Informed consent — what your doctor must obtain before treatment

The Indian doctrine of informed consent — the doctor's obligation to obtain the patient's voluntary, informed and competent permission before any diagnostic or therapeutic procedure — is governed by the Supreme Court's decision in Samira Kohli v Dr Prabha Manchanda, (2008) 2 SCC 1, which laid down seven propositions distinguishing the Indian "real consent" standard from the Anglo-American "informed consent" standard. The doctrine sits on a tripod — the common-law tort of battery (operating without consent at all), the tort of negligence (operating with inadequate disclosure of risks), and the regulatory framework of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Regulation 7.16, which carries the obligation as a disciplinary norm now superintended by the National Medical Commission. Consent is statutorily regulated in specific contexts — the Medical Termination of Pregnancy Act, 1971; the medical-examination provisions of Sections 51 to 53 of the Bharatiya Sakshya Adhiniyam, 2023 (formerly Sections 53 and 53A of the Code of Criminal Procedure, 1973); and the advance-directive regime crystallised in Common Cause v Union of India, (2018) 5 SCC 1. This guide walks the elements, the exceptions and the doctrinal anchors.

Consent is the legal and ethical hinge on which the doctor-patient relationship turns. Without it, the touching that is inherent in every physical examination, every injection, every operation is an unauthorised trespass on the body — a battery in tort, an unlawful touching in criminal law, and a violation of the constitutional right to bodily integrity that the Supreme Court has read into Article 21 of the Constitution of India. The Indian regime that governs this consent is the product of three interlocking strands — the common-law tort of battery and negligence under the law-of-torts framework summarised in Jacob Mathew v State of Punjab, (2005) 6 SCC 1 and elaborated for consent specifically in Samira Kohli v Dr Prabha Manchanda, (2008) 2 SCC 1; the regulatory standard in Regulation 7.16 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, the disciplinary code that now binds every registered medical practitioner under the National Medical Commission framework; and the statutory consent regimes embedded in the Medical Termination of Pregnancy Act, 1971, the Bharatiya Sakshya Adhiniyam, 2023 (Sections 51-53, the medical-examination provisions), the Mental Healthcare Act, 2017 and the Transplantation of Human Organs and Tissues Act, 1994. The constitutional outer envelope is the right of self-determination that the Constitution Bench in Common Cause v Union of India, (2018) 5 SCC 1 read into Article 21 to recognise the advance-directive form of consent. This guide walks the elements, the exceptions and the disclosure standard.

The three doctrinal anchors — battery, negligence and the disciplinary code

The medical-consent regime in India sits on three doctrinal anchors that operate in parallel and overlap on the facts of any case.

The tort of battery. Touching the patient without consent — or in excess of the consent given — is the tort of battery. The Supreme Court in Samira Kohli traced the doctrine to the foundational dictum of Cardozo J in Schloendorff v Society of New York Hospital (1914) — "every human being of adult years and sound mind has a right to determine what shall be done with his body; and a surgeon who performs an operation without his patient's consent commits an assault for which he is liable in damages". Battery is the doctrinal home of the no-consent case — the patient who has not authorised the procedure at all, or who has authorised procedure A and undergone procedure B.

The tort of negligence in disclosure. Where consent has been obtained, but the disclosure on which it rests is inadequate — the doctor failed to inform the patient of material risks, alternatives or side-effects — the legal home shifts from battery to negligence. The question is whether the doctor's disclosure fell below the standard of care of a reasonably competent practitioner. The Indian standard, as Samira Kohli made clear, is the modified Bolam standard from Sidaway v Bethlem Royal Hospital Governors, [1985] 1 All ER 643 — the doctor's duty is to disclose what a reasonably prudent practitioner in the same speciality would disclose; the duty is not, in the Indian formulation, the patient-centred "what a reasonable patient would want to know" standard adopted in Canterbury v Spence, 464 F.2d 772 (1972) and elsewhere in North America.

The disciplinary code — NMC Regulation 7.16. Beyond civil liability, the medical practitioner is bound by the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 — now superintended by the National Medical Commission under the National Medical Commission Act, 2019. Regulation 7.16 prescribes that "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"; and that "in an operation which may result in sterility the consent of both husband and wife is needed". Breach of the Regulations is a disciplinary infraction that can attract removal of the practitioner's name from the medical register — the regulatory enforcement layer that complements the tort liability layer.

Samira Kohli and the seven propositions — the architecture of Indian consent

The Supreme Court's decision in Samira Kohli v Dr Prabha Manchanda, (2008) 2 SCC 1 is the doctrinal anchor for Indian consent law in 2026 — and the seven propositions in the concluding section of the judgment (paragraphs 31 to 33) are the operative test that every medical-negligence forum applies.

The facts — an unmarried woman of 44 admitted for a laparoscopy under general anaesthesia for menstrual irregularity; the surgeon, finding endometriosis, performed a bilateral salpingo-oophorectomy (removal of uterus, fallopian tubes and ovaries) on the basis of consent given mid-operation by the patient's mother who was waiting outside; the patient, on regaining consciousness, learnt that she had undergone a sterilising hysterectomy without her authorisation. The Supreme Court held that the consent obtained was not "real consent" for the procedure performed, and awarded damages of Rs 25,000.

The seven propositions are these. One — a doctor has to seek and secure the consent of the patient before commencing a treatment; the consent must be real and valid, meaning the patient should have the capacity and competence to consent, the consent should be voluntary, and the consent should be on the basis of adequate information. Two — adequate information for "real consent" means information necessary to make a decision — the nature and procedure of the treatment, its purpose, benefits and effect; alternatives if any; an outline of the substantial risks; and the adverse consequences of refusing treatment. The doctor need not disclose "all possible side-effects or remote consequences". Three — consent given only for a diagnostic procedure cannot be construed as consent for therapeutic treatment; consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure; the fact that the unauthorised additional surgery is beneficial does not validate it. Four — the consent given for "additional procedure" by relatives of an unconscious patient is not valid except in genuine life-threatening emergencies. Five — in cases where the proposed surgery is a major one, two consents — one for hospitalisation and diagnostic procedure and another for the operation procedure — should be taken. Six — the nature and extent of information depends on the nature of the proposed treatment; the practitioner's duty is the Bolam-standard duty to disclose what a competent body of medical opinion would disclose. Seven — the Indian standard is "real consent" — the patient-information standard of the Anglo-American "informed consent" cases (the so-called "reasonable patient" or "prudent patient" standard) is not adopted.

The seven propositions, taken together, define what "real consent" means in Indian law and what the doctor must do to obtain it. Each proposition has been applied repeatedly by the Consumer Commissions, the High Courts and the Supreme Court since 2008.

"Real consent" versus "informed consent" — the Indian-American divide

The terminological choice in Samira Kohli — "real consent" rather than "informed consent" — is doctrinally significant. The Anglo-American jurisprudence (more accurately, the North American jurisprudence; English law sits closer to the Indian position) developed the "informed consent" doctrine through Canterbury v Spence, 464 F.2d 772 (DC Cir 1972), which abandoned the professional-disclosure standard for a patient-centred standard — the doctor must disclose every risk that a reasonable patient would consider material to the decision, including risks that the medical profession would not conventionally disclose.

The Indian Supreme Court in Samira Kohli considered Canterbury and the "prudent patient" line, considered also the English position in Sidaway (which retained the Bolam professional-disclosure standard with a qualification for risks of grave consequences), and aligned the Indian standard with the English Bolam-modified position rather than the American patient-centred position. The doctrinal reason given was the public-health context of Indian medical practice — the burden on the practitioner of disclosing every conceivable risk to every patient is impractical given the doctor-patient ratio and the pressures on the public-health system, and the patient-centred standard would generate defensive medicine and a litigation surge that the system cannot absorb.

The practical upshot for the patient is that the disclosure standard in Indian law is what a competent body of medical opinion in the same speciality would disclose — not what the patient in retrospect would have wanted to know. The doctor who has disclosed the nature of the procedure, its purpose, the substantial risks (those material in the medical-professional judgment), the alternatives and the consequences of refusing has met the legal standard, even if a particular patient later complains that a particular non-substantial risk was not mentioned. The qualification — drawn from Sidaway and absorbed into Indian law — is that risks of grave consequence (death, serious permanent disability) must always be disclosed even where the probability is low.

Capacity, voluntariness and the elements of "real consent"

"Real consent" as elaborated in Samira Kohli and as drawn from Section 13 of the Indian Contract Act, 1872 (definition of consent) and Section 14 (definition of "free consent") has three constituent elements that must each be satisfied.

Capacity / competence. The patient must have the capacity to consent — meaning the patient must be of the age of majority (eighteen years under the Indian Majority Act, 1875), of sound mind, and capable of understanding the nature of the proposed treatment, its purpose, benefits, risks and alternatives. The Mental Healthcare Act, 2017 elaborated the capacity standard for persons with mental illness — a presumption of capacity, with specific safeguards for the determination of incapacity. Where the patient is a minor, the consent is to be given by the parent or guardian — and Regulation 7.16 of the NMC Code requires written consent of the guardian. Where the patient is incapable of consenting (unconscious, mentally incapacitated to the necessary degree), the consent of the next-of-kin is sought, with the substituted-judgment standard (what the patient would have wanted) operating where ascertainable.

Voluntariness. The consent must be free of coercion, undue influence and misrepresentation — the Section 14 Indian Contract Act vitiation grounds, applied to the medical-consent context. Consent obtained from a patient who is in extremis, under sedation, in fear of the consequences of refusal, or under misrepresentation by the doctor of the necessity of the procedure, is not "real consent".

Information. The consent must rest on disclosure that meets the modified-Bolam standard — nature of the procedure, purpose, substantial risks, alternatives and consequences of refusal. The disclosure must be made in language the patient understands; where the patient is illiterate, the consent form should be explained in the patient's vernacular and a witness signature obtained. The disclosure must be made before the procedure begins — consent obtained after the patient is on the operating table, sedated, or anaesthetised is liable to be invalid.

The emergency exception and the doctrine of additional or extension surgery

The general rule that touching without consent is battery has a narrow exception for life-saving emergencies. The doctrine — drawn from Section 92 of the Indian Penal Code, 1860 (now Section 28 of the Bharatiya Nyaya Sanhita, 2023) and from the common-law principle of necessity — permits the medical practitioner to act without consent where the patient is incapable of consenting (unconscious, in shock, in extremis) and the procedure is necessary in good faith for the patient's benefit and there is no reasonable possibility of obtaining consent from the patient or a competent relative within the time available. Section 92 IPC expressly contemplates the surgeon "trepanning" the unconscious accident victim before the patient regains the capacity to consent.

The Supreme Court in Samira Kohli developed the cognate doctrine of "additional surgery" or "extension surgery" — the question of what the doctor may do, having begun a consented procedure, when an unexpected pathology is encountered intra-operatively. The Court held that the doctor may proceed to the unconsented additional procedure only where (i) the additional procedure is necessary to save the patient's life, or (ii) the additional procedure is necessary to prevent imminent and serious damage to the patient's health, and (iii) it would be unreasonable to delay further to obtain consent. Where the additional pathology is non-emergent — even if continuing the operation now would save the patient a future operation, future expense and future risk — the doctor must close the patient up, allow recovery, obtain proper informed consent, and operate again. The convenience of operating in one sitting does not justify proceeding without consent.

The doctrinal point is that the emergency exception is narrow and is to be invoked only on facts that satisfy the necessity-of-saving-life or preventing-grave-damage threshold. The Samira Kohli facts themselves did not meet the threshold — the endometriosis was a chronic condition, not an emergency, and the Court held that the doctor should have closed the patient up after the diagnostic laparoscopy, obtained informed consent for the hysterectomy specifically, and operated again.

Consent under the Medical Termination of Pregnancy Act

The Medical Termination of Pregnancy Act, 1971 (substantially amended in 2021) codifies the consent regime for the termination of pregnancy. Section 3(4) of the Act provides — "(a) No pregnancy of a woman, who has not attained the age of eighteen years, or, who, having attained the age of eighteen years, is a mentally ill person, shall be terminated except with the consent in writing of her guardian; (b) Save as otherwise provided in clause (a), no pregnancy shall be terminated except with the consent of the pregnant woman."

The architecture is significant. The competent adult pregnant woman is the sole authority for her own consent — neither the husband, nor the parents, nor any other relative can override the woman's consent or refusal. The Supreme Court in Suchita Srivastava v Chandigarh Administration, (2009) 9 SCC 1 — a case of a mentally retarded woman in State custody who was pregnant as a result of rape — held that the right to reproductive choice is a part of the Article 21 right to personal liberty, and that the Section 3(4)(b) requirement of the pregnant woman's consent is not to be displaced by judicial substitution where the woman has the capacity to consent or refuse. The Court emphasised the "best-interests" standard for the determination, but located the consent authority firmly in the woman herself wherever capacity is present.

For a minor pregnant person or a mentally ill pregnant woman lacking capacity, the consent is that of the guardian — but the medical practitioner is required to consider the pregnant woman's preferences and circumstances and the determination of mental illness is governed by the framework of the Mental Healthcare Act, 2017.

Medical-examination consent under the BSA / BNSS framework

The criminal-procedure framework regulates the medical examination of an arrested person and of a person accused of rape under what were formerly Sections 53 and 53A of the Code of Criminal Procedure, 1973 and are now substantially re-enacted in the Bharatiya Sakshya Adhiniyam, 2023 read with the Bharatiya Nagarik Suraksha Sanhita, 2023. Sections 51 to 53 of the BSA / BNSS framework deal with medical examination by a registered medical practitioner — the examination of an arrested person on the request of the police where there are reasonable grounds for believing that the examination will afford evidence of the offence (the BSA Section 51 / BNSS Section 51 framework, corresponding to CrPC Section 53); the examination of a person accused of rape (the BSA Section 52 / BNSS Section 52 framework, corresponding to CrPC Section 53A); and the examination of the victim of rape with the victim's consent (the BSA Section 53 / BNSS Section 53 framework, corresponding to CrPC Section 164A).

The doctrinal point is that the consent regime in the criminal-procedure context is distinct from the ordinary medical-consent regime. Where the police produce an arrested person for medical examination under the statutory framework, the registered medical practitioner is statutorily authorised to conduct the examination on the police request, and the consent of the arrested person is not the gatekeeper. For the rape victim, on the other hand, the consent regime is voluntary — the victim must consent to the medical examination, and the examination is conducted with the victim's consent and in the manner specified by the statute. The lawful authority of the criminal-procedure regime does not, however, dispense with the medical practitioner's obligation to conduct the examination with dignity and in accordance with the medical-ethics standards in NMC Regulation 7.

The advance directive — Common Cause v Union of India

The fullest constitutional articulation of the right of self-determination — and its operationalisation through prospective consent — came in the Constitution Bench decision in Common Cause v Union of India, (2018) 5 SCC 1. The Court — building on the earlier passive-euthanasia framework in Aruna Ramchandra Shanbaug v Union of India, (2011) 4 SCC 454 — held that the Article 21 right to life includes the right to die with dignity, and recognised the constitutional validity of the "advance directive" or "living will".

An advance directive is a document, executed by a competent adult, specifying the medical treatment the person consents to or refuses in the event of future incapacity. The Constitution Bench laid down detailed procedural safeguards — the directive must be in writing, executed by a person of sound mind and capable of taking an informed decision, signed in the presence of two attesting witnesses, and counter-signed by a Judicial Magistrate of the First Class. On the patient becoming incompetent, the treating hospital is to constitute a medical board to determine whether the patient's condition triggers the directive, and a second board (with the District Collector and a Judicial Magistrate) reviews the determination. The Court refined the procedural framework in Common Cause (II), (2023) — making the procedure less onerous and more practically workable.

The doctrinal significance for medical-consent law is that consent need not be contemporaneous with the treatment — a competent person can give prospective consent or refusal that binds the practitioner at the future moment of incapacity. The advance directive sits alongside the conventional contemporaneous-consent regime as a recognised form of "real consent" under Indian law.

Documentation, written consent and the practical drafting points

The legal standard for "real consent" is substantive — the disclosure made and understanding generated — and not merely formal. A signed consent form is evidence of consent, not consent itself; a consent form signed without disclosure is not "real consent". The Supreme Court in Samira Kohli emphasised the substance-over-form rule, but Regulation 7.16 of the NMC Code requires written consent for operations and the practical advice to medical practitioners is uniformly to obtain written consent in every non-emergent procedure.

The drafting points are these. One — the consent form should be specific to the procedure proposed, not a blanket consent to "any treatment necessary". Two — the form should record the disclosure made — the nature and purpose of the procedure, the substantial risks (using the modified-Bolam standard), the alternatives, the consequences of refusal — and the patient's affirmation of understanding. Three — the form should be signed by the patient (or the guardian where the patient lacks capacity), the doctor obtaining the consent, and a witness. Four — for sterilisation procedures, the consent of both spouses is required under Regulation 7.16. Five — where the patient is illiterate, the form should be explained in the vernacular and the explanation recorded; thumbprint with witness attestation is the appropriate execution mode. Six — consent should be obtained at a time when the patient has the capacity to deliberate — not immediately before the procedure when the patient is sedated, in pain, or in fear. Seven — where a major surgery is proposed, the Samira Kohli two-consent rule applies — one consent for the diagnostic / preparatory procedure, and a second specific consent for the operation.

Outcome — what the doctrinal framework requires

The Indian informed-consent regime, in its post-Samira Kohli form, requires the medical practitioner to obtain from the competent patient — before any procedure is begun — a voluntary, informed consent that meets the seven-proposition test. The disclosure standard is the modified-Bolam professional-disclosure standard, not the patient-centred standard of Canterbury v Spence; the consent must be specific to the procedure proposed and cannot be stretched to cover additional procedures discovered intra-operatively except in genuine life-saving emergencies; written consent is required by Regulation 7.16 of the NMC Code and is the prudent practice in every non-emergent case; the statutory consent regimes — the MTP Act for termination of pregnancy, the BSA / BNSS framework for criminal-procedure medical examinations, the Mental Healthcare Act for persons with mental illness, the Transplantation of Human Organs and Tissues Act for organ donation — overlay the common-law framework in their respective domains; and the advance directive recognised in Common Cause v Union of India permits prospective consent and refusal that binds the practitioner at the future moment of incapacity.

The doctrinal anchor for every analysis is Samira Kohli v Dr Prabha Manchanda — its seven propositions are the operational test, the modified-Bolam disclosure standard is the substantive content, and the doctrine of "additional / extension surgery" carves a narrow emergency-only exception. The constitutional outer envelope is the Article 21 right of self-determination, the regulatory floor is NMC Regulation 7.16, and the statutory specifications occupy the particular contexts. Together they define what an ethical doctor must obtain — and what an aggrieved patient can challenge — before any treatment begins.