NHPS: “One Nation, One Scheme is Enticing”, But Will It Work?

Posted on March 12, 2018 by Tapan Ray

Yet another slogan: “One nation – One Universal Health Coverage (UHC)” would indeed be enticing for many, including India.

Nevertheless, that’s just a hope. Let’s now try to get a message out of what has been recently happening around this area through some reality checks. The reality is, during post union budget (2018-19) television discussions on the ‘National Health Protection Scheme NHPS’, various experts very enthusiastically created a general impression that the scheme is a game changer for India. Many of us also felt that India is moving fast towards a viable UHC in the country!

As a consequence of which, it was widely expected that State Governments, too, will make necessary provision in their respective health budgets towards this ambitious insurance-based healthcare project. This specific step is absolutely essential, as the State Governments are supposed to contribute 40 percent towards NHPS.

Is it happening that way?

Intriguingly, on March 9, 2018, when Maharashtra State budget was announced, one witnessed a different reality altogether on the ground. In its 2018-19 budget, the Maharashtra Government, reportedly, ‘slashed its budget allocation for the health insurance scheme for the poor by over 50 percent.’

The Finance Minister of Maharashtra announced an allocation of ₹576 crore for the ‘Mahatma Jyotiba Phule Jan Aarogya Abhiyan’ in 2018-19 as against the last year’s budget outlay of ₹1,316 crore for the same area.

Keeping this latest development just as an example, in this article I shall explore some of the recent developments on the much talked about NHPS. Before doing that, let me give a perspective on the NHPS.

NHPS: not a new promise:

Rekindling the perennial hope on UHC in India, ‘National Health Protection Scheme NHPS’ was first announced by the incumbent Government in its 2016 budget, but the scheme didn’t take off. In its first avatar NHPS offered ₹100,000 insurance cover, with a top-up of ₹30,000 for senior citizens.

“It couldn’t get implemented, but that scheme is now subsumed by this current scheme,” reportedly, justified Manoj Jhalani, Additional Secretary in the Ministry of Health and Family Welfare, who has been given additional charge and designated as Mission Director of Ayushman Bharat, currently.

There isn’t any doubt that NHPS has been recast in the Union Budget Proposal of 2018-19, with a slight modification in naming it to ‘Ayushman Bharat—the National Health Protection Scheme (AB-NHPS)’. The modified scheme is also termed by many as “Modicare”, probably following ‘Obamacare’ in the United States. The Union Finance Minister of India in his Budget speech also termed this scheme as ‘the world’s largest government funded healthcare program.’

A recast of insurance-based public health coverage:

As a part of ‘Ayushman Bharat Program’, the scheme will now provide health insurance cover of up to ₹500,000 to 100 million poor and vulnerable families. Its benefits are now expected to reach 500 million individuals – 40 percent of India’s population, raising health insurance cover by up to 17 times from the existing Rashtriya Swasthya Bima Yojana (RSBY) that pegs the health coverage at ₹30,000 per year.

Just to give a flavor of the past, the National Family Health Survey-4 (2015-16) indicates that in India only 28.7 percent families have, at least, one person covered by a health insurance policy.

In the health insurance coverage based NHPS, the center and states will split financing the scheme in a 60:40 ratio. However, it is still not clear how would they do it. Neither is it known how the NHPS will fit in with the existing RSBY or various already existing state level schemes.

Apprehension expressed by some States:

Several other Indian States, such as Kerala, Tamil Nadu, Andhra Pradesh, Telangana, Madhya Pradesh, Chhattisgarh, Karnataka, West Bengal and Rajasthan already have a similar health protection scheme in place. Probably because of this reason some of these states, such as West Bengal and Karnataka, reportedly, have raised doubts about whether they will actually join the scheme.

On the other hand, health officials from Telangana, Tamil Nadu and Kerala intend to seek clarifications from the Centre on various aspects of the plans. As I mentioned before, this is mostly because all States will require to contribute 40 percent of total expenses towards funding the ‘Ayushman Bharat—the National Health Protection Scheme (AB-NHPS).’

A fresh evaluation: Experts don’t rate public health insurance schemes high:

Interestingly, some fresh apprehensions on the effectiveness of insurance-based health coverage continues to come up. One such is as follows:

“The current approach of National Health Mission – whereby states must pre-commit to expenditure allocations across 2,000 budget lines with no real flexibility to subsequently move expenditures between different line items – will render NHPS ineffective.”

This apprehension has been raised by none other than Dr. Arvind Panagariya, currently Professor of Economics at Columbia University and the Vice Chairman of the Government of India’s think-tank NITI Aayog, between January 2015 and August 2017. This article, titled “It’s all in the design: Ayushman Bharat can be transformational if the governance of public healthcare is altered”, was published in the Times of India on March 07, 2018.

Dr. Panagariya further observed: “For the poorest of the poor to seek private hospital care speaks volumes for their lack of confidence in the public healthcare system. Studies by experts do not give high marks to existing insurance schemes either.”

Some key observations:

In his above recent article, Dr. Arvind Panagariya made some key observations that include some of the following:

A 2017 study of the Rashtriya Swasthya Bima Yojana (RSBY), published in the journal Social Science and Medicine, concludes, “Overall, the results [of our study] suggest that RSBY has been ineffective in reducing the burden of out-of-pocket spending on poor households.”

In 2014-15, private hospitals treated 58 percent of in-patient cases in rural areas. Even among the poorest 20 percent rural households, 42.5 percent of the patients went to private hospitals for in-patient treatment.

Resource shortage has resulted in less than adequate infrastructure and personnel in the public health facilities. Consequently, in 2014-15, a mere 28 percent of those needing outpatient care came to the public health facilities. A hefty 72 percent of patients went to private providers.

Considering that the private providers are predominantly unqualified individuals, often having no more than a high school education and no formal medical education, such disproportionate reliance on them is indicative of a serious failure at the public health facilities, especially in rural India.

Design and implementation challenges facing NHPS are even greater. Hospitals will have an inherent interest in pushing patients towards more expensive procedures or towards procedures not even required. Any lack of clarity in delineating the included and excluded procedures will become a source of abuse.

Superior outcomes would require a fundamental change in governance whereby performers are rewarded, and non-performers are punished. The story on secondary and tertiary care is not especially different.

In my view, these observations are worth taking note of, urgently, and more importantly, by learning from the past, avoiding similar mistakes getting repeated. Meaningful implementation of NHPS on the ground should be a top priority, especially when around 7 percent of the country’s population gets pushed below the poverty line, every year, due to high out of pocket health expenditure.

I also discussed the subject in this Blog on February 05, 2018. The article was titled “Union Budget 2018: The ‘WOW’ Moment for Indian Healthcare?”

Conclusion:

Any meaningful initiative on public healthcare for all, will be wholeheartedly welcomed in India, just as many other announcements made earlier by various Governments over a period of time. AB-NHPS – although announced in the very last year of the incumbents Government’s first 5-year term, has attracted similar interest. No less enthusiasm was displayed by the stakeholders, when the NHPS was first announced in the 2016 Union Budget of India.

The good news is, in the midst of all this, on March 06, 2018, Prime Minister Narendra Modi has, reportedly, reviewed the preparedness for the launch of AB-NHPS.’ However, details of the same are not known to many, just yet.

That said, any type of insurance-based public health coverage, spanning across the length and the breadth of India, without access to well-equipped and well-staffed health facilities, currently poses a serious handicap for the nation. It may be a legacy factor, but nothing significant happened in the last four years, either. This is regardless of around 70 percent of the country’s population still live in rural India, with a sizeable majority denied of access to affordable health care, as up till now.

Let me come back to the basic question: ‘One Nation, One Scheme, though, is enticing, but will it work?’ I reckon, unlike, 2016, if NHPS is effectively implemented urgently, together with ‘Ayushman Bharat’ program in its entirety, as desired, things could possibly change for the better, in a medium to long term time frame.

However, it appears, a workable game plan of AB-NHPS is still unclear to many, including a large number of State Governments who are supposed to be the key implementers of NHPS. In this scenario, would AB-NHPS fetch any palpable near-term dividend to the target citizens, at least in 2018 or even in 2019?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Health Care in India And ‘Development For All’ Intent

Posted on December 25, 2017 by Tapan Ray

‘Development for All’ has become a buzzword, especially in the political arena of India, and is being used frequently during all recent elections as no one can deny its crucial importance in a country like ours.

Nonetheless, some do feel that there should be greater clarity on what all it encompasses. There is no scope for assumption, either, that it definitely covers the economic growth of the nation. But, does it include health care for all, as well? This is a relevant question, since health care plays a crucial role in maintaining high growth of Gross Domestic Product (GDP) by any country, over a long period of time.

The ideal answer to this question would, of course, be an emphatic ‘yes’? However, on the ground is it really so? I explored that subject in my article published in this Blog on November 06, 2017 titled, ‘Healthcare in India And Hierarchy of Needs’.

In this article, I shall focus on health care and the ‘Development for All’ agenda of the Government, as witnessed by many in recent elections. Let me illustrate the point using one of the most recent state assembly elections as an example – Gujarat Assembly election of December 2017. I am citing this example, because it generated so much excitement among many, across the country, for different reasons, though.

Who is responsible for public health care in India?

A recent submission made on the floor of Parliament by the Government, explains the point unambiguously. It goes, as hereunder:

“Public health is a state subject. Under the National Health Mission, support is being provided to States/UTs to strengthen their health care systems to provide accessible, affordable and quality health care to all the citizens. Moving towards Universal Health Coverage wherein people are able to use quality health services that they need without suffering financial hardship is a key goal of 12th Plan.” This is what the Minister of State, Health and Family Welfare, reiterated in the Lok Sabha, just about a year ago, on November 25, 2016.

Since, public health is predominantly a state subject, and so important for each individual, besides being one of the key indicators for long-term socioeconomic progress of a country and, one expects health care to be a key issue during the state Assembly elections. This is necessary to maintain the pace of development in this area, be it a state or the country.

Intriguingly, it appears to have no more than a ‘me-too’ reference in the election manifestos of political parties.

Does health care scenario in a state matter?

Now, zeroing on to Gujarat election as an example, the media report of March, 2017 highlighted, gradually reducing budget allocation percentage of health care in Gujarat. It elaborated, the State has reduced its budgetary allocation for health care from 5.59 percent of the total budget in 2015-16 to 5.40 percent of the revised budget of 2016-17, and now to 5.06 percent in 2017-18.

Consequently, the health care budget and spending on the proportion to the Gross State Domestic Product (GSDP) is going down year after year. Whereas, globally, the percentage of GSDP spent on health and education is considered a key parameter of human development, the report states.

According to a report of the Observer Research Foundation dated December 06, 2017, Gujarat still has a high dependency to the private sector for both outpatient (84.9 percent cases) and also the inpatient (73.8 percent cases). As a result, the out of pocket spending on health care of the state stands at 63.7 percent. This makes Gujarat climbing up the ladder of per capita income, while slipping down the slope of health and social indicators,” the article states.

Just as what happens in all other Indian states, the recent state assembly elections offered an opportunity for the political leadership, cutting across the party line, for a significant course correction. Making health and nutrition one of the top priority focus areas, would have also ensured sustain economic development for Gujarat, in a more inclusive manner, for a long time to come.

What we are witnessing, instead:

The ‘best’ intent of a political party on any area of governance, if it comes to power, generally gets reflected in the respective election manifestos. From that perspective, let’s take a quick look at the key promises on health care, made in the respective election manifestos of the two principal political parties, on the eve of December 2017Gujarat election. I found these, as follows:

Key highlights on health care in BJP Manifesto:

The party promised to open more generic medicine shops
Introduce mobile clinics and laboratories
Making Gujarat free of vector-borne diseases.

Key highlights on health care in Congress Manifesto:

Universal health care card

That’s all?… Yes, that’s it.

India is ‘developing’, but public health care is not:

‘The Lancet’ editorial titled, ‘Health in India, 2017’, published on January 14, 2017, discussed about the current status of public health care in India. It underscored that the government expenditure on health being one of the lowest in the world at 1·4 percent of GDP, is totally inadequate to train staff, buy necessary equipment, or efficiently run public health facilities.

Corruption and an unregulated private sector usually fill this vacuum, and in so doing, fuel irresponsible prescribing, and global export of antimicrobial resistance, besides misery and medical bankruptcy for those within the country, lacking financial protection.

The editor articulated that the solution of this important issue is clear. Publicly financed Universal Health Coverage (UHC) has not only been deliberated in India since the dawn of the nation, but has also been highly recommended by both the domestic and the external stakeholders.

Nevertheless, successive governments seem to be lacking either the spine or the heart to act. As recently as 2011, progressive universalism was included in the government’s 5-year plan, but was never funded – the editorial commented.

Both the States, and also the national election campaigns, offer an opportunity for the politicians who the prospective lawmakers, to steer the States, and in that process the country as a whole, moving towards the UHC.

Conclusion:

As heath is a state subject, the issue of providing access to high quality and affordable health care to all should ideally become one of the core issues for all voters, at least, in the State Assembly elections. More so when the sound bite on ‘development for all’ reaches a feverish pitch. There can’t be any holistic ‘development for all’, sans health care and education.

Nonetheless, the reality is, unlike the United States, Europe or Japan, besides a few other countries, the voters in India are also not expressing their concerns in this area, meaningfully. In all probability, ‘development for all’ slogan of the politicians doesn’t include health care to all Indians.

This is likely to continue, in the same way, till the awareness of the socioeconomic impact on health care carves out a niche for itself in the popular political agenda for the voters. Just as what happens with many other economic, technological necessities and other aspirations of people. The recent assembly elections are important pointers to this long persisting trend.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Healthcare in India And Hierarchy of Needs

Posted on November 6, 2017 by Tapan Ray

“Russia and India climb World Bank’s Doing Business rankings”, was a headline in the Financial Times on October 31, 2017. India jumped 30 places – from 130 out of 190. Almost instantly, the domestic media flashed it all across the country, as the prime news item of the day. It brought great satisfaction to many, and very rightly so.

The news is also worth cheering as it ignites the hope of a large section of the society that sometime in the future more business will come into the country, more jobs will be created, and in that process India will emerge as a more healthy and wealthy nation, just as many other countries around the world.

This loud cheer, in tandem, also transcends into a hope for a well-oiled public healthcare system functioning efficiently in India, alongside greater wealth creation. This is because, while expecting a healthier nation, one can’t possibly keep the public healthcare system of the country out of it, altogether. Thus, I reckon, it won’t be quite out of place to have a quick look at India’s current ranking on other healthcare related indices too, such as ‘Healthcare Index’ and ‘Human Development Index’ and ‘Hunger Index’:

Healthcare index:

With that perspective, when go through the Global Burden of Disease Study 2016, published in The Lancet on September 16, 2017, it will be difficult to wish away the fact that India ranks 154 among 195 countries in ‘Healthcare Index’. Surprisingly, India ranks much behind Sri Lanka (72.8), Bangladesh (51.7), Bhutan (52.7) and Nepal (50.8) though, of course, above Pakistan (43.1) and Afghanistan (32.5). This is what it is, regardless of the fact that India’s Healthcare Access and Quality (HAQ) index has increased by 14.1 – from 30.7 in 1990 to 44.8 in 2015.

Human Development Index:

The ranking of India in the Human Development Index (HDI) is also not encouraging, either. Many would know, HDI is a composite index of life expectancy, education, and per capita income, which are used to rank countries in human development. As life expectancy also depends on the quality of healthcare, HDI has a significant bearing on this count, as well.

The ‘2016 Human Development Index Report (HDR)’ released by the United Nations Development Program (UNDP) in March 2017 shows that India has slipped by one rank from 130 to 131, among 188 countries. According to UNDP, ‘in the past decades, there has been significant gains in human development levels almost in every country, but millions of people have not benefited from this progress. This report highlights who have been left behind and why?’

I shall dwell on the ‘Global Hunger Index Report’ below at an appropriate context.

Why is this comparison between different indices…and now?

The above question is indeed a very valid one. Nonetheless, it is important to do so. I am quoting these rankings to flag the sharp contrast in our mindset to rejoice the good rankings, and lampooning the adverse ones, citing one reason or the other.

It is obvious from the general euphoria witnessed by many on such good news – highlighted so well by the print, television and social media, with high decibel discussions by experts and politicians. There is nothing wrong in doing that, in any way. However, similar media discussions were not evident for taking effective corrective measures, soon, when ‘global burden of disease rankings’ or ‘Human Development Index Report (HDR)’ or the ‘Global Hunger Index’ rankings were published in September, March and October 2017, respectively.

Does it therefore mean that effectively addressing issues related to crumbling public healthcare infrastructure in the country attracts much lesser importance than ensuring ease of doing business in the country? Do both the politicians and the voters also consider so? Perhaps the answer is yes, as many would envisage in the largest democracy of the world.

What’s happening elsewhere?

In many developed and also the developing countries of the world, general public or voters’ expectations for having an affordable and robust public healthcare delivery system from the respective Governments seem to be high. Consequently, it also directs the focus of the politicians or lawmakers on the same. This scenario includes even the oldest democracy of the world – America. Such expectations on comprehensive healthcare covers the need for affordable drug prices too.

That voters are greatly concerned about healthcare in those countries is supported by many contemporary surveys. Just before the last year’s American Presidential election, Kaiser Health Tracking Poll: September 2016, substantiated this point. It said, besides considering personal characteristics of the candidates, the voters clearly articulated their priority on patient-friendly healthcare laws and affordable drug prices, as follows:

Over 66 percent of voters expressed that healthcare law is very important to their vote
77 percent said prescription drug costs are unreasonable, expressing widespread support for a variety of actions in order to keep healthcare costs down

Accordingly, The New York Times on September 17, 2017 reported: “The public is angry about the skyrocketing cost of prescription drugs. Surveys have shown that high drug prices rank near the top of consumers’ health care concerns, and politicians in both parties - including President Trump — have vowed to do something about it.”

I haven’t come across such widespread demand from the voters getting captured in any survey, before either any State Assembly or the Parliament elections in India. Hence, public healthcare continues to languish in the country, as various Governments come and go.

What happens post-election in the oldest democracy?

We have enough examples that post-election, the oldest democracy of the world tries to satisfy the well-articulated healthcare needs of the voters, on priority. To illustrate the point, let me help recapitulate what happened in this regard, immediately after the last two Presidential elections in America.

After swearing in on January 20, 2009, then American President Barack Obama, as expected by the voters and promised by him accordingly, enacted the Affordable Care Act (ACA), popularly known as ‘Obamacare’, almost within a year’s time – on March 23, 2010. Similarly, within a few months of swearing in as the American President, Donald Trump administration is mulling to address the voters demand and his electoral promise to make the prescription drugs more affordable.

Public demand and outcry for affordable healthcare, including affordable drugs have led to several serious consequential developments in the United States. Let me illustrate this point with another example of recent lawsuits filed against alleged price fixing of generic drugs – many of these are new, but a few started in the last few years.

Vigil on drug prices continues:

As high drug prices are a burning issue even in America, a lot many steps are being taken there on that issue – just as many other developed and developing countries are taking.

It is rather well known that even after enactment of the Affordable Care Act (ACA) in 2010, the Department of Justice of the country expanded probing into the allegation of price fixing by many generic drug manufacturers operating in America. One such illustration is October 31, 2017 public notice of the State Attorney General (AG) of Connecticut. It states that the AG is leading a coalition of 46-states in new, expanded complaint in Federal Generic Drug Antitrust Lawsuit. It further mentioned: States allege broad, industry-wide understanding among numerous drug manufacturers to restrain competition and raise prices on 15 generic drugs, where some senior executives have been sued.

Interestingly, in this notice the AG said, “The generic drug market was conceived as a way to help bring down the cost of prescription medications. For years, those savings have not been realized, and instead the prices of many generic drugs have skyrocketed.” He alleged that the defendant companies’ collusion was so pervasive that it essentially eliminated competition from the market for the identified 15 drugs in its entirety. ‘Ongoing investigation continues to uncover additional evidence, and we anticipate bringing more claims involving additional companies and drugs at the appropriate time,” the Attorney General further added.

By the way, the expanded complaint of the states reportedly also includes several large Indian companies, such Dr. Reddy’s Laboratories, Emcure, Glenmark, Sun Pharma, and Zydus Pharma. Curiously, the expanded complaint also names two individual defendants, one among them is the promoter, the chief executive officer and managing director of a large Indian pharma manufacturer.

Examples such as this vindicate, even if a robust public healthcare system is put in place, the regulators would still keep a careful vigil on drug prices.

Getting back to the key link between some indices:

Let me now get back to where I started from – the link between ‘ease of doing business’ and ‘becoming a healthy and wealthy’ nation, over a period of time. This would subsequently bring us to the link between healthy nation and the existence of a robust and functioning affordable public healthcare system in the country.

From that angle, I raised a key question. Why the general public, and specifically the voters in India aren’t making effective delivery of an affordable public healthcare as one of the top priority areas while voting for or against a political dispensation? The question assumes greater relevance when one sees it happening in many other countries, as discussed above. Is it, therefore, worth pondering whether this issue can be explained, at least to a great extent, by applying the well-known ‘Maslow’s theory of hierarchy of needs.’

Maslow’s hierarchy of needs and hunger index:

As the literature says, ‘Maslow’s hierarchy of needs’ is a theory of motivation in psychology developed by Abraham Maslow in 1943. He believed people move through different stages of five needs that motivate our behavior. He called these needs physiological, safety, love and belonging (social), esteem, and self-actualization.

As we see, the first two basic needs are physiological and then safety. Maslow explains the ‘physiological needs’ as food, water, sleep, and basic biological functions. When these physiological needs are adequately met, our safety needs would usually dominate individual behavior.

Similarly, Maslow’s ‘safety needs’ in the modern era are generally expressed as the needs of job security, financial security, and health and well-being, among a few others. Thus, the need for healthcare falls under ‘safety needs’, following the most basic ‘physiological needs’.

As Food is one the first basic needs, India’s current ranking in the ‘Global Hunger Index (GHI)’, would suggest this primary need of having at least two square meals of nutritious food a day, has not been adequately met by a large population of Indians, not just yet.

India’s ranking in the Global Hunger Index (GHI):

The Global Hunger Index (GHI) has been defined as a multidimensional statistical tool used to describe the state of countries’ hunger situation. The GHI measures progress and failures in the global fight against hunger. It is now, reportedly, in its 12th year, ranking countries based on four key indicators – undernourishment, child mortality, child wasting and child stunting.

The International Food Policy Research Institute (IFPRI) report, titled ‘2017 global hunger index: The inequalities of hunger ’, indicates that India ranks below many of its neighboring countries, such as China (29th in rank), Nepal (72), Myanmar (77), Sri Lank (84) and Bangladesh (88), but ahead of Pakistan (106) and Afghanistan (107). Just for the sake of interest, North Korea ranks 93rd while Iraq is in 78th position.

The primary basic need of food and nutrition does not seem to have been fully met for a large Indian voter population, as yet. Many of them are still struggling and searching for appropriate means of earning a dignified livelihood. It includes support in agricultural production and the likes. Thus, many voters don’t feel yet, the second level of need that prompts a vocal demand for an affordable and robust public healthcare system in the country. The same situation continues, despite ‘out of pocket’ expenditure on healthcare being one of the highest in India, alongside the cost of drugs too.

Conclusion:

This brings us to the key question – When would the demand for having an affordable and robust public healthcare system in the country, assume priority for the general public in India, and the voters, in particular?

Sans Government’s sharp focus on public healthcare, including the cost of drugs, devices, and education, it will be challenging for a democracy of India’s size to make a decisive move, for a long term – from average to good – and then from good to great, even in the economic parameters.

Applying Maslow’s hierarchy of needs onto various health related global indices, it appears that the primary basic need of food and nutrition has not been fully met for a large Indian voter population, as yet. This possibly makes a large section of Indian voters to move into the second level of need, raising a widespread vocal demand for an affordable and robust public healthcare system in the country.

Rejoicing country’s advancement in the World Bank’s ranking on the ease of doing business by 30 points in a year has its own merits. However, in the same yardstick, doesn’t health care losing the priority focus of the nation also highlight the demerits of misplaced priority in a country’s governance process, and just because the voters are not quite demanding on this issue?

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

National Health Policy 2017: Some Silver Linings, Some Trepidation

Posted on March 27, 2017 by Tapan Ray

In September 2016, the Supreme Court directed the Indian Government to finalize the ‘National Health Policy (NHP)’ guaranteeing ‘assured health services to all’, a draft version of which was already made available to the public on December 30, 2014.

In its order the Apex Court had said: “In case the Union of India thinks it worthwhile to have a National Health Policy, it should take steps to announce it at the earliest and keep issues of gender equity in mind.”

After a wait of over two years, on March 16, 2017, the Union Cabinet approved the final version of the National Health Policy 2017 (NHP 2017) for implementation. The tough socioeconomic distress of the general population related to health care, fueled by near collapsing public health care delivery system when private health care providers are becoming more and more expensive, prompted the current Government to initiate drafting yet another new ‘Health Policy’, with a gap of around 15 years.

NHP 2017 covers a gamut of subjects while articulating its primary aim, which is to inform, clarify, strengthen and prioritize the role of the Government in shaping health systems in all its dimensions. These are investments in health, organization of health care services, prevention of diseases and promotion of good health through cross sectoral actions, access to technologies, developing human resources, encouraging medical pluralism, building a knowledge base, developing better financial protection strategies, strengthening regulation and health assurance.

In this article, primarily for greater clarity in understanding by the readers, I shall start with the reasons of my trepidation and then focus on the silver linings of the NHP 2017.

Some trepidation:

While explaining the reasons for my trepidation, I shall go back to what I said even before. Over several decades, many of us have tried to ferret out the reasons of giving low national priority to provide access to reasonably affordable, quality public health care to all its citizens by the successive Governments in India but in vain. The quest to know its rationale becomes more intense, as we get to know, even some developing countries in Asia, Africa and Middle East are taking rapid strides to catch up with the health care standards of the developed countries of the world.

In the last few years, many such countries, such as, Thailand, Turkey, Rwanda and Ghana, besides China, have successfully ensured access to quality and affordable health care to their citizens through well-structured national initiatives. The Governments of economically poorer countries, such as, Sri Lanka and Bangladesh too are making rapid progress in this direction, protecting the most vulnerable populations in their respective countries from getting sucked into extreme poverty.

In this context, it will be worthwhile recapping that the NHP 1983, which was revised in 2002, also recommended an increase in public health expenditure to 2.0 percent of GDP in 2010. Not too long ago, in October 2010, the then Government in power constituted a ‘High Level Expert Group (HLEG)’ on Universal Health Coverage (UHC) under the chairmanship of the well-known international medical expert Prof. K. Srinath Reddy. The HLEG was mandated to develop a framework for providing easily accessible and affordable health care to all Indians. The HLEG Report defined UHC as follows:

“Ensuring equitable access for all Indian citizens, resident in any part of the country, regardless of income level, social status, gender, caste or religion, to affordable, accountable, appropriate health services of assured quality (promotive, preventive, curative and rehabilitative) as well as public health services addressing the wider determinants of health delivered to individuals and populations, with the government being the guarantor and enabler, although not necessarily the only provider, of health and related services”.

That said, the reality is, even in the Union budget for 2017-18, the public spending on health keeps hovering around abysmal 1 percent of the GDP. The Union Budget Allocations for several critical health related programs have either remained just around the same as before, or have declined, in real terms. Almost similar trend is noticed in the States, as well. For example, according to the latest Maharashtra State Budget for 2017-18, the State has decided to spend much less on its medical and public health sector schemes in the forthcoming financial year.

Thus, leaving aside implementation of the most critical 1983 NHP goal of providing “Health for all by the year 2000 A.D”, even in 2017 India continues to grapple with the same sets of challenges for ensuring adequate availability, accessibility, affordability, and high quality of comprehensive health care for all.

Some silver linings:

Let bygones be bygones. Let me now focus on the silver linings of the NHP 2017.

Besides gradually raising public expenditure for health care from the current around 1.2 percent to 2.5 percent of GDP, following are examples of some silver linings as I see enshrined in several key objectives of the new health policy, besides several others:

Progressively achieve Universal Health Coverage: Assuring availability of free, comprehensive primary health care services; ensuring improved access and affordability, of quality secondary and tertiary care services through a combination of public hospitals and the strategic purchasing of services in health care deficit areas, from private care providers, especially the not-for profit providers; achieving a significant reduction in out of pocket expenditure due to health care costs with reduction in proportion of households experiencing catastrophic health expenditures and consequent impoverishment.

Reinforcing trust in Public Health Care System: Strengthening the trust of the common man in the public health care system by making it predictable, efficient, patient centric, affordable and effective, with a comprehensive package of services and products that meet immediate health care needs of most people.

Align the growth of the private health care sector with public health goals: Influence the operation and growth of the private health care sector and medical technologies to ensure alignment with public health goals.

Achieve specific quantitative goals and objectives: These are outlined under three broad components viz. (a) health status and program impact, (b) health systems’ performance and (c) health system strengthening. These goals and objectives are aligned to achieve sustainable development in the health sector in keeping with the policy thrust.

I was encouraged to note a few more silver linings, especially the following ones, from various different areas of the NHP 2017, which:

Intends to achieve the highest possible level of good health and well-being, through a preventive and promotive health care orientation, besides its emphasis on allocating up to two-thirds or more of resources to primary care followed by secondary and tertiary care.

Plans creation of Public Health Management Cadre in all States to optimize health outcomes and National Health Care Standards Organization to maintain adequate standards in public and private sector.

Advocates extensive use of digital tools for improving the efficiency and outcome of the health care system by creating a National Digital Health Authority (NDHA) to regulate, develop and deploy digital health covering the entire process of health care, besides encouraging the application of the ‘Health Card’ for access to a primary health care facility and services anytime, anywhere.

States that Health Technology Assessment (HTA) is an important tool to ensure that technology choice is not only participatory, but also guided by considerations of scientific evidence, safety, cost effectiveness, social values; and commits to the development of an institutional framework and required capacity for HTA’s quick adoption.

Assures timely revision of the National List of Essential Medicines along with the appropriate price control.

Promotes compliance to right of patients to access information on condition and treatment.

The high and low points in NHP 2017:

As I see it, following are - just one each - the most critical high and low points in NHP 2017:

A high point:

NHP 2017 making a categorical promise to increase public health spending to 2.5 percent of GDP in a time-bound manner, guaranteeing Universal Health Care (UHC), is indeed not just encouraging, but also a high point in its silver linings. This is because, without adequate Government spending in this area, it’s just not possible to give shape to UHC, however robust a national health policy is on paper.

A low point:

The draft version of the NHP 2017 had proposed making health a fundamental right for Indian citizens – quite like denial of health is an offence, and reiterated on enactment of this law as follows:

“Many industrialized nations have laws that do so. Many of the developing nations that have made significant progress towards universal health coverage, such as Brazil and Thailand, have done so, and … such a law is a major contributory factor. A number of international covenants to which we [India] are joint signatories give us such a mandate – and this could be used to make a national law. Courts have also rulings that, in effect, see health care as a fundamental right — and a constitutional obligation flowing out of the right to life.”

The draft NHP 2015 also assured, “The Centre shall enact, after due discussion and at the request of three or more states a National Health Rights Act, which will ensure health as a fundamental right, whose denial will be justiciable.”

Thus, one of the lowest points or most disappointing aspects of the NHP 2017, as compared to its draft version, is the absence of the intent of having a National Health Rights Act. This change makes UHC yet another promise, just as before, without any strong legal backing. As many experts believe, when legal rights and mechanisms institutionalize collaborative goals, methods, and service delivery, they create legally binding duties. Government agencies, patient advocates, and the public can invoke such laws to urge collaboration and seek required public health care services, as promised, always.

The reason behind general expectations for the National Health Rights Act, is mainly because previous National Health Policies also assured ‘health for all’ within a given time-frame. The same promise was also carried through by various successive Governments in the past, but did not come to fruition. Nothing has changed significantly on the ground related to public health care, not just yet. Hence, exclusion of the proposed section of this Act in the final version of the NHP 2017 is a low point for me.

The trepidation lingers. Will it be or won’t it be, yet another repetition of the Government promises made through NHPs or otherwise, is the moot question now.

In conclusion:

Specific time frame for achieving most of these policy objectives and intents are still awaited.

Nonetheless, while a robust health policy for a new India, and a commensurate increase in Government spending on public health is much warranted, building a well integrate, comprehensive and accountable health infrastructure that will be sensitive to public health care needs of the country, should assume top priority today.

There exists an 83 percent shortage of specialist medical professionals in the Community Health Centers (CHCs) of India, according to the Rural Health Statistics 2015 released by the Ministry of Health & Family Welfare, which was reported by IndiaSpend on September 21, 2015. Again, on February 27, 2016, quoting similar Government Data, IndiaSpend reported that public-health centers across India’s rural areas – 25,308 in 29 states and seven union territories – are short of more than 3,000 doctors, the scarcity rose by 200 percent (or tripling) over 10 years.

Other sets of similar data on the grossly inadequate number of doctors, nurses, paramedics and hospital beds per thousand population in India, coupled with frugal rapid transportation facilities in the vast and remote areas of the country, send a clear signal that capacity building in these areas can’t wait any longer. It has been always essential, but did not feature in the ‘to-do’ list of the Government, until now. In that sense, silver linings in the NHP 2017 open the door of great expectations, especially for UHC, despite some trepidation.

Reasonably well-crafted and robust NHP 2017, needs to be integrated with similar initiatives of the States, soon. Effective implementation of a comprehensive, well-integrated and time-bound health care strategic plan, with requisite budgetary allocations having a periodic review process and assigning specific accountabilities to individuals, are the needs of the hour. Otherwise, the social and economic consequences of the status quo in the health care space of India, would impede the sustainable growth of the nation, seriously.

To progress in this direction, the prevailing status-quo must be disrupted, now – decisively and with a great sense of urgency. It is imperative for the Government to make each one of us not only to believe it, but also experience the same in our everyday life. It is important for all concerned to remember what none other than Prime Minister Modi tweeted on March 16, 2017: “National Health Policy marks a historic moment in our endeavor to create a healthy India where everyone has access to quality health care.”

The National Health Policy 2017 is in place now, this is the time to walk the talk!

By: Tapan J. Ray

Awaiting The Two To Tango: Pharma Innovation And Public Health Interest

Posted on January 2, 2017 by Tapan Ray

“The rewards for the breakthrough drug discovery must be substantial, but if prices are the only mechanism through which returns on research flow, affordability will be compromised,” articulated an article titled, ‘Pharmaceutical Policy Reform – Balancing Affordability with Incentives for Innovation’, published in The New England Journal of Medicine (NEJM) on February 25, 2016.

The article arrived at this conclusion, on the backdrop of the high prices of prescription drugs becoming an issue of paramount concern, not just in the United States, but across the world. This concern is so acute that it found its way into policy proposals from both the prime candidates, in the American Presidential election held on November 8, 2016.

Through last several decades, healthcare sector in general and particularly the pharmaceutical industry, witnessed many innovations that cure and effectively manage ailments to improve the general quality of life. It enormously impacted the lives of many in the developed countries, and a few others which offer high quality Universal Health Care in a comprehensive format, for all.

A trickle-down impact:

Nevertheless, even no more than its just a trickle-down impact, helped increase overall life expectancy of the population in many developing and poor countries, mostly driven by the expanding number of cheaper generic drugs, fueled by more treatment and disease management options.

The paper titled, ‘World Population Prospects – The 2015 Revision’ of the Department of Economic and Social Affairs, Population Division of the United Nations’ reported that the life expectancy at birth rose by 3 years between 2000-2005 and 2010-2015, that is from 67 to 70 years. All major areas shared in the life expectancy gains over this period, but the greatest increases were in Africa, where life expectancy rose by 6 years in the 2000s, after rising by only 2 years in the previous decade.

Similarly, the global life expectancy at birth is projected to rise from 70 years in 2010-2015 to 77 years in 2045- 2050 and to 83 years in 2095-2100. Africa is projected to gain about 19 years of life expectancy by the end of the century, reaching 70 years in 2045-2050 and 78 years in 2095-2100. Such increases are contingent on further reductions in the spread of HIV, and combating successfully other infectious as well as non-communicable diseases.

The availability of cheaper generics gave some respite:

Out of a total population of 7.3 billion, as the above report says, the World Bank estimated that in 2013, 767 million people still lived on less than US$ 1.90 a day. Unfortunately, despite the greater availability of a large variety of cheaper generic drugs, the basic health care remains elusive to hundreds of millions of people in the world.

What causes more concern is the fact that 6 percent of people in low and middle-income countries are tipped into or pushed further into extreme poverty because of health spending, as the June 12, 2015 report of the World Health Organization (W.H.O) and the World Bank highlights. W.H.O has estimated that over a billion population of the world still suffer from neglected tropical diseases.

How many people benefitted from pricey patented drugs?

Nevertheless, despite so much innovation in the pharma industry, access to these new drugs remains elusive to a large section of even some the most developed nations, such as the United States, as they can’t afford these high-priced drugs. The overall situation, in this regard, is going from bad to worse. For example, the March 16, 2015 study published in the Mayo Clinic Proceedings reveals that the average annual cost of cancer drugs increased from roughly US$ 10,000 prior to 2000 to an astounding over US$ 100,000 by 2012.

Further, an August 31, 2015 article published in the ‘Health Affairs’ also gave examples of Biogen Idec’s multiple sclerosis drug, Tecfidera, which costs US$ 54,900 per patient per year; hepatitis C cures from Gilead Sciences, with a sticker price of $84,000 per patient; and Orkambi, a cystic fibrosis drug from Vertex Pharmaceuticals approved this month, priced at a whopping US$ 259,000 per year. A Kaiser Health Tracking Poll last July 2015 found that 73 percent of Americans find the cost of drugs to be unreasonable, and most blamed drug manufacturers for setting prices too high, the article stated.

The health care scenario in India is no better:

A study conducted by the ‘National Sample Survey Organization (NSSO)’ from January to June 2014, which was the 71st round of the ‘National Sample Survey’, and published in the ‘Health in India’ report, narrates a very gloomy picture for India, especially for a clear majority of those who incur ‘out of pocket’ expenses on medicines. The report states, out of all health expenditure, 72 percent in rural and 68 percent in urban areas was for buying medicines for non-hospitalized treatment.

Thus, many patients cannot afford health services, even when these are needed the most. As many as 68 percent of patients in urban India and 57 percent in rural areas attributed “financial constraints” as the main reason to take treatment without any medical advice, the report adds.

In this situation, the challenges that the Governments and the civil society are facing in many developing, and to some extent even in some developed countries, though for different reasons, are multi-factorial. It has been well established that the humongous global health care challenges are mostly of economic origin.

Pharma innovation benefitted the developed countries more:

A study titled, ‘Pharmaceutical innovation and the burden of disease in developing and developed countries’ of Columbia University and National Bureau of Economic Research, to ascertain the relationship across diseases between pharmaceutical innovation and the burden of disease both in the developed and developing countries, reported that pharmaceutical innovation is positively related to the burden of disease in the developed countries but not so in the developing countries.

Making the two to tango:

These facts prompt the need to make the pharma innovation and public health interest to tango. Several suggestions have been made and initiatives taken in this direction. Some of which are as follows:

Responding to this need, in 2006 W.H.O created the ‘Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)’. The primary focus of IGWG is on promoting sustainable, needs-driven pharmaceutical R&D for the diseases that disproportionately affect developing countries. One positive effect of this global debate is that some global pharmaceutical companies have initiated their R&D activities for neglected tropical diseases, such as, Malaria and Tuberculosis. Many charitable organizations like, Bill & Melinda Gates Foundation and Clinton Foundation, are allocating significant funds for this purpose.

A paper titled, “Optional reward for new drugs for developing countries” published by the Department of Economics, University of Calgary, Institute of Health Economics, proposed an optional reward fund for pharmaceutical innovation aimed at the developing world to the pharmaceutical companies, which would develop new drugs while ensuring their adequate access to the poor. The paper suggests that innovations with very high market value will use the existing patent system, as usual. However, the medicines with high therapeutic value but low market potential would be encouraged to opt for the optional reward system. It was proposed that the optional reward fund should be created by the governments of the developed countries and charitable institutions to ensure a novel way for access to innovative medicines by the poor.

‘Open Innovation’ or the ‘Open Source Drug Discovery (OSDD)’ is another model of discovering a New Chemical Entity (NCE) or a New Molecular Entity (NME). Imbibing ‘Open Innovation’ for commercial results in pharmaceuticals, just has what has happened to android smartphones, would encourage drug discovery initiatives, especially for the dreaded disease like cancer, to make these drugs affordable for a very large section of people across the globe. In this model, all data generated related to the discovery research will be available in the open for collaborative inputs. In ‘Open Innovation’, the key component is the supportive pathway of its information network, which is driven by three key parameters of open development, open access and open source. This concept was successfully used in the ‘Human Genome Project’ where many scientists, and microbiologists participated from across the world to sequence and understand the human genes. Currently, pharmaceutical R&D is a well-protected in-house initiative of innovator global companies to maximize commercial benefits. For this reason, only a limited number of scientists working for the respective innovator companies will have access to these projects. In India, the Council of Scientific and Industrial Research (CSIR) is the champion of the OSDD movement, locally. CSIR believes that for a developing country like India, OSDD will help the common man to meet his or her unmet medical needs in the areas of mainly neglected tropical diseases.

Conclusion:

Thus, the ongoing heated debate on Innovation, Intellectual Property Rights (IPR) and Public Health Interest is gathering steam all over the globe.

Argumentative Indians are also participating in this raging debate. I reckon rightly so, as India is not only the largest democracy of the world contributing 16.7 percent of the global population, it is also afflicted with 21 percent of the global burden of disease. Considering this, the reason for similar heated debate in our country is indeed no-brainer to anyone.

Many would possibly not disagree, both encouraging innovation and safeguarding the public health interest are equally important to any society, be it in the developed nations or developing countries. Nevertheless, some constituents of ‘Big Pharma’ and their trade association still highlight that ensuring access to high price innovative drugs is the responsibility of the respective Governments. Any other regulatory mechanism to bring down such prices will be construed as a barrier to encouraging, protecting and rewarding innovation.

Be that as it may, most other stakeholders, across the world, especially the patients, are awaiting these two goals to tango. From that point, I reckon, giving a quick shape to commercially well-tested initiatives, such as, ‘Open Innovation’ model could well be an important step to ensure access to innovative new medicines for a larger number of patients of the world, meeting their unmet medical needs with greater care.

By: Tapan J Ray

Escalating Antibiotic Resistance, And Thwarting Ban Of Irrational FDCs

Posted on November 21, 2016 by Tapan Ray

September 2016 ‘Fact Sheet’ of the World Health Organization (W.H.O) raised a red flag on fast increasing incidence of Antimicrobial Resistance (AMR). It poses a serious threat to global public health, more than ever before. Consequently, effective prevention and treatment of an ever-increasing and complex range of infections caused by bacteria, parasites, viruses and fungi are becoming more and more challenging.

In this situation, various medical procedures, such as, organ transplantation, cancer chemotherapy, diabetes management and major surgery like, caesarean sections or hip replacements, invite much avoidable a very high element of risk.

Further, a July 2014 paper titled ‘Antibiotic resistance needs global solutions’, published in ‘The Lancet’ reports increase of incidences of drug-resistant bacteria at an alarming rate. In fact, antibiotic resistance is one of the most serious threats in the history of medicine, and new antibiotics and alternative strategies should be sought as soon as possible to tackle this complex problem.

Another more recent paper titled ‘Fixed-dose combination antibiotics in India: global perspectives’, published in ‘The Lancet’ on August, 2016 finds that nowhere in the world this problem is as stark as in India. It emphasizes that the crude infectious disease mortality rate in India today is 416.75 per 100,000 persons, which is twice the rate prevailing in the United States. Misuse, or rather abuse, of Antibiotics is a major driver of resistance. In 2010, India was the world’s largest consumer of antibiotics for human health, the paper says.

Thus, this critical issue calls for urgent action across all government sectors and the society, in general, as W.H.O cautions.

The Devil is also in irrational antimicrobial FDCs:

The reasons for the fast spread of antimicrobial resistance are many, and each one is well documented. One such factor is the use of irrational antimicrobial FDCs. Some of these have already been banned by the Union Government of India, though continue to be manufactured, promoted, prescribed, sold and consumed by the innocent patients unknowingly.

In this article, I shall focus on the banned FDCs of such kind, highlighting how the consequential serious threat to public health and safety is repeatedly getting lost in the cacophony of protracted court room arguments against these bans.

Irrational FDCs and antimicrobial resistance:

That ‘irrational’ FDCs of antibiotics very often hasten the spread of antimicrobial resistance, is now a well-documented fact.

The ‘National Policy for Containment of Antimicrobial Resistance in India 2011’ clearly recognizes that: “Antimicrobial resistance in pathogens causing important communicable diseases has become a matter of great public health concern globally including our country. Resistance has emerged even to newer, more potent antimicrobial agents like carbapenems.” The Policy also recommends removal of irrational antibiotic FDCs from the hospital drug list.

‘The Lancet’ article of August, 2016, as mentioned above, also reiterates, while citing examples, that “Studies of several antibiotic combinations, such as meropenem and sulbactam, have reported no additional advantage over their individual constituents, and have been reported to cause toxic reactions and promote resistance. Despite repeated investigations into the shortcomings of some FDCs, such drugs are still being manufactured and promoted on the Indian drug market.”

Why does it matter so much?

Corrective regulatory measures to contain the spread of antibiotic resistance are absolutely necessary in India, for the sake of the patients. According to a paper titled ‘Antibiotic Resistance in India: Drivers and Opportunities for Action’, published in the PLOS Medicine on March 2, 2016: “Out of around 118 antibiotic FDCs available in the Indian market, 80 (68 percent) are not registered with the Central Drugs Standard Control Organization (CDSCO). Moreover, 63 (19 percent) of around 330 banned FDCs are antibiotics.”

The global relevance:

Such regulatory bans of antimicrobials FDCs in India are important from a global perspective too, as ‘The Lancet’ article of August 2016 observes.

The article recapitulates that the ‘New Delhi metallo-β-lactamase’ – an enzyme that causes bacteria to be resistant to antibiotics, was first reported in India in 2008 and is now found worldwide. The growth of worldwide trade and travel has allowed resistant microorganisms to spread rapidly to distant countries and continents. In addition, some of these banned FDCs in India are reported to be exported to African and Asian countries too.

That said, each country will also need to play a significant role to curtail the abuse or misuse of antibiotics, locally. I find a glimpse of that in England, besides a few other countries.

A research paper of Antibiotic Research UK and EXASOL dated November 12, 2015, concluded that overall antibiotic prescriptions are coming down across England. However, the same paper also articulated that in the deprived areas of the country, such as Clacton-on-Sea, antibiotic prescribing rates are almost twice the national average.

Some big MNCs are no different:

In the Government’s ban list of irrational FDCs even some top brands of pharma MNCs feature, including antibiotic FDC of antibiotics. For example, on Mar 14, 2016, Reuters reported that one of the largest pharma MNCs operating in India – Abbott Laboratories, was selling a FDC of two powerful antibiotics Cefixime and Azithromycin, without approval of the DCGI. This could possibly be a legacy factor, arising out of its acquisition of a good number of branded generic drugs, together with their management, from a domestic pharma company. Abbott, otherwise is well regarded by many as a distinguished global institution, practicing high standards of business ethics and values, across the world.

Be that as it may, this powerful antibiotic cocktail that poses huge health risk to patients has reportedly not received marketing approval in the major global pharma markets, such as, the United States, the United Kingdom, Germany, France or Japan.

The Reuters report also elaborates that the drug ‘had been promoted and administered as a treatment for a broad array of illnesses, including colds, fevers, urinary tract infections, drug-resistant typhoid and sexually transmitted diseases.’ It also found chemists who were selling the drug to prevent post-operative infection and for respiratory problems. After the ban, the company has reportedly stopped manufacturing and sales of this antibiotic FDC.

Irrational FDC ban – a significant corrective measure:

Keeping all this in perspective, the regulatory ban on irrational FDCs of antibiotics on March 10, 2016, along with products falling in several different therapy areas, was a significant regulatory measure, among many others, to contain the menace of AMR in India.

Unfortunately, quite a lot of these formulations are still in the market, actively promoted by their manufacturers and widely prescribed by the doctors, till date. This is mainly because, to protect the revenue and profit generated from these brands, concerned pharma companies have obtained an injunction from various high courts against the ban, which was notified by the Government, earlier.

Thwarting FDC ban – a key issue:

Looking back, 294 FDCs were banned by the DCGI in 2007. At that time also, the same important issue of patients’ health, safety and economic interest got caught in an intriguing legal quagmire. As a result, implementation of the Government’s decision to ban of these irrational FDCs got delayed, indefinitely.

Added to this, irrational antimicrobial FDCs featuring in the ban list of March 10, 2016, got trapped in exactly the same legal battle, yet again. Thus, repeated stalling of Government ban on irrational FDCs, including antibiotics, continue to remain a key health and safety issue in India.

The latest development:

In September 2016, the Union Government has reportedly moved the Supreme Court of India in defense of its March 2016 ban on irrational FDCs.

In its petition, the Union Government has reportedly urged that all cases against the orders related to ban of ‘irrational’ FDCs, now being heard in various High Courts across the country, be transferred to the apex court and heard as a single case. The move is expected to cut any ambiguity that could arise from differing verdicts between high courts.

In case of a verdict favoring the ban of all the notified irrational FDCs, scores of patients will be benefited by not just falling victims to possible health menace arising out of such unjustifiable drugs, as the Government argues, but also due to expected containment of rapid spread of deadly antimicrobial resistance in the country.

Conclusion:

With the ban of irrational FDCs, the Union Ministry of Health has taken one of the much-needed steps to restrict antibiotic resistance in India, besides addressing other health and financial menace caused by such drugs.

The support of the Apex court of India to urgently resolve this legal jig-saw-puzzle, would also help control, though not in a holistic way, the scary antibiotic resistance challenge in India. In that process India would possibly be able to contribute its little bit towards the antibiotic resistance challenge, across the world, if we consider the ‘New Delhi metallo-β-lactamase’ case as a glaring example in this area.

It is, therefore, widely expected that for the greater public interest, the honorable Supreme Court may view this important health and safety issue accordingly, while pronouncing its final verdict. If and when it happens, hopefully soon, the prevailing industry practice in the country to make profits with dubious drug cocktails sans any robust medical rationale, basically at the cost of patients, can’t possibly be thwarted any longer, and will be effectively implemented on the ground.

By: Tapan J. Ray

Counterfeit Drugs In India: A Malady Much Deeper

Posted on October 24, 2016 by Tapan Ray

Many debates and discussions continue being lined up in India almost regularly, generally by the pharma trade associations, besides a few others, on the issue of counterfeit drugs. A good number of these events are sponsored by the global and local anti-counterfeit product manufacturers and the related service providers, presumably to get a captive pharma audience. By and large, these gatherings are well publicized, and very rightly so, to focus for a while on this growing menace in the country.

One of the key objectives of such proceedings, I reckon, besides recommending the immediate action steps for the government in saddle, is to encourage the manufacturers of high quality drugs to protect their brands from the onslaught of counterfeiters through anti-counterfeit measures. Several of these involve a state of the art non-cloning technology. The core message that gets filtered-through, in most of these occasions is, if the suggested steps are followed by the drug companies with the related products and services, these won’t just help protect the patients’ health interest, but also provide a boost to the top and bottom lines in the pharma business, significantly.

There are no qualms about this initiative, not at all. Nonetheless, can this be considered a holistic approach to tackle the menace of counterfeit drugs, especially by the pharma players in India, and considering various other different ways the menace keep striking the patients, so surreptitiously?

Thus, in this article, my point of focus will be on a critical question, which is not asked with the same vigor always in many of the above events: Hasn’t the malady of counterfeit drugs in India spread much wider, and taken its root considerably deeper?

Counterfeit drugs and what it includes?

According to the World Health Organization (W.H.O), there is currently no universally agreed definition among its member states in what is widely known as ‘Counterfeit medicines’. Nevertheless, W.H.O does indicate that the term ‘counterfeit’ is widely used to include falsified, unlicensed, falsely packaged, stolen and substandard medical products. Jurisdictions across the world define counterfeit medicines in many different ways.

It’s worth noting here, according to W.H.O, substandard medical products also belong to this category. In 2009, W.H.O defined ‘substandard’ drugs as “genuine medicines produced by the manufacturers authorized by the NMRA (national medicines regulatory authority) which do not meet quality specifications set for them by national standards”.

Hence, notwithstanding whatever will be accepted as the general consensus of the W.H.O members on the definition of counterfeit drugs, from the patients’ perspective, any drug failing to meet with the claimed efficacy, safety and quality standards, should come under the same ‘category definition’, including substandard drugs.

Controversy over the term ‘Counterfeit’:

Many W.H.O member countries believe that the term counterfeit is closely associated and legally defined within the Intellectual Property (IP) legislation, and concentrates on trademark protection. Consequently, usage of this terminology has been perceived to have reduced the focus from what is first and foremost a public health issue. Thus, it has become quite important for W.H.O to separate the different categories of what is widely used as ‘counterfeit drug’, for the purpose of analysis and identifying strategies, to effectively address the issue of the public health menace that such activities give rise to.

Types of counterfeit drugs:

A Review Article titled “Anti-counterfeit Packaging in Pharma Industry” dated February 17, 2011, published in the “International Journal of Pharmacy and Pharmaceutical Sciences”, divided the types of counterfeit mechanisms into five categories, in which drugs are manufactured or distributed without proper regulatory clearance, and do not meet the determined standards of safety, quality, and efficacy:

No active ingredient (43 percent)
Low levels of active ingredient (21 percent)
Poor quality drugs (24 percent)
Wrong ingredients (2 percent)
Wrong packaging or source (7 percent)

This particular article will dwell mainly on a very important segment in this category – the substandard or poor quality drugs.

The magnitude of the problem:

On May 17, 2016, a Research Article titled, “Public Awareness and Identification of Counterfeit Drugs in Tanzania: A View on Antimalarial Drugs”, published in ‘Advances in Public Health’ – a peer-reviewed, open access journal that publishes original research articles, highlighted something that should cause a great concern not just for the Indian drug regulators, but also the Indian pharma manufacturers, in general.

The research paper, besides other points, underscored the following:

“Currently, it is estimated that 10–15 percent of the global drugs supplied are counterfeit. The prevalence is higher in developing countries in Africa and in parts of Asia and Latin America where up to 30–60 percent of drugs on the market are counterfeit. India is a major supplier of poor quality drugs whereby 35–75 percent of fake/counterfeit drugs globally originate from India.”

Another report of ‘Pharmexcil’ dated October 04, 2010 also states: “According to the Organization for Economic Cooperation and Development (OECD), 75 percent of fake drugs supplied world over have origins in India, followed by 7 percent from Egypt and 6 percent from China. India is also a leading source of high quality generic and patent drugs in the legitimate commerce worldwide. Since drugs made in India are sold around the world, the country’s substandard drug trade represents a grave public health threat that extends far beyond the subcontinent.”

Substandard drugs: a potential crisis in public health:

An article with the above title, published in the British Journal of Clinical Pharmacology on November 29, 2013 cautioned on the potential crisis in public health with substandard drugs, as follows:

“Poor-quality medicines present a serious public health problem, particularly in emerging economies and developing countries, and may have a significant impact on the national clinical and economic burden. Attention has largely focused on the increasing availability of deliberately falsified drugs, but substandard medicines are also reaching patients because of poor manufacturing and quality-control practices in the production of genuine drugs (either branded or generic). Substandard medicines are widespread and represent a threat to health because they can inadvertently lead to health care failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals.”

Hence, the potential of health crisis with various substandard drugs is quite similar to other types of counterfeit drugs.

Substandard drugs and small pharma players:

As I said before, the malady of counterfeit, fake and substandard drugs are spreading much wider and deeper in India. What’s happening around today in this area prompts us to believe, it may no longer be proper to keep all the large pharma manufacturers away from the ambit of discussion on substandard or counterfeit drugs. This apprehension is raising its head, as it is generally believed that only small, unknown, or fly-by-night type of drug manufacturers, are responsible for substandard, fake or counterfeit drugs. Whereas, the reality seems to be different. There are now ample reasons to believe that even some large drug manufacturers, both local and global, who have been caught by the regulator for the same wrongdoing, are also equally responsible for causing similar adverse health impact on patients.

Substandard drugs and large pharma players:

That the issue of substandard drugs is quite widespread in India, involving both global and local pharma players – small and large, is also quite evident from the following report, published in the May 14, 2016 edition of the well-reputed national daily – Hindustan Times:

“A day after French major Sanofi announced a recall of some batches of its popular painkiller Combiflam, India’s drug regulator said over 102 medicines have been highlighted for quality concerns and withdrawal in the last five months. The list includes several popular painkillers.”

The report also indicated that these are generic medicines, both with and without brand names, such as, CIP-ZOX of Cipla, Orcerin of MacLeod Pharma, Zerodol-SP of Ipca Laboratories, Pantoprazole of Indian Drugs and Pharmaceuticals Ltd and Norfloxacin of Karnataka Antibiotics & Pharmaceutical Ltd. According to the public notices of the Central Drugs Standard Control Organization (CDSCO), these batches were manufactured in June 2015 and July 2015, and carried expiry dates of May 2018 and June 2018.

The CDSCO also reportedly said that in notices posted on its website in February and April, 2015, it found some batches of Combiflam to be “not of standard quality” as they failed disintegration tests. The point to note is, according to the US-FDA, disintegration test is used to assess the time it takes for tablets and capsules to break down inside the body and are used as a quality-assurance measure.

“All drugs listed under the drug alert list should be recalled with immediate effect. We have found some serious problems with the making of the drug because of which we have highlighted quality concerns. Hence, recall is necessary for all companies,” GN Singh, the Drug Controller General of India (DCGI), reportedly told the above newspaper.

Should the ‘intent behind’ be considered as the key differentiating factor?

This takes me to another question: What’s the ‘intent behind’ manufacturing substandard drugs? It is not difficult to make out that the only ‘intent behind’ manufacturing substandard drugs by illegal, some small or fly-by-night type of drug operators would be to make quick money, by cutting corners, and criminally falsifying the entire process.

Until recently, I used to strongly believe that those large manufacturers who are getting caught for releasing substandard drugs to the market, have made sheer mistakes, and these are no more than minor aberrations. However, recent findings by the US-FDA, after rigorous manufacturing quality audit of several production facilities of large and small generic drug producers of India, make me wonder whether this thin differentiating line of ‘intent behind’ manufacturing substandard drugs, though still exists, has started getting blurred. The foreign regulators have imposed import ban on drugs produced in those facilities on the ground of willingly compromising drug quality, and grossly falsifying data.

I am not going into those much discussed details here, once again, as the drugs involved in the above cases are meant for exports and the import bans, by the foreign regulators were aimed at protecting the health and safety of citizens of those countries. In this article my focus is on India, and health interest of the local Indian population.

Thus fathoming a different ‘intent behind’ manufacturing substandard drugs, especially by the large and well-known manufacturers, is the real challenge. What sort of anti-counterfeit events will be able to possibly address this perturbing issue, that is now getting revealed much faster than even before?

Who in India ensures that all drugs are safe?

Possibly none, not even the drug regulators and the enforcers of the drug laws, as a number of national and international media reports reveal. General public doesn’t get any assurance from any authorities that the medicines sold by the drug retail outlets, pan India, are all standard quality and genuine.

At the same time, it is equally challenging for anyone to ascertain, with absolute certainty, that it’s a counterfeit, substandard or a fake drug, in whatever name we call it, is responsible for avoidable suffering or even death of an individual. In such a sad eventuality, one has no other choice but to accept that the causative factor was either a wrong diagnosis of the disease, or delayed onset of treatment.

Is CDSCO still in a denial mode?

It’s an irony that the government sources often highlight that the incidence of substandard, spurious or fake drugs in India has declined from around 9 percent in the 1990s, to around 5 percent in 2014-15, quoting the CDSCO sample survey findings.

Nevertheless, while looking at the same CDSCO survey results of the last four years – from 2011-12 to 2014-15, the incidence of spurious and substandard drugs in India appears to be static, if not marginally increased, as follows:

Year	Tested Samples	Substandard Samples	Spurious or Adulterated samples	% Failed
2011-12	48,082,00	2,186.00	133.00	4.82
2012-13	58,537.00	2,362.00	70.00	4.15
2013-14	72,712.00	3,028.00	118.00	4.32
2014-15	74,199.00	3,702.00	83.00	5.10

Source: Central Drugs Control Organization (CDSCO)

In my view, these CDSCO results should be taken perhaps with dollops of salt, not merely the sample size for these surveys is too small, but also the complexity involved in the collection of the right kind of samples that will always pass the acid test of independent experts’ scrutiny. Right representational sample size – state-wise, is so important, primarily considering that India is the world’s third-largest pharmaceutical market by volume, consumes 383 billion medicines per annum, according to a 2015 Government report, and is quite a heterogeneous pharma market.

A September 06, 2016 media report well captured the palpable hubris of the Government on this worrying subject. It quoted the Drug Controller General of India (DCGI) – Dr. G N Singh as saying: “This is an encouraging trend when it comes to comparing Indian made generics with that produced in regulated markets. This will help us dispel the myth that India is a source of substandard drugs as compared to any other regulated market.”

Interestingly, other studies and reports do indicate that this menace could well be, at least, thrice as large.

Be that as it may, according to an October 22, 2016 media report, CDSCO is expected to release the findings of the latest survey on ‘spurious drugs’ in India by end October 2016.

Two recent good intents of CDSCO:

Apparently, as a response to the widespread public criticism on this issue, despite being in a denial mode earlier, CDSCO has recently expressed two good intents to address this issue, as follows:

As reported on October 18, 2016, it has sent a recommendation to the Union Ministry of Health to amend the Drugs & Cosmetics Act to facilitate implementation of bar coding and Unique Identification Number (UIN) on every pack of domestic pharma products.

To ensure consistency and uniformity in the inspection process, on May 26, 2016, by a Public Notice, it issued a new draft checklist of ‘Risk Based Inspection of the Pharma Manufacturing Facilities’ for verification of GMP compliance as per the provisions stated under Schedule M of Drugs and Cosmetics Rules, 1945, and sought suggestions from the stakeholders. This checklist would be used by drug regulatory enforcement agencies as a science based tool. It also envisaged that the pharma industry would find this checklist useful for self-assessment.

Let’s now wait and watch, to get to know the timeline of translating these good intents into reality on the ground, and the impact that these decisions will make to reverse the current worrying trend of counterfeit and substandard drugs in India.

Conclusion:

The malady of counterfeit or substandard drugs is not just India centric. Various credible sources have estimated that around a million people fall victim to such so called ‘medicines’, each year. However, unlike many other countries, India still doesn’t have any structured and effective regulatory or other mechanisms, not even any spine-chilling deterrent, in place to address this public health menace of humongous implications.

That said, besides serious health hazards, the adverse financial impact of substandard drugs on patients is also significant. Such drugs, even when non-fatal, are much less effective, if not ineffective or trigger other adverse reactions. Thus, a longer course of treatment, or switching over to a different medication altogether, may often be necessary, multiplying the cost of treatment.

In that sense, substandard, spurious, fake or counterfeit drugs, in whatever name one describes these, increase the disease burden manifold, besides being life-threatening. This issue assumes greater significance in India, where 58.2 percent of the total health expenditure is incurred out-of-pocket by a vast majority of the population. Medicines alone, which are mostly purchased from private retail outlets, across India, account for between 70 and 77 per cent of the individual out of pocket health spending, according to a W.H.O report.

High decibel campaigns on various anti-counterfeit technology solutions for fast selling, or expensive brands of large pharma companies, whether sponsored by placing the commercial interest at the top of mind, or even otherwise, are welcome, so are the two recent good intents of the Union Government, in this area.

However, the desirable proactive focus on curbing the menace of substandard medicines in India, which cause similar health risks as any other type of counterfeit drugs, does not seem to be as sharp, not just yet, barring the pharma export sector. Nor does this issue attract similar zest for a meaningful discourse related to patients’ health and safety within the country, as associated with various other anti-counterfeiting technology solution oriented events. The anomaly remains intriguing, especially when the malady spreads, with its root reaching deeper.

By: Tapan J. Ray

Pharma In 2016 Rio Olympics

Posted on August 29, 2016 by Tapan Ray

On August 4, 2016, the ‘Adweek’ – a well-known weekly American advertising-trade publication, reported that even a day before the games began, the national ad sales revenue of just one major network in ‘2016 Rio Olympics’ had set a new record for itself, exceeding a never before turnover of US$ 1.2 billion. This figure is believed to be the most of any network for any media event in the history of the United States, and includes broadcast, cable and digital advertising.

The strongest advertising categories include automotive, beverages, telecommunications, insurance, movie studios and pharmaceuticals, as the advertisers were exceptionally bullish on Rio Games, the report highlighted.

Another report, published in the August 9, 2016 edition of ‘U. S. News’, states that the Democratic presidential nominee Hillary Clinton also aired US$ 13.6 million in campaign commercials during this Olympic games, far exceeding her nearest rival, seeking to reach the millions of television viewers who can’t skip past the commercials as they watch live coverage of the Olympics. This example underscores the perceived importance of Olympic events to various types and genres of advertisers.

My article will focus on this new found interest of many global pharma companies, their level of participation, with an idea of approximate expenditure to be incurred to run various types of ad campaigns in such well-awaited global events, held once in every four years.

The key advantages and the potential:

One of the key advantages of advertisements during Olympic games is their much larger captive audience and eyeball grabbing power, in every respect, both global and local. This, in turn, offers an attractive opportunity to the advertisers to exploit its immense potential for shaping and re-shaping public opinion and preferences, on various target areas.

Probably for this reason, a wider spectrum of new advertisers, including pharma players have now started favoring this event more than ever before.

Entry of pharma:

According to available reports, about 20 pharma brands and companies ran 293 TV ads during the coverage of Rio Olympic games. Some of these companies ran brand advertisements, while some others selected non-brand disease awareness campaigns, or in a very few instances – both.

According to real time TV ad tracker iSpot.tv, pharma contributed US$ 45 million and occupied the mid-space of the table for blockbuster TV advertisers, during the 17-day Rio events.

Two types of marketing strategies followed:

In Rio Olympics pharma companies had opted for primarily two different types of marketing strategies, as follows:

Product branding
Corporate branding, mainly through disease awareness

Global majors such as, Pfizer (for pain management – Lyrica and anti-inflammatory – Xeljanz), Novo Nordisk (Antidiabetic – Victoza), Bayer and Johnson & Johnson (anticoagulant – Xarelto) and Lundbeck and Takeda (antidepressant – Trintellix), appeared to be brand focused.

Whereas, companies such as, Merck and Mylan were disease awareness focused. Pfizer seemingly opted for both product branding and R&D focused corporate branding.

‘Product Branding’ versus ‘Corporate Branding’:

Product branding is defined as a marketing strategy wherein a business promotes and markets an individual product without the company name being at the center in the advertising campaigns.

Corporate branding, on the other hand, is broadly defined and explained as, the practice of promoting the brand name of a corporate entity, as opposed to specific products or services. The activities and thinking that go into corporate branding are different from product and service branding, because the scope of a corporate brand is typically much broader.

The success parameters:

A product branding is considered successful when it pushes up both the top and the bottom lines of the brand, with a commensurate increase in its top of mind recall and market share.

Whereas, a corporate branding is considered successful, when consumers hear or see the name of the company they will associate with a unique value and positive experiences. No matter what product or service the corporation offers, the corporate name is always an influence.

If I am to cite just one example out of many, and outside the pharma industry, I would say, ‘Apple’ has been established as a powerful corporate brand that focuses on the strength of its name as much as the features of any ‘Apple’ products.

Thus, for any successful corporate brand, the name would immediately evoke a positive reaction in the consumers’ mind, without any detailed list of product features, and for which many consumers would be willing to pay even a premium price, without any grudge or grumble.

Those who kept away from hard selling of a brand:

In Rio Olympics, as stated above, according to recent reports, some large pharma companies, interestingly, preferred to keep themselves away from hard selling of any of their brands. They, on the contrary, chose to make use of this powerful event to facilitate much wider public engagement with important and interesting health issues, like disease awareness, through craftily produced TV clips. The key intent is, of course, enhancing their corporate image to the public at large, for sustainable and long term business excellence.

A few such examples, as witnessed during Rio Olympics, are as follows:

Merck ran an eyeball grabbing, top class and emotional disease awareness ad for HPV vaccinations.

Mylan ran its “Face Your Risk” ad. This clip advises people with allergens to talk to their doctor about a prescription treatment for severe reactions, because every six minutes, someone with life-threatening food allergies is sent to the hospital.

Pfizer, in addition to brand promotion, also ran an interesting, yet fact based campaign, titled “Before it Became a Medicine”. This ad narrates an emotive story of bringing a medicine to life, which is no different from any other process of creation. It requires innovation, imagination, and restless perseverance in the face of obstacles, both expected and unforeseen.

One is a double-edged sword:

Strong high profile brand promotion in the global events such as Rio Olympics, could well be perceived as a double edged sword, having both the up and the downsides.

The upside is of course a strong boost in the sales and profit of the concerned brands. However, there is also a significant downside. When the details of huge pharma marketing expenditure, just on TV ads and also for only a 17- day event though important, would come to public knowledge, it could add more fuel to the fire on the ongoing public criticism towards humongous marketing expenditure, incurred by some pharma players, which at times exceeds the same for even R&D.

This is important, as a very large number of different stakeholders, including the patients, firmly believe that such ‘unnecessary’ expenditures on brand marketing, are ultimately passed on to the final consumers or the payers in terms of high pricing of those brands. Whereas, the possibility of triggering such type negative public opinion, with similar ads and during the similar events, with corporate brand or disease awareness campaigns, I guess, would be rather slim or improbable.

Let me hasten to add, I strongly believe that sales and marketing are absolutely necessary for pharma brands, just as any other branded consumer durables or non-durables. Nevertheless, I would also not brazenly ignore the prevailing reality, and the public optics associated with this sensitive issue, in any way.

How much does it cost?

To answer this question, I would try to give just a feel of the type of deep pocket that an interested pharma advertiser would require to have to get involved on such interesting ball game. During Rio Olympic games, the top three high spending pharma brands, reportedly, were as follows:

Pfizer (the pain medication Lyrica): US$ 9.1 million
Pfizer (the anti-inflammatory Xeljanz): US$ 5.7 million
Novo Nordisk (GLP-1 diabetes treatment Victoza, which featured Olympic gold medal basketball player Dominque Wilkins): US$ 9.2 million

It is worth noting that the top spending brands for consumer product such as Chrysler, spent US$ 25 million on one commercial, along with US$ 15.2 million on another. Similarly, Samsung spent US$ 17.1 million on one ad and US$ 12 million on another one.

Is there any right approach?

Instead of trying to pontificate on what sort of approach is right or wrong for pharma companies in these global events, I would only elucidate, what type of marketing approach could possibly be able to create and leave a stronger and long term residual impact on the viewers’ mind, considering the prevailing global scenario and the general sentiment towards the pharma companies, in general.

I reckon, in the events like the Olympics, it is possible for a pharma player to reap a rich harvest and get a long-term dividend with media outreach, carefully keeping away from hard-selling of clearly identifiable brands. The well-created campaigns may focus primarily on the softer aspects of public health care, such as, caring for patients, disease awareness, making life more enjoyable while fighting a disease, bringing newer drugs for better life, or even achievements in the space of corporate social responsibility.

Conclusion:

Global events such as Rio Olympics, could be well leveraged by the individual pharma players, especially to revamp the generally declining public image for greater overall business predictability and sustainability.

The types of corporate branding that some of us had witnessed in Rio Olympics, have the potential to significantly help achieving this objective.

The realization of the fast declining negative public image of pharma, in general, appears to have dawned on its global trade organizations only now. This has indeed been a long saga, though many pharma players still ignore it, rather unabashedly.

The broader impact of the creation of a positive and robust corporate public image with direct connects with consumers through the relevant ads such as on diseases awareness, could be profound, also for a sustainable business growth, even in a country like India.

Thus, the entry of pharma companies in the widely viewed global events, such as the 2016 Rio Olympics, unravels yet another new strategic platform for many other players. Its multiple judicial use, in tandem with other business blueprints, could facilitate the industry to effectively neutralize and navigate through the strong headwind of negative public perception, while managing the challenge of change.

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

Tag Archives: public

NHPS: “One Nation, One Scheme is Enticing”, But Will It Work?

Health Care in India And ‘Development For All’ Intent

Healthcare in India And Hierarchy of Needs

Awaiting The Two To Tango: Pharma Innovation And Public Health Interest

Escalating Antibiotic Resistance, And Thwarting Ban Of Irrational FDCs

Counterfeit Drugs In India: A Malady Much Deeper

Pharma In 2016 Rio Olympics