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.

Drug Price Control in India: When A Local Media Goes Against, A Global CEO Doesn’t

Posted on November 14, 2016 by Tapan Ray

‘Variety is the spice of life’, as the good old saying goes. The week, just gone by, was indeed packed with a wide variety of surprises, well encompassing various important areas, some of which are as follows:

Effective November 08, 2016 midnight, Indian currency notes of ₹500 and ₹1000 denominations ceased to remain legal tenders. This demonetization followed extensive media coverage, both national and international, on unprecedented administrative and public chaos around this otherwise bold and good intent.

The same day witnessed much unexpected triumph of Trump as the 45th President-Elect and the Commander-in-Chief of the United States of America. It is entirely a different matter though, that post-election, millions of Americans reportedly took to streets across the United states to vent their fury over the billionaire’s election victory.

On November 07, 2016, a well-known Indian business daily, ‘The Economic Times’, in its editorial, apparently expressed its solidarity with the pharma industry, in general, to do away with drug price control in India. The key reason for this advocacy, as I could sense, is to encourage the drug players to grow by making more profits. I respect this view of the editor will all humility. However, the point that I am unable to ferret out though, what happens to especially the poor patients in such an eventuality. With hands-on experience in the pharma industry over several decades, it appears to me that the editorial suggestions, as well, grossly lack in requisite depth of understanding of the core issue.

On November 09, 2016, quite opposite to what the above editorial of ‘The Economic Times’, the current global CEO of GlaxoSmithKline – Sir Andrew Witty, in an interview, strongly argued in favor of the necessity of drug price control in India, that improves access to medicines for a vast majority of the country’s population. To substantiate this point Sir Andrew said in another interview on the same day, “We’ve seen demand of products jump 45 percent after the price is cut by 20 percent. The problem arises when we don’t have supply to cater to the demand, leaving patients frustrated. A bit more predictability (on the part of government) will help.”

As if this diametrically opposite views are not enough, on November 10, 2016, the well-known civil society organization – ‘All India Drug Action Network (AIDAN)’, reportedly sent legal notices to the CEO of Niti Aayog CEO and secretaries to the Health Ministry, Department of Pharmaceuticals and Department of Industrial Policy and Promotion over their talks to cut the powers of the National Pharmaceutical Pricing Authority (NPPA). AIDAN has termed this Government move “anti-national” and “anti-people”, further adding that it affects an ongoing case at the Supreme Court over various aspects of the drug price control.

In this article, I shall restrict myself to the pharma related issue of the past week, especially on the interesting advocacy through editorial, against the drug price control in India. Simultaneously, I shall also underscore its relevance in the country, primarily to improve access to medicines for millions of Indians, as articulated by one of the leading voices from the global pharma industry.

Is the yardstick of judging pharma industry different?

This particular question floats in my mind because of several reasons. One such is, almost regularly sponsoring fully paid trips for doctors, especially in an exotic foreign land, by many pharma companies. Such practices of the drug companies are generally inferred, more often than not spearheaded by a large section of the media, as dubious means of the organization to entice, or influence prescribing decisions of physicians in favor of their respective high priced brands, ignoring the health and economic interest of patients.

In similar context, just after having a quick glance over a not so important article, written on various operations at the headquarter of a global drug company situated in a beautiful locale of the world, when one focuses the fine print at the end as a disclaimer, which reads: “This reporter was in (name of the country) on an invitation by (name of the global company)…, do the readers arrive at the same conclusion on ‘gratification’, as above, and its consequent possible outcome on pharma related writings of these reporters?

Can the concerned members of the ‘Fourth Estate’ possibly claim desired intellectual independence in their analysis of a situation involving such companies or their trade associations, even after the above disclaimer? Or for that matter, related publications too, which allow acceptance of such avoidable ‘gratis’ by its reporters? Shouldn’t such incidences, whenever these happen, irrespective of who availed these, be perceived in the same light?

In the current scenario, this issue is something for us to seriously ponder. This is mainly because, for following similar practices, why should there be two different yardsticks to gauge the quality of professional independence of two different otherwise highly respectable professions?

This reminds me of a great pharma reporter, writing for an internationally acclaimed business daily, mainly on the drug industry and healthcare. I met him in India a few years back on his invitation. Although, I shall not take either his or his paper’s name. This is to show respect to our free and frank interaction. He flew down to India with his employer paying all the pharma reporting work related expenses. He met with all those in the Indian drug industry that he wanted to, primarily to capture the nuances of the thought pattern of large and small Indian pharma players. I was so impressed with his intellect, and independent professional outlook, like all those who met him during his that specific visit to India. Even now, I can feel his independent perspective, as I read his articles. It would be great to experience similar feelings, while reading pharma related articles and editorials, in various publications of my own country. At the same time, I shall be delighted to be proved wrong regarding any such possibilities in this area.

That said, I shall now move on to the relevance of drug price control in India.

Any relevance of drug price control in a ‘Free Market Economy’?

No doubt, this is a very pertinent question. Equally pertinent answers are also available in a 2014 paper titled, “Competition Issues in the Indian Pharmaceuticals Sector” of Delhi School Economics (DSE). The paper deals with issues related to failure of ‘Free Market Economy’, despite intense competition, especially for branded generic drugs in India.

Quoting a practicing surgeon, the DSE article states: “Sometimes it could be just plain ignorance about the availability of a cheaper alternative that makes doctors continue to prescribe costlier brands. But one cannot ignore the role of what is euphemistically called marketing “incentive”, which basically mean the inappropriate influence pharmaceutical companies exert on doctors. This runs deep. Hospitals choose to stock only certain drugs in their in-house pharmacies and insist that hospitalized patients buy drugs only from the hospital pharmacy. Drug companies sell drugs to hospitals at a price much lower than what the patient is charged, further incentivizing the hospital to stock their products. The cheaper brands often get left out in this game.”

Further, in an ideal free-market economic model, for all approved branded generics with exactly the same formulation, having the same claimable efficacy, safety and quality standards, though marketed by different pharma companies, competitive forces should prompt some parity in their pricing.

Any generic brand with exactly the same formulation as others and offering the same therapeutic value, but costing significantly more, should ideally attract a lesser number of customers, if and where purchase decisions are taken by the consumers directly. However, for prescription medicines it’s not so. The well proven process of consumers exercising their own choice to select a brand, mostly influenced by advertising or word of mouth, does not happen at all.

The Government attributes ‘Market Failure’ for pharmaceuticals:

In its price notification dated July 10, 2014, the NPPA has categorically stated the following:

There exist huge inter-brand price differences in branded-generics, which is indicative of a severe market failure, as different brands of the same drug formulation, which are identical to each other in terms of active ingredient(s), strength, dosage, route of administration, quality, product characteristics, and intended use, vary disproportionately in terms of price.

It is observed that, the different brands of the drug formulation may sometimes differ in terms of binders, fillers, dyes, preservatives, coating agents, and dissolution agents, but these differences are not significant in terms of therapeutic value.

In India the market failure for pharmaceuticals can be attributed to several factors, but the main reason is that the demand for medicines is largely prescription driven and the patient has very little choice in this regard.

Market failure alone may not constitute sufficient grounds for government intervention, but when such failure is considered in the context of the essential role of pharmaceuticals play in the area of public health, which is a social right, such intervention becomes necessary, especially when exploitative pricing makes medicines generally unaffordable and beyond the reach of most and also puts the huge financial burden in terms of out-of-pocket expenditure on health care.

Civil Society echoed the same sentiment:

In this context, it is important to note that seven large Civil Society Organizations in a letter of August 20, 2014 addressed to Mr. Ananth Kumar, the present Minister of Chemicals and Fertilizers with a copy to Prime Minister Modi, articulated similar views, as follows:

“Limiting all price regulation only to a list of 348 medicines and specified dosages and strengths in the DPCO 2013 goes against the policy objective of making medicines affordable to the public. The National List of Essential Medicines, a list of 348 rational and cost-effective medicines, is not the basis for production, promotion and prescription in India. In reality the most frequently prescribed and consumed medicines are not listed in the NLEM.”

Last week, AIDAN has also indicated that the reported Government move to curtail the power vested on the NPPA for drug price, affects an ongoing case at the Supreme Court over various aspects of the drug price control.

Are medicines cheapest in India…really?

It is often highlighted that medicines cost much cheaper, if not the cheapest, in India. This is too simplistic a view on this subject. It compares the prevailing Indian drug prices in Rupee, against the prices of similar drugs in other countries, just by simple conversion of the foreign currencies, such as, US$ and Euro into Rupee. To make the comparison realistic and credible, Indian drug prices should be compared against the same in other countries, only after applying the following two critical parameters:

Purchasing Power Parity and Per Capita Income
Quantum of per capita ‘Out of Pocket Expenditure’ on drugs

The Department of Pharmaceuticals (DoP) with the help of academia and other experts had earlier deliberated on this issue in one of its reports on patented drug pricing. The report established that post application of the above two parameters, medicines in India are virtually as expensive as in the developed world, causing great inconvenience to the majority of patients in the country.

Hence, common patients expectedly look for some kind of critical intervention by the Government, at least, on the prices of essential drugs in India.

‘Cannot do away with Drug Price Control’ – said the New Government:

On August 24, 2015 in an interview with a national business daily, V K Subburaj, the Secretary of the Department of Pharmaceuticals commented, “Price control on drugs a shot in the arm for health care” and “the Government cannot do away with it.”

He argued, “A large section of the population is poor. Suddenly, your system is disturbed if you have to spend more on drugs. Drugs are an important component of health care expenditure.”

Accepting the fact that in India, big and small companies investing in research would need more money, Mr. Subburaj said, “In India, we can’t afford to remove controls as the burden of disease is high.”

All stakeholders expect that there is some predictability in what the Government says. Can the stand taken by the policymakers change in just a year’s time, probably wilting under industry pressure?

Conclusion:

The drug price control in India is in vogue since 1970, uninterruptedly. The retail audit data continue to indicate that the growth of the Indian pharma industry, over the last four and half decade long price control regime, has been nothing less than spectacular. This would consequently mean, increasing consumption of drugs, leading to improved access to medicines in India, including its hinterland, though may still not be good enough. Sir Andrew Witty of GSK also articulated the same view, just the last week. It’s a different story altogether that some of the industry sponsored expensive market surveys attempt to wish it away.

Coincidentally, at the commencement of drug price control regime in India in 1970, almost all the players in the ‘Top 10’ pharma league table of the country, were multi-national drug companies. Today the situation has just reversed. Out of ‘Top 10’, about seven are home grown drug companies. Many of these companies were born post 1970. Without frequent M&As by the pharma MNCs, this number could have been probably higher today.

By the way, what’s the span of drug price control in India really – just about 18 percent of the total domestic pharma market now? Around 80 percent of the local drug market continues to remain in the ‘free-pricing’ and ‘high-profit’ zone.

When it comes to profitability, it is worth mentioning, the promoter of the so called ‘low margin’ generic pharma company – Sun Pharma, is the second-richest person in India. He created his initial wealth from India, despite ostensible ‘growth stunting’ price control.

Keeping this in perspective, is it not baffling to fathom the reason behind a local business publication’s apparently endorsing the advocacy initiatives of pharma industry against drug price control through an editorial, when a well-regarded global pharma CEO expresses a strong favorable view in this regard?

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

What Happens To Pharma’s Incredible Ride On The ‘Gravy Train’?

Posted on September 26, 2016 by Tapan Ray

India continues to be one of the fastest growing pharmaceutical market of the world with its over 40 percent of the total pharmaceutical produce is exported around the world. Over half of the total exports constitute of formulations, and the balance comprises of bulk drugs. India has been consistently maintaining its supremacy in the formulation exports since my salad days.

According to Export Statistics (2014-15) published by the Pharmaceutical Export Promotion Council of India (Pharmexcil), United States (US) is the largest market for the India’s pharmaceutical exports with a share of 27 percent of the total, followed by the United Kingdom (UK), South Africa, Russia, Nigeria, Brazil and Germany.

A red flag raised:

Up until recently, it has almost been like walking over a bed of roses in this front for Indian pharma exporters. However, it does not seem to be so now, and at least in the foreseeable future, for a number of reasons.

The Press Release of ‘CRISIL Research’ dated May 17, 2016 has also raised a red flag in this area. The report foresees growth in pharma formulations (in US dollar terms) declining sharply to 10-12 percent annually over the next 5 years, as compared with a growth of ~19% seen in the last decade.

This adverse impact will be felt mostly in the US – the largest export destination of India, followed by the UK.

I reckon, there are three basic reasons for this changing scenario, namely, pricing, quality and lesser number of branded small-molecule blockbuster drugs going off patent.

The ride on the ‘gravy train’:

Pharma companies across the world consider that doing business in the US market would provide them a lot of money without facing any head wind, fundamentally driven by the drug pricing freedom in the country, as compared to any other market of the world.

This unfettered freedom of charging a hefty price premium in the largest pharma market of the world, on an ongoing basis, has been a critical factor of attraction for many pharma players to do business in the US, coming from various corners of the globe, including India, just as honey attracts the bees, as it were.

Thus far, it has been an incredible ride on the ‘gravy train’, as it were, for most of them.

However, ongoing activities of a large number of drug companies, dominated by blatant self-serving interests, have now given rise to a strong general demand for the Government to initiate robust remedial measures, soon. The telltale signs of which indicate that this no holds barred pricing freedom may not be available to pharma, even in the US, any longer.

In this article, I shall focus mainly on this point, drawing both global and local examples, as this development has a strong potential to add more to the existing miseries of many Indian drug exporters, of course in tandem with many other large MNCs.

Some recent developments:

The April 21, 2016 issue of ‘The Financial Times’ quoted Joe Jimenez, the Global Chief Executive (CEO) of Novartis, where he said that pharma companies can no longer count on the “hockey-stick” trajectories for new products in the US. This is primarily due to the aggressive control of the drug expenses by the insurers and other healthcare payers, besides lawmakers and the public at large, of this most lucrative pharma market of the world.

As Jimenez said in the report, yesterday’s business model that pharma companies have followed since long, has now changed, slowing the pace of growth of innovative patented products in the US.

This trend is now heading north, primarily driven by the consolidation among the US insurers and healthcare providers. Consequently, the payers are making effective use of their greater bargaining power over the drug companies, especially to avail new incentives for cost savings, as provided in President Barack Obama’s Affordable Care Act, the article highlights.

To give a feel of it, I am quoting the example of a Novartis drug from the same ‘Financial Times’ article. It states, “Entresto, a treatment for heart failure, launched last year on the back of stellar clinical trial results, has so far sold more quickly in Europe than the US, marking a reversal of usual patterns in the pharma industry.”

A key differentiator in global ranking:

In this emerging scenario, all global companies will be adversely impacted for increasing pricing pressure in the US market.

This factor remaining the same for all the pharma players in the world, one of the key differentiating factors that would now play even more important role, is the richness of the advanced stage R&D pipeline of each innovator company.

For example, according to ‘Evaluate Pharma World Preview 2016, Outlook to 2022’ report, the overall R&D pipeline value of Roche is US$ 43.2 billion, far ahead of the same of Novartis’ US$ 24.1 billion and AstraZeneca’s at US$ 23.2 billion, followed by Eli Lilly, AbbVie, Pfizer, Sanofi, Celgene, Biogen and J&J and in that order. As a result, Roche is expected to overtake Novartis and Pfizer in the ranking by 2022, just when the global pharma industry would possibly cross as US$ 1Trillion mark.

Currently Novartis, though quite a small player in the Indian Pharmaceutical Market (IPM) holding the rank of 23 (AIOCD Pharmasofttech AWACS retail audit report, MAT August 2016), is number three in the global ranking, just ahead of Roche.

Indian generic players to feel the heat:

According to the Reuters report of September 11, 2016, US Department of Justice has sent summons this month to the US arm of Sun Pharma – Taro Pharmaceutical Industries Inc. and its two senior executives seeking information on generic drug prices. In 2010, Sun Pharma acquired a controlling stake in Taro Pharmaceutical Industries.

On September 14, 2016, quoting a September 8, 2016 research done by the brokerage firm IIFL, ‘The Economic Times’ reported that some large Indian generic drug manufacturers, such as, Sun Pharma, Dr. Reddy’s, Lupin, Aurobindo and Glenmark have also hiked the prices of some of their drugs between 150 percent and 800 percent in the US. This invites even more apprehensions in the prevailing scenario.

As I wrote in this Blog on September 12, 2016, the subject of price increases even for generic drugs has also reverberated in the ongoing Presidential campaign in the US.

The Democratic Party’s presidential nominee – Hillary Clinton has already promised, if elected in November 2016, she would constitute an ‘Oversight Panel’ to protect the consumers of her country from hefty price increases for long-available life-saving drugs.

Import bans:

In the midst of all this, import bans of a large number of formulations and bulk drugs by the US-FDA from several manufacturing facilities of Indian drug manufacturers of various scales and sizes, have further compounded the future risk potential of Indian pharma business growth in the US.

As investors are raising concerns, the following comment of the Co-Chairman and Chief Executive of Dr. Reddy’s Laboratories, reported by ‘Financial Express’ on August 24, 2015, well captures the pharma business risks in this area:

“The U.S. market is so big that there is no equivalent alternative. We just have to get stronger in the U.S., resolve our issues, build a pipeline and be more innovative to drive growth.”

However, this still remains a good intent. It is worth noting, for most Indian pharma exporters, the US is the single largest export market, with a stake, as high as nearly half of most of these companies’ annual revenue, and probably much more in profit, both of which are now showing a declining trend.

Price control coming in the UK:

On September 15, 2016, the Department of Health of the United Kingdom (UK) reportedly introduced a new Bill in Parliament to use its statutory power to limit the price of generic medicines where competition in the market fails, and pharma companies charge the NHS unreasonably high prices.

The Bill would also allow the government to apply penalties for non-compliance and to recover any payments owed through the courts following a right of appeal to a tribunal. The penalties can be a single penalty not exceeding £100,000 or a daily penalty not exceeding £10,000.

UK drug regulatory authorities had also announced import bans of APIs and formulations from some manufacturing facilities of a couple of leading Indian drug manufacturers, but on a lesser scale as compared to the USFDA.

Action in EU:

As reported by Bloomberg on July 22, 2016, The European Medicines Agency (EMA) has called for a halt to sales of hundreds of medicines that were tested in India, after an inspection of a research site found “substitution and manipulation” of the study samples. The affected companies include both large Indian and multi-national players.

According to a PTI report of July 27, 2015, after this incident Pharmexcil estimated that exports worth US$ 1-1.2 billion are likely to be affected, if cancellation of 700 generic drugs by the EU stands.

Conclusion:

All these developments, particularly on pricing and mostly in the US, could have a retarding effect on the business growth trend of a large number of global and local pharma companies.

Focusing nearer home, the evolving scenario in the world’s top pharma market, viewed together with what’s happening in Europe, both on pricing and the data integrity fronts, send a strong cautionary signal to the Indian drug exporters, in general.

Inadequate remedial measures could unleash this pressure to reach a dangerous threshold, impacting sustainable performance of the concerned companies. On the other hand, adequate remedial action, both strategic and operational in nature, could lead to significant cost escalation, with no space available for its neutralization through price increases, gradually squeezing the margin.

As I see it, ease of doing pharma business in these top export markets will no longer be quite the same as in the past. Many believe, pharma industry has invited these measures sans perceptible self-control, over a long period of time.

Is it mostly a self-inflicted injury of the industry players? The drug companies, in general, don’t believe so. Will this change be irreversible? Only the future could unravel this. However, regarding the possibility of future US Government legislation on drug pricing, it’s now a wait and watch game for the stakeholders. On a shorter time-frame, the ghost in this area, would keep haunting globally, primarily for business in the US market, at least, till the end of this year.

However, for the Indian pharma exporters, pricing appears to be just one among several other critical issues, especially, in the two most lucrative markets of the world. The overall situation in this area, by and large, remains unchanged till today, besides expression of a plethora of good intents.

Thus, pharma analysts’ quest to ferret out an answer to the Gordian knot on the continuity of Indian pharma exporters’ incredible long ride on the ‘gravy train’, has also not been plain sailing, so far. Further mired by the local manufacturers’ prolonging errors of judgement, the status quo ante is expected to still remain elusive, at least, for now.

By: Tapan J. Ray

Leveraging 3D Printing In Pharma, For Cost Containment And Patient-Centricity

Posted on June 6, 2016 by Tapan Ray

Today, although a number of new and state of the art drugs is regularly being developed, and brought to the market at a reasonably rapid pace, their access to the majority of the global population has still remained a huge challenge. One of the key access barriers continue to remain exorbitant prices of these drugs.

Keeping commensurate pace with gradual improvement in the pinpointed diagnosis of various diseases with modern diagnostics, processes, devices and techniques, fueled by increasing health awareness within a sizeable section of the population, more patients are now aspiring for access to a better quality of life, and greater productivity at work. This is happening all over the world, though with varying degree and magnitude.

Consequently, there has been a sharp increase in the demand for healthcare, which has caused a huge bottleneck in the overall healthcare delivery process, for various reasons. The huge gap between the availability of high-tech drugs/healthcare services, and their access to the general population, mostly due to affordability reasons, is going north at a rapid pace.

Two-pronged cost containment pressure:

This unfettered ascending trend is creating primarily the following two types of cost containment pressure:

Being driven purely by the economical reasons, the Governments and other payers have started taking stringent cost-containment measures, bringing huge pricing pressure, especially on the drugs and medical device manufacturers.

In countries, such as, India, where the ‘Out of Pocket’ expenditure on healthcare in general, and the medicines in particular, is hovering around 70 percent, the patients, several Governments have started announcing drug price control policy to protect the health interest of patients.

However, currently, only some piecemeal measures are being initiated, including in India, where a holistic approach for all, such as, Universal Health Care (UHC) and several other similar options, are long overdue.

Three different remedial measures:

In my view, consideration of either of these three following approaches, or an innovative blend of these, would enable the Governments to address this pressing issue, remove the existing bottle neck, and thereby bridge the healthcare access gap, holistically:

A. Fast implementation of Universal Health Care (UHC).

B. Closer look at the entire Pharmaceutical Value Chain with a resolve to work out innovative, game-changing solutions to reduce cost of each of its critical components, significantly.

C. Effectively addressing the emerging need of Patient-Centricity.

A. Fast implementation of Universal Health Care (UHC):

I have already discussed UHC in one of my articles titled, “Universal Health Coverage: The Only Alternative To Drug Price Control in India?”, published in this Blog on November 9, 2015.

B. Cost containment with 3D printing:

A report of IMS Health, published on November 18, 2015, forecasts the increase of total global spend for pharmaceuticals by US$ 349 billion on a constant-dollar basis, compared with US$182 billion during the past five years. It also indicated, more than half of the world’s population will live in countries where the use of medicine will exceed one dose per person per day by 2020, up from 31 percent in 2005, as the “medicine use gap” between the developed and the emerging markets narrows.

This steep ascending trend would eventually affect the pharma ‘Value Chain’ in a significant way, throwing open several path-breaking high-technology based options, with impressive favorable impact on the general costs of medicines. 3D-printing technology is expected to play a significant role in this initiative.

Before proceeding further, let me zero-in on a few critical components, as follows, of the pharma ‘Value Chain’, as I see visualize these:

Drug innovation (R&D)
Manufacturing
Marketing
Supply Chain

According to my understanding, at least in 3 of the above 4 ‘Value Chain’ components, there is an immense potential of leveraging 3D printing technology effectively, and in a big way.

In my article of January 11, 2016, published in this Blog, titled “3D Printing: An Emerging Game Changer in Pharma Business”, I have already discussed the game changing impact of 3D Printing technology on the drug discovery process, drug manufacturing strategy, and supply Chain effectiveness in the pharma business.

Hence, I prefer not to dwell on those areas, yet again, here. Instead, I shall briefly deliberate on the application of 3D Printing technology to effectively address the emerging need of ‘Patient-Centricity’ with an interesting and a very recent example.

C. Improving ‘Patient-Centricity’ with 3D printing:

At this stage, there is a need to understand what exactly is the ‘’Patient-Centricity’. It seems to be a popular buzzword now with the health care related companies, primarily to give an impression that they are really focusing on ‘Patient-Centricity’.

However, there does not seem to exist any universally accepted definition of this terminology, just yet. Nevertheless, one appropriate definition could well be: “A focused and transparent approach to providing maximum possible benefits to a patient from a drug, device, technology, or health care services.”

I briefly focused on a part of this basic issue in my article titled, “‘Disease Oriented Treatment’ to ‘Patient Oriented Treatment’- An evolving trend’, published in this Blog on January 7, 2013.

As I said before, in this article, to explain ‘Patient-Centric’ approaches with 3D printing, I would quote from a very recent, and a path-breaking work in this area.

On May 25, 2016, ‘The Straits Times’ reported, the researchers at the National University of Singapore have found a way to use 3D printers to create low-cost tablets. With the help of this technology a tablet can be so personalized to respond to individual patient’s needs that the drug can be customized to take on different release profiles, such as, constant release, pulsed release, increasing or decreasing release, and any arbitrary interval as required by the patient. However, the most striking is, different drugs with different release profiles can also be combined in a single pill.

Once administered, the tablet dissolves layer by layer over a period of time, releasing the drug at a controlled rate. The duration can be altered by changing the chemical composition of the liquid.

It is worth noting here that the conventional tablets are only capable of a constant rate of release, requiring the patient to manually control the dosage and release rate, by taking doses according to a prescribed schedule, given by the doctor. In this scenario, if a patient requires different drugs with different dosages and intervals, it can become inconvenient to keep track and potentially dangerous, especially when the patient misses a dose, the report highlighted.

The commercially available printer used in the project costs just S$2,000.

The Assistant Professor Soh Siow Ling, who leads the project, reportedly, expects that the low cost will allow it to be used in hospitals and neighborhood clinics. He further explained, “Every single person is different, based on many factors such as genetics, age, body mass and so on. Different people also have different activity levels and consumption habits, which affect their needs. It is, (therefore), not desirable to use the same drug to treat different illnesses which have similar apparent symptoms.”

The report indicated that in October, 2015, these findings were published in an issue of Advanced Materials, which is a peer-reviewed materials science journal.

A patent for the tablets was filed last year, and they are currently in talks with multinational corporations, and medical professionals to identify potential applications, the article highlighted.

Changing role of doctors:

From the above developments, it appears that unleashing the full potential of 3D printing technology in the pharma industry, would also enable the medical profession to move further towards ‘Patient-Centricity’, in its true sense.

This technology would empower them offering to each patient, the right drug or drug combinations, with most suitable drug delivery system, and exactly the way individual patients would prefer, with a very high degree of precision.

Thus, from overall disease treatment perspective, especially with medicines, this approach offers a great potential to be significantly more effective, and convenient to individual patients, as compared to the conventional approaches.

I reckon, over a period of time, professional competitiveness would drive the doctors further honing their effectiveness in the disease treatment process, and that too with a high degree of precision. In that situation, many doctors may decide to setup on-demand 3D drug-printing facilities even at their clinics.

The gradual embodiment of this brilliant technology by the doctors, is expected to throw open new vistas of opportunity, also to personalize the shapes, colors and flavors of any medicine, according to individual patient’s choice. This, in turn, would improve patient compliance, ensure a predictable relief from the disease, and demonstrate ‘Patient-Centricity’ of a high order by the medical profession, in general.

Conclusion:

For the first time ever, with Aprecia Pharmaceuticals in the United States getting approval of the US-FDA on August 3, 2015 for the market launch of a 3D printed prescription drug for oral use by the epilepsy patients, dawns a new paradigm in the global pharma business horizon.

Effective application of this ‘disruptive innovation’ could well be a game changer not just in the ‘value chain’ of conventional pharma business models, across the world, but also for taking a giant leap towards ‘Patient-Centricity’. The doctors are also expected to be very much an integral part of this process.

Besides all the above benefits, 3D printing can also encourage low-volume production, whenever required, and a wide variety of Active Pharmaceutical Ingredients, to meet any immediate demand, mostly for use in research and developmental work.

Thus, noting the ongoing significant progress in this area, I reckon, leveraging 3D printing technology in pharma, not just to address the cost containment pressure, effectively, but also to ensure a tangible and visible move towards ‘Patient-Centricity’, in true sense. All-round success in the innovative application of this cutting-edge technology in the global pharma industry, would eventually separate men from boys in pursuit of business excellence.

By: Tapan J. Ray

The Next Frontier: Frugal Innovation For High-Tech Drugs

Posted on May 30, 2016 by Tapan Ray

Should drug innovation models remain as expensive as what these are claimed to be now by the global pharma industry, in general?

Finding a credible, appropriately quantifiable, and generally acceptable answer to this question is critical. It won’t, then, just be a myth-buster for billions of dollar price tag, that is now being attached to drug innovation and development initiatives, by the global pharma industry, as a justification for arbitrarily fixing high new drug prices. If the upcoming and new startups with frugal models for even high-tech drug innovation succeed with flying colors, the patients and the payers would also possibly breathe a huge sigh of relief, from the increasing burden of disease and the cost of medicines.

I believe, it would eventually happen, may not be overnight, but over a period of time. I shall discuss in this article about some bright sparks, already visible in that direction.

The facade of high cost of drug innovation:

At the very outset, to avoid any possibility of misunderstanding, let me confess up front, just as many others, I also strongly believe that drug innovation is extremely important. It needs to be encouraged, protected and rewarded reasonably.

That said, let me also give the right perspective of how the cost of ‘drug innovation’ is being often misused as a facade for keeping the drug prices high, if not exorbitant.

According to a contentious study of ‘Tufts University Center for the Study of Drug Development’, the total cost of innovation of a new drug and bringing it to market, has increased more than double from US$ 1.22 billion in 2003 to US$ 2.6 billion in 2014.

Despite these numbers being vehemently challenged in credible journals, many global pharma majors still keep justifying the high new drug prices on the same old pretext. As a diversionary tactic, they relentlessly argue that innovation has to be adequately rewarded to keep its wheels moving in perpetuity, though no one challenges this basic fact, not even remotely.

The moot questions:

The moot questions, therefore, are: how expensive is the drug innovation and how does the global drug industry establish its relationship with high new drug prices? The answers to these queries must be clear, specific, quantifiable and credible, and not ethereal, if not airy-fairy.

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

The above BMJ article also put forth similar questions: “What does it really cost to bring a new medicine to the market, and do these costs justify the high price?”

The authors pointed out that the pharmaceutical market is not actually a “free market” based on supply and demand with minimal government intervention through taxes, subsidies, or regulation. On the contrary, the pharma market is highly manipulated, and not focused on achieving the best prices, or even fair prices for essential and life saving medicines.

No linear link between high drug price and innovation cost:

As I discussed this subject in my previous article titled, “Arbitrary Pricing of Essential Drugs Invites State Intervention”, it has been well established by now that there is no linear, or any relationship between high drug prices and cost of drug innovation. Since long, this argument is being misused just as a façade to keep the cost of medicines high, and making high profits even at the cost of lower sales volume.

The façade has started crumbling:

In India too, the pharma MNCs often use the same façade to keep the prices of also their branded generics much higher than the comparable formulations manufactured by larger domestic pharma manufacturers. However, the façade has started crumbling in many countries, across the world. This gradually increasing general realization is welcoming.

The Governments in many countries, have now started acting. They are increasingly forcing the drug makers to eye for volume growth, by reducing the fat margin, and improving patients’ access to high-priced drugs.

Just to draw an example, I would quote a very recent development in this area, outside India. On May 20, 2016, the Chinese health authorities announced price cuts of up to two-thirds to three patented drugs, in their latest move to reduce the cost of healthcare for patients. It is noteworthy that this happened in the world’s second-biggest economy, after the United States.

Why is arbitrary drug pricing continuing?

It appears, the only reason for the majority of the drug players to continue keeping the new drug prices high is because they can still make huge money through a small segment of patients who can afford their brands. What about the rest? This doesn’t seem to matter to them, at all, unless compelled to, in various ways.

Need to totally demolish the façade of innovation:

Thus, there is a compelling need is to demolish the façade of innovation, decisively, for keeping medicine prices high.

To move towards this direction, some flickers of a sound possibilities, are now visible in the horizon. The ‘Frugal’ or the ‘Silicon Valley’ type startups for high-tech drug innovation models, especially in the biotech sector, have shown high potential to be a game changer in this area.

Frugal innovation models for high-tech drugs:

The quest to find a pathway towards this direction continues. Recently, Professor Atul Butte, Director of the University of California Institute of Computational Health Sciences, highlighted that like other Silicon Valley startups, almost anyone can bring a drug to market from their garage with just a computer, the internet, and freely available data. Professor Butte, students, and research staff have already explored various methods and approaches of scientifically utilizing this data in search for new medicines.

As reported in the May 5, 2016 issue of ‘The Conversation’, Professor Butte outlined this process for an audience of local and international scientists and medics in a talk given at the Science on the Swan conference held in Perth in May 2016.

Professor Butte outlined several models of ‘Frugal Innovation’, especially for new biotech drugs or finding new indications for existing drugs.

A. The search for a new target:

There could be several approaches to the search of a new biotech drug. An example of one such, that Butte’s team is reportedly engaged in, is the construction of a map of how the genetic profiles of people with particular diseases are related to each other. The team looked for diseases with very similar genetic profiles.

Some may argue, this process of discovering other uses of drugs, conventionally termed as “drug repositioning”, is in the strictest sense is not exactly a novel one. They may attempt to establish it by drawing an example from Viagra, which was originally developed for treatment of cardiovascular conditions. However, the major difference is that Viagra’s repositioning for erectile dysfunction is an outcome triggered by its side-effects in patients taking the drug for its original cardiovascular disease treatment.

B. Desk research and discovery:

The primary desk research can start from the freely available enormous published genetic data, based on thousands of studies on humans, mice and other animals. The publications’ websites are also highly credible, such as, National Institute of Health and the European Molecular Biology Laboratory. Thus, as a result of abundantly available high quality genetic data, the cost of genetic sequencing, using gene chip technologies, is also coming down quite rapidly.

C. Animal testing:

After the potential drug discovery in the garage, there is a need to test the drugs on animals.

As Professor Butte suggests, this process also can be made much less expensive. For this purpose, he recommends the internet and the websites, such as, Assay Depot. This site is structured like Amazon, from which a researcher can order an experiment to be carried out to test a drug on a range of animal models, as the report states.

Butte finds this Internet based process very useful for ‘choosing the experiment type the researcher wants, adding it to a shopping cart, paying by credit card and getting the experimental results mailed back in a few weeks’ time.’ Such websites also offer wide choices to the researchers, even regarding the laboratory they would like to use, including the country where the laboratory is located.

D. Human Trial:

As ‘The Conversation’ article indicates, once a new use for a drug has been shown to work in an animal model, the next step would be to test the drug on human volunteers, get approval for the use of the drug for that condition, and then finally take the drug to market.

This purpose could involve spinning out startups with money from investors. In California, Professor Butte and his students have already followed this process after discovery of new uses for several drugs.

As Professor Butte epitomizes, none of this would be possible without sharing data. The ‘Frugal innovation’ models also highlight, how the growth of availability of open research data will be able to discover a range of uses, that would not have been foreseen, when the individual experiments were being carried out.

Would Big Pharma gobble up these startups?

If ‘Big Pharma’ starts gobbling up these startups paying exorbitant prices, the expectations of lower prices of novel drugs may possibly not come to fruition. Nevertheless, the facade of innovation for high drug prices would crumble. But, surely some other different and well-orchestrated pretext would surface, to maintain their stubbornness to continue with the same business model of very high margin and lesser volume sales, with cash register ringing, as ever.

Here is an example. ‘The Huffington Post’, in an article of May 10, 2016, reported on Big Pharma’s betting on a cancer drug startup.

The May 2016 article said, the pharmaceutical giant AbbVie acquired a startup named ‘Stemcentrx’ in a deal that values it at as high as US$10 billion.

The startup Stemcentrx has found out a unique approach, though somewhat controversial, for treating several forms of cancer. While most of today’s treatments view cancer as a result of unchecked cell growth, wherein any cell is capable of becoming cancerous, Stemcentrx believes that cancer primarily sprouts from only one cell type: cancer stem cells.

Conclusion:

Be that as it may, hopefully, the evolving models of ‘Frugal innovation’, development and commercialization of high-tech drugs, are expected to be the game changer for quickly bringing a number of new drugs, or existing drugs for new indications to the market, for many disease conditions, at very affordable cost.

Big Pharma may not allow it happen so easily, just for vested interest, but the pressure group must keep a close vigil on this development, and more importantly, must prevail.

Thus, the next frontier of pharma research and development, would possibly shift to small startups of ‘Frugal Innovation’, especially for affordable high-tech drugs, extending their access to the majority of the patients, the world over.

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.

Arbitrary Pricing of Essential Drugs Invites State Intervention

Posted on May 23, 2016 by Tapan Ray

Arbitrary drug pricing has now become a subject of a raging debate, all over the globe. It involves both patented and generic drugs, as we have recently witnessed in the largest pharma market in the world – the United States.

In many countries the same issue is inviting the direct intervention of the Government to protect health interest of a vast majority of the populations. India, I reckon, belongs to this group of countries.

In this article, I shall discuss this issue, citing examples from both the global and local recent developments.

Most high drug price increases defy logic:

Published in March 2016, the ‘Express Scripts 2015 Drug Trend Report’ points out, in the perspective of the United States, that over the last 30 years more and more dollars are spent on specialty, rather than on traditional medications.

Most drug development and spend in the late ‘80s and early ‘90s, used to be on traditional, mostly small-molecule oral solid drugs, used to treat conditions, such as, peptic ulcer, depression, hypertension and diabetes. Today, 37.7 percent of drug spends go for specialty medications, with the number expected to increase to 50 percent by 2018, and continue to grow further, thereafter.

The report also states that there are 7,000 potential drugs in development, with most aimed at treating the high-use categories of oncology, neurologic disorders and infectious diseases.

High-cost therapies for non-orphan conditions, particularly for cancer, high cholesterol and Alzheimer’s disease, will continue to increase the population of patients with high annual drug expenditures.

‘Express Scripts Exclusive Prescription Price Index’ reveals a brand-price inflation in the United States, nearly doubled between 2011 and 2015, with the greatest impact seen in more recent years. Compared to 2014, brand prices in 2015 were 16 percent higher. Brand medications have increased in price by 164 percent between 2008 and 2015, the report highlighted.

Similar trend, though may not be of similar magnitude and proportion, has commenced in India too. In this emerging situation, the patients with high ‘out of pocket’ expenditure on medicines have started feeling the pinch too. This is becoming more intense as the disease pattern has started shifting from short-term infectious and parasitic diseases to almost lifelong non-infectious chronic ailments.

The pressure started building up:

The drug industry is likely to come under increasing scrutiny on product pricing, to alleviate the ‘pressure cooker’ situation for the patients, in general, especially during chronic and life-threatening disease conditions.

May 10, 2016 issue of ‘Bloomberg’, in an article titled, “Mutual Fund Industry to Drug makers: Stand Up and Defend Yourself”, reported: “In a sign of how U.S. political pressure to rein in drug pricing is weighing on pharmaceutical companies and their investors, a group of major funds called an unusual meeting with top biotech and pharma lobbyists, urging them to do a better job defending their industry.” This is indeed unusual, and I reckon, should happen in India too.

The article also states: “Investors are stepping up pressure on pharma lobbyists at a critical time for the industry, as drug pricing has become a potent political issue on the presidential campaign trail and in Congress. Democratic candidate Hillary Clinton sent biotech stocks tumbling last year when she first talked about ‘price gouging,’ and Donald Trump has suggested that Medicare should negotiate with manufacturers.”

It also reported that responding to this emerging pressure situation, the global pharmaceutical lobbying organizations, such as, PhRMA in the Washington, DC has already set up a dedicated webpage called “Costs in Context” with infographics and fact sheets. It has also tried to peg responsibility on insurance companies for making it hard for patients to access medicines.

Patients’ can no longer be taken for granted:

That patients’ can no longer be taken for granted with costly drugs, backed by high profile marketing campaigns, is evident from a recent study.

In May 2016, Harvard T.H. Chan School of Public Health, published a poll result on “Americans’ Attitudes About Changing Current Prescription Drug & Medical Device Regulation”.

Among many other related issues, the study reflected that around 57 percent of the poll participants believe that pharmaceutical companies should no longer be allowed to advertise prescription drugs on television. This is because of interesting reasons. The respondents believe that ads for prescription medicines sometimes encourage and persuade the patients to ask for costlier drugs that may not be appropriate for them.

In this context, it is worth recapitulating that on November 17, 2015 the American Medical Association (AMA) also called for a ban on direct-to-consumer advertising of prescription drugs and medical devices, including television advertisements.

According to a statement released by the group, “member physicians are concerned about a growing proliferation of ads driving demand for expensive treatments, despite the clinical effectiveness of less costly alternatives.”

Hence, the bottom-line is, even the American patients, most of whom are covered by health insurance of different kinds, are now feeling the bite of increasing medicine prices.

Many patients seem to be realizing that such unfair price increases, driven by the respective pharma manufacturers, are avoidable. This serious concern may assume a snowballing effect, notwithstanding high voltage lobbying and campaigns to negate these general stakeholders’ feelings by the top global pharma lobbying organizations, across the world, India included.

Premium pricing of MNCs’ branded generics arbitrary?

One gets its reflection even in the Indian branded generic market, where the MNCs usually market their generic single molecule or FDC brands at a huge premium price. Such high priced products are backed by intense marketing of all kinds. The MNCs’ justification of charging a high premium stand on the promise of adherence to world-class drug quality standards, unlike many domestic generic manufacturers.

There are not enough evidences either to accept or ignore this claim. However, it has received a big jolt even recently, raising similar suspicion as I briefly raised in my article titled, “Ease of Doing Pharma Business in India: A Kaleidoscopic View”, published in this blog on March 28, 2016.

On May 12, 2016 Reuters reported that Central Drugs Standard Control Organization (CDSCO) of India, in the notices posted on its website in February and also in April, has made it public that it has found some batches of Sanofi’s ‘Combiflam’ (FDC of paracetamol and ibuprofen) to be “not of standard quality”, as they failed disintegration tests.

According to the US-FDA, this particular test is used as an integral part of quality-assurance measure in pharmaceuticals, and its non-conformance makes the drug ‘sub-standard’.

Hence, huge premium charged for all those branded generics, which are outside DPCO, and mostly by the MNCs, may be construed by many as baseless and arbitrary.

Premium pricing, with payment to doctors is a winner?

This has again been vindicated in a recent study.

A paper, published in the May 09, 2016 issue of JAMA Internal Medicine, establishes that: ‘Pharmaceutical industry payments to physicians may affect prescribing practices and increase costs, if more expensive medications are prescribed.’

Although no such credible study has been published in the Indian context, it is widely believed, the prevailing situation in this regard, within the country, is no different. Nevertheless, arbitrarily high drug pricing, even for the branded generics, is considered as a winning strategy by many pharma companies.

When the Government steps in:

It happened in India recently, yet again.

As we know, the ‘National List of Essential Medicines 2011 (NLEM 2011)’ came under intense public criticism, as it did not include many modern drugs for chronic and lifesaving diseases under its fold, for inclusion in the drug price control order of the Government.

The Experts Committee formed for this purpose recommended addition of a number of drugs for a variety of serious diseases, such as, cancer, hepatitis C, diabetes, cardiovascular, and HIV in the NLEM, to make them more affordable to patients.

Acting on this proposal, the Union Ministry of Health replaced the NLEM 2011 by NLEM 2015 in December 2015. This increased the span of drug price control from 684 to 875 medicines.

According to the well-reputed pharma market research organization – AIOCD Pharmasofttech AWACS Pvt Ltd., with NLEM 2015, still only 18 percent of Indian Pharmaceutical Market (IPM) by value will now come under price control, against 17 percent with NLEM 2011.

On May 12, 2016 the ‘National Pharmaceutical Pricing Authority (NPPA)’ started with revising prices of 54 recently included essential medicines in the NLEM 2015, in some cases bringing them down up to 55 percent, in conformance with the DPCO. Again on May 19, 2016 another set of 27 formulations, which, among others, include the treatment for epilepsy, infections and diabetes, were brought under price control.

Does ‘free market economy’ work in pharma industry?

As the NPPA has articulated a number of times, with umpteen number of examples, that arbitrary and wide variation in pricing for the same kind of branded generics is a result of ‘market failure’.

We all are living in a unique situation, where the consumers are unable to participate in the process of an affordable drug selection, much unlike any other consumer goods in a ‘free economy’.

I deliberated this issue in my article titled, “Does ‘Free-Market Economy’ Work For Branded Generic Drugs In India?”, published in this Blog on April 27, 2015.

Conclusion:

Arbitrary drug pricing is increasingly attracting the ire of many Governments, other payers, patients and even some important investors, as we have seen in the United States. Most Indian fund houses and other investors are probably taking stock of the possible emerging situation. A large number of them are, by and large, going by the same old and traditional way of evaluating a pharma business.

Pharma companies, across the world, instead of trying to find out an innovative way to douse this fire for the benefit of all concerned, are getting more and more desperate to rationalize their arbitrary drug pricing, in whatever way they possibly can.

The approach taken by them is convincing none, instead, adding further fuel to the fire. Getting favorable views from some handful of seemingly spoon-fed write-ups, would possibly not help resolve this raging issue or protect public health interest, in any way.

All concerned should try to realize that a utopian ‘free market economy for medicines’, with patients exercising their informed choices, backed by active support from the treating doctor, does not exist in the real world, not just yet.

Thus, arbitrary pricing for essential drugs, where market competition is made irrelevant by many drug makers, allegedly by unethically influencing the prescribers in various ways, merits state intervention, unquestionably, solely to protect patients’ health interest.

By: Tapan J. Ray

Pharma R&D: Chasing A Rainbow To Replicate The Past

Posted on January 25, 2016 by Tapan Ray

Would future be always a replica of the past?

If the response is yes, the efforts of many global pharma players to replicate the successful Research and Development (R&D) models of long gone by days, would continue to be a grand success. The new drug pipeline would remain rich and sustainable. R&D costs would be increasingly more productive, with the rapid and more frequent churning out of blockbuster drugs, in various therapy areas.

However, an affirmative response to this question, if any, has to be necessarily supported by relevant credible data from independent sources.

Additionally, yet another equally critical query would surface. Why then the prices of newer innovative drugs have started going through the roof, with the rapid escalation of R&D expenses?

Thus, there is a need to ponder whether the continued hard effort by many large innovator companies in this direction is yielding the desired results or not.

In this article, I shall try to dwell on this issue with the most recent data available with us.

A new research report:

A new research report of the Deloitte Center for Health Solutions titled, “Measuring the return from pharmaceutical innovation 2015: Transforming R&D returns in uncertain times” states that the R&D returns of major life sciences industry groups have fallen to their lowest point in 2015, since 2010. The report tracked and reviewed the estimated returns of 12 leading global life sciences companies.

Some of the data presented in this report would give an idea about the magnitude of current challenges in this space. Nevertheless, there could be a few rare and sporadic green shoots, which can also be cited to claim a revival in this area.

I am quoting below some key pharma R&D trends, for the period starting from 2010 to 2015, as illustrated in the Deloitte report:

A. Declining R&D productivity:

Year	R&D return (%)
2010	10.1
2011	7.6
2012	7.3
2013	4.8
2014	5.5
2015	4.2

B. Increasing drug development cost with decreasing estimated sales:

During 2010 to 2015 period, the average peak sales estimate per drug has fallen by 50 percent from US$ 816 million to US$416 million per year, while the development costs per drug, during the same period increased by 33 percent, from US$ 1.188 billion to US$ 1.576 billion.

C. Smaller Companies showing better R&D productivity:

Between 2013-2015, relatively smaller companies showed better R&D productivity as follows:

Big companies: 5 percent
Mid to large cap companies: 17 percent

D. External innovation becoming increasingly more important:

Again, mid to large cap companies opting for more external innovation are showing a higher proportion of late stage pipeline value, as below:

Big companies: 54 percent
Mid to large cap companies: 79 percent

A fear of failure?

The Deloitte report throws some light on the general stakeholders’ concerns about the exorbitantly high price fixation for innovative new drugs by the concerned companies, together with consequential macroeconomic pressures.

One of the key suggestions made in this report, is to increase the focus on reduction of R&D costs, while accelerating the new drug development timelines. I shall broach upon this point briefly just in a short while.

However, the stark reality today, the hard efforts still being made by many large global drug companies to almost replicate the old paradigm of highly productive pharma R&D, though with some tweaking here or there, are not yielding expected results. The return on R&D investments is sharply going south, as the new drug prices rocketing towards north.

Is it happening due to a paralyzing fear of failure, that moving out of the known and the traditional sphere of the new drug discovery models could impact the stock markets adversely, making the concerned CEOs operational environment too hot to bear?

Be that as it may, without venturing into the uncharted frontiers of the new drug discovery models, would it at all be possible to bring out such drugs at a reasonable affordable price to the patients, ever?

I have deliberated before, in this blog, some of the possible eclectic ways in this area, including in one of my very recent articles on January 4, 2016 titled, “2015: Pharma Industry Achieved Some, Could Achieve Some More”.

New innovative drugs evaluated over priced:

Here, I would not quote the prices of Sovaldi and its ilk, which are known to many. I intend to give examples of just two other new drugs that have triggered significant interest as potential advances for the care of patients in two common disease areas, namely, asthma and diabetes. These two drugs are GlaxoSmithKline’s Nucala® (Mepolizumab) for Asthma and Novo Nordisk’s Tresiba® (Insulin Degludec) for Diabetes.

According a December 21, 2015 report of the ‘Institute for Clinical and Economic Review (ICER)’ of the United States:

“The annual price of mepolizumab would need to be discounted 63-76% to be better aligned with value to patients and the health system, while insulin degludec would need to be discounted less than 10% to do so.”

Thus, there has been a growing mismatch between the value that new innovative drugs, in general, offers to the patients and the price that the innovator companies fix for such drugs. This trend, if continues, would significantly limit patients’ access to new drugs, as the pharma players keep chasing disproportionately high profitability to increase their shareholder value.

External sourcing of R&D may not make new drugs affordable:

Taking a cue from the highly successful strategy of Gilead, especially what it has done with Sovaldi and Harvoni, if other major global pharma players’ also try to enrich their late stage new drug molecule pipeline from external sources, would that effectively resolve the core issue?

In my view, this could possibly be one of the ways to contain R&D expenses and with much lesser risk, as suggested in the Deloitte report. However, I doubt, whether the same would effectively help bringing down the prices of newer innovative drugs, in tandem.

This is primarily because of the following contemporary example, that we now have with us.

Although the active compound that is used to manufacture Sovaldi, or for that matter even Harvoni, is not Gilead’s in-house discovery, the prices of these drugs have already gone through the roof.

It is altogether a different matter that robust patent laws along with the Government vigilance on obnoxious drug pricing is gradually increasing in various countries. Some developed and developing markets of the world, including the Unites States and the United Kingdom, either already have or are now mulling for an effective counter check to irresponsible drug pricing, primarily by putting the ‘innovation’ bogey right at the very front.

In India, prompted by its robust patent law and to avoid any possibility of Compulsory Licensing (CL), Gilead ultimately decided to give Voluntary Licenses (CL) for Sovaldi to several Indian drug companies. These pharma players will manufacture the drug in India and market it in the country at a much lesser price.

A new cooperative effort for cancer drugs:

On January 11 2016, ‘The New York Times’ reported the formation of ‘National Immunotherapy Coalition (NIC)’. This is a cooperative effort by some leading global pharma companies to speed up the testing of new types of cancer drugs that harness the body’s immune system to battle tumors. The NIC will try to rapidly test various combinations of such drugs.

This is important, as many researchers believe that combinations of two or more drugs that engage different parts of the immune system might be effective for more patients than a single drug.

On the face of it, this initiative appears to be a step in the right direction and could make the cancer drugs more affordable to patients. However, only future will tell us whether it happens that way or not.

Conclusion:

Nevertheless, the bottom line is, to make the new innovative drugs available at an affordable price to patients, along with strict vigilance by the government bodies, the old and a traditional ball game of drug discovery has to change.

This would necessarily require fresh eyes, inquiring minds and high IQ brains that can bring forth at least significant eclectic changes, if not a disruptive innovation, in the new drug discovery and development process, across the world.

Otherwise, and especially when the low-hanging fruits of drug discovery have already been plucked, if the major global pharma players continue striving to replicate the grand old path of new drug discovery, the efforts could very likely be, and quite akin to, chasing a rainbow.

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

Tag Archives: Medicines

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

Drug Price Control in India: When A Local Media Goes Against, A Global CEO Doesn’t

Counterfeit Drugs In India: A Malady Much Deeper

What Happens To Pharma’s Incredible Ride On The ‘Gravy Train’?

Leveraging 3D Printing In Pharma, For Cost Containment And Patient-Centricity

The Next Frontier: Frugal Innovation For High-Tech Drugs

Arbitrary Pricing of Essential Drugs Invites State Intervention

Pharma R&D: Chasing A Rainbow To Replicate The Past