The Maharashtra Clinical Establishments (Registration and Regulation) Bill, 2026
Key Features Every private clinical establishment must register.  It must fulfil minimum standards, and requirements on personnel, records, and reporting.  Registration will be valid for five years. Obligations of clinical establishments include displaying rates and charges, not charging above the displayed rates, and providing emergency care without considering ability to pay. The Bill grants certain rights to patients.  These relate to access to information, non-discrimination, second opinion, and privacy, confidentiality, and dignity. The state government will establish a State Council.  Its key functions include determining minimum standards and services to be provided to patients, and maintaining a state register of clinical establishments. Operating without registration will attract a civil penalty of up to one lakh rupees on first contravention.	Key Issues and Analysis Government clinical establishments are not covered under the Bill.  This may lead to different regulatory standards for public and private health facilities, and a lack of legal protections for patients accessing public health facilities. Registration will be valid for five years and will have to be renewed.  Recurring renewal may increase compliance burden and create scope for corruption.  The Bill has other mechanisms to ensure compliance. The Bill requires public display of the evidence on compliance with standards submitted for registration, and invitation of objections from the public.  Given that such evaluations are technical in nature, the need for such processes is unclear. The Bill does not grant certain rights recognised by the National Human Rights Commission to patients.  There are no provisions for grievance redressal. The Bill does not ensure representation of professional bodies related to various fields of medicine in the State Council.  This is different from comparable laws.
The Bill seeks to repeal the Maharashtra Nursing Homes Registration Act, 1949, and replace it with a framework covering all private clinical establishments in the state.

PART A: HIGHLIGHTS OF THE BILL

“Public health and sanitation, hospitals and dispensaries” is a state subject under the Constitution.[1]  Hence, only states can make a law on this subject.  Further, Parliament may make laws on a state subject if two or more states pass a resolution in this regard.[2]  Other states may adopt such a law by passing a resolution.  The National Health Policy, 2002 had envisaged enactment of law to regulate minimum infrastructure and quality standards in clinical establishments.[3]  Upon resolution by four states, Parliament passed the Clinical Establishments (Registration and Regulation) Act, 2010 to regulate private as well as public clinical establishments.[4]  This Act has been adopted by 12 states and seven union territories.[5]  Maharashtra has not adopted this law.  States such as Karnataka, Gujarat, Tamil Nadu, and West Bengal have passed their own laws to regulate clinical establishments.[6]^,[7],[8],[9]

In Maharashtra, while nursing and maternity homes are regulated under the Maharashtra Nursing Homes Registration Act, 1949, there are no laws to regulate other forms of clinical establishments such as diagnostic labs, day care centres, and hospitals.[10]  The Maharashtra Clinical Establishments (Registration and Regulation) Bill, 2026 was introduced in the Maharashtra Legislative Assembly in July 2026.  The Bill seeks to repeal the 1949 Act, and provide for a common framework for regulation of clinical establishments.  According to the statement of objects and reasons of the Bill, it seeks to enact a law similar to the central Act, tailored to Maharashtra.

• Applicability:  The Bill applies to clinical establishments across various systems of medicine.  These include allopathy, ayurveda, homoeopathy, siddha, and unani.  Clinical establishments include: (i) hospitals, (ii) nursing homes, (iii) maternity homes, (iv) day care centres, (v) dispensaries, (vi) clinics, (vii) sanatoriums, and (viii) labs and diagnostic centres.  However, the Bill exempts establishments owned, controlled or managed by: (i) armed forces, (ii) mental health facilities under the Mental Healthcare Act, 2017, and (iii) the central government, state government, local self-government, or government public sector undertakings.
• Registration of clinical establishments:  Every clinical establishment must register with the Clinical Establishment Registering Authority.  All existing clinical establishments must also register.  For registration and continuation, it must fulfil: (i) minimum standards of facilities and services, (ii) the requirement of personnel, and (iii) provisions for maintenance of records and reporting, and (iv) other prescribed conditions.  Registering authority will be constituted for a notified area, and will comprise a chairperson, a member secretary, and other members, as may be prescribed.
• Provisional registration:  The Bill provides for a system of provisional and permanent registration.  Existing establishments must apply for provisional registration: (i) within six months from the commencement of the Act, or (ii) six months prior to expiration of existing registration, whichever is earlier.  The provisional registration is valid for a period of six months and is renewable.  The registering authority will not conduct any inquiry prior to the grant of provisional registration.  Once standards are notified for a category of establishments, provisional registration will not be granted or renewed beyond: (i) two years, for establishments existing before the notification of standards, and (ii) six months, for those established afterwards.
• Permanent registration:  An establishment holding provisional registration must apply for permanent registration at least 60 days before its provisional registration expires.  It must also submit evidence of complying with prescribed minimum standards.  The registering authority will display the submitted information to the public and invite public objections.  The objections will be communicated to the establishment for response.  Permanent registration will be valid for five years.
• State Council:  The state government will establish the Maharashtra State Council for Clinical Establishments. Key functions of the Council include: (i) determining the minimum standards of clinical establishments and specifying the services they may provide, and (ii) compiling and updating the state registers of clinical establishments.  The Council will be chaired by Minister of Public Health and Family Welfare, and have eight other members.  Ex-officio members include: (i) Public Health Secretary, (ii) Commissioner, Health Services, (iii) Director, Medical Education and Research, (iv) Director, AYUSH (Ayurveda), and (v) Director, Health Services.  The state government will nominate three representatives from amongst six state councils relating to: (i) medicine, (ii) dentistry, (iii) nursing, (iv) pharmacy, (v) allied healthcare, and (vi) Indian medicine.
• Obligations of clinical establishments:  Every clinical establishment must: (i) provide emergency care and basic life support on priority, without considering ability to pay, (ii) display a list of rates and charges, (iii) not charge above the displayed rates, and (iv) issue itemised bills.
• Rights of patients:  Every clinical establishment must observe and give effect to specified rights of the patients.  These include the right to: (i) receive information on diagnosis and treatment, (ii) access medical records, (iii) informed consent prior to investigation or procedure, (iv) seek a second opinion, (v) privacy, confidentiality, and dignity in course of treatment, (vi) non-discrimination on specified grounds such as religion, race, caste, sex, or disability, and (vii) receive information on rates and itemised bills.
• Inspection:  The registering authority shall have the right to inspect or inquire in respect of any registered clinical establishment.  These actions may also be carried out by an officer authorised by the registering authority, state council, or the state government.  The clinical establishment will be entitled to be represented during the inspection or inquiry.  The authority will have powers to require the establishment to address the findings.  The authority or an officer authorised by it may enter and search a clinical establishment, if it has reason to believe that it is operating without registration.
• Cancellation:  The registering authority may cancel registration if: (i) conditions of registration are not complied with, or (ii) if the person entrusted with management has been convicted of an offence under the Bill.  It may cancel only after giving a three-month show-cause notice, and providing a reasonable opportunity for hearing.
• Appeal:  A person may file appeal before the Commissioner of Health Services against the refusal of registration or renewal, or cancellation of registration.  Appeal against the decision of the Commissioner of Health Services may be filed before the state government.
• Offences and penalties: Operating a clinical establishment without registration will attract a civil penalty of up to: (i) one lakh rupees for first contravention, (ii) three lakh rupees for second contravention, and (iii) five lakh rupees for subsequent contraventions.  Knowingly serving in an unregistered establishment will be penalised with a civil penalty of up to one lakh rupees.  Following contraventions will attract a civil penalty of up to five lakh rupees: (i) disobedience of a direction, (ii) obstructing any person or authority in discharge of its functions, (iii) withholding or providing false information.  Contravention of the Act resulting in deficiencies that pose no imminent danger, will attract a civil penalty of up to Rs 50,000.  Contravention of any other provisions will be punishable with fine up to: (i) Rs 50,000 for the first offence, (ii) one lakh rupees for the second offence, and (iii) five lakh rupees for subsequent offences. 

PART B: KEY ISSUES AND ANALYSIS

The Bill requires clinical establishments in the state to register.  They must fulfil: (i) standards of facilities and services, (ii) the requirement of personnel, (iii) provisions for maintenance of record and reporting, and (iv) other prescribed conditions.  The Bill exempts clinical establishments owned, controlled, or managed by: (a) the armed forces, (b) establishments for persons with mental illness under the Mental Healthcare Act, 2017, and (c) the central or state government, local self-government, local authority, or government public sector undertakings.  Such exemption may create different regulatory standards for public and private health facilities.

The approach under the Bill is different from a similar law passed by Parliament in 2010 (which applies to states that adopt it).[11]  This law only exempts clinical establishments run by armed forces.  While examining that Bill, the Parliamentary Standing Committee on Health and Family Welfare had observed that a majority of people only access public health facilities.[12]  It further observed that exemption would deprive such people of the protections provided by the legislation.  The Committee had recommended that accountability should apply to all medical establishments, whether government or private, with the objective of achieving “health for all”.

The Bill requires clinical establishments in the state to register.  We discuss certain issues with related provisions below.

Whether requirement for periodic renewal of registration is appropriate

The Bill provides that registration of a clinical establishment will be valid for five years.  An application for renewal must be made within six months before the expiry of the registration.  It is unclear how recurring renewal will aid the purposes of the Bill.  The Bill does not envisage any specific due diligence requirements on the part of the registering authority at the time of renewal.  It may be argued that recurring renewal increases compliance burden and creates scope for corruption.  The Bill contains some provisions to ensure compliance with prescribed standards.  It grants the registering authority powers to inspect, and to require the establishment to address the findings.  Continuation is subject to maintenance of facilities and standards, and of records and reporting as may be prescribed.  Further, contraventions of the provisions of the Bill are punishable with a criminal fine or a civil penalty.

Need for display of information submitted for registration to public

For the purposes of registration, the Bill requires a clinical establishment to submit evidence of having complied with the prescribed minimum standards.  It also requires the registering authority to display the evidence received for information of the public at large.  It must invite objections from the public, and communicate them to the establishment.  It may be argued that compliance with minimum standards is a technical evaluation, and will require professional expertise for scrutiny.  It is unclear how a public consultation will aid this evaluation.  The central law on clinical establishments also has similar provisions.[13]  While examining the corresponding Bill, the Parliamentary Standing Committee on Health and Family Welfare had noted certain objections to these provisions raised by stakeholders: (i) the responsibility of verifying compliance may be pushed to the public at large, (ii) such provisions may be misused by business rivals or vested interests to raise false and fictitious objections.[14]  While concurring with the provisions on grounds of transparency, the committee recommended that any obligation on the part of the registering authority to conduct inspections prior to grant of registration should not be substituted.

The Bill requires clinical establishments to observe and give effect to the rights of patients.  Under the Bill, patients have the right to: (i) receive information on diagnosis and treatment, (ii) access medical records, (iii) informed consent prior to investigation or procedure, (iv) seek a second opinion, (v) privacy, confidentiality, and dignity in course of treatment, (vi) non-discrimination on specified grounds such as religion, race, caste, sex, or disability, and (vii) receive information on rates and itemised bills.  Further, the Bill requires that a clinical establishment must attend an emergency patient on priority without considering his financial capability.  The establishment must provide basic life support as per available facility and expertise in such a case.  It may thereafter refer to a suitable nearest referral hospital.  We discuss certain issues with these provisions below.

The Bill does not provide for certain rights recognised by NHRC

The National Human Rights Commission (NHRC) recommended a Charter of Patients' Rights in 2018.[15]  Several rights recognised under this charter are not included in the Bill.  These include the right to: (i) choose the source for obtaining medicines or tests, (ii) proper referral and transfer which is free from perverse commercial influence, (iii) protection for patients involved in clinical trials, biomedical or health research, (iv) receive the dead body of a patient without delay, including in cases of non-payment of dues or payment disputes, and (v) grievance redressal.

No provisions for grievance redressal

The Bill does not provide for a grievance redressal mechanism for patients when their rights are violated.  In contrast, the West Bengal law on clinical establishments requires them to: (i) maintain a public grievance cell for complaints relating to treatment, billing, services, or staff conduct, and (ii) establish a help desk to provide regular and proper communication.[16]  It also establishes a regulatory commission which has powers to award compensation up to Rs 50 lakh in case of injury or death of service recipients.  Compensation may be payable where harm has occurred due to negligence or deficiency in providing services.  The Commission may also order cancellation of licence or closure of clinical establishment in case of grievous injury or death of a service recipient.

The Bill seeks to establish the Maharashtra State Council for Clinical Establishments.  The Council will determine minimum standards of clinical establishments and specify services to be provided to patients.  The Council will be chaired by the Minister of Public Health and Family Welfare, and will have the following other ex-officio members: (i) Secretary, Public Health, (ii) Commissioner, Health Services, (iii) Director, Medical Education and Research, (iv) Director, AYUSH (Ayurveda), and (v) Director, Health Services.  It will also have three representatives nominated by the state government from amongst six statutory professional bodies: (i) Maharashtra Medical Council, (ii) Maharashtra State Dental Council, (iii) Maharashtra Nursing Council, (iv) Maharashtra State Pharmacy Council, (v) Maharashtra State Allied Healthcare Council, and (vi) Maharashtra Council of Indian Medicine.  The Bill does not require rotation of representatives from amongst these Councils.  This may lead to situations where some of these statutory bodies are not represented in the Council for several years.  In contrast, the central law on clinical establishments and a similar law in Gujarat guarantee at least one representative of specified statutory bodies in the corresponding Council.  These include bodies relating to the following fields: (i) medicine, (ii) dentistry, (iii) nursing, (iv) homoeopathy, and (v) ayurveda.[17]^,[18]

The Bill empowers the state government to constitute a registering authority for a notified area.  The authority will consist of a chairperson, a member-secretary, and other prescribed members.  Functions of the authority include: (i) registering, renewing, suspending, and cancelling registration of clinical establishments, (ii) levying fees for registration and renewal, and (iii) imposing fines and monetary penalties.  The authority and officers authorised by it will also have powers to inspect clinical establishments, and powers to enter and search.  The Bill does not specify minimum qualification or rank of the persons who will be part of the registering authority.

Under the central law and the Gujarat law, registering authority is constituted at the district level.[19]^,[20]  These laws designate the District Collector as the chairperson of the registering authority.  Under the central law, other members include: (i) District Health Officer, and (ii) three other members as per terms and conditions prescribed by the central government.  Under the Gujarat law, other members include: (i) Chief District Medical Officer or Medical Superintendent, (ii) Chief District Health Officer, (iii) one Dean of the medical faculty of a university in the concerned district, and (iv) an expert in the concerned subject nominated by the District Collector (if required).

The Bill requires that a clinical establishment must attend an emergency patient on priority without considering his financial capability.  The establishment must provide basic life support as per available facility and expertise in such a case.  It may thereafter refer to a suitable nearest referral hospital.  It also provides that necessary golden hour treatment protocols must be followed.  However, it is unclear who will bear the expense of treatment where it is beyond the patient’s financial capability. 

The approach under the Bill is different from other laws mandating emergency care.  For instance, the Motor Vehicles Act, 1988 passed by Parliament requires every registered medical practitioner or doctor to immediately attend a person injured in a road accident, and provide medical aid or treatment.[21]  The Act requires the central government to make a scheme for cashless treatment of victims of the accident during the golden hour.  It also provides that the scheme may contain provisions for creation of a fund for such treatment.  The Rajasthan Right to Health Act, 2022 confers a right to have emergency treatment and care for accidental emergency and other prescribed emergencies.  It further provides that if the patient does not pay requisite charges, the healthcare provider will be entitled to receive requisite fee and charges or proper reimbursement from the state government in the prescribed manner.[22] 

The Bill empowers the registering authority or an officer authorised by it to enter and search a clinical establishment.  Such an action may be taken if there is reason to suspect that anyone is operating clinical establishment without registration.  The Bill lacks certain safeguards against such powers available in other comparable laws.  For instance, the central law on clinical establishments requires that the authority or the authorised officer must give notice of his intention to do so.[23]  In Karnataka, no residential accommodation can be entered without a search warrant issued by a Magistrate.  The Karnataka law also provides that all searches will be in accordance with the provisions of the Code of Criminal Procedure, 1973 (replaced by the Bharatiya Nagarik Suraksha Sanhita, 2023).[24]

Annexure

Table 1: Comparison of central and select state laws on clinical establishments

Parameter	Maharashtra (2026)	Central Act (2010)	Karnataka (2007)	West Bengal (2017)	Gujarat (2021)
Regulation of clinical establishments
Registration of private clinical establishments	Yes	Yes	Yes	Yes	Yes
Exemption to government establishments	Yes	No	Yes	Yes	No
Authority to determine minimum standards	State council, chaired by the Health Minister	National council, chaired by DG-Health Services	State government, expert committees may be constituted to advise	State government, also constitutes a regulatory commission	State Council, chaired by the Health Minister
Registering authority	Per notified area	District-level	District-level	Per notified area	District-level
Validity of registration/licence	Five years	Five years	Five years	Period prescribed under Rules	Five years
Obligations of clinical establishments
Display prices/rates	Yes	Not provided	Yes	Yes	Not provided
Provide emergency care irrespective of ability to pay	Yes	Yes	Yes	Yes	Yes
Funding of emergency care provision	Not provided	Not provided	Not provided	Right to recover from patient in due course of time	Not provided
Must provide e-prescription	No	No	No	Yes	No
Rights of Patients
Rights of patients	Information on diagnosis and costs; access to records; informed consent; second opinion; privacy, confidentiality, dignity; informed rates and itemised bill; and non-discrimination	Not provided	Covers all rights under Maharashtra Bill; additional rights: redressal, receive dead body without prior payment of dues	No standalone charter but certain aspects covered under obligations of establishments: non-discrimination; timely release of dead bodies	State Council will specify rights of patients
Grievance redressal	Not provided	Not provided	Yes	Yes	Not provided
Compensation for injury/death due to negligence or service deficiency	Not provided	Not provided	Not provided	Up to Rs 50 lakh, determined by a Regulatory Commission	Not provided
Offences and Penalties
Operating without registration	Civil penalty of up to Rs 1 lakh for first contravention, rises to up to Rs 5 lakh for subsequent contraventions	Civil penalty of Rs 50,000 for first contravention, rises to up to Rs 5 lakh for subsequent contraventions	Imprisonment up to three years and a fine up to Rs 1 lakh	Civil penalty of up to Rs 1 lakh, Rs 1,000 per day for continuing contravention, subject to a maximum of Rs 10 lakh	Civil penalty of up to Rs 25,000 for first contravention, rises to up to Rs 1 lakh for subsequent contravention
Contravening registration conditions and standards	Criminal fine up to Rs 50,000 for first offence, rises to up to Rs 5 lakh for subsequent offences	Civil penalty up to Rs 10,000 for first contravention, rises to up to Rs 5 lakh for subsequent contraventions	Criminal fine up to Rs 25,000 for first offence, rises to up to Rs 50,000 for subsequent offences	Imprisonment up to three years	Criminal fine up to Rs 10,000 for first offence, rises to up to Rs 1 lakh for subsequent offences
Appeals
Appellate Authority against refusal of registration or renewal, or cancellation	Commissioner, Health Services, and a second appeal to the state government	State Council (chaired by Health Secretary)	Five-member appellate authority, chaired by the Commissioner for Health and Family Welfare	To be prescribed by the government	State Council

Sources: The Maharashtra Clinical Establishment (Registration and Regulation) Bill, 2026, The Clinical Establishments (Registration and Regulation) Act, 2010, The Karnataka Private Medical Establishments Act, 2007, The West Bengal Clinical Establishments (Registration, Regulation and Transparency) Act, 2017, The Gujarat Clinical Establishments (Registration and Regulation) Act, 2021; PRS.