16. CLINICAL ESTABLISHMENT ACT AND RULES

CLINICAL ESTABLISHMENT ACT AND RULES

On 17th August 2010, the Clinical Establishments Act was passed by the Indian Parliament to provide for the registration and regulation of all clinical establishments in the country, with the goal of recommending minimum standards of facilities and services offered by them, in order to fulfil the mandate of Article 47 of the Constitution for public health improvement.

The Act was notified vide Gazette notification dated 28th February, and on 1st March 2012, the Act was first implemented in four states, namely Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim, along with all Union Territories except Delhi.

The Act was also adopted by Uttar Pradesh, Rajasthan, Bihar, Jharkhand, Uttarakhand, and Assam under Article 252 clause (1) of the Constitution. Currently, the Act is implemented in these 10 states and 6 Union Territories.

Objectives of Act

1. To create a national, state, and district-level digital registration of clinical establishments.
2. To combat quackery by unqualified practitioners through an obligatory registration system.
3. To improve the quality of healthcare by standardisation of healthcare facilities and services in all healthcare establishments except teaching hospitals.
4. To ensure compliance with registration requirements such as standard treatment guidelines, emergency medical care, display of service charges, and maintenance of records.

Salient Features of the Act

1. All clinical establishments, including diagnostic centres and single doctor clinics, in public and private sectors are covered under the Act, except Armed Forces establishments.
2. The Act helps create a reliable digital registry of clinical establishments at national, state, and district levels.
3. A standard application form is used for registration to maintain uniformity in data collection.
4. The Act helps the government obtain data required for public health interventions such as epidemic and disaster management.
5. Provisional registration is granted through self-declaration without inspection.
6. Permanent registration is granted after classification, categorisation, and fulfilment of minimum standards.
7. Registration applications can be submitted online, in person, or by post.
8. Every clinical establishment must provide treatment to stabilise emergency medical conditions.

NATIONAL COUNCIL FOR CLINICAL ESTABLISHMENTS

For the purposes of the Clinical Establishments Act, the Central Government shall establish a National Council for Clinical Establishments through notification.

Constitution of National Council

1. The Chairperson shall be the Director-General of Health Services, Ministry of Health and Family Welfare.
2. One representative each shall be elected from:
   • Dental Council of India
   • Medical Council of India
   • Nursing Council of India
   • Pharmacy Council of India
3. Three representatives shall be elected by the Central Council of Indian Medicine representing Ayurveda, Siddha, and Unani systems.
4. One representative shall be elected by the Central Council of Homoeopathy.
5. One representative shall be elected by the Indian Medical Association.
6. One representative shall be elected by the Bureau of Indian Standards.
7. Two representatives shall be elected by the Zonal Council.
8. Two representatives shall be elected by the North-Eastern Council.
9. One representative shall be elected from paramedical systems.
10. Two representatives shall be nominated from National Level Consumer Groups.
11. One representative shall be nominated from Associations of Indian Systems of Medicine.
12. The Secretary-General of the Quality Council of India shall be an ex officio member.

Nominated members hold office for three years and may be re-nominated for one additional term. Elected members also hold office for three years and are eligible for re-election.

Functions of National Council

1. Compile and publish a National Register of clinical establishments within two years.
2. Classify clinical establishments into different categories.
3. Prescribe and review minimum standards regularly.
4. Develop guidelines for healthcare services.
5. Compile statistical data related to clinical establishments.
6. Perform additional functions assigned by the Central Government.

STATE COUNCIL FOR CLINICAL ESTABLISHMENTS

Every State Government or Union Territory shall establish a State Council or Union Territory Council for Clinical Establishments through notification.

Constitution of State Council

1. Secretary of State for Health shall be the Chairman.
2. Director of Health Services shall be the Member-Secretary.
3. Directors of Indian Systems of Medicine shall be ex officio members.
4. One representative each shall be elected from:
   • State Medical Council
   • State Dental Council
   • State Nursing Council
   • State Pharmacy Council
5. Three representatives shall represent Ayurveda, Siddha, and Unani systems.
6. One representative shall be elected by the Indian Medical Association State Council.
7. One representative shall represent paramedical systems.
8. Two representatives shall be elected from consumer groups or NGOs.

Members serve for three years and are eligible for re-nomination or re-election as applicable.

Functions of State Council

1. Compile and update State Registers of clinical establishments.
2. Submit monthly returns for updating the National Register.
3. Represent the State in the National Council.
4. Hear appeals against orders of authorities.
5. Publish annual reports regarding implementation of standards.

REGISTRATION FOR CLINICAL ESTABLISHMENTS

No person shall run a clinical establishment unless it is duly registered under the provisions of this Act.

Conditions for Registration

1. Every clinical establishment must fulfil minimum standards of facilities and services.
2. Minimum personnel requirements must be fulfilled.
3. Proper maintenance of records and reporting systems is required.
4. Other prescribed conditions must also be complied with.
5. Clinical establishments must provide emergency treatment to stabilise patients.

PROCEDURE FOR REGISTRATION

1. Application for provisional certificate of registration
2. Application for permanent certificate of registration

Application for Provisional Certificate of Registration

1. Application shall be submitted in prescribed form along with fees.
2. Application may be submitted personally, online, or by post.
3. Applications must contain all prescribed information.
4. Existing establishments must apply for permanent registration within one year, while newly established units must apply within six months.

Provisional Certificate

The authority shall issue a provisional registration certificate within ten days of receipt of application.

Validity of Provisional Registration

The provisional registration remains valid for twelve months from the date of issue and may be renewed.

Display of Certificate

The certificate of registration must be displayed prominently in the clinical establishment.

Duplicate Certificate

A duplicate certificate may be issued if the original is lost, destroyed, or damaged, upon payment of prescribed fees.

Certificate to be Non-transferable

1. The registration certificate is non-transferable.
2. Any change in ownership or management must be informed to the authority.
3. If category or location changes, a fresh registration certificate must be obtained.

Application for Permanent Registration

Application for permanent registration must be submitted in the prescribed form with prescribed fees.

Verification of Application

The clinical establishment must provide evidence of compliance with prescribed minimum standards.

Certificate of Permanent Registration

1. Permanent registration certificate is issued after approval.
2. The certificate remains valid for five years.
3. Renewal applications should be submitted within six months before expiry.

OFFENCES AND PENALTIES

Violation of the provisions of this Act may result in fines up to ₹10,000 for first offence, ₹50,000 for second offence, and ₹5,00,000 for subsequent offences.

Penalty for Non-registration

1. Operating without registration may attract fines up to ₹50,000 for first offence, ₹2,00,000 for second offence, and ₹5,00,000 for subsequent offences.
2. Persons knowingly working in unregistered establishments may be fined up to ₹25,000.

Penalty for Minor Deficiencies

Minor deficiencies that do not immediately threaten patient safety may attract a fine up to ₹10,000.