The Clinical Establishments (Registration and Regulation) Act, 2010 regulates hospitals, clinics, and diagnostic centres by mandating registration and minimum quality standards. It promotes patient safety, transparency in pricing, ethical practices, and accountability among healthcare providers. Although adopted in several States and Union Territories, variations in implementation exist, with some states following their own healthcare regulations.
Clinical establishments like hospitals, clinics, and diagnostic centres are the backbone of the healthcare system in any country. The Clinical Establishment Act, 2010, ensures minimum standardisations for these establishments and has been adopted in 19 states/UTs of India. This page will cover what this act is about and how it would benefit both the patients and the doctors.
Latest Update on Clinical Establishments Act, Feb 2026
Rajya Sabha MP Swati Maliwal has urged the Central Government to make the Clinical Establishments Act mandatory across all states, highlighting that not even Delhi has adopted it yet. She also called for “treatment first, bill later” in emergencies and a more transparent and fair hospital billing system to protect patients from exploitation and rising healthcare costs.
What Is a Clinical Establishment?
A clinical establishment refers to any healthcare facility that provides diagnosis, treatment, or care for illness, injury, deformity, or pregnancy. This includes:
Hospitals
Clinics
Nursing homes
Maternity homes
Dispensaries
Diagnostic and pathology laboratories
These facilities may be run by:
The government
Private organisations
Charitable trusts
Societies
Individual practitioners
Whether small or large, any centre offering medical services to patients falls under the scope of a clinical establishment.
What Is the Clinical Establishments Act, 2010?
The Clinical Establishments (Registration and Regulation) Act, 2010, is a central legislation introduced to make the registration and regulation of clinical establishments mandatory across India. Its main objectives are to:
Standardise healthcare services nationwide
Ensure minimum quality and safety standards
Improve transparency in treatment and pricing
Promote ethical medical practices
Protect patient rights
Prevent unregistered and unsafe medical facilities
Under this Act, healthcare providers must register their establishments and comply with prescribed norms related to infrastructure, staffing, equipment, and service delivery. Authorities are empowered to inspect facilities and take action against those violating the rules.
History & Evolution of the Clinical Establishments Act
The Clinical Establishments Act evolved over decades to create a uniform legal framework for regulating healthcare facilities and improving service quality across India.
1946
1980s–1990s
2005
2007
2010
2012
2014 onwards
2018–Present
The Bhore Committee recommends state responsibility and standardisation of healthcare services.
The growing private healthcare sector highlights the need for national regulation.
National Rural Health Mission (NRHM) stresses quality standards and facility regulation. (Ministry of Health and Family Welfare (MoHFW), "National Rural Health Mission: Mission Document (2005-2012))
Draft bill on registration and regulation of clinical establishments is proposed.
Clinical Establishments (Registration and Regulation) Act is passed by Parliament. (The Clinical Establishments (Registration and Regulation) Act, 2010 (No. 23 of 2010))
Central Government notifies rules for implementation of the Act.
States and Union Territories begin adopting the Act and creating State Councils.
Digital registration portals and national databases introduced for better monitoring.
Objectives of the Clinical Establishments Act
The Clinical Establishments (Registration and Regulation) Act, 2010 was enacted to strengthen India’s healthcare system by setting clear rules and standards for medical facilities. Its key objectives are:
Ensure Minimum Standards of Healthcare
Create a Uniform Regulatory Framework
Improve Patient Safety and Service Transparency
Prevent Malpractice and Unethical Practices
Establish a Centralised Digital Registry
To guarantee that all clinical establishments meet prescribed norms related to infrastructure, equipment, staffing, hygiene, and patient care.
To bring consistency in the regulation of healthcare facilities across different states and Union Territories.
To enhance safety in treatment practices and promote transparency in procedures, fees, and service delivery.
To curb illegal operations, unqualified practice, misleading treatments, and other unethical medical activities.
To develop a national online database of registered healthcare facilities for better monitoring, planning, and public access.
Scope & Applicability of the Clinical Establishments Act
The Clinical Establishments (Registration and Regulation) Act, 2010 has a wide scope and applies to most healthcare facilities operating in India. It is designed to ensure that medical services across different systems and settings follow uniform standards.
Coverage of the Clinical Establishments Act
All Public and Private Clinical Establishments cover healthcare facilities run by the government, private organisations, trusts, societies, and individual practitioners.
All Recognised Systems of Medicine Act includes all major systems of medicine practised in India, such as: Allopathy, Ayurveda, Yoga, Naturopathy, Homoeopathy, Siddha, and Unani.
Different Types of Healthcare Facilities apply to a wide range of medical institutions, including Hospitals, Clinics, Nursing homes, Diagnostic centres, and Pathology laboratories.
Exemptions of Clinical Establishments Act
Armed Forces Medical Establishments such as Healthcare facilities run by the Armed Forces are exempt from the provisions of this Act and are governed by separate military regulations.
Registration Under the Clinical Establishments Act
Under the Clinical Establishments (Registration and Regulation) Act, 2010, registration is mandatory for all eligible healthcare facilities. No clinical establishment is permitted to operate legally without being registered under the Act.
Registration is managed by the District Registering Authority and follows a structured two-stage process to ensure both ease of entry and long-term compliance.
1. Provisional Registration
Provisional registration is the first stage of registration and is granted based on self-declaration by the applicant.
It is usually issued within 10 days of application.
No physical inspection is conducted at this stage.
It is valid for one year.
It allows establishments to begin operations legally while upgrading their facilities to meet prescribed standards.
This stage encourages new and existing healthcare providers to come under the regulatory framework without immediate procedural delays.
2. Permanent Registration
Permanent registration is granted after verifying that the establishment complies with the prescribed minimum standards.
Authorities conduct inspections and document verification.
Infrastructure, staffing, safety measures, and service quality are assessed.
Once approved, permanent registration is issued.
Key features such as it is valid for five years, It must be renewed periodically before expiry, and only permanently registered establishments are considered fully compliant under the Act.
Documents Required for Clinical Establishment Registration
To apply for registration, healthcare providers must submit the following documents:
Identity and address proof of the owner or authorised person
Proof of premises ownership or valid lease agreement
Qualification and registration certificates of doctors and medical staff
Details of infrastructure, medical equipment, and healthcare services
Biomedical waste management authorisation certificate
You can download the forms for registration from - https://clinicalestablishments.mohfw.gov.in/en/download
Minimum Standards & Mandatory Compliance
Under the Clinical Establishments (Registration and Regulation) Act, 2010, every registered healthcare facility must comply with prescribed minimum standards to ensure safe, ethical, and quality patient care.
Prescribed Infrastructure, Staffing & Equipment Standards
Registered establishments are required to meet defined standards relating to:
Adequate infrastructure and space
Qualified medical and paramedical staff
Essential medical equipment and safety systems
These standards are designed to ensure that patients receive treatment in a properly equipped and professionally managed environment.
Emergency Medical Care
All registered clinical establishments must provide emergency medical treatment to stabilise patients, regardless of their financial status, before referring them to higher centres if necessary.
Display of Registration & Service Rates
To promote transparency and accountability, establishments must:
Display the registration certificate prominently within the premises
Clearly display the schedule of charges and service rates for public view
This helps patients make informed decisions and prevents overcharging.
Maintenance of Records & Data Submission
Clinical establishments are required to:
Maintain proper medical and administrative records
Maintain electronic health records where prescribed
Submit data to authorities when required for regulatory or public health purposes
Digital Registry of Clinical Establishments
The Clinical Establishments (Registration and Regulation) Act, 2010 mandates the creation of a digital registry at the National, State, and District levels to maintain verified records of healthcare facilities. This registry promotes transparency by giving the public access to authorised establishments. It also helps authorities monitor compliance, registrations, and renewals. Additionally, it supports healthcare planning and prevents illegal or unregistered operations.
Transparency & Patient Rights
Under the Clinical Establishments (Registration and Regulation) Act, 2010, registered establishments are required to clearly disclose treatment costs, service charges, and details of the facilities and services offered. This information must be displayed prominently to ensure openness in healthcare delivery.
By mandating transparency in pricing and services, the Act empowers patients to make informed decisions about their treatment and protects them from overcharging, hidden costs, and potential exploitation.
Penalties for Non-Compliance
Under the Clinical Establishments (Registration and Regulation) Act, 2010, failure to comply with the provisions of the Act attracts monetary penalties. If an establishment violates any requirement and no separate penalty is prescribed elsewhere, it is liable for fines as follows:
First offence
Second offence
Subsequent offences
Fine which may extend up to ₹10,000
Fine which may extend up to ₹50,000
Fine which may extend up to ₹5,00,000
State-Wise Adoption & Variations of Clinical Establishments Act
The Clinical Establishments (Registration and Regulation) Act, 2010 has been adopted in Arunachal Pradesh, Assam, Bihar, Haryana, Himachal Pradesh, Jharkhand, Mizoram, Rajasthan, Sikkim, Telangana, Uttar Pradesh, Uttarakhand, and all Union Territories except Delhi.
Some states have their own separate regulatory laws instead of adopting the central Act. For example, Karnataka follows the Karnataka Private Medical Establishments Act (KPME Act), while Kerala is governed by the Kerala Clinical Establishments Act, 2018.
For State Specific Rules, you can refer to - https://clinicalestablishments.mohfw.gov.in/en/state-and-uts-rules-and-notification
Impact of the Clinical Establishments Act on Healthcare Providers
The Clinical Establishments (Registration and Regulation) Act, 2010 has significantly increased regulatory oversight over healthcare facilities. Providers are now required to ensure strict compliance with prescribed infrastructure, staffing, equipment, and record-keeping standards.
The Act promotes greater operational transparency by mandating disclosure of service charges and facility details, which also improves clarity in health insurance billing and claims processing. While this leads to improved service quality and patient trust, it also brings added administrative responsibilities such as documentation, inspections, renewals, periodic reporting to authorities, and coordination with health insurance providers for reimbursement compliance.
Impact of the Clinical Establishments Act on Patients
For patients, the Act enhances safety and reliability in healthcare services by ensuring minimum quality standards across registered facilities. Transparent pricing requirements help patients make informed decisions and reduce the risk of overcharging or hidden costs.
Patients also benefit from the obligation of establishments to provide emergency stabilisation care and from increased accountability of healthcare providers through regulatory monitoring and penalties for non-compliance.
Challenges & Criticism of the Clinical Establishments Act
Despite its positive impact on healthcare regulation, the Clinical Establishments (Registration and Regulation) Act, 2010, has faced several challenges and criticisms. One major concern is the compliance burden on small clinics and individual practitioners, who often find it difficult to meet detailed documentation and regulatory requirements. The cost of upgrading infrastructure, equipment, and facilities to prescribed standards can also be financially challenging, especially for smaller establishments.
Additionally, the uneven implementation of the Act across states has led to inconsistencies in enforcement and monitoring. There has also been resistance from private healthcare providers, who argue that excessive regulation may increase operational costs and affect service delivery.
Conclusion
The Clinical Establishments (Registration and Regulation) Act, 2010 plays a vital role in regulating healthcare facilities through mandatory registration, prescribed minimum standards, and enhanced transparency. It safeguards patient safety, promotes accountability among healthcare providers, and helps improve the overall quality of healthcare delivery in India. Despite state-wise variations in implementation, the Act continues to strengthen the healthcare system by encouraging ethical practices, reliable services, and greater public trust in medical institutions. https://clinicalestablishments.mohfw.gov.in/en
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FAQs on Clinical Establishments Act
Is registration under the Clinical Establishments Act mandatory?
Yes, registration is mandatory for all eligible clinical establishments. Operating without valid registration is illegal under the Act and may attract penalties.
Which systems of medicine are covered under the Act?
The Act covers all recognised systems of medicine, including Allopathy, Ayurveda, Yoga, Naturopathy, Homoeopathy, Siddha, and Unani.
Is provisional registration compulsory before permanent registration?
Yes, provisional registration is the first mandatory step. Establishments must obtain provisional registration before applying for permanent registration.
How long is a permanent registration certificate valid?
A permanent registration certificate is generally valid for five years and must be renewed before expiry.
Are diagnostic labs required to register under this Act?
Yes, diagnostic centres and pathology laboratories are treated as clinical establishments and must be registered under the Act.
What happens if a clinic operates without registration?
Operating without registration can lead to monetary penalties, closure notices, and legal action under the Act.
Is emergency treatment mandatory under the Act?
Yes, registered establishments are required to provide emergency medical care to stabilise patients before referral if needed.
Does the Clinical Establishments Act apply to government hospitals?
Yes, the Act applies to both public and private clinical establishments, except those run by the Armed Forces.
Which states have not adopted the Clinical Establishments Act?
States that have not adopted the central Act follow their own healthcare laws. For example, Karnataka and Kerala have separate regulatory frameworks.
Can states modify or create their own clinical establishment laws?
Yes, states have the authority to modify the central framework or enact their own laws to regulate clinical establishments based on local requirements.
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