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Indian Pharma To Stay Ahead of The Technology Curve

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In the ever-changing business environment, many industrial sectors have now started leveraging different cutting-edge technological platforms to improve overall strategic and operational effectiveness, keeping a sharp focus on better stakeholder engagement for greater customer satisfaction.

These companies have accepted the inevitability of a paradigm shift in the algorithm of the traditional business process. It has dawned on them that it may not be possible to be in the pole position by tweaking the existing process with multiple incremental changes – a time is just right now to take a quantum leap in this direction. Placing the company ahead of the technology curve to acquire the critical X-factor in outperforming the competition is going to be the new mantra. This is likely to happen even in the sales and marketing domains, much sooner than one can possibly imagine, as the marketplace becomes increasingly tougher.

Moving closer to this direction, Artificial Intelligence (AI) based digital tools, I reckon, is likely to be one of the key game changers. The term AI was coined in 1956 by John McCarthy at the Massachusetts Institute of Technology (MIT) and is usually defined as the science of making computers do things that require intelligence when done by humans. AI helps to ferret out critical answers to many real-life issues and gain a competitive edge in business management, by creating and then effectively analyzing a huge pool of real life data.

AI is the fulcrum of business operations for several leading companies of the world, such as, Apple, Amazon and Uber. It has already started replacing human intelligence in a number key business operations in various industries. As a widely-known Indian business leader recently said, anything that can go digital will go digital. This wave is unstoppable in this modern era.

In this article, I shall restrict the scope of discussion to the application of AI in pharma sales and marketing.

A recent illustration from India:

The application of AI via a digital tool, called Chatbot – the short form of ‘Chat Robot’, is one of the ways in this direction. It is a complex computer program that simulates human conversation, or chat, through auditory or textual methods. Various industries have now started developing the Chatbot dialog application systems for a specialized purpose of human communication, including a variety of customer interaction, information acquisition and providing a range of customized services to the target group.

To illustrate the above point, let me draw upon a recent example from the banking sector of India. On March 05, 2017, a leading bank in India announced the launch of an AI-driven Chatbot named Eva, coined from the words Electronic Virtual Assistant (EVA), to add more value to their services for greater customer satisfaction.

According to reports, Eva is India’s first AI driven banking Chatbot that can answer millions of customer queries on its own, across multiple channels, immediately. It assimilates knowledge from thousands of sources and provide answers in a simple to understand language format in under 0.4 seconds. This is a good example of taking a quantum leap in improving operational efficiency by delighting the new generation of customers. “Within the first few days of its launch, Eva has answered over 100,000 queries from thousands of customers from 17 countries across the globe” – the bank reportedly claimed.

To do routine services more efficiently with a customer-centric approach, this AI-based  Bank OnChat combines a disruptive technology platform for a human-like conversation, powered by AI, and the Bank’s deep domain expertise and long acquired insight of banking related customers. Earlier this year, for a similar customer-oriented initiative using AI and Robotics technologies, the same bank launched an interactive  humanoid called Intelligent Robotic Assistant or IRA.

Although, these are just illustrations in the Indian context, an important question that surfaces: if these can happen in the banking industry, why not in the pharma sector of India?

Resisting changes versus finding innovative means to overcome challenges:

Coming back to the pharma industry, we all are aware that this knowledge sector, over the last four and a half decades in India, has been navigating through umpteen challenges, none of which has been easy, by any measure.

Nevertheless, as compared to the past, I notice a palpable difference today. Significantly more number of shrill voices with fierce resistance to changes are now outnumbering the out of box mindset, desire and efforts to still thrive, by overcoming those critical challenges. Since the formative years of the Indian pharma industry, it has been successfully overcoming the challenges of change, which are unavoidable though.

Such kind of indomitable ‘animal spirit’ within many leaders of the Indian pharma industry, created today’s national pharma behemoths like, Sun Pharma, Lupin, Cadila, Dr. Reddy’s, Alkem and many others. They are thriving despite continuation of immensely challenging business environment and tough socioeconomic demand in the country. By the way, the second richest person in India is from the Indian pharma industry and grew from a scratch, during this very period.

Making creative changes help, moaning doesn’t:

While facing the newer sets of challenges today, many industry greenhorns, I reckon, need to spend more quality time to effectively overcome these turbulences – provided of course they possess the requisite mindset, knowledge and other wherewithal.

Acquiring new insight through modern technological platforms, such as AI, will pay a rich dividend. Better customer engagement and relationship management with new genres of AI tools, furnishing stimulating and modern web-based content with personalized access, would help achieve the desired strategic goals in the changing paradigm – but just moaning won’t, surely.

A few global pharma players are now fathoming the scope and depth of this area, most others are still not sure about its usefulness for customer engagement and interactions, and commensurate real-life data requirements for AI related analytics.

A predictable pattern of a series of unpredictable challenges and developments:

According to Eularis, integrating AI based analytics with a pharma product offerings can provide substantial benefits including, among others, the following:

  • Identification of both tangible and intangible enhanced value proposition
  • Enhanced competitor differentiation
  • Optimal resource allocation for maximum market share gain, revenue and profit
  • Ability to see which levers to pull to maximize growth
  • Customizing sales and marketing messaging for greater customer engagement
  • Automation of sales and marketing messages and channels.

In my view, while moving in this direction, AI based analytics are now far more reliable than any human analysis of the humongous volume of different kinds of data. Doing so is sometimes beyond the capacity of any conventional computers that a marketing professional generally uses for this purpose. The prime requirement, therefore, is not just huge volume of data per se, but good quality of a decent volume of data, that a state of the art analytics would be able to meaningfully deliver to meet specific requirements of pharma marketers for creating a cutting-edge marketing strategy.

This will be an absolute necessity in the complexity of an evolving new paradigm in the cyberspace. In a similar context, as I wrote even earlier, any such technology-driven changes would usually follow a predictable pattern of a series of unpredictable challenges and developments in the business environment, which has already commenced in the pharma industry.

The Market:

According to an April 2013 article, published by the McKinsey  Global Institute, applying big-data strategies to better inform decision making could generate up to US$100 billion in value annually only across the US health care system, by optimizing innovation, improving the efficiency of research and clinical trials, and building new tools for physicians, consumers, insurers, and regulators to meeting the promise of more individualized approaches.

Mandatory generic prescriptions won’t make pharma marketing less important:

Even if the much talked about mandatory prescription in generic names comes to fruition, the new paradigm won’t make pharma marketing less important. This would, however, be more about providing patient-centric, credible and tangible disease management or treatment solutions or both, rather than just selling a drug giving a trade name to it.

Thus, the need for interaction with physicians by the pharma players, besides some additional new target groups, would continue to remain important. Nonetheless, the message – mostly its form, substantive content, the targeting process and the usage of various tools for delivery of the same, would undergo substantive modifications. These changes would generally be prompted by fresh thinking, together with a fresh pair of eyes and mind, in the prevailing business environment, at any given point of time, well supported by data and tested with state of art analytics. The depth and gravity of environmental changes may also hasten the process of digital transformation of pharma sales and marketing, in various ways.

Those who are still trying harder to milk the traditional prescription demand generation process to the extent possible, despite its lesser and lesser yield, would need to introspect now, if they are able to. The time, and the prevailing pharma business environment probably demands jettisoning the conventional mindset faster, and search for the best-suited and most innovative modern tools to hit the bull’s eye. The young pharma professionals with a ‘can do’ spirit to effectively navigate through the strong headwind, are likely to emerge as early winners – provided of course their seniors and diehard ‘trainers’ don’t block their required elbow space.

‘Virtual Representatives’:

Deploying ‘Virtual Representatives (VR)’, well- supported by analytics for key target customers that QuintilesIMS is recommending, could be one among several other important examples in this area. VRs are appropriately equipped to take any doctor’s call online, for any product or related information, at any time the physicians find convenient – during or after their busy practicing hours.

The ‘push-pull’ balance between the doctors and the pharma players for such engagements can also be appropriately configured, and that too at a fraction of the current cost incurred to for similar purpose. This process and the technology used will be quite close to Chatbot, that has recently been introduced by an Indian bank, as illustrated above.

In conclusion:

Despite the rapidly changing business environment, pressing socioeconomic demands and a national dream for ‘Digital India’, the pharma industry hasn’t demonstrated any significant appetite for a change in the process of doing the business in the country. Individual players, by and large, have remained mostly consistent in strictly adhering to much tried processes and tools, though in their multiple permutations and combinations, especially in the domain of sales and marketing.

Other industries, like banking – also facing different types of tough challenges, are making efforts to stay ahead of the technology curve for operational excellence and greater consumer satisfaction. Fast scaling up of digital applications, such as Chatbots, Humanoids and the likes, vindicate this point.

Notwithstanding the availability of a large gamut of cutting-edge technological platforms, such as those based on AI, most players within the pharma industry continue to be rather slow in adopting these important and innovative resources. Could it be due to dearth of requisite talent, especially in pharma sales and marketing leadership within the industry? Well, many may argue so – some may also feel otherwise. Nevertheless, finding the right answer for a slow response of pharma in this domain still remains elusive.

That said, amid a gradually shifting paradigm, Indian pharma companies may wish to consider imbibing innovative technological interventions, such as, AI-based digital applications in sales and marketing. This has a great potential to successfully sail through many uncertainties, not just the latest one. It would also help changing the traditional ball game with a flexible, multitasking and contemporary one – right from conceptualizing – to charting out a customer-centric sales and marketing strategy – and then its immaculate execution, catapulting the company to a new and fascinating growth orbit altogether. Thus, staying ahead of the technology curve by the Indian pharma players, assumes critical importance for a long-term business sustainability, more than ever before.

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.

Is The Department of Pharmaceuticals On The Same Page As The Prime Minister?

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“The open secret is that pharmaceutical companies throw all manners of inducements on doctors to prescribe their medicines. The victim of their misdemeanors is the unsuspecting patient. Mr. Modi clearly wants to break this self-serving chain” – highlighted a media report on April 20, 2017.

“Prime Minister Modi wants to end the unholy doctor-drug industry nexus” – echoed another media headline on the same day.

In a step towards this direction for the benefits of patients, the PM hinted at making prescriptions in generic names of drugs mandatory through a legal framework. There could be many challenges ahead to achieve this objective, but the fact remains just the same. A study published in a well-acclaimed medical journal, even after the PM’s much talked about pledge, re-establishes the adverse impact of this alleged nexus through a bioequivalarge research study.

In this article, I shall not go into the details of what the PM had said in this regard and the impact of the same on patients, pharma companies, different types of service providers to the branded-generic business, and the Indian Pharma Market (IPM), as I have already done that. Neither shall I focus here on the action expected from the Union Ministry of Health, as they have, at least, amended the statute making the bioequivalence studies mandatory, though several other action steps need to follow. Today, I shall deliberate only on one question: Is the department of pharma on the same page with the PM on effectively addressing the alleged ‘doctor-drug industry nexus’?

A recent study:

The following very recent study elegantly highlighted the criticality of snapping this unholy link, as many believe, for the patients’ sake.

The May 2, 2017 JAMA editorial titled, “Reconsidering Physician – Pharmaceutical Industry Relationships” articulated, physicians need to balance the risk and benefits of treatments, especially when inputs come from companies whose interests may conflict directly with those of patients. Drug costs, though revenue to their respective manufacturers, are high out of pocket expenditure to patients, many of whom seriously struggle to afford their medical treatment.

The above editorial comment was based on an ‘Original Investigation’ study titled, “Association Between Academic Medical Center Pharmaceutical Detailing Policies and Physician Prescribing”, published on the same day in the same esteemed journal.

This large study was aimed at measuring the outcome of an effort by some Academic Medical Centers (AMCs) in the United States to regulate physicians’ conflict of interest in this area. These AMCs enacted policies restricting pharmaceutical representatives’ visits to physicians for product detailing, between 2006 and 2012. Accordingly, the paper analyzed the association between detailing policies enacted at these AMCs and the physicians’ prescribing of actively detailed and not detailed drugs. This study included 16,121, 483 prescriptions, written between January 2006 and June 2012, by 2126 attending physicians, at the 19 intervention group AMCs, and by 24, 593 matched control group physicians.

The authors concluded with a fresh reaffirmation that the implementation of policies at AMCs, which restricted product detailing by the respective company medial representatives, between 2006 and 2012, was associated with a modest but statistically significant reduction in prescribing of detailed drugs across 6 of 8 major drug classes.

Significant cost reduction, with important economic implications:

It’s worth noting, the patients did not suffer at all, in any way, with such restrictions, on the contrary were probably benefitted with this policy, though individual pharma player’s sales revenue might have been adversely impacted.

Quoting the researchers, a Public Release of May 2, 2017 titled, “Restricting sales visits from pharmaceutical reps associated with changes in physician prescribing” also reiterates: The reduction in the prescribing of detailed drugs and the increase in the prescribing of non-detailed drugs potentially represent a large reduction in costs, with important economic implications.

Why aren’t the erring players brought to justice in India?

Instances of serious marketing malpractices of several pharma companies in India are also being widely reported from time to time, both by the international and national media, including expressions of serious concern in the Parliament, and a reported Public Interest Litigation (PIL) pending in the Supreme Court.

Any instances of levying massive fines, or other punitive measures taken by any competent Indian authority for such delinquency by many pharma companies operating in the country, have not been reported, just yet, in my view. This is because, India doesn’t have in place any specific regulatory mechanism with built-in legal teeth that would deter, detect, investigate and take exemplary punitive actions against the erring players, wherever justifiable.

Is the department of pharma on the same page as the PM?

Much before this recent development, the Department Related Parliamentary Standing Committee on Health and Family Welfare in its 58th Report, placed before the Parliament on May 08, 2012, strongly indicted the Department of Pharmaceuticals (DoP) for not taking any tangible action in this regard. The committee observed that the DoP should take immediate action in making the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ mandatory to contain ‘huge promotional costs and the resultant add-on impact on medicine prices’.

It has just been reported, soon after the Prime Minister’s hint for a legal framework mandating doctors to prescribe in generic names, 73 percent doctors surveyed across the country opposed the PM’s initiative, raising concerns about the quality of all non-branded generic drugs. The report further stokes the apprehension of a concerted effort by this alleged nexus to further strengthen the make-believe perception, sans requisite credible favorable evidence, that branded-generics as a category is superior in quality to non-branded generics, which is not the fact.

Unfortunately, nothing substantive has yet happened on the ground regarding this issue, except the announcement of voluntary implementation of the DoP’s ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, effective January 1, 2015 for six months for its assessment. Thereafter, the date extension process on the voluntary implementation of the UCPMP has become a routine exercise for the DoP on various pretexts, such as continuing discussion with the pharma trade associations and other stakeholders or to give legal teeth into it with penal provisions.

This situation prompts an important question: Is the DoP on the same page with the PM to contain, if not eliminate, the alleged unholy doctor-drug industry nexus?

Scope of mandatory UCPMP goes beyond prescriptions with generic names:

The scope of several intricate types of marketing malpractices, goes well-beyond influencing prescriptions for brand name drugs, due to various reasons. Hence, what Prime Minister Modi recently hinted at is not an alternative or a replacement for UCPMP, which will fall within a legal framework and be applicable to all the concerned players. Although, there could possibly be some degree of overlap with the prescriptions in generic names, mainly from the perspective of protecting patients’ health interest, the scope of both these initiatives is mutually exclusive, in many respects.

This would also encourage, especially the millennial generation, for innovative strategic thinking to work out cutting edge pharma marketing game plans with active patient engagement, while charting the uncharted frontiers, despite prescriptions in generic names, as and when it comes, if at all. As a result, new warhorses with proven cerebral power and agility would get newer opportunities to hold the leash and occupy the center stage in the pharma marketing warfare.

But…the indefinite wait continues:

Although the DoP apparently maintains a radio-silence on this important issue, a media report of February 26, 2017 indicates that the department will ‘soon’ issue an order making UCPMP mandatory for the drug manufacturing industry, bringing all doctors, chemists, hospitals and states in its ambit, and a blanket ban on expensive freebies such as cruise or vacation tickets. Intriguingly, no one seems to know how ‘soon’ would this ‘soon’ be – hence, the agony of an indefinite wait for justice continues.

Conclusion:

For the last three and a half decades, ‘Code of Pharmaceutical Marketing Practices’, prepared by various global pharma trade associations and many large global pharma companies individually, has come into existence for ‘strictest’ voluntary adherence. These are being relentlessly propagated by them as a panacea for all marketing malpractices in the drug industry.

Squeaky clean ‘pharma marketing codes for voluntary practices’ can be seen well placed in the websites of almost all large global pharma players and their trade associations. Although, its concept and intent are both commendable, a regular flow of media reports on such malpractices raises a relevant question: Do the votaries, sponsors and creators of these codes “walk the talk”?

If yes, why then mind boggling sums in billions of dollars are being paid as settlement fees by a large number of global pharma companies for alleged colossal marketing malpractices in different countries of the world.

This scenario prompts many stakeholders believe, though over-hyped by the global pharma industry, ‘Voluntary Practices’ alone of Pharma Marketing Code’, has never worked anywhere in the world. Thus, India needs a legally binding UCPMP for all concerned.

Prime Minister Modi has hinted at an effective pathway to mitigate this malevolent nexus for the benefit of patients. Understandably, that way can’t be construed as an exhaustive one, nor a cure-all. A slew of other effective steps should follow from different Government authorities, in tandem. The Union Ministry of Health has, at least, taken a related measure falling in their space. Nevertheless, an intriguing apathy of the DoP, as it were, in this area would encourage many to ponder: Is this important Government department on the same page as the PM in containing the alleged ‘doctor – pharma industry nexus?’

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.

 

Generic Drug Quality: Cacophony Masks An Important Note, Creates A Pariah

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In the ongoing debate between branded-generics and generic drugs without brand names, the concern about drug quality is occupying the center stage, with the former generally being painted in white, and the later in black – with no shades of gray in-between. Interestingly, many large domestic companies manufacture and sell both these genres of generic medicines, and the marketing approval process of both is no different, in a relative yardstick. The degree of difficulty in testing their quality standards, across the country, is no different, either.

On February 25, 2017, even the USFDA, reportedly, raised concerns, for the first time, on the quality and efficacy of medicines, in general, being sold within India. The news report further highlighted: ‘Over the past two years, many domestic majors, including Sun Pharma, Dr. Reddy’s, Cipla and Zydus Cadila have faced regulatory ire over quality of medicines exported from here and sold in the US and other overseas markets’.

It is undeniable, if prescriptions in generic names are made mandatory, there could be direct job losses within the industry, just as loss of significant business clientele of many professional service providers for branded generic business, directly or indirectly. Its net impact needs to be factored-in too, while taking a final decision on this subject.

Lack of enough credible scientific data establishing superiority of branded-generics over their non-branded equivalents are also striking, so are few instances of doctors filing Pharmacovigilance reports with the DCGI on the inferior quality of non-branded generic drugs. Neither is the most competent body in this area – the Central Drugs Standard Control Organization (CDSCO), has concurred with any such claims, so far. Without these, the whole debate based on seemingly over the top claims of superiority of branded generics as a class, is based no more than a matter of conjecture.

I discussed most of these points in one of my earlier articles published in this blog on April 24, 2017. Thus, in this article, I shall focus mostly on an important generic-drug-quality related amendment, very recently made in the Drugs and Cosmetics Act of India, which hasn’t received as much attention as it deserves. This finer note in the drug regulatory playbook, in fact, got nearly masked in the high-decibel cacophony of arguments and counterarguments on Prime Minister Modi’s recent hint on making prescriptions in generic drug names mandatory.

The core issue remains the same, both for non-branded and branded generics:

In the marketing approval process of any branded generic or a non-branded generic drug, Bioequivalence (BE) studies hold immense scientific importance. It ascertains whether the generic equivalent possesses similar efficacy and safety profile as the original molecule for interchangeability. Which is why, in most countries, including Europe and the United States, BE testing is mandatory for approval of any generic drug. Even the large buyers of these drugs, such as the World Health Organization, buy only those generics with proven BE.

Nonetheless, like many other nations, in India, as well, the marketing approval standards for all generic drugs, with or without a brand name, are exactly the same. However, this approval process gets alarmingly relaxed, for both these generic types, with the passage of time, which is the core issue.

New drug definition in India:

According to section 122-E of Drugs and Cosmetics Rules, 1945 (D&C Rules) new drugs will include unapproved drugs, modified or new claims, such as, indications, dosage forms (including sustained release dosage form) and route of administration of already approved drugs and combination of two or more drugs. A new drug shall continue to be considered as new for a period of four years from the date of its first approval or its inclusion in the Indian Pharmacopoeia, whichever is earlier.

BE studies necessary only for ‘New Drugs’:

For all such new drugs and their Fixed Dose Combinations (FDC), including those which are not covered by a patent, if introduced for the first time in India, would necessarily require its applicant to submit the marketing approval documents well-supported by phase III clinical trial data, which includes BE studies against the original molecules. BE of a drug product is achieved if its extent and rate of absorption do not show statistically significant differences from those of the reference product when administered at the same molar dose.

After the 4-year period BE tests not necessary:

Interestingly, after the 4-year period, D&C rules allow subsequent manufacturers of similar drugs to generally rely on the data generated by other pharma companies to obtain marketing approvals for their drugs. In other words, after this 4-year period, manufacturers of branded or non-branded generic drugs are not required to establish comparable safety and efficacy of their formulations with the original molecule through BE and other studies. It is worth noting here, unlike India, BE tests are mandatory for approval of all generic drugs at any time, in most countries across the world.

How would a doctor select only those branded-generics with BE studies?

As there isn’t any easy way to know and identify, both by the doctors and also the patients, which branded or non-branded generics were introduced without BE studies, both these categories pose equal risks to patients – not just the cheaper generic drugs sans brand names.

Changes recommended:

This laxity in the regulatory framework in India did create a lot of uneasiness about the quality of branded and non-branded generic medicines approved by the drug regulators and sold in the country. Responding to this issue, Professor Ranjit Roy Chowdhury Committee Report recommended in July 2013 to make BE and bio­availability studies mandatory for all types of generic drugs, even after the 4-year period.

Cacophony masks an important note:

The good news is, on April 3, 2017, by a Gazette Notification, Indian Government enacted amendments to the Drug and Cosmetics Act (1940) requiring mandatory BE studies for marketing approval of all generic drugs even beyond the 4-year period of the ‘new drug’ definition. It says, “The applicant shall submit the result of bioequivalence study referred to in Schedule Y, along with the application for the grant of a license of the oral dosage form of drugs specified under category II and category IV of the biopharmaceutical classification system.”

Biopharmaceutics Classification System:

The Biopharmaceutics Classification System (BCS) is a scientific framework to differentiate the drug formulations based on their aqueous solubility and intestinal permeability, and mainly depends on two factors:

  • How well the drug dissolves in the stomach and intestinal fluids (drug solubility)
  • How readily the drug passes through the intestinal wall into the blood flow (drug permeability)

The BCS was introduced by Gordon L. Amidon in 1995 to classify drugs into the four categories based on these parameters, as follows:

  • Class I: High Solubility – High Permeability
  • Class II: Low Solubility – High Permeability
  • Class III: High Solubility – Low Permeability
  • Class IV: Low Solubility – Low Permeability

CDSCO still needs to find the right answer to a key question:

Interestingly, this so important note in the regulatory playbook of India got masked in the high-voltage cacophony on branded and non-branded-generics. However, CDSCO would still require finding out the right answer to a key question: how would a doctor or a patient possibly know on which branded and non-branded generic drugs BE tests were not carried out, before the above amendment came into force.

Reported data on substandard drugs in India:

Quoting CDSCO data, the September-October 2015 issue of the ‘Indian Journal of Endocrinology and Metabolism’ summarized that ‘during the years 2011-2014, the regional laboratories tested samples at 91 percent of the installed capacity, but their overall detection rate of sub-standard drugs were only 3.6 percent’. Many have expressed doubts about these numbers though, nevertheless, these are Government data, and don’t fall in the realm of any conjecture.

In any case, the Union Ministry of Health doesn’t seem to concur that the issue of substandard drugs in India, that includes both the branded and non-branded generics, has assumed a public health menace in India or even alarming.

No qualms on value added branding of generic drugs, but fix the loophole for all:

It is understandable, when generic drugs are branded for tangible value-added product differentiation even within the identical or the same drug molecules. There are no qualms on such branding per se, though it comes at a high cost.

Marketing approval requirements being the same for all branded and non-branded generic drugs with the same pitfalls of no mandatory BE-testing requirement after the 4-year period, branding should add commensurate tangible value. Otherwise, why should most patients pay a significantly extra amount for heavily promoted branded-generics? Is it to help the pharma companies fighting with each other to increase their respective pies of revenue and profit on an essential commodity? Instead, stakeholders should now focus on easy detection of all those branded and non-branded generic drug formulations that avoided mandatory BE studies, prior to April 3, 2017.

In conclusion:

Despite CDSCO’s statistical data on substandard drugs, the general concern regarding the efficacy and safety of medicines manufactured in India is often raised both inside the country, as well as by some well-respected overseas drug regulators. Curiously, when raising the same concern CDSCO banned hundreds of branded FDCs, as these drugs came to the market without carrying out required scientific tests due to some major lacunae in the regulatory system, there was a huge protest in the country raised by almost the same people, as business interests prevailed over patients’ health interest.

Interestingly, displaying a sharp contradiction in today’s cacophony, patients’ health interest has been put in the forefront to protect business interests, especially when the CDSCO has raised no such concern, whatsoever.

The reverberating claims on superior drug quality for branded-generics as a class, over their cheaper non-branded equivalents, with the former generally being painted in white, and the later in black – with no shades of gray in-between, as I said before, is based mostly on conjecture rather than enough hard facts. Thus, the question comes up, who is responsible for ensuring drug efficacy and safety for the patients in India – CDSCO or non-fact based claims being raised mostly by those who have a direct or indirect financial interest in branded-generic business?

Keeping this in perspective, it is indeed intriguing, why such an important regulatory step of April 3, 2017 requiring mandatory BE studies for marketing approval of all generic drugs, even after the 4-year period, is getting masked in the cacophony, mostly favoring the branded-generics as a category. However, it’s no-brainer to understand that this din would continue, projecting all generic drugs sans brand names – a pariah!

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.

Disruptive Digital Innovation To Reduce Medication Need?

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Application of digital technology in various spheres of not just business, but in our individual day to life also, promises a disruptive change for the better, from the traditional way of doing things and achieving goals – freeing a lot of precious time for us to do much more, and even faster. An impending tsunami of this digital revolution, as it were, is now all pervasive, with various digital application platforms becoming increasingly more cost effective, quite in tandem with the fast pace of cutting-edge innovation. This is so different from what is generally witnessed in the pharma business.

Interestingly, despite high demand for cost effective health care from all over the world, not much progress in this area is still visible within this industry, in general, and particularly in the pharma business. Various reasons may be attributed to this apathy, which I shall not venture to go into, today.

On the other hand, sniffing a huge opportunity in this largely vacant space, many tech giants and startups are investing heavily to make health care of people easier, and at the same time reap a rich harvest, far outpacing the big pharma players.

As I connect the different dots on world-class digital initiatives in the health space, a clear trend emerges on the global scenario. The way Internet revolution, to start with, followed by smartphones and many other wireless digital services is changing the rhythm of life for many making it much easier, is just amazing. These include a plethora of everyday ‘must-do’ and several other functions, such as, precise need-based information gathering, online banking, tax-filing, shopping, payment, social networking, cloud computing and storage, besides a gamut of other digital services.

Similar disruptive digital innovations are expected in the health care space too, involving many long-awaited patient-centric areas, such as, significant reduction in the cost of medication. I discussed a similar issue in one of my earlier articles, published in this blog. However, today, I shall focus on this specific area, in view of its possible huge impact on the traditional pharma business model.

May reduce need of medication:

That tech startups are developing digital tools that reduce the need of medication, was very recently reported in an article titled, ‘Digital disruptors take big pharma beyond the pill’ published in the Financial Times on April 24, 2017. For example, a California-based startup, has reportedly come out with a digital device, smaller than an iPhone and fitted with a cellular chip, that can keep instant and accurate track of blood sugar levels. If the readings fall in the danger zone, an appropriate text message will be automatically generated for the person, such as – “drink two glasses of water and walk for 15 minutes”. The individual can also seek further help over the telephone from a trained coach – a highly-qualified dietitian for further guidance, the article highlights.

The whiz kid developers of wearable digital devices and apps are now intently working on many innovative health care solutions. Many of these can help early disease detection, and chart the risk profile of persons prone to various ailments, based on an enormous amount of well researched scientific data, significantly reducing the need of medication through effective disease prevention and management protocols. For example, there are umpteen evidences, demonstrating that specific moderate physical exercises help control diabetes just as well as medication, when detected early.

Thus, I reckon, such wearable digital devices and apps carry a huge promise to detect many diseases like, diabetes at its very onset or even before, and influence the person to take the necessary measures. In case of diabetes, it could be like, walking a certain distance every day, along with regular dietary advices from a remote center. Won’t such digital interventions work out far cheaper and convenient than lifelong visits to physicians and administration of anti-diabetic drugs?

The notes of the pharma business playbook need to be rewritten?

Let me quickly elaborate this point with an example of a common chronic ailment, say, diabetes. For effective management of this disease, global pharma players prefer to focus on better and better antidiabetic drug development, and after that spend a fortune towards their effective sales and marketing for generating enough prescription demand. Branded generic manufacturers are no different. This is important for all of them as most patients will have to administer the medicines for chronic ailments for a lifetime, incurring significant recurrent expenses for effective disease control. The first access point of such disease management has always been a doctor, initially for diagnosis and then for lifelong treatment.

Disruptive digital innovation could change the first point of intervention from the doctors to various digital apps or devices. These digital tools would be able to check and capture the person concerned predisposition to chronic diseases like, hypertension and diabetes, besides many other serious ailments, including possible cancer. When detected early, primary disease management advice would be available to patients from the app or the device itself, such as, the above-mentioned device for diabetes. If the preventive practices can manage the disease, and keep it under control, there won’t be any serious need to visit a doctor or pop a pill, thus, avoiding any need of active medication.

In that sense, as the above FT article has articulated, ‘rather than buying a pill, people might buy an overall solution for diabetes’ can’t be more relevant. When it happens, it will have a multiplier effect, possibly impacting the volume of consumption of medicines, just as what disease prevention initiatives do. Consequently, the notes of the pharma business playbook may have to be rewritten with right proactive measures.

As reported, the good news is, at least a couple of global pharma players have started fathoming its impact. This is apparent from Sanofi’s collaboration on digital devices and patient support for diabetics, and to some extent with Pfizer on immuno-oncology, using expertise in data analytics to identify new drug targets.

The key players in this ‘healthcare value chain’:

When the digital health care revolution will invade the current space of traditional-health care, it will create both the winners and losers. This was clearly highlighted in an article titled, ‘A digital revolution in healthcare is speeding up’, published by ‘The Economist’ on March 02, 2017.

From this article, it appears, when viewed in the Indian context that primarily two groups of players are currently ‘fighting a war for control’ of this ‘healthcare value chain’, as follows:

  • Traditional innovators: These are pharma companies, hospitals and medical-technology companies, such as, Siemens, GE and Phillips.
  • Technology insurgents: These include Microsoft, Apple, Google, and a host of hungry digital entrepreneurs and startups – creating apps, predictive-diagnostics systems and new devices.

Where is the threat to traditional pharma innovators?

This emerging trend could pose a threat to traditional innovators as the individual and collective knowledge base gets wider and wider – the above article envisages. With the medical records getting increasingly digitized with new kinds of patient data available from genomic sequencing, sensors and even from social media, the Government, including many individuals and groups, can now get a much better insight into which treatments work better with avoidable costs, on a value-based yardstick. For example, if digital apps and wearable devices are found even equally effective as drugs, with the least cost, to effectively manage the menace of diabetes in the country, notwithstanding any strong ‘fear arising’ counter propaganda, as we often read and here and there, those will increasingly gain better acceptance from all concerned.

The moot question, therefore, arises, would the drug companies lose significantly to the emerging digital players in the health care arena, such as, Microsoft, Apple and Google?

Tech giants are moving faster:

In several disease areas like, cancer and diabetes, the tech giants are taking longer and bigger strides than the traditional pharma innovators. For example:

  • Microsoft has vowed to “solve the problem of cancer” within a decade by using groundbreaking computer science to crack the code of diseased cells so that they can be reprogrammed back to a healthy state.
  • Apple has a secret team working on the holy grail for treating diabetes. The Company has a secret group of biomedical engineers developing sensors to monitor blood sugar levels. This initiative was initially envisioned by Steve Jobs before his death. If successful, the advance could help millions of diabetes patients and turn devices, like Apple Watch, into a must-have.
  • Verily – the life sciences arm of Google’s parent company Alphabet, has been working on a “smart” glucose-sensing contact lens with Novartis for several years, to detect blood glucose levels through tears, without drawing any blood. However, Novartis has since, reportedly, abandoned its 2016 goal to start testing the autofocus contact lens on people, though it said the groundbreaking product it is “progressing steadily.” It has been widely reported that this could probably be due to the reason that Novartis is possibly mulling to sale its eye care division Alcon.
  • Calico, which is also owned by Google’s parent company Alphabet, has US$ 1.5 billion in funding to carry out studies in mice, yeast, worms and African naked mole rats for understanding the ageing process, and how to slow it, reports MIT Technology Review.

No wonder, why an article published in Forbes magazine, published on April 15, 2017 considered these tech giants as ‘The Next Big Pharma’. It said, ‘if the innovations of Google and Apple are another wake-up call for the life science industry, which oftentimes has relied on the snooze function of line extensions and extended-release drugs as the source of income and innovation.’

In conclusion:

An effective disease treatment solution based on different digital platforms has a key financial advantage, as well. This is because the process of generation of huge amounts of credible scientific data, through large pre-clinical and clinical trials, establishing the efficacy and safety of new drugs on humans for regulatory approval, is immensely expensive, as compared to the digital ones.  Intriguingly, no global pharma player does not seem to have launched any significant digital health care solution for patients to reduce the overall cost of disease burden, be it prevention or management.

In that context, it’s encouraging to note the profound comment of the Chief Operating Officer – Jeff Williams of Apple Inc., made during a radio show – ‘Conversations on Health Care’, as reported by ‘appleinsider.com’ on January 06, 2016. During the interaction, Williams reiterated that the rapid progress of technology in this direction is very real, as ‘Apple’ and other smartphone health app developers are stretching the commoditization of computer technology to serve health sciences. In not so distant future, with relatively inexpensive smartphones and supporting health apps – the doctors and researchers can deliver better standards of living, even in severely under-served areas like Africa, where there are only 55 trained specialists in autism.

Thus, it now looks reasonably certain to me that disruptive digital innovation on various chronic health care solutions is ultimately going to reduce the need of medication for many patients, across the world, including India, significantly.

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.

Prescriptions in Generic Names Be Made A Must in India?

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Would prescriptions in generic names be made a must in India?

Yes, that’s what Prime Minister Modi distinctly hinted at on April 17, 2017, during the inauguration function of a charitable hospital in Surat. To facilitate this process, his government may bring in a legal framework under which doctors will have to prescribe generic medicines, the PM assured without any ambiguity whatsoever.

“In our country doctors are less, hospitals are less and medicines are expensive. If one person falls ill in a middle-class family, then the financial health of the family gets wrecked. He cannot buy a house, cannot conduct the marriage of a daughter,” he reiterated.

“It is the government’s responsibility that everybody should get health services at a minimal price,” the Prime Minister further reinforced, as he referred to the National Health Policy 2017. His clear assurance on this much-debated issue is indeed music to many ears.

Some eyebrows have already been raised on this decision of the Prime Minister, which primarily include the pharma industry, and its traditional torch bearers. Understandably, a distinct echo of the same one can also be sensed in some English business dailies. Keeping aside these expected naysayers, in this article, after giving a brief backdrop on the subject, I shall argue for the relevance of this critical issue, in today’s perspective.

Anything wrong with generic drugs sans brand names?

At the very outset, let me submit, there aren’t enough credible data to claim so. On the contrary, there are enough reports vindicating that generic drugs without brand names are generally as good as their branded equivalents. For example, a 2017 study on this subject and also in the Indian context reported, ‘93 percent of generic and 87 percent branded drug users believed that their drugs were effective in controlling their ailments.’

Thus, in my view, all generic medicines without any brand names, approved by the drug regulatory authorities can’t be inferred as inferior to equivalent branded generics – formulated with the same molecules, in the same strength and in the same dosage form; and vice versa. Both these varieties have undergone similar efficacy, safety and quality checks, if either of these are not spurious. There isn’t enough evidence either that more of generic drugs sans brand names are spurious.

However, turning the point that generic drugs without brand name cost much less to patients than their branded generic equivalents on its head, an ongoing concerted effort of vested interests is systematically trying to malign the minds of many, projecting that those cheaper drugs are inferior in quality. Many medical practitioners are also not excluded from nurturing this possible spoon-fed and make-believe perception, including a section of the media. This reminds me of the famous quote of Joseph Goebbels – the German politician and Minister of Propaganda of Nazi Germany till 1945: “If you tell a lie big enough and keep repeating it, people will eventually come to believe it.”

The lower prices of generic drugs without brand names are primarily because their manufacturers don’t need to incur huge expenditure towards marketing and sales promotion, including contentious activities, such as, so called ‘Continuing Medical Education (CME)’ for the doctors in exotic locales, and several others of its ilk.

Thus, Prime Minister Modi’s concern, I reckon, is genuine to the core. If any doctor prescribes an expensive branded generic medicine, the concerned patient should have the legal option available to ask the retailer for its substitution with a less expensive generic or even any other branded generic equivalent, which is supposed to work just as well as the prescribed branded generic. For this drug prescriptions in INN is critical.

Provide Unique Identification Code to all drug manufacturers:

When in India, we can have a digitally coded unique identification number, issued by the Government for every individual resident, in the form of ‘Aadhaar’, why can’t each drug manufacturer be also provided with a similar digitally coded number for their easy traceability and also to decipher the trail of manufacturing and sales transactions. If it’s not possible, any other effective digital ‘track and trace’ mechanism for all drugs would help bringing the wrongdoers, including those manufacturing and selling spurious and substandard drugs to justice, sooner. In case a GST system can help ferret out these details, then nothing else in this regard may probably be necessary.

Past initiatives:

In India, ‘Out of Pocket (OoP) expenditure’ as a percentage of total health care expenses being around 70 percent, is one of the highest in the world. A study by the World Bank conducted in May 2001 titled, “India – Raising the Sights: Better Health Systems for India’s Poor” indicates that out-of-pocket medical costs alone may push 2.2 percent of the population below the poverty line in one year. This situation hasn’t improved much even today, as the Prime Minister said.

Although, ‘prescribe drugs by generic names’ initiative was reported in July 2015, in the current context, I shall focus only on the recent past. Just in the last year, several initiatives were taken by the current Government to help patients reduce the OoP expenses on medicines, which constitute over 60 percent of around 70 percent of the total treatment cost. Regrettably, none of these steps have been working effectively. I shall cite hereunder, just three examples:

  • On February 29, 2016, during the Union Budget presentation for the financial year 2016-17 before the Parliament, the Finance Minister announced the launch of ‘Pradhan Mantri Jan-Aushadhi Yojana (PMJAY)’ to open 3,000 Stores under PMJAY during 2016-17.
  • On August 04, 2016, it was widely reported that a new digital initiative of the National Pharmaceutical Pricing Authority (NPPA), named, “Search Medicine Price”, would be launched on August 29, 2016. According to NPPA, “Consumers can use the app before paying for a medicine to ensure that they get the right price.”
  • In October 2016, a circular of the Medical Council of India (MCI), clearly directed the medical practitioners that: “Every physician should prescribe drugs with generic names legibly and preferably in capital letters and he/she shall ensure that there is a rational prescription and use of drugs”

A critical hurdle to overcome:

Besides, stark inefficiency of the MCI to implement its own directive for generic prescriptions, there is a key legal hurdle too, as I see it.

For example, in the current situation, the only way the JAS can sell more of essential generic drugs for greater patient access, is by allowing the store pharmacists substituting high price branded generics with their exact generic equivalents available in the JAS. However, such substitution would be grossly illegal in India, because the section 65 (11) (c) in the Drugs and Cosmetics Rules, 1945 states as follows:

“At the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed. 20 [(11A) No person dispensing a prescription containing substances specified in 21 [Schedule H or X] may supply any other preparation, whether containing the same substances or not in lieu thereof.]”

A move that faltered:

To address this legal issue, the Ministry of Health reportedly had submitted a proposal to the Drug Technical Advisory Board (DTAB) to the Drug Controller General of India (DCGI), for consideration. In the proposal, the Health Ministry reportedly suggested an amendment of Rule 65 of the Drugs and Cosmetics Rules, 1945 to enable the retail chemists substituting a branded drug formulation with its cheaper equivalent, containing the same generic ingredient, in the same strength and the dosage form, with or without a brand name.

However, in the 71st meeting of the DTAB held on May 13, 2016, its members reportedly turned down that proposal of the ministry. DTAB apparently felt that given the structure of the Indian retail pharmaceutical market, the practical impact of this recommendation may be limited.

The focus should now move beyond affordability:

In my view, the Government focus now should move beyond just drug affordability, because affordability is a highly relative yardstick. What is affordable to an average middle class population may not be affordable to the rest of the population above the poverty line. Similarly, below the poverty line population may not be able to afford perhaps any cost towards medicines or health care, in general.

Moreover, affordability will have no meaning, if one does not have even easy access to medicines. Thus, in my view, there are five key factors, which could ensure smooth access to medicines to the common man, across the country; affordable price being one of these factors:

1. A robust healthcare infrastructure
2. Affordable health care costs, including, doctors’ fees, drugs and diagnostics
3. Rational selection and usage of drugs by all concerned
4. Availability of health care financing system like, health insurance
5. Efficient logistics and supply chain support throughout the country

In this scenario, just putting in place a legal framework for drug prescription in generic names, as the Prime Minister has articulated, may bring some temporary relief, but won’t be a long-term solution for public health care needs. There arises a crying need to put in place an appropriate Universal Health Care (UHC) model in India, soon, as detailed in the National Health Policy 2017.

Brand names aren’t going to disappear:

Prime Minister Modi’s assertion to bring in a legal framework under which doctors will have to prescribe generic medicines, probably will also legally empower the retailers for substitution of high priced branded generics with low priced generic or branded generic equivalents.

This promise of the Prime Minister, when fulfilled, will facilitate making a larger quantum of lower price and high quality generic drugs available to patients, improving overall access to essential medicines. Hopefully, similar substitution will be authorized not just for the JAS outlets, but by all retail drug stores, as well.

Brand names for generic drugs will continue to exist, but with much lesser relevance. the Drugs & Cosmetic Rules of India has already made it mandatory to mention the ‘generic names or INN’ of Drugs on all packing labels in a more conspicuous manner than the trade (brand) name, if any. Hence, if a doctor prescribes in generic names, it will be easier for all retail pharmacists and even the patients, to choose cheaper alternatives from different available price-bands.

Possible changes in the sales and marketing strategies:

If it really happens, the strategic marketing focus should shift – from primarily product-brand marketing and stakeholders’ engagement for the same, to intensive corporate-brand marketing with more intense stakeholder engagement strategies, for better top of mind recall as a patient friendly and caring corporation.

Similarly, the sales promotion strategy for branded generics would possibly shift from – primarily the doctors to also the top retailers. It won’t be unlikely to know that the major retailers are participating in pharma company sponsored ‘Continuing Pharmacy Education (CPE)’ in similar or even more exotic places than the doctor!

There are many more.

International examples:

There are enough international examples on what Prime Minister Modi has since proposed in his speech on this issue. All these are working quite well. To illustrate the point with a few examples, I shall underscore that prescribing in generic name or in other words “International Nonproprietary Name (INN)’ is permitted in two-thirds of OECD countries like the United States, and is mandatory in several other nations, such as, France, Spain, Portugal and Estonia. Similarly, pharmacists can legally substitute brand-name drugs with generic equivalents in most OECD countries, while such substitution has been mandatory in countries, such as, Denmark, Finland, Spain, Sweden, Italy. Further, in several different countries, pharmacists have also the obligation to inform patients about the availability of a cheaper alternative.

However, the naysayers would continue saying: ‘But India is different.’

Impact on the pharma industry:

The March 2017 report of ‘India Brand Equity Foundation (IBEF)’ states that Indian pharmaceutical sector accounts for about 2.4 per cent of the global pharmaceutical industry in value terms, 10 per cent in volume terms and is expected to expand at a Compound Annual Growth Rate (CAGR) of 15.92 per cent to US$ 55 billion by 2020 from US$ 20 billion in 2015. With 70 per cent market share (in terms of value), generic drugs constitute its largest segment. Over the Counter (OTC) medicines and patented drugs constitute the balance 21 percent and 9 percent, respectively. Branded generics constitute around 90 percent of the generic market. In my view, if the above decision of the Prime Minister is implemented the way I deliberated here in this article, we are likely to witness perceptible changes in the market dynamics and individual company’s performance outlook. A few of my top of mind examples are as follows:

  • No long-term overall adverse market impact is envisaged, as ‘the prices of 700 essential medicines have already been capped by the National Pharmaceutical Pricing Authority (NPPA). However, some short-term market adjustments are possible, because of several other factors.
  • There could be a significant impact on the (brand) market shares of various companies. Some will have greater exposure and some lesser, depending on their current sales and marketing models and business outlook.
  • Valuation of those companies, which had acquired mega branded generics, such as Piramal brands by Abbott Healthcare, or Ranbaxy brands by Sun pharma, may undergo considerable changes, unless timely, innovative and proactive measures are taken forthwith, as I had deliberated before in this blog.
  • Together with much awaited implementation of the mandatory Uniform Code of Pharmaceutical Marketing Practices (UCPMP) sooner than later, the sales and marketing expenditure of the branded generic players could come down significantly, improving the bottom-line.
  • Pharma marketing ballgame in this segment would undergo a metamorphosis, with brighter creative minds scoring higher, aided by the cutting-edge strategies, and digital marketing playing a much greater role than what it does today.
  • A significant reduction in the number of field forces is also possible, as the sales promotion focus gets sharper on the retailers and digitally enabled patient engagement initiatives.

The above examples are just illustrative. I hasten to add that at this stage it should not be considered as any more than an educates guess. We all need to wait, and watch how these promises get translated into reality, of course, without underestimating the quiet lobbying power of the powerful pharma industry. That said, the long-term macro picture of the Indian pharma industry continues to remain as bright, if appropriate and timely strategic interventions are put well in place, as I see it.

In conclusion:

It is an irony that despite being the 4th largest producer of pharmaceuticals, and catering to the needs of 20 percent of the global requirements for generic medicines, India is still unable to ensure access to many modern medicines to a large section of its population.

Despite this situation in India, Prime Minister Modi’s encouraging words on this issue have reportedly attracted the wrath of some section of the pharma industry, which, incidentally, he is aware of it, as evident from his speech.

Some have expressed serious concern that it would shift the decision of choosing a specific generic formulation of the same molecule for the patients from doctors to chemists. My counter question is, so what? The drug regulator of the country ensures, and has also repeatedly affirmed that there is no difference in efficacy, safety and quality profile between any approved branded generic and its generic equivalents. Moreover, by implementing an effective track and trace system for all drugs, such misgiving on spurious generic medicines, both with or without brand names, can be more effectively addressed, if not eliminated. Incidentally, reported incidences of USFDA import bans on drug quality parameters and breach of data integrity, include many large Indian branded generic manufacturers. Thus, can anyone really vouch for high drug quality even from the branded generics in India?

Further, the expensive branding exercise of essential medicines, just for commercial gain, and adversely impacting patients’ access to these drugs, has now been questioned without any ambiguity, none else than the Prime Minster of India. The generic drug manufacturers will need to quickly adapt to ‘low margin – high volume’ business models, leveraging economies of scale, and accepting the stark reality, as was expressed in an article published in Forbes – ‘the age of commodity medicines approaches’. Even otherwise, what’s wrong in the term commodity, either, especially when generic medicines have been officially and legally classified as essential commodities in India?

Overall, the clear signal from Prime Minister Modi that ‘prescriptions in generic names be made a must in India ‘, well supported by appropriate legal and regulatory mechanisms – is indeed a good beginning, while paving the way for a new era of Universal Health Care in India. God willing!

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.

Making New Cancer Drugs Cost-effective

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The prices of new cancer drugs are increasingly becoming unsustainable across the world, and more so in India. A sizable number of poor and even middle-income patients, who spend their entire life’s savings for the treatment of this dreaded disease, is pushed towards extreme economic hardship. Their plight in India would continue to remain so, till Universal Health Care (UHC) comes into force, as enunciated in the National Health Policy 2017.

Thus, the delivery of affordable and equitable cancer care poses one of India’s greatest public health challenges. Public expenditure on cancer in India remains below US$ 10 per person, as compared with more than US$ 100 per person in high-income countries. The May 2014 paper, published in ‘The Lancet Oncology’, analyzed this concern in detail.

In this article, after giving a brief backdrop, I shall explore a possible alternative to make cancer treatment with new drugs affordable to many by scaling up this strategic option.

Cancer – the second leading cause of death:

According to the World Health Organization (W.H.O), cancer is the second leading cause of death globally and accounted for 8.8 million deaths in 2015. This works out to nearly 1 in 6 of all global deaths, with US$ 1.16 trillion being the estimated total annual economic cost of cancer in 2010. Lung, prostate, colorectal, stomach and liver cancer are the most common types of cancer in men, while breast, colorectal, lung, cervix and stomach cancer are the most common among women. To reduce significant disability, suffering and deaths caused by cancer worldwide, effective and affordable programs in early diagnosis, screening, treatment, and palliative care are needed. Treatment options may include surgery, medicines and/or radiotherapy – the report reiterates. In many instances, anti-cancer drugs are the mainstay treatment.

For the country, Indian Council of Medical Research (ICMR) reported over 736, 000 people succumbing to the disease in 2016. This figure is expected to shoot up to 880,000 by 2020. ICMR estimated the total number of new cancer cases at around 1.45 million in 2016, and the same is likely to reach 1.73 million by 2020. The situation in this area, therefore, rather grim across the world, including India.

Cancer treatment cost in India is one of the highest in the world:

Anticancer drugs are generally expensive. As stated in a related article, published in the Nature Reviews Clinical Oncology on March 14, 2017, in the United States, a novel anticancer drug routinely costs more than US$ 100,000 per year of treatment. When adjusted for per capita spending power, these lifesaving medicines become most unaffordable in economically developing nations, such as India and China. Not only are their launch prices high and fast rising, but these also often escalate during the respective patent exclusivity period.

That in terms of the ability to pay for drugs, cancer drugs are most affordable in Australia and least affordable in India and China, was established in one of the largest research study presented at the 2016 Annual Meeting of the American Society of Clinical Oncology. Moreover, even in those cases where cancer could be detected early, about half the patients in India are compelled to skip the treatment for high drug cost, highlights another article.

Interestingly, the concerned drug manufacturers seldom, if at all, justify such astronomical drug prices and subsequent price increases well supported by some rational factors, such as, the extent of benefit patients are likely to derive, the novelty of the agents, or detailed spending on research and development, the above paper states.

The increasing trend of price escalation of cancer drugs harms many patients, often directly, through increased out-of-pocket expenses, which reduce levels of patient compliance, or drive thousands of cancer patients skipping the drug treatment, altogether. Consequently, it also harms the society by imposing cumulative price burdens on many patients that are unsustainable.

Despite high cost, annual global spending on anticancer drugs has already exceeded US$100 billion, and is predicted to reach US$150 billion by 2020. In India too, oncology is a leading therapeutic segment, which reached a turnover of Rs. 2,000 Crore (around US$ 320 million) in 2013 and is expected to grow to Rs. 3,831 crore (around US$ 615 million) by the end of 2017, according to a report of Frost and Sullivan.

The reason for high drug price:

The real reason for the high cost of cancer drugs, just as many other life-saving medicines, is quite challenging to fathom. Many attribute its reason to unsustainable R&D models of the global pharma companies, in general.

For example, “the spiraling cost of new drugs mandates a fundamentally different approach to keep lifesaving therapies affordable for cancer patients” – argued an article titled, “How Much Longer Will We Put Up With US$ 100,000 Cancer Drugs?”, published by Elsevier Inc. In the same context, another article titled “Making Cancer Treatment More Affordable”, published in the ‘Rare Disease Report’ on Feb 09, 2017, reiterated that the current R&D model needs to change, as the cost of many such treatments is higher than the cost of an average person’s house in the United States.

Nonetheless, the drug manufacturers answer this difficult question with ease and promptness, citing that the cost of innovation to bring these drugs through a complex research and development (R&D) process to the market, isn’t just very high, but is also increasing at a rapid pace.

Pharma R&D cost:

An analysis by the Tufts Center for the Study of Drug Development, published in the Journal of Health Economics in March, 2016 pegged the average cost to develop and gain marketing approval for a new drug at US$ 2.558 billion. It also said that the total cost of innovation of a new drug and bringing it to market, has increased more than double from US$ 1.22 billion in 2003 to US$ 2.6 billion in 2014. Although these numbers are being vehemently challenged in several credible journals and by the international media, many global pharma majors justify the high new drug prices

by highlighting that developing a new molecule takes an enormous amount of time of 12 to 14 years, lots of financial resources and huge efforts.

On the other hand, an article titled, “Does it really cost US$ 2.6 billion to develop a new drug?”, published in The Washington Post on November 18, 2014 observed that: ‘The never-ending debate about what drugs should cost is in part driven by the fact that no one seems to know what it actually costs to develop one.”

But, why is the decline in the R&D productivity trend?

According to a 2014 review article titled, “Recent Advances in Drug Repositioning for the Discovery of New Anticancer Drugs”, published in the International Journal of Biological Sciences, while the total R&D expenditure for drug discovery worldwide increased 10 times since 1975 (US$ 4 billion) to 2009 (US$ 40 billion), the number of NMEs approved has remained largely flat (26 new drugs approved in 1976 and 27 new drugs approved in 2013). The average time required for drug discovery to market launch has also increased over time in the US and in the EU countries from 9.7 years during 1990s, to 13.9 years from 2000 onwards.

Be that as it may, the bottom-line is regardless of tremendous advancement in biological science, technology and analytics, especially in the new millennium, coupled with increasing investments in pharma R&D, the total number of NMEs that has reached the market hasn’t shown commensurate increase.

One of my articles published in this blog titled, “How Expensive Is Drug Innovation?” found an echo of the same in a globally reputed journal. This study, published by the BMJ on May 2016, titled “Propaganda or the cost of innovation? Challenging the high price of new drugs”, expressed deep concern on the rising prices of new medicines. It reiterated that this trend is set to overwhelm health systems around the world.

Need for an alternative R&D strategy:

The hurdles in discovering and developing new drugs call for alternative approaches, particularly for life threatening diseases, such as cancer. I reckon, it’s about time to scale-up a viable alternative strategy to bring down the R&D cost of new drugs, improve the success rate of clinical development, reduce a decade long ‘mind to market’ timeframe for an innovative drug or a treatment, and of course, the mind blogging cost of the entire process, as asserted in the above report from the Tufts Center.

One such alternative strategy could well be: ‘Drug Repurposing’

Drug Repurposing:

As defined by the National Center for Advancing Translational Sciences, ‘drug repurposing’ “generally refers to studying drugs that are already approved to treat one disease or condition to see if they are safe and effective for treating other diseases”.

As many molecules, with well-documented records on their pharmacology and toxicity profile, have been already formulated and undergone large clinical trials on humans, repurposing those drugs building upon the available documents and experiences for fresh clinical trials in different disease conditions, would hasten the regulatory review process for marketing approval, and at a much lesser cost.

I shall quote here just two such examples of ‘drug repurposing’ from well-known molecules, as follows:

  • Sildenafil (Viagra): The blockbuster drug that was launched by Pfizer in 1998 for the treatment of erectile dysfunctions was originally developed for the treatment of coronary artery disease by the same company in 1980s.
  • Thalidomide: Originally designed and developed by a German pharmaceutical company called Grünenthal in Stolberg as a treatment for morning sickness in 1957, but was withdrawn in 1961 from the market because it caused birth defects. The same molecule was reintroduced in 1998 as a ‘repurposed drug’ to effectively treat patients with erythema nodosum leprosum (ENL) – a complication of leprosy, and multiple myeloma – a type of cancer.

I had given many more examples of ‘drug repurposing’ in one of my earlier articles published in this blog.

Repurposing drugs for cancer:

The above-mentioned review article of International Journal of Biological Sciences 2014 clearly noted: “Drug repositioning has attracted particular attention from the communities engaged in anticancer drug discovery due to the combination of great demand for new anticancer drugs and the availability of a wide variety of cell and target-based screening assays. With the successful clinical introduction of a number of non-cancer drugs for cancer treatment, ‘drug repurposing’ now became a powerful alternative strategy to discover and develop novel anticancer drug candidates from the existing drug space.”

The following are some recent successful examples of ‘drug repurposing’ for anticancer drug discovery from non-cancer drugs, which are mostly under Phase I to II clinical trials:

Drug Original treatment Clinical status for cancer treatment
Itraconazole Fungal infections Phase I and II
Nelfinavir HIV infections Phase I and II
Digoxin Cardiac diseases Phase I and II
Nitroxoline Urinary Tract Infections Preclinical
Riluzole Amyotropic lateral sclerosis Phase I and II
Disulfram Chronic alcoholism Phase I and II

‘Drug repurposing’ market:

A January 2016 report by BCC Research estimates that the global market for drug repurposing will grow from nearly US$ 24.4 billion in 2015 to nearly US$ 31.3 billion by 2020, with a compound annual growth rate (CAGR) of 5.1 percent for the period of 2015-2020.

Expressing concern just not enough:

There are enough examples available across the world regarding stakeholders’ expression of great concern on this issue, with the buzz of such protests getting progressively shriller.

However, in India, high prices of cancer drugs do not seem to be a great issue with the medical profession, just yet, notwithstanding some sporadic steps taken by the National Pharmaceutical Pricing Authority (NPPA) to allay the economic burden of cancer patients to some extent. Encouragingly, the top cancer specialists of the American Society of Clinical Oncology are reportedly working out a framework for rating and selecting cancer drugs not only for their benefits and side effects, but prices as well.

In a 2015 paper, a group of cancer specialists from Mayo Clinic also articulated, that the oft-repeated arguments of price controls stifle innovation are not good enough to justify unusually high prices of cancer drugs. Their solution for this problem includes value-based pricing and NICE like body of the United Kingdom. An interesting video clip from Mayo Clinic justifies the argument.

All this can at best be epitomized as so far so good, and may help increase the public awareness level on this subject. However, the moot point remains: Has anything significantly changed on the ground, on a permanent basis, by mere expression of such concerns?

Conclusion:

This discussion may provoke many to go back to the square number one, making the ongoing raging debate on Innovation, Intellectual Property Rights (IPR) and Public Health Interest to gather more steam, but the core concern continues to remain unresolved.

I hasten to add that all such concerns, including strong protests, may no doubt create some temporary pressure on drug manufacturers, but they are experienced enough to navigate through such issues, as they have been doing, so far. However, for making new cancer drugs cost-effective for a vast population of patients, coming out of the current strategic mold of pharma research and development would be necessary. Grant of Compulsory License (CL), or the expectation of the local drug manufacturers for a Voluntary License (VL) of new cancer drugs, can’t be a routine process either, as it appears unrealistic to me, for various reasons.

I have discussed in this article just one alternative R&D strategy in this area, and that is Drug Repurposing (DR). There could be several others. DR is reportedly gaining increasing focus, as it represents a smart way to exploit new molecular targets of a known non-oncological drug for a new therapeutic applications in oncology. Be that as it may, pharma companies and the academia must agree to sail on the same boat together having a common goal to make new cancer drugs cost-effective for majority of cancer patients struggling hard, for life.

I would conclude this article quoting the President and Chief Science Officer of Illinois-based Cures Within Reach who said: “What I like about drug repurposing is that it can solve two issues: improved health-care impact and reduced health-care cost – That’s a big driver for us.”

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.

Define And Adapt To Reality: Two Pivotal Pharma Leadership Skills For Sustainable Excellence

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Max DePree – a much quoted American businessman and author had once said: “The first responsibility of a leader is to define reality.”

While defining the reality within the drug industry today, it makes many industry leaders to ponder, despite so much of the good work done by the industry in various fields of pharma business, across the world, including India, why is the public perception on the overall leadership of this sector still so negative, and continue going south? Pharma leaders know the reasons too, but they seem to be still searching for the right set of answers without breaking the traditional mold of business.

Around end 2007, being concerned with this trend, the then Chairman of Eli Lilly reportedly expressed publicly what many industry observers have been saying privately for some time. He said: “I think the industry is doomed, if we don’t change”.

On the general apathy of breaking the traditional mold after having defined the business reality, an interesting article titled, “Healthcare Leadership Must Shift From A Cottage Industry To Big Business”, published on June 2, 2014 in Forbes, made some interesting observations, which are as relevant to India, just as many other countries of the world.

The article states that the ‘Healthcare Leadership’ has not kept up with the industry’s evolution to big business over the past 25-30 years – nor does it possess the required change management competencies to effectively lead and rapidly turn around an adaptive health care business model. Thus, unlike many other knowledge industries, pharma sector is still struggling hard to convert the tough environmental challenges into bright business opportunities. This leads to an important question: Being mostly inward looking, are these leaders failing to properly define reality around them, and therefore, not adapting to the critical external business environmental needs, soon enough?

Is current pharma leadership too inward looking?

From the available details, it appears that today, many inward-looking pharma leaders tend to ignore many serious voices demanding access to high quality medicines at affordable prices, especially for life threatening ailments, such as, cancer. Instead of engaging with the stakeholders in search of a win-win solution, global pharma leadership apparently tries to push the ball out its court with a barrage of mundane and arrogant arguments highlighting the importance of ‘drug innovation’ and hyping how expensive it is. Notwithstanding that by now, many people are aware of its frequent use, generally by the global pharma players, mostly as a veil, whenever required. Even then, many pharma leaders, instead of accepting the reality, continue to remain insensitive to the concerns not just of most patients, but other stakeholders and their respective governments also. This mindset further reinforces their inward-looking and self-serving image. This brings to the fore the key issue: Is this high time to pass the baton to a new breed of pharma leaders?

In the above backdrop, this article dwells on some intrinsic issues involved with the leadership puzzle of the industry, as it were. Thereafter, it deliberates on the importance of making some easy self-tests available to the young and especially the millennial pharma professionals, to facilitate them to self-discover themselves in this space, and that too at an early stage of their professional career, as they try to understand and define the business and environmental realities facing the industry.

Leadership skills are difficult to find:

Focusing on the pharma industry, I would say, especially in the pharma sector, leadership skill in all its functional areas though is considered as the most important one, but are equally challenging while identifying the right persons.

The 20th Pharma CEO Survey, March 2017 of PwC, vindicates this point. The survey covered 89 pharma CEOs from 37 countries. Nearly all the Pharma CEOs participating in this survey picked out leadership as the most important for their organization, giving it the top spot, closely followed by problem-solving, creativity and innovation, all bracketed in the second, with collaboration and adaptability occupying the equal third rank, as follows:

Relative importance of skills in pharma industry Skill sets Respondents answering somewhat difficult or very difficult to get each one of these
1. Leadership 79
2. Creativity & Innovation 75
3. Emotional intelligence 72
4. Adaptability 63
5. Problem-solving 55

Over two-thirds of the CEOs face difficulty in recruiting people with the requisite skills that they consider most important to their organization, such as, leadership, problem-solving, and creative skills, the report highlighted. For further deliberation hereunder, I shall pick up the top one – the leadership skill for the pharma industry, as I see it.

The age-old question – ‘Are leaders born or made?’

A critical question that is often asked even today – ‘Are leaders born or made?’ The question keeps coming as some enthusiasts continue to argue that successful leaders are born with visible or apparently invisible leadership traits.

Are leaders born?

To answer this question, let me quote an example. The Management Study Guide (MSG), well-articulated an approach to the study of leadership known as the ‘Great Man Theory’, giving examples of the great leaders of the past, such as, Alexander the Great, Julius Caesar, Napoleon, Queen Elizabeth I, Abraham Lincoln and Mahatma Gandhi. They all seem to differ from ordinary human beings in several aspects, possessing high levels of ambition coupled with clear visions of precisely where they want to go.

Added to these examples are many top business executives, sports personalities, and even contemporary politicians, who often seem to possess an aura that sets them apart from others. These persons are cited as naturally great leaders, born with a set of personal qualities that made them effective leaders. Thus, even today, the belief that truly great leaders are born, is not uncommon. Thus, according to the contemporary theorists, leaders are not like other people. They do not need to be intellectually genius or omniscient prophets to succeed, but they should certainly have the ‘right stuff’, which is not equally present in all people, MSG highlights.

Even today, some continue to believe in the ‘Great Man Theory’, regardless of many well carried out research studies of the behavioral scientists establishing that it is quite possible for individuals becoming leaders through various processes, such as, self-learning, keenly observing or working with some good leaders, following their advices, training, and practicing the experiences thus gained in one’s real life.

Are leaders made?

Just as above, to answer this question, as well, I would cite another important example.

A September 21, 2016 article titled, “What Science Tells Us About Leadership Potential”, published in the ‘Harvard Business Review (HBR)’, while answering the question ‘who becomes a leader’, stated as follows:

“Any observable pattern of human behaviors is the byproduct of genetic and environmental influences, so the answer to this question is ‘both’.  Estimates suggest that leadership is 30%-60% heritable, largely because the character traits that shape leadership - personality and intelligence - are heritable. While this suggests strong biological influences on leadership, it does not imply that nurture is trivial. Even more-heritable traits, such as weight (80%) and height (90%), are affected by environmental factors. Although there is no clear recipe for manipulating the environment in order to boost leadership potential, well-crafted coaching interventions boost critical leadership competencies by about 20%–30%.”

What would a young pharma professional do in this situation?

The current breed of top leaders would continue grooming and promoting mostly those who fit their profile, while in the family owned businesses succession usually takes place from within the family. The situation is no different in the pharma industry. However, various studies indicate that millennial professionals with leadership traits will develop themselves.

Keeping this in mind and, at the same time, going by the above HBR article, I would tend to accept the dictum that, “Any observable pattern of human behaviors is the byproduct of genetic and environmental influences”. Thus, for identifying and then honing leadership skills in the pharma business, just as many other industries, I would prefer the process of dovetailing the heritable leadership traits with various environmental influences.

An ambitious pharma professional with high aspiration to make a difference in the organization that the individual represents, would obviously wonder what the way forward for him to achieve the goals. In my view, an honest self-test is the first and basic move in this direction.

The self-test:

Taking a cue from the article titled “Strategic Leadership: The Essential Skills”, published in the January-February 2013 issue of The Harvard Business Review (HBR), I would suggest that the young professionals may wish to ask themselves the following important questions:

  • Do I have the right networks to help myself see opportunities before competitors do?
  • Am I comfortable challenging my own and others’ assumptions?
  • Can I get a diverse group to buy into a common vision?
  • Do I learn from mistakes?

The answer to each of these ones should be clear and honest, as one doesn’t need to disclose those answers to anyone else. Nonetheless, by following this process, a young professional gets a clear view of where he or she stands in each of these important areas, which cover some of the basic traits of a leader.

The leadership package:

Irrespective of whether an individual has some heritable leadership traits or not, the above self-test would reveal a person’s strengths and weaknesses, help address the deficits and optimize the full portfolio of leadership skills, independently or otherwise.

Nevertheless, it is important to bear in mind, as several research studies have already established, though leadership skills are important and difficult to find, a few other salient skills such as, ability to apply in real life a creative and innovative mindset, supported by high emotional intelligence or emotional quotient (EQ) are also critical. This is because, together these offer the all-important leadership package for an all-round successful leader.

Should pharma leadership be eclectic?

I guess so, as there does not seem to be any better alternative either. Thus, I reckon, traditional pharma leadership needs to be eclectic. It has still got a lot to learn from other industries too. Let me give a relevant example here – to speed up development of electric cars by all manufacturers, the Cofounder and Chief Executive Officer Elon Musk of Tesla Motors has reportedly decided to share its patents under ‘Open Source’ sharing of technologies with all others. Elon Musk further reiterated: “If we clear a path to the creation of compelling electric vehicles, but then lay Intellectual property (IP) landmines behind us to inhibit others, we are acting in a manner contrary to that goal.”

In the important ‘green’ automobile space, this is indeed a radical, gutsy and an exemplary decision to underscore Tesla Motor’s concern about global warming.

Why such type of leadership is so rare in the global pharma world, even today? Besides sanctimonies, as these appear, why the global pharma leaders are not taking similar large scale initiatives for drug innovation, especially in the areas of difficult diseases, such as, Cancer, Alzheimer’s, Multiple Sclerosis and Metabolic disorders, just to name a few? For this purpose, pharma organizations would require mettlesome change agents who can break the traditional mold –new leaders of the millennial generation having a different business outlook altogether, could possibly do so.

Becoming a change agent:

Today, more than ever before, the ultimate goal of pharma leaders requires moving beyond making more money to satisfy the shareholders and stock markets. It also needs to include the requirements of society, in general, more than what mandatory CSR demands. This is palpable today, as many stakeholders vehemently questioning the business game plan of many pharma players. Would this situation change? I don’t know, but it should, which prompts a change in the overall quality of pharma leadership, at all levels. I have had reason to believe that a good number of bright, millennial pharma professionals look for empowerment to discover themselves early. Right at that stage, they also need to chart a road map for self-development, which would facilitate attaining their professional goals, quite in sync with the broad societal expectations, as they move on in life.

New pharma leadership would require greater focus on ethics and engagement:

While pharma industry leaders, in general, have been impressive articulators of all right things that need to happen, ‘Talking the Talk’ and ‘Walking the Walk’ in the frontiers of business ethics, values and shared goals are found wanting in many of them. These articulations are probably used to run expensive global ‘Public Relations (PR)’ campaigns, lobbying and advocacy initiatives in the corridors of power.

What else then could possibly be the reason for such perception gap that this great industry has allowed to increase, over a long period of time? Could it be that many pharma leaders have not been able to adequately adapt themselves to the demands of the changing healthcare environment and the needs of various stakeholders in this sector? Is the leadership, therefore, too archaic and it’s a time for a change?

Thus, unlike the current pharma leadership, the new age leadership needs to be ethically grounded, and engage all stakeholders effectively in a transparent manner with impeccable processes of governance involving all areas of business. Such leaders may not be know-all individuals in the pharma business, but must possess a clear vision of where they want to lead the company to, and don’t slip back, especially in terms of public image and meeting patients’ expectations.

In conclusion:

Pharma business in modern times faces rapidly changing stakeholder expectations, which are generally difficult to predict well in advance. Thus, today’s pharma leaders require to adapt their strategic approach and the tactical game plans accordingly for business excellence in an inclusive manner, and simultaneously try to shape the environment to the extent possible.

There is a growing expectation from the pharma leaders to do business by imbibing a caring outlook towards the society, where it operates. Spending time and money to transplant the past practices in the changed environment, or continuing with the traditional business approaches, I reckon, is a no-win game today.

Thus, there arises a need to help the young pharma professionals, from the early stages in their professional life, for shaping up as the chief change agent in the organization that they would lead. Even after reaching where they wanted to reach, these leaders should keep studying on a continuous basis, various other successful leadership styles, approaches and visions, to splice them into a more productive strategic approach for the business or functional areas that they lead.

This new breed of leaders would also require defining the reality prevailing in the industry on an ongoing basis, to pave the way for a glorious future for their respective organizations. This effort would call for regular and effective engagement with all the stakeholders through various digital and other platforms. The critical question that the new pharma leadership should never forget to continually ask themselves: “How can my organization provide better access to high quality and effective medicines to most patients along with achieving commercial excellence in business?”

Properly defining and quickly adapting to associated environmental realities with a creative mind, requisite emotional intelligence and ethical business practices, would call for coming out of the zone of comfort with promptness. These, I reckon, would be the two pivotal success factors for new pharma leaders for inclusive and sustainable success in business, as the industry moves on.

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.

MDGs Break Ground For SDGs: Is India Poised To Achieve The Health Goals?

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The Millennium Development Goals (MDGs) were placed in the pages of history amid several other remarkable global initiatives of the United Nations (UN), as the timeframe for achievement of these targets got over in 2015.

In 2000, the leaders of 189 countries signed this historic millennium declaration at the United Nations Millennium Summit for improving the lives of the world’s poorest people. Eight MDGs, were agreed upon by its members, each one supported by 21 specific, measurable targets and more than 60 indicators with clear deadlines, as a concerted global movement in this direction. The eight goals spanned across the areas of poverty alleviation, providing universal primary education, ensuring gender equality, preventing child mortality, meeting maternal health needs, protecting the environment and entering various global partnerships, with a target achievement date of 2015.

Did the glass remain ‘half-full’ or ‘half-empty’?

At the end of 2015 the UN reportedly called the MDGs ‘the most successful anti-poverty movement in history’. However, it could probably be a matter of looking at this glass either as ‘half-full’ or ‘half-empty’.

An interesting article published in the international daily ‘The Guardian’ on July 06, 2015, highlighted some hits and misses of MDGs from the global perspective.

Globally, several goals of the MDGs have not been made for various reasons. Focusing on health-related areas, I find, though the child mortality rate has reduced by more than half over the past two and a half decades from 90 to 43 deaths per 1,000 live births, its MDG target of an expected decline by two thirds could not be achieved.  Similarly, the global maternal mortality ratio despite falling by nearly half, was far short of its aim of a two-thirds reduction. Likewise, despite the reduction of the number of new HIV infections by around 40 percent between 2000 and 2013, its MDG goal of halting and beginning to reverse the spread of HIV/Aids by 2015 has not been met.

The overall status in India:

According to the United Nations in India, in the above focus areas, the country has made some progress in reducing its under-five mortality rate, which declined from 125 per 1,000 live births in 1990 to 49 per 1,000 live births in 2013; maternal mortality rate also declined from 437 per 100,000 live births in 1990-91 to 167 in 2009.

India recorded significant progress in reducing the prevalence of HIV and AIDS across different types of high-risk categories, with adult prevalence reducing from 0.45 percent in 2002 to 0.27 percent in 2011. However, a quarter of global TB cases still occur in India with nearly 2.2 million people are diagnosed with the disease annually, and an estimated 220,000 die as a result.

MDGs and India’s achievements:

Coming now to target versus achievements, the Millennium Development Goals India Country Report 2015 released by the Ministry of Statistics & Program Implementation (MoSPI) in February 2015, states that India had put considerable emphasis on all the MDGs with significant progress. Although the nation could meet targets of some of these well ahead of the 2015 deadline, overall, only six of the 18 targets adopted as part of the eight goals in 2000 have been fully met. However, according to another report brought out by the U.N. Economic and Social Commission for Asia and the Pacific, India has met only four of the eight MDGs.

As per Sample Registration System 2013, though the overall reduction of Under 5 Child Mortality Rate (U5MR) was nearly 60 percent happened during 1990 to 2013, India had missed this target.

Similar were the performances for a reduction in the Infant Mortality Rate (IMR) and the proportion of one year old children immunized against measles and improving the Maternal Morality Ratio (MMR). However, the prevalence of HIV among pregnant women aged 15-24 years showed a declining trend and incidence of Malaria also came down. Thus, it appears that the progress made and the achievements recorded in India against MDG targets are indeed a mixed bag.

The same question, therefore, logically follows for India too: Has the glass become ‘half-full’, or remained half-empty post MDG efforts?

MDGs break ground for ‘Sustainable Development Goals (SDGs)’:

The MDGs comprising of eight goals to eradicate extreme poverty, were indeed a laudable concerted global initiative of the United Nations. It could reportedly bring over a billion people out of extreme poverty. According to ‘United Nations (2015): The Millennium Development Goals Report’, during the period of 1990 to 2015, extreme poverty fell in developing countries from 47 to 14 percent. Similarly, the proportion of undernourished people fell by almost half, with almost similar decline in the child and maternal mortality rate. Nevertheless, communicable diseases, gender/income inequalities and striking disparities between rural and urban areas continued to persist with the world’s poor remaining overwhelmingly concentrated in several areas.

Thus, learning valuable lessons and significantly benefitting from them, MDGs broke ground for the next logical global initiative in this genre. As the time-frame for implementation of MDGs got over in 2015, the global leaders on the same platform of the United Nations followed it through with the newly developed ‘Sustainable Development Goals (SDGs)’ in the same year.

While aiming to make the outcomes of the new drive more sustainable with a focus on the environmental goals, SDGs did not altogether jettison some of the unfinished agenda of MDGs – mainly for continuity. Unlike MDGs, SDGs are targeted primarily to the developing, least developed and poorest countries. Nevertheless, all member countries of the UN require participating, fund and actively contribute in achieving SDGs targets, no matter how developed they are.

While MDGs had only 8 goals, 21 targets and 63 indicators, SDGs are a set of 17 goals and 169 targets that all 193 UN Member States, including India have committed to achieve between 2016 and 2030. Importantly, though MDG targets were adopted in 2002 and got over in 2015, its effective time span for achievement was of 25 years, as the baseline data used were for the year 1990 with some subsequent revisions. Whereas the baseline for SDGs starts from 2015 estimates, which may be revised to actual figures as and when these are made available.

Health goals in SDG:

Health has a central place in SDG 3 to ‘ensure healthy lives and promote well-being for all, of all ages’. Briefly speaking, it commits itself to a global effort to eradicate epidemics of both communicable and non-communicable disease and strengthen health systems’ capacity, ensuring Universal Health Coverage (UHC), along with making medicines and vaccines affordable to all. In addition, SDG 3 clearly focuses on mental health issues with suicide being the second leading cause of death globally between the ages of 19 to 25. It also aims at reducing the numbers of deaths and illnesses caused by air, water, and soil pollution and contamination, significantly.

Towards further enhancing public policy efforts, SDG 3 emphasizes on strengthening the implementation of the WHO Framework Convention on Tobacco Control; supporting the research and development of vaccines and medicines; substantially increasing health financing; the recruitment, development, training, and retention of the health workforce; and strengthen early warning, risk reduction, and management of health risks. Besides, a few targets falling under other different goals are also linked to the health goal of SDG 3, in various ways.

SDG 3 targets:

According to the ‘Resolution adopted by the General Assembly on 25 September 2015’ on ‘Transforming our world: the 2030 Agenda for Sustainable Development’, SDG 3 lays down nine key targets, as follows, though a few of which overlap with the MDGs:

  • Reduce the global maternal mortality ratio to below 70/100,000.
  • Reduce neonatal mortality to below 12/1,000 and U5MR to below 25/1,000.
  • End the epidemics of AIDS, tuberculosis, malaria, and neglected tropical diseases and combat hepatitis, waterborne diseases, and other communicable diseases.
  • Reduce by one-third premature mortality from non-communicable diseases.
  • Strengthen the prevention and treatment of substance abuse.
  • Halve the number of global deaths and injuries from road traffic accidents (by 2020).
  • Ensure universal access to sexual and reproductive health care services.
  • Achieve universal health coverage.
  • Reduce the number of deaths and illnesses from hazardous chemicals and air, water, and soil pollution and contamination.

Is India poised for it now?

This is indeed a critical question. I guess, no one can just yet vouch, with a great degree of certainty, what exactly would India ultimately achieve against the SDG 3 targets. That said, I reckon, India has now all its success ingredients in place. Let me deliberate on just a few broad but very important ones out of all those, as hereunder:

  • With the announcement of the National Health Policy 2017 (NHP 2017) and commitment to the same by none other than Prime Minister Modi himself, focusing on public health has now been recognized as one of the critical ingredients for the future economic prosperity of India. Hence, there is a fair chance now that the nation’s public health expenditure as a percentage of GDP would be gradually raised from around 1.2 percent to 2.5 percent – expectedly by 2020, bringing health in the core development agenda of both the Central and the State Governments.
  • The unfinished task of achieving MDGs needs to be completed faster, driven by its ongoing momentum. The national and the respective States-specific goals, along with a clear roadmap to achieve the targets within the specified time-frame, outlining the success indicators for each deliverable, assigning accountability to designated individuals with a periodic review system for the same, needs to be put in place, soon, actively encouraged by the current national development oriented Union Government, if not initiated already.
  • The process of implementation of the Universal Health Coverage (UHC), as enunciated in the NHP 2017 should be hastened. This is necessary to bring the entire population, without any discrimination whatsoever, as the beneficiary of this movement.
  • Scaling up the capacity building process at a much faster pace for the entire public health infrastructure and service delivery systems, along with skill development programs need to be placed at the center stage of the public health agenda of India, to bring SDG 3 to fruition.
  • Strategic involvement of private players and the credible NGOs to achieve SDG 3 targets would help move faster to ultimately experience the sense of a great public health related achievement for all concerned within, and probably outside the country, as well.

In conclusion:

As MDGs break ground for SDGs, India seems to me quite poised to achieving its health goals.

Moving towards this direction will invite a sharp focus on addressing the  non-communicable diseases, as well, while accelerating the ongoing efforts on maternal and child health, and nutrition.

It goes without saying that meeting SDG 3 targets will require adequate public investments for health, besides a well-crafted and time-bound public health policy, charting a clear roadmap for the same. The current Union Government now appears to have committed to both, putting its National Health Policy 2017 in place.

Once these goals are attained, it will enable India to clearly ‘Ensure healthy lives and promote well-being for all, at all ages’. In that process, a new India will be created where all essential public health related needs and demands of all, irrespective of their socioeconomic status, will be expeditiously taken care of, delivering with precision high quality of products and services.

Hopefully, the transformed India would then demonstrate to the world, as someone had said before, it’s just not a matter of ‘more money for health, but also more health for money’.

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.