The Dismal State Of Health Care In India

The Dismal State Of Health Care In India

By Graham Peebles

29 November, 2013
Countercurrents.org

To speak of growth is to allude to one thing only: economic development, GDP and GNP figures, which of course should be increasing for the world to stay on track to become a global shopping emporium. The word has been confiscated by the economically erudite and the political ideologues. Monthly statistics are chanted, mantra like, by the politically aligned media, ignored by most and washed away with the residue. They are of no consequence to the majority trying to meet the basic requirements of living and are issued along with other contemporary anxiety stimulants: deficit, austerity and debt to name but three of the more popular narcotics of control.

India has recorded two delightful decades of around 9% ‘growth’, which has produced umpteen rupee resplendent billionaires who live in decadent luxury in the cities. Along with the government, which is seduced by all things corporate, they turn a comfortable blind eye to the hundreds of millions living in rural poverty and those in slums on the other side of town, where children play beside open sewage, where there are no functioning toilets or latrines: where child malnutrition is rife and where there are no health care facilities worthy of the name. The billionaires sit aloft a hierarchy of corporate wealth and power: they tower over the lesser millionaires (in 2012 there were 152,750 US $ millionaires); and see in the far distance the desperately upwardly that form a gaggle called the ‘new middle class’.

This group of city dwellers has benefited greatly from twenty years of market liberalization and government reforms, which have shifted support from the needy to the corporate greedy, resulting in increased levels of rural poverty and a multitude of suffering. The United Nations Human Development Index (UNHDI), which “represents a push for a broader definition of wellbeing and provides a composite measure of three basic dimensions of human development: health, education and income”, paints a vivid picture of Indian life after years of economic flowering. India comes in 136th out of 187 countries. Factor in inequality – “in each dimension of the HDI” plus gender inequality (considering the disadvantages facing women and girls), and India plummets even further down the table.

So, following P.Sainath’s noble lead, one asks who is this growth for? Not the poor, the marginalized and dispossessed, the Dalit’s (untouchables) or Adivasi (indigenous) people, the smallholder farmers, children and certainly not women.

Inequality and illness

The inequities in health care provision represent the extreme levels of inequality and social injustice pervading the country, as The Lancet makes clear, “mainly because of insufficient government funding for health.” Although the urban population continues to grow (currently thought to be around 377 million), by most estimates 75% of the population – (a staggering 900 million people) live in rural areas, where health-care is universally appalling. It is here in relation to health, disease and mortality that statistics have meaning to the people. According to the World Health Organisation (WHO), India as a whole accounts “for 21% of the worlds global burden of disease”: as a % this is greater than the population ratio. The 21% is concentrated in rural areas where diseases lead to huge numbers of deaths that, correctly diagnosed and given access to treatment, are preventable. It is thought e.g. that over 2 million deaths occurred in 2008 due to preventable causes, such as diarrhea, dengue, measles, typhoid and malaria. The middle and upper classes seduced as they are by multi-national western exports of fast food, cigarettes and alcohol have seen stark increases in obesity-related illnesses like diabetes and cardiovascular problems, records Health India.

Mahatma Gandhi believed the soul and spirit of India rested in its village communities. He said: “The true India is to be found not in its few cities but in its seven hundred thousand villages. If the villages perish, India will perish too.” Neglected and ignored rural communities are indeed perishing:

Adivasi people, who have lived on the land for generations, are being displaced in their millions as mining companies move in to extract the bauxite, iron-ore and tin. Trapped into debt and crushed by the corporate take-over of the countryside, smallholder farmers, of which there are an estimated 120 million (down 9 million since 2001), are committing suicide at the unimaginable rate of two every hour. Huge infrastructure projects are underway throughout the country, the waterways are being swiftly privatized and millions of villagers, with no access to adequate health care, are dying. One imagines the ‘Father of the Nation’ would be ashamed, as the current government should be.

Within rural areas there is a dire lack of health care resources; human and material, including medicines as well as properly equipped Primary Health care centres (PHCs), which are the main state run facility. Although India is said to have a Universal health care system administered by the various states, who have as their “primary duty” as stated in the constitution the “raising the level of nutrition and the standard of living of its people and the improvement of public health”, up to 60% of the population do not have access to adequate health care provision.

The conurbations, (with just 25%/30% of the population), have four times more doctors and three times more nurses than the PHCs in rural India; this means that of the latter almost 10% have no medical staff at all, 40% are without lab technicians and almost 20% lack a resident qualified pharmacist. The results of this dearth of medical support is (and here are some more statistics that matter) that 50% of all villagers have no access at all to allopathic healthcare providers, 10% of all babies die before their first birthday and 50% of all rural babies are likely to be permanently stunted for want of proper nutrition [according to Health India].

Water and Waste

Limited access to safe drinking water coupled with non-existent sanitation in rural India (and city slums) is a major factor in the spread of parasitic and bacterial infections, causing disease and malnutrition. Over a third of people living in villages have no access to toilets, while 50% of the population defecate in the open, added to which UNICEF, finds that “44% of mothers are disposing of their children’s faeces in the open”, resulting in “a very high risk of microbial contamination (bacteria, viruses, amoeba) of water which causes diarrhoea in children”, which is the primary cause of childhood mortality. Within rural families they found that only 11% “dispose of child stools safely”, whilst “80 % are left in the open or thrown into the garbage”, and shockingly, “only 6% of rural children less than five years of age use toilets”.

Drinking water is another major source of disease, and whilst UNICEF makes clear that access to safe sources of drinking water has improved, (from 68% in 1990 to 88% in 2008), with under a quarter of slums dwellers having access to this most rudimentary of needs, inequality poisons even their most basic human right. The problem is made worse, they say, by falling levels of groundwater, groundwater pollution and the widespread natural occurrence of “arsenic and fluoride in the groundwater”, which pose a major health threat. Proper sanitation methods and clean drinking water are not an issue of concern within the high-rise middle class city developments, or the gated communities in Delhi and Mumbai: they have toilets, bidets and Evian, or some such. It is the 75% that are left without health care, with restricted access to safe drinking water and no sanitation facilities. Where has the 9% growth gone?

The divide between the tiny percentage that have benefitted from economic development and market liberalization, and the vast majority that have been condemned to a life of extreme poverty and illness, is approaching cosmic proportions. Most people live in rural areas, but the beneficiaries of growth have primarily been city residents, where wealth is concentrated in the coffers of a handful of men. It is said that the 100 richest Indians own wealth equivalent to 25% of the national GDP (Annual GDP $1.84 trillion 2012), and, whilst Mukesh Ambani the chairman of Reliance Industries earns $18 million a year two-thirds of the population (according to the World Bank), lives on less than $2 a day. The 9% begins to rise to the divisive surface.

Two decades of economic growth have granted great benefits to the Ambani’s of India, but no improvements to the lives of rural people, and in particular have effected no change to health provision. Child malnutrition for example, which at 48% (UNICEF) is the highest in the world, fell by just 1% in the years since 2001.

Gender inequality compounds the economic and social divisions in the country. The treatment endured by women is universally appalling across a range of areas. Rape, (although barely reported-there is little point when cases take years to process), is endemic, female infanticide is widespread (12 million girls were aborted during the last two decades according to the United Nations UN), dowry killings commonplace: a trinity of abuse at the top of a list of mistreatment suffered by Indian women (specifically but not exclusively poor women). Add to this poor maternal health, causing 57,000 maternal deaths in 2010 (one mother dying every ten minutes, most of which occurred in rural areas), making India home “to the greatest burden of maternal, newborn and child deaths in the world”, (the WHO report). Forced marriage, although illegal is commonplace causing almost 50% of Indian women to (reluctantly) marry before they reach 18, resulting in early pregnancies, high morbidity and mortality rates, to say nothing of the unrecorded levels of depression and anxiety. Poor health care provision for women sits within a broader, horrific picture of gender inequality and prejudice, state neglect and female suffering. Collectively, according to a recent study by TrustLaw, they make India, the worst country for a woman to live out of the G20 nations, one place below Saudi Arabia.

Private Public

Health care is offered by public and private providers: with the public Primary health care centers (PHCs) understaffed and under-resourced with restrictive opening times, as well as long waiting times and in many cases sited miles from villages, the majority of visits (92%) are made to private centers. Around 70 % of private visits are made by city dwellers. They pay for their care by making ‘out of pocket’ payments, i.e. not covered by health insurance, which, The Guardian reports, only 11% of the population possess. The private sector has the monopoly on medical staff and materials, with, according to Government figures, 80% of all doctors, 26% of nurses, 49% of beds and 78% of ambulatory services working for the corporate boys. Care is expensive (up to nine times the cost of PHCs), and consistent with corporate irresponsibility, (sanctioned by government neglect and weakness); according to Gram Vaani it is “often unregulated and variable in quality. Besides being unreliable for the illiterate, it is also unaffordable by low income rural folks”.

With 9% growth for two decades one would expect a major level of government investment into health and education, however this is far from the case. Spending on public health care according to the WHO is 1.1% of GDP, placing India below Pakistan, China and Nigeria in the spending table. Cash (or out of pocket) payments are increasing (up to 80%) amongst those who have the money, but for the majority health care is an unaffordable luxury. In a country with more people living in poverty than all Sub-Saharan African countries combined, an additional 40 million a year are estimated to be forced into destitution by medical costs. So where has the growth gone; who is it for: who has benefitted from the ‘economic miracle’? The middle class have become rich; the rich have become super rich: the super rich stellar rich. This tiny group of city beneficiaries have as Arundhati Roy puts it, “ascended into outer space from where they look down at the indigenous people and the poor.” And as for the poor: their numbers have grown, their land has been stolen from them, their problems increased: they have been condemned to a life of illness, exploitation and suffering. And their voices are ignored.

Delivery deferred - The Hindu

Delivery deferred - The Hindu

‘A year on, no progress on PM’s I-Day promise of free medicines’ | Business Line

‘A year on, no progress on PM’s I-Day promise of free medicines’ | Business Line

HEALTH CARE MORTGAGED TO HEALTH SECTOR

Dr.Amit Sengupta

24th August 2012

A FEW months back the Planning Commission of India had put its foot squarely in its mouth by claiming that the poverty line in India can be pegged at a consumption expenditure of Rs 28.65 per day. It was just one more example of how today’s ruling classes are content in distancing themselves from the harsh reality of people’s lives in most parts of the country. The Planning Commission is now back in the news with a bold new plan to refurbish health care in India. The prescription is simple --- gradually wind up the public healthcare system and hand it over to corporate hospitals! Ridiculous as this may sound, it is the essence of the Planning Commission’s Health chapter in its Twelfth Five Year Plan document.

PLANNING COMMISSION: TRAIL OF BROKEN PROMISES

It may be argued that the Twelfth Five Year Plan document is of little consequence, as seldom do plan documents translate into any actual action by the government. One has only to look at past plan documents to understand this. The Eleventh Plan document, for example, had said: “In the last two years of the Plan, total Plan expenditure will need to rise at about 48 per cent annually. This will result in a total health expenditure of 0.87 per cent of GDP by the centre and 1.13 per cent by States in 2011---12.” Nothing but empty promises; the total public expenditure on health has stagnated at around 1.1 per cent of GDP (0.32 per cent by the centre and 0.7 per cent by states). It is significant to note that the major source of shortfall has been the meagre allocation by the central government --- just 37 per cent of what had been promised in the Eleventh Five Year Plan.

The plan document had also projected that all sub-centres (about 1,75,000) and primary health centres (PHCs --- about 30,000) would be functional by 2010, and all Community Health Centres (CHCs --- about 6,500) would be functional by 2012. Yet statistics for 2011 show a shortfall in the targets set of 17 per cent, 18 per cent and 34 per cent respectively, for sub-centres, PHCs and CHCs. It was also projected that Infant Mortality Rate (number of infant deaths per 1,000 live births) would come down to 28 by 2012. The infant mortality rate in 2011 stood at 48! One can continue enumerating the huge differences between targets set by the plan document and actual realisation, but suffice it to say that there is almost no correspondence between promise and delivery on the ground.

The consequences of poor commitment to public health are clearly visible.Two decades after neo-liberal reforms were initiated, India now lags behind Bangladesh and Nepal in many health indicators --- in South Asia we only outperform Pakistan! (See Table below.)

Under 5 Mortality Rates in South Asia

Country	Under Five Mortality Rate (Child who die before the age of 5/1,000 live births)
	1990	1995	2000	2005	2010
India	115	100	86	73	63
Pakistan	124	115	101	94	87
Sri Lanka	32	27	23	19	17
Bangladesh	143	114	86	64	48
Nepal	141	110	84	65	50

Source: World Bank Database

(http://data.worldbank.org/)

It then raises the legitimate question --- why should one be concerned about the contents of the Twelfth Five Year Plan document? The reason for grave concern is ideological --- for the prescriptions in the new plan document are ideologically motivated. For the first time, a public document to be released by the government of India, proposes a road map for handing over health care to the corporate sector. In proposing such a trajectory the plan document is following in the footsteps of what neo-liberal governments have done --- often with disastrous consequences --- in other developing countries (Mexico and Colombia are prominent examples).

HEALTH SECTOR REFORMS IN NEO-LIBERAL FRAMEWORK

Health sector reforms that are located in the neo-liberal framework follow a familiar pattern today --- be it Mexico, Colombia or India. Three decades back, the World Bank and IMF imposed several conditionalities on developing countries. The prominent among these that impacted on the health sector, was a demand that public expenditure be curtailed and user fees be imposed on public services. The decades of the eighties and nineties witnessed savage cuts on public expenditure, leading to an exponential rise in private expenses. It led to the dismantling or weakening of public health services and to the consolidation of an organised private sector that stepped in to fill the demand for health services. By the end of the nineties it had become clear that public financing of health care needed to be restored and the World Bank started advocating such restoration.

But this did not mean that the neo-liberal agenda was abandoned --- it was brought back in a different avatar. It was acknowledged that government expenditure must increase. It was also acknowledged that something had to be done fast, if large populations were to be rescued from the distress caused by a collapse of the public health system. Capital never gives up on its attempts to find a way to maximise returns. So the solution that was found was not located in a restoration of public health services. Instead, by a sleight of hand, a new opportunity emerged for capital. Government (public) expenditure must be increased, but this expansion will not be used to develop and strengthen public facilities. Instead, public money will now be pumped into the organised private sector, to whom will be handed over the responsibility of providing health care. Governments will finance but not provide care, they will become ‘managers’ of care. This is the managed care model of care that is now being promoted by neo-liberal theorists.

REFORMS IN INDIA

The roll out of such a plan in India had its own twists and turns. The UPA-1 government, under some influence of the Left, was forced to respond to the looming crisis of health care (brought on substantially by huge cuts in health budgets in the 1990s when Sri Manmohan Singh presided over the initiation of neo-liberal reforms as finance minister) by launching the National Rural Health Mission (NRHM). The NRHM was designed explicitly to strengthen and expand public health facilities. The NRHM was flawed on two counts, however. It was grossly under-funded --- we have seen earlier how promised central allocation was cut by over 60 per cent. As a consequence it proved to be inadequate in fulfilling the demand for health care --- especially in the tertiary hospital sector, thereby paving the way for the emergence of an organised corporate led growth of the private sector.

The public health system stands at a critical juncture. For all its deficiencies, the NHRM has resulted in some expansion and strengthening of the public health care system. The logical step forward would have been to invest in further expansion and strengthening of this system. But for the present government, the neo-liberal logic was too difficult to resist. The first challenge that was mounted against the public system came in the form of the Rajiv Gandhi Swasthya Bima Yojana (RSBY) and similar insurance schemes in many states. Almost entirely publicly funded, these schemes provided an insurance cover for Rs 30,000 for BPL families. The catch was that institutions accredited as part of these schemes were largely private hospitals. So instead of using this substantial public investment to strengthen the public system and create long term national assets, public money was pumped into the private sector. Horror stories have now started emerging about how private hospitals have bled the RSBY and similar schemes to make money and to make a mockery of public health. In Chhattisgarh the state health department has initiated action against 22 nursing homes against which it found prima facie evidence of surgeries being done without legitimate medical reasons. It is estimated that over the last eight months, hospitals and nursing homes have claimed Rs two crore under RSBY scheme for removing the wombs of 1,800 women (Hindustan Times, August 14, 2012). Many such stories are just waiting to be uncovered in different parts of the country.

However, in spite of such challenges, the NRHM and the public health system still survives and continues to be an eyesore for the votaries of private enterprise. Lest we miss the point, the private medical sector in India is extremely powerful and has friends in high places. Today some of them have transformed into mega corporations, combining hospital care, private insurance, clinical trials industry, and pharmaceutical services. Prominent CEOs of such corporations confidently stride through the corridors of power, populate ‘task forces’ and ‘expert’ committees and have a profound influence on public policy. It is this lobby, representing the private hospital sector --- unregulated and often promoted through government subsidies --- whose not so hidden hand is clearly visible in the draft health chapter of the Planning Commission.

GROSSLY INADEQUATE ALLOCATION FOR HEALTH

Let us now turn to some of the specific proposals in the Planning Commission’s draft (these points have been highlighted in a press statement by the Jan Swasthya Abhiyan on August 8). It may be recalled that in the led up to the formulation of the report the Planning Commission had set up a “High Level Expert Group” to give its recommendations on how the present system could be reformed. The Ministry of Health and Family Welfare had also constituted different expert groups to provide inputs. Over the last year several reports from these committees had indicated various proposals which were essentially designed to strengthen the public health system. There has been uniform speculation, based on various pronouncements by the government, that public expenditure would be significantly enhanced in the Twelfth Five Year Plan period.

Yet, the Plan document now recommends increase in public expenditure on health from the present 1.02 per cent to 1.58 per cent of GDP. This is even less than the modest projections made in the Eleventh Five Year Plan, which had proposed that two per cent of GDP be spent on health. The target is not only lower than previous commitments made by the government, but much lower than a minimum of five per cent of GDP that is recommended by agencies such as the World Health Organisation. The gross inadequacy of the increase proposed has to be seen in the context that India has one of the most privatised health systems in the world. Public expenditure accounts for just 29.2 per cent of health spending in India. Of about 200 countries listed by the World Bank (2010), only 13 countries --- Guinea-Bissau, Guinea, Sierra Leone, Afghanistan, Myanmar, Azerbaijan, Haiti, Cote d'Ivoire, Uganda, Georgia, Yemen, Chad and Tajikistan --- perform worse than India! The following table compares India’s performance in public health care spending with global averages:

Percent Public Health Expenditure

Country/Region	Public Expenditure on Health as Percent of Total Health Expenditure
India	29.20
Average of High Income Countries	65.10
Average of Low Income Countries	38.78
Average of Middle Income Countries	52.04
World	62.76

Source: World Bank Database

(http://data.worldbank.org/)

GOVERNMENT TO ABANDON ROLE OF HEALTH CARE PROVIDER

What is of even greater concern is the strategy proposed for restructuring of the health system. The plan document proposes a transition from: “…..the present system which is a mixture of public sector service provision plus insurance, to a system of health care delivered by a managed network.” A clear road map for the government to abandon its central role of providing health care and remain a mere ‘manager’ of health services.

The document’s vision of ‘universal provision of public health care’ includes two components. “…..preventive interventions which the government would be both funding and universally providing,” and “clinical services at different levels, defined in an Essential Health Package, which the government would finance but not necessarily directly provide.” Thus the government would confine itself to providing a small package of services while virtually all clinical services would be opened up for the corporate private sector. The government would play the role of a ‘purchaser’ of care, and will thus finance (with public money), strengthen and bolster an already resurgent corporate sector --- a diabolical ploy to hand over the profit-making clinical services sector to corporate hospital chains, and progressively wind up the public health system.

The public health system will now be asked to compete with the private sector to attract patients. A system is envisaged where: “each citizen family would be entitled to an Essential Health package in the network of their choice. Besides public facility networks organised..… private and NGO providers would also be empanelled to give a choice to the families.” Even this truncated role of the public system is qualified by the proviso that “…..public facilities will have to be strengthened, networked, and their managers provided sufficient autonomy to purchase goods and services to fill gaps as per need.” In other words, public only in name, but incorporating larger and larger components outsourced to the private sector.

Further, the document repeatedly talks about expansion of the RSBY scheme and its vision of universal healthcare is nothing but a more expanded version of the RSBY scheme. Even the Planning Commission’s own expert group had recommended against the continuance of these insurance schemes.

IDEOLOGICAL BIAS OF PLANNING COMMISSION

The document announces another bonanza to the corporate medical sector in the form of grants to set up hospitals and private medical colleges. It says: “Health has now been included with other infrastructure sectors which are eligible for Viability Gap Funding up to a ceiling of 20 per cent of total project costs under a PPP scheme. As a result, private sector would be able to propose and commission projects in the health sector, such as hospitals and medical colleges outside metropolitan areas, which are not remunerative per-se, and claim up to 20 per cent of the project cost as grant from the Government.” It may be noted that the only eligibility requirement is the location, and not any contribution to public health goals.

Also of concern are recommendations that public health facilities will have “flexibility” to raise their own finances. The Plan document says: “Tertiary care facilities would have an incentive to generate revenues if they are provided an autonomous governance structure, which allows them flexibility in the utilization of self-generated resources within broad policy parameters laid down by the Government”. There are several ways in which such flexibilities can be misused, including in the form of levying of user charges and arrangements with private entities that seek to extract benefits that conflict with the public health goals of public institutions.

The ideological bias of the Planning Commission’s report is clear when it says: “A pure public sector delivery system involves funding a large public sector health system, with little incentive for the service providers to deliver a quality product.” Such an assertion flies in the face of global evidence that the best performing health systems are those that are publicly financed and where health care is provided by the public sector.Neighbouring Sri Lanka has been long held as an example of such a system, where over 90 per cent of in-patient care and over 50 per cent of out-patient care is provided by the public sector. Mortality and morbidity rates in Sri Lanka are far better than in India, in spite of the country having a lower per-capita GNP. In contrast, the United States, provides ‘choice’ between public and private providers but is by far the worst performing health system among all developed countries, in spite of spending over eight per cent of GDP on health care.

As we have noted earlier, the Planning Commission’s draft chapter on health for the Twelfth Five Year Plan is a clear ideological assault on the very notion of public health. The dangerous formulation in the Planning Commission’s draft must not be allowed to go through. It is understood that the Ministry of Health has expressed serious reservations regarding the Planning Commission’s document. How these differing positions within the government play out will also indicate whether policy is formulated by the parliament and executed by ministries, or whether the Planning Commission enjoys powers to veto the will of the people.

Time for another revolution in medicines access The ‘test case’ of Herceptin

Time for another revolution in medicines access The ‘test case’ of Herceptin

Amit Sengupta 15th February 2013 The last fifty years is witness to a virtual explosion in the creation of new knowledge. Capitalism has used this characteristic of modern science and technology to constantly create products and tools to constantly revolutionize the productive forces. At the same time it is also seized with the necessity to control the expressions of new knowledge. Control over knowledge is one of the most important tool that modern day Capitalism uses to maintain its hegemony. Perhaps the most common expression of control over knowledge is the Intellectual Property system – which operates through the medium of patents, copyrights, trademarks, etc. This dual nature of capitalism in the arena of knowledge creation – knowledge creation and its control are both embedded in the nature of capitalism. Without new knowledge and the creation of new products, capitalism is unable to survive. At the same time, it cannot allow the free use of such knowledge, as this jeopardizes the very basis of capitalist accumulation based on hegemony over the process of production. This inherent contradiction is starting to express itself in a new dilemma – control over knowledge production is now a fetter on creation of new knowledge. TRIPS – a cruel agreement This dilemma s being played out in the field of innovations that leads to discovery of new medical products. It is being played out in two very important ways. The 1980s and 1990s were a period of intense struggle, waged by developed capitalist countries, to put in place a global system that would legalise its hegemonistic control over knowledge. The result was the signing of the TRIPS (Trade Related Intellectual Property Rights) agreement in 2004. The TRIPS agreement legitimized the control over knowledge through a strengthened patent regime that was to be applicable to all countries in the world (with some limited waivers in the form of transition periods for developing and least developed countries). The TRIPS agreement is a cruel agreement – what it basically says is that access to knowledge that can save lives would be limited to those who can pay (as individuals or through their governments). The decade of the 1990s saw the unfolding of one of the worst man-made tragedies ever, in the form of the HIV AIDS epidemic. Nominally, the disease is caused by a virus, but the conditions for the devastation it caused (and is still causing) was a human creation. In less than a decade after HIV infection was first detected in humans, the first drugs to effectively treat it were being rolled out. Yet it raged across the poorest countries of the world, especially in sub-Saharan Africa, decimating huge swathes of the population. Almost a whole generation succumbed to the disease in the region. Not because remedies were not available. Not because we did not understand how the spread of the disease could be stopped. But because these remedies were not allowed to reach those who needed them the most. They were not allowed to be used because a handful of CEOs of giant pharmaceutical companies priced these drugs way out of the reach of people who needed these drugs in poor countries. Sub-Saharan Africa was already reeling under massive debt burdens foisted on them by policies promoted by the IMF and World Bank. They were now asked to shell out money to buy drugs that would save their people – money that amounted to, in some cases, over 50% of the entire GDP of the country. In 2001, and Indian company – Cipla – entered the fray. It announced that it would supply drugs to treat HIV AIDS at 1/40th (that is just 2.5%) of the price charged by multinational corporations. Drug prices of anti-retrovirals (those that treated HIV AIDS) fell from the earlier $12,000 per patient/per year to $300. Since then the prices of these early anti-retrovirals have fallen to less than $100 for a year’s treatment. Biologics – the new frontier of disease control The above story, known to many, merits repeating because it is now being played out in another area of medicinal products. The next new-frontier of disease control lies in finding remedies that can effectively cure and control cancers and several degenerative diseases. Cancers of different kinds are a cause for over 8 million deaths every year (i.e. almost 15% of all deaths) and 70% of these deaths occur in low and middle income countries. Even 3 decades back most cancers were considered a death sentence. No more so. Over the past decades new treatments and products are starting to win significant victories over a number of types of cancers. New products are being developed and many are already in use – many of which are a significant advance over existing treatments. As such opportunities open up, they are also opening up opportunities for pharmaceutical companies to reap super-profits at the expense of human misery. While the basic research for virtually all cancer treatments are done in public funded institutions, the ultimate products are controlled by a handful of companies. Simultaneously we are seeing another development taking shape. Fewer and fewer new drugs that are significant advances over current treatments are being researched. Partly this is a consequence also of what we have noted earlier – the patents system, by controlling access to knowledge, finally also acts as a fetter to the creation of new knowledge. Most patents registered today do not protect an invention, they actually are designed to prevent others from doing research. Known as ‘patent thickets’ these patents prevent transmission of knowledge, and its further development. In India less than a handful of new medicines are introduced every year, yet several thousand patents are granted. This is a global phenomenon not restricted just to India. While the number of patents is growing, the number of new drugs that are being researched continue to fall alarmingly. There is, however, and exception to this trend. The field of biotechnology is starting to live up to its earlier promise and is delivering entirely new forms of treatment. Thus while we have fewer drugs of promise that are being developed through the earlier route of chemical synthesis, exciting new treatment avenues are being opened up by research using the biotechnology route for drug development. Drugs developed using biotechnology are different because they are produced in living cells. The molecules which make up these drugs are larger in size and more complex than the ‘small molecule’ drugs manufactured using the chemical synthesis method. The manufacturing systems used to produce these drugs need to be monitored differently. These drugs – termed as biologics – have several potential advantages. They can, theoretically, be tailored to hit specific ‘targets’ in the human body. This is of particular interest in diseases which are caused by altered or aberrant functioning of specific genes – such as in the case of several types of cancers. Traditional cancer drugs are called ‘cytotoxic’ drugs, i.e. they are poisonous to cells in the body. The basic principle on which they work is that they selectively kill cells that proliferate very fast (as happens in the case of cancer cells). However they are never entirely selective and that is why cytotoxic drugs have a range of side effects caused by the destruction or alteration of normal cells in the body as well. Biologics are being developed that only target specific gene sequences in cells and thus would have less side effects. The Herceptin Story One such drug that is a breakthrough drug is called trastuzumab. The drug is used to treat a certain kind of breast cancer that is particularly aggressive and difficult to treat or manage. Trastuzumab works in a way that is very similar to the way antibodies work in the body. Antibodies are produced by the body’s immune system, which is the body’s defense system against foreign invaders – like viruses, bacteria, and other biological agents. They are able to recognise these foreign agents and bind to them. The body’s immune system then gets into action to destroy these foreign cells. Trastuzumab binds to a gene called the HER2 gene, that is more active in some breast cancer patients. The HER2 gene stimulates the growth of cancer cells. By binding to the HER2 gene, Trastuzumab suppresses its activity. It also stimulates the body’s own immune cells to destroy the tumour cells. Trastuzumab belongs to a class of biologics that are called monoclonal antibodies. Monoclonal antibodies are produced from a single cell-line (hence the term ‘mono’), which is cloned to produce a very large number of cells. The cells are genetically engineered (i.e. a piece of foreign gene is introduced into the cell) to secrete the antibody we desire. Trastuzumab, for example, is made by substituting a portion of a human gene into a mouse using recombinant DNA technology. The mouse cells are thus ‘fooled’ into producing the antibody. To continue the Trastuzumab story – the drug was marketed in 1998 by Genetech (later acquired by the Swiss multinational, Roche). It is sold under the brand name Herceptin. It is interesting to note that though the product has now been around for almost 15 years, Roche still enjoys global monopoly over the drug. The story would have been very different if Herceptin had been a drug that could be produced by the chemical synthesis route. Given the drug’s important public health benefit, many generic manufacturers (especially in India, the major centre of generic drug manufacture in the developing world) would be interested in producing their own versions of Trastuzumab. Herceptin was introduced in the global market at a time when the Indian Patent law allowed generic versions of patented drugs to be produced without any restrictions. The inability of Indian companies to come up with a generic version is related to special features that characterize biologics like Trastuzumab. Unlike in the case of conventional ‘small molecule drugs’ it is never possible to produce an exact replica of the original drug. Biologics are extremely sensitive to the manufacturing process and the starting material. As the starting material is a living cell, it is impossible to have an exactly similar starting cell. Moreover very small changes in the manufacturing process can bring about changes in the final product. Thus, even in the case of the original product, there are variations in the product – between batches and even within the same batch. Thus the equivalents of generic versions of generics are called ‘biosimilars’. Biosimilar manufacture is a relatively new area as the processes involved are entirely different from those used to produce drugs through the chemical synthesis route. Further, there are regulatory hurdles because the process of getting regulatory approval for biosimilars is more cumbersome than for ‘small molecule’ drugs. This is again because of the nature of biologics – because it is impossible to replicate the original drug, more data is demanded by regulatory agencies to prove that the quality, safety and efficacy profile of the biosimilar is identical to that of the reference drug (i.e. the original biologic). Consequently, in the case of biologics, patent barriers are not the only barrier to the production of biologics. The time to act is ‘now’ Herceptin has recently been in the news because of two reasons. First, because of the interest being generated about use of Compulsory licenses (i.e. licenses issued to generic companies to manufacture patented drugs) after India issued its first compulsory license last year for another anti-cancer drug – sorafenib. The second reason is that it is only now that Indian companies have started acquiring the capacity and technical competence to produce biosimilars. Because it now appears possible that biosimilars of Herceptin can be introduced, it is important to examine the economics and the public health importance of the drug. Treatment with Herceptin typically consists of 12 intravenous doses of the drug, administered every three to four weeks over the course of a year. Roche sells the drug for more than Rs.70,000 per dose. Clearly the cost is prohibitive for almost any Indian patient. The cost has to be seen in the context that breast cancer is the most prevalent form of cancer among urban women, and the second most prevalent for rural women According to the national cancer registry, over 1,00,000 women in India develop breast cancer every year (about 1 in 22 women in India stand at risk of getting breast cancer in their lifetime). Out of the total number of breast cancer patients, about 25% benefit from Herceptin (there are tests that can show which patients will benefit). Thus approximately 25-30,000 women would benefit from the use of Herceptin. Importantly, Herceptin is useful in the most aggressive form of the cancer, which typically afflicts younger patients. Yet because of the misuse of the monopoly situation that Roche enjoys, barely 5% of eligible patients are able to access the drug, and many of those who do are put on a lower dosage than recommended. The situation cries for an immediate remedy. There are several issues that need to be addressed in order to expedite the entry of biosimilars of Herceptin in the Indian market. First, patent barriers need to be removed by expeditious issue of a compulsory license. The patent status of Herceptin is not clear in India as it is the subject of several litigations, however a compulsory license is the fastest way to make sure that patents are not a barrier to introduction of biosimilars. Simultaneously regulatory procedures need to be streamlined to ensure that entry of biosimilars are fast-tracked, while of course ensuring that quality is not compromised. Finally, public investment is necessary to build larger capacity in India to produce biosimilars. Herceptin is a test case. If the attempt to get Inidan biosimilars of Herceptin in the market is successful, it has the potential to open the doors for a range of other biosimilars of other new biologic drugs that are already in the market or are being developed. Cipla’s pioneering action in 2001 revolutionized HIV AIDS treatment. Biosimilars produced by Indian companies can change the face of treatments for many diseases, now considered virtually untreatable, not just in India but across the world. There is no reason why the experience of a 97.5% drop in prices, seen in the case of HIV AIDS drugs when generics were introduced, cannot be replicated in the case of biosimilars. A bold and responsive government and regulatory agencies need to act in tandem to make this a reality. The time to act is now.

 

NHRM

FROM HEALTH ACTION

TUBERCULOSIS IN INDIA

India's TB burden is staggering. Every year , 1.8 million people get the disease ; and about 800,000 cases are infectious. Until recently , 370,000 died of it annually. An estimated 100 million workdays are lost to it, with the country incurring a huge cost -- nearly $ 3 billion . The direct costs are $300 million . Since its launch in 1998 through Revised National Tuberculosis Control Programme , more than 14.2 million patients have been treated and 2.6 million lives saved with DOTS.(The Hindu,21 October,2012 )

LEPROSY ERADICATED?????

It was announced that leprosy  had been virtually eradicated . But the curse is very much here. In 2010 , out of 2,28,000 cases in the world , India accounted for 1.26,000. We need to step up efforts to achieve zero prevalence( Times of India,29 January, 2013)

POLITICAL ECONOMY OF HEALTH