INTRODUCTION

India has been an underdeveloped country throughout the last century. However, it embarked upon the 21st century, as the fastest growing economy of the world. According to certain reports, this nation of 1.27 billion people is poised to become the third largest economy of the world much before the end of this century. With its ever expanding economic base, improved literacy rate, living standards, longevity and purchasing power, India is in the process of putting in place the largest health infrastructure the world has ever seen. Medicine and medical services have already turned themselves into an ever expanding industry contributing substantially to the gross national product.

While in most developed countries, doctor to patient ratio is in the range of 200 to 500 patients per doctor, in India it is over 2000 patients per doctor. There are only 50,000 medical college seats registered with the Medical Council of India today which includes government as well as private colleges. Indian cabinet has recently cleared a proposal to add 10,000 more medical seats in government colleges and aims to reduce the doctor to patient ratio in the country from current 2000 to 1000 with the help of private medical colleges. Natural outcome of these factors are proliferation of private medical colleges and private hospitals all over the country. While some of them match the world standards, producing good doctors and good quality medical services, a great majority of them remain barely equipped and with questionable quality. Notwithstanding above, entrepreneurs today see medical services and pharmaceutical industry as one of the most rewarding business models in the country. Medicine no longer remains a patient centric activity where patient’s welfare is the prime objective. All aspects of medical services today are driven by the motive of profit like any other profit making activity in the economy. This is a dangerous trend and a great hazard to the public health.

Under the above circumstances, it becomes incumbent upon the government to ensure that all aspects of public health are protected and regulated by stringent and thorough legal framework which is sophisticated and refined enough to adapt itself to the rapid improvement in technology and innovation that is so characteristic of modern medicine. Unfortunately, such a framework does not exist in India and howsoever little laws are there, they are insufficient to handle the dangers of rapid commercialization of medical services and the threat that it poses to public health in India.

Sweeping changes in medical services outlined above has affected the doctor patient relationship as well. Lucky were the doctors of the past who were treated like Gods and revered without questioning. Today the doctor-patient relationship has transformed to such an extent that hospitals and doctors have started viewing their patients as customers and patients have started viewing their doctors as service providers. Even though the services of doctors attracted laws such as the Law of Torts, IPC etc. In the past also, however, after passing of the Consumer Protection Act in 1986, medical services legally came under it. Litigation against doctors under this act has since been on a steady rise. The Central Consumer Protection Council in 1993 tried to bring government medical and health services within the ambit of the Consumer Protection Act, but met with strong resistance from the ministry of health. Health Ministry opposed it as it felt that government hospitals were not prepared for such a law. They lacked infrastructure, resources and drugs to withstand the demands of this act. The Consumer Protection (Amendment) Act, 1993 was later passed by the Parliament, without bringing into its ambit Govt. health services.

The main issue concerning public health in the world of medicine is the “medical negligence”. The concept of ‘negligence’ is a tort in civil law. It is an act or omission that causes harm to an individual’s property, reputation or interests. Tort imposes a duty of care where one party could reasonably foresee that his or her conduct may cause harm to another. Therefore, in cases of medical negligence, the claimant has to prove that he or she has suffered injury or harm because of the negligence of the medical practitioner. The evolution of the legal concept of medical negligence is a rather recent development. The tort of negligence itself was founded in the UK with the case of Donoghue v. Stevenson1, when commercial liability for defective produce was established. The key ingredient in the establishment of medical negligence was provided by the Bolam proceedings of 1950. This case introduced what is called the ‘Bolam test’, which has underpinned the UK’s arrangements for more than half a century. The test forms the basis of defense for medical professionals when they have “acted in accordance with a practice accepted as proper by a responsible body of medical opinion. In practice, this makes proving a negligence claim very difficult. The Bolam test was amended by a judgment in the late 1990s to permit a judge to conclude that a medical decision that is not capable of withstanding logical analysis is unreasonable and the treatment therefore negligent.

In the UK, to deal with clinical negligence in the National Health Scheme (NHS), the Government created a centrally funded pool of resources to meet the costs of any claims brought against the NHS. The NHS Litigation Authority (NHSLA) was set up in 1995 to contest law suits on behalf

1 [1932] AC 562

of the Secretary of State. Contributions were extracted from NHS Trusts on the basis of assessments of their risk management procedures. Suits against general practitioners (GPs) and other primary care professionals are not dealt with by the NHSLA, but are defended by a number of other medical defense organizations. The Department of Health, in UK acknowledged the high level of adverse incidents in NHS hospitals, revealing that 10 per cent of in-patient admissions resulted in some form of adverse outcome, and five per cent of the general population report suffering some injury or other adverse effects of medical care. The factors cited in explanation include underfunding, staff shortages and overwork and conflicting priorities. However, it is also accepted that risk management and the avoidance of clinical error has not received the focus that it deserves in the past.

In India too, lack of alternatives to legal redress had made it very difficult for the victims of medical accidents or negligence to secure compensations / apologies from the erring medical practitioner. .This is because the laws of the land that provided relief in cases of medical negligence under the Law of Tort and Indian Penal Code had some well documented problems. These included the following: (i) Inordinate delay in the legal system, which in medical negligence cases, tends to be greater; (ii) the cost of bringing an action, is notoriously high in relation to the sums recovered in damages; (iii) limited access to the courts; (iv) success depends on proof of both negligence and causation (which can be particularly difficult in cases of medical negligence). Hence the necessity to provide for an alternate system which would be easily accessible, speed and cheap, gave birth to the Consumer Protection Act. This Act was made applicable to the doctors because there are no provisions in the Indian Medical Council Act, 1956;

15th March is celebrated as World Consumer Rights Day. On this day in 1962, President J.F. Kennedy declared four basic consumer rights in the special message to the American Congress, i.e. (a) and other rights were added to it by IOCU.

In India also, these rights are enshrined in our Consumer Protection Act, 1986. In addition, Indian Penal Code, 1860 sections 52, 80, 81, 83, 88, 90, 91, 92 304-A, 337 and 338 contain the law of medical malpractices in India. A number of Acts specific to certain aspects of public health is also passed by the parliament. These are – The medical termination of pregnancy Act, The Pre-Natal Diagnostic Techniques (PNDT) Act, Acts in Disability, Insecticide Act, Maternity Benefit Act, Narcotic Drugs and Psychotropic Substances Act, Prevention of Food Adulteration Act, Drugs and Cosmetic Act, Bio-medical Waste Act 1988, The Pharmacy Act, 1948, The transplantation of Human Organs Act, Environment Act, Food Safety and Standard regulation

Act, Food Safety and Standards (Prohibition and Restriction on Sales) Regulation Act, 2011 are some of the ad hoc measures taken by the government to protect the public health.

THE CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) BILL, 2007

Article 47 of the Constitution of India says:

The state shall regard the raising of the level of nutrition and the standard of living of its people, and the improvement of public health, as among its primary duties and, in particular, the state shall endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and drugs which are injurious to health.

At a time when the meaning of the fundamental right to life has been expanded and would even in minimalist terms include the right to health and nutrition, the National Health Policy 2002 expresses concern that the “existing public health infrastructure is far from satisfactory”, and locates the problem in insufficient funding and trained personnel, gross inadequacy of consumables, obsolescent equipment, dilapidated buildings, non-availability of essential drugs, low quality of services, and overcrowding of poor facilities.

The Working Group on Clinical Establishments, Professional Services Regulation and Accreditation of Health Care Infrastructure, constituted by the Planning Commission for the 11th Five-Year Plan, points out in its report that although the “for-profit private sector accounts for...50% of inpatient care and 60-70% of outpatient care...[it] has...remained largely fragmented and uncontrolled”, with problems ranging from “inadequate and inappropriate treatments, excessive use of higher technologies, and wasting of scarce resources, to serious problems of medical malpractice and negligence". The Clinical Establishments (Registration and Regulation) Bill 2007 reiterates the concerns of the Working Group in its statement of objects and reasons.

This is an Act that is proposed to be brought into force to streamline the functioning and provision of services by clinical establishments. Importantly, it is a matter that regulates not just allopathic facilities, but also clinical establishments that provide services in a range of Indian systems of medicine. The relevance of this enactment lies in the fact that there has been an increasing concern about the gross inadequacy of public health facilities on the one side and the lack of any standards to regulate the existing facilities both public and private on the other. The virtual collapse of the public health system, particularly in rural and remote tribal areas, has rendered already marginalised communities totally vulnerable to unregulated, unmonitored health care providers. In the cities there has been a takeover of health services by corporate health care, without any transparent processes of accountability being put in place.

With the recent discovery of the theft of kidneys from unsuspecting poor people and the offer of huge sums of money in return for kidneys to people on the brink of survival by a “homoeopathic” doctor who ran a hospital that specialised in kidney transplants near Delhi, the question of regulation of clinical establishments is an urgent one.

Main Features

The Bill defines a “clinical establishment” as:

(a) a hospital, maternity home, nursing home, dispensary, clinic, sanatorium or an institution by whatever name called that offers services, facilities with beds requiring diagnosis, treatment or care for illness, injury, deformity, abnormality or pregnancy in any recognised system of medicine established and administered or maintained by any person or body of persons, whether incorporated or not; or

(b) a place established as an independent entity or part of an establishment referred to in sub-clause (i), in connection with the diagnosis or treatment of diseases where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services with the aid of laboratory or other medical equipment, are usually carried on, established and administered or maintained by any person or body of persons, whether incorporated or not, and includes clinical establishments owned, controlled or managed by the Government, a Trust, a Corporation, a local authority and a single doctor establishment, but does not include the clinical establishments owned, controlled or managed by the Armed Forces.

Recognised systems of medicine include allopathy, yoga, naturopathy, ayurveda, homoeopathy, siddha and unani, or any other system of medicine as may be recognised by the central government. The Bill envisages the constitution of a “National Council” that will draw representatives from professional bodies in the fields of dentistry, nursing, associations of the different systems of medicine, etc.

Composition of the National Council

Chairperson (DGHS) 1

Elected Members

Dental Council of India 1

Medical Council of India 1

Nursing Council of India 1

Pharmacy Council of India 1

Central Council of Indian Medicine (Ayurveda, Siddha & Unani) 3

Central Council of Indian Medicine (Homoeopathy) 1

Central Council of the Indian Medical Association 1

Bureau of Indian Standards 1

Zonal Councils 2

North-Eastern Council 2

Paramedical System 1

Nominated Members (represent any system of medicine without statutory authority)

3

Total 19

The function of this council will be to determine standards for clinical establishments, prescribe minimum standards, develop classifications of these establishments, and take responsibility for periodic review and maintenance of a national register of clinical establishments. The state director of health services or any officer subordinate to him will be designated state registrar of clinical establishments, and will be responsible under the proposed legislation for the performance of functions of classification, review and compilation of records at the state level, to be sent to the national council periodically.

Registration, under the proposed legislation is mandatory; the Bill provides for provisional registration for a period not exceeding three years for establishments already in existence without prior inquiry. Permanent registration will be granted only to those establishments that are found to fulfill the standards set by the central government. The proposed legislation envisages a pyramidal structure for the registering authorities from the district to the national level, with the authorities both at the state and district level being personnel of the department of health services. The legislation will not apply in the states of Andhra Pradesh, Maharashtra, Madhya Pradesh, Manipur, Nagaland, Orissa, Punjab and West Bengal. Of these states West Bengal and Maharashtra have in place Acts that came into force in 1950 and 1949 respectively, Madhya Pradesh in 1973, the other states relatively recently between 1991 and 2002.

The Bill was introduced in the Lok Sabha on August 30, 2007. The Bill has been referred to the Standing Committee on Health and Family Welfare2.

2 Chairperson: Shri Amar Singh

Highlights of the Bill

The Clinical Establishments (Registration and Regulation) Bill, 2007 seeks to register and regulate, and set standards for clinical establishments. It shall be applicable to all union territories and four states. Other states may adopt the Bill.

A clinical establishment is defined as a hospital, maternity home, nursing home and any similar facility with beds. The definition also includes a laboratory that carries out pathological, bacteriological and other diagnostic services.

The central government shall establish a National Council. Its main functions include prescribing standards for clinical establishments and maintaining a register of clinical establishments.

Every clinical establishment will need to register. The Bill provides for both provisional registration and permanent registration upon satisfaction of prescribed conditions.

The district registering authority is responsible for registering clinical establishments, inspecting such establishments and cancelling registrations in case of non-compliance with prescribed standards.

Key Issues and Analysis (Part-A)

The definition of “clinical establishment” refers to dispensaries and clinics; however it also states that the facilities should have beds. This would arguably exclude clinics which only provide out-patient services.

In case of change of ownership or management, the clinical establishment will need a new registration. This requirement differs from other sectors in which the registering authority is informed and the transfer is recorded in the register.

The regulator for all clinical establishments (including government establishments) at the district level is also the administrator for government health services. This could lead to conflict of interest.

The Bill stipulates that a register has to be maintained in digital format. This could prevent the use of new technologies which might not be digital in nature.

The Bill is not applicable in areas where eight state Acts have jurisdiction. These Acts do not cover all the different types of clinical establishments listed in the Bill.

Applicability

The Bill shall be applicable to all union territories and four states (Arunachal Pradesh, Himachal Pradesh, Mizoram, and Sikkim). Other states may adopt the law by passing a resolution in the state legislatures.

Registration of Clinical Establishments

Every clinical establishment has to be registered to admit patients for providing treatment. Norms required to be met prior to registration include (a) minimum standards of facilities; (b) minimum qualifications for the personnel; and (c) provisions for maintenance of records. The National Council may prescribe different minimum standards for each category of clinical establishment.

Every state government shall designate the Director of Health Services or any other subordinate officer as the Registrar of clinical establishments. The Registrar shall compile the state register and monthly returns in digital format for updating the national register (maintained by the National Council). The state government shall designate the District Health Officer or the Chief Medical Officer as the district registering authority for clinical establishments.

The central government shall notify standards for each type of clinical establishment. The Bill provides for a system of provisional and permanent registration. The provisional registration is valid for a period of one year. These may be granted till three years after the central government notifies minimum standards for that type of establishment. After that period, only permanent registration may be granted.

Existing clinical establishments have to apply for registration within one year from the date of commencement of the Act. Irrespective of registration under any existing law, every clinical establishment has to register under the Act. The registering authority is required to grant provisional registration within 10 days of receiving the application. No inquiry is required before granting of such provisional registration.

A clinical establishment, applying for permanent registration, has to submit evidence of it having complied with the prescribed minimum standard. The information shall be displayed for 30 days for any objection to be filed. Permanent registration shall be granted only when a clinical establishment fulfils the prescribed standards for registration. A clinical establishment can reapply even if its application has been rejected.

Inspection of Clinical Establishments

The registering authority may authorise an inspection or an inquiry of any clinical establishment. The clinical establishment shall have the right to be represented during the inspection or inquiry. The authority shall convey its views and may advise the establishment on the action to be taken.

A show cause notice may be issued if the authority feels that a clinical establishment is not complying with the conditions of its registration or the person managing the establishment has been convicted of an offence punishable under the Act. The authority may cancel the establishment’s registration if it feels there is a breach of the law. The authority may enter and search in the prescribed manner after giving notice of its intention to the clinical establishment, if it suspects that an establishment is operating without registration.

Penalties

If anyone operates a clinical establishment without registration, he shall on first conviction be punishable with fine up to Rs 50,000, on second offence with fine up to Rs 2 lakh and for any subsequent offence with fine up to Rs 5 lakh. If someone knowingly serves in a clinical establishment which is not registered he shall be punishable with fine up to Rs 25,000. If any person violates the provisions of the Act and no penalty is provided elsewhere, he shall bepunishable with fine up to Rs 10,000 for the first offence. For a second offence, the fine may extend to Rs 50,000 and for any subsequent offence it may extend to Rs 5 lakh.

Key Issues and Analysis (Part-B)

1) Exclusion of Out-Patient Clinics:

The definition of a clinical establishment appears to exclude dispensaries, clinics etc without beds, i.e., those that deal only with out-patients. Since private out-patient facilities constitute 60-70 per cent of the private sector health care in India, the purpose of the Bill to register and regulate all clinical establishments might not be served if such establishments are excluded from its purview.

2) Transfer of Ownership:

The Bill requires a clinical establishment to apply for fresh registration in case of transfer of ownership or management. This requirement differs from the case of transfer of ownership in several other cases, in which the registering authority is informed and the transfer is recorded in the register. (For example, if A sells a car to B, the registration number remains the same, but the ownership is changed by informing the registration office). Furthermore, in case of a clinical establishment which is registered as a company and trades on the stock exchanges, the ownership structure changes every time the stock trades. This provision would imply that a new registration is required on each such instance.

CLINICAL ESTABLISHMENTS (REGISTRATION AND REGULATION) ACT, 2010

In August 2010, the Parliament of India passed the ‘Clinical Establishments (Registration and Regulation) Act, 2010’, which came into force in March 2012. Through the CEA 2010, all private and public (excluding the armed forces) medical facilities (called clinical establishments), which cover all systems of medicine, laboratories & diagnostic centres and single doctor establishments, need to be registered. It is applicable in the States of Arunachal Pradesh, Sikkim, Mizoram, Himachal Pradesh and all Union Territories. The States that have adopted this act are Uttar Pradesh, Rajasthan, Bihar and Jharkhand. Maharashtra and other states are keen on adopting the CEA 2010. The central government is keen on pushing the State governments to adopt the central Act. Kerala & Tamil Nadu are keen on having their own Act in line with the CEA 2010. In Punjab and Gujarat, there is massive opposition for adopting or enacting similar legislations. Among the States & UTs the CEA 2010 is applicable and adopted the progress has been slow due to various reasons. In Himachal Pradesh and Sikkim the offline registration of clinical establishments is in progress. In the other States and UTs the governments are in the process of notifying the State / UT councils, the District Registration Authorities and the Rules under section 54 of the act. The National Informatics Centre has developed a web-based software for the implementation of the CEA 20103. The copies of the Act, Rules are available on this site.

Firstly it is necessary to note that the framing of the Clinical Establishments (Registration and Regulation Act, 2010 (CEA 2010) was necessitated since there has been practically no regulation for private clinical establishments in the country. This has been due to the opposition by certain sections of the medical profession and owners of clinical establishments for any kind of accountability or transparency.

Many state governments were not able to push for enacting legislation regulating private clinical establishments. In Maharashtra, the Bombay Medico- Friends- Circle group which took

3 http://clinicalestablishments.nic.in/

the lead 15 years back by filing a PIL in the Bombay High court, not much progress has been achieved in the State. In the above context it was felt that having a central act, would put pressure on those state governments that do not have any legislation to adopt a central act and those States to modify their outdated & deficient existing acts regulating private providers. This seems to have been achieved to an extent.

The National Council, through multi stakeholder participation and a consultative process is presently in the process of categorization and classification of clinical establishments, determination of minimum standards, information to be collected from clinical establishments, determining the rates and charges to be charged among other aspects.

SALIENT FEATURES

The salient features of the CEA 2010 are that there would be digital registry of all types of Clinical Establishments at National, State & District level. All information provided by the clinical establishment would be available in the public domain. It would assist government in obtaining data from clinical establishments required for public health interventions including outbreak and disaster management among others. The provisional registration would be through self declaration, without any inspection. Permanent registration would be undertaken after categorization and determination of minimum standards within two years from the date of notification. Every clinical establishment needs to provide treatment “within the staff and facilities available” to stabilize the emergency medical condition of any individual brought to such establishment. Details of charges, facilities available should be prominently displayed at a conspicuous place by each establishment. Clinical Establishments shall charge the rates for procedures and services within the range of rates determined by the Central Government from time to time in consultation with the State Governments. Compliance to Standard Treatment guidelines as may be issued by Central/State Govt. to be ensured by CEs.

The Clinical Establishments (Registration and Regulation) Bill, 2010 was introduced in

the Lok Sabha on April 15, 2010 by the Minister of Health and Family Welfare, Shri

Ghulam Nabi Azad.  The Bill was passed by the Lok Sabha on May 3, 2010 and is

pending in Rajya Sabha. 

The Bill shall be applicable to all union territories and four states (Arunachal Pradesh,

Himachal Pradesh, Mizoram, and Sikkim).  Other states may adopt the law by passing a

resolution in the state legislatures.

The Bill seeks to register and regulate clinical establishments.  “Clinical establishment”

is defined as hospitals and clinics and similar facilities that offer treatment for illness in

any recognised system of medicine (allopathy, yoga, naturopathy, ayurveda,

homoeopathy, siddha and unani).  It also includes any laboratory which offers

pathological, chemical and other diagnostic services.  An establishment can be owned by

the government, a trust, and a single doctor establishment.  The Bill does not apply to

any clinical establishment owned or managed by the Armed Forces.

The central government shall establish a National Council of Clinical Establishments to

(a) determine the minimum standards of health care by a clinical establishment; (b)

classify them into categories; and (c) maintain a national register of clinical

establishments.  The Council shall be chaired by the Director General of Health Services

(DGHS) and 22 other members (includes consumer groups and Associations of Indian

Systems of Medicine).

Every clinical establishment has to be registered to admit patients for providing

treatment.  Norms required to be met prior to registration include (a) minimum standards

of facilities; and (b) minimum qualifications for the personnel.  It may prescribe different

minimum standards for each category of clinical establishment.

National Register shall be compiled within two years from the date of commencement of

the law and determine the first set of standards for clinical establishments within two

years of setting up the Council. 

Every state government shall establish a State/Union Territory Council for clinical

establishments.  Members shall include Secretary, Health; Director of Health Services;

elected representatives from state Medical Council, Nursing Council and Pharmacy

Council, and state-level consumer groups or reputed NGOs etc.

The state government shall set up a district registering authority for registering clinical

establishments at district level.  Members shall be the District Collector, the District

Health Officer and 3 members with such qualifications to be prescribed by central

government. However, the District Health Officer and Chief Medical Officer shall act as

registering authority for provisional registration.

The functions of the Council include compiling state registers and hearing appeals

against orders of the authority for registration.

The central government shall notify standards for each type of clinical establishment. 

The Bill provides for a system of provisional and permanent registration.  Provision

registration may be granted for a year.  For clinical establishment whose minimum

standards have been notified, provisional registration will only be granted for a specified

time-limit.  Permanent registration shall be valid for five years and application for

renewal should be made six months before expiry of registration.

A clinical establishment, applying for permanent registration, has to submit evidence of

it having complied with the prescribed minimum standard. 

The registering authority may authorise an inspection or an inquiry of any clinical

establishment through a multi-member inspection team to be prescribed.  A show cause

notice may be issued if the authority feels that a clinical establishment is not complying

with the conditions of its registration.  It may also cancel the registration.  The authority

may enter and search in the prescribed manner after giving notice of its intention to the

clinical establishment, if it suspects that an establishment is operating without

registration.

Regulatory requirements for private clinics

A clinic may be defined as a place of professional practice with facilities for outdoor consultation and treatment during scheduled hours by one or more physicians and staff and equipment essential for the services provided. It may or may not have the facilities for limited investigations specific to the scope of services provided.

A large percentage of the population, in rural as well as urban areas, is dependent on private clinics and, therefore, the quality of healthcare services provided by them is very important. At

present there is no system of registration of private clinics by health authorities in India. The Clinical Establishments (Registration and Regulation) Bill, 2007 is still pending in the parliament.

Presently, the operation of private clinics is being governed by the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations 2002 and certain other legislations as outlined below.

1. Registration/Requirement of Licenses

• Registration with health authorities is not mandatory for private clinics but the clinic will be subject to inspections in case of any complaints. If and whenever the Clinical Establishments (Registration and Regulation) Bill, 2007 is passed by the parliament and implemented by the states, registration of all clinics (Private/Public) of all systems of medicine will become mandatory;

• Registration with the municipal authorities (Delhi Shops and Establishments Act, 1954);

• Recognition for usage of narcotic drugs (Delhi Narcotic Drugs (Amendment) Rules, 2002;

• Authorisation for generation of Bio-Medical Waste, if treating 1,000 or more patients per month;

• Permit for procurement/usage of spirit;

• Registration under the Medical Termination of Pregnancy (MTP) Act 1971, the Pre-Natal Diagnostic Techniques (PNDT) Act, 1994, as applicable.

2. Regulations Related to Employment of Staff• Employment of staff (Doctors, Nurses, Pharmacists) only after proper credentialing;

• Prevention of sexual harassment of women at work place4

• Responsibility of employer for safety of employees5

• Rules governing the employment of staff6

4 Judgment of the Supreme Court of India (SCI) in Sakshi Vs the Union of India and Others 2004 Supp(2) SCR 7235 Delhi High Court Judgment in Ms XYZ Vs Shanti Mukund Hospital, Delhi and Punjab & Haryana High Court Judgment in Jasbir Kaur Vs the state of Punjab CWP No.25449 of 20126 Delhi Shops and Establishments Act, 1954

• Immunisation / other measures for protection of staff from Occupational Health hazards.

3. Sign Boards• Rules for the size, contents and correct place for sign boards (IMC Regulations 2002).

4. Information to be displayed at the Clinic• Certificate of registration of clinic with the municipal authorities;

• IMC/SMC registration certificate7

• Charges for consultation and other procedures/services (IMC Regulations 2002);

• Clinic timings, closed days (Delhi Shops and Establishments Act, 1954).

5. Documents to be maintained by the Clinic• Registration of the clinic with the municipal authorities8

• Record of employment of adults, letters of employment issued and hours of work;

• Maintenance of record of patients treated (IMC Regulations 2002) and a register of medico-legal cases (MLCs);

• Maintenance of a register of medical certificates issued;

• Copies of medical certificates issued;

• Registration certificates of doctors/nurses/pharmacists with the State Medical Councils (SMCs);

• Professional qualifications (degrees/diplomas) of the staff;

• Record of consumption of Morphine (if applicable)9

• Account of money receipts and expenses10

7 IMC Regulations, 20028 Delhi Shops and Establishments Act, 19549 Delhi Narcotic Drugs Rules, 200210 Income Tax Act, 1961

• Authorisation for generation of Bio-Medical Waste and record of category wise waste generated (BMW Management Rules, 1998);

6. Issue of any medical certificate, notification, document or report, which is untrue, misleading or improper is a misconduct and punishable offence (IMC Regulations 2002, Section 197 of Indian Penal Code);

7. Regulations Related to Treatment of Patients• Valid consent for examination/investigation/treatment/research procedure (or informed refusal of consent), as applicable (IMC Regulations, 2002);

• Confidentiality of privileged communication, as far as permitted under the law;

• Life saving treatment of emergency cases11

• PNDT Act 1994, Conduct of Euthanasia12 , MTP Act 1971 and IPC sections 312-315, 318;

• Rules for issue of prescriptions (IMC Regulations, 2002);

• Maintenance of Medical Records of the patients treated for a period of three years and as per the format vide Appendix 3 to the IMC Regulations, 2002;

• Reporting of Medico-Legal cases to the police;

• Reporting of occurrence of occupational diseases;

• Responsibility for ensuring safety of patients

• Rights of patients;

• Privacy of patients during consultation, examination and treatment;

• Professional indemnity insurance cover of an appropriate amount13

• Laws applicable to medical negligence — Vicarious Liability, Respondeat Superior, Indian Contract Law, Tort law, Consumer Protection Act, 1986, Indian Penal Code sections14.

11 SCI Judgment in Parmanand Katara Vs Union of India, AIR 1989 SC 2039 and The Delhi State CDRC (Consumer Disputes Redressal Commission) Judgment in the case of death of NB Sub K L Guliani12 SCI Judgment in Aruna R Shanbaug Vs Union of India & Others, (2011) 4 SCC 45413 Insurance Regulatory and Development Authority Act, 199914 52, 80, 88, 89, 92, 93, 274-276, 284, 304-A, 336, 337, 338 and 376-D

8. Drug and Cosmetics Act 1940, Drugs (Control) Act 1950, Narcotic Drugs and Psychotropic Substances Act 1985, Drugs and Magic remedies (Objectionable Advertisements) Act, 1954, Pharmacy Act, 1948.

9. Submission of Reports/Returns to Health Authorities• Cases of notifiable diseases as applicable in the state15

• Report of cases of food poisoning, if required by Municipal Health Authorities16

• Incidence of needle stick injuries;

• Annual report under BM Waste Management Rules, 1998 (if applicable);

• Reports on the MTPs carried out;

• Reports on the USG abdomen (abdominal ultrasonography) done on the pregnant women.

10. Safe disposal of infectious/hazardous waste generated at the clinic17.

11. Prohibition of unethical activities, such as soliciting patients directly or indirectly, by a physician, a group of physicians, or by institutions or organisations by advertising, self-promotion or self-aggrandizement; use of touts for procuring patients; giving/offering or receiving rebates, gifts, commissions, cutbacks or kickbacks in return for referral or procurement of patients etc (IMC Regulations, 2002).

12. Prohibition of Smoking in Public Places Rules, 2008, Fire Safety Regulations, Financial Regulations: Income Tax Act, Value Added Tax (VAT) Act, Central Sales Tax Act, etc.

13. State laws for prevention of vandalism/violence against medical service staff and institutions.

CRITIQUE

15 Section 371, Delhi Municipal Corporation Act16 Prevention of Food Adulteration Act, 195417 BMW Management Rules, Environment Protection Act 1986, IPC Section 269, 270

There has been opposition and resistance from private providers, owners and the IMA for any efforts to adopt the CEA 2010 or enact similar legislations.

The Act will lead to “license and inspector raj”; it is anti-people and curtails freedom of medical practice, and the penalties are harsh. Another reservation expressed is that the Act makes it obligatory for clinical establishments to provide treatment and stabilize patients who are brought in an “emergency medical condition. The standards prescribed are harsh and would lead to closure of single doctor clinics and small medical establishments and this will raise the costs of treatment for the general public.

The apprehensions and reservations voiced by them are unfounded and not based on clear reading of the provisions of the Act.

Firstly it needs to be stated that the registration of establishments is a process of applying to the District Registration Authority by providing details either by post, online or in-person. There is no inspection and the grant of registration to the establishment is time bound, so that no application remains unattended. There are provisions for appeal before the State /UT Council of Clinical Establishments. Regarding penalties the act has consciously not kept any provision for imprisonment, only monetary penalties, as the intention is to seek compliance with the provisions rather than taking punitive action. With regard to Standards being harsh it needs to be noted that presently there are no standards prescribed. As mentioned earlier the National Council is presently in the process of categorization of different types of clinical establishments and determining uniform minimum standards. It is ironic that IMA, which is represented in the National Council, should make statements that the standards are harsh.

IMA along with the Quality Council of India has been engaged by the Union Ministry of Health and Family Welfare to survey existing standards in clinical establishments in states where it is applicable. IMA would need to support its argument that minimum standards would lead to closure of clinical establishment and increase costs with evidence. The premise of the Act is that there are few clinical establishments that operate using standards of care, guidelines and protocols and monitoring of these in the country is deficient.

IMA’s refusal to accept this is contrary to the interests of patient care and public health. The IMA’s reservation that the medical profession is already governed by number of Acts through multiple regulating bodies is baseless. The CEA 2010 was passed by the parliament on the request of many state governments that did not have legislation for clinical establishments. The provision of the Act, which mandates that every clinic must provide basic emergency care, is being opposed by the IMA. It is well known that private hospitals and clinics do not admit accident victims who require critical emergency care because it can lead to a medico-legal case,

or the patient or their families will be unable to pay for the treatment costs or are uninsured. This malaise is widely prevalent.

Taking note of this, the Supreme Court of India as long back as 1989 passed a ruling18 that made it obligatory for all practitioners to provide emergency medical care. The Act reemphasizes the judgment. It states: 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.

Further there are concerns being voiced that concerned stakeholders (including consumer groups) have not been represented in the various bodies of the CEA 2010. It needs to be noted that the CEA 2010 has 3 institutional mechanisms ie: The National Council, State / UT council and the District Registration Authority and in each of the bodies there is representation from consumer groups and professional medical association or bodies.

CONCLUSION

Health and human rights activists have for at least two decades now demanded a closer scrutiny of medical establishments and health care systems. This demand has focused on a range of specific concerns −mental health care, primary health care and sex-selective abortions, to randomly name a few −alongside a more general demand for more effective public health services. There has also been a growing acknowledgement among practitioners of allopathy of possible conversations between it and other systems of Indian medicine. At the same time there has been a resistance to controls by medical professionals across the board, the most telling example being the case of regulation under the Pre-conception and Pre-Natal Diagnostic Techniques (Prohibition of Sex Selection) Act (PCPNDT Act) 1994.

This Bill comes as a response to the demand for greater scrutiny in the wake of spiralling malpractices and gross negligence. In terms of its objects and reasons, therefore, it is a welcome move. In terms of its operational elements, however, there are too many gaps, which might well mean that we have one more legislative response to a public demand that is a mere “action taken report” that cannot be implemented. Finally, the question of self-regulation, transparency and its prospects where clinical establishments are concerned is one that must be revisited time and again by professional bodies and individual practitioners. The resistance to the commodification of health services, and unethical, illegal practices need to come as much from within as without.

18 Parmanand Katara v. Union of India AIR 1989 SC 2039

The CEA 2010 is not a perfect act, it has many problems and issues that have not been covered. However one needs to remember that when enacting an act there are various pressures from various stakeholders. Secondly is there a perfect legislation that meets the needs of all interested stakeholders involved and finally do we keep debating and discussing and wait for a perfect legislation. It is crucial that the clinical establishments in the country are accountable and transparent which would greatly improve the quality of health care in our country.

While the above effort is by all means laudable, yet it is not adequate to deal with the challenges confronting the field of medicine. A much larger and comprehensive view is required to be taken on the subject. Prevailing consumer protection rules which are basically designed to protect the interest of consumers in respect of goods and services are barely adequate to handle the complex medical negligence cases and cases of medical malpractices. The need of the hour is to formulate a comprehensive action dedicated to medical negligence and medical malpractices to regulate all aspects of the conduct of doctors and hospitals providing health services to the citizens of India.