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National Health Policy 2017: Some Silver Linings, Some Trepidation

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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

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.

Patient Services Aren’t Optional Any More For Pharma Business Excellence

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In the modern world of abundance of information through various sources and platforms, patients are increasingly looking for greater engagement in their healthcare decision-making process with the doctors, slowly but steadily, and in that process seeking better services from different service providers in this area, including the pharmaceutical companies.

This trend has now been well-captured, globally. Various research studies have conclusively established that greater patient’s engagement in health care contributes to improved health outcomes. The obvious question that surfaces in this context is what is this patient engagement?

Patient engagement:

It broadly means a process that realizes the importance of providing adequate knowledge, skills and related services to people effectively, making them understand various disease management and alternative treatment measures, and thereby facilitating them to be an integral part of their health care related interventions, for better health outcomes.

When patients, physicians, other related constituents, including the pharma companies share both the process and goal of disease management or treatment processes, a win-win situation evolves to everybody’s full satisfaction. This has immense commercial relevance too.

Deserves to be a part of the grand design:

In that sense, pharmaceutical companies, especially those operating in India, would need to roll up sleeves and pull up socks to play a greater role in delivering a better experience for patients through effective engagement and offering relevant high quality services. This exercise now deserves to be an integral part of a grand design and planning of any sales and marketing strategy. A recent survey by Accenture Consulting also concluded that patient services from pharma companies are most important to patients.

Key patient service providers:

Besides several others, especially the following two important constituents can play defining roles as patient service providers by directly engaging with patients, to achieve this objective:

  • Patient advocacy groups or organizations (PAO): These entities provide a special attention to patient care and protection of their rights, and engage them accordingly. Patient advocates of these groups are a liaison between patients and various healthcare providers to improve or maintain a high quality of health care for the former. Some global drug players also recognize that these groups possess a highly influential voice in the healthcare system.
  • Pharmaceutical, biotech or device companies: Some of these companies, mostly in the developed world have established strategic patient advocacy functions within their corporate structure to foster relationships with patients, their caregivers, and the disease-specific nonprofit advocacy groups usually support them. These interactions should ideally ensure that the voice of patients is understood across every function within the company, from R&D to commercialization, as articulated in a recent Whitepaper of BioNJ on this subject.

There is a need to strengthen this approach within the Indian pharma industry, as well, for the benefit of local patients, of course, by scrupulously avoiding any possible serious controversy, which I shall discuss below.

A recent study:

A 2016 report by Accenture concludes that patient services are no longer optional for pharma companies, as they are gradually becoming a cutting edge competitive driver. In a situation like this, the question isn’t whether they should really gear up to offer such services, the immediate need, instead, is to put their ears on the ground to carefully decide which ones would be most appropriate for the individual players, and how best to offer them.

For this study, Accenture surveyed more than 200 patient services executives, covering seven therapeutic areas: heart, lungs, brain, immune systems, bones, hormone/metabolism and cancer. The respondents agreed that much work and greater resources need to be invested in this area to gain a competitive edge in business.

This is further evident from the trend that around 84 percent of pharma companies in the United States plans to invest more in patient-centric services, such as adherence, remote monitoring and medication delivery – over the next 18 months, as the report highlights.

For marketing patient services alone to facilitate direct communications to patients, the digital platforms are most preferred with social media and web page usages being 51 percent and 49 percent, respectively.

A serious concern:

Providing various health related services useful to patients, by the PAOs or by pharma, biotech or device companies separately, without any form of financial relationship or influence of any kind to one another, would probably earn a great appreciation from all stakeholders.

Nevertheless, serious concerns are often expressed on the core intent of various pharma company’s generous funding to various patient advocacy organizations, including the eminent ones involved with patients suffering from cancer, HIV, Alzheimer’s, and other diseases. Several of them don’t even report such contributions, besides providing justifiable explanations on the objectives and actual use of such financial contributions.

If one wants to draw a simile, this is what exactly allegedly happening today, because of such type relationship, between pharma, biotech or device companies on the one hand, and doctors, many other health care providers, including retail chemists, on the other. In the Indian context, as well, it holds good. A paper from ‘CUTS International’, aptly drives home this point. Another September 17, 2016 article published in ‘The New York Times’, reiterates the same.

What’s wrong in funding PAOs?

Some may argue, what’s wrong with pharma industry’s funding the PAOs. On the face of it, there may not appear to be anything wrong either. However, scholarly articles still express serious concern on such practices, mainly for conflicts of interest. For example, a September 2013 article titled, “Patient Advocacy Organizations: Institutional Conflicts of Interest, Trust, and Trustworthiness”, published in The Journal of Law Medicine & Ethics unambiguously states as follows:

“Numerous studies have found that even established and respected researchers and physicians are influenced by drug company money and gifts, which can bias study conclusions and encourage increased prescribing of potentially harmful medications. There is no reason to believe that PAOs are any less susceptible to such influence. In fact, there is little oversight of relations between PAOs and their for-profit donors, which in itself increases the potential for undue influence. Similar concerns regarding the lack of oversight have been raised regarding the physician professional groups that develop clinical care guidelines.”

Why is it a potential conflict of interest?

Many construe such financial relationships as potential conflicts of interest, because pharma players appear to be more interested in earning maximum possible profit through high drug pricing, while PAOs advocate for highly efficacious, safer and more affordable medicines for all, besides some other interests and rights of patients. Moreover, some large constituents of patient advocacy groups aren’t even seen lending their voices to the concerted protests of other stakeholders, including the political leaders – irrespective of their affiliations, against the sharp increase in prices of many life-saving drugs, covering both patented and generic medicines.

Several studies on this concern: 

A March 02, 2017 report titled, “Conflicts of Interest for Patient-Advocacy Organizations”,

published in ‘The New England Journal of Medicine (NEJM)’, probably vindicates this point. This is mainly because, if pharma funding gets reciprocated through their remaining quiet, passive or even indirectly supporting any possible bias in the physicians prescribing decisions for high cost drugs – having other cheaper alternatives, that may not be in the best health and economic interest of many patients.

After examining and analyzing 104 large patient-advocacy organizations with an annual revenue of minimum USD 7.5 million, the researchers of the above study found that 83 percent of PAOs receive significant financial support from drug, device and biotechnology companies; and more interestingly, industry executives often serve on these groups’ governing boards.

Another article on this report commented though, that this study may have some limitations as the most organizations examined in this study did not provide exact figures for their reported donations, besides only 10 percent of patient-advocacy organizations revealed how they used the industry donations.

This NEJM study is not just one of its kind, another January 2017 report published in JAMA Internal Medicine, also concluded that there is a need to improve this conflict of interest issue of the patient advocacy groups or PAOs on their conflict of interest policies to help maintain public trust.

In conclusion:

Keeping aside altogether the contentious issue of funding PACs by the pharma, biotech or device companies, I would submit that it’s about time that the pharma industry in India realizes that patients have started perceiving themselves as consumers of health care. This perception is increasing by a manifold with improving access to not just the Internet, but consequent word of mouth sharing of such information with even those who do not have digital or health literacy.

The quest of many patients to ride the crest of this wave by gaining relevant information, especially through numerous digital platforms, besides word of mouth, is increasing. A lot more would eventually seek a wide range of relevant information on various disease treatment options and their effective management processes. Facilitated by this knowledge, many patients would opt only for those ones offering the best value within their respective economic means. Some enlightened individuals have already started expressing their preference to take part in the treatment and prescribing decision making process with the doctors. This visibly ascending trend is unstoppable now, as patients increasingly perceive themselves as consumers of health care.

Consequently, the pharma, biotech or device players in India would require to deeply understand the patients’ needs on the ground, not what they think those are, and treat patients as the key partner for business excellence – at least, as much as what they consider for other stakeholders, such as doctors and hospitals, if not even much more than that. Some companies are trying to make it happen through doctors, which don’t seem to be working as much as these should, according to another Accenture study.

Currently, several global pharma, biotech or device players claim that they follow ‘patient-centered’ approaches, and try to drive home this point through advocacy campaigns. However, many stakeholders don’t buy it any more. This is because such an approach must always lead to a win-win outcome. It, therefore, requires passing the acid test of conformance to the very definition of a ‘patient-centered’ approach, which requires establishing a partnership to ensure that all related decisions would respect patients’ wants, needs and preferences and solicit patients’ input on the education and support they need to make decisions.’

Thus, respective players in this arena need to shift gears fast, as the ball game is fast changing with its traditional version unlikely to yield the desired business results any longer. The name of the new version of this game is ‘direct engagement with patients’ to impart high quality of meaningful services in the therapy areas that the respective companies are in, by charting clear, innovative and well integrated strategies, and not just through single minded focus on sales and marketing. It’s important for all of us to realize that providing patient services aren’t optional any more for pharma business excellence.

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.

Digital Divide And Indian Pharma Industry

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Over the last one and half decades of this new millennium, despite making significant headway in digital literacy, fueled by consistent progress in the penetration of broadband Internet and availability of more affordable smartphones, a large section of Indian population is still not digitally literate, not even in its importance and awareness, creating a sharp digital divide in the country.

This populace with inadequate or no digital literacy spans across a large section of our society, such as those who are generally poor, many living in rural areas, or lacking in adequate digital awareness, or exhibiting strong preferences in adhering to traditional approaches of doing things, or differently abled individuals, and many elderly persons.

In the health care arena, this citizenry constitutes one of the most vulnerable segments of the society often posing serious health risks, and mostly unable to make use of various digital tools while availing several social sector benefits of the government, as and when required.

However, more concerning is the fact that this gap is not just quite significant, there does not seem to be any near-term possibility of bridging it, either, as all accompanying responsibilities now lying on the government alone. Effective measures to bridging this gap do not depend on just technology, as the issue is multidimensional in nature, necessitating participation of all the stakeholders, pharma included – for a quantum leap in the business growth too.

This should not go unnoticed and unappreciated. Addressing this scenario effectively would call for a different strategic approach – not the usual run of the mill type ad hoc measures, both by the government, and in healthcare, also by the pharma marketers. In this article, I shall dwell in this area.

What it means?

In the modern era, the term ‘digital divide’ broadly refers to the gap between demographics and regions that have access to modern Information and Communications Technology (ICT), and those who don’t or have restricted access to it. Post late 1990s, this terminology is primarily used to describe the split between those with and without Internet access, particularly broadband.

In the global perspective, according to ‘Tech Target’ – the global network of technology-specific websites, the ‘digital divide’ typically exists between those in cities and those in rural areas; between the educated and the uneducated; between socioeconomic groups; and between the more and less industrially developed nations. Even among populations with some access to technology, the digital divide can be evident in the form of lower-performance computers, lower speed wireless connections, lower-priced connections, such as dial-up, and limited access to subscription-based content. The report also points out, while adoption of smartphones is growing, even among relatively lower-income groups, the cost of various data plans and the difficulty of performing tasks and transactions on smartphones continue to inhibit the closing of the gap.

To a large extent, this is applicable to India, as well.

It’s not just a technological issue:

Bridging the ‘digital divide’ in health care is not just a technological issue. It’s rather a complex one with many dimensions. It also depends on the health literacy of individuals, or a society, or the location where they live in. The World Health Organization (WHO) defines health literacy as: ‘The cognitive and social skills which determine the motivation and ability of individuals to gain access to, understand, and use information in ways which promote and maintain good health.’

This is not just the ability of a person to understand the health messages, it also involves the individual’s ability to look for the required information, and taking further action accordingly. As a December 2016 study of Michigan State University Extension concludes, those who are more likely to experience low health literacy are, older adults, racial and ethnic minorities, people with less than a high school diploma, people with low income levels, facing language issue for communication and those with compromised health status, such as chronic health conditions. Culture and access to resources also affect people’s health literacy. Another October 2016 study published in the Journal of Medical Internet Research, establishes the connection between low health literacy and the skepticism on health technologies.

Effectively bridging ‘digital divide’ alone, may not resolve the issue of health literacy. Neither, just addressing the health literacy can bridge the gap of ‘digital divide’, effectively. Thus, there isn’t any ‘one size fits all’ type of solution, to address both these issues, for a synergistic outcome in improving affordable access to quality health care for all.

Bridging the ‘Digital Divide’:

That said, bridging the digital divide, especially in the healthcare segment, has immense relevance in the modern days. As PwC’s Global Digital IQ Survey report of May 2016 observes, health care is arguably one of the world’s most information-intensive sectors, and the opportunities to improve quality, encourage affordability and enhance the consumer experience are vast. Wider application of digital technology can help this sector tackle many of these pressing challenges, effectively. However, the sector is currently behind the curve, the report highlights.

According to another 2016 report by PwC on Indian healthcare, the digital connectivity of the country is expected to grow from 15 percent access in 2014 to 80 percent access in 2034, with rural Internet users increasing by 58 percent annually, which presents a great potential for telemedicine and remote diagnosis in the country. This is indeed encouraging.

Can pharma industry hasten the process?

As I said before, bridging the ‘digital divide’ and improving health literacy, may be construed by many as a primary responsibility of the Indian government, through various robust initiatives backed by allocated budgetary provisions. Nonetheless, in the realm of healthcare, I reckon, pharmaceutical and other related industries can significantly help hastening the process, not just as a social responsibility, but for significant growth in businesses, simultaneously creating a win-win situation for all.

Just to cite an example out of many, various pharma companies can set up ‘digital health information kiosks’ especially in those areas where awareness and participation of the local population related to healthcare issues are poor or suboptimal. These ‘digital health information kiosks’, providing various diseases or treatment related information that a pharma company may be interested in, can be set up at convenient locations, of course, with the approval of local authorities. Such information, should encourage people to seek more and more health information digitally, explaining the whole process, and at the same time persuading them to take available disease prevention measures. and advising them to visit doctors, to initiate early treatment, wherever necessary.

I repeat, this is just an illustration, there could several other ways of achieving the same result.

Increasing relevance:

For healthcare, the above trend would mean empowering most of the population to have unfettered access to knowledge in various health related fields, especially in prevention, management and available treatment options, for various diseases, encompassing both acute and chronic conditions. Thus, this process has the potential to create a significant snowballing effect, not just on

deeper penetration of telemedicine, but also on remote diagnosis in India. In tandem, leveraging this trend early enough and in innovative ways, is likely to enable the pharma players to provide a much-needed boost to their respective business ventures.

Advantage pharma:

Rapid transformation in the complex market dynamics, coupled with increasing challenges in making productive face to face interaction with important doctors for prescription generation and consequent fast decline in the economic outcome of traditional product detailing, is likely to hasten this metamorphosis. On the other hand, this change also brings a blessing in disguise for the pharma players, by opening many new doors of opportunity based on digital platforms, and thereby paving the way for reaping a rich harvest, for all those who will choose to be early adopters.

In the above context, intimate business involvement with the digital world in many areas, such as ‘digital sales and marketing’ assumes a high priority for Indian pharma players, just as it’s being imbibed by some global players, including many in other industries. The speed of its becoming the centerpiece in pharma sales and marketing strategy formulation process ought to be directly linked to the increasing speed of broadband Internet penetration, smart phone and other digital platform usages by people of all ages with enquiring mindsets. Thus, the destiny’s call is clearly ‘Advantage Pharma’.

Key benefits:

According to a paper of April 16, 2014, published by Salford Business School, Manchester, UK, the major benefits of ‘Digital Marketing’ are as follows:

  • It helps businesses to develop a wider customer base as it does not rely on physical presence or interaction.
  • It encourages customers to interact directly with businesses.
  • It is not limited by conventional opening times – customers can interact at a time and place convenient for them

Calibrated increase in usage of digital platforms:

It is worth noting, traditional methods of sales and marketing, barring a few exceptions, are currently prevailing in the Indian pharma industry. In this scenario, each pharma player, must carefully evaluate its current and future product-mix, along with customer types and base, as they would decide, first to initiate, and then to scale up their sales and marketing operations in the digital space in a well-calibrated manner.

In this new ball game, the fresh entrants would need to consider only the credible research-based data, on the rapidly changing aspirational mindset of young Indians, including doctors and patients, with smart phones being a key enabler, on the one hand. While on the other, these should provide optimal digital penetration in different geographical regions or areas, together with the usage of platforms and related demographic configurations.

For example, if a region shows high smartphone usage for community or group chat within the general population, a pharma company may explore the possibility of creatively designing a smart phone based ‘digital patient chat group’ as a part of its patient engagement initiative. In this ‘digital patient chat group’, the members suffering from chronic or even acute ailments can discuss with each other the issues for which one is seeking a solution, where even the pharma companies can intervene, wherever they can add value and is legally permissible.

The effectiveness in working out a game changing crafty blend of both brand and patient-centric communication package with digital tools would separate the men from the boys. It would demand top quality cerebral inputs from the pharma marketers – a requirement that is not so easily available in the current space of pharmaceutical marketing, dominated by a wide variety of freebies.

In conclusion:

Humongous digital divide in India is a fall out, predominantly of disparate availability and access to ICT, not just between those living in rural and urban areas, but spans across several other areas such as, between educated and uneducated people, demographic and economic classes, to name a few. Nonetheless, especially, since the last one and a half decades, the country has made significant headway in gradually reducing this gap, though a lot more ground is yet to be covered in this direction.

Today in India, we witness even various political parties, which used to be very traditional in their approaches have started using a wide variety of digital marketing tools successfully by deploying astute domain experts, to achieve their goals.

For the healthcare sector, including the pharma industry, this progress throws open many doors of opportunities, both for the public, as well as for the industry. Notwithstanding this digital divide and general prevalence of an overarching traditional behavior and response patterns, displaying visible apathy or inability to embrace the promises of the emerging cyber era, several doctors and patients have already started reaping the benefits offered by various digital platforms, tools and media. The regulators governing this sector, are also not lagging far behind, with their presence visible in the digital space too, including social media.

This challenge of change should be effectively leveraged by all stakeholders in healthcare, reaping a rich harvest. Like many other constituents in this intricate, yet interesting ball game, pharma industry too needs to assume an active, pragmatic and proactive role in several innovative ways.

Flooring the gas pedal to move into the digital space of healthcare, would provide significant competitive and commercial advantages to the early movers, more than ever before. When political narratives can be made more productive by embracing the digital platforms, why not the business narratives of the pharma industry in India?

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.

In a Quandary of Drug Quality, Price Control, Innovation and Patient Interest in India

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The patients in India have every reason to apprehend, whether the prescription drugs that they consume are efficacious, safe and conform to the government approved prices, alongside another important question: Do they affordable access to the fruits of innovation?

The regulator responsible for drug quality in India is responsible for ensuring the first two, and the drug price regulator of the country ensures the remaining two.

Apparently, both these esteemed government bodies, are sure that they are doing the best jobs in their respective areas. Moreover, in these days of social media blitzkrieg, it won’t be uncommon to witness some of them, creating hype on some issues that many feel is better avoided, and at times even contradictory in nature.

Amid this seemingly chaotic continuity of the same or a bit deteriorating scenario, patients are often caught in an unenviable footing.

In this article, I shall discuss on these concerns afresh, quoting a few recent examples. My objective is to encourage all concerned to move away from incessant hype creation by accepting the reality, as the patients feel. This is necessary, because anyone, including the regulators can fall victim of such unfettered developments, at any point of time.

Thus, it may be appropriate for all to jettison any residual arrogance or a faint shade of narcissism, before putting the nose to the grindstone to resolve these pressing issues decisively, for patients’ sake.

Are we consuming effective and safe medicines?

I raised this question first in an article titled, “Are We Taking Safe and Effective Medicines?” published in this blog on November 13, 2013. That deliberation was primarily based on US-FDA ‘import bans’ from various drug manufacturing facilities in India, involving even the top Indian pharma players. Based on their own quality and safety audits, the US regulator had concluded that drugs produced in those factories are not safe for consumption by the patients in America.

This apprehension has now almost reached its crescendo, when on February 24, 2017, probably for the first time ever, US-FDA publicly voiced its apprehension about the efficacy of medicines being sold and consumed by patients in India.  The observation came from the India director of the US-FDA in an annual conference of a large pharma trade association of some of the top domestic pharma companies. While commenting, “I do not think any one of us wants to take such drugs which lack efficacy”, the official reportedly revealed, he occasionally gets samples sent from the US embassy health unit in Delhi, and complaints are usually about the medicines not giving the desired results.

It is noteworthy, as earlier, rubbishing claims levelled by media expressing growing concern among overseas regulators over the quality of Indian made drugs, the Drug Controller General of India (DCGI) had reportedly strongly reiterated that there have been no lapse or compromise on quality parameters of the drugs manufactured throughout the country, as the efficacy of the drugs and safety of the patients have always remained the top priority of DCGI.

Yet another news article of August 22, 2016 reported that after a year-long survey involving Government, civil society and pharmacy professionals, and testing nearly 50,000 drug samples across the country during this period, the Ministry of health of India found that medicines produced in India are safe and effective. This study was kicked off in the wake of rising concerns that several medicines made in the country posed risks to patients, the report highlighted.

Should ‘Self-certification’ by industry prevail?

Intriguingly, when questions on drug quality manufactured in India, are regularly being raised by other equally responsible drug authorities, we find ‘self-certification’, in this regard, coming from all those who are expected to resolve this issue beyond an iota of doubt, always prevails.

Apparently, not just the drug regulator and the Union Ministry of Health are in a sustained denial mode, many large pharma companies also seem to be in the same mode. On March 01, 2017, the media reported, “Close on the heels of US FDA India office raising concerns over the quality of medicines marketed in India, pharma leaders came together to defend the quality of their products. There is no question of compromising quality of Indian products meant for domestic market and export, they pointed out.” This rebuttal was expected. Nevertheless, the apprehension lingers: Should such self-certification by pharma players prevail?

That said, one may try to justify this quandary by saying that effectively regulating over 20,000 domestic pharmaceutical companies, including third party and loan license manufacturers, poses a serious challenge to the DCGI and the State Drug Controllers. However, the moot point is, who has been encouraging such over-proliferation of drug manufacturing facilities over a long period of time, in any case? In that sense, whose prime responsibility is it to ensure that drugs consumed by patients in India are efficacious and safe?

The answer to these vexing questions continues to remain unanswered.

Did patients benefit from drug price control orders?

Let me first draw a brief sketch on the global perspective of price increases in generic drugs. It appears that in all those countries where there is no drug price control in place, the entire pharma industry is being adversely impacted by huge generic drug price inflation. This finding has been well captured in a study by Elsevier. It shows, between November 2013 and November 2014, out of its research sample of 4421 generic drug groups, there were price increases in 222 drug groups by 100 percent or more. In 17 drug groups price increases were taken even over 1000 percent, which include even tetracycline. With this trend sharply moving north, many patients, across the world, are struggling hard to find ways to survive in this situation. With this backdrop, I now get back to its India perspective.

I have read some media editorials questioning, just as the pharma industry, whether it is the right approach to make essential medicines affordable through drug price control in India? Nevertheless, there isn’t an iota of doubt in my mind that yes, it is, in the prevailing health care scenario of the country sans universal health care, with out of pocket expenses on medicines being the highest in the world and when market competition doesn’t bring down the price of medicines, for obvious reasons. My questions, on the contrary, will be, is drug price control being enforced in India the way it should? Are the patients getting commensurate benefits out of it? If not, why?

However, on the face of it, the answer to the question above “Did patients benefit from drug price control orders”, may appear to be an affirmative one. This is mainly because, on July 28, 2017, no less than the Union minister for Chemicals and Fertilizers, in a written reply to the Rajya Sabha reportedly conveyed that the Indian consumers have saved nearly Rs 5,000 crore due to the Government fixing the prices of essential medicines under the Drugs Price Control Order (DPCO) 2013.

The ground reality of drug price control:

Let me try to explore a bit in this area with some recent examples.

According to the data from India’s drug pricing watchdog – the National Pharmaceutical Pricing Authority (NPPA), compliance to various Drug Price Control Orders (DPCO) is far from satisfactory. Outstanding dues for non-compliance to notified ceiling prices, including penalty, from scores of pharma companies, have now reportedly piled up over the past two decades exceeding Rs. 4,551 crore (around USD 700 million). Thus, the same question haunts: Has drug price control benefitted the patients in India, as was intended to?

The situation is no different, even with DPCO 2013. On February 23, 2017, NPPA notified the ‘Suspected cases of Noncompliance of Ceiling Price by Pharmaceutical Companies,’ of 634 drugs, along with a ‘Public Notice’ for the same. This listed included the products marketed by some leading pharma companies in India, such as, Cipla, Abbott India, Alkem Labs, AstraZeneca, Dr Reddys Lab and Cadila, among many others.

Yet another fresh allegation related to drug pricing has just come to light. Interestingly, it relates to an anti-diabetic drug that falls outside DPCO 2013. On March 01, 2017, a news articled reported, “India’s drug regulator will look into allegations that four leading pharmaceutical companies are colluding to set the price of anti-diabetic drug Vildagliptin, a move that may rattle the almost Rs. 10,000 Crore (around USD 1540 million) market in the country.” Vildagliptin is a proprietary drug of Novartis, which has licensed it to three other companies. All of them sell Vildagliptin in India under their own brand names. Abbott sells it as Zomelis, USV as Jalra and Emcure as Vysov. The combined sales of these brands stood at Rs. 822 Crore (around USD 125 million) last year, the report states.

Be that as it may, the bottom line, as many believe, continues to remain unchanged, as it has always been – the patients don’t derive intended benefits due to lackluster and apparently ineffective enforcement of the drug price control in India.

Another crucial player:

Besides the two important and powerful Government authorities – DCGI and NPPA, there is another very critical player in this game – the Indian drug industry. Without whole-hearted cooperation and result-oriented action by all the three players, in tandem, nothing can possibly change this agonizing status quo, in this area.

The industry too is in a denial mode:

Quite like the other two critical constituents, who always deny any serious allegation on their actions, not being good enough to fetch the intended benefits for the patients, the drug industry too doesn’t seem to be any different. It always appears to be in a pre-programmed denial mode against all such allegations, irrespective of whether these are on drug quality, price, or on frequent misuse of the term innovation. They always try to justify their action, playing the victim card, as it were, and expecting other stakeholders to believe that they are doing right, always.

Let me now explore each of these areas separately, basically from the pharma industry perspective:

Drug quality: Pharma players, just as the Indian drug regulator, do not seem to accept that many drugs in India do not provide desirable benefits to patients, as alleged even by the US-FDA after studying some test results, following complaints from their local establishments. Many of us, at an individual level, may also have experienced just the same, and nurture the same doubt on the efficacy and safety profile of some branded generics that we consume, but have no wherewithal to prove the same. Doctors just change the brands, when any patient comes with such complaints, as Pharmacovigilance has not taken-off in the country with full steam, just yet. Thus, both the government regulators and the industry are in sync with each other, on this issue.

Drug price control: In this specific area, unlike the issue of drug quality, the respective stands of the government and the industry are poles apart. The former believes that it is working well, and the latter says, it isn’t.

The industry, as I see it, wants to project an impression that drug price control is the root cause of all evils, including compromises on drug quality, and some drugs going out of the market. The industry further highlights that drug price control offers a crippling blow to innovation, as they can’t garner enough financial resources through increased drug prices. It is another matter that they can’t possibly claim, drug price control offers a telling blow on their profit, as despite price control pharma is one of the highest profit making industry in India and globally too.

What innovation means to patients:

Interestingly, both the domestic and multinational pharma players often use the term of innovation, mostly construed as a façade, as it were, in their different advocacy initiatives, and during media outreach, as well. For global players, it primarily means innovation of new products, which offers monopolistic marketing and pricing advantage. Whereas, for generic players, it is generally process innovation, and different generic or biosimilar product development.

This is fine, but why should patients pay high drug prices, only because pharma players want to spend more on innovation, either for a new drug or a new process? I reckon, almost none will be willing to pay just for the heck of it.

Commensurate incremental price for incremental value:

Many patients, on the other hand, will be willing to pay more for any commensurate incremental value that a drug or a process will offer for a speedy recovery from illness, or to live a better quality of life, or for a lesser net treatment cost. Thus, the price of any brand is considered by stakeholders as a function of the value that it promises to offer. Consequently, brand marketing is deemed a value delivery system. For medicines, this value must be easily perceptible, quantifiable and scientific research based. Accordingly, the outcome of any such innovation should convince the regulators, doctors, hospitals and ultimately the patients – what value delivery – path breaking or incremental, for which patients need to pay commensurate incremental prices.

Various ways of ensuring it:

There are several different ways of addressing it, even for branded generics in India. For example, when branded generics of the same drug or similar FDCs of different drugs, are marketed by different companies with a huge price difference, the pharma players should necessarily submit before appropriate authorities, prior to marketing approval, all data regarding incremental and quantifiable value offerings, especially for those branded generics falling at the top of the price band. This is necessary, as an increasing number of brands in the market of the same generic molecules or the same FDCs, may not necessarily lead to greater competition with any significant impact on price. I shall argue on this point below.

What happens, generally:

For any drug falling outside price control in India, branded generic drug makers, usually set prices based on whatever each of them considers the market will accept. This consideration is highly elastic in nature, varying from a very low to a very high price, for any specific molecule and its FDCs. As I said before, it has been well-established by now that competition doesn’t play any significant role to bring down the branded generic drug prices, unlike many other consumables in different industries.

Why market competition doesn’t work for medicines?

This is primarily because, the purchasing decision for medicines does not depend on individual patients, unlike many other consumables. This decision is taken by the doctors while writing prescriptions for them. It is widely alleged, all over the world, that many important doctors are heavily influenced by the drug companies, often through dubious and highly cost intensive means, to prescribe their respective brands or branded generics in the process of treatment of a wide variety of medical conditions. In this rat race of generation of more and more prescriptions, pharma companies require to have a deep pocket to achieve their financial goals. Thus, many brands attract high prices to generate more profit and keep moving this vicious circle. Value based brand differentiation for many leading branded generics or even me-too patented products, aren’t mostly robust enough to stand any scientific or peer scrutiny. Consequently, the prescription demand of a most branded generics or me-too patented products do not have any linear relationship with the nature of market completion, and therefore, on their prices. In this perspective, setting a price for a pharma brand doesn’t depend on quantifiable value offerings for patients, as someone said before, “It is not a science. It is a feel.”

In conclusion:

The overall concern spans across several important public health and safety related issues, which also involve general quality standards of medicines, the effectiveness of drug price control, the core intent of so frequent use of the term ‘innovation’ in various pharma advocacy initiatives, including media outreach.

In this scenario, is the pharma industry, together with the drug quality and pricing watchdogs, failing to fathom the grave residual impact of continuity of this situation? In my view, this specific assumption appears too simplistic, naïve, and unrealistic. Or else, could it be that they are actually in a quandary, not being able to decide what would be the most effective actionable blueprint to resolve these issues?

I reckon, this is high time now for all concerned to accept the reality, seriously introspect on these critical issues, opt for a dip-stick expert analysis to assess the real status, and then work out a time-bound action plan with assigned accountability on the ground.

Together they may wish to address the following queries, among several others:

  • Why are they still running on a treadmill, as it were, over the last four decades, to come nearer these issues for better understanding, without moving an inch on the ground, despite public outcry?
  • Are they really in a quandary?
  • Are these concerns not an outcome of basically governance related failures?
  • Why hypes are being created all around on significant savings over out of pocket expenses on medicines because of ‘good enforcement’ of DPCOs, when it doesn’t seem so?
  • What prompts all the key players to be in a consistent denial mode on dubious drug quality standards in India, when foreign drug regulators are pointing it out in public?
  • Isn’t the term ‘innovation’ being rampantly misused, more as a major tool for advocacy to gain free pricing advantage?
  • Shouldn’t ‘Que Sera, Sera’ days change now?

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.

Stem Cell Therapy in India: A Potential Game Changer in Disease Treatment

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Stem Cells (SC) offer an incredible potential to instill a new lease of life virtually to any organ of the human body, bringing them back to the pre-disease state through its own biological repair mechanism. Intensive research initiatives are on across the world to harness this unique possibility that will be able to successfully address a plethora of serious and chronic ailments for mankind. The good news is, the global scientific community is taking rapid strides in understanding the complex stem cell biology to give shape to a game changing medical treatment blue print for tomorrow.

Capturing one such pursuit, on February 21, 2017, well-reputed British news daily – ‘The Telegraph’, reported the outcome of a path-breaking medical study for freezing the progression of yet another complex and crippling ailment – Multiple Sclerosis (MS). This research followed a unique SC transplantation process. Intriguingly, both such diseases and the treatment are not generally much talked about, particularly in India. If done, it would increase public awareness and help many patients fetch greater benefits from the available and approved SC therapy in the country. Probably, considering the unfathomable scope of the body’s own repairing toolbox with SC, Prime Minister Narendra Modi reportedly called on Indian biologists to motivate school children for pursuing a career in stem cell research.

Let me now go back for a moment to Multiple Sclerosis (MS) as I am aware of this this disease condition rather closely. One of our close family friends who was a very senior official in one of the top multinational corporations of the world, had to give up his job prematurely being a victim to this serious illness. In that sense, this particular news item rekindles a new hope for many to look for a better quality of life while managing many other diseases of such kind, all over the world, including India.

‘The Telegraph’ reported: in so far, the largest long-term follow-up of SC transplantation treatment study of MS, which was spearheaded by Imperial College London, established that 46 per cent of patients who underwent this treatment did not suffer a worsening of their condition for five years. The treatment works by destroying the immune cells responsible for attacking the nervous system. This is indeed a very significant development in the space of medical research.

This new treatment, called autologous hematopoietic stem cell transplantation (AHSCT), was given to patients with advanced forms of MS who had failed to respond to other medications. However, the researchers noted that the nature of the treatment, which involves aggressive chemotherapy, carried “significant risks”.

It’s worth recapitulating here that MS is caused by the immune system malfunctioning and mistakenly attacking nerve cells in the brain and spinal cord, leading to problems with movement, vision, balance and speech. It’s a lifelong condition and often causes serious disability, with no cure still in sight. The disease is most commonly diagnosed in people in their 20s and 30s, although it can develop at any age.

A new hope with a game changing potential:

The above study of SC transplantation conducted by Imperial College London in MS, is just a recent example, among scores of major steps being taken in this frontier of medical science in preparation of a decisive battle against many more life-threatening and serious debilitating diseases.

No doubt that various treatments involving stem cells are generally considered a novel and rapidly advancing medical technology. However, in a small number of developed countries, such as the United States (US), a number medical procedures with stem cells are being practiced since around last three decades. Bone marrow transplant is the most widely used stem-cell therapy in this area, which was first performed in 1968.

According to California Institute for Regenerative Medicine (CIRM) and various other medical literature, SC treatment has the game changing potential for successful use to:

  • Replace neurons damaged by spinal cord injury, stroke, Alzheimer’s disease, Parkinson’s disease or other neurological problems
  • Produce insulin that could treat people with diabetes and heart muscle cells that could repair damage after a heart attack, or
  • Replace virtually any tissue or organ that is injured or diseased

Thus, stem cells offer limitless possibilities, such as tissue growth of vital organs like liver, pancreas. Today there are many diseases for which no effective treatment still exists, besides giving symptomatic relief, such as Multiple Sclerosis, Parkinson’s disease, Alzheimer’s, severe burn, spinal cord injury. There is a host of other diseases, including several chronic ailments, such as diabetes, heart ailments, rheumatoid arthritis, or some types of cancer, which can’t just be reversed, however, could be managed with a lifelong treatment. For most of these diseases, and several others involving tissue degeneration, SC therapy has the potential to be a huge life and a game changer. It may involve, besides patients, several industries, including pharmaceuticals and biotech sectors.

Major stem cell sources and some key milestones:

Medical scientists and researchers have conclusively established that stem cells are the master cells of any human body. These are undifferentiated cells of the same lineage, retaining the ability to divide throughout life and grow into any one of the body’s more than 200 cell types. Some of the major sources of stem cells in the human body are bone marrow, cord blood, embryonic cells, dental pulp and menstrual blood.

As captured by ‘ExploreStemCells’ of UK, some key events in stem cell research include:

  • 1978: Stem cells were discovered in human cord blood
  • 1981: First in vitro stem cell line developed from mice
  • 1988: Embryonic stem cell lines created from a hamster
  • 1995: First embryonic stem cell line derived from a primate
  • 1997: Cloned lamb from stem cells
  • 1997: Leukemia origin found as hematopoietic stem cell, indicating possible proof of cancer stem cells
  • 1998: University of Wisconsin isolated cells from the inner cell mass of early embryos and developed the first embryonic stem cell lines.
  • 1998: Johns Hopkins University derived germ cells from cells in foetal gonad tissue; pluripotent stem cell lines were developed from both sources.
  • 1999 and 2000: Scientists discovered that manipulating adult mouse tissues could produce different cell types. This meant that cells from bone marrow could produce nerve or liver cells and cells in the brain could also yield other cell types.

All these discoveries were exciting for rapid progress in the field of stem cell research, along with the promise of greater scientific control over stem cell differentiation and proliferation. Currently, many more research studies are underway in globally acclaimed institutions and other boutique laboratories exploring the possibility of wide scale use of SC therapy, even in the treatment of several chronic diseases, including diabetes and heart disorders.

A controversy:

The controversy related to SC research mainly involves Embryonic Stem Cells (ESC) and raises several difficult questions for a speedy resolution. As articulated by the ‘Genetic Science Learning Centre’ of the University of Utah, these are mainly:

  • Does life begin at fertilization, in the womb, or at birth?
  • Is a human embryo equivalent to a human child?
  • Does a human embryo have any rights?
  • Can destruction of a single embryo be justified to provide a cure for a countless number of patients?
  • Since ESC can grow indefinitely in a dish and can, in theory, still grow into a human being, is the embryo really destroyed?

However, in 2006 scientists learned how to stimulate a patient’s own cells to behave like embryonic stem cells. These cells are reducing the need for human embryos in research and revealing exciting new possibilities for stem cell therapies, according to this Centre.

Stem cell research in India:

India has pursued SC research since over a couple decades reasonably supported by the Government, especially the Department of Biotechnology (DBT), besides several remarkable initiatives from the private sector. Ethical guidelines in this regard are also in place, so also are the National Guidelines for Stem Cell Research in India. These guidelines are aimed at obtaining licenses from the Drug Controller General of India (DCGI).

Further, in a major move to regulate and oversee the activities by streamlining SC research in the country, the Government has also set up an Institutional Committee for Stem Cell Research and Therapy (IC-SCRT) and the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT). This necessitates the researchers on human stem cells, both institutions and the individuals, to be registered with NAC-SCRT through IC-SCRT. To ensure that the concerned companies and individuals follow the National Guidelines, these committees will review, approve and monitor each research project in this area. It now calls for even greater focus from all other stakeholders to help accelerate growth of this niche segment of medical science for patients’ benefits.

SC transplantations using umbilical cord blood and bone marrow for treating neurological, hematological, hepatic and cardiac disorders are being pursued by some well-known medical institutions, such as, AIIMS, PGI Chandigarh, CMC Vellore, AFMC Pune, Manipal Hospital Bangalore. For example, AIIMS, reportedly, undertook a major multi-center trial to look at the role of stem cells in repairing tissue damaged during acute heart attacks, where other treatment process, including a cardiac bypass surgery fails to adequately improve the heart function. Similarly, Shankar Netralaya in Chennai has successfully carried out limbal stem cell transplantations for restoring vision to several patients.

That said, this is a cost intensive area of research, which involves expensive equipment, reagents and other consumables. Moreover, ensuring continuous training for SC researchers and clinicians also poses a major problem. Greater international collaboration in this area, and increasing number of Public-Private-Partnership (PPP) could accelerate the progress of India in this hugely promising area of medical science, reaping a rich harvest for a large patient population of the country.

Stem cell banking:

SC banking is a fast-developing area in this field, especially designed for SC therapy. As not many patients are not currently as much aware or interested in SC therapy as they ought to, it may not appear as an immediate requirement for many. However, an encouraging trend is fast catching up, especially within some enlightened persons, to have in a bank a large reserve of their own or their baby’s stem cells that would be available for any medical emergencies or more effective treatment options, in the future.

It assumes increasing importance because, as we age, illness and the natural process of aging could reduce the number of stem cells available to regenerate organs, muscles and bone. At that time, while treating a serious illness or a grave injury, a person may have fewer adult stem cells that have the collective power to make an effective healing response to SC therapy.

In that context, SC banking provides a great opportunity to store, multiply and utilize a newborn’s or even an adult person’s younger and healthy stem cells for SC therapy during any medical emergency, such as a serious accident or a crippling illness, at a later stage in life.

There are broadly the following two types of SC banking facilities are now available in India:

A. Cord blood stem cell banking:

This is type of SC banking is the process of collecting, processing, cryogenically freezing and preserving the ‘Cord blood’ that remains in the vein of the umbilical cord and placenta at the time of birth, for potential future medical use during SC therapy. Stems cells extracted from the umbilical cord blood have been shown to be more advantageous than those extracted from other sources such as bone marrow. These banked stem cells are considered as a perfect match for the lifetime of the donor baby, and for other family members, as well. This is significant as there exists a greater chance for success in a stem cell transplant between siblings than with unrelated donors and recipients.

B. Adult stem cell banking:

Some state-of-the-art adult stem cell banking services are either already available or in the process of coming up in many places of the world, including India. As an individual’s fat (adipose tissue) is an important source of adult stem cells, with the application of a high precision medical technology of separating, multiplying, and storing adult adipose tissue-derived mesenchymal stem cells for autologous use by physicians, ‘Adult stem cells are stored in these banks.

The good news is, increasing awareness in this area has now started prompting many parents, and also some adults to bank or store their own SC and the baby’s cord blood rich with a specific types of stem cells, that can be utilized, at a later date, in a variety of SC therapy while treating many life-threatening and debilitating diseases, if required.

Types of stem cell therapy:

There are two major types of SC therapies, and both are available in India:

  • Autologous stem cell therapy: uses the adult patient’s own stem cells obtained from the blood, bone marrow.
  • Allogenic stem cell therapy: uses donated stem cells, but faces chances of donor stem cell rejection.

As articulated in the revised stem cell guidelines, stem cells can’t be offered to patients in India as ‘therapy’ unless these are proven effective and safe supported by unequivocal clinical trial data and approved by the DCGI. Otherwise, these can be used only in ‘clinical trials’ as will be approved by the DCGI. The only exception to this is the use of haematopoietic (blood forming) stem cells for treating blood disorders, which is considered as ‘a proven therapy,’ according to available reports.

The Market – Global and India:

September 14, 2015 issue of ‘The Pharma Letter’ stated based on a recent report that the global stem cells market was valued at US$ 26.23 billion in 2013, and is estimated to be worth US$ 119.52 by 2019, registering at a Compounded Annual Growth Rate (CAGR) of 24.2 percent. Whereas, in India, the stem cell market is expected to be around US$ 600 million by 2017. Another report, titled ‘India Stem Cells Market Forecast & Opportunities, 2020’ of ‘Pharmaion’, states that stem cells market in India is expected to grow at a CAGR of over 28 percent during 2015 – 2020.

In terms of services offered, stem cells market in India has been segmented into two main categories, namely SC banking, and SC research. The latter dominated the market in 2014, and is likely to continue its dominance through 2020. Adult stem cells accounted for the majority share in India’s SC market in 2014, as a lot of research being carried out using adult stem cells, besides growing adult stem cell banking and other associated applications in therapeutics.

The major growth drivers for SC market are: increasing patient awareness, an increase in the approval for clinical trials in stem cell research, growing demand for stem cell banking services,

Government support, rising investments in research, and ascending trend of development for regenerative treatment to meet unmet medical needs.

The first stem cell based product approval in India:

On May 30, 2016, a Press Release of ‘Stempeutics Research’ of Bengaluru announced that for the first time in India, DCGI has granted limited approval for manufacturing and marketing of its allogeneic cell therapy product named Stempeucel® for the treatment of Buerger’s Disease – a rare and severe disease condition affecting the blood vessels of the legs, which finally may require amputation. Stempeucel® treatment is designed to enhance the body’s limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularization. The prevalence of Buerger’s Disease is estimated to be 1,000,000 in India and two per 10,000 persons in the EU and US, as the release stated. Stempeutics Research’ is a company of Manipal Education & Medical Group and a Joint Venture with Cipla Group.

Conclusion:

Research on stem cells, across the world, is taking rapid strides. It has already demonstrated its healing power in changing many human lives either by significantly stalling the progression of several serious ailments, such as Multiple Sclerosis (MS), or reversing the disease conditions, such as serious damage to the heart caused by massive myocardial infarction.

An increasing number of stem cell banks coupled with growing public and private investments in stem cell research, positive narratives are getting scripted for this space in India. With rapidly growing middle class population and comparatively less stringent rules and regulations, India is emerging as a perfect destination for many more global and local stem cell banking companies. Consequently, the stem cell market in the country is expected to witness robust growth in the coming years.

However, only future research on stem cells will be able to unravel whether an Alzheimer’s victim will get back the stolen memory; a cancer patient won’t have to mentally prepare to die of cancer anytime soon, besides spending a fortune towards cancer therapy; an insulin dependent diabetic will no longer require insulin; an individual with damaged heart won’t have to continue with lifelong medication, and it goes on and on.

Nevertheless, if it does… and God willing – it will, ‘Stem Cell Therapy’ would not just be a life changer for many patients, it will be a game changer too for several others, including the pharma, biotech companies and many more within the healthcare sector. If any skeptic still asks, will it really happen? My counter question, in response, will be: Why not?… Why the hell not?

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.

 

Dwindling Drug Innovation: Declining Image: Unchanged Business And Advocacy Models

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A report of ‘The United States International Trade Commission (USITC)’ released on December 22, 2014 suggested, if tariffs and investment restrictions were fully eliminated, and standards of IP protection were made comparable to the U.S and Western European levels, American exports to India would rise by two-thirds.

A year later, on February 01, 2015 an interesting news article highlighted that the flashpoint of this issue “has clearly been pharmaceutical companies and their lobby group Pharmaceutical Research and Manufacturers of America (PhRMA), which have made some of the strongest representations to the US government against India’s IPR regime.” The same report also indicated that many other companies including the aircraft maker Boeing and the generic drug giant Abbott felt that India offered adequate IP protection and that they had not experienced major IP problems in the country.

The above stance of USITC continued echoing right from the beginning of this year. In January 2017, the CEO of US Biotechnology Innovation Organization (BIO) reportedly told our Prime Minister Narendra Modi, ‘if he follows western practices on intellectual property protection, his country would see a “tidal wave” of biotech industry investment.’

On February 08, 2017, when the fifth edition of ‘U.S. Chamber International IP Index’ report was released by the ‘Global Intellectual Property Center (GIPC)’, India featured in the 43rd rank out of 45 countries. With this India remained virtually at the bottom of the IP index for the fourth year on the trot. The GIPC report underscored India’s “anaemic IPR policy”, Section 3.d of the Indian Patents Act, besides several others, as major market access barriers.

On February 14, 2017, another news article reported that America’s pharma sector has asked the US Trade Representative (USTR) to continue to keep India on its Priority Watch List (PWL), which includes countries that are alleged violators of US patent laws, claiming that the environment on the ground remains ‘challenging’ in India. Among the areas of concern for the US pharma companies operating in India, unpredictable IP environment, high tariffs and taxes on medicines, regulatory data protection failure, discriminatory and non-transparent market access policies and unpredictable environment for clinical research were listed among others.

With this backdrop, the key question that haunts many industry watchers, when the World Trade Organization (WTO) has no complaint with the Indian Patents Act 2005, and finds it TRIPS compliant, why are these reports coming from the United States consistently emphasizing that the current IP regime of the country is a key barrier to market access, especially for research-based pharma companies?

Is the core issue of the global pharma industry in India is predominantly not encouraging innovation well enough, or the dearth of inadequate Intellectual Property (IP) protection – or it is something beyond that, and is more fundamental in nature. In this article, I shall dwell in this area, first in the global perspective, and then zeroing-in to India.

A global perspective:

“The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (R&D). Yet the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms.  There have been many proposed solutions to the problem of declining R&D efficiency. However, their apparent lack of impact so far and the contrast between improving inputs and declining output in terms of the number of new drugs make it sensible to ask whether the underlying problems have been correctly diagnosed,” articulated an important article published on March 01, 2012 in the Nature Reviews Drug Discovery.

This trend continues, virtually unchanged. R&D efficiency continues to remain a cause of great concern to the research-based global pharmaceutical companies. Accordingly, a 2016 report of the Deloitte Center for Health Solutions titled, ‘Measuring the return of pharmaceutical innovation’, among other findings, has captured the following:

  • Annual projected pharma R&D return declines to 3.7 percent from 10.1 percent in 2010
  • Peak sales per asset fall 11.4 percent year-on-year since 2010

What then is its basic solution?

When the right solution eludes:             

In this scenario, when the right solution is still eluding, to record growth in corporate profit and earning to meet shareholders’ expectations, keeping the existing business model intact, the global research-based pharma companies have the following two limited options, which they are actively pursuing:

  • Take high price increases for the existing products
  • Launch the limited new products at a very high price

A report published in The First Word Pharma on October 06, 2015 quoting The Wall Street Journal (WSJ) vindicated exercising the first option. It reported that many drug makers have succeeded in increasing revenue on products despite a flat or declining demand by consistently increasing prices. An analysis revealed that revenue for the top 30 products in the United States zoomed by 61 percent over the past five years, three times the increase in the number of prescriptions sold over that period. While another report by Credit Suisse illustrated that 80 percent of the growth in net profit for the top 20 drug makers was attributable to price hikes.

To substantiate application of the second option, I quote from the CBS News, which on April 05, 2016 reported that an investigation into the cost of prescription drugs revealed huge price hikes over the past five years. Several brand name medications more than doubled in price. Again, on  August 24, 2016, it gave a sense of this trend with the following examples, covering the launch price of innovative drug, and price increases of generic drugs:

  • Gilead fixed their new hepatitis C drug Sovaldi’s cost at US$ 900 – 1,000 per pill
  • Mylan Pharmaceuticals’ increased the cost of its anti-allergic drug EpiPen from about US$ 57 in 2007 to more than US$ 500 in 2016
  • Turing Pharmaceuticals increased the price of the anti-malaria drug Daraprim by 5,000 percent last year, charging US$ 750 per pill for a drug that used to cost US$ 13.50 per pill.

PhRMA – the often quoted trade association in America, representing the country’s leading pharma and bio-pharmaceutical research-based companies, reportedly said in a statement: “Focusing solely on the list prices of medicines is misleading because it ignores the significant discounts and rebates negotiated by insurers and pharmacy benefit managers.”

Even if, this argument is accepted as such, the tough impact of regular hefty drug price increases on the consumers is real, unquestionably.

The current business model leaves behind many patients:

The ‘Access to Medicine Index 2016’ report also finds that companies generally do not systematically target populations with the highest needs in their registration, pricing and licensing actions. Although, we continue to make progress toward major public health goals, such as, polio is close to being eradicated, as is guinea worm; more than 45 percent of people living with HIV/AIDS have access to ARVs; important vaccines for malaria and dengue fever are being implemented, still business models for providing healthcare are leaving many people behind. Globally, two billion people cannot access the medicines they need, most of whom live hand to mouth.

Particularly, the big global pharma companies, as the innovators and producers of life-saving medicines, need to act much earlier in the patients’ value chain. Without or inadequate action by these companies, alongside governments, NGOs and others, it will be impossible to bring modern medicine to everyone.

Public outrage over high drug prices:

Many studies indicate that the research-based global pharma and biotech companies, still strive hard to stick to their existing overall business models with a sharp focus on improving both the top and bottom lines of the business, though the R&D projects are becoming lesser and lesser productive. This prompts them resorting to hefty price increases, and introducing new products with high price. Fueled by this self-serving mindset, a simmering public outrage, globally, over high drug prices is fast catching up, further undermining the trust in the industry, as another report says.

No wonder why in the Gallup Poll of August 15, 2016, pharmaceutical industry featured just one above the bottom among the ‘Worst-Rated U.S. Business Sectors’. Moreover, even the Harris Poll released on January 17, 2017 found that 91 percent of U.S. consumers believe pharmaceutical and biotechnology companies put profits over patients.

The industry continues chasing rainbows:

In response to this mounting stakeholders’ criticism, arguably the richest pharma association in the world in its member subscriptions – PhRMA, reportedly launched a new ad campaign costing tens of millions of dollars on January 25, 2017. It aims to highlight innovation and scientific breakthroughs to change the public’s negative perception of the industry. This campaign will span across television, print, digital, and radio, the report elaborates.

Following is an example, as reported, listing three important and interesting comments on this campaign for pharma image revamp from some of those who matter:

  • Lawmaker Peter Welch, who chairs the House Democratic Caucus’ task force on drug pricing, said, “The issue here is not whether drugs have some benefits … The issue is whether pharma is going to be able to kill us with their pricing power or whether we will get transparency and competition.” He added, “The campaign is all about defending their pricing power and pushing their product.”
  • Similarly, another lawmaker Sen. Chuck Grassley (R-Iowa) said, “This is [PhRMA] trying to change the subject and to try and divert people’s attention away from drug pricing. Continuing to ignore drug pricing is probably not going to work.”
  • Ameet Sarpatwari, a drug pricing policy researcher at Harvard University said, “It’s really a matter of being tone deaf in terms of thinking somehow that this is going to change public perception”

Isn’t a great example of chasing rainbows by the industry association, in the number one pharma and biotech market of the world, instead of amending to the root cause of this burning issue?

The situation in India:

In this backdrop, amid a tough global situation, let me assess the related Indian scenario.

The research-based global pharma companies, apparently want to introduce the whole range of their patented products at a high price and in a monopolistic situation in India too, for much higher growth in revenue and profits. Thus, they are consistently pushing hard, with all guns blazing, for major changes in the Indian Patents Act 2005, which would involve jettisoning many patients’ health interest related safeguard conditions enshrined in the Act, such as Section 3.d that restricts ever-greening of patents, and introducing several other tougher IP measures, such as data exclusivity under the garb of imaginary patient safety issues with generic drugs.

They don’t seem to like price control of essential drugs in India, either. While intensely lobbying for it, the lobbyists vehemently argue in favor of the absurd, which is the affordability of medicines does not help to increase drug access to all those who need these most, even when on the ground, the out of pocket expenses for drugs in the country is as high as around 65 percent and universal health care does exist in the country, much to the dismay of many.

It has now been generally established by many global experts, including our own National Pharmaceutical Pricing Authority (NPPA) that market competition does not necessarily bring down drug prices, including for generics, quite unlike many other industries, but various pressure groups, including the media, can catalyze it, and quite effectively. What has happened recently with the cardiac stents price in the country, is just an example.

Is the devil in the traditional pharma business model?

An article titled, “How Pharma Can Fix Its Reputation and Its Business at the Same Time”, published on February 03, 2017 in The Harvard Business Review, emphatically states: “It’s a fact that the current business model of pharma companies is not working efficiently.” It suggests, besides enhancing the current unenviable public image of the industry, expanding access to medicines will help pharma companies enhance shareholder value. The success of a new business model depends on both the willingness and the ability of pharmaceutical companies to fully integrate access to medicine into their business strategies, the article emphasizes.

A July 2015 paper of McKinsey & Company titled, “Pharma’s next challenge”, also reiterates that in the developed economies, market access is chiefly concerned with pricing, and with satisfying local conditions. Whereas, in the emerging markets, to overcome the barriers, pharma players need to shift the focus of their commercial models from marketing and sales to access, and from brand-by-brand access planning to integrated cross-brand planning.

In pursuit of a new model:

Based on the above premises, the search for a new pharma business model, especially for the research-based pharma companies, in my view, may broadly focus on the following areas:

  • Learn from innovation models of the IT industry: Win-Win collaborative innovation models, including ‘Open Source Drug Discovery’, if scaled up, could reduce the cost of innovation significantly and making the new innovative drugs generally affordable. Thus, larger volume sales may adequately offset a voluntary cut in the product margin, creating a multiplier effect.
  • Be a part of the solution and not the problem: Because of fiercely pushing the blatant self-serving agenda, inconveniencing many patients, the core mindset of the pharma industry is considered by many as an integral part of the main problem. While pharma industry, quite rightly, seek more market access, they need to act as a facilitator too, to improve general access to medicines, in various imaginative ways, which is, of course, possible. This will make the pharma industry to be a part of the solution to the national problem, over a period of time.
  • Walk the talk: While pharma industry speaks all right things, in terms of ethical conduct of business, at a time when both national and international media frequently expose their gross wrongdoings. This continues, unabated. Sales and marketing functions are indeed very important, but not at the cost of good corporate governance. I am aware, all compliance rules exist immaculately on paper for many companies, but the senior management officials should demonstrate that they walk the talk, giving exemplary punishment to the wrongdoers, including their peers.
  • Change the current advocacy model: The current advocacy model of the research-based pharma companies is too self-serving. For example, in India it mostly demands, which is bordering obsession, to change the IP laws of a sovereign country, when the World Trade Organization (WTO) has no problem with these, whatsoever. There is a need for them to demonstrate, sans any shade of arrogance, visible respect to any country’s general sentiment on its Patents Act, as it’s their own decision to operate in those countries. An imaginative win-win change in this area, would significantly help to create a strong bond and mutual respect with other important stakeholders.

Are senior citizens in pharma business a barrier to change?

A recent white paper of ‘Eye for Pharma’, says in its conclusion “many of those now running pharma organizations have come through the ‘golden age’ of pharma and so may be reluctant to change”. Does this issue need to be addressed first by the Independent Directors of the respective Boards of the pharma companies?

In conclusion:

Many questions do spring up while addressing this issue. One common belief is that, pharma industry, in general, is reluctant to change its traditional business model, beyond just tweaking, despite declining overall productivity and in its public image.

In advocacy initiatives, while drawing stakeholders’ attention to the core grievance agenda, though they try hard to project their business focus on patients, especially using the buzzwords, such as, ‘patient centric approach’ or ‘patient engagement’, among many others, has anything visibly changed, just yet?

As the business environment is getting tougher and consumer expectations are fast changing, drug innovation is also steadily dwindling, so is the declining industry image. However, pharma business and advocacy models continue to remain mostly unchanged. It remains intriguing, why are the ‘wise guys’ of pharma business still so deeply obsessed with chasing rainbows, with so much of zeal, hectic activity and money, while majority of patients keeps bearing the brunt?

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.

‘Digi Gaon’: Will It Augment Access To Affordable Health Care In India?

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In the Union Budget speech of 2017-18, Indian Finance Minister articulated his intent, among several others, to launch a new initiative named ‘Digi Gaon’, which would extend the broadband digital technology in rural India. Besides education and skills, ‘Digi Gaon’ would facilitate affordable access to e-healthcare in the in the hinterland of the country.

“Under the Bharat Net, optical fiber has been laid in 1,55,000 km. I have stepped up the allocation for Bharat Net projects to Rs 10,000 crore in 2017-18 and by the end of 2017-18, high speed broadband on optical fiber will be available in more than 1.5 lakh gram Panchayats with hotspots and access to digital services at low tariff,” the Finance Minister said.

“This will give a major fillip to mobilizing broadband and Digital India, for the benefit of people living in rural areas,” he further added.

Increased penetration of ‘Telemedicine’, per se, in the country has the potential to improving time, cost and the quality of access to affordable health care in rural India, as confirmed by several important studies.

A broad perspective:

A report of the World Health Organization (W.H.O), titled “Telemedicine – Opportunities and developments in the Member States”, states that the term ‘Telemedicine’, was coined in the 1970s, which literally means “healing at a distance”. It signifies the use of modern Information and Communication Technologies (ICTs), such as computers, the Internet, and cell phones, to improve patient outcomes by increasing access to care and medical information.

Recognizing that there is no one definitive definition of ‘Telemedicine’ – a 2007 W.H.O study, after reviewing 104 peer-reviewed definitions of this word, adopted the following broad description:

“The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities”

‘Telemedicine’ in India:

Before I get into other relevant details in this area, let me briefly explore in which segments of the three important areas – Market, Services and Providers, ‘Telemedicine’ has already started working in India, though with a varying degree of success.

 Market segments:

‘Telemedicine Market’ in India can broadly be segmented into nine key categories. A recent research report on “India E-Health Services Market Outlook to 2020” by Ken Research captures the top three of these segments as follows:

  • Tele-radiology: The top segment in India that involves the electronic transmission of radiographic images of patients, such as, X-Ray, CT scan or MRI from one location to another location for an expert interpretation by a radiologist sitting there to quickly facilitate appropriate treatment.
  • Tele-consultation: Ranked second in terms of revenue earning of the Indian telemedicine industry in 2015. It involves establishing a clear audio and video communication link between the patient and doctors of different disciplines, as required. Patients’ demand for online consultations with the doctors is fast increasing as it helps to get disease specific medical advice from the different experts located anywhere in the world.
  • Tele-ICU: Was ranked as the third largest segment. It involves the use of an off-site command center in which a critical care team (intensivists and critical care nurses) connects with patients in distant ICUs to exchange health information through real-time audio, visual, and electronic means.

The following are the other six segments, which I am presenting below with a brief definition of each, for convenience:

  • Tele-ophthalmology: It delivers eye care through digital medical equipment and on telecommunications technology platforms.
  • Tele-dermatology: It involves communication technology to connect patients with dermatologists to improve skin health. The technology allows the patient to be examined and even treated without making a physical trip to a dermatologist.
  • Tele-surgery: It is the ability for a doctor to help perform surgery on a patient even though they are not physically in the same location. It is a form of telepresence.
  • Tele-pathology: It involves the practice of pathology at a distance using telecommunications technology to facilitate the transfer of image-rich pathology data between distant locations for the purposes of diagnosis, education, and research.
  • Tele-psychiatry: it is the application of telemedicine to the specialty field of psychiatry. The term typically describes the delivery of psychiatric assessment and care through telecommunications technology, usually video-conferencing.
  • Tele-Home Care and Nursing: This is primarily meant for patients who prefer receiving various health care services at home, such as those suffering from serious chronic diseases, post-surgery, and to cater to the critical regular heath needs of elderly persons.

Service segments:

Similarly, various international literature has segmented the ‘Telemedicine services’ into two broad types, as hereunder:

  • Real Time telemedicine services: These services include telephonic call or video-conferencing where both the doctors and the patients need to be present at the same time, and real time interaction happens between them.
  • Store and Forward telemedicine services: These do not require both the doctor and the patient be present at the same time and transmission and assessment of the medical records can be done at any convenient time.

Types of Providers:

Ken Research Report categorized the ‘Telemedicine Providers’ available in India into the following three groups:

  • Private Hospitals, such as Apollo Tele Health Services, Narayana Health Telemedicine Centers and Aravind Eye Care and telemedicine centers of Medanta, besides others.
  • Government Hospitals and Medical Colleges, such as, AIIMS, SGPGI and several others have made alliances with various districts and sub-district hospitals of different states in India. Some States such as Punjab, Gujarat and Uttarakhand have adopted a PPP model.
  • NGO run centers, such as, World Health Partners are the largest NGO in India that has 1100 with a market share of 56.1 percent.

The critical barriers to overcome:

There are several critical barriers to the rapid penetration of ‘Telemedicine’ in India. However, in this article, I shall discuss only five of those, which India has not cared much to resolve over a long period, and need to be addressed, sooner than later:

  • Frugal broadband Internet network:

Probably realizing that this stark reality still exists, despite earlier initiatives of ‘Digital      India’ slogan, the Finance Minister in his 2017-18 budget speech announced a fresh budget allocation for the new ‘Digi Gaon’ project.

An efficient broadband Internet is an absolute must for any efficient ‘Telemedicine’ project, as most of the applications of ‘Telemedicine’, as mentioned above, would work effectively only in that environment. In 2016, India’s broadband Internet penetration was an abysmal 7 percent, as reported in a white paper of the International Telecommunication Union (ITU), and quoted by the chairperson of the Telecom Regulatory Authority of India (TRAI).

  • High initial cost of setting up a telemedicine network:

The initial cost of setting up a viable ‘Telemedicine’ network, including training of personnel, developing user-friendly smartphone-based apps with state of the art technology, is high with low current Return on Investments (ROI).

  • Availability and training of personnel:

- At the village end: Availability of proper technician, other IT staff and qualified local doctors and their periodic training and performance assessment.

- At the consulting centers: Appropriate training, coordination with other relevant staff and administration as required for compliance and monitoring performance standard.

  • No legal framework governing Telemedicine in India:

At present, there is no legal framework in India governing Telemedicine of the country. The Government would need to urgently consider this issue, as it creates related facilities and infrastructure in the country.

  • Lack of revenue generating business models for sustainability:

In India, ‘Telemedicine’ is generally considered as a part of ‘social responsibility’ of public, private, large corporate hospitals and NGOs. In the some of the private hospitals it is alleged that the underlying objective is to raise the bed occupancy rate when the patients on ‘Telemedicine’ require hospitalization.

Currently, there exists a dearth of revenue generating business models for ‘Telemedicine’ in India, taking it beyond the realm of just ‘social responsibility’, and enabling it to play an increasing role in the overall health care space for long-term sustainability, with a win-win outcome for both its investors and patients.

Thus, the Government would require playing the role of an enabler to encourage, attract and support more and more private players and startups coming up with sustainable commercial business models in this area. Simultaneously, it should also play an active role to help increase public awareness in ‘Telemedicine’, eliminating patient inhibition, enhancing competition and reducing patients’ cost for various services.

Is ‘Affordable health care’ a victim of circumstances?

India with its public spend as a percentage of GDP on health care being consistently one of the lowest in the world over a period of a very long time, despite being the fastest growing global economy, the importance of high penetration of ‘Telemedicine’ in the country assumes a high importance. More so, when grossly inadequate public health care facilities continue to pose serious health risks for many of the country’s population.

On the other hand, in Indian private health care space, including drugs and pharmaceuticals, where a sizeable section of global pharma players and their lobbyists are continually pushing hard, predominantly an Intellectual Property (IP) orientated blatant self-serving agenda. They want to sell more of high price monopoly products and services to earn more and more profit, depriving a huge majority of local patients. It’s happening, even when the image of the global pharma industry has plunged to a new low, and is still going south, despite tons of money allegedly being spent on lobbying of various nature, more than ever before.

No wonder, why the globally acclaimed doyen of the IT industry – Mr. Narayana Murthy also openly acknowledged this fact, suggesting some science and technology based remedial measures. While addressing the Bio Asia 2017 on February 08, 2017 in Hyderabad he said: “India has fallen behind in healthcare, but science and technology can indeed play a role in bridging the gaps. Science and technology can play a key role in diagnosis and management of disease, of mass application of drugs and availability of drugs on a scale and at an affordable cost,” as reported in the Economic Times.

Thus, sandwiched between either side, ‘Affordable health care’ continues to remain a major victim of the circumstances, and is desperately looking for a strong Government intervention, just as what’s now happening in several developed countries, including the United States.

Conclusion:

Although ‘Telemedicine’ is an important enabler and enhancer, I reckon, it’s not a panacea. It would never replace brick and mortar high quality generally affordable health care facilities, along with affordable modern life saving medicines, any time in the foreseeable future.

The announcement of ‘Digi Gaon’ to facilitate ‘Telemedicine’ in India, without a well-charted roadmap and overcoming its critical success barriers, is intriguing. Nevertheless, this initiative has an underlying potential to transform ‘Telemedicine’ into a robust revenue generating model, even at the village level entrepreneurship, with sharp application of creative minds.

It’s a matter of great concern that in the space of Governance in India, public health care is increasingly becoming more a subject of a general lip service, rather than immaculate execution of a robust, comprehensive, time-bound National Health Policy with assigned accountability for each project and backed by requisite budgetary allocation, both by the Central and the State Governments. Consequently, one would seldom witness any such well hyped announcements on various public health care projects seldom coming to fruition on the ground, as promised.

Even if the recently announced ‘Digi Gaon’ initiative is considered as a standalone project for greater access to ‘Telemedicine’ in the hinterland of the country, it is important to understand that, in the short term, investment in ‘Telemedicine’ won’t be a magic wand for India to demonstrate a commensurate increase in health outcomes, along with reaping its consequential economic benefits.

To succeed in this area, several critical barriers need to be effectively overcome, soon. This would help showcasing ‘Telemedicine’ as an integral part of everyday e-health care solution for many. Otherwise, the Government is likely to face enormous challenges to leverage the true potential of ‘Digi Gaon’ for alleviation of acute miseries caused by poor, or lack of access to affordable health care, especially in rural India.

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.

Union Budget 2017-18: ‘Modicare’ Remains A Pie In The Sky

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Universal Health Care (UHC), as narrated in the National Health Policy (NHP) 2015 (NHP 2015 Draft) of Narendra Modi Government, making health a ‘Fundamental Right’ for Indian citizens, was considered a profound step by many, both in its both content and intent.

Being enormously enthused with this development, in my article of April 06, 2015 in this blog, titled “Would Affordable ‘Modicare’ Remain Just A Pipe Dream In India?”, I also termed this new draft health policy as ‘Modicare’, just as a few others did. If implemented both in its letter and in spirit, NHP 2015 has the potential to overshadow even the ‘Obamacare’ of the United States, almost hands down. Although it’s an altogether different story that under the new President Donald Trump’s administration, this Act faces a real threat of extinction, at least, in its current Avatar.

Is health care also a serious political issue?

Prompted by what has been happening in the oldest democracy in the world, the above fundamental question does surface. Its answer could be both, ‘yes’ or ‘no’, depending on the voters’ awareness on the subject, and the importance attached to it for individual well-being, including work productivity.

However, in this article, to impress upon how important are the promises on health care to the common citizens in the oldest democracy, I shall draw two back to back examples of pre-election campaign promises related to universal health care in the Unites states, where the answer to the above question has been an emphatic ‘yes’. Thereafter, I would explore what is happening in India in this area to fathom what could its answer possibly be in the largest democracy of the world.

The United States:

On November 4, 2008, Senator Barack Obama of Illinois was elected as the president of the United States. Just in a year’s time ‘The Patient Protection and Affordable Care Act’ popularly known as ‘Obamacare’, was passed in the Senate on December 24, 2009, and passed in the house on March 21, 2010. It was signed into law by President Obama on March 23rd, 2010 and upheld in the supreme court on June 28, 2012.

By enacting this historic health care reform legislation, President Obama fulfilled his election campaign pledge to provide healthcare to all in the United States of America, almost immediately after coming to power.

Similarly, during his 2016 election campaign, Donald Trump pledged to repeal the ‘Affordable Care Act (Obamacare)’, if elected, calling it a “total disaster.” Accordingly, on January 20, 2017 – the same day of becoming the 45th president of the United States, in his first executive order, President Trump, told government agencies to scale back aspects of the Affordable Care Act – fulfilling his pledge to undo Barack Obama’s signature healthcare law that made medical services accessible to millions of Americans.

Whether, it is a good or bad decision may not be a point of discussion in this article, but so far as the pre-election pledge on health care reform is concerned, both the Presidents – Obama and Trump indeed ‘walked the talk’.

India:

Besides the above two examples, the general expectation of the stakeholders in India was that in the priority agenda of the new Government health care will feature much higher than ever before. This was because the main ruling party of the Government in power now had promised to deliver a robust healthcare reform in its Election Manifesto 2014, if it is voted to power. Let me just reproduce below some of those critical promises:

  • India needs a holistic health care system that is universally accessible, affordable, effective and drastically reduces the out of pocket spending on health.
  • The Party accords high priority to the health sector, which is crucial for securing the economy.
  • As NRHM has failed to meet the objectives, it will be radically reformed.
  • The overarching goal of health care would be to provide, ‘Health Assurance to all Indians and to reduce the out of pocket spending on health care’, with the help of state governments.
  • The current situation calls for radical reforms in the health care system with regards to national health care programs and delivery, medical education and training and financing of health care.

The manifesto then goes into the details of each reform areas, after stating, “the last health care policy dates back to 2002; India now needs a comprehensive health care policy to address the complex health care challenges, keeping in view the developments in the health care sector and the changing demographics. The party will initiate the New Health Policy.”

This expectation flickered yet again:

This expectation flickered yet again, when just on the eve of the 2017-18 Union Budget Session, no less than the President of India, honorable Pranab Mukherjee on the last Tuesday reportedly reiterated that his Government assures ‘Health care for all’.

It’s about three years since the new Government is firmly placed on the saddle, after being voted to power. Regrettably, much promised, the new and comprehensive health care policy of India is still not in place. Could it mean, unlike in the US, pre-election political pledges on health care is still not considered a top priority area for quick implementation either by the Indian voters or the winning political parties, post-election? Probably, it doesn’t also sound as vote catching as a plethora of other ‘developmental activities’, ‘Foreign Direct Investments (FDI)’ and ‘GDP growth’ do, for winning a national election in our soil.

In India, most of the population think or feel about medical treatment and prevention of diseases mostly when we ourselves, or our near and dear ones suffer from serious morbidity, or are almost in a dying condition from serious ailments. At that moment of truth, most of us face almost an insurmountable barrier to treatment access due to individual ‘affordability’ condition. In the absence of enough decent public health facilities, one is compelled to go for private medical services that cost a bomb, most of which being out of pocket. At other times, it does not seem to matter much to many, or becomes an integral part of a burning social, political or economic agenda. It has thus far remained a dormant need, which needs to be brought to open by creating greater awareness in ambitious India, even during and after bringing a Government to power.

The fastest growing nation incurs lowest public health expenditure:

Even post ‘Demonetization’ exercise in the country, India would continue to remain the fastest growing large country in the world. However, the Government allocates just around one percent of GDP on public healthcare expenditure, ranking among the lowest in the world, in this area. Regrettably, there does not seem to be an adequate realization both among the public, corporate head honchos, including a large section of the country’s highly partisan media that sans sharp focus on health care, this immaculate growth story can get adversely impacted, in the long run.

Incoherent union health budgets sans any report card on achievements:

Be that as it may, in this article, I shall present before you a snapshot of the health care budgetary measures announced by the Finance Minister in his Budget speech both in 2016-17 vis-a-vis in 2017-18. Thereafter, I would try to explore how incoherent these are, and without any comprehensive status report on time-bound set goals. This is important, as taxpayers hard earned money was spent on those ‘goodies’, probably to give an impression that health care has not been totally left out by the Government during its annual budgetary allocation.

To demonstrate how incoherent and ad hoc these health budgets are, let me place before you what were the key areas of Union Budgetary allocations in 2016-17. If I may refer to my article of March 07, 2016 in this Blog titled, “Healthcare: Unwrapping The Union Budget (2016-17)”, we shall find that the key features were as follows:

The previous Union Budget of 2016-17:

  • The Government will launch a new health protection scheme, which will provide health cover up to Rs. One lakh (Rs. 100,000) per family. For senior citizens, age 60 years and above, belonging to this category, an additional top-up package up to Rs. 30,000 will be provided.
  • To reinvigorate the supply of generic drugs 3,000 stores under Prime Minister’s Jan Aushadhi Yojana will be opened during 2016-17.
  • Starting a ‘National Dialysis Services Program’ to provide dialysis services in all district hospitals. The funds were to be made available through PPP mode under the National Health Mission. To reduce the cost, the budget proposed exemption of certain parts of dialysis equipment from basic customs duty, excise/CVD and SAD.

I am not sure how many stakeholders, if any, are aware of the exact status report on those proposals of the last year’s Union Budget allocation for health care. If that’s the prevailing situation, we now get another small bundle of different sets of ‘goodies’ in the Union Budget 2017-18, as follows:

Current Union Budget of 2017-18:

Even in the absence of a comprehensive National Health Policy, there are many other health related critical issues that may eventually impede the GDP growth rate of the country. A few examples of which are as follows:

  • The estimated premature deaths caused by cardiac ailments, stroke and diabetes, reportedly, will result in a loss of national income of over US$ 250 billion in the coming decade,
  • Mental health becoming a silent epidemic, affecting around 13 percent of the population and just 10 percent of them getting treatment,
  • Millions of families are unable to get access to secondary and tertiary care services for diagnosis and treatment of serious diseases, such as cancer, as they cannot afford private facilities, which gets compounded as India records one of the highest out-of-pocket health expenditure in the world, higher than even many lower income, lower-middle income, as well as the middle-income countries.

Nevertheless, the Union Finance Minister in his 2017-18 budget proposal announced a strong resolve for elimination of:

  • Kala-azar or Leishmaniasis and filaria by 2017
  • Leprosy by 2018
  • Measles by 2020
  • Tuberculosis by 2025

Unquestionably, these are grossly inadequate, especially, in young and ambitious India. Moreover, very people industry watchers would know whether the deadline set for each is achievable, and a periodic report card on the same will be made public or not.

Similarly, the government’s determination to reduce Infant Mortality Rate (IMR) to 28 by 2019 (39 in 2014) and Maternal Mortality Rate (MMR) to 100 in 2020 (167 in 2011-13) is also praiseworthy. However, both these, including tuberculosis prevention, diagnosis and treatment interventions, were a part of the Millennium Development Goals (MDGs) for India. These are an ongoing exercise set out in the Millennium Declaration in 2000. Moreover, why annual budgetary allocation only for those two now, out of 8 MDG goals?

A few other equally ad hoc health care measures, probably picked up at random, and announced by the Union Finance Minister in his February 01, 2017 budget speech were the following:

  • Rs 6,000 financial aid for pregnant women to cover hospital admission, vaccination and nutritional food.
  • Two new All India Institute of Medical Sciences (AIIMS) at Jharkhand and Gujarat.
  • 1.5 lakh health sub centers to be converted to Health Wellness Centers
  • Amendment of the Drugs and Cosmetics Rules to ensure availability of drugs at reasonable prices and promote the use of generic medicines
  • New rules for regulating medical devices to be formulated, which will be internationally harmonized and attract investment into this sector
  • Structural reforms in the medical practice and education.
  • For senior citizens, Aadhar based Smart Cards containing their health details. A beginning will be made through a pilot in 15 districts during 2017-18.

By all these, the government has proposed 27.7 percent increase in allocation for Ministry of Health and Family Welfare to Rs.47, 352.51 Crore in the latest budget from Rs 37,061.55 Crore in 2016-17, on the current abysmally low base of around 1 percent of GDP. A sizeable chunk of this budget is expected to go towards setting up of two new AIIMS and for conversion of 1.5 lakh health sub centers to Health Wellness Centers. The National Health Mission (NHM) for the entire nation, which the Government earlier said is not working, receives an increase of Rs. 3,000 Crore. According to media reports, the Public Health Foundation of India (PHFI) also considers this budget allocation as a frugal one.

Besides the general expectation for the beginning of a Universal Health Care (UHC) regime in India, pharma industry had generally expected the following immediate term relief, which also found no mention in the budget:

  • Corporate tax cut
  • Extension of time line for weighted deductions of R&D expenditure and adding filing fees and clinical trial expenses under the exemption.
  • Rationalization in excise duty for APIs to bring it on par with formulations.
  • Changes to excise duty due to impending implementation of goods and service tax (GST) Withdrawal of service tax on health insurance
  • Exemption of input service tax on support services

Conclusion:

The reason why I brought ‘Modicare’ in my budget discussion is that it needs well-articulated budgetary allocation, even for just the beginning of its implementation, besides having a robust policy in place. Even on the eve of the 2017-18 Union Budget Session, no less than the President of India had reiterated that his Government assures ‘health care for all’ – further rekindling this hope.

In the absence of a well-charted pathway for public health care in India, no wonder that this budget, in my opinion, demonstrates a clear lack of direction, incoherent and inconsistent, just as the previous ones.

I hasten to add that the Government’s focus on rural infrastructure and development, providing financial benefit to farmers, help building affordable houses, creating new jobs, ensuring ease of doing business, putting more disposable income in the hands of the people are well appreciated. However, none can possibly refute the dictum, especially in the young and highly ambitious India that: “It takes a healthy nation to build a wealthy nation”.

The bottom line, therefore, is, the fastest growing nation of the world continues to feel wise and smart with its lowest expenditure on public health. It also leaves a general impression that the Government has removed from its list of priority all the pledges made on health care, before, during and after having a firm grip on the leash of power. Consequently, this has made ‘Modicare’ no more than a pie in the sky, as it were, for many, even after years of sustenance of an indomitable hope of it coming to fruition.

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.