Issues Relation to Health and Human Resources ( Health): Paper-2 GS

Universal Healthcare

Free essential Drugs

NCHRH bill

National Urban Health Mission (NUHM)

Clinical Establishments Act

Three and a half years medical course

Generic Prescription of Drugs

Universal Healthcare

Universal Healthcare, as the term suggests, is defined as the universal guarantee of healthcare to all citizens. It implicitly affirms healthcare as a right.

The colossal scope of UHC necessitates government involvement to ensure its success. Governments do this either through legislation, mandate, or regulation.

Achieving Universal Health Care is dependent on balancing two critical factors – coverage and cost. The details of delivery and access are addressed under the broad umbrella of coverage while health economics wrestles with the tough problem of the cost and funding of the details.

For the present, coverage has precedence. Globally, healthcare delivery systems are somewhat in place even if, in many cases, rudimentary.  Yet many millions around the world go without access because they can’t afford it.

UHC models were developed internationally, to plug the gap that kept people out of the healthcare system and to satisfy the moral, ethical and economic need of progressive societies.

No one model fits all groups. Member countries are working in close collaboration with the WHO to develop indigenous versions that incorporate the local culture and better serve the local community.

What is UHC?

UHC is an evolved form of health franchise where the government guarantees equitable access to key promotive, preventive, curative and rehabilitative health interventions at affordable costs for all its citizens.

In 2005, the World Health Assembly urged its member states to work toward UHC after considering the particular macroeconomic, socio-cultural and political context of each country.

UHC is a globally recognized public health concept, goal and aspiration that varies in its details according to the population it aims to serve. Therefore, the term does not seek to define standards but expresses within it the components and characteristics of an affordable health system accessible by all. These include: people, services and needs; where people should get free and affordable medical services according to their needs1.

A concise yet comprehensive definition has been articulated by the HLEG (High Level Expert Group) report, commissioned by the Indian Government to develop a blue print for health reform. Here, UHC is defined as: “Ensuring equitable access for all Indian citizens regardless of income level, social status, gender, caste or religion, to affordable, accountable, appropriate health services of assured quality as well as public health services addressing the wider determinants of health, with the government being the guarantor and enabler, although not necessarily the only provider of health and related services.”

At the level of the consumer, UHC aims to provide the 4As (affordable, accessible, assured quality and appropriate health); whilst simultaneously guaranteeing the 3Es at the delivery platform (efficiency, effectiveness and equitable health with accountability)

Making the case for UHC:

The argument for UHC can be neatly summed under three headings: 1. Moral/ethical, 2. Economic and 3. Financial hardship

The moral/ethical question: The political and economic dialogue has spilled over into health with the oft touted question; is health a responsibility or a right; a duty or an entitlement? For those that work in the health sector and for the people who have a personal experience with illness, this question is moot. Their experience attests to the common knowledge that while responsible health behavior leads to better outcomes; that alone, in and of itself, cannot guarantee freedom from debilitating disease. Linking better health to responsible behavior is mistaking the correlative for the causative. Our bodies are biological machines. Despite the adoption of the best possible practices; there are times (the simple process of aging is itself an example) when the balance tilts to infirmity and/or disease. At that point, can a society dissociate itself from the obligation to provide the benefit of available treatment and knowhow to a large swath of its people simply because of financial considerations? Health is a right to be enjoyed by all; not a privilege to be enjoyed by a few. This is also asserted as such, by Article 25 of the UN’s Universal Declaration of Human Rights.

Economic inequity : We live in a large heterogeneous structure called society, within which actions are enmeshed and interrelated with outcomes. Health is a complex system within this framework. A healthy population is a determinant of economic and social development. Contrarily, a society wherein large numbers of people are ill or do not have access to treatment languishes from a marked waste of human potential, man-hours and productivity. The chasm in health metrics is an ever widening one, between rich and poor nations; between the haves and the have-nots. A recent WHO report4

describes the socio-economic disparity in stark numbers: A citizen of a wealthy nation can live up to 40 years longer than someone in a poor country. Of the 136 million

women who give birth annually, about 58 million (43 %) receive no medical assistance during childbirth or the postpartum period. Per capita health care spending statistics reveal more of the same, ranging from around 6000 USD in wealthy nations to 20 USD in the poorest. Traditionally, countries that have large gaps in economic equality have more difficulty transitioning from private systems to a public funded UHC. Health and economic inequity make the system lopsided and promote unstable growth with the ultimate consequence of social unrest, chaos and collapse.

Financial Hardship: In the context of health, the WHO4 defines financial catastrophe as spending that exceeds 40% of household income on health after basic costs have been met. Even for those that can afford health to some moderate extent; the potent combination of rising costs and inadequate coverage can lead to financial catastrophe in a health crisis. This is true across the spectrum of nations from the very rich to the very poor. Medical expenses are the commonest cause of bankruptcy in the US (almost 60 % of personal bankruptcy). At the other end of the scale, more than 100 million people around the world are pushed below the poverty line, annually, because of medical bills and another 150 million suffer financial hardship.

A cursory look at the graph of health care costs worldwide shows movement in only one direction – upward. Countries that have a more homogeneous, less fragmented system of paying for health are able to better contain costs. At the same time, they also provide an equitable standard of services. More than 3 billion people around the world rely on direct payment (out of pocket) to pay for medical care. High out of pocket costs invariably result in people choosing to not take treatment at all and often, women and children are the first to fall through the money gap. Health economics research has consistently proven that wherever direct payment is the dominant reimbursement method; fewer people can afford to purchase health; people with precarious financial situations teeter into poverty and/or medical bankruptcy and those that can afford to pay at the time of need, face rising costs and unaffordability at a later time. The solution to keep costs down is to increase coverage, pool funds, pool financial risk, standardize reimbursement, make it accountable and reduce direct payment to lower than 15% of total cost.

1. More than 11% suffer severe financial hardship every year, stemming from a health related cause

2. More than 5% are pushed into poverty and health bankruptcy every year. The economic and social costs of this to a society are a looming crisis

3. As populations age, and as medical advance leapfrogs us into the era of tissue engineering; people will live longer and disease will get more chronic. Chronic illness threatens the financial stability of an individual, a family and a society and is expected to absorb 70% of all healthcare

(Figures from the WHO 2010 Health Report on Health Systems Financing4)

EVOLUTION AND CRITERIA

Evolution

International accreditation of the right to health was first achieved in the Universal Human Rights charter in 1948. This position was ratified again in 1966 by the International Covenant on Economic and socio-cultural rights. These were followed by the Alma Ata Conference in 1978 that defined health, for the first time in a positive context, as ‘a state of wellbeing and not merely the absence of infirmity’. Alma Ata also captured the public health goal for nations in a Declaration, “Health for All”. It brought Comprehensive Primary Health Care (CPHC) to the center of health reform and stressed a holistic approach that integrated social development with health.

Hardly was the agenda set at Alma Ata, when a movement that shifted focus from CPHC to Selective Primary Health (SPH) took shape; first in a conference in Bellagio in 1970 and later endorsed by both the UNICEF and the World Bank. SPH rejected the holistic approach of CPHC and launched instead the GOBI program that focused on four vertical and distinct child interventions – Growth monitoring, Oral Rehydration, Breastfeeding and Immunization. In 1982; this was expanded into the GOBI-FFF to include food Supplementation, Family planning and Female literacy.

Many nations followed the lead established by the international organizations and shifted priorities accordingly. Two decades on, the consequences were visible. While there was definite improvement in these predetermined areas of interest; overall public health metrics had deteriorated and the move towards ensuring the universal right to health for populations was severely derailed. SPH had translational difficulties too. By standardizing implementation models; it ignored local sociocultural determinants of health which are important to policy success and thus, struggled to translate its goals into positive outcomes.

By 2000, many lessons had been learnt and the UN once again included the central role of the universal right to health and CPHC in the millennium development goals. In the past decade; the WHO has taken the lead in setting the public health agenda of nations with two major statements. In 2005, it passed the UHC resolution – defining UHC as the international standard for progressive reform and development in health, and in 2008, the WHO annual health report brought CPHC back to the core of its global health program. Despite these laudatory efforts, international organizations like the WHO and the UN have normative functions of setting agendas and directing efforts. On the ground, both UHC and CPHC are political processes and require political and governmental will for success.

Apart from and alongside these institutional efforts, individual nations have charted their own course towards fulfilling their responsibilities to the health of their peoples. The country experience with UHC is long and varied.

National aspirations for UHC preceded the international impetus. Nationwide health insurance was set in motion by Germany in the late nineteenth century. The UK followed this example by instituting NHS in 1911. Today, both these robustly far thinking systems continue to thrive and sustain their populations. Further, all of the OECD (save the USA) nations have followed suit and provide near total health insurance coverage, of some sort, for their populations.  At the present time; 58 countries around the world have achieved and delivered on UHC and 23 more have legally mandated it.

Criteria of coverage

What comprises the criteria of coverage? How is a country determined to have achieved UHC?

Since coverage cannot include 100% of the people for 100% of services; UHC is accepted as achieved when: 1) more than 90% of the population has insurance coverage and 2) more than 90% of the population has access to maternal skilled health workers.

UHC broadly encompasses two themes: population coverage with access to an affordable package of healthcare services and the infrastructure for delivery with an adherence to a minimum quality standard. Simple coverage of a population does not mean much unless it comes with the guarantee of quality and services. It is easier to define what constitutes population coverage than to agree on the package of services that insurance will cover and the quality of delivery. At this level; the decisions become intensely political and local and no one blanket model or system can be laid down across cultures and continents. The most that international organizations can do is lay down the norms for practice and work with national ministries to develop a health system that best suits their needs and sets them firmly on the UHC road.

Can governments of poor countries afford UHC? The general consensus and the empirical evidence say, yes. Poverty, per se, is not seen as a deterrent; contrariwise, inaccessibility to health is one of the factors contributing to poverty. A more-true deterrent to the implementation of UHC is the lack of functioning systems and/or the infrastructure that will ensure delivery and convert the program into a success. Much of the success of UHC is therefore in the domain of the political will and muscle of the government to implement true reform in infrastructure and reform. Mexico, Thailand and Chile are shining examples of success.

Health has thus moved into the purview of universal fundamental rights. The dramatic progress in treatment options (drugs, devices and procedures) has increased the potential for cure, extended lifespans and enhanced quality of life despite disability. Every individual has the right to expect to avail of the benefits of these advances in science. Health is a need, not an entitlement. Not an avoidable item in a consumer’s budget. It is fundamental to living and ranks high amongst people’s priorities for a good life and for a measure of happiness.

UNIVERSAL HEALTH COVER- INDIA

Case for UHC for India

Cost of treatment largely unaffordable: Almost 80% of urban households and 90% of rural households are estimated to find average cost of in-patient treatment to be almost half of their annual household expenditure, indicating a high degree of financial hardship. It is estimated that 3% of India’s population slips below poverty line each year because of health-related expenses.

Utilization of health care services depends on affordability: According to the NSSO’s 66th round survey of household expenditure on various goods and services, between the bottom-most decile and the highest decile of Monthly Per Capita

Expenditure (MPCE) classes, the number of people reporting the use of in-patient care in urban and rural areas increases by 2 and 3.5 times, respectively.

Significant population remains untreated: Nearly 12%–15% of reported ailments are estimated to remain untreated due to the cost of treatment being unaffordable. This number could be much higher in real time, as sensitivity to ailments is a function of the ability to avail health care.

Inequitable distribution of infrastructure: Though rural India bears three-fourths of the ailment burden, it has only one-ninth of the total number of beds and one-fourth of the number of human resource for health.

Previously, the economic challenges of being a subsistence economy may not have been conducive to adopt UHC as a policy imperative. However, with India now well on the path of economic resurgence, the time has come to actually turn UHC into reality.

Although the economic benefits of UHC may not be quantifiable, the benefits are likely to be substantial in terms of impact on GDP through increased productivity from a healthy population and the creation of employment opportunities in the health care sector.

Relevance of global experiences

International experience strongly suggests that there is no unified approach to delivering a successful UHC program. All countries need to make tradeoffs, particularly in the way pooled funds will be raised and utilized. Priorities need to be constantly revised in terms of whom and how resources will be raised from, whom and for what will the resources be utilized and the proportion of total health care costs.

Health care spend as a percentage of GDP across most nations that have achieved more than 80% coverage of population through universal health systems is 5%–12%, with exceptions such as Thailand (3.9% of GDP) and the Philippines (3.6% of GDP). To assume appropriateness of these reference points as benchmarks and take them as representatives of the typical cost burden of UHC may not be correct in the Indian scenario.

On the contrary, the efficiency of health care systems, and policies and practices adopted by nations (which in the case of India are unique and may not be comparable with other countries) define costs of health care delivered and, consequently, the extent of GDP spends on health care.

In India, the lower affordability of average citizens has led to the creation of systems and policies that are capable of delivering health care at low costs. We need to be acutely sensitive of preserving them while creating a UHC system that is sustainable at a reasonable level of spend while ensuring outcomes that are comparable globally.

Free Essential Drugs

To achieve this the ministry has sent the National List of Essential Medicines (NELD) 2011 (348 drugs which includes anti-AIDS, analgesics, anti-ulcers, anti-psychotic, sedatives, anaesthetic agents, lipid lowering agents, steroids and anti-platelet drugs) to all the states to use as reference. 

The states have also been asked to create their own lists of essential drugs keeping mind the geography and demographics of the state and the diseases that affects those places. The Centre intends to bear 75% of the costs for the state medicines.  5% of the funds will be used to purchase drugs outside the essential list. The cabinet also approved a proposal to set up a Central Procurement Agency for bulk order of drugs. A scientific committee will have to draw up the EDL list for the states. 

Right now a staggering 78% of health expenditure in India is out of pocket – one of the highest out of pocket procurement numbers in the world – and 72% of this is spent on drugs.

Measures are also being taken to devise standard treatment protocols in order to avoid unnecessary treatments.

The states will procure drugs directly from manufacturer or importer through an open tender. Companies applying for the tenders will have to have GMP compliance certificate, a no conviction certificate and should have a specified annual turnover. The drugs must carry a not-for-sale label printed on the packaging.

A district-level state-of-the-art warehouse will have to be set up by states to store the drugs and a passport driven system will move the medicines to district hospitals, CHCs and PHCs will then send the drugs to the sub centres. 

It is being made mandatory for all doctors in the public sector to prescribe generic drugs and salt names and not brands. Action will be taken against doctors found prescribing brands. 

Some states have been providing free medicines in their public health centres like Tamil Nadu and Rajasthan

The government had launched a similar program under the Jan Aushadhi scheme which looked to launch generic drug stores. Though the plan was to have 3000 stores by 2012 only 300 of them were set up. And that’s what worries us that though the intention is there, this scheme will come up against the same logjams that any government initiative faces. There’s also the issue of rampant corruption among the different players involved in this initiative be it – the doctors, pharmaceuticals or even the drug regulation body.

Doctors’ Strike: Why the NCHRH bill is not a good idea

The main reason is the decision to dissolve the Medical Council of India (MCI) and other paramedical bodies like the Nursing Council of India and the Dental Council of India and the formation of National Council for Human Resources in Health (NCHRH). The doctors fear the NCHRH will be governed by bureaucrats instead of doctors and this will lead to vested

interests. It is also likely that  it will increase red tapism and lead to harassment of doctors and their ilk. They are also opposing the implementation of the Clinical Establishment act. 

 Implications of the NCHRH being implemented are as follows:

NCHRH 2011will lead to centralization which will take away the autonomy of all the different medical institutions and councils.

The NCHRH will simply be an arm of the health department which is run by bureaucrats and will have no doctors on board.

There are no elected members in the NCHRH.

There are no provisions for professional  organisations to be part of the NCHRH

The bill fails to define modern medicine, dentistry, nursing, pharmacy and paramedics personnel.

There is no clear roadmap in the NCHRH bill  on how the NCHRH will work

There seems to be absolutely no explanation on how the funds from various institutions will be transferred to the NCHRH.

It’s actually considered misconduct for docs to take up other professions.

Some other issues pertain to medical education in the country

It has been proposed that one medical exam will be conducted for ALL medical students in the country. This will harm students who haven’t studied in the CBSE board.

It takes the medical council’s inputs on education and gives that power to the National Board of Health Education which would simply mean that education would be controlled by academicians only and not doctors

It has actually proposed a distance learning course which is extremely dangerous considering the medical profession is based on hands-on experience

 Some other issues include

The membership pattern of the NCHRH is unacceptable. Docs will be represented by state bodies instead of organisations

Candidates registered in one state won’t be able to practice in other states

 In short the IMA feel that

1. Medical education is a specified area.

2. The NCHRH is of the Government, by the Government and for the Government and doesn’t care for the health profession or education at all.

3. NCHRH will negatively affect the health education and healthcare scenario of the country.

4. There is a need for independent Councils not a centralized government one.

It looks like the NCHRH will improve healthcare and accountability the fact remains that all it will do is put more power in the hands of bureaucrats with vested interests and take away any say that people who are actually part of the medical profession – doctors, pharmacists, paramedics, dentists and nurses – have in the running of the healthcare sector. It will give the health ministry too much power and lead to a big brother-like scenario. It will also hamper medical education in the country. The trickle-down effect here will be the fact that this will make it even harder to provide healthcare to the millions in a country where out of pocket expenditure on medicine is so high.

National Urban Health Mission (NUHM)

The NUHM will meet health needs of the urban poor, particularly the slum dwellers by making available to them essential primary health care services. This will be done by investing in high-caliber health professionals, appropriate technology through PPP, and health insurance for urban poor.

NUHM will be launched with focus on slums and other urban poor. At the State level, besides the State Health Mission and State Health Society and Directorate, there would be a State Urban Health Programme Committee. At the district level, similarly there would be a District Urban Health Committee and at the city level, a Health and Sanitation Planning Committee. At the ward slum level, there will be a Slum Cluster Health and Water and Sanitation Committee. For promoting public health and cleanliness in urban slums, the Eleventh Five Year Plan will also encompass experiences of civil society organizations (CSO) working in urban slum clusters. It will seek to build a bridge of NGO–GO partnership and develop community level monitoring of resources and their rightful use. NUHM would ensure the following:

• Resources for addressing the health problems in urban areas, especially among urban poor.

• Need based city specific urban health care system to meet the diverse health needs of the urban poor and other vulnerable sections.

• Partnership with community for a more proactive involvement in planning, implementation, and monitoring of health activities. • Institutional mechanism and management systems to meet the health-related challenges of a rapidly growing urban population.

• Framework for partnerships with NGOs, charitable hospitals, and other stakeholders.

• Two-tier system of risk pooling: (i) women’s Mahila Arogya Samiti to fulfil urgent hard-cash needs for treatments; (ii) a Health Insurance Scheme for enabling urban poor to meet medical treatment needs.

NUHM would cover all cities with a population of more than 100000. It would cover slum dwellers; other marginalized urban dwellers like rickshaw pullers, street vendors, railway and bus station coolies, homeless people, street children, construction site workers, who may be in slums or on sites.

The existing Urban Health Posts and Urban Family Welfare Centres would continue underNUHM. They will be marked on a map and classified as the Urban Health Centres on the basis of their current population coverage. All the existing human resources will then be suitably reorganized and rationalized. These centres will also be considered for upgradation.

Intersectoral coordination mechanism and convergence will be planned between the Jawaharlal Nehru National Urban Renewal Mission (JNNURM) and the NUHM.

Clinical Establishments Act, 2010: Salient Features & Critical Analysis

1. The Act was enacted by the Central Govt under Article 252 of the constitution for the states of Arunachal Pradesh, Himachal Pradesh, Mizoram and Sikkim (and also for implementation in the Union Territories). Other states have a choice of implementing this legislation or enacting their own legislation on the subject.

2. The purpose of the Act is to provide for the registration and regulation of clinical establishments with a view to prescribe minimum standards of facilities and services, which may be provided by them.

3. The implementation is to be affected through a three-tier structure — the Central Council, the State Council and the District Registering Authority.

4. The act will be applicable to all clinical establishments (hospitals, maternity homes, nursing homes, dispensaries, clinics, sanatoriums or institutions by whatever name called, that offer services for diagnosis, care or treatment of patients in any recognised system of medicine (Allopathy, Homeopathy, Ayurveda, Unani or Siddha), public or private, except the establishments run by the armed forces.

5. Registration is mandatory for all clinical establishments. No person shall run a clinical establishment unless it is registered and for that the establishment has to fulfil the following conditions:

(a) The maintenance of minimum standards of facilities and services and staff, as prescribed;

(b) Maintenance of records and submission of reports and returns as prescribed;

(c) Undertaking 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 brought to any such establishment;

(d) The clinical establishment will charge the rates for each type of procedures and services within the range of rates determined and issued by the Central Govt in consultation with the State Govt;

(e) The rates charged for each type of service/facility provided shall be displayed in local and English language conspicuously;

(f) The establishment shall ensure compliance of the standard treatment guidelines as may be determined and issued by the Central or the State Govt;

(g) The establishment shall maintain and provide electronic health records (EHR) and electronic medical records (EMR) of every patient as may be prescribed by the Central or the State Govt;

(h) Every establishment shall maintain information and statistics in respect of all other applicable laws and rules, thereunder.

6. It prescribes Procedure for Registration and punishment for offence.

Critical Analysis

1. The old Acts for registration of hospitals / nursing homes in nine states (mentioned in the Schedule to the Act), make the registration mandatory only for the hospitals and nursing homes (not for the clinics, dispensaries or laboratories) to get registered with the state health authorities. Further, it was applicable only to the Allopathic establishments. Ayurveda, Unani, Siddha or Homeopathy establishments were not covered by them.

The new Central Act is a blanket legislation making it mandatory for all establishments — hospitals, nursing homes, private clinics, laboratories, blood banks, imaging centres etc, of all systems of medicine (including Homeopathy, Ayurveda, Unani, Siddha) public or private, to get registered by a common single Registering Authority called the District Registering Authority.

It, however, exempts the establishments run by the Defence services from registration, for reasons not known.

If some of the states are allowed to continue with their old legislations, then the private clinics / laboratories / imaging centres of all systems and hospitals / dispensaries of non-allopathic systems in those states will not be required to be registered in those states. This will defeat the purpose and will not be a desirable situation.

2. The Central and State Councils include the members from non-allopathic systems also (for dealing with non-allopathic establishments) but representation of non-allopathic systems is not mentioned in the District Registering Authority.

3. Conformity to the Standards: It will take time to lay down the standards for so many different types of establishments pertaining to different systems of medicine.

Meeting the prescribed standards will have cost implications, which is one of the reasons for resistance by private clinics. Fear of inspector raj and undue harassment is another factor.

Monitoring the compliance with standards by hundreds of thousands of establishments will require an army of officials. It will be difficult to ensure implementation of standards, which is known to be our weakest point. We enact beautiful legislations but they remain mostly on paper because we are very poor in enforcement of legislations.

4. Schedule of Charges for Services to be decided by the State: This is a provision, which may not be palatable to the clinical establishments at all. The state cannot and should not dictate the fees for various services/procedures. Even while conforming to the prescribed minimum standards, there may be a lot of difference between the standard of facilities and expertise provided by the establishments, catering to the different locations, clients, standards / tastes / expectations and paying capacity of clients. Every clinical establishment should have the right to determine the charges for the services provided by it. Government should not try to regulate the charges for services.

5. Standard Treatment Guidelines issued by the Central Govt: The standard treatment protocols, in principle, are a good idea as it helps ensure certain basic standards of treatment. But they can be acceptable only as long as they are limited to broad principles, life threatening emergencies (CPR, anaphylactic shock, poisoning, treatment of snake bite etc) or treatment of major public health problems (such as AIDS, malaria, pulmonary tuberculosis). Physicians should have adequate freedom to decide as per their learning and experience, which modality of treatment to use in which situation in broad compliance with the protocols practiced by the professional community nationally and internationally.

6. Maintenance of EHR and EMR of every patient as may be determined and issued by the Central or State Govt. It is a good idea, in principle, but a requirement, which is likely to be resented by the private clinics because of the added cost (of the system, software and the salary of the computer operator) as well as additional workload for busy clinicians. Besides, a large percentage of the physicians, especially those of the ISM (Indian Systems of Medicine), may not be computer savvy at all.

7. Fear of Scrutiny: What is perhaps worrying the physicians more is the fear of scrutiny and exposure of their professional inadequacies, shortcuts, poor facilities, and mistakes as well as the harassment caused by the inspecting officials. So far hundreds of thousands of private clinics, even nursing homes, have been operating all over the country, unknown and hence not subject to any scrutiny / inspection / questioning by anyone. Since they are not known or registered, there is no check over their facilities or standards and many of them go on giving care and treatment of dubious quality, often in utter disregard of the rules and regulations. Their fear is that once registered, they would no more be able to hide from the legal and professional scrutiny.

8. Publishing the particulars of the clinical establishment for public comments / objections / observations, after grant of provisional certificate, does not appear to be a sound idea. It is not clear what purpose will it serve. Firstly, the public will have no clue about the technical aspects / standards of the hospital especially in case of the establishments newly commissioned. Secondly, the local community or the rival establishments are unlikely to come forward with any meaningful comments.

Yes, periodic feedback / comments from public about the quality of services provided by the establishments can be important in case of establishments already registered permanently because their renewal will be due after five long years.

9. Cancellation of Registration (Clause 32): Cancellation of registration in case of private clinics, diagnostic labs, nursing homes etc may be possible but in case of hospitals it may not be a practically feasible idea in view of a large number of patients admitted at different stages of treatment. In case of repeated violations and reckless disregard for the safety of patients, exemplary penalties, to the tune of a yearly profit amount and/or imprisonment for the trustees/CEO/COO (if found negligent), may be more practical.

10. Treatment of Emergency cases —Life-saving treatment in the case of life-threatening emergencies has always been and will always remain the prime duty of every doctor, wherever, in whatever position or location. Shirking this responsibility or refusal to render necessary assistance in timely transportation of patient will be viewed as medical negligence liable to punishment.

However, non-payment of medical bills of treatment of emergency cases is a point of serious and genuine concern of the medical community. The Act is silent on this aspect. The authorities concerned must redress the grievance to the satisfaction of medical professionals by putting in place a mechanism of ensuring problem free reimbursement of bills. The liability may be borne by the insurance agencies or by the government itself.

11. Plus Points of the Act:

In spite of the lacunae mentioned above, the Act is a positive development, the need for which was being felt since long. If it is implemented in all the states in the form, broadly in line with the Central Act and Rules,

(a) It would act as the first ever factual census of the number, category, speciality and location of all the physicians and all the medical establishments of all the systems of medicine in the country. That would be a great achievement as it would be a great help in the countrywide planning and posting of physicians as well as healthcare establishments. Up to now the authorities do not know exactly how many of what category are available in which area.

(b) Registration without any inquiry or inspection, on the basis of the documents submitted by the establishment, should be encouraging for many nursing homes / private clinics to come forward and get registered. This may be the biggest plus point of the Act.

(c) It will also help isolate and identify the hundreds of thousands of quacks that are playing havoc with the lives of millions of people all over the country.

(d) Once in place, the system of registration will necessarily help in improving the standards of healthcare establishments within a couple of years. It will also bring about some uniformity in the standards of care across the country.

The Clinical Establishments (Registration and Regulation) Act, 2010 is, perhaps, the most important public health legislation enacted so far with far reaching effects. For maximum benefits and uniform effects, ideally the Central Act should have been made applicable in all the states and union territories. However, being a state subject, that is not possible. Since most of the states would be enacting their own legislations, there will be some variation in the provisions from state to state. But the important aspect is the speed of enactment and enforcement of legislation in the states. There should be no delays on any account. For its successful implementation, it would be prudent that the lacunae are addressed and removed and the legislations made more acceptable to the medical community. It is also expected that the medical professionals rise above the individual interests and think of larger public as well as professional interests.

Three and Half year Medical course

What are your views about the three and a half years medical course?

Answer:

1 — A three and a half years medical course is not something that is new or never existed or cannot exist. As a matter of fact, a large number of courses, basically similar, were offered by various universities and medical colleges in India and these were immensely popular and useful and served the backbone of modern medical care to the masses. Titles of seven such courses, listed in schedule 3, part 1 of the Indian Medical Council (IMC) Act, 1956, are listed below:

i) DMMS — Diploma in Modern Medicine and Surgery (Orissa)

ii) DMS — Diploma in Medicine and Surgery (Madras, Indore)

iii) LCPS — Licentiate of College of Physicians and Surgeons (Bombay)

iv) LMF — Licentiate of Medical Faculty

v) LMP — Licentiate Medical Practitioner

vi) LMS — Licentiate of Medicine and Surgery

vii) LSMF — Licentiate of State Medical Faculty

2 — The erstwhile LSMF (Licentiate of State Medical Faculty) course co-existed with the MBBS course till 1956. Both degree holders having LSMF or MBBS degrees were registered with the state medical council. Both were recognised medical qualifications in the IMC Act, 1956.

3 — However, the government took a decision to stop the licentiate courses mentioned above. The result was that we have no licentiates in modern medicine today. Unfortunately, they have been replaced by quacks of all sorts, including those not registered with the medical council but still practicing allopathy.

4 — The logical and common sense answer to the twin problems of quackery and shortage of doctors in rural areas is to re-introduce a short-term medical course, which would be duly registered by the medical council. This is exactly what the government wanted by introducing the course known as BRMS (Bachelor of Rural Medicine and Surgery). It was recommended by health planners and experts including professors of AIIMS (All India Institute of Medical Sciences, New Delhi).

5 — The background of the government’s proposal regarding the BRMS/BRHC/BSc course proposal is as follows:

i) — Dr Meenakshi Gautam, filed a Writ Petition (Civil) in which the Hon’ble Delhi High Court had given order to the Medical Council of India (MCI) two months’ time to finalize the curriculum and syllabus of the 3.5 year Primary Healthcare Practitioner Course, the

implementation of the introduction of which was approved by the Union of India. The course was named ‘Bachelor of Rural Health Care (BRHC)’. A further period of two months was given to the Ministry of Health and Family Welfare for the enforcement of the same. Thus, BRHC should have been introduced by March 2011 as per the timelines stipulated by the Court in its order.

ii) — The facts behind the writ are as follows:

a) — The existing healthcare systems are entrenched with inequalities and unable to meet the needs of the people. The main source of professional primary healthcare in rural areas is through the network of Primary Health Centres (PHCs). However, these are very few and far between. Many of the remote PHCs do not have doctors in position. On the demand side, people living in India’s roughly 600,000 villages need a well-trained health provider within easy walking distance who is available 24 hours and who can take care of the bulk of common illnesses and who can provide first aid in emergencies, and who can identify and refer complicated cases in a timely manner. In the absence of trained primary health providers, this care at first contact is currently delivered by quacks.

b) — The National Health Policy, 2002 made several recommendations including a cadre of licentiates of medical practice.

c) — In the high-level 9th Conference of Central Council of Health and Family Welfare chaired by the Union Health Minister, where all state health ministers and officials participated, the resolution was passed that all states should introduce a 3-year diploma course in Medicine and Public Health in order to provide manpower to address rural healthcare needs, on the lines of Chhattisgarh and Assam legislations

On 13.11.2007, it was resolved in this Conference that “All State Govts bring out an enabling legislation… so as to introduce a 3-year diploma course in Medicine and Public Health in order to provide manpower to address rural healthcare needs.

d) — In 2007 a Task Force appointed by the Ministry of Health and Family Welfare, Medical Education Reforms for National Rural Health Mission, recommended the introduction of the 3-year Rural Practitioner Course to fill the vacuum of healthcare providers in rural areas. However, all these proposals had run into opposition from vested interests and in particular MCI. This is despite the fact that MCI’s own sub-committee in 1999 had noted that the existing system of medical education has “utterly failed” the health needs of the majority population in our country.

e) — There is ample evidence of different types of models of mid-level cadres from many countries, including both nursing as well as non-nursing types of models of mid-level practitioners. These include: Health Assistants and Community Medical Assistants in Nepal; Clinical Officers and Assistant Medical Officers in 47 sub-Saharan African countries; Health Officers and Health Assistants in the Western Pacific Region etc.

iii) — Thus, the petition was filed seeking directions to the Government from the Hon’ble Court to introduce a short-term course for training mid-level health workers for primary healthcare in rural areas and then license and regulate graduates of the said course.

iv) — The course was delayed and the petitioner filed a contempt petition in the Delhi High Court. It is still pending. In their reply, the government informed the court that delay occurred because MCI had declined to be involved in this course due to certain legal issues and that the government had now got the NBE (National Board of Examination) to help in place of the MCI. The government has given an undertaking to the court that the course will be started in the forthcoming session, which means July 2013.

6 — Where the government goofed was this:

i) — The course was named as BRMS (Bachelor of Rural Medicine and Surgery), giving a handle to the critics by raising the human rights issue, saying that rural people are not inferior to be catered by less qualified persons.

ii) — There was unnecessary emphasis on restricting the graduates of the short-term medical course to rural areas for 10 years after graduation. Such an approach was wrong for the following reasons:

a) — A person competent to treat patients in a rural area cannot become incompetent to treat patients in an urban area.

b) — Nobody can be ordered to stay put in a rural area for 10 years if he wants to come to an urban area. If he translocates to an urban area, his rights under Article 21 of the Constitution cannot be curbed.

7 — What the government should have done was to revive the erstwhile DMMS (Diploma in Modern Medicine and Surgery). Such persons, produced in large numbers, would be an asset because:

i) — They would be real grassroots physicians / GPs (General Practitioners) working in the community, especially rural, remote and slum areas.

ii) — They would be duly licenced in terms of the IMC Act, 1956, and hence no laws would be broken.

iii) — They would continue to be GPs because, not being MBBS, they would not be able to take the MD route or the migration abroad route.

iv) — They would not compete with MBBS doctors but might work under them or as assistants to them.

v) — They would be an effective antidote against quacks.

vi) — They would provide cheap and reliable medical care to the poor people who cannot afford to go to MBBS/MD doctors.

8 — Also, the government should not have tagged the course to service in the PHCs as CHO (Community Health Officer). A bond of say, Rs 2.5 lakh could have been fixed on the payment of which the graduates would be free to practice in the community or get a job.

9 — It is unfortunate that the IMA (Indian Medical Association) decided to oppose the above course. It is surprising why MBBS doctors should feel threatened by short-term course doctors. Such short-term doctors would any day be better and preferable to quacks, including AYUSH quacks.

10 — The government further goofed up in the following manner:

i) — It should have taken the R out of BRMS and named the course as BMS. This would have taken care of the objection related to “treating the villagers as second class citizens”. It should have removed the restriction about compulsory rural service for 10 years. Further, preferably, it should have named the course as DMS (Diploma in Medicine and Surgery) to cause even less irritation to the IMA. The IMA would not have objected to a DMS/DMMS course.

ii) — It renamed the course as BSc (Community Health). This was an unwise move, which immediately invited the objection that a BSc course cannot be a medical course and no arrangement had been announced by the government as to by which regulatory and registering council would such a course be supervised.

11 — Those MBBS doctors who criticise the course say that the proposed course is a ploy on the part of the authorities concerned to make money by granting recognition to short-term course colleges in an underhand manner. Such apprehension is unrealistic. It seems the government plans to conduct this course in government institutions and not private institutions. There is no question of underhand dealing / recognition in respect of government colleges unlike private colleges.

12 — There is no evidence that the short-term medical courses listed above had any disadvantages. The doctors having the above degrees were very effective as medical care providers to the general public. They acted as real GPs because they did not look forward to become specialists and super-specialists, which was possible only after an MBBS degree.

13 — The MCI/GoI’s decision to abolish the short-term medical courses was not a sound idea for the following reasons:

i) — LSMF doctors were rooted in the community, including rural areas. They worked as real GPs. They never boasted about themselves and never competed with MBBS doctors. Even the public knew the difference between an LSMF and an MBBS.

ii) — They were destined to remain life long GPs because they could not get an MD specialist degree without an MBBS degree. This was good for the community because the public needs more GPs, not more specialists.

iii) — They tended to work in rural areas because they knew and acknowledged that an MBBS was superior to them. Most of them preferred not to compete with MBBS and MD doctors.

14 — There is no reason why a short-term medical course, which was useful 50 years ago should not be useful today, especially when the trend even in the West is to have nurse practitioners discharge some basic medical care.

15 — Summary and Conclusions:

i) — The government should revive the short-term medical courses that existed earlier. The proper name for such a course would be DMMS. The revival would not need any legal backing because the IMC Act, 1956, already provides for such courses.

ii) — The government should not have the following names:

a) BRMS — This artificially differentiates between rural/urban medicine and practitioners of medicine.

b) BRHC — This is not a medical course name and hence cannot entitle a person to be registered with a medical council.

c) BSc — This is a strict no-no. A BSc (Community Health) cannot be given the responsibilities carried out by a physician.

iii) — The IMA should welcome a DMMS course and should not oppose it.

iv) — A large number of DMMS graduates means that much reduction in AYUSH quackery.

v) — Graduates of this course should be on a bond to serve in the PHCs for 10 years, failing which they should pay up the bond amount to the government.

vi) — The introduction of the short-term course will, from the point of view of the modern medicine graduates, have the following beneficial effects:

a) It will markedly reduce quackery (including quackery in the nature of allopathic practice by AYUSH graduates).

b) It might lead to a situation when AYUSH colleges either close down (like the MBA courses/colleges nowadays) or convert into BRHC colleges.

c) It will lead to the creation of a large number of new jobs for modern medicine graduates who will be needed as faculty in the BRHC colleges.

d) It will raise the status of MBBS, which has been currently reduced to the lowest degree in the medical/health field. With BRHC in place, MBBS doctors may as well act as referral doctors for patients referred by BRHC graduates.

e) When BRHC graduates are in place, the need for obligatory rural service for MBBS doctors would decrease.

f) When the BRHC graduates are in place, MBBS doctors posted in rural areas will not find that they are left to fend for themselves with no staff, equipment and facilities in remote areas. It is natural that equipment and facilities will have to improve with BRHC graduates in place. In other words, service in remote and rural areas will be less of an ordeal for MBBS doctors.

g) MBBS doctors having nursing homes will be able to employ BRHC graduates without any problem instead of employing AYUSH graduates which is illegal in terms of the NCDRC

(National Consumer Disputes Redressal Commission) decision in Prof P N Thakur Vs Hans Charitable Hospital (16 August 2007).

Generic Prescription of Drugs – Need of the Hour

A generic drug (generic drugs, short: generics) is a drug defined as "a drug product that is comparable to brand/reference listed drug product in dosage form, strength, route of administration, quality and performance characteristics, and intended use." It has also been defined as a term referring to any drug marketed under its chemical name without advertising.

Use of generic name is strongly recommended versus brand name in the prescription because:

1. Generic medicine is cheaper than the same brand named medicine. Medical bills are likely to see a drop as the government plans to make it mandatory for doctors to prescribe low-cost generic medicines.

2. It favours pharmacists to keep limited stock of medicines.

3. It means that physician does not show inclination towards a particular brand of medicine.

4. Generic name remains the same in all countries, so if patients visit another country or state, it is easier to know the drug as compared to brand name where it is different. So, the use of generic name eliminates confusion among healthcare professionals and public.

Domestic market for generic drugs is small in India because:

1. Brand names are brief, catchy, though often misleading. They need not be remembered. Sales agents drum them into the physician’s ears constantly.

2. Prescribing by brand names carries rewards from the pharmaceutical companies in various forms.

3. There is no punishment for using brand names in place of generic names. Likewise, there is no reward for prescribing by generic names.

4. It is easy to confuse a patient into thinking that a new and better medicine is being prescribed when, in fact, only the brand is changed.

5.  Generic drugs are cheaper and hence their use is less beneficial for all concerned, except for the patient who has to make the payment.

Disadvantages of prescribing by brand names are as follows:

1. Brand drugs are more costly.

2. Brand drugs produced by shady companies are likely to be spurious or of low quality yet some doctors are prone to prescribe them.

3. Brand names can be similar and confusing. It is not uncommon for the same generic drug to have 30, 40 or even 100 brand names from different companies. Confusion can lead to prescription errors (wrong drug being prescribed or supplied by the chemist or the dispenser). Prescription errors are a well-known cause of risk to patient.

4. Brand drugs are often undesirable combinations of two or more generic drugs. It is a safer and better medical practice to minimise the use of combination drugs.

Challenges in promoting generic drugs:

1. Lack of uniformity in quality and bioequivalence.

2. Lack of uniformity in supply of same generic drugs every time.

3. Unethical syndicate existing between drug manufacturers, drug inspectors, chemists, medical representatives and doctors to promote branded drugs and irrational fixed dose combinations (FDC).

4. Inflated maximum retail price (MRP) on the labels of the generic drugs.

5. Substitution of generic drug is not advisable in –

a) Medications with a narrow therapeutic index (Warfarin, Digoxin);

b) When the consumer has a negative attitude to substitution.

6. Lack of awareness among healthcare professionals.

7. Lack of implementation of quality control norms.

8. For fixed dose combination (FDC) drugs it is difficult to write various ingredients with amount in the prescription.

Branded drugs are costly due to following reasons:

1. Expenditure incurred in the research and development of innovator (new molecule) drug.

2. Marketing expenses.

3. Stringent manufacturing quality control (i.e. batch to batch uniformity).

Promotion of generic drugs:

Generic drugs are cheaper and should be promoted initially in the government hospitals and later on should be applied to the whole country step by step by reconstructing and improving our drug policy.

Quality Assurance of Drugs in Govt Hospitals:

Establishment of separate department (Gujarat Medical Service Corporation) for the procurement, testing, storage and distribution of human drugs, medicines, surgical and sutures, kits, reagents to the government medical institutions of the state.

Gujarat Medical Service Corporation (GMSC), Tamil Nadu Medical Service Corporation (TNMSC) and Rajasthan Medical Service Corporation (RMSC) follow strict quality standards in the supply of drugs and medicines being issued to the common public through various government hospitals.

1. Open tender for drug procurement from manufacturing companies with “good manufacturing practices” compliance certificate with specific annual turnover.

2. Every batch of drugs and medicines supplied is kept under quarantine and is tested at the initial supply stage through empanelled laboratories.

3. Random samples are drawn from every warehouse where the batch has been supplied. Batch-wise drug sample de-coding is done through strict confidential system.

4. De-coded samples are sent for quality checking randomly to any of the empanelled laboratories, which are located throughout the country.

5. On the receipt of “Quality Passed” certificate from an empanelled laboratory that batch is “Released” for distribution of drugs to government hospitals.

6. During the shelf life of drugs, random samples are periodically drawn from the warehouse and quality is checked to ensure that the drug is of standard quality up till the date of expiry.

7. Randomly picked control samples are sent to government laboratories as well as to empanelled laboratories for analysis to compare the accuracy and correctness of testing quality of the empanelled laboratories.

8. If any drug batch subsequently fails in quality on testing in the empanelled laboratories or in the government labs the remaining stock in the warehouse is frozen, the unused hospital stock of the drug of failed batch is recalled to the warehouse and returned to the supplier.

9. If three batches of any drug fail during the tender period either at the time of initial receipt or during the shelf life of the drug the product is blacklisted for five years.

10. If the supplier supplied more than one item and 50% of such items during the relevant tender period fail, then the suppler is blacklisted for five years.

11. Information of failed batches and blacklisted companies should be put up on the Internet.

The Central Government needs to concentrate on the following points to promote generic drugs in the country:

1. Generic drug manufacturers must demonstrate that a drug is bioequivalent to a reference drug product.

2. New Drug Pricing Mechanism and formula by New Drug Price Control Order (DPCO) for essential medicines approved by the “empowered group of ministers” (EGoM) under review by the department of pharmaceuticals in the ministry of chemicals and fertilizers.

3. Updating the “Standard Treatment Guidelines” (STG) followed by updating “Indian Drug Formulary” for the country.

4. Generic drug information services for healthcare persons and public.

5. Public awareness that generic medicines are manufactured according to the same quality standards as all other medicines. Many people doubt about the efficacy of generic medicines because generic drugs are cheaper than their branded versions. They wonder if the quality and effectiveness have been compromised to make the less expensive products. Public education is also required about the clinical trials: initial cost – patent – expiry of patent – production of the same drug by original name – competition – still cheaper.

6. In case of an emergency (Swine Flu – Oseltamivir) or very costly medicine (Example, “Sorafenib tosylate”, brand name is Nexavar, a drug used in advanced kidney and liver cancer, by Bayer (priced at Rs 2.8 lakh per patient per month). A “Compulsory Licence” (CL) is issued by the Government to authorise procurement, import, manufacture and marketing of an affordable generic version of an expensive patented medicine on the payment of a royalty to the patent holder. This is done to make medicines affordable. In 2011, Natco Pharma started the CL proceedings by applying first for a voluntary licence from Bayer and then following it up with an application before the Patent Controller. Offering to market the drug at Rs 8,800 per person per month, Natco received the first CL in March 2012, against the payment to Bayer of 6% royalty on sales.

Government hospitals of various states are needed to concentrate on the following points to promote generic drugs:

1. Formulating standard treatment guidelines of the state (on the basis of the country’s STG) followed by finalizing the State Drug Formulary.

2. Formulating standard treatment guidelines for all tertiary care hospitals of the state followed by formation of the Hospital Drug Formulary.

3. Manufacturing generic drugs for the state or the country by the government following “Good Manufacturing Practice” guidelines.

4. Swift and secure delivery of generic drugs in the hospital.

5. Every doctor in a government hospital should prescribe medicines with generic names and shall ensure that there is a rational prescription and use of medicines. [Rule 1.5 of Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002].

6. State governments should open low cost generic medicine medical stores — “Jan Aushadhi” — stores in every government hospital to provide low cost good quality generic medicines to patients.

7. In the 12th Five Year Plan, Rs 13,000 crore is already allotted to purchase generic medicines for government hospitals in states in which 75 per cent of the money will be given in the form of central grant. To get this 75 per cent grant, the state government should have to prepare its own Standard Treatment Guidelines and State Drug Formulary.

Physicians not working in government hospitals should have the freedom to prescribe generic or brand-name drugs until the government make strict laws to promote generic medicines.

Name: Arjun Bopanna