Issues Relation to Health and Human Resources ( Health): Paper2 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 cant
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
needs 1.
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 UNs 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 report 4 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 Financing 4)
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 consumers budget. It is fundamental to living and ranks
high amongst peoples 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 Indias population slips below poverty line each year because
of health-related expenses.
Utilization of health care services depends on affordability:
According to the NSSOs 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 thats what
worries us that though the intention is there, this scheme will come up
against the same logjams that any government initiative faces. Theres 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.
Its 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 havent
studied in the CBSE board.
It takes the medical councils 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 wont 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 doesnt 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 NGOGO 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) womens 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
under
NUHM. 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

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 lifethreatening 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 coexisted 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 governments
BRMS/BRHC/BSc course proposal is as follows:

proposal

regarding

the

i) Dr Meenakshi Gautam, filed a Writ Petition (Civil) in which the Honble

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 Indias 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 MCIs 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 Honble 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 superspecialists, which was possible only after an MBBS degree.
13 The MCI/GoIs 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 physicians 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
countrys 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