Inadvertent Mischief caused by V P Shantha and BNS 106(1) need to be addressed

“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

Q. Medical fraternity in India is greatly agitated on the two woes inflicted on the profession.

Firstly, the inadvertent mischief caused by inclusion of Health Care as service in Consumer Protection Act 1986 by the judgment in IMA vs V P Shantha, 1995.
Secondly, by criminalizing ‘acts of registered medical professional should the procedure performed by him result into death of the patient’ by inserting a clause in Bhartiya Nayay Sanhita 2023. This insertion surprised and dismayed the profession as the minister while moving the Bill had announced that the Sec 304A of IPC that criminalized the medical act of a doctor, will be suitably amended in BNS sections to ‘decriminalize’ it.

AI: > Comparing New Legal Changes with Previous Regulations

1. Inclusion of Healthcare under the Consumer Protection Act Pre-1995: Medical services lay outside the Consumer Protection Act, 1986. Patients seeking redress relied on:
   • Civil courts (tort claims) for compensation
   • Criminal prosecutions under the IPC in extreme cases
   • Disciplinary action by Medical Councils (no power to award damages)
   Post-1995 (IMA vs VP Shantha): The Supreme Court held that paid medical services qualify as “service” under CPA 1986. This opened consumer forums to:
   • Hear deficiency-in-service complaints against doctors and hospitals
   • Award compensation without civil-court delays or criminal standards
   • Operate via district, state, and national commissions with streamlined procedures
      
2. 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 before prosecuting doctors BNS Section 106 (2023) 1. Death by general negligence
   2. Hit-and-run fatalities 1. Up to 5 years’ imprisonment + fine
   2. Up to 10 years’ imprisonment + fine Registered medical practitioners capped at 2 years’ imprisonment + fine when a procedure causes death Key Distinctions
   • Punishment Ceiling –
     • 304A IPC: Max 2 years for all offenders
     • BNS 106(1): Raises general maximum to 5 years; retains 2 years for doctors
     • BNS 106(2): Creates a 10-year penalty for fleeing drivers
   • Explicit Medical Clause –
     • Under IPC, doctors faced the same standard as any negligent individual, subject to judicially developed safeguards (e.g., Jacob Mathew guidelines).
     • BNS carves out a statutory cap for “registered medical practitioners,” yet still criminalizes procedural death—contrary to ministerial assurances of decriminalization.
   
    
3. Disciplinary vs. Criminal Regimes Before BNS, medical misconduct invoked:
   • Medical Council Act: Suspension or de-registration for professional misconduct
   • Civil law: Compensation via tort
   • IPC (304A): Criminal negligence in rare fatal cases
   The new BNS framework retains:
   • Medical Council disciplinary powers (unchanged)
   • Expanded criminal liability under Section 106 for procedural and vehicular deaths
   • Consumer redress remains via CPA 1986 (unchanged since 1995)
   By juxtaposing these layers, we see the profession has moved from largely civil and disciplinary oversight to a hybrid regime where consumer claims, professional regulation, and enhanced criminal sanctions all apply—often with overlapping consequences.  

Proposed Reforms to Improve Conditions for Medical Professionals

1. Legislative Amendments
   • Exclude routine healthcare from the definition of “service” under the Consumer Protection Act, or embed a gross-negligence threshold.
   • Decriminalize procedural deaths by removing doctors from BNS Section 106, reserving criminal sanctions for willful or grossly negligent acts only.
   • Statutorily define “gross negligence,” drawing on the Jacob Mathew guidelines to ensure clarity and consistency.
2. Institutional Mechanisms
   • Establish specialized Health Tribunals comprising medical and legal experts to handle negligence claims instead of general consumer forums.
   • Mandate pre-litigation Expert Review Panels to assess medical standards and causation, issuing binding opinions before cases proceed.
   • Implement a no-fault compensation scheme to expedite patient relief without attributing individual blame.
3. Professional Safeguards
   • Introduce safe-harbor provisions shielding practitioners who adhere to approved clinical protocols and guidelines.
   • Strengthen and subsidize professional indemnity insurance to ensure affordable, comprehensive coverage for all doctors.
   • Enact robust Good Samaritan protections guaranteeing no civil or criminal liability for emergency care offered in good faith.
4. Procedural Safeguards
   • Require mandatory mediation or conciliation before consumer courts admit medical negligence cases.
   • Enforce time-bound resolution processes in tribunals to reduce legal uncertainty for patients and practitioners alike.
   • Cap compensation awards through standardized tariff schedules to prevent unpredictable and disproportionate liabilities.
5. Capacity Building and Awareness
   • Expand continuous medical education on risk management, informed consent, and medico-legal obligations.
   • Launch patient-awareness campaigns clarifying realistic treatment outcomes and consent rights.
   • Create government-funded helplines offering real-time legal and ethical advice to practitioners, reducing reliance on criminal prosecution.

By integrating these legislative, institutional, and procedural reforms, India can achieve a balanced framework—safeguarding patient rights while protecting medical professionals from undue legal peril.

Q. Can you elaborate on the no-fault compensation scheme? How would these reforms affect patient rights and safety? What steps are needed to implement these reforms effectively?

AI: > The No-Fault Compensation Scheme: An Overview

Key Features of a No-Fault Model

• Eligibility determined by causation, not by proof of negligence or fault
• Administrative—rather than court—based claims process, reducing legal complexity
• Fixed or tariff-based compensation schedules for common injuries
• Expedited payout timelines, often within months of application
• Potential for additional support services (rehabilitation, counselling) alongside financial awards

How These Reforms Enhance Patient Rights and Safety

• Faster Compensation: Patients receive timely financial redress without protracted litigation, reducing out-of-pocket costs and stress.
• Encouragement of Open Disclosure: Replacing blame with inquiry fosters honest reporting of adverse events, strengthening trust between patients and providers.
• Improved Quality of Care: Data from no-fault claims feed back into patient-safety systems, enabling systemic fixes rather than finger-pointing at individuals.
• Equal Access: All eligible patients—regardless of age, socioeconomic status, or legal resources—benefit from compensation, promoting equity in healthcare rights.

Comparison: Fault-Based vs No-Fault Compensation

Aspect	Fault-Based System	No-Fault System
Burden of Proof	Patient must prove provider fault	Patient only shows treatment–injury link
Speed of Resolution	Often years of litigation	Typically months via administrative body
Legal Costs	High (attorneys, expert witnesses)	Low (minimal legal involvement)
Impact on Safety Reporting	Chilling effect on error reports	Encourages transparent reporting
Coverage	Only negligent cases	Broader coverage of avoidable harm

Steps to Implement a No-Fault Scheme Effectively

• Legislative Foundation: Draft and enact clear enabling legislation defining scope, eligibility criteria, and compensation tariffs.
• Establish an Administrative Authority: Create a dedicated agency or trust to process claims, administer funds, and liaise with healthcare providers and insurers.
• Secure Sustainable Funding: Options include:
  • A small levy on healthcare services or procedures
  • Surcharges on insurer premiums (as with COVAX vaccine compensation)
  • Allocation from general health budgets
• Define Standardized Compensation Schedules: Develop injury-specific tariff tables to ensure consistency and predictability of awards, reducing disputes over amounts.
• Integrate with Patient-Safety and Reporting Systems: Link no-fault claim data to quality-improvement initiatives so that aggregated insights drive safety reforms.
• Launch Stakeholder Engagement & Education: Conduct informational campaigns for patients, providers, insurers, and legal professionals to clarify processes and benefits.
• Implement Monitoring & Evaluation:
  • Track metrics: claim volumes, payout timelines, patient satisfaction
  • Conduct periodic reviews to adjust eligibility, tariffs, and processes based on real-world performance
• Ensure Review and Appeal Mechanisms: Provide an independent review panel or ombudsman for disputed claims, maintaining fairness and accountability.

Additional Considerations

• Align professional regulation and disciplinary procedures so that compensation inquiries dovetail with—but do not impede—clinical governance.
• Protect the confidentiality of claimants while still enabling data-sharing for safety research.
• Tailor the model to local contexts, drawing lessons from New Zealand’s ACC and the WHO’s COVAX no-fault compensation program for vaccine injuries.
• Plan for transitional phases, allowing existing tort claims to wind down while ramping up the no-fault system.

Conclusion: By implementing these steps, policymakers can create a patient-centric, transparent compensation regime that not only upholds rights but actively promotes safer, higher-quality care.

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.

AI: 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

1. 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.
    
2. 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.
    
3. 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.
    
4. 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.
    
5. 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.

Q. Can you explain ‘gross negligence’ in legal terms? How do other countries handle criminal liability in medical practices? What are potential impacts of these reforms on patient care?

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

Different jurisdictions balance patient protection with safeguarding medical professionals by varying both procedural routes and liability thresholds.

Country/Region	Primary Route	Criminal Liability	Key Features	Citation
Europe (e.g., France, Germany)	Civil/judicial	Rare	Handled by judges; payouts more likely but smaller, as negligence alone need not trigger criminal fault	22
Russia	Criminal courts	Frequent	In 2017, 1,800 criminal cases filed; prosecutions led by state investigators rather than medical panels	22
Italy	Criminal predominant	High	Most malpractice suits filed criminally; evidence gathering by state; high defensive medicine due to liability concerns	27
United Kingdom	Civil tort & gross-negligence manslaughter	Exceptional (“gross negligence manslaughter”)	Requires proof of duty, breach, causation of death, and an obvious risk of death to a reasonable person in the defendant’s position	9
United States	Predominantly civil	Limited; rare criminal prosecution	Criminal charges arise only in cases of 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.

By articulating “gross negligence” distinctly, aligning international practices, and calibrating liability thresholds, reforms can reduce fear-driven practice, improve emergency care, and bolster patient-safety systems—while ensuring that truly egregious conduct remains sanctionable.

How does medical malpractice differ from gross negligence?

Can you elaborate on a specific country’s approach to medical liability? Can you provide examples of gross negligence cases in medicine?

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.

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