Laws & Articles Related to Medical Negligence in India!

Medical negligence is a critical issue in India, raising serious concerns about patient safety and healthcare standards. A medical professional is deemed negligent when they deviate from established medical practices, resulting in harm to the patient. The framework addressing medical negligence includes statutory provisions, judicial precedents, and professional guidelines. These measures aim to protect patient rights and ensure accountability among healthcare professionals.

The legal framework governing medical negligence in India is quite expansive; it includes consumer protection legislation, penal laws, and special legislation concerning healthcare services. The Consumer Protection Act of 2019, provides scope for patients to avail of this area under the deficiency in medical services. Other than that, some provisions under the IPC make the medical professional liable for criminal negligence leading to an injured person or death. This has been further fleshed out by landmark Supreme Court judgments, defining standards of care and extent of liability; and by the Medical Council of India through guidelines on ethical conduct and professional accountability.

Both doctors and patients should be very conversant with these laws and articles implicated in medical negligence cases to safeguard the standards of medical practice in India. This overview wonders into the essential legal provisions and leading case laws in the area of medical negligence in India.

Consumer Protection Act, 2019

The Consumer Protection Act, 2019 was enacted by the Government of India with the prime motive of protection and promotion of the rights of the consumer. It came into practice instead of the Consumer Protection Act, of 1986, and had various new provisions for the protection of consumers in the country.

Main Features of the Consumer Protection Act, 2019:

Definition of Consumer: The Act defines a consumer as any person who purchases any goods or hires any service for consideration. A consumer also means the person who uses the goods with the approval of the buyer.

Consumer Rights: The Act enumerates the various rights of consumers, which include protection from hazardous goods and services, the right to information relating to goods and services, the right to seek redressal against unfair trade practices and exploitation, etc.
CCPA: The Act provides for the establishment of a Central Consumer Protection Authority that will promote, protect, and enforce the interests of consumers. The aforesaid CCPA shall have powers to investigate, withdraw unsafe goods, and impose penalties against the manufacturer or service provider.
Consumer Dispute Redressal Commission: The Act establishes a Consumer Dispute Redressal Commission at the district, state, and national levels which shall adjudicate consumer complaints.
Consumer Dispute Redressal Mechanism: The provisions for mediation as a mode of dispute resolution in the Act are amended specifically to settle consumer disputes speedily and cost-effectively.
Product Liability: This Act will introduce the principle of product liability and shall hold liable any manufacturer, seller, or service provider for causing any harm to consumers on account of defective products or deficient services.
E-commerce Transactions: The Act encompasses e-commerce transactions, defining the roles and liabilities of e-commerce platforms in cases of counterfeit products or deficient services sold through them.
Consumer Rights Awareness: The Act emphasises consumer awareness and provides for the constitution of consumer protection councils at the district, state, and national levels to promote and protect consumer rights awareness.
Penalties and Compensation: The Act provides stringent penalties by way of imprisonment and fines for misleading advertisements, unfair trade practices, and non-compliance with the provisions of the Act. Along with that, it provides compensation to the consumer for such loss or injury due to defective goods or deficient services.

Importance and Impact:

Stronger Consumer Protection: It has strengthened the framework of the law of consumer protection in India by introducing lucid definitions, rights, and redressal mechanisms.
Promotion of Fair Trade Practices: The Act seeks to ensure that there will be fair competition and that consumers are not exploited by preventing unfair trade practices and fraudulent advertisements.
Consumer Empowerment: It sets up mechanisms through which consumers will get remedies, besides holding the manufacturer or service provider accountable.
Adaptation to the new consumer landscape: This Act takes into account new challenges arising from digital transactions and e-commerce, ensuring that consumers are protected within the digital marketplace.

Indian Penal Code (IPC), 1860

The Indian Penal Code of 1860 represents the basic criminal code of India. It was enacted on the 6th of October 1860 during British rule and is applicable throughout India. IPC was drafted by the First Law Commission which had Lord Thomas Babington Macaulay as its chairman.

Key features of IPC are:

Structure and Contents: The IPC is divided into 23 chapters and comprises 511 sections, which consist of a variety of criminal offences. Each chapter provides certain types of offences, such as offences against the state, offences against public tranquillity, offences relating to marriage, offences against property, and so on.

Offences Classified Under the IPC: Crimes under the IPC are classified into two broad categories:

Cognizable offences: These are serious offences wherein the police are empowered to arrest without a warrant and initiate an investigation on their own without the permission of the court.
Non-cognizable offences: These are less serious offences wherein the police cannot arrest without a warrant. The permission of the court has to be taken before starting the investigation.
Punishments: IPC provides different punishments for many offences, which range from fines to imprisonment and, in some cases, even the sentence of death. The quantum of punishment is decided by the nature of the offence.

Amendments: The IPC has undergone repeated amendments over the years to reflect societal changes and legal evolution. They incorporated new offences into the statute book, changed the provisions of some sections, and altered punishment.
Application: IPC comes into action in the case of all citizens of India and persons of any nationality on Indian land as well.
Principles: The IPC is based upon the principle of the presumption of his innocence till he is proven guilty, and lays emphasis on a fair trial, and due process.

The Clinical Establishments (Registration and Regulation) Act, 2010

The Clinical Establishments (Registration and Regulation) Act, of 2010 is one of the most important Acts in India for the regulation of the establishment and operation of the clinical establishment, including hospitals, clinics, and diagnostic centres. The key points and objectives of the Act are as follows:

Purpose: The Act relates to ensuring minimum standards of facilities and services provided by any clinical establishment to patients.
Applicability: It applies to all clinical establishments in India, both in the public and private sectors, excluding those run by the armed forces.
Registration: Clinical establishments need to be registered with the appropriate authority as specified by the state governments.
Minimum Standards: It provides for the establishment of minimum standards of facilities and services, including personnel, equipment, infrastructure, and clinical practices.
Clinical Establishments Council: The Act provides for the constitution of a Central Council and the formation of State Councils to monitor the implementation and enforcement of the Act in the country.
Compliance and Inspection: Compliance by clinical establishments with the prescribed standards under the said Act, as well as regular inspection and assessment, are some of the important tasks and steps taken to ensure compliance.
Penalties: Based on non-compliance, there are provisions enunciating penalties in the form of fines, suspension, or withdrawal of registration.
Patient Rights: It emphasises the rights of the patients about information, informed consent, and redressal mechanisms with regard to grievances.
Transparent Pricing: Clinical establishments are required to have transparency in pricing for services offered from time to time.
Medical Ethics: It promotes adherence to standards of professional conduct and medical ethics on the part of healthcare providers.

Current Legal Framework:

Under Section 304A of the IPC, medical negligence resulting in death is treated as a criminal offence, punishable by imprisonment for up to two years, a fine, or both. This categorisation equates medical negligence to rash and negligent acts leading to death.

Proposed Changes:

The new Bharatiya Nyaya Sanhita (BNS), passed in December 2023 provides some relief for doctors from criminal liability for medical negligence. This amendment is intended to relieve medical professionals from the fear of criminal prosecution and allow them to perform their duties without the pressure of potential legal repercussions .

Rationale:

The Indian Medical Association (IMA) advocated for this change, highlighting that the current laws deter doctors from making critical decisions due to fear of criminal charges. The government believes that decriminalising medical negligence will encourage a more confident and effective healthcare environment . However, they will still be accountable under civil laws and professional guidelines, which means they can be sued for compensation or face disciplinary actions by medical councils.