Licenses, Acts & Preventive Legal Measures in Hospitals

Licenses, Acts & Preventive Legal Measures in Hospitals

Introduction

Hospitals function as highly regulated institutions where patient care intersects with law, ethics, and medical professionalism.

Since hospitals deal with human lives, their operations are governed by a comprehensive framework of licenses, statutory acts, and regulatory measures.

These ensure patient safety, uphold medical ethics, and protect doctors and institutions from legal disputes.

At the same time, preventive legal measures—such as proper documentation, informed consent, and ethical decision-making—help reduce medico-legal risks and enhance trust in healthcare delivery.

Licenses and Acts Applicable to Hospitals

A. Licenses Required

Registration of Hospital under State Acts

Mandatory registration under Clinical Establishments Act, 2010 (or relevant state acts).

Ensures standards of infrastructure, manpower, equipment, and quality of care.

Biomedical Waste Management Authorization

License under Biomedical Waste Management Rules, 2016.

Compliance with segregation, collection, transportation, and disposal norms.

Pharmacy / Drug License

Mandatory under the Drugs and Cosmetics Act, 1940.

Required for procurement, storage, and dispensing of medicines.

Blood Bank License (if applicable)

Governed by Drugs and Cosmetics Rules.

License from State Drugs Controller and compliance with NBTC (National Blood Transfusion Council) guidelines.

Radiology / Imaging License

License under Atomic Energy Regulatory Board (AERB) for X-ray, CT, MRI, and radiotherapy equipment.

Compliance with PNDT Act (Pre-Conception and Pre-Natal Diagnostic Techniques Act, 1994) to prevent sex determination misuse.

Nursing Home License

State-specific regulations requiring hospitals/nursing homes to register with local health authority.

Food License (FSSAI)

Required if hospital runs a kitchen or dietary service.

Fire Safety Certificate

Issued by local Fire Department to ensure safety compliance.

Lift & Building Safety Clearance

For multi-storey hospitals with elevators and large infrastructure.

Water & Pollution Control License

Consent from State Pollution Control Board for effluent discharge and environmental safety.

B. Acts Applicable to Hospitals

Indian Medical Council Act, 1956 → Governs professional conduct of doctors.

Clinical Establishments Act, 2010 → Standardization and regulation of healthcare facilities.

Consumer Protection Act, 2019 → Patients can sue hospitals/doctors for negligence.

Indian Penal Code (IPC) → Relevant for criminal negligence, causing death, or fraudulent practices.

Medical Termination of Pregnancy Act, 1971 → Governs abortion practices.

Mental Healthcare Act, 2017 → Protects rights of mentally ill patients.

Transplantation of Human Organs and Tissues Act, 1994 → Regulates organ donation and transplantation.

PNDT Act, 1994 → Prohibits sex determination and female foeticide.

Drugs and Cosmetics Act, 1940 → Governs drug use, storage, and distribution.

Bio-Medical Waste Management Rules, 2016 → Ensures scientific waste disposal.

Epidemic Diseases Act, 1897 / Disaster Management Act, 2005 → Relevant during outbreaks or emergencies.

Preventive Steps for Doctors and Hospitals to Avoid Litigation

Proper Documentation: Maintain complete, legible, and chronological medical records.

Informed Consent: Ensure written, informed, and voluntary consent for all major/minor procedures.

Communication: Transparent communication with patients and relatives to avoid misunderstanding.

Adherence to Protocols: Follow standard treatment guidelines and evidence-based medicine.

Maintain Confidentiality: Protect patient’s personal and medical information.

Insurance Coverage: Professional indemnity insurance for doctors and liability coverage for hospitals.

Regular Training: Medico-legal awareness programs for staff.

Safety Protocols: Fire safety, infection control, biomedical waste management, etc.

Audit Systems: Periodic clinical and legal audits to identify gaps.

Legal and Ethical Handling of Sensitive Issues

A. Consent Forms

Types of Consent:

Implied Consent: For routine examination.

Informed Consent: For surgeries, anesthesia, invasive procedures.

Proxy Consent: Taken from guardian if patient is minor or incapacitated.

Legal Validity:

Must be written, voluntary, informed, and signed.

Should specify procedure, risks, benefits, alternatives, and complications.

B. Life Support Withdrawal

Ethical and legal dilemma in cases of terminal illness or brain death.

Governed by Supreme Court of India (Aruna Shanbaug case, 2011) allowing passive euthanasia with strict safeguards.

Steps:

Decision by medical board.

Informed consent of relatives.

Approval from High Court in certain cases.

C. Dying Declaration

A written or verbal statement made by a patient who is about to die, regarding cause of death or circumstances.

Legally admissible in court under Section 32 of Indian Evidence Act, 1872.

Precautions:

Recorded by a doctor or magistrate.

Patient must be conscious, coherent, and mentally fit.

Must be signed/attested properly.

D. Death Certificate

Issued under Births and Deaths Registration Act, 1969.

Responsibilities:

Only a registered medical practitioner can certify cause of death.

In medico-legal cases, certificate is withheld until postmortem.

Natural vs unnatural deaths must be carefully distinguished.

E. High-Risk Procedures

Examples: organ transplant, cardiac surgery, neurosurgery, experimental treatments.

Legal Safeguards:

Detailed informed consent.

Pre-operative counseling.

Multi-disciplinary board approval if required.

Documentation of risks explained.

F. Postmortem Guidelines

Conducted under request from police or magistrate in medico-legal deaths.

Steps:

Written requisition from legal authority.

Body identification and proper documentation.

Complete external and internal examination.

Preserve viscera for toxicology if required.

Special Precautions:

Maintain chain of custody.

Impartial and scientific approach.

Avoid unnecessary delay in submission of report.

Video Description

·        Don’t forget to do these things if you get benefitted from this article

·        Visit our Let’s contribute page https://keedainformation.blogspot.com/p/lets-contribute.html

·        Follow our page

·        Like & comment on our post

·