“Courts have played a salutary and corrective role in innumerable instances. They are highly respected by our people for that. At the same time, the dividing line between judicial activism and judicial overreach is a thin one.”
— Prime Minister Dr. Manmohan Singh
“Judicial activism is not the same as judicial overreach. The former is a peacemaker; the latter is a trespasser.”
— Former CJI Ranjan Gogoi
Medical Liability in India: Key Concerns
The medical fraternity in India is greatly agitated by two major issues:
- The inadvertent inclusion of healthcare under the Consumer Protection Act, 1986 by the IMA vs. V.P. Shantha (1995) judgment.
- The criminalization of registered medical professionals under the Bharatiya Nyaya Sanhita (BNS), 2023 when a procedure results in the patient’s death—despite earlier assurances of decriminalization.
Comparing New Legal Changes with Previous Regulations
- Inclusion of Healthcare under the Consumer Protection Act Pre-1995: Medical services were not covered under the CPA 1986. Patients relied on:
- Civil courts (tort claims) for compensation
- Criminal prosecutions under IPC in rare cases
- Disciplinary action by Medical Councils (no power to award damages)
- Hear deficiency-in-service complaints
- Award compensation without civil-court delays
- Use district, state, and national commissions
- Criminal Liability for Death by Negligence Regulation Scope Penalty Medical Exception Section 304A IPC (1860) Death by rash or negligent act not amounting to culpable homicide Up to 2 years’ imprisonment, or fine, or both No statutory carve-out; courts require proof of gross negligence BNS Section 106 (2023) 1. Death by general negligence
2. Hit-and-run fatalities 1. Up to 5 years + fine
2. Up to 10 years + fine Doctors: Capped at 2 years + fine when a procedure causes death
Key Distinctions
- Punishment Ceiling:
- IPC 304A: Max 2 years for all
- BNS 106(1): Max 5 years (general), but 2 years for doctors
- BNS 106(2): 10 years for fleeing drivers
- Explicit Medical Clause:
IPC applied uniform standards; BNS offers capped punishment but continues criminalization, despite decriminalization promises.
- Disciplinary vs. Criminal Regimes:
- Before BNS: Handled via Medical Councils, tort law, and rarely IPC 304A
- After BNS: Adds expanded criminal liability while retaining existing forums
Proposed Reforms to Improve Conditions for Medical Professionals
- Legislative Amendments
- Exclude routine healthcare from CPA or insert gross-negligence threshold
- Remove procedural death liability for doctors under BNS 106
- Define “gross negligence” using Jacob Mathew case standards
- Institutional Mechanisms
- Set up Health Tribunals with medical and legal experts
- Use pre-litigation Expert Review Panels for causation and negligence
- Launch a no-fault compensation scheme
- Professional Safeguards
- Provide safe-harbor for adherence to clinical protocols
- Subsidize professional indemnity insurance
- Ensure Good Samaritan legal protection
- Procedural Safeguards
- Mandatory mediation before consumer court admission
- Time-bound case resolution
- Compensation caps via standard tariff schedules
- Capacity Building and Awareness
- Expand CME on risk, consent, and medico-legal literacy
- Run awareness campaigns on treatment expectations
- Launch legal helplines for medical professionals
No-Fault Compensation Scheme: An Overview
Key Features
- Causation-based eligibility
- Administrative process (not courts)
- Fixed compensation schedules
- Fast payout timelines
- Possible additional support services (rehab, counselling)
How These Reforms Improve Patient Rights & Safety
- Faster Compensation: Less stress and legal costs
- Encourages Disclosure: Less blame, more transparency
- Data-Driven Safety: Uses claims data to enhance system-level care
- Equal Access: Ensures equitable redress regardless of background.
Comparison Table: Fault-Based vs. No-Fault
| Aspect | Fault-Based System | No-Fault System |
|---|---|---|
| Burden of Proof | Patient must prove provider fault | Only need to show treatment–injury link |
| Speed of Resolution | Years of litigation | Months via administration |
| Legal Costs | High | Low |
| Error Reporting | Discouraged due to legal risk | Encouraged by non-punitive system |
| Coverage | Only in negligence | All avoidable harm |
Steps to Implement Effectively
- Draft enabling legislation with clear criteria
- Create an administrative authority or trust
- Fund via levies, insurance premiums, or health budgets
- Develop standardized tariff-based compensation
- Link data to patient-safety reform systems
- Conduct stakeholder education campaigns
- Monitor metrics and review periodically
- Provide appeals/review boards for disputed claims
Additional Considerations
- Ensure clinical regulation aligns with no-fault findings
- Preserve confidentiality while sharing safety data
- Customize model to Indian context, e.g., New Zealand’s ACC
- Allow phased transition from tort to no-fault model.
Initial Issue
Q. This takes care of the inadvertent mischief caused by the V P Shantha judgment. No fault compensation will be available to the patients even after health care is declared out of CPA. However, the mischief caused by blanket inclusion of ‘medical procedure by a registered medical practitioner’ to criminalizing medical profession, has to be addressed. This can be done by parliament only.
Reforming Criminal Liability for Medical Procedures: Parliamentary Pathways
Problem Statement: Blanket Criminalization
Patients and doctors face uncertainty because “medical procedure by a registered medical practitioner” is swept into general criminal provisions without nuance.
This blanket inclusion exposes routine clinical decisions—even when taken in good faith, with consent and adherence to standards—to criminal prosecution.
A targeted legislative fix from Parliament is the only way to clarify boundaries, safeguard professional discretion, and protect patient rights.
Core Legislative Amendments
- Amend the relevant clause in the Bharatiya Nyaya Sanhita (or IPC), carving out a “clinical acts in good faith” exception.
- Introduce “gross negligence” as the threshold for criminal liability, replacing the current “any negligence” standard.
- Require prior sanction or a prima facie review by a medical board before any criminal proceeding can be launched.
- Explicitly recognise informed consent and adherence to established clinical protocols as a defense to criminal charges.
Drafting the Amendment Bill: Key Provisions
| Current Text Issue | Proposed Amendment |
|---|---|
| All medical acts by registered practitioners can attract criminal liability. | Exclude clinical acts done in good faith, with consent, from criminal provisions. |
| Negligence standard undefined—any error risks prosecution. | Define “criminal negligence” as conduct showing gross disregard for patient safety. |
| No pre-prosecution medical review. | Mandate a medical-expert committee review before filing. |
| Absence of explicit consent defense. | Insert a clause validating documented informed consent. |
Steps to Enact Reform
- Drafting and Stakeholder Consultation
- Ministry of Health leads bill-drafting with inputs from medical councils, patient groups, legal experts.
- Circulate a white paper outlining proposed exceptions and thresholds.
- Parliamentary Committee Review
- Refer the draft to a Joint Committee on Law and Health for detailed clause-by-clause scrutiny.
- Invite testimony from clinicians, jurists, and patient-rights advocates.
- Debate and Passage in Parliament
- Introduce the bill in Lok Sabha and Rajya Sabha, ensuring explanatory statements highlight patient-safety and doctor-protection.
- Amend based on committee feedback; secure majority support.
- Presidential Assent and Notification
- Obtain Presidential assent; publish in the Gazette of India.
- Set an effective date, allowing a transition period for medical boards to form review committees.
- Rule-Making and Capacity Building
- Frame rules detailing the composition and powers of the pre-prosecution medical review board.
- Train law-enforcement officers and prosecutors on the new threshold and procedures.
Additional Considerations
- Align criminal-law reforms with professional disciplinary mechanisms under the National Medical Commission.
- Monitor impact via periodic parliamentary reviews: track number of prosecutions, case outcomes, and stakeholder feedback.
- Draw lessons from the UK’s gross-negligence manslaughter threshold and New Zealand’s ACC “good-faith” carve-outs.
- Communicate changes widely—through medical associations, patient-rights NGOs, and law-enforcement training—to ensure clarity and compliance.
This parliamentary roadmap will recalibrate the balance between accountability and professional autonomy, ensuring that only truly culpable conduct faces criminal sanction while preserving trust in the medical profession.
Gross Negligence: Legal Definition
- Gross negligence occupies a higher threshold than ordinary negligence, reflecting an extreme departure from the standard of care expected of a reasonable person.
- Defined as the “lack of slight diligence or care” or a “conscious, voluntary act or omission in reckless disregard of a legal duty and of the consequences to another party”.
- It goes beyond mere carelessness, involving a willful or wanton disregard for the safety or rights of others.
- In medical contexts, gross negligence might include operating on the wrong patient, amputating the wrong limb, or ignoring critical allergy alerts.
International Approaches to Criminal Liability in Medical Practice
| Country/Region | Primary Route | Criminal Liability | Key Features |
|---|---|---|---|
| Europe (e.g., France, Germany) | Civil/judicial | Rare | Handled by judges; payouts more likely but smaller, as negligence alone need not trigger criminal fault |
| Russia | Criminal courts | Frequent | 1,800 criminal cases filed in 2017; prosecutions led by state investigators rather than medical panels |
| Italy | Criminal predominant | High | Most malpractice suits filed criminally; evidence gathering by state; high defensive medicine due to liability concerns |
| United Kingdom | Civil tort & gross-negligence manslaughter | Exceptional | Requires proof of duty, breach, causation of death, and an obvious risk of death to a reasonable person |
| United States | Predominantly civil | Limited | Criminal charges only in extreme recklessness or intentional harm; most disputes resolved via malpractice insurers |
Potential Impacts of Liability Reforms on Patient Care
- Reduction in defensive medicine: Clearer “gross negligence” standards and immunity for good-faith emergency acts help doctors focus on optimal care rather than fearing prosecution.
- Preservation of emergency services: Protections for life-saving interventions encourage timely decisions, reducing hesitation in critical situations.
- Strengthened patient-safety culture: Distinguishing systemic errors from culpable conduct channels adverse-event data into quality-improvement initiatives rather than individual blame.
- Equitable access to compensation: A high negligence threshold may delay or limit recourse for patients harmed by substandard—but not grossly negligent—care.
- Enhanced trust and transparency: Clear legal benchmarks foster open disclosure of medical errors, building stronger patient–provider relationships.
- Risk of unintended barriers: If the gross-negligence standard is set too narrowly, some patients might perceive hurdles in claiming redress for genuine harms.
Q. The difficulty is in defining gross in terms of intent or application and not quantum of damage. Gross negligence (act) as per your definition may not result in any harm while a non-gross act may result in death. As per the provisions of BNS, grossness is either causing grievous hurt or death. BNS Sec 106(1) is for causing death which may be by a simple procedure like just inserting a needle in the chest or attempt to remove wax from ear. Medical act is a procedure performed by a licensed medical practitioner with the consent of the patient. By itself it cannot be gross, it may be risky. To my mind, gross medical negligence is when the act is either done by an incompetent person not licensed to treat, or the procedure is not recognized and approved, and is palpably not medical.
AI: Understanding Gross Medical Negligence
Legal Framework under BNS Sec 106(1)
- BNS Sec 106(1) treats “grossness” as conduct causing grievous hurt or death.
- Mere harm isn’t enough; the statute targets acts so egregious they result in serious injury or fatality.
Why “Gross” Is about the Act, Not Just the Outcome
- A licensed doctor’s procedure—even if risky—follows an accepted standard and informed consent.
- If no grievous harm occurs, the act may be negligent but not “gross” under the intent-based lens.
- Conversely, a minor mishap by a quack can be “gross” if the practitioner had no right to perform it.
Key Criteria for Gross Medical Negligence
- Practitioner Competence
- Performed by someone lacking the required license or credentials.
- No reasonable expectation that they could foresee or prevent the risk.
- Recognition and Approval
- Procedure falls outside sanctioned medical practice (no textbooks, no peer-review).
- Lacks institutional or regulatory backing (medical boards, hospital protocols).
- Palpable Departure from Standard of Care
- So far removed from accepted norms that any competent peer would instantly deem it unacceptable.
- Not a mere error in technique but a fundamental breach (e.g., injecting household bleach).
Applying This Definition in Practice
- Evidence-Gathering
- Verify practitioner’s licensing, training records, hospital affiliations.
- Collect expert opinions on whether the intervention has any basis in medical literature.
- Causation vs. Grossness
- You must link the act to the injury (causation) and show the act was so extreme it violated fundamental professional duties (grossness).
Beyond the Statute: Comparative Perspectives
- In several common-law jurisdictions, gross negligence is judged against a “recklessness” standard—did the actor consciously disregard a substantial risk?
- India’s approach aligns: intent need not be malicious, but indifference or extreme departure suffices.
What aspects of gross negligence interest you most?
Its proof in court, comparative rules in other countries, or strategies to prevent such acts in healthcare settings?
What strategies can healthcare professionals use to prevent gross negligence?
Written By: Dr Shri Gopal Kabra
MBBS, LLB, MSc, MS(Anatomy), MS(Surgery)
Email. [email protected] Mobile: 8003516198
