Clinical Establishments Act: A new chapter for the Indian medical sector

The Union Cabinet has recently approved the proposal of the Ministry of Health & Family Welfare to the introduction of the ‘Clinical Establishments (Registration and Regulation) Bill, 2010’ in order to achieve the mandate of Article 47 of the Constitution for improvement in public health. Let us have a closer look at some salient features of this Act and view it from the main players’ perspectives that include the patients, government and last but not the least the medical fraternity.

Initially the law (Clinical Establishment (registration and regulation) Act), after enactment by Parliament, is coming into effect in a select few states like the states of Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim and all Union Territories. It is expected that other states would also adopt this legislation. The Act had been passed by the Union Government in 2010 and state governments will have to adopt it, with changes, if required.

The basic objective of this law is to provide a legislative framework for the registering and regulating of

‘Clinical Establishments’ in the country. The Act comes in the series of attempts by the Central Government Health agencies to codify and manage the healthcare medical services sector in the country.

The regulatory authorities have always felt that the data and information on the providers has been static and minimally real time. Implementation of ‘Ideal’ or ‘Quality’ standards has been a fringe issue in the monitoring of this sector. This Act aims at bringing concerns of quality too at the forefront of regulation. This Act in its purest form does bring in much hope for the common consumer regarding the level of prescribed minimum standards of infrastructural and ethical issues in healthcare.

Admittedly this means a gigantic exercise if all the information would have to be collated afresh and would need physical inspection to validate it. The Act includes in its scope all the agencies ranging from  hospitals, maternity and nursing homes, dispensaries, clinics, sanatoriums, radiology and pathology laboratories, and allopathy, naturopathy and ayurveda massage centres.

The policy makers

According to government sources there is no data of how many healthcare centres operate in various states. Making registration mandatory for all medical establishments will help the administration compile data on healthcare service providers. The Clinical Establishment Bill also aims to fix any loopholes in the existing Acts and ensure that issues such as ethics, infrastructure, quality management and bio medical waste are tackled. The Act would also help in strict implementation for often flouted norms. Unlike earlier punishments the indicative penalties being considered are, for the first offence may be up to ` 10,000; for the second, ` 50,000, but for subsequent offences, it may be even ` 5 lakh.

The authorities by the virtue of the information collected due to this Act will be able to set clear parameters while penalising the offender by taking into account the size, type and condition of the clinical establishment.

Inspection and registration

The Act requires that the registration would be at a committee level headed by a collector level official and assisted by a health official. The registration would be non-transferable and in the event of change of ownership, one will have to apply for a fresh certificate.

The applicants and facilities would be verified physically for their compliances with the Act by the government authorities. Only then, would the permanent registration be issued. Healthcare providers will be required to display the registration certificate so that it is visible to citizens and patients visiting the establishment.

The overall feel and objective of the government is that this would lead to a

1. Creation of a national registry of healthcare establishments
2. Comprehensively and efficiently managed regulatory system
3. Maintenance of minimum standards and their periodic review

Consumer perspective

Issues which will be tackled in the interest of the patients would be standards include:

• Unprecedented consumer empowerment due to the provisions of the law
• Minimum requirement of staff numbers to attend to the patient needs
• General and medical and especially emergency facilities to stabilise the medical condition of a patient in case of a life threatening condition
• Maintenance of records; this would keep the data current and real time for the authorities
• An expected positive effect on the cost cutting/ price control

Medical fraternity

The overall impression about the Act was viewed with some introspection and apprehension from some quarters. Some medical bodies felt that single doctor clinics may receive different handling as they may not be able to keep pace with the situation in view of their size of work. This law is more suited to big government institution and corporate private healthcare providers.  Attending emergencies in small clinics may be an issue, which needs further elaboration. This may also lead to double registration fees if both systems exist parallel. The Act may encourage license raj in medical practice

What would be the future role of the existing councils (National or State Councils)?

The proposed council has no representation of Homeopathy representation, whereas there would be nominations from the professional associations of Ayurveda, Siddha & Unani. Homeopathy clinics and practitioners constitute a large chunk of primary private healthcare providers. It seems there is no provision for Homoeopathy presently.

To this effect there have been instance of legal remedies being sought by certain IMA groups. This demonstrates that there is a certain level of apprehension among section of the medical practitioners and healthcare providers.

This could get easily resolved by proper interpretation and communication by the health authorities to all concerned. We can assume the government would be in the near future be taking all efforts to make the provisions transparent and lucid to those affected by it.

General observation

From a general perspective it is clear that CEA is a reality now and will be covering all the relevant entities as it is implemented throughout. All healthcare providers are expected to obey this statute as any other legal promulgation.

As the implementation crystallises there are several beneficial possibilities. This will be allowing a formal classification, standardisation and categorisation of different healthcare institutions, based on their respective location, scale of services offered and level of specialisation creating a be a national level based registry. The mere action of creating a registry, codifying information, monitoring standards and having access to databases throws up highly exciting and useful opportunities for the agencies engaged in healthcare.

• Country wide implementation of patient safety and quality benchmark norms
• Commonality in data storage would enable countrywide data assimilation and data sharing
• Comprehensive accreditation implementation
• Emerging of synergies among different states for tackling public health issues
• Sharing high level medical personnel resources
• Creating a repository of health records in a specified coded manner
• Ease of handling complicated issues like, Organ Transplantation Act (OTA), organ donation in a centralised manner

Possible partnerships between government and private healthcare institutions would also constitute as a significant step in the move towards comprehensive health insurance cover for the entire population of the country to achieve universal health coverage. 

(m.naseem@zonhealthcare.com)