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India can boast of a flourishing and diverse medical industry. The ailing have a variety of options and treatments to choose from, including the best modern hospitals and the traditional homeopathy and Ayurveda cures. With a market of more than a billion people readily available, clinical establishments of all sorts have mushroomed and thrived. Medical malpractice however, has also grown proportionately. News of fake doctors, fake medicines, inadequate facilities, outdated equipment, and incompetent and negligent staff is no longer rare.
The Central government has, with the intention of regulating clinical establishments, sought to introduce the Clinical Establishments (Registration and Regulation) Act, 2010 (“the Act”). The malice of introducing defective legislation seems not limited to the Lokpal Bill.
The Act seems to me a confused piece of legislation that has been passed without much debate. It is bound to face constitutional hurdles. The purpose of the Act, according to its Preamble, is to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of facilities and services that may be provided by them. While there are many Central and state legislations that seek to regulate the medical profession, the objective of establishing a regulatory structure where all clinical establishments are required to meet certain standards seems to be a noble one.
However a perusal of the Act shows that there is no nexus between the Act as it stands, and the objects that it seeks to achieve. The first strange anomaly is in Section 1 itself, as per which, the Act shall come into force only in the states of Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim, and the Union Territories. Given the aim of the Act to prescribe minimum facilities in order to improve the larger public health, it seems extremely odd to selectively implement the Act in only four states and the Union Territories.
The Act applies to all “clinical establishments” defined under Section 2 (c). The definition is an unnaturally wide one, and includes hospitals, maternity homes, nursing homes, dispensaries, clinics, sanatoriums and institutions that offers services or facilities requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy, in any recognised system of medicine. “Recognized system of medicine” under the Act covers Allopathy, Yoga, Naturopathy, Ayurveda, Homeopathy, Siddha, and Unani systems of medicine, as well as any other system of medicine that may be recognised by the Central government. Every conceivable range of treatment is sought to be included within the parameters of the Act. Under Section 11 of the Act, no person can run a clinical establishment unless it has been duly registered in accordance with the provisions of the Act. A severe monetary penalty is provided under the Act for carrying on an establishment without registration.
The Act seeks to regulate shady medical establishments—but it has unreasonable standards. Image above is taken from gruntzooki’s photostream on Flickr, here. Image (but not the rest of this work) is licensed under a Creative Commons Attribution-ShareAlike 2.0 Generic License.

The Act seeks to regulate shady medical establishments—but it has unreasonable standards.

Image above is taken from gruntzooki’s photostream on Flickr, here.

Image (but not the rest of this work) is licensed under a Creative Commons Attribution-ShareAlike 2.0 Generic License.
This in itself would not be overly onerous, if it was not for the extremely unreasonable standards that the Act mandates every clinical establishment, in every recognised system of medicine, to have. Section 2 (d) of the Act incorporates a very vast definition of ‘emergency medical condition’ (which includes symptoms of sufficient severity, including severe pain, that may cause serious bodily impairment or dysfunction), and imposes on every clinical establishment, the duty to provide facilities ‘to stabilize’ an ‘emergency medical condition’ and to provide such medical treatment necessary to assure within reasonable medical probability, that no material deterioration results during the transfer of the individual from a clinical establishment. What this effectively means is that if a person has a heart attack and is taken to a Yoga centre, the Yoga centre must provide for the minimum medical treatment necessary to ‘stabilize’ him, in terms of the definition above. Quite clearly, this seems like an unworkable and even an unconstitutional onus to impose.
The above features of the Act curtail the right of medical practitioners to carry on their occupation, under Article 19 (1)(g) of the Constitution of India, 1950. The Act forces clinical establishments to provide services that they may not wish to provide at all. Implicit in the right to carry on an occupation under Article 19 (1)(g) is the right not to carry on a particular occupation. While this obligation is imposed, the Act is completely silent on how these clinical establishments will be remunerated for the services to be provided under the Act. This obligation of the State to improve public health is being transferred to the private establishments, in the guise of regulation.
The Act also seems to suffer from the vice of excessive delegation of non-delegable functions. Section 3 of the Act establishes a ‘National Council’ with the powers of classifying all clinical establishments and developing minimum applicable standards. Under Section 12 of the Act, every clinical establishment must have these prescribed conditions of minimum standards and requirements necessary for registration and continuation. Therefore, the Act purports “to prescribe minimum standards of facilities and services” and to “determine the standards for clinical establishments”. No such prescription of any standards for facilities and services, are however discernible from the text of the Act. Instead, the Act delegates this essential legislative function to the Central Government and the National Council, empowering them to prescribe the necessary standards. To impose a stringent regulatory regime, without prescribing the parameters of the regime and any guideline based on which the delegate can formulate minimum standards, seems to me an abdication of the constitutional duty to lay down the law and an unconstitutional delegation of non-delegable powers to the Executive.
Not unsurprisingly, a lot of medical associations and doctors who have become aware of this legislation, are strongly opposing it. The Act, applicable to the Union Territory of Chandigarh, was recently challenged in the Punjab and Haryana High Court, but the challenge was withdrawn as premature because the Act was yet to come into force through a notification. Nevertheless, what is being argued is that, the conditions that are sought to be imposed under the Act, can only be provided by large scale, multi-specialty hospitals, and therefore in the guise of providing a regulatory framework, the Act will virtually eliminate small and medium-scale clinical establishments, creating a monopoly in favour of large hospitals.
The Act therefore may have the completely opposite effect of the object it seeks to achieve. Instead of improving the standards of public health, it may lead to depriving several millions of people of adequate healthcare facilities, which are provided by individual doctors or small clinical establishments. While the regulation of clinical establishments is important, the Act as it stands today, is discriminatory and vague, and in my opinion, will not meet the strong constitutional objections that will be raised against it in the future.
 
(Animesh Sharma is an advocate at the Punjab and Haryana High Court.) 
This entry was posted in History, Human Rights, Litigation and tagged analysis, clinical establishments, courts, hospitals, Lokpal Bill, medical law, medicine on September 8, 2011.