places the following responsibility on a doctor:

"13. Before performing an operation the physician should obtain in writing the consent from the husband or wife, parent or guardian in the case of a minor, or the patient himself as the case may be. In an operation which may result in sterility the consent of both husband and wife is needed."We may also refer to the following guidelines to doctors, issued by the General Medical Council of U.K. in seeking consent of the patient for investigation and treatment:

"Patients have a right to information about their condition and the treatment options available to them. The amount of information you give each patient will vary, according to factors such as the nature of the condition, the complexity of the treatment, the risks associated with the treatment or procedure, and the patients own wishes. For example, patients may need more information to make an informed decision about the procedure which carries a high risk of failure or adverse side effects; or about an investigation for a condition which, if present, could have serious implications for the patients employment, social or personal life.

You should raise with patients the possibility of additional problems coming to light during a procedure when the patient is unconscious or otherwise unable to make a decision. You should seek consent to treat any problems which you think may arise and ascertain whether there are any procedures to which the patient would object, or prefer to give further thought before you proceed."

The Hon’ble National Consumer Disputes Redressal Commission in the matter titled as “Saroj Chandhoke versus Ganga Ram Hospital, 2007 (3) CPJ 189 (NCDRC) has held that:

“(ii). Consent:

These days, complete information with regard to surgery is required to be given to the patient so that the patient becomes aware of the procedure which is sought to be followed by the Surgeon. It should not be presumed that a patient may not/need not know the procedure or is incapable of understanding the medical terms and, therefore, there is no use in explaining them. There cannot be a presumption that all patients are ignorant about their anatomy or the adverse effects or benefits of surgery, and, in any case, those days are over. Hence, properly informed written consent before operation is the necessity.”

The Hon’ble National Consumer Disputes Redressal Commission in the matter titled as “H. S. Tuli versus Post Graduate Institute of Medical Education & Research, 2008 (1) CPJ 392 (NCDRC) has held that:

“Express Written Consent:

Express written consent is to be obtained for: (i) all major diagnostic procedures; (ii) general anaesthesia; (iii) surgical operations: (iv) intimate examinations; (v) examination for determining age, potency and virginity; and (vi) in medico-legal cases.

32. Brain surgery is a major surgery requiring several hours and use of general anaesthesia. Informed consent for high risk in writing has to be obtained either from the patient or from her close relatives and if that is not taken and if the patient becomes paralysed or dies then certainly there are chances that the patients relatives would allege negligence on the part of the treating surgeons and the hospital. Hence, informed consent is very essential.”

Thus, a medical practitioner cannot examine, treat or operate upon the patient without the patient’s consent, except by committing a trespass or assault. This consent, which may be implied, amounts to an agreement on the part of the patient to permit the treatment in question and is sufficient for an implied promise to exercise proper care and skill. Further the consent obtained should be legally valid.