Various perpectives on clinical establishment act

Clinical Establishment Act . . .

The vedas have long ago stated the fact that in kaliyug the do gooders would be hounded out and the the corrupt would flourish.The clinical establishment act seem to fulfill this profesy not in part but in full measures

There are stringent and huge monitory penalties for non registration by any medical professional which are more than many criminal penalties of IPC.
Well, I’m sure quite a lot of Indians would have some sort of idea of what this is. Well, for the dummies, this act would lay down basic criteria for operationalising clinics, hospitals, laboratories etc.
For the uninitiated person, who has no idea about the masala of Indian healthcare, the natural response would be – ‘Great, this is something each citizen would definitely benefit from. Access to quality healthcare at your beck and call’. Well, appearances can be very deceptive.

What would the CEA lead to in most of the regions of the country –
1. Healthcare which is already expensive would become more expensive.
2. Healthcare would become inaccessible to most of the Indian poor unless they live in a state which has good public healthcare.
3. Specialists would become more in demand. Their salaries would rocket sky-high
4. Most of the small nursing homes and hospitals especially mission hospitals would have to be closed down.
5. Healthcare would become an industry rather than a service

One among the multiple thoughts I had about the CEA was the fact that in spite of quite stringent rules, all through these years quacks and allied health professionals have been practicing medicine in almost the whole of our country. I wonder why the government should insist on specialists alone handling the clinical work.
“This Act is a step towards corporatisation of healthcare. All small units of healthcare like clinics will not be able to survive if this Act is introduced. It has been made keeping the foreign countries in mind and this is the biggest flaw in it. According to the Act, each clinic should have one nurse and pharmacist each despite the fact that the WHO, in a 2010 report, has revealed that India is grappling with shortage of medical staff.”
“At least 70% of the total health services in the country are provided by clinics and they should not be restricted through the guidelines of this Act. Also, medical facilities in rural areas are already in a bad shape and with the requirements being asked at a medical establishment, it is next to impossible to run a clinic in rural areas. Not only will this be a problem for doctors as it needs high investment but also for the patients who will have to bear high cost.”

It’s worthwhile looking at a statement made by the IMA back in 2010 in this regard:

“The sincerity of the govt. may be appreciated, if it initiate[s] and strives to eradicate the quacks and quackery from our country which has been crippling our society’s health in the guise of providing first-aid care….[putting] corporate hospitals and rural area hospital in same line to accredit-ate is unjustifiable as it favours corporatization of health care and jeopardising the health services within reach of common man”
Unresolved issues in the Act

While in many ways a regulatory framework is essential, there are still unresolved problems with the Act. Some of them are listed here.

Section 12(2)
It states thus: “The clinical establishment shall undertake to provide within the staff and facilities available, such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to such clinical establishment.”

What this boils down to is that all clinical establishments are expected to stabilise a patient in an emergency medical condition before transferred to another hospital. Such interventions, the Act says are to be made “within the staff and facilities available.” But one doesn’t have to stretch the imagination to see that its interpretations can vary.

The original Supreme Court directive on this regard was meant for providing life-saving first aid for victims of accidents. It’s quite unrealistic-and potentially unfair to the doctors to extend this to any and all emergency situations.

Lack of provision for extra machinery for additional workload of regulating private clinics
In this backdrop, it’s hard to see how a fair implementation of the Act is possible-affecting not just the doctors but also the patients. For instance, the Act has called for the establishment of the National Council-which is supposed to have a special secretary: the director-general(DG) of health services, Ministry of Health and Family Welfare as an ex-officio member and chairperson.

This implies that important decisions could be delayed if the DG cannot squeeze out more time for this additional task. There are to be no additional appointments at the state level to manage this work. And at the district level, the situation could be potentially worse. For in the districts the chairperson and the secretary of the registering authority are to be the district collector and the district health officer respectively. Needless to say, this increases their workload by a long stretch, causing further delays in getting things done.

Those who wish to appeal against the order of the district health authority must approach the state council
Even if a marginal number of establishments from a state wish to go for an appeal, this would amount to a substantial volume of appeals from within distinct district registering authorities. But the doctors must approach the state capital for matters related to the disputes. That’s on ordeal that could be avoided with a simplified provision.

These are but a few of the issues that one find in the Act, giving the doctors substantial basis for opposing it.

Such issues point to the necessity for a more involved discussion between the government and the medical fraternity. The key issue here is the provision of adequate healthcare to a huge number of people. And it’s the state’s job to ensure that care-givers, regardless of the size of their institutions are able to provide that in the best possible manner, facing minimal hassles.

I personally have much misgiving to the regulations of the Act in the present form.

1. In a country like India which is very vast and the majority of the population (about 70%) lives in villages, it is going to be very difficult for anybody to set up hospitals in semi-urban and rural areas. The stipulations are going to be very hard to meet that setting up a hospital would hardly be a profitable venture. The other side is that even if hospitals are set up, the cost of care would be quite expensive. Almost all of us have mostly depended on small clinics or nursing homes which are run by a single doctor with the help of a nurse or by a doctor family. In fact, quite a lot of us may have knowingly or unknowingly gone to a unqualified practitioner or quack for our small medical problems. At present I live in a place where almost 95% of the population go to a quack first for treatment. They have bungled up cases where the patient ultimately died. However, nobody has been able to do anything. The only reason being that these guys are the only people who have some knowledge about medicine in remote settings. And they come very cheap. The regulations appear to be giving more importance for corporate multi speciality hospitals. This is quite protectionist in nature towards encouraging a corporate model which will ensure that healthcare is only available at a premium in the absence of an efficient public health care system.
2. There is enough scientific evidence that family practice and nurse practitioner based primary care is as efficient, and rather more people friendly than specialist doctors in full fledged hospital set ups.
3. If you consider any of the complex clinical conditions one can think of, the primary level of care is much more important than high tech healthcare. We have examples of countries like Brazil and South Africa, where Family Medicine graduates have major role in healthcare. The present regulations would only increase costs. If you look at the regulations, the first level of treatment is going to be a Level 1 Hospital which needs to have a staffing of at least 6 for a place which do not have inpatient care.
4. Most of our tertiary care centres are burdened with primary care. It is not uncommon for any faculty in our medical colleges who end up complaining that most of the patients that they see could have been easily managed at a Primary Health Centre or even by a Nurse practitioner. The ultimate result is that quite a many of our specialists are over-worked to the extent that they are not able to do justice to the specialised skills they’ve obtained.

If we can think of changes that can be proposed, I would propose the following –

1. Legalising Nurse-Practioner Care: Nurses should be trained to treat simple illnesses allowed to prescribe medicines. A major need would be to allow a category of healthcentres which are entirely run by nurses who may or may not supervised by doctors. At least for populations who have poor access to healthcare, they would be a major boon. In fact, such nurse-led primary care centres have already been in existence in the country, mainly facilitated by various congregations of the Catholic Church.
2. Provision for single doctor healthcare centres: We are all very familiar with such single doctor establishments. A 100 square feet room with a familiar friendly face to whom you ran when you had a toothache or a cold. You pay about 50 rupees and then you pay some more for the medicines and some basic investigations. The whole process took not more than half an hour. If the regulations in it’s present form are accepted and finalised, the family doctor would be history.
Section 55 of the act enlists the ‘Rights of patients’ as follows:
(1) The patients and / or Person authorized by patient shall receive the relevant information about the nature, cause of illness, proposed care, and the expected results of treatment, possible complications and the expected costs.

(2) Confidentiality of treatment and privacy during examination. Examination of female patient should be carried out in presence of female attendant.

(3) Person suffering from HIV/AIDS shall not be denied care.

(4) Complaint register should be made available in Clinical establishment.

(5) List of Specialists along with Qualifications Should be displayed at prominent place in Clinical establishment.

(6) Patient has the right to seek second opinion. All medical and diagnostic reports shall be made available to the patient or authorised person to facilitate second opinion.

(7) Patient and / or Person authorised by patient or guardian if patient is minor has a right to have an access to his / her clinical records during admission to Clinical establishment and Photocopy of indoor papers should be made available on demand after discharge.

(8) Discharge card should be issued to patient mentioning: Diagnosis, clinical findings, results of investigations, treatment given, the patient’s condition at the time of discharge and advice to patient.

(9) Patient has right to choose registered pharmacy or recognised diagnostic center at his / her own responsibility.

(10) Protection ensured by statutory guidelines and legally enabled provisions applicable to Clinical Establishments which are conducting clinical research.

(11) Informed consent prior to potentially hazardous tests / treatment.

Thus, if the intents of the Act are preserved, it is likely to benefit both-the patients and the health care service providers alike.
Cl. 2(c)(i) defines clinical establishments as facilities with beds. Thus, out-patient clinics which comprise 60-70% of private healthcare (Report of the Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Healthcare Infrastructure (RWG)) are automatically excluded. Independent laboratories and radiology facilities that perform diagnostic and/or investigative services are covered under 2(c)(ii). Outpatient surgery, now-a-days a common feature in the United States (see this report), is beginning to catch on in India as well – several scientific reports have been published involving specific surgical procedures – though no actual numbers are available on the pervasiveness of their practice in freestanding clinics (A good guess may be that less capital intensive procedures (eg. traditional forms of cataract surgery) are more prevalent). Facilities conducting such procedures are usually attached to outpatient clinics, require patients’ presence only for the duration of the operation itself followed by a brief period of post-operative supervision usually amounting in toto to less than a full day and warrant no beds or admission. Such facilities too, notwithstanding the substantive nature of care involved, would not come under the purview of this act.

Cl. 5 empowers the government to develop ‘proper’ as well as minimum standards for healthcare. The latter alone is to be applied in reviewing the state of any facility. In a country with limited information about the nature and quality of healthcare, no national program for development of practice guidelines or medical review criteria (World Bank Report, 2003) in addition to vast regional and social disparities, creating such standards will be quite a difficult task. The RWG acknowledges this (para 37) and being a long-drawn process, recommends delinking it from registration (para 40(x)), a view incorporated in the draft bill.

Cl. 10 designates the District Health Officer (DHO) or Chief Medical Officer (CMO) as the district registering authority for registration of clinical establishments in each district. The DHO/CMO also shoulders responsibilities for the management of government facilities in that district. This leads to a conflict of interest.

Cl. 39 has a limiting stipulation that the register must be maintained in digital format. There is a concern that newer non-digital technologies may therefore be excluded.
Is state regulation a smart idea? This fundamental question at the heart of the debate has no easy answer. The RWG which recommended this step (para 67) does not appear to have seriously debated the merits of this solution. The report discusses briefly the problems of quality and lack of regulation in the private sector (para 6) and from there, jumps to a discussion on the forms of regulation, previous legislations, their inadequacies, and comparative approaches in other countries, with little mention of how legislative enactment will address specific issues, how far it ought to go or why it is a superior approach relative to the rest. It does stress that central legislation is necessary to ensure uniform standards (para 26). However, to foster cooperation and mitigate the skepticism of the private healthcare establishment, the National Council which is tasked with developing standards (Cl. 5) is required to adopt a consultative approach (Cl. 7).
A World Bank (WB) Report from 2003 titled ‘Health Policy Research in South Asia: Building Capacity for Reform’, a goldmine of information on the private sector (the RWG appears to have drawn from it at several places), summarises the various malpractices that previous studies have noted in the private sector (p. 235): “Stories abound of problems with diagnostic and treatment practices; with inadequate facilities and equipment; and of doctors over-prescribing, subjecting patients to unnecessary investigations and interventions, charging patients exorbitantly, using unethical and irrational practices, and failing to provide information to patients.” The report, similar to several other studies, generally favours regulation though its authors (who are all prominent in the field) are not entirely in agreement upon the way forward. One of them recommends decentralisation and a better regulatory regime (p .59); a second, writing in greater detail upon this question strongly argues for a ‘minimum set of basic regulations covering the licensing of practitioners and institutions, measures to ensure minimum standards of quality, guidelines regarding pricing, and actions to prevent the oversupply of services (including technology)’ (p. 240); a third, though convinced of the imperative for state intervention, insists that rigorous evaluation is a necessary prerequisite for there is little understanding of the regulatory mechanisms already put in place (p. 250). It must be noted however that many of the studies that recorded evidence of malpractice were not limited to private hospitals and nursing homes. They often focused on individual healthcare providers and also included those operating in exclusively ambulatory clinics with no separate assessment of the proportional contributions in each type of setting. Given the predominance of such clinics, regulatory scrutiny of a large fraction of such ethical violations will be precluded under the terms of this legislation.
The RWG also insists that though ‘state-specific variations would certainly exist, the need of the hour is [to have] uniform standards’ (para 34). The bill, in the statement of objects and reasons, repeats this theme (para 3). All of which brings us to the next question: Is a uniform standard a good idea? The definitive answer will have to wait till these standards are actually enunciated. One can speculate based on the wording of the bill and the RWG of the ministry’s thinking.
Cl. 12(i) entails minimum standards of facilities and services and cl. 12(ii) of personnel, for clinical establishments to meet the requirements of the Act. Regarding facilities, the legislation is likely to have beneficial effects at least with regard to private institutions in urban areas. Important findings previously reported in limited studies have been a lack of hygienic conditions and limitations of space (Nandraj, 1994). Both are easily identified though the latter may be difficult to remedy in a congested urban environment (that study was conducted in Bombay). How much leeway may be offered by the regulating authority for such locations remains to be seen.
Services can be loosely categorised into two: those that directly relate to patient care and those that are either peripheral to patient care but involve interfacing with the public or are more directly concerned with the institution’s own upkeep. The former includes medical, surgical, nursing and other services that directly relate to patient care whose practices are governed by professional guidelines and the conduct of whose professionals, to a significant extent, is overseen by professional bodies and also comes within the ambit of other laws (such as the Consumers’ Protection Act, 1986). Any regulation may end up interfering with not only the jurisdiction of these bodies but affect professional autonomy and are likely to engender profound resistance. However, egregious instances of medical errors that get reported often involve poor professional practice or judgment. Several previous efforts have resulted in little noticeable alteration in practices, their failure being blamed on ‘weakness’, lack of clarity or relevance, strong resistance from practitioners and state apathy (Bhat, 1999; Nayar, 2002). Some provisions to examine medical records for irregularities already exist on the statute in some states but have not been implemented (Bhat, 1996). It remains to be seen whether a similar fate awaits this renewed effort with no verification mechanism put in place to check whether the developed standards are being regularly followed (Prominent instances attracting media attention may still lead to exacting regulatory scrutiny in the absence of a routinely enforced system of auditing records of private health centers). The second kind of services are more amenable to regulation – governments and accreditation agencies usually target them in their efforts to improve quality of healthcare. The same is likely in India also. In fact, the RWG mentions the standards developed by the National Accreditation Board for Hospitals and Healthcare Providers (NABH), a constituent board of the Quality Council of India (QCI) (para 62). Other accrediting bodies have also emerged (para 63 and 64). It is quite possible that the standards adopted finally under this Act will be significantly drawn from some of these existing models.
Personnel problems abound in the healthcare sector. Apart from the widely publicized issue of rural doctor shortage, nursing shortages have also been reported. The vast differences in the number of medical colleges in different states (Supe and Burdick, 2006) also means that the number of graduating physicians will continue to be uneven with location, lifestyle preferences and linguistic barriers potentially preventing large-scale redistribution from overserved to underserved areas. These problems, being rooted in the existing system of incentives and restrictions, are destined to remain for a while. The question here is: how will new regulations affect them? If the medical education system is anything to go by, the answer is: adversely. Professional medical colleges are bound by the standards for faculty recruitment laid down by the MCI and risk losing their recognition should they flout those norms. At the same time, they have been facing an acute shortage of faculty in several (primarily non-clinical) specialties for which the blame is partly laid at the door of the MCI with calls to reduce these requirements to address this issue. Similar staff shortages exist in the general healthcare sector as well. Allopathic hospitals sometimes operate with homeopathic house surgeons (Nandraj, 1994) and recruit untrained nurses (Bhat, 1996; WB Report, 2003). If qualification requirements are strictly enforced, private institutions, faced with the prospect of losing their license, may either rise in revolt or resort to a variety of unsavoury methods to pass inspection (see ‘Hoodwinking the medical council’ in this news item). In rural areas, this problem has been overcome to some extent by existing personnel performing additional services outside the scope of their training. I knew of a surgeon in a popular rural facility in North Karnataka who also doubled as a gynaecologist and was said to be proficient in performing orthopaedics surgery when the regular orthopaedic surgeon was out of town. The WB Report acknowledges this practice in Uttar Pradesh (p. 274-5) but recognising that the alternative is the absence of any service, recommends allowing it to continue ‘for now’ with the rider that full disclosure be made by practitioners to community leaders and the public. A proviso to cl. 13(2) insists that ‘in prescribing the standards for clinical establishments, the Central Government shall have regard to the local conditions’. I found this somewhat ironical – are not the notions of uniformity and Central intervention antithetical to the idea of a local solution? Are Central experts truly more conscious and sensitive of local considerations than local health officials? In any case, not providing for some flexibility in the regulations framed under Cl. 12(ii) will certainly hurt rural providers. How these diverse requirements will be handled remains to be seen.
There have also been various reports of a variety of inadequacies in the conduct of individual providers – widespread absenteeism, unfilled vacant posts, incompetence and tardy work ethic (Nandraj, 1994; Das and Hammer, 2004; Hammer et al, 2006). Many of these have been reported in the public sector and the lack of robust accountability practices has been blamed for this (Hammer et al, 2006). How will better regulatory standards impact this? Cl. 42-44 allow the government to levy fines for failing to conform and a proviso to cl. 32(3(b)) allows for the institution to be restrained from ‘carrying on’ if there is imminent danger to the health and safety of patients. As mentioned before (vide supra), with the DHO/CMO holding overall responsibility for government facilities in the district, the ensuing conflict of interest makes it quite unlikely that he/she would be willing to take strong action against erring individuals or facilities. Apart from this, the coercive impact is blunted as any fine levied is merely one arm of the government paying another. There may be more severe consequences if a facility is actually forced to shut down for non-compliance. That is however likely to be a rare event; if it is serious enough to scandalise the government or even otherwise jolt it into action, the finger will once again point to the very DHO/CMO who ordered it. Thus, even if better accountability standards are developed and adopted, these constraints are likely to hamper their effective implementation.
Apart from uniformity between states, the RWG also talks about parity between public and private healthcare institutions (para 36): “Private sector players are quick to accuse the govt. of observing double standards in prescribing minimum standards for private establishments and doing nothing to improve the pathetic conditions in public health institutions. This issue would need to be addressed in the right spirit by the government. No exemptions have been provided for government institutions in laws framed for management of bio medical waste, setting up of blood banks and pre-natal diagnostic tests etc. All these laws have had salutary impact on their specific areas. All the more reason that government establishments should also be required to register and comply with prescribed standards.” On the face of it, the initiative is a laudable one. However, Ajay Mahal, in the WB Report from 2003, quoting classical economic theory has this to say (p. 59): “…particularly the suggestion to improve the quality of public sector care, run[s] into the problematic observation made by Besley and Coate (1991) that greater equity can be achieved and insurance for the poor improved if the quality of available public services is not ‘too high’. They argue that the interests of the poor could be served by the public sector if the richer groups start using private care or unsubsidised public facilities such as paid inpatient wards. For this to happen, however, the non poor would have to perceive the quality of care in the private, unsubsidised facilities as being better than that of subsidised public services.” He also found that the BIMARU states and Orissa have the least egalitarian distribution of public health subsidies, i.e., the wealthier sections use public health facilities more than the poorer sections of society. If the prescribed minimum standards are high enough to require both public and private establishments to upgrade their facilities causing greater parity, it might then end up worsening the targeting of subsidies to impoverished sections and enhance healthcare disparities. The same result would also occur if private establishments, finding themselves unable to meet the requirements, simply shut shop or move elsewhere.
The Indian Medical Association (IMA) which has consistently resisted state regulation, not surprisingly, came out against this particular effort also. As it alleges, this is, in a sense, a return to the license-permit raj with registration and inspection becoming potential focal points of corruption.
In conclusion, in a highly diverse country such as ours, I remain skeptical about a nationwide effort to bring uniformity through state-mandated regulation. The Act may well have some positive effects characterised by noticeable improvements in the urban private sector institutions. However, a full assessment must include the entire array of costs and benefits incurred by all constituent parts of the healthcare system as well as its participants. Only a few states have so far signed on to this initiative. If this remains the case, it may eventually provide an opportunity after it has been implemented (if at all it comes into effect), to examine, through comparative analysis, how effective it has turned out to be.

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. “Recognised 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.

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 stabilise’ 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 ‘stabilise’ 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.

IMA proposals are …

The bill unleashes license raj with powers of penalties upto 5 lacs .The registering authority can impose fines for non compliance and if a CE fails to pay the same ,it would be recovered as an areears of land revenue.

The penalties are stringent and for first offence the penalties are more than that in IPC. For first offence it is 1000 INR ,then for second offence it is 50000 and for third offence it is 5 lacs. Disobeying any direction or obstruction to inspection entails Rs 5 lac penalty.

The bill unleashes licence Raj with draconian powers to the inspectors with little provision for appeal.

Are doctors doing some illegal work to be harassed like this

IMA proposes that the act should not be implemented at all. If at all government is adamant and hell bent it should be such the single doctors clinics to be considered for minimal registration only without applying strict rules.The provision should be prospective in implementation and old clinics and hospitals should be excluded.

IMA wants that only those establishment with indoor facilities should be included in the act.Also till date existing establishments should be exempted from the provisions of the act.

IMA Proposes that the requirements of pharmacist and clinical psychologists in various places should be done away. Pharmacists are not needed as most drugs are formulated and psychologists are mostly non medical persons masquerading as doctors.

IMA proposes that the ethics and rules are different and should not be mixed.Stablising a patient is ethical and making a rule is like asking an inappropriate person to treat the disease and waste time in referral.
Danielle Ofri on what plagues American medical system ,one of the costliest in the world writes that insurance and consumer affair concerns makes American doctors do too much of paper work which is more than the time spent in treating patients.This is what we are trying to imitate.IMA proposes that section of the act which entails reporting data of the patient be withdrawn completely.Other than notifiable communicable diseases , no data will be provided to the government as it will hamper direct patient care,considering our large population.

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