Regulatory Oversight In Healthcare
As a healthcare professional let me elucidate the need for regulatory oversight in medical education and practice. Regulation ensures compliance to set standards of healthcare for patients’ benefit and is especially more important to healthcare administration as it carries the responsibility of public health.
Conforming to set standards in training and practice of medicine ensures correct procedures and requisite levels of care to patients are met in a transparent process. The recommendations that regulation has to be made more pervasive and improved than what it is today, stems from the fundamental concerns arising from the failure of the Medical Council of India (MCI). The key stakeholders (government, doctors, administrators, assorted health workers, medical colleges, patients, and now corporate hospital business owners etc) and public in general, acknowledge that regulatory oversight is needed when factors as essential as life, health and medical education are involved. Policy debates, for most part, swirl not around whether oversight should exist or not but, instead, around the way it should be structured.
Work of regulators includes that of setting standards, detection of wrongs/wrongdoings, measuring/monitoring performance and enforcement of rule of law and safety.
There are two basic models of regulation used by regulators – that of deterrence and compliance. However, a move towards an intermediate area of responsive or smart regulation has been emerging in recent years in healthcare. In practical terms, the model of deterrence can be viewed as a hard law approach as is prevalent in United States. A divergent “model of compliance” or a soft law approach has been followed by Europe, Britain and India. Recent regulatory reforms of healthcare systems in both the US and the UK, show an interesting move by regulatory bodies towards a middle ground or hybrid model of regulation, which combines the best of both deterrence and compliance models.
Contemporary evolution of healthcare regulation developing across globe in the last two decades has brought positive results with better defined endpoints or goals for regulatory oversight in healthcare. India’s current approach to regulatory reform in its healthcare sector is not only following the path taken by Britain (and to some extent, the US) but also points to the fact that, we are moving towards a more responsive regulatory regime, despite differences in our respective healthcare systems (the UK provides UHC to its citizens; whereas the US spends almost $10,000-per capita on its healthcare). What we are witnessing now as changes in healthcare regulation in the form of National Medical Commission, is an evolving global phenomenon in almost all countries where mature governments understand the importance of regulation of medical education and practice in public health.
Consequently, it is pertinent for stakeholders to play their rightful part to establish an efficient regulatory system, which is goal oriented, evolves according to changing needs of our citizens and brings the nation’s healthcare from the deep depths of third-world status to a pioneering first-world status.
History And Evolution Of Medical Regulation In India
Formation of a British government in India after the first war of independence in 1857 led to initiation of several services including Indian Medical Service (IMS). The central and provincial medical services and subordinate medical services were initiated to provide medical services and improve public health. A public health commissioner and a statistical officer were also appointed to government of India. In 1869, medical departments in the three presidencies were amalgamated into a (pan) Indian medical service. A competitive examination was conducted in London to recruit people into the IMS. European officers of IMS headed military and civil medical operations in the three presidencies. However, they needed trained assistants and supporting staff such as apothecaries, compounders and dressers in their work. These European doctors came with large financial cost. This prompted the British government to look towards establishing a system of medical education in India to recruit locals.
Formation of IMS and starting of a medical college in Calcutta, followed by Bombay and Madras gave rise to a cadre of doctors called “native doctors” or the colloquial sobriquet ‘brown sahib’, which led to formation of register of practitioners, and was probably the first baby step in formation of regulatory apparatus for medical practice. Even so, the medical register of 1877 had a list of 8,000 doctors. Among them, only 450 were trained in modern medicine or allopathy and the rest were practitioners of Indic systems of medicine.
This practice of several systems of medicine (modern medicine, Ayurveda, Unani, Siddha etc) in British India did not continue for long. The discriminatory Madras Medical Registration Act of 1914 stopped registration of doctors practising any forms of indigenous or Indic medicine. Practitioners of Indic systems of medicine, who served about 90 per cent of people of the land, were reduced to untouchables of the profession by allopathic practitioners, who considered themselves as ‘seraphim illuminati’ of the day in healthcare. This colonial yoke of state sponsored discrimination against Indic systems of medicine continues even today after 70 years of independence as allopathy continues to be accorded the status of official state sponsored healthcare system.
The bright spots for modern medicine during colonial times were initiation of public health measures, vaccination and elevation of tropical diseases to a special subject/department of studies. The state took responsibility for sanitation and hygiene. Collection of vital statistics was initiated and a number of epidemiological and research studies were conducted on cholera, plague, malaria, tuberculosis and leprosy, leading to better outcomes in management.
The act number XXVII of 1933 was passed by British parliament, leading to the constitution of MCI. Through the section 2(d) of this Act, modern medicine was accorded the status of ‘official medicine’. Section 2(g) recognised only those educated in modern medicine as practitioners of medicine in British India and section 2(f) allowed licensing and entry of names in provincial medical practitioners' register of only those who had been trained in modern medicine. With this, the regulation of medical education and practice became the monopoly of MCI.
I invite the readers of this article to read pages 161 to 171 of the original Indian Medical Council Act of 1933 to understand how nothing has changed in MCI since its formation in 1933. The thought process behind it, its constitution, its composition and its modus operandi. Not surprisingly, even medical education methodology and medical practice regulation have not changed to suit the changing needs of independent India.
The Indian Medical Council Act of 1956 which came into being after repeal of IMC Act 1933 did not change anything with regards to basic structure and function of regulatory apparatus of medical education and practice. Successive governments brought in amendments several times in 1958, 1964, 1993, 2001, 2005, 2010, 2012 and 2013. Nevertheless, basic monopolistic structure of MCI remains unchallenged.
Medical Council of India After 1956 Indian Medical Council Act
This act, to be fair, provided a solid foundation for development of post graduate medical sciences in first two decades of its enactment. However, by 1990, a group of elected representatives in MCI had yielded to lobbying and quid pro quo for permissions given and inadequacies spared (by the MCI as a regulator) in private medical colleges.
Analysis of healthcare regulators globally during the same period demonstrates that elections as a means to appoint regulators to medical education and practice had fallen out of favour and had been abandoned in all countries. Ketan Desai, the MCI president, oversaw a 10-year bull run of corruption as president of the council. He was finally arrested by Central Bureau of Investigation (CBI) after multiple complaints in April 2010, and having caught red-handed accepting bribe.
MCI as regulator of medical education in India has repeatedly failed on all its mandates over the past decades. Deteriorating quality of medical education can be assessed by the fact that a fresh medical graduate today is not competent enough to manage something as simple as a straightforward, uncomplicated normal labour and other similar common issues he might face as an independent practitioner.
The less said about the quality of post graduates the better. Selection of most students in private institutions is seldom on merit, reducing overall quality of students entering medical field to become doctors. Standards of education in both undergraduate and postgraduate categories leave a lot to be desired.
Even under the watchful eyes of oversight committee set up by Supreme Court of India, you can notice that most of the members of MCI come from corporate hospital practice without any representation for public health intellectuals and patient rights groups. Medical practice regulations and policy are being ghost written by council members and elected members of MCI who come from purely commercial practice background, destroying the “social calling” which formed the very core for many of us to take up medical practice as a vocation. Corporate hospitals today are nothing but profiteering businesses run by MBAs and business leaders masquerading as doctors with zero social responsibility, thriving on business of scale and referral fees (with marketing department budgets bigger than overall salaries they pay to doctors and nurses put together). Imagine the regulations to practice under direct control of these unscrupulous corporate business leaders (not doctors anymore).
Out of 40 disciplines in modern medicine, cardiologists, cardiac surgeons, general surgeons and general medicine practitioners from corporate hospitals get maximum representation. It is as if other disciplines and academicians are non-existent or are considered incapable of contribution towards regulation of medical profession. Cut-practice or referral fee-based practice has reached such alarming proportions under MCI that, there are books written on it. Criminalisation of medical practice in India has been reported in many medical journals including international journals of repute like BMJ and Lancet. In addition to above issues, dispute resolution by MCI, with regards to complaints of medical negligence lacks credibility, as we rarely see negligent doctors being punished. As in so many spheres, concentrated monopoly of power is the underlying problem, and the safest remedy is to abolish the MCI.
The National Medical Commission (NMC) Bill
The best thing about NMC bill is that it is disbanding MCI. Here below, I relegate myself to critically analysing the NMC with suggestions for improvement to parliamentary standing committee (PSC) to which it has been referred to now.
In the current form, the NMC Bill proposes a 25-member all powerful “commission” appointed by the central government, a chairperson, a member secretary, 12 ex-officio members and 11 part-time members. Of these members, 20 will be appointed by a search committee chaired by the Cabinet Secretary. Nomination will be done for 12 ex-officio and six part-time members. Three of these will be from disciplines such as management, law, medical ethics, health research, consumer or patient rights advocacy, economics and science and technology. Only five will be elected by the registered medical practitioners from amongst themselves.
Critique: Search and selection committee for above appointments will be headed by the Cabinet Secretary. Commission apart from overseeing board functions shall also be the appellate authority with respect to decisions of the boards. The above arrangement leads to too much power in the hands of a few.
Critique: The above composition of commission and the power the central government-controlled bureaucracy wields in it, is unacceptable. According to above structure of NMC, Health and Family Welfare Ministry of the central government has absolute control over NMC and consequently on medical education and practice, converting it from earlier self-regulated monopoly of the MCI to a state-controlled monopoly of NMC now. NMC in current form looks like a subservient department of this ministry. Politicians with influence on this ministry and those who own private medical colleges can change policy to suit their needs. We may have just moved from frying pan to fire unless change in the structure and composition of NMC made to bring in checks and balances in the organisation.
Author’s recommendation: Addition of members, who are independent of influence of central government, is a must and there should be an acceptable balance of government-nominated members and independent members of NMC. In current form, all are directly or indirectly serving the central government.
Critique: In matters as important as medical education and practice which affects healthcare directly, states have no say. It is state councils that do all the hard work on the ground and it is states that run most number of medical colleges and universities. Giving adequate representation to states is a federal obligation. NMC in its present form is a failure of federal structure at the very least. Leaving NMC under total control of central government and its bureaucrats and politicians is a recipe made for disaster.
Author’s recommendation: Every state must be represented in the commission at least once in two years, in current format it happens only once in 20 years. This will increase number of members in the council from current five to 15. It also brings in federal nature of our governance to the fore and individual state's contribution to NMC is better appreciated.
Critique: MCI in its presentation before the Arvind Panagariya led-committee had asked for expanding representation of doctors in MCI by one person for every 20,000 practising doctors. In current composition of the commission, practising doctors are represented by only five members. This is brazen injustice to nearly 8 lakh practitioners of the country.
Author’s recommendation: Every 50,000 practising doctors must have a member representing them. They can be selected by lottery from medical registers of the state. That will be an addition of 11 members to commission from the current five, taking the total of independent practising doctor members of commission to 16. This will bring the most needed “checks and balances” system into the organisation of the commission. I strongly recommend a foolproof method of selection by lottery using a computer algorithm to select the practising doctor member here. Involving the biggest voluntary membership organisation of doctors, the IMA, is key to making doctors feel their contribution is valued. This will remove elitist nature of the commission and also strengthen the element of self-driven regulation most needed in practice.
Although central government wields more power in commission, increasing state representation and representation of practising doctors, who are not nominated by central or state governments, will bring more stability to the organisation and structure of the commission.
The medical advisory council is a joke with only advisory role and no powers to enforce anything at all. The PSC should work a mechanism to make it more productive than what it is proposed now.
Critique: The four autonomous boards: (a) the Under-Graduate Medical Education Board, (b) the Post-Graduate Medical Education Board, (c) the Medical Assessment and Rating Board, and (d) the Ethics and Medical Registration Board are by their very structure, made elitist, with ample room for owners of private medical colleges and corporate hospitals to manipulate as insiders. Again, the checks and balances approach, needed for foolproof functioning of these boards, is missing. The selection criteria are such that the chairmen of the boards and its members can be filled with cronies of political masters.
Author’s recommendation: Addition of two independent members into each of the boards from among the independent 16 practising doctors in the commission will change the elitist nature of these boards. Decision-making in these boards has to be on a unanimous basis and not majority. This will most certainly address the need for checks and balances in decision-making of the boards.
Critique: Equating of post-graduate degrees from medical institutions and universities with DNB from NBE is unacceptable. A conventional post-graduation with regular full-time teachers and professors is definitely superior to a DNB degree obtained from corporate hospital training or training in nursing homes. If an independent body inspects this arrangement, it will conclude that DNB students are abused and exploited by corporate hospitals and nursing homes (which are approved for the course) as cheap labour. These students join DNB because they did not get a post graduate seat in conventional teaching institutions. Ideally, NBC must take steps to increase the number of seats available for post-graduation or bring in stringent teaching and training norms to elevate DNB training to that of conventional post graduate training. Equating DNB post graduate presently with conventionally-trained post graduate is gross injustice to medical colleges, post graduate institutions and universities. Such a step will eventually lead to demise of conventional training and research, as there is no added incentive for full-time professors teaching students their trade. Post graduate training will become a casualty of corporate greed.
Will NMC and the government of India equate the training of post graduate from AIIMS/PGI to DNB training? If yes, why spend so much money on training institutions? Government of India can build corporate hospitals instead.
Author’s recommendation: Confirming with MCI standards, a DNB post graduate must complete two years of post DNB status to be considered equal to a post graduate degree from conventional medical college/university. Commission has to appreciate the difference in training of both these post graduate courses and not be influenced by corporate hospitals lobbying for DNB, looking for cheap labour.
Clause 49 sub clause (3): regarding development of specific educational modules to be introduced in under graduate or post graduate courses of different systems of medicine to allow a pluralistic approach – this needs to be studied further. Research and pilot studies must prove beyond any doubt, that such an interface between different systems will benefit patients. Until such time, the commission must not indulge in it.
Clause 49 sub clause (4): Training of AYUSH doctors with a bridge course and allowing them to practise allopathy is a foolish decision on many counts and must be abandoned. Commission has a prejudiced notion (owing to United Nations prescribed standards and also lobbying by corporate hospitals looking for cheap labour) that there is shortage of doctors in India. Shortage of doctors is mostly in rural areas while in metros and major cities, there is an oversupply.
Author’s recommendation: Abandon bridge courses. Various state governments must study and replicate Tamil Nadu model where today there is a waiting list of doctors wanting to join the rural health force, instead of experimenting on patients’ lives with bridge doctors or mini doctors as is being done now in Jharkhand. Job of the commission is to regulate medical education and practice and ensure better doctors, not to dance to the tunes of government or corporate hospital lobby looking for cheap labour.
Critique: Accreditation and rating function of Medical Assessment and Rating Board (MARB) should be out of the ambit of NMC. This was the recommendation of the parliamentary committee report in March 2016.
Author’s recommendation: It should be kept out of the ambit of NMC as earlier experience with MCI shows that this is an area prone for corruption, lobbying and rent-seeking.
Critique: Finally, chairperson of the commission must not come from corporate hospital or private medical college background at any cost. Criteria for selection of chairperson of NMC are easily met by many millionaire and billionaire doctor business leaders owning or running single or multiple hospitals and/or colleges. It is not in the interest of medical education or practice to hand over reins of commission to them.
Author’s Recommendation: Selection criteria for chairman of commission and presidents of four autonomous boards must include exclusion criteria to exclude doctors from for-profit hospitals and those closely associated with running of private medical colleges.
The author appreciates NEET and NEXT concepts brought to fruition by NMC.
Regulatory oversight in medical education and practice is evolving to suit changing needs of stakeholders and public, globally. It is our duty as stakeholders to work together to create a responsive regulator which adapts to changing needs and meets the goals set. I hope changes made in NMC by PSC it is referred to now, can bring about all these and be a model regulatory organisation.
Special note by the author: Along the way, we have completely ignored Indic and non-Western concepts of disease and discarded alternative ways of providing succour to humanity. Even today in my observation, traditional Indic medical systems prevails in primary levels of healthcare in rural areas and among urban poor, while Western medicine is more popular as people move up the social and economic ladder. Focus of Indic systems of medicine has always been on health promotion and prevention of disease (prime among them is Yoga), rather than curative bias seen in Western medical systems. Had a dialogue been successfully initiated under proper regulatory oversight and on specific outcome-based research, between these two systems, the resulting symbiotic growth and outcome might have probably got us our Nobel in medicine (traditional Chinese medicine expert “To Youyou” won Nobel for her contribution in 2015) and would have contributed to better health of people. The abject lack of communication and learning between Western systems of medicine on one hand and indigenous Indic systems of medicine on other hand has not worked well for the country. Indic systems of medicine will greatly benefit from institution of scientific temper, standardisation and quality control, improving and providing uniform educational standards along with clinical research, better curricula and peer review from doctors across the aisle from Western system of medicine. It is the government’s job to bring in necessary changes in regulatory apparatus of Indic systems of medicine to inculcate the above and let them grow. This will ensure development of a symbiotic relationship of medicine leading to mutual respect among the practitioners and the nation also will be better served. Trying shortcuts like bridge courses is reckless and unwise.
Dr Jagadish Hiremut also known as The Good Doctor is a practicing medical professional and a public healthcare intellectual. He runs a company, ‘ACE Intensive Care Services and Consulting’, which provides intensive care services at low cost to hospitals outsourcing it to his company. He consistently believes value is quality divided by cost and trusts in value-based healthcare services over cost effective healthcare services. He can be contacted on Twitter on @Kaalateetham and email, email@example.com
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