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

Posted on January 2, 2017 by Tapan Ray

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

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

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

A trickle-down impact:

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

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

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

The availability of cheaper generics gave some respite:

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

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

How many people benefitted from pricey patented drugs?

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

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

The health care scenario in India is no better:

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

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

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

Pharma innovation benefitted the developed countries more:

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

Making the two to tango:

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

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

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

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

Conclusion:

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

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

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

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

By: Tapan J Ray

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.

Escalating Antibiotic Resistance, And Thwarting Ban Of Irrational FDCs

Posted on November 21, 2016 by Tapan Ray

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

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

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

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

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

The Devil is also in irrational antimicrobial FDCs:

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

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

Irrational FDCs and antimicrobial resistance:

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

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

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

Why does it matter so much?

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

The global relevance:

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

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

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

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

Some big MNCs are no different:

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

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

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

Irrational FDC ban – a significant corrective measure:

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

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

Thwarting FDC ban – a key issue:

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

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

The latest development:

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

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

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

Conclusion:

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

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

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

By: Tapan J. Ray

Millennial Generation Doctors And Patients: Changing Mindset, Aspirations, And Expectations

Posted on November 7, 2016 by Tapan Ray

The term ‘Millennial Generation’ normally refers to the generation, born from 1980 onward, brought up using digital technology and mass media. According to ‘Millennial Mindset’ – a website dedicated to helping businesses understand millennial employees and new ways of working, the key attributes of this generation are broadly considered as follows:

Technology Driven:
Socially Conscious
Collaborative

The millennial mindset:

The publication also indicates that the overall mindset of the millennial generation is also vastly different from the previous generations, which can fall into four categories:

Personal freedom, Non-hierarchical, Interdependent, Connected, Networked, Sharing
Instant gratification, Wide Knowledge, Test and learn, Fast paced, Always on, Innovative
Fairness, Narcissistic, Purpose driven
Balance, Eco-friendly and Experience focused

Seeks different professional ecosystem:

In the professional arena too, this new generation’s expectations from the professional ecosystem are often seen to be distinctly different, as they are generally seen to be:

Willing to make a meaningful professional contribution, mostly through self-learning
Seek maintaining a reasonable balance between work and personal life
Prefer flexible work environment, unwilling to be rigidly bound by convention, tradition, or set rules
Impatient for fast both personal and organizational growth, often on the global canvas

The ‘Millennial Generation’ in India:

The millennium generation with a different mindset, aspirations and value system, already constitutes a major chunk of the Indian demography. According to the 2011 Census, out of estimated 1.2 billion population, around 701 million Indians (60 percent) are under 30 years of age, which also very often referred to as ‘demographic dividend’ of India.

Currently, a large number of Indians belonging to the millennial generation are entering into the work stream of both national and International companies operating in the country.

The challenge in healthcare arena:

In the healthcare sphere too, we now come across a fast increasing number of technology savvy and digitally inclined patients and doctors of this generation. Accurately gauging, and then meeting with their changing expectations has indeed been a challenging task for the pharma companies, and the related service providers.

Their expectations from the brands and other services, as provided by the pharma companies, don’t seem to be quite the same as before, either, so are the individually preferred communication formats, the way of processing, and quickly cross-verifying the product and other healthcare information. Before arriving at any decision, they were found to keenly observe the way brands are marketed, their intrinsic value, type and the quality of interface for engagement with them by the companies, whenever required.

Thus, from the pharma business perspective, qualitatively different strategic approaches, to both the millennial doctors and patients, would be of increasing importance and an ongoing exercise. The goal posts would also keep moving continuously. Achieving proficiency in this area with military precision, I reckon, would differentiate the men from the boys, in pursuit of business performance excellence.

In this article, I shall primarily discuss on the changing mindset and needs of the patients and doctors of the ‘millennial generation’.

A. Treating millennial patients differently:

Around 81 percent of millennial doctors, against 57 percent of older generation doctors think that millennial patients require a different relationship with their doctors than non-millennial patients. About 66 percent of millennial doctors actually act upon this and change their approach, as the survey reported.

The difference:

The key differences on millennial doctors’ treating millennial patients, are mainly in the following areas:

Expects more, doesn’t get swayed away: Millennial doctors are more likely to advise the millennial patients to do additional research on their own for discussion. 71 percent of millennial doctors believe it’s helpful for patients to do online research before their appointment. However, they don’t get swayed by requests from more-informed patients, as only 23 percent of millennial doctors say they are influenced by patient requests when it comes to prescribing a treatment, whereas 41 percent of non-millennial doctors report finding those requests influential.

Gets into the details: The millennial doctors are more likely to simplify and streamline explanations for older patients, whereas non- millennial doctors were more likely to simplify explanations for millennial patients too, treating them exactly the same way.

Relies on digital resources: Millennial doctors rely mostly on using digital resources for treating millennial patients, but only around 56.5 percent of them do so for non-millennial patients.

B. Treating millennial doctors differently:

For effective business engagement and ensure commensurate financial outcomes, pharma companies will first require to know and deeply understand the changing mindset, expectations, and aspirations of the millennial doctors, then work out tailor-made strategic approaches, accordingly, to achieve the set objectives.

Top 3 expectations from the pharma industry:

According to a June 2016 special survey report on Healthcare Marketing to Millennials, released by inVentive Health agencies, the top 3 expectations of millennial and non-millennial doctors from the pharma industry, are as follows:

Rank	Millennial Doctors	%	Rank	Non- Millennial Doctors	%
1.	Unbranded Disease Information	67	1.	Unbranded Disease Information	58
2.	Discussion Guides	48	2.	Latest Specific News	46
3.	Adherence Support	40	3.	Healthy Life Style Information	42

Pharma players, therefore, can provide customized offerings and services, in various innovative platforms, based on these top 3 different expectations of millennial and non-millennial doctors, to achieve much needed critical competitive edge for a sustainable business performance.

Brand communication process needs a relook:

The above report also noted a number of the interesting trends related to the millennial doctors. I am quoting below just a few of those:

Only 16 percent of millennial doctors found pharma promotional materials to be influential when considering a new treatment compared to 48 percent of non-millennial doctors who do.

79 percent of them refer to information from pharmaceutical companies only after they’ve found that information elsewhere.

65 percent of these doctors indicated, they did not trust information from pharmaceutical companies to be fair and balanced, while only 48 percent of their older peers shared that sentiment.

50 percent found educational experiences that are driven by their peers to be the most relevant for learning and considering about new treatments, against 18 percent of non-millennial physicians.

52 percent of them, when learning about new treatment options, favor peers as their conversation partners.

They are much more likely to rely on a third-party website for requisite product or treatment information

60 percent of millennial doctors are more likely to see a pharma rep, if they offer important programs for their patients, compared to only 47 percent of non-millennial doctors. This also reflects greater patient centric values of the millennial doctors.

However, an overwhelming 81percent of millennial doctors believe that any type of ‘Direct To Consumer (DTC)’ promotion makes their job harder, because patients ask for medications they don’t need.

41 percent of millennial doctors prefer a two-way and an in-person interaction, against just 11 percent of them with online reps. Here, it should be noted that this has to be an ‘interaction’, not just predominantly a monologue, even while using an iPad or any other android tablets.

Redesigning processes to meet changing expectations and needs:

Thus, to create requisite value, and ensure effective engagement with millennial doctors, the pharma companies may consider exploring the possibility of specifically designing their entire chain of interface with Millennials, right from promotional outreach to adherence tools, and from medical communications to detailing, as the survey report highlights. I shall mention below just a few of those as examples:

Communication platforms:

For personal, more dynamic and effective engagement, non-personal digital platforms – driving towards personal interactions with company reps, together with facilitating collaboration between their professional peer groups, came out as of immense importance to them.

Adherence and outcomes:

There is a need for the pharma companies to move the strategic engagement needle more towards patient outcomes. This is mainly because, medication adherence is a large part of the patient outcome equation. It involves a wide range of partnerships, such as, between patients and physicians, and also the physicians and pharma players. This particular need can be best met by offering exactly the type of collaborative approach that millennial doctors favor.

Medical communication:

Redesigning the core narrative of medical communication around a disease state and product, engaging the wisdom and enthusiasm of scientific, clinical, and educational leaders primarily to serve a well-articulated noble cause, are likely to fetch desired results, allaying the general distrust of millennial doctors on the pharma companies, in general.

Medical representative:

Earning the trust of the millennial doctors by respecting, accepting, and appealing to their value systems, is of utmost importance for the medical reps. To achieve this, drug companies would require to equip their reps with tools and programs that offer value in terms of patient support and adherence, while demonstrating compelling outcomes with a positive patient experience, and greater efficiency in treatment decisions.

Building reputation:

The “Purpose Generation” – that’s how millennials are often referred to. In that sense, to build a long lasting business reputation among them, pharma companies need to be in sync with this new generation.

Weaving a trusting relationship with them involves meeting all those needs that these doctors value, such as, adherence solutions, innovative patient support programs, and creating shared value for communities. This would mean, for many drug companies, charting an almost uncharted frontier, where there aren’t many footsteps to follow.

Need to induct younger generation to top leadership positions faster:

To capture these changes with precision, and designing effective engagement strategies for millennial patients and doctors accordingly, an open, innovative and virtually contemporary mindset with a pair of fresh eyes, are essential. As against this, even today, many ‘Baby Boomers’ (born approximately between 1946 and 1956), who have already earned the status of senior citizens, meticulously nursing a not so flexible mind with traditional views, still keep clutching on to the key top leadership positions in the pharma industry, both global and local.

This prevailing trend encompasses even those who are occupying just ornamental corporate leadership positions, mostly for PR purpose, besides being the public face of the organization, sans any significant and direct operational or financial responsibilities. Nevertheless, by pulling all available corporate levers and tricks, they hang-on to the job. In that way, these senior citizens delay the process of change in the key leadership positions with younger generation of professionals, who understand not just the growing Millennials much better, but also the ever changing market dynamics, and intricate customer behavior, to lead the organization to a greater height of all round success.

I hasten to add, a few of the younger global head honcho have now started articulating a different vision altogether, which is so relevant by being a community benefit oriented and patient centric, in true sense. These icons include the outgoing GSK chief Sir Andrew Witty, who explains how ‘Big Pharma’ can help the poor and still make money, and the Allergan CEO Brent Saunders promising to keep drug prices affordable. Being rather small in number, these sane voices get easily drowned in the din of other global head honchos, curling their lips at any other view point of less self-serving in nature. Quite understandably, their local or surrounding poodles, toe exactly the same line, often displaying more gusto, as many believe.

Conclusion:

The triumph of outdated colonial mindset within the drug industry appears to be all pervasive, even today. It keeps striving hard to implement the self-serving corporate agenda, behind the façade of ‘Patient Centricity’. When the demography is changing at a faster pace in many important countries, such as India, a sizeable number of the critical decision makers don’t seem to understand, and can’t possibly fathom with finesse and precision, the changing mindset, aspirations and expectations of the millennial generation doctors and patients.

Expectedly, this approach is increasingly proving to be self-defeating, if not demeaning to many. It’s affecting the long term corporate performance, continually inviting the ire of the stakeholders, including Governments in various countries.

From this perspective, as the above survey results unravel, the millennial doctors and patients, with their changing mindset, aspirations, expectations and demands, look forward to an environment that matches up with the unique characteristics and values of their own generation.

To excel in this evolving scenario, especially in India – with one of the youngest demographic profiles, proper understanding of the nuances that’s driving this change, by the top echelon of the pharma management, is of utmost importance. Only then, can any strategic alignment of corporate business interests with the expectations of fast growing Millennials take shape, bridging the ongoing trust deficit of the stakeholders, as the pharma industry moves ahead with an accelerated pace.

By: Tapan J. Ray

Counterfeit Drugs In India: A Malady Much Deeper

Posted on October 24, 2016 by Tapan Ray

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

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

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

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

Counterfeit drugs and what it includes?

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

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

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

Controversy over the term ‘Counterfeit’:

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

Types of counterfeit drugs:

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

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

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

The magnitude of the problem:

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

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

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

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

Substandard drugs: a potential crisis in public health:

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

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

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

Substandard drugs and small pharma players:

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

Substandard drugs and large pharma players:

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

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

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

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

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

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

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

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

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

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

Who in India ensures that all drugs are safe?

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

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

Is CDSCO still in a denial mode?

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

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

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

Source: Central Drugs Control Organization (CDSCO)

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

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

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

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

Two recent good intents of CDSCO:

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

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

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

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

Conclusion:

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

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

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

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

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

By: Tapan J. Ray

Patient Services: No Longer An Optional Competitive Driver

Posted on September 19, 2016 by Tapan Ray

The emerging global trend of patients’ demand for greater engagement in their treatment decision making process, could well be a game changer in the prescription demand generation process for pharma brands, even in India, and in not too distant future. This would assume a critical importance not just from the patients’ perspective, but also for the pharma companies and other health care players, for commercial success.

The fast penetration of Internet services is increasingly becoming a great enabler for the patients to get to know, learn and obtain more and more information about their fitness, overall health, various illnesses, disease symptoms, available diagnostic tests, including progress in various clinical trials, besides the drugs and their prices – and all these just with several clicks.

Thus, equipped with relevant information from various dependable and user-friendly sources from the cyberspace, patients have started asking probing questions about the risks and benefits of various types of treatment decisions and diagnostics tests, when recommended by the doctors. At times, especially in the Western world, such interactions even lead to changes, additions or deletions in the choice of therapy, including drugs, devices and diagnostics tests.

Even in a developing country, such as India, many of such types of patients would no longer want to play just a passive role in their disease treatment or health and fitness improvement processes. Although, they would continue to want the doctors to take a final decision on their treatment, but only after having meaningful interactions with them.

A 2016 Report:

An April 2016 report of Accenture titled, “The Patient is IN: Pharma’s Growing Opportunity in Patient Services,” finds that the patients in the top global pharma markets want and expect consistent services coming from the pharma companies.

These patients are increasingly seeking more services from the pharma players before they are treated for a disease, regardless of the types of illnesses they have. However, it’s more important to note that patients’ responses during this survey have clearly indicated that while they highly value the services they use, a vast majority of them do not know about the services, which, as the pharma companies claim, are already available for them.

The Accenture study covered 203 executives at pharmaceutical companies, 100 in the United States and 103 in Europe (8 countries) from October to November 2015, covering seven therapeutic areas: heart, lung, brain, cancer, immune system, bones, and hormones/metabolism. Annual revenues of the surveyed companies ranged from nearly US$ 1 billion to more than US$ 25 billion.

Some important findings:

Following are some key findings of this report:

1. Patient services are delivering value with a significant increase in focus, and investment expected over the next two years, with 85 percent of companies are raising their investment in patient-centric capabilities over the next 18 months. However, the companies have only become slightly more patient-centric over the past two years. 9 of the following top 10 services are attracting above average business impact, which is an increase over hopping 73 percent that currently offer such patient services:

Disease education
Patient segmentation and insight
Patient experience management
Medication delivery/support
Patient risk assessment
Wellness information and health management
Nurse/ physician/patient access portal
Medication/ treatment reconciliation
Patient outreach, reminders, and scheduling
Adherence program management

2. Digital platforms play a dominant role in making patients aware of the services offered. Thus, companies are going big with investments in digital engagement technologies and supporting analytics, with 95 percent of companies planning to invest in patient engagement technologies over the next 18 months.

3. Much of this investment (but not all) is aligned to what patients value. 50 percent of the following top 10 fastest growing services are perceived by the patients delivering significant value:

Benefit coverage and access support
Health coach/counselor
Adherence program management
Co-payment assistance programs
Remote monitoring
Affordability and reimbursement support
Nursing support services
Reward/ incentive programs
Medication delivery/support
Patient outreach, reminders, and scheduling

Out of these, ‘medication delivery and support’, ‘remote patient monitoring’ and ‘adherence program management’ were highly valued by 85, 79 and 77 percentages of patients, respectively.

To give an example, pharma companies in the United States use digital as the primary channel for direct communications for patients. They use social media (51 percent) and web pages (49 percent) to market patient services. The use of TV is around 53 percent.

The challenge:

Let me re-emphasize here, as on date, just 19 percent of the surveyed patients are familiar with already available services meant for them. This had happened, despite respective pharma companies’ basic reliance and dependence on health care professionals for dissemination of their respective well-targeted services.

Thus, lack of awareness among patients about the services provided, throws a major challenge to pharma players to accurately ascertain, finding out effective ways, and then continuously measure and evaluate the impact of those services on outcomes, to further hone the process. Such a mechanism needs to be put in place before channeling further major investments in this important space.

Key takeaways:

Following are the key takeaways from this study:

Patient services will become a competitive driver and are no longer optional for pharmaceutical companies.

Investment should be led by what patients value, but measuring business value is critical to sustainability.

Clear organizational and operating strategy must be in place to ensure companies are structured for success.

Effective communication to patients the economic value of services, is central to healthcare professional interactions.

Patient-services strategy:

Accenture’s North American Managing Director of patient-services epitomized the findings of the report during its release on April 2016 by saying, “In this changing competitive environment, the question will no longer be if life sciences companies should offer these services, but rather which ones, and how they should be implemented.”

Thus, development of a robust patient-services strategy by the pharma players, that syncs well with the patients’ needs on the ground, will be absolutely necessary for the pharma players, as we step into the future. More importantly, there should be an effective alignment of the strategy with different health care professionals, through effective communication of various types and kinds, to ensure that the brand value offerings, well supported by carefully tailored patients’ services, generate a synergistic outcome for the target group.

Conclusion:

Patient services are increasingly assuming importance of a cutting-edge competitive driver of success in the pharma business. Accordingly, various types of such services have already started attracting greater investments, especially in the Western part of the globe, and are soon expected to become a key competitive driver of success in the healthcare market of India too.

However, while crafting an effective patient-services strategy, one-size-fit-all type of approach won’t work. This is primarily because, not just the service requirements would vary within patients or patient groups, the method of the preferred service delivery mechanism would also vary. For example, some patients may prefer to engage with their doctors for this purpose, some others’ preference could well be Internet based interactive digital platforms, or through a smart app available in a smartphone.

Thus, to succeed in this area for business excellence, pharma marketers must find out the most effective ways to offer these services to each types or groups of patients.

Moreover, the patient services strategy should be an ongoing exercise, as the target groups’ needs of the types of services, and preferred delivery platforms for the same would also keep changing over time.

In India too, quite slowly though, but steadily, the process of arriving at treatment decisions for the patients is undergoing a metamorphosis. Taking a fast mover advantage in the country, in a big way and now, would help reaping a rich harvest, in the near future.

Are Indian pharma players too taking note of this shifting paradigm for sustainable business excellence?

By: Tapan J. Ray

Déjà Vu In Pharma Industry

Posted on September 12, 2016 by Tapan Ray

It’s happening in the West, and is equally widespread in the Eastern part of the globe too, though in different ways and forms, as both the national and international media have been reporting, consistently. The phenomenon is all pervasive, and directed towards stalling almost all possible future laws and policies that a large section of the pharma industry sees as a potential apocalypse for their business models.

It has a wide reach and covers, for example, the policy-decision makers or possible policy-decision makers in the near future, other policy influencers, many hospitals, and the final interface with the patients – the prescription decision makers.

Although, it affects health care as a whole, in this article I shall focus just on the pharma industry.

Looking West:

While looking at the West, I would cite a recent example from the United States. It’s yet another déjà vu for the western pharma industry.

On August 26, 2016, ‘The Los Angeles Times’ in an article titled, “Drug companies spend millions to keep charging high prices” stated, “Of roughly US$ 250 million raised for and against 17 ballot measures coming before California voters in November, more than a quarter of that amount – about US$ 70 million – has been contributed by deep-pocketed drug companies to defeat the state’s Drug Price Relief Act.”

The Drug Price Relief Act of California, is aimed at making prescription drugs more affordable for people in Medi-Cal and other state programs by requiring that California pays no more than what’s paid for the same drugs by the Department of Veterans Affairs of the United States. It would, in other words, protect state taxpayers from being ripped off.

The report also quoted Michael Weinstein, President of the AIDS Healthcare Foundation saying that industry donations to crush the Drug Price Relief Act “will top US$ 100 million by the election, I’m quite certain of it.” He further added, “They see this as the apocalypse for their business model.”

Looking East:

While citing a related example from the eastern part of the globe, I shall draw one from nearer home – India, as China has already been much discussed on this matter. This particular media report on a wide-spread pharma industry practice, though took place in a different form, as compared to the United States, belongs to the same genre, and captures yet another déjà vu involving the pharma players operating in the eastern world, similar to what’s happening in the west.

India:

On August 30, 2016 a report published in ‘The Economic Times’ titled, “Pharma cos offer freebies to doctors, violate code: MP” quoted a serious allegation of a Rajya Sabha Member of the Parliament on this issue. The MP claims, he has evidence of four drug companies’ recently bribing doctors across India to push their products. These four companies include both large Indian and multinational pharma players, and two out of these four features, among the top five companies of the Indian Pharma Market (IPM).

The lawmaker further said, “I am waiting for the minister’s response on this issue. Nothing has come so far. We also have the names of the doctors who have taken bribes, which we will release eventually,”

Another September 06, 2016 report, published by the same business daily in India, categorically mentioned that TOI has documents to establish that one of these companies took hundreds of doctors from across India to places like Vancouver, Amsterdam, Oslo, Venice, New York, Boston, Brussels and Moscow. The documents reportedly include email exchanges between the company executives, city-wise lists of doctors with ‘legacy codes’, names of spouses, passport copies and visa copies, and show how the company has spent several millions of rupees in taking doctors and sometimes even their spouses, ostensibly to attend medical conferences.

Other NGOs have also reportedly submitted proof of the same to the Government for remedial measures in India, against such gross ongoing unethical practices in pharma marketing.

It is worth mentioning here that all these expenses are part of the marketing budget of a company and the sum total of which is built into the ‘retail price to the patients’ of the respective drugs, even in India.

Two broad processes for the same goal:

Thus it emerges, very broadly, there are two key processes followed by many in the pharma industry to achieve the same goal of increasing profit. These are as follows:

Marketing malpractices in various forms to influence prescription decision
Arbitrary increase of drug prices, for both branded and generic medicines

The justification:

Many global pharma majors still keep justifying, though the number of its believers is fast dwindling, that the high new drug prices have a linear relationship with the cost of new drug innovation. Even for argument’s sake one nods in favor, the critical question that needs to be answered is, if this is the basic or primary axle on which the wheel of innovation moves, won’t affordability and access to drugs for a significant number of the population be seriously compromised?

If not, why is this furor, across the world, is fast assuming a snowballing effect? Why are even the generic drug prices going up steeply even in the United States, where some of the largest Indian drug manufacturers are being questioned for the same by the competent authorities of the country?

I deliberated on a similar subject in my article titled, “The Next Frontier: Frugal Innovation For High-Tech Drugs”, published in this Blog on May 20, 2016.

Marketing malpractices:

Laws are fast catching up to book the offenders resorting to pharma marketing malpractices in most of the countries of the world, including China. This is vindicated by the fact that global pharma players are now paying billions of dollars a fine, in various countries, especially in the West.

Just as no criminal law can totally eliminate any crime, anywhere in the world, despite a heavy dent in pharma’s reputation related to this area, many companies still continue to indulge in such malpractices, blatantly, and even with some brazenness.

India:

Unfortunately, in India, the inertia to catch the bull by the horn and lack of governance in this regard continues, making patients pay a heavy price. As the above media report indicates, both MNCs and the local players indulge into this deplorable activity almost without any inhibition. As many industry watchers believe, some companies have started hiring these services through professional third parties just to create a facade for taking the high moral ground, as and when required, both with the government and also other stakeholders.

Initiating a step in this direction, on December 12, 2014, the DoP announced details of the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, which became effective across the country from January 1, 2015. The communique also said that the code would be voluntarily adopted and complied with by the pharma industry in India for a period of six months from the effective date, and its compliance would be reviewed thereafter on the basis of the inputs received.

UCPMP, though not a panacea, was aimed at containing pharma marketing malpractices in India. However, as happened with any other voluntary pharma marketing code, be it of a global drug major or their trade associations, similar non-compliances were detected even by the DoP with voluntary UCPMP. This gross disregard to the code, apparently prompted the DoP contemplating to make the UCPMP mandatory, with legal implications for non-compliance, which could possibly lead to revocation of marketing licenses.

In this context, it is worth recapitulating that the Union Minister of Chemicals and Fertilizer – Mr. Ananth Kumar, in his reply in the Indian Parliament, to a ‘Lok Sabha Starred Question No: 238’ on the UCPMP based on the inputs received, also had admitted:

“The Government had announced Uniform Code for Pharmaceutical Practices (UCPMP) which was to be adopted voluntarily w.e.f. 1st January, 2015 for a period of six months and has last been extended up to 30.06.2016. After reviewing the same it was found that the voluntary code was not working as expected. The Government consulted the stakeholders, including NGO’s / Civil Society members and after examining their suggestions it is now looking into the viability of making the Code Statutory.”

This seems to be yet another assurance, and expression of a good intent by the Union Minister. The fact today is, after extending the UCPMP in its original form up to June 30, 2016 with four extensions and despite the Government’s public admission that it is not working, by a circular dated August 30, 2016, the Government has informed all concerned, yet again, that voluntary UCPMP has now been extended ‘till further orders’.

This not only creates public apprehension on the DoP’s true intent on the subject, but also gives enough room for speculation regarding behind the scene power play by the vested interests to keep a mandatory UCPMP, having sufficient legal teeth, away, as long as possible. Are these forces then also visualizing its enforcement as an apocalypse for their business models in India too?

Thus, the possibility of containing pharma marketing malpractices in India is still charting in the realm of the decision makers’ assurances and no further.

Arbitrary drug price increases:

Arbitrary price increases of important drugs are drawing increasing public ire in the West, the latest being a 400 percent price increase of generic EpiPen of Mylan. This is now being considered yet another business malpractice in the pharma industry, as whole.

No robust regulatory or legal measure is now being followed in the West to contain the drug over pricing public health menace. Thus, it is increasingly assuming a critical political significance today to win over the voters, especially in the forthcoming Presidential election of the United States.

Thus, as reported by Reuters, on September 02, 2016, Hillary Clinton announced that, if elected, she would create an oversight panel to protect the consumers of the United States from large price hikes on longer-available, life-saving drugs and to import alternative treatments if necessary, adding to her pledges to rein in overall drug prices.

She would give the ‘Oversight Panel’ an aggressive new set of enforcement tools, including the ability to levy fines and impose penalties on manufacturers when there has been an unjustified, outlier price increase on a long-available or generic drug.

On September 08, 2016, reacting to these proposed measures articulated by Hilary Clinton, the global CEO of the world’s largest pharma player reportedly commented, as expected, that it “will be very negative for innovation.”

Nonetheless, the bottom-line is, even in the United Sates, a transparent mechanism to deal with arbitrary price increases of the existing important medicines, still charts in the realm of several assurances of the probable decision makers, just as it is India to effectively deal with pharma marketing malpractices.

A global CEO’s lone voice stands out:

In this context, I would start with yet another example of astronomical price increase of a widely used anti-diabetic product, besides EpiPen of Mylan. According to Dr. Mayer Davidson, Professor of Medicine at the Charles R. Drew University of Medicine and Science in Los Angeles, who has carefully tracked the rapid and repeated increases, from 2011 to 2013 the wholesale price of insulin went up by as much as 62 percent in the United States. Whereas, from 2013 to 2015 the price jumped again, from a low of 33 percent to as much as 107 percent.

In the midst of this scary situation, a solitary and apparently a saner voice from the global pharma industry stands out. According to an article published in the Forbes Magazine on September 06, 2016, Brent Saunders, CEO of Allergan, ‘explicitly renounced egregious price increases.’ Saunders also said that the industry needs to ‘end its addiction to price hikes far in excess of inflation, often taken several times in a single year.’ While outlining his company’s “social contract with patients,” Saunders vowed that Allergan would:

Limit price increases to single-digit percentages, “slightly above the current annual rate of inflation,” net of rebates and discounts.
Limit price increases to once per year.
Forego price increases in the run-up to patent expiration, except in the case of corresponding cost increases.

Though this seems to be a lone voice in the pharma industry, it makes the CEO stand much taller than his peers.

India:

On this score, India has already put in place the ‘National Pharmaceutical Pricing Authority’ to regulate the drug prices of primarily those falling under the ‘National List of Essential Medicines (NLEM)’. However, it is a different matter that as per its own public admission, NPPA is still unable to strictly enforce these price controls, with significant incidences of non-compliance. Therefore, the net benefits to the patients in India for having this mechanism, is indeed arguable.

The core issue:

All that we witness in this area are mostly assurances, promises and good intent on the part of various Governments of different political dispensation, over the last several decades. The same indifference to public health care, in general, continues. Nothing seems to be working effectively in the public health care space of the country, even today. A large section of patients, bearing the tough burden of the highest out of pocket health expenditure in India, are under significant consequential stress of all kinds.

An important part of this scenario is well-captured in the statement of the erstwhile Secretary of the Department of Pharmaceuticals (DoP) – V K Subburaj at an event in New-Delhi on April 19, 2016, when he said, “In the entire world, I think our drug control system probably is the weakest today. It needs to be strengthened.”

Is it a legacy? Possibly yes. But, who will fix it, and what steps are we taking now for its satisfactory resolution?

The core issue in the pharmaceutical arena is, therefore, about striking an optimal balance between drug profitability and patient affordability, to avoid any adverse impact on access to drugs for a large majority of population in the world.

Conclusion:

Thus, it appears to me, if those who now decide for the people’s health interest, also refuse to wake up from deep slumber and remain as indifferent as before, soon we may hear or read or experience yet another or more of similar deplorable developments, having serious adverse repercussions on the patients.

Interestingly, despite such incidents, pharma stocks remain generally unaffected and buoyant. Its overall trend continues heading north, factoring-in that no implementable Government action is forthcoming, for obvious reasons. Consequently, pharma business remains as robust as ever, but the patients continue to suffer increasingly more.

Pharma industry in general, has been seriously attempting to wash its hands off for this scary emerging situation, since long. It blames the governments for trying to throttle the money spinning business with ‘unnecessary’ regulations, as discussed above, for something that is only the state responsibility, as they perceive. The governments, in turn, blame the industry and try to regulate it more strictly. Invariably, the patients in need of right and affordable medical care get caught in this cross-fire – some succeed to overcome the health crisis, but mostly exposing themselves to huge financial uncertainty in the future, many others can’t.

When the business continues to flourish with current business ‘practices’, why would the pharma players bother about rapidly tarnishing industry reputation, and public outcry? Does it really matter at all on the ground, for running a money spinning business machine, especially when there exists a fair chance of stalling the new laws and policies, with deep pockets, as alleged by many?

In this scenario, what else a common man would do while falling seriously ill, except praying to the almighty for divine care and blessings for a speedy recovery, along with possibly lamenting, it’s déjà vu in the pharma industry?

By: Tapan J. Ray

Cancer Care: Dawns A New Era Of Precision Medicine In India

Posted on August 22, 2016 by Tapan Ray

The concept of ‘Precision Medicine’ has started gaining increasing importance, in the treatment process of many serious diseases, such as cancer. It is now happening in many countries of the world, including India.

The National Institutes of Health (NIH) of the United States, describes ‘Precision Medicine’ as:

“An emerging approach for disease treatment and prevention that takes into account individual variability in genes, environment, and lifestyle for each person.”

This is quite in contrast to the widely practiced “one-size-fits-all” type of drug treatment approach, where disease treatment and prevention strategies are developed for the average person, with less consideration for the differences between individuals.

It continues, irrespective of the fact that the same drug doesn’t always work exactly the same way for everyone. It can be difficult for a physician to predict, which patient will benefit from a medication and who won’t, besides having any advance inkling on who will experience Adverse Drug Reactions (ADR) with it, and who will not.

Whereas, the treatment path of ‘Precision Medicine’ allows doctors to predict more accurately which treatment and prevention strategies will work most effectively for a particular disease, and in which groups of people. This is mainly because, ‘Precision Medicine’ looks at the root cause of the ailment for each patient.

For example, in cancer care, use of the term ‘Precision Medicine’ would mean a treatment process for patients with similar tumors, that has been immaculately worked out in accordance with their unique genetic, physical, psychosocial, environmental, and lifestyle factors. Thus, especially for the treatment of life-threatening diseases, a gradual shift from “one-size-fits-all” types of medicines to ‘Precision Medicines”, could bring a new hope of longer survival or remission, for many such patients.

For example, in precision cancer care, it is all about analyzing a patient’s tumor to determine with specificity what drug or combination of drugs will work best with least side effects for that particular individual.

In this article, I shall focus on the development, use and benefits of ‘Precision Medicine’ in cancer, especially in India.

Not a radically new concept:

Several examples of ‘Precision Medicine’ can be found in a few other areas of medicine, as well, though its use in everyday health care is not very widespread, as on date.

One such example can be drawn from the blood transfusion area. A person requiring it, is not given blood from a randomly selected donor. To minimize the risk of any possible post-transfusion related complications, the blood for transfusion is selected only after scientific confirmation that the donor’s blood type matches to the recipient.

Difference between ‘Precision’ and ‘Personalized’ Medicines:

There is a significant overlap between these two terminologies. According to the National Research Council (NRC) of the United States, ‘Personalized Medicine’ is an older term having a meaning similar to ‘Precision medicine’, but may not always be exactly the same.

This change was necessitated as the term ‘Personalized’ could be interpreted to imply that treatments and preventions are being developed uniquely for each individual. Whereas, in ‘Precision Medicine’, the focus is on identifying which approaches will be effective for which patients based on genetic, environmental, and lifestyle factors, as stated above. The NRC, therefore, preferred the term ‘Precision Medicine’ to ‘Personalized Medicine’ to avoid such confusions or misunderstandings. Nevertheless, these two terms are still being used interchangeably.

Another terminology – ‘Pharmacogenomics’ is also used by some, in the same context, which is, in fact, a part of ‘Precision Medicine’. According to National Library of Medicine, United States, Pharmacogenomics is the study of how genes affect a person’s response to particular drugs. This relatively new field combines pharmacology (the science of drugs) and genomics (the study of genes and their functions) to develop effective, safe medications and doses that will be tailored to variations in a person’s genes.

Global initiatives taking off:

Currently, in various parts of the world, there are many initiatives in this area. However, one singular state sponsored initiative, I reckon, is exemplary and stands out.

According to NIH, in early 2015, President Obama announced a research effort focusing on bringing ‘Precision Medicine’ to many aspects of health care. The President’s budget for fiscal year 2016 included US$216 million in funding for the initiative for the NIH, the National Cancer Institute (NCI) – the NIH institute focused on cancer research, and the Food and Drug Administration (FDA).

‘The Precision Medicine Initiative’ has both short-term and long-term goals:

The short-term goals involve expanding precision medicine in the area of cancer research. Researchers at the NCI hope to use this approach to find new, more effective treatments for various kinds of cancer based on increased knowledge of the genetics and biology of the disease.

The long-term goals focus on bringing ‘Precision Medicine’ to all areas of health and healthcare on a large scale.

The market:

According to a July 2016 research report by Global Market Insights, Inc., the ‘Precision Medicine’ market size was over US$39 billion in 2015, and has been estimated to grow at 10.5 percent CAGR from 2016 to 2023, expanding the market to US$ 87.79 billion by end 2023.

The demand for ‘Precision Medicine’ is expected to significantly increase, specifically in cancer treatments, and also would be driven by advancements in new healthcare technologies, and favorable government regulations, in this area.

Faster US regulatory approval:

According to an August 15, 2016 article, published in the ‘MedCity News’ – a leading online news source for the business of innovation in health care, companion diagnostics, this trend is gaining currency as novel drugs are being paired up with tests that determine which patients will have a higher chance of responding to that drug.

This is vindicated by an expert analysis of a recent study, which found that the probability of a drug approval jumped three-times to 25.9 percent of those drugs that were approved with a predictive biomarker, from 8.4 percent for drugs without one. This means a threefold increase in success, as determined by FDA registration, if any pharma or biologic drug company had a predictive marker in its new product development strategy. This indication would expectedly encourage more drugs to come with companion diagnostics than without, as the analysis underscored.

The National Institutes of Health (NIH) of the United States defines ‘Biomarkers’ or ‘Biological Markers’ as, “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacological responses to a therapeutic intervention.”

‘Precision Medicine’ in India:

In the Indian health care space, ‘Precision Medicine’ is still in its nascent stage. This is despite its need in the country being high, especially while treating life threatening ailments, such as cancer, with greater precision, predictability and, therefore, more effectively than at present.

In several focus group studies too, the local medical specialists have also concurred with the global estimation of the inherent potential of ‘Precision Medicine’, as it rapidly evolves in India, particularly for use in oncology.

Local research:

Studies related to ‘Precision Medicine’ have already commenced, though in a modest scale, in a number of Government research centers, such as, Centre for Cellular and Molecular Biology (CCMB), Indian Council of Medical Research (ICMR), National Institute of Biomedical Genomics (NIBMG) and Institute of Genomics & Integrative Biology (IGIB).

Some large Government Hospitals too, like, All India Institute of Medical Sciences (AIIMS), National Institute of Mental Health and Neurosciences (NIMHANS), and even in Tata Memorial Hospital are making good progress in this area.

Local potential and market impact:

In March 2016, a leading daily of India had reported with examples that oncologists have started using ‘Precision Medicine’, in the country.

In this report, a molecular geneticist was quoted saying, “We see patients with blood, breast, lung, and colon cancer being referred for genetic testing on a routine basis. This testing is either for predictive purposes or for precision medicine guidance, where genetic tests are increasingly being used to determine which drug may be used for treatment.”

“We have had more than a few cases where patients respond well after being put on a new drug based on the results of these tests,” the expert said.

According to a May 2016 report of the Indian Council of Medical Research (ICMR), in the year 2016, the total number of new cancer cases is expected to be around 14.5 lakh (1.5 million), and the figure is likely to reach nearly 17.3 lakh (1.7 million) of new cases in 2020.

Over 7.36 lakh (736,000) people are expected to succumb to this disease in 2016 while the figure is estimated to shoot up to 8.8 lakh (880,000) by 2020. The data also revealed that only 12.5 percent of patients come for treatment in early stages of the disease.

Taking note of this fast ascending trend, it would be quite reasonable to expect that treatment with ‘Precision Medicine’, using advanced genetic profiling, would catch up, and grow proportionally in some section of the population, sooner than later. This trend is expected to keep pace with the commensurate increase in the anti-cancer drug market of India.

In tandem, the demand for preventive measures, especially, for cancer, cardiovascular, psychosomatic and many chronic metabolic diseases at the onset or prior to even onset stages, based on genome-based diagnostics, are also expected to go north. This would primarily be driven by increasing health awareness of the younger generation of India.

The spin-off commercial benefits for the pharma and diagnostic players in India, competing in these segments, could well be a significant boost even in the market potential of the older generic drugs in new patient groups, prompted by many out-of- box diagnostic and disease treatment strategies.

Another interesting article on genomic diagnostics for ‘Precision Medicine’, published on March 15, 2016 by ‘Pistoia Alliance’ – a global, not-for-profit alliance in life science that aims at lowering barriers to innovation in R&D, also expressed similar views regarding the future potential of ‘Precision Medicine’ in India.

Some key strategic steps:

Taking proactively some key strategic steps for business planning and development by the domestic pharma and diagnostic players, is now more important than ever before. This may call for developing some critical studies that would accelerate working out novel strategies for ‘Precision Medicine’ in India, besides obtaining required regulatory approvals in the coming years. The studies may include, among others:

Detailed analysis of target patient populations
Their genetic makeup for different types, or sub-types of diseases
Addressable sub populations
Their current treatment strategies, costs, affordability and differentiated value offerings of each, if any.

Conclusion:

Genomic research in India is now mainly directed towards routine genome-based diagnostics for a number of conditions, mostly for cancer. The country needs to encourage taking rapid strides to first sharpen and then gradually broaden this area, in various ways, for more effective and predictable treatment outcomes with ‘Precision Medicine’. As on date, most of such studies are carried out in the United States and Europe.

Alongside, a robust regulatory framework is required to be put in place, for wider usage of ‘Precision Medicine’ in India, without causing any concern to stakeholders. Government should also explore the need of clearly defining, and putting in place transparent, patient-friendly and robust Intellectual Property (IP) policies in the ‘Precision Medicine’ related areas to encourage innovation.

Healthcare expenditure being out-of-pocket for a vast majority of the population in India, the additional cost to be incurred for genomic sequencing tests, still remains a huge concern for many. Nevertheless, the good news is, many players have now gradually started entering into this area, spurring a healthy competition. This process would also gain accelerated momentum, as we move on.

This is just a dawn of a new era of ‘Precision Medicine’ in India. Its rapid development, is expected to be driven by a large number of startups, equipped with state-of-art technology, and hopefully, with greater health insurance penetration and the support from the Government. All this would bring the ‘Precision Medicine’ treatment cost affordable to a sizeable section of the population in the country, particularly for the treatment of cancer. The evolving scenario appears to be a win-win one, both for the patients, as well as the pharma and diagnostic players in India.

By: Tapan J. Ray

On Serious Healthcare, Some Bizarre Decisions

Posted on August 15, 2016 by Tapan Ray

On August 04, 2016, it was widely reported by the media that the Union Minister of Chemicals and Fertilizers – Mr. Anant Kumar, would launch a new digital initiative of the National Pharmaceutical Pricing Authority (NPPA), named, “Search Medicine Price”, on August 29, 2016.

This is an app developed by the National Informatics Centre, for android smartphones ‘that will enable patients to check the prices of essential medicines on-the-go’. It will be an extension of NPPA’s “Pharma Jan Samadhan” web-portal facility. The Indian price regulator believes that wide use of this app would successfully reduce the instances of overcharging the consumers by the pharma companies and retail chemists, especially for lifesaving, and other expensive medicines.

India’s drug pricing watchdog is planning to introduce this app to enable the patients check the prices of essential medicines on-the-go, and expects that this measure will hold drug companies and medicine retail outlets more accountable to patients.

In the test version of the app, which has since been released for stakeholder feedback, patients can search for the ceiling price of all medicines under the National List of Essential Medicines (NLEM), on the basis of its generic name and the state they’re buying it from.

The Chairman of NPPA, reportedly, further said, “Consumers can use the app before paying for a medicine to ensure that they get the right price. At present, whatever action we take against the companies, including recoveries, the consumer does not get back the overcharged amount he or she has paid.”

Good intent with a basic flaw:

The intent of the Government in this regard is indeed laudable. However, the initiative seems to underscore the blissful ignorance of the prevailing ground realities in India.

The media report highlights that with this app, the patients can search for the ceiling price of all medicines featuring in the NLEM on the basis of their generic names.

Whereas, the ground reality to make any meaningful use of this app is quite different. This is primarily because, in the Indian Pharmaceutical Market (IPM), over 90 percent of drugs are branded generics. An overwhelming majority of the doctors, as well, follow this trend while writing prescriptions for their patients, in general. For any single ingredients or Fixed Dose Combination (FDC) formulation, there are as many as even 30 to 40 brands, if not more.

In that case, when the prescriptions given to patients are mostly for branded generic drugs, how would that person possibly get to know their generic names, to be able to check their ceiling prices with the help of the new “Search Medicine Price” app?

Not just a solitary example:

This is just not a solitary instance of ignorance of the Government decision makers on the realities prevailing in the country.

With an admirable intent of making drugs more affordable for increased access, especially, to all those patients incurring out-of-pocket health expenditure, the Government has been taking several such measures, and is also trying to create a hype around these. Unfortunately, most of these efforts, miss the core objective of increasing access to drugs at the right price, by miles.

Another recent example:

This particular example, in my view, is even more bizarre.

It happened on February 29, 2016, the day when the Union Budget proposal for the financial year 2016-17 was presented before the Parliament of India.

In this budget proposal, the Union Finance Minister announced the launch of ‘Pradhan Mantri Jan-Aushadhi Yojana (PMJAY)’. 3,000 Stores under PMJAY will be opened during 2016-17.

Many consider this scheme as a repackaged old health care initiative, only adding the new words ‘Pradhan Mantri’ to it.

Just to recapitulate, Jan-Aushadhi is an ongoing campaign launched by the Department of Pharmaceuticals in 2008, in association with Central Pharma Public Sector Undertakings (PSU), to provide quality medicines at affordable prices to the masses.

Under this scheme, Jan Aushadhi Stores (JAS) are being set up to provide generic drugs, which are available at lesser prices, but are equivalent in quality and efficacy as expensive branded drugs.

The Department of Pharmaceuticals had initially proposed to open at least one JAS in each of the 630 districts of the country, so that the benefit of “quality medicines at affordable prices” is available to at least one place in each district of India.

If the initiative becomes successful, based on its inherent merit and the cooperation of all stakeholders, the scheme was to be extended to sub divisional levels as well as major towns and village centers by 2012. However, after 5 years, i.e. up to February, 2013, only 147 JAS were opened, and out of those only 84 JASs are functional.

More recently, according to a June 02, 2015 report, “under the new business plan approved in August 2013, a target of opening 3,000 Jan Aushadhi stores during the 12th plan period i.e. from 2013-14 to 2016-17 was fixed. As per the Standing Committee on Chemicals and Fertilizers report in March 2015, till date only 170 JAS have been opened, of which only 99 are functional.”

Tardy progress:

The tardy progress of the scheme was largely attributed to:

A lackluster approach of State governments
Poor adherence to prescription of generic drugs by doctors,
Managerial/ implementation failures of CPSU/ BPPI.
Only 85 medicines spread across 11 therapeutic categories were supplied to the stores and the mean availability of these drugs was found to be 33.45 percent, with wide variations across therapeutic categories.

There is no doubt, however, the intent of ‘Pradhan Mantri Jan-Aushadhi Scheme’ of 2016 is as laudable as the earlier “Jan-Aushadhi Scheme”, launched by the Department of Pharmaceuticals in 2008, was at that time. But, the moot question that comes at the top of mind: Is it robust enough to work effectively in the present situation?

Why it may not fetch the desired outcome?

Besides strong support from the State Governments, and other factors as enlisted above, making the doctors prescribe drugs in generic names would be a critical issue to make the “Pradhan Mantri Jan-Aushadhi scheme’ a success, primarily to extend desirable benefits to a sizeable section of both the urban and rural poor. Another relevant question that comes up now, how would the Government ensure that the doctors prescribe drugs in the generic names?

A critical challenge:

Since, the generic drugs available from ‘Jan Aushadhi’ retail outlets are predominantly prescription medicines, patients would necessarily require a doctor’s physical prescription to buy those products.

Despite some State Government’s circulars to the Government doctors for generic prescription, and the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, that states: “Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs”, the doctors, in India, prescribe mostly branded generics. It includes even many of those prescriptions, generated from a large number of the Government hospitals.

The legal hurdle for generic substitution:

In a situation such as this, the only way the JAS can sell more for greater patient access to essential drugs, if the store pharmacists are allowed to substitute a high price branded generic with exactly the same generic molecule that is available in the JAS, without carrying any brand name, but in the same dosage form and strength, just as the branded ones.

However, this type of substitution would be grossly illegal in India. This is 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.]”

Thus, I reckon, the most important way to make ‘Jan Aushadhi’ drugs available to patients for greater access, is to legally allow the retailers substituting the higher priced branded generic molecules with their lower priced equivalents, sans any brand name.

A move that did not work:

Moving towards this direction, the Ministry of Health had reportedly submitted a proposal to the Drug Technical Advisory Board (DTAB) to the Drug Controller General of India (DCGI), for consideration.

In this 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.

Conclusion:

Considering all this, just as ‘Pradhan Mantri Jan Aushadhi Yojana’, the likes of ‘Search Medicine Price app’, apparently, are not potentially productive health care related initiatives, if not just one-offs, ‘feel good’ type of schemes for the general population.

These are not robust enough either, to survive the grueling of reality, impractical for effective implementation, and thus, seriously handicapped to fetch any meaningful benefits for the patients, on the ground.

It is, therefore, still unclear to me, how would the needy patients, and the Indian population at large, could derive any benefit from such bizarre decisions, on so serious a subject as health care.

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.

PILMAN

A Tapan Ray Website

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