Informed consent form for clinics in India: the rules What Samira Kohli, IMC 7.16, the Majority Act and the DPDP Act ask of an OPD, with a checklist.

Short answer: an Indian clinic needs the patient's real consent before any treatment, and written consent before any operation or procedure that carries risk. Implied consent covers ordinary examination and consultation. For anything more, the Supreme Court in Samira Kohli (2008) expects the doctor to explain what is planned, why, the alternatives, the substantial risks and what happens if the patient says no, and the patient to agree to that specific procedure. Regulation 7.16 of the 2002 conduct regulations requires the consent for an operation to be in writing. Data consent under the DPDP Act is a separate signature.

What does informed consent mean under Indian law?

The leading case is Samira Kohli v. Dr. Prabha Manchanda, decided by a three-judge bench of the Supreme Court on 16 January 2008 ((2008) 2 SCC 1). An unmarried woman aged 44 signed consent for "diagnostic and operative laparoscopy. Laparotomy may be needed". While she was under anaesthesia, the surgeon's assistant took her mother's consent outside the theatre, and the surgeon removed her uterus and ovaries. The Court started from what consent is in a clinic:

Consent can be implied in some circumstances from the action of the patient. For example, when a patient enters a Dentist's clinic and sits in the Dental chair, his consent is implied for examination, diagnosis and consultation. Except where consent can be clearly and obviously implied, there should be express consent.

In paragraph 32 the Court summarised the principles. Principle (i): "A doctor has to seek and secure the consent of the patient before commencing a 'treatment' (the term 'treatment' includes surgery also)." The consent must be "real and valid", which means "the patient should have the capacity and competence to consent; his consent should be voluntary; and his consent should be on the basis of adequate information concerning the nature of the treatment procedure, so that he knows what is consenting to."

Principle (ii) lists what that adequate information is. The doctor should disclose "(a) nature and procedure of the treatment and its purpose, benefits and effect; (b) alternatives if any available; (c) an outline of the substantial risks; and (d) adverse consequences of refusing treatment." The Court added that there is "no need to explain remote or theoretical risks involved, which may frighten or confuse a patient and result in refusal of consent for the necessary treatment."

Principle (v) sets the standard for how much to say. It "need not be of the stringent and high degree mentioned in Canterbury", the American reasonable-patient test, "but should be of the extent which is accepted as normal and proper by a body of medical men skilled and experienced in the particular field." In paragraph 33 the Court said it had preferred this "having regard to the ground realities in medical and health-care in India", and that a day may come when India moves to the stricter test, "But not for the present."

Is consent for one procedure valid for another?

No. Principle (iii) of Samira Kohli says: "Consent given only for a diagnostic procedure, cannot be considered as consent for therapeutic treatment. Consent given for a specific treatment procedure will not be valid for conducting some other treatment procedure." That the extra procedure helped the patient, saved time or money, or relieved future pain is not a defence. The only exception is where the additional procedure "is necessary in order to save the life or preserve the health of the patient and it would be unreasonable to delay" it until the patient regains consciousness.

Principle (iv) allows "a common consent for diagnostic and operative procedures where they are contemplated", and for "a particular surgical procedure and an additional or further procedure that may become necessary during the course of surgery." Those further procedures have to be named. In Samira Kohli the Court read "Laparotomy may be needed" as covering only conservative steps, "and not radical surgery involving removal of important organs." It also rejected the reading of the phrase "such medical treatment as is considered necessary" as consent to remove the uterus and ovaries. A blanket line on a form protects nobody.

The Court found that the removal without consent "amounted to a tortious act of assault and battery and therefore a deficiency in service". It accepted that the surgeon had acted "in good faith and for the benefit of the appellant", so it ordered her to forgo "the entire fee charged for the surgery" and pay ₹25,000 as compensation. The Court said the surgeon "cannot be held to be negligent, merely because she chose to perform radical surgery", but that "The correctness or appropriateness of the treatment procedure, does not make the treatment legal, in the absence of consent for the treatment."

When does an OPD need written consent?

Regulation 7.16 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, which the NMC still applies, reads: "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." Other regulations ask for consent in specific settings:

The charter is the Charter of Patients' Rights and Responsibilities approved by the National Council for Clinical Establishments, as updated on 23 August 2021. Rights (i) to (xiii) were sent to all states and union territories for adoption by a Ministry of Health letter dated 2 June 2019. Whether it binds your clinic depends on what your state has adopted under its clinical establishments law.

What about an injection, a dressing or a nebulisation? We found no national rule that names routine OPD injections as needing written consent. Samira Kohli treats consent for ordinary examination as implied, and requires express consent wherever consent is not "clearly and obviously implied". A practical line for a clinic: anything that cuts, removes, inserts or carries a risk you would mention to a family member gets a signed form; a routine injection gets a note in the record that it was explained and agreed. Your state rules or specialty body may set a stricter line.

How does consent connect to the Consumer Protection Act?

Samira Kohli itself came to the Supreme Court as an appeal from the National Consumer Disputes Redressal Commission. The Consumer Protection Act, 2019 defines deficiency in section 2(11) to include "any act of negligence or omission or commission by such person which causes loss or injury to the consumer" and "deliberate withholding of relevant information by such person to the consumer". A complaint does not have to prove the treatment was wrong if it can show the patient was never told something they should have been. A signed form, with the risks written in and a note of who explained them, is how you answer that.

How a consumer case against a doctor runs, and which commission hears it, is in our post on the Consumer Protection Act and medical negligence. If you carry cover, check what your policy says about consent claims; our guide to professional indemnity insurance for doctors explains the terms.

Does consent have to be in the patient's language?

For treatment consent, we found no national rule that names a language. What the rules do require is understanding. Samira Kohli asks for information sufficient that the patient "knows what is consenting to". Section 28 of the Bharatiya Nyaya Sanhita, 2023 says consent given "under a misconception of fact" is not consent for the purposes of the Sanhita where the doer knows or has reason to believe it, and the same for a person who, from unsoundness of mind or intoxication, "is unable to understand the nature and consequence of that to which he gives his consent". Regulation 7.21 asks for information "at her own level of comprehension" for IVF. A form in English signed by a patient who reads only Marathi does not show any of that.

For data consent the DPDP Act is explicit. Section 6(3) says every request for consent "shall be presented to the Data Principal in a clear and plain language, giving her the option to access such request in English or any language specified in the Eighth Schedule to the Constitution". Section 5(3) gives the same option for the notice.

In practice: keep the form in English and the main language of your area, explain it in the language the patient speaks, and write on the form which language you used and who explained it. If an attendant interprets, write their name and relationship.

Who signs for a minor, or for a patient who cannot consent?

For an adult, only the patient. Samira Kohli says: "When a patient is a competent adult, there is no question of someone else giving consent on her behalf." The mother's consent in that case "cannot be treated as valid or real consent" because there was no emergency and the patient was only temporarily unconscious; the surgeon "ought to have waited till the appellant regained consciousness".

The age of majority is eighteen. Section 3(1) of the Majority Act, 1875, as substituted in 1999, says: "Every person domiciled in India shall attain the age of majority on his completing the age of eighteen years and not before." Regulation 7.16 then asks for the written consent of the "parent or guardian in the case of minor" before an operation.

The criminal law sets a different line at twelve. Section 27 of the BNS protects acts done in good faith for the benefit of "a person under twelve years of age, or person of unsound mind" by, or with the consent of, the guardian. Section 28(c) says consent given by a person under twelve is not consent, unless the context shows otherwise. Section 25 refers to consent from a person "above eighteen years of age". For a patient between twelve and eighteen these rules do not line up into one answer. Regulation 7.16 is the rule that speaks to doctors directly, and it asks for a parent or guardian before an operation on a minor. If you regularly treat adolescents without a parent, ask your council or a lawyer how to document it.

When no one can consent in time, section 30 of the BNS protects an act done in good faith for a person's benefit "even without that person's consent, if the circumstances are such that it is impossible for that person to signify consent, or if that person is incapable of giving consent, and has no guardian or other person in lawful charge of him from whom it is possible to obtain consent in time". One of its illustrations is a surgeon operating on an unconscious man. The exception does not cover intentionally causing death, or hurt for any purpose other than preventing death or hurt. Record why consent could not be taken, and inform the family as soon as you can.

Is data consent under the DPDP Act the same as treatment consent?

No. Treatment consent is about what you do to the patient's body. Data consent under the Digital Personal Data Protection Act, 2023 is about what you do with the patient's personal data. Section 6(1) requires it to be "free, specific, informed, unconditional and unambiguous with a clear affirmative action", limited to the data necessary for the specified purpose. Section 7(a) allows processing without fresh consent for the purpose for which the person "has voluntarily provided her personal data", and section 7(f) for "responding to a medical emergency involving a threat to the life or immediate threat to the health" of the person or anyone else.

For children the Act uses eighteen. Section 2(f) defines a child as someone "who has not completed the age of eighteen years", and section 9(1) requires "verifiable consent of the parent of such child or the lawful guardian" before processing a child's data. These sections come into force eighteen months after G.S.R. 843(E) was published on 13 November 2025, that is in May 2027.

Keep the two consents separate on paper. A consent form for a procedure should not also sign the patient up for WhatsApp reminders or marketing messages; that is a separate, specific purpose under section 6(1). What a clinic must do under the Act is in our DPDP guide for clinics.

What should an OPD consent form contain?

This list follows the Samira Kohli principles, regulation 7.16 and the BNS consent sections. Adapt it to the procedure; a generic form with blanks left empty does not meet principle (ii).

1. Clinic name, address, and the doctor's name and registration number (regulation 1.4.1 asks for the registration number on prescriptions, certificates and receipts).
2. Patient's name, age, sex and clinic ID, and the date and time.
3. The procedure by name, in plain words, and the side or site where it applies.
4. Why it is advised and what it is expected to do.
5. Alternatives, including doing nothing for now.
6. The substantial risks, each written out by name.
7. What may happen if the patient refuses.
8. Any further procedure that may become necessary during this one, named specifically, with a separate tick (Samira Kohli principle (iv)).
9. Anaesthesia, if any, and its type.
10. A line that the patient was able to ask questions and they were answered.
11. The language in which it was explained, and the name of any interpreter.
12. Signature or thumb impression of the patient; for a minor or a patient who cannot consent, the parent's or guardian's, with the relationship written in. Both spouses for a procedure that may cause sterility (regulation 7.16).
13. Signature of a witness who is not the doctor, with name.
14. Doctor's signature, with the date and time.

Keep the signed form with the visit record. If the patient refuses, write the refusal on the same form or in the notes, with what you told them about the consequences, and ask them to sign. Our free consent form format gives you a printable form with these fields that you can fill in the browser.