Biosimilar Drugs: First Indian Foot Print In An Uncharted Frontier

Posted on April 4, 2016 by Tapan Ray

A homegrown Indian biologic manufacturer is now about to leave behind its first foot-print, with a ‘made in India’ biosimilar drug, in one of the largest pharma market of the world. This was indeed an uncharted frontier, and a dream to realize for any Indian bio-pharma player.

On March 28, 2016, by a Press Release, Bengaluru based Biocon Ltd., one of the premier biopharmaceutical companies in India, announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved its biosimilar Insulin Glargine in a prefilled disposable pen. The product is a biosimilar version of Sanofi’s blockbuster insulin brand – ‘Lantus’.

The Company claims that Glargine is a high quality, yet an affordable priced product, as it will reportedly cost around 25 percent less than the original biologic brand – Lantus. This ‘made in India’ biosimilar product is expected to be launched in Japan in the Q1 of 2017. Incidentally, Japan is the second largest Glargine market in the world with a value of US$ 144 Million. Biocon will co-market this product with its partner Fujifilm.

Would it be a free run?

Although it is a very significant and well-deserved achievement of Biocon, but its entry with this biosimilar drug in Japan’s Lantus market, nevertheless, does not seem to be free from tough competition. This is because, in 2015, both Lilly and Boehringer Ingelheim also obtained Japanese regulatory approval for their respective biosimilar versions of Lantus. In the same year, both these companies also gained regulatory approval from the US-FDA, and the European Medicine Agency (EMA) for their respective products.

Moreover, Sanofi’s longer acting version of Lantus – Lantus XR, or Toujeo, to treat both Type 1 and Type 2 diabetes, has already been approved in Japan, which needs to be injected less, expectedly making it more convenient to patients.

Key barriers to a biosimilar drug's success:

Such barriers, as I shall briefly outline below, help sustaining monopoly of the original biologic even after patent expiry, discourage investments in innovation in search of biosimilars, and adversely impacts access to effective and much less expensive follow-on-biologics to save patients’ precious lives.

These barriers can be broadly divided in two categories:

A. Regulatory barriers:

1. Varying non-proprietary names:

A large number of biosimilar drug manufacturers, including insurers and large pharmacy chains believe, just as various global studies have also indicated that varying non-proprietary names for biosimilars, quite different from the original biologic, as required by the drug regulators in the world’s most regulated pharma markets, such as, the United States, Europe, Japan, and Australia, restrict competition in the market for the original biologic brands.

However, the innovator companies for biologic drugs hold quite different views. For example, Roche (Genentech), a developer of original biologic, reportedly explained that “distinguishable non-proprietary names are in the best interest of patient safety, because they facilitate Pharmacovigilance, and mitigate inadvertent product substitution.”

Even, many other global companies that develop both original biologic and also biosimilar products such as, Amgen, Pfizer and others, also reportedly support the use of ‘distinguishable nonproprietary names’.

That said, the Biosimilars Council of the Generic Pharmaceutical Association argues that consistent non-proprietary naming will ensure robust market formation that ultimately supports patient access, affordability, Pharmacovigilance systems currently in place and allow for unambiguous prescribing,

2. Substitution or interchangeable with original biologics:

Besides different ‘non-proprietary names’, but arising primarily out of this issue, automatic substitution or interchangeability is not permitted for biosimilar drugs by the drug regulators in the major pharma markets of the world, such as, the United States, Europe and Japan.

The key argument in favor of interchangeability barrier for biosimilar drugs is the fact that the biological drugs, being large protein molecules, can never be exactly replicated. Hence, automatic substitution of original biologic with biosimilar drugs does not arise. This is mainly due to the safety concern that interchangeability between the biosimilars and the original biologic may increase immunogenicity, giving rise to adverse drug reactions. Hence, it would be risky to allow interchangeability of biosimilar drugs, without generating relevant clinical trial data.

On the other hand, the Generic Pharmaceutical Association (GPhA) and the Biosimilars Council, vehemently argue that a biosimilar drug has a lot many other unique identifying characteristics “including a brand name, company name, a lot number and a National Drug Code (NDC) number that would readily distinguish it from other products that share the same nonproprietary name.”

Further, the interchangeable status for biosimilar drugs would also help its manufacturers to tide over the initial apprehensions on safety and quality of biosimilar drugs, as compared to the original ones.

3. 12-year Data Exclusivity period for biologics in the United states:

Currently, the new law for biologic products in the United States provides 12 years of data exclusivity for a new biologic. This is five years more than what is granted to small molecule drugs.

Many experts believe that this system would further delay the entry of cost-effective biosimilar drugs, restrict the biosimilar drug manufacturers from relying on the test data submitted to drug regulator by the manufacturers of the original biologic drugs while seeking marketing approval.

A rapidly evolving scenario in the United States:

The regulatory space for approval of biosimilar drugs is still evolving in the Unites States. This is vindicated by the fact that in March 2016, giving a somewhat positive signal to the biosimilar drug manufacturers, the US-FDA released another set of a 15-page draft guidelines on how biosimilar products should be labeled for the US market. Interestingly, it has come just around a year of the first biosimilar drug approval in the United States – Zarxio (filgrastim-sndz) of Novartis.

The US-FDA announcement says that all ‘comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.’ Besides labeling issues, this draft guidance document, though indicates that the ‘interchangeability’ criteria will be addressed in the future, does not still throw enough light on how exactly to determine ‘interchangeability’ for biosimilar drugs.

That said, these key regulatory barriers are likely to continue, at least in the foreseeable future, for many reasons. The biosimilar drug manufacturers, therefore, would necessarily have to work within the set regulations, as applicable to different markets of the world.

I deliberated a related point in my article of August 25, 2014, titled “Scandalizing Biosimilar Drugs With Safety Concerns”

B. Prescribers’ skepticism:

Initial skepticism of the medical profession for biosimilar drugs are, reportedly, due to the high voltage advocacy of the original biologic manufacturers on the ‘documented variability between original biologic and biosimilars. Which is why, any substitution of an original biologic with a related biosimilar drug could lead to increase in avoidable adverse reactions.

‘The medical platform and community QuantiaMD’, released a study just around September 2015, when by a Press Release, Novartis announced the launch of the first biosimilar approved by the US-FDA – Zarxio(TM) (filgrastim-sndz). However, in 2006, Novartis after suing the US-FDA, got the approval for its human growth hormone – Omnitrope, which is a biosimilar of the original biologic of Genentech and Pfizer. At that time a clear regulatory guideline for biosimilar drugs in the United States, was not in place.

The QuantiaMD report at that time said, “Only 12% of prescribing specialists are ‘very confident’ that biosimilars are as safe as the original biologic version of the drug. In addition, a mere 17% said they were ‘very likely’ to prescribe a biosimilar, while 70% admitted they were not sure if they would.”

Since then, this scenario for biosimilar drugs is changing though gradually, but encouragingly. I shall dwell on that below.

The major growth drivers:

The major growth drivers for biosimilars, especially, in the world’s top pharmaceutical markets are expected to be:

Growing pressure to curtail healthcare expenditure
Growing demand for biosimilar drugs due to their cost-effectiveness
Rising incidences of various life-threatening diseases
Increasing number of off-patent biologics
Positive outcome in the ongoing clinical trials
Rising demand for biosimilars in different therapeutic applications, such as, rheumatoid arthritis and blood disorders.

This in turn would probably usher in an unprecedented opportunity for the manufacturers of high quality biosimilar drugs, including in India.

Unfolding a huge emerging opportunity with biosimilars:

This unprecedented opportunity is expected to come mainly from the world’s three largest pharma market, namely the United States, Europe and Japan, due to very high prices of original biologic drugs, and simultaneously to contain rapidly escalating healthcare expenditure by the respective Governments.

Unlike in the past, when the doctors were apprehensive, and a bit skeptic too, on the use of new biosimilars, some new studies of 2016 indicate a rapid change in that trend. After the launch of the first biosimilar drug in the US, coupled with rapidly increasing incidences of various complex, life-threatening diseases, better knowledge of biosimilar drugs and their cost-effectiveness, doctors are now expressing much lesser concern, and exhibiting greater confidence in the use of biosimilars in their clinical practice.

Yet another, March 2016 study indicates, now only 19.5 percent of respondents feel little or no confidence in the use of biosimilar monoclonal antibodies compared to 61percent of respondents to a previous version of the survey undertaken in 2013 by the same market research group. The survey also shows that 44.4 percent of respondents consider that the original biologic and its biosimilar versions are interchangeable, as compared with only 6 percent in the 2013 survey.

As a result of this emerging trend, some global analysts of high credibility estimate that innovative biologic brands will lose around US$110 billion in sales to their biosimilar versions by 2025.

Another March, 2016 report of IMS Institute for Healthcare Informatics states that lower-cost biosimilar versions of complex biologic, could save the US and Europe’s five top markets as much as US$112 billion by 2020,

These encouraging developments in the global biosimilar arena are expected to encourage the capable Indian biosimilar drug players to invest in this high-tech format of drug development, and reap a rich harvest as the high priced blockbuster biologic brands go off-patent.

Conclusion:

Putting all these developments together, and considering the rapidly emerging scenario in this space, it now appears that challenges ahead for rapid acceptance of biosimilar drugs though are still many, but not insurmountable, at all.

The situation necessitates application of fresh and innovative marketing strategies to gain doctors’ confidence on biosimilar medicines, in total conformance with the regulatory requirements for the same, as they are, in the most important regulated markets of the world.

It goes without saying that success in the generation of enough prescriptions for biosimilar drugs is the fundamental requirement to benefit the patients, which, in turn, would lead to significant savings in health care cost, as estimated above, creating a win-win situation for all, in every way.

As more innovator companies start joining the biosimilar bandwagon, the physicians’ perception on these new varieties of medicines, hopefully, would also change, sooner.

Biocon’s grand announcement of its entry with a ‘made in India’ biosimilar drug in one of the word’s top three pharma markets, would probably be a great encouragement for all other Indian biosimilar drug manufacturers. It clearly showcases the capabilities of an Indian drug manufacturer to chart in an uncharted and a highly complex frontier of medicine.

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.

Ease of Doing Pharma Business in India: A Kaleidoscopic View

Posted on March 28, 2016 by Tapan Ray

Ensuring ease of doing any ethical business activity in India, is a new focus area of the Government and is very rightly so. Creating ease of doing ethical pharma business too, falls under this overall national objective.

In this article, restricting myself to the drug sector, I shall deliberate on various aspects, which are now being considered by the pharma industry, related to the ‘ease of doing pharma business in India’. My discussion would cover all subsets of pharma players, irrespective of whether they fall under Multinational (MNC) or purely homegrown Indian companies, with different scales of operations – large, medium, small, or micro.

To help the Government facilitating the ‘‘ease of doing pharma business in India’, it is just not enough to make the business models for all subsets of the Indian pharma sector looking ethical, conforming to all relevant laws, policies, rules and norms. Each pharma player need also to maintain an ongoing strict internal vigil, religiously, to ensure that the requirements of high quality clinical development, manufacturing and selling practices for effective, safe and rational medicines, are properly understood and strictly followed by all the employees within the organization.

A Kaleidoscopic View:

The above situation is something that ought to happen, as the Government keeps striving to improve the ‘ease of doing pharma business’ in India. However, while looking through a Kaleidoscope, as it were, the colors of industry expectations in this area keep changing rapidly, as the new contentious issues keep emerging. Consequently, the ground reality of assessing the same, by a large section of the pharma players in India, seems to veer only around different types of just self-serving demands, expecting those to act as a powerful tailwind pushing their business interests rapidly forward.

Such expectations keep surfacing, rather frequently, from all the subsets of the pharma industry, be they MNCs and their trade associations or the Companies of purely Indian origin and their trade bodies. The accusation to the Government pertaining to all these issues, is a common one: ‘Where is the ease of doing pharma business in India?’

Citing even some recent incidents, they are voicing with equal gusto, that the root causes of all these problems lie miles outside the pharma industry. The causative factor, they indicate, is rooted at the very doorsteps of the Government, as its ministries initiate tough action to root out corruption in the pharma industry as concurrent measures, disturbing their business comfort zones, and upsetting the apple carts.

The Government has its task cut out:

I hasten to add that I have no intention to paint it as a confrontation between the Government and the pharma industry, in any way. The Government is also facing the brunt from the various stakeholders, relentlessly, for its utter negligence of public health care, and public expenditure over it.

The impact of this Government indifference, though also comes on the patients, the industry does not seem to have much to crib over it as a direct impediment to the ‘ease of doing pharma business’ in India.

Probably as a diversionary tactic, the industry keeps using this critical Government inaction in the hope of diverting the public, or media attention from its own alleged business malpractices, even at a time when these are being covered both by the national and international media, regularly. Nevertheless, the industry credibility on these issues, seems to have started waning fast, as the genie is out of the bottle.

A common punching bag of all industry dissatisfaction on the Government:

It is worth noting that despite some key differences between the MNC and Indian pharma companies, which I shall discuss later, the common punching bag of the industry dissatisfaction on various Government decisions, always has been the lack of ‘ease of doing pharma business’ in the country.

This discontentment may be well justified. I have no qualms about it. However, when this dissatisfaction gets tagged with some recent Government action, taken to protect public health interests and does not have much to do with the ‘ease of doing ethical pharma business’, many eyebrows are obviously raised.

Against some of these critical patient-centric actions, the industry continues to express its annoyance in unison, while for some other Government decisions, it speaks in different voices – some are happy ones, and the others are not so. However, the common thread of expression of all such dissatisfactions is always linked with the lack of ‘ease of doing business’ in India.

A. Where the pharma Industry in India speaks in unison:

I shall now give two major examples of the key Government decisions, that have irked the entire pharma industry immensely, and makes it voicing that those Government actions grossly violate the fundamental requirements of its smooth running of business. Is that fair? Let me analyze that below with these two examples:

1. Drug price control:

The industry, by and large, opines that individual drug company should be allowed to decide the way it would price any drug, as the market forces, especially for generic drugs, would determine its price.

Indian Parliament, the Supreme Court of India, the Government in power at different times, most of the independent experts and the NGOs, on the contrary, consider drug price control is necessary in India, especially for essential drugs. It makes high quality essential medicines affordable and accessible to the general population.

National Pharmaceutical Pricing Authority (NPPA) has also announced and explained that the competition does not work on controlling prices for pharma products, where the consumers are not the decision makers. The key prescribing decision makers for the patients are the doctors, who are mostly and unethically influenced by the drug companies having vested interest in making such decisions. This unholy nexus has been widely alleged globally, and also established through umpteen number of studies of high credibility.

Nevertheless, the doctors, from across the globe, including in India, have long disputed that any payments, if and when they receive from pharmaceutical companies, have no relationship to how they prescribe drugs.

A March 17, 2016 study of ProPublica has conclusively established that: “The more money doctors receive from drug and medical device companies, the more brand-name drugs they tend to prescribe. Even a meal can make a difference.” This study may be in the context of the Unites States, but India in this in this regard is no exception, as captured even in the parliamentary Committee reports.

Thus, conceding to high voltage pharma advocacy, made on the pretext of ‘encouraging innovation’ and ‘ease of doing business in India’, if any Government contemplates the abolition of drug price control in India is, it would make not just essential drugs inaccessible to a large section of society, but encourage blatant corrupt practices. This caution has come, besides many others, also from a Parliamentary Committee report, unambiguously. Incidentally, the present Government too strongly speaks against corruption, in any form.

Thus, I reckon, if the industry believes that the price control of essential drugs, which are for public health interest, goes against ease of doing pharma business in India, so be it.

2. Manufacturing and selling of irrational FDCs:

A Fixed Dose Combination (FDC) drug may appear irrational to drug regulators and well-qualified experts, after necessary scientific scrutiny, for various reasons. This may happen, primarily because of the following reasons:

When the medical rationale of the FDC along with the ingredient details, submitted to the regulatory authority for marketing approval, are considered scientifically inappropriate.

When the evolving medical science establishes the irrationality of the FDC after a period of time.

When the analysis of ‘Adverse Drug Event’ reports from the ongoing Pharmacovigilance studies signals a red alert.

Widespread uncontrolled misuse or abuse of FDCs, where the consumers’ health risks far outweigh the drug benefits, as provided in the drugs Act, for public health interest.

Some regulatory loopholes were misused by the drug manufacturers in the past to get the irrational FDCs approved by the State Drug Authorities, violating the new FDC regulatory approval Policy.

Any irrational FDC so identified by the drug regulators and experts, by putting a system of scrutiny in place, must be banned forthwith, in public health interest. There should not be any scope of negotiation with drug manufacturer to make the bans effective.

Incidentally, realizing the gravity of public health risks posed by irrational FDCs, even the NPPA has reportedly decided to review afresh all new applications for price fixations of FDC and examine their safety and efficacy profile.

Moving towards this direction, the NPPA Chairman, has reportedly sent back more than 200 applications for price fixation of FDCs, instructing the concerned manufacturing and marketing companies to apply again with a declaration that their formulations are not “irrational.” It was also reported that the price regulator has also brought under the lens third-party drug makers and pharma companies that outsource to them, to check illegal sales of irrational FDCs and spurious drugs.

Two key questions being raised now:

Despite all these, the industry keeps repeating, especially, the following two questions, which are worth looking at, one by one:

1. Why is the ban now?

I discussed the issue of FDC ban in my previous article in this Blog on March 21, 2016 titled, “The Recent Ban On Irrational FDCs: History Repeats Itself”.

In the above article, I also argued that large section of the industry and its associations are protesting against the Government ban of 344 irrational FDCs, and questioning vigorously, even outside the Delhi High Court – ‘why is the ban now?’

The point ‘why now’ is absolutely irrelevant, as not taking any action ever, against a wrong doing ignored over a long period time for whatever reasons, does not confer any regulatory legitimacy to an irrational FDC formulation to be considered as a rational one for all time to come, and thereby, exposing patients to serious health risks, knowingly.

2. Why is this ban so sudden, and in some cases after decades?

Sudden banning of drugs, which are in the market for a long time, is not a recent Indian phenomenon in India. In 2011, according to a report, in the world’s largest pharma market – the United States, the FDA banned 500 prescription drugs that had been on the market and working for decades. USFDA ban also happened suddenly, and that includes cough syrups too. Thus, it is intriguing, why is this fuss created by the Industry in India now?

In the midst of it, one odd, knee-jerk, apparently ‘spoon-fed’ and ill-informed editorial in some Indian business daily, raises more questions about its real intent, rather than help finding answers to the poorly sketched problems.

I would hope, the Government would stay firm and be able to convince the Delhi High Court today, i.e. on March 28, 2016, with its robust data-based arguments, accordingly.

Be that as it may, in my perspective, if the industry still believes that bans of irrational FDCs to protect public health interest, as decided by the independent experts after long and structured deliberations, would go against ‘ease of doing pharma business’ in India, so be it.

B. Where the pharma industry in India speaks in different voices:

As stated above, there are several other key areas, where the MNC and Indian Pharma players have sharp differences in their perspectives. Despite these differences, the aggrieved section does not even blink a bit to attribute those Government actions to the lack of ‘ease of doing pharma business’ in the country.

In this area, I shall give just the following three examples:

1. The Patents Act:

MNCs say that section 3 (d) of the Indian Patents Act 2005, which is aimed at curbing patent ever-greening or frivolous inventions, is against the ease of doing business in India. However, the Indian Pharma players, do not think so, at all. Similar disagreement also exists in other critical areas too, such as, ‘Data Exclusivity (DE)’ and ‘Compulsory Licensing (CL)’.

Thus, in my opinion, if some ‘public health interest’ related provisions of the robust Indian Intellectual Property (IP) Act, such as, section 3 (d), DE and CL, are considered as going against the ‘ease of doing pharma business in India’ by the MNCs, so be it.

2. Mandatory Uniform Code of Pharma Marketing Practices (UCPMP):

Need to have a mandatory UCPMP, though, is reportedly supported by the MNCs, Indian pharma players do not seem to be quite in sync with this idea. I am not sure, whether the delay in the announcement of mandatory UCPMP, almost in every 3 months, has any coincidence with it or not. However, the reality is, no one still knows clearly, when would it definitely come, if at all.

Media reports on pharma MNC support to mandatory UCPMP, and repeated reiteration that its members in India rigidly follow the IFPMA Code of Marketing Practices, though commendable, seem to grossly lack in credibility.

Interestingly, despite the existence of this code and high-decibel vouch for its rigid conformance, maximum number of MNCs have been fined billions of dollars, by the Government in various countries, for alleged gross marketing and other business malpractices. It has been happening over a long period of time, and is being reported by the international media, frequently.

What is really happening, especially, on the so called total support of ethical marketing practices by the MNCs? Are they trying to create just good optics by craftily framing and supporting such showpiece codes, and blatantly defying these to achieve self-serving goals? The voice gets shriller, even when they are being levied hefty fines, after getting caught red handed, as reported by the global media? I guess, the future would ultimately unfold the reality. But would it, at all?

The Indian Scenario:

Even in India, such alleged marketing malpractices involving even a top pharma MNC have often been reported by the media. Just to illustrate, “Prescribe a drug maker’s medicine and get a free vacation”, reported a news article. There are several other similar reports too. Hence, the credibility of pharma MNC statements regarding strict conformance to ethical marketing codes, ably formulated by the well-known pharma trade associations, such as, IFPMA, appears to be very low, if exists at all.

The well-reputed medical Journal BMJ in one of its articles titled, “Corruption ruins the doctor-patient relationship in India”, published on May 8, 2014, expressed serious concern on this issue.

It concluded that corruption, kickbacks and the nexus between doctors and pharmaceutical firms are rampant India. This eventually prompted the BMJ, in June 2014, to launch a campaign reportedly called ‘Corruption in Medicine’.

On this issue, way back in May 08, 2012, even the Indian Parliamentary Standing Committee on Health and Family Welfare in its 58th Report, placed before the Parliament on May 08, 2012, expressed its serious concern.

Indian lawmakers, recommended in the report that the Department of Pharmaceuticals (DoP) should take decisive action, without further delay, in making the UCPMP mandatory, so that effective checks could be ensured on ‘huge promotional costs’ and the resultant add-on impact on medicine prices. Unfortunately, despite a change in the Government in 2014, UCPMP has still not been mandatory.

It is anybody’s guess, despite all these reports, what type of external pressure, if at all, the DoP is still facing to put in place a robust mandatory UCPMP with strong deterrent measures.

Under this backdrop, in my view, if mandatory UCPMP having enough teeth, to curb ongoing blatant marketing malpractices to protect patients’ health interest in India, is considered by any as going against the ‘ease of doing pharma business in India’, so be it.

3. Drug manufacturing quality:

Enough discussions have already been made on import ban of USFDA from over 45 drug manufacturing facilities of Indian Companies, of all sizes and scale of operations, on the ground of drug quality standards. USFDA considered drugs manufactured in those banned facilities are unsafe for the consumption of American patients. Some other foreign drug regulators, from the developed countries, have also taken similar action.

Taking advantage of this development, it was reported that attempts are indirectly being made to establish that MNC marketed generic drugs are superior to similar ones, manufactured even by the large Indian drug producers.

The fact, apparently, is quite different. MNCs operating in India has not come under the USFDA scanner in this regard as much, probably not because of their far superior drug manufacturing quality standards in India, as compared to even the best of their Indian counterparts. I reckon, it is mainly because, very few MNC drug manufacturing facilities in India export India manufactured drugs for consumption in the United States.

It may not, therefore, make any real sense to conclude that MNC marketed generic drugs in India, either manufactured my themselves or under loan & license or under a third party, are generally better in quality than the similar ones manufactured even by the large Indian manufacturers.

In any case, I feel that there is a huge scope for Indian drug regulators to ensure uniformly high drug quality standards. This is necessary for Indian patients’ health and safety. There also should be stringent regular quality audits in all drug manufacturing facilities in India, where non-conformance with prescribed standards would attract serious punitive measures. The Union Ministry of Health, together with the State Governments would require increasing the number of auditors accordingly.

However, the reality is, many Indian drug manufacturers have expressed that maintaining stricter drug manufacturing standards (cGMP) would involve huge expenditure, which they will not be able to afford. Consequently, this would go against the ‘ease of doing pharma business’ in India.

Again, in my view, if the stringent regulatory requirements for maintaining high drug manufacturing standards in India to protect public health interest, is considered as going against the ‘ease of doing pharma business’ in India, so be it.

Conclusion:

Improving ‘ease of doing pharma business’ in India is an absolute necessity, just as all other businesses. Pharma sector deserves it very badly too, as it has been experiencing excruciating delay in multiple regulatory clearances. Single window clearances of all applications, with a much greater sense of urgency, without bureaucratic red tapes and avoiding other unnecessary delays, is certainly the way forward for India. It would require urgent policy reforms, maintaining a right balance between, public, consumers and business interests.

Pharma sector is not all villain, either, by any yardstick. It is instrumental in saving and improving the quality of lives of so many people across the globe, since a very long time, with its both innovative and generic medicines. All must acknowledge it, and the Government does it too, openly, several times.

That said, the space of focus of the pharma industry appears to be getting increasingly narrowed down to more of its self-serving acts, and in their hard selling, through hugely expensive advocacy campaigns, even at the huge cost of attracting frequent self-defeating scathing criticisms, across the world.

At the same time, the Governments in different times hugely disappointed its citizens, in charting a clear road map for quality and affordable health care for all in India, along with appropriate budgetary allocations and policy reforms, and thereafter, in its implantation with military precision.

However, that doesn’t mean, in any way, while facilitating ‘ease of doing pharma business’ in India, the Government would turn a blind eye on the rapidly breeding corruption in the pharma business practices, and give in to unjustified industry muscle-flexing, sacrificing the health interest of its citizens in the country.

While looking through this Kaleidoscope, it appears to me, if the pharma sector considers the appropriate Government actions to protect public health interest, against the unacceptable industry practices, would also go against the ‘ease of doing pharma business’ in India… Well, so be it.

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.

The Recent Ban On Irrational FDCs: History Repeats Itself

Posted on March 21, 2016 by Tapan Ray

The recent regulatory ban on a large number of irrational Fixed Dose Combination (FDC) drugs is not a new incident in India. A similar mega ban was announced even before, about nine years ago. Intriguingly, the saga continues, for various reasons, without any tangible outcome for the patients on the ground.

On March 11, 2016, the latest ban, again on a large number of irrational FDCs, was notified. It caused a flutter and an immediate sharp adrenaline rush to the impacted drug companies and was soon followed by an interim stay order, again by an honorable High Court of the country.

Thus, when I connect the past dots with the latest one, on mega ban of irrational FDCs in India, a similar sequence of events gets unfolded, following each of such ban notifications of the Government.

Looking back, 294 FDCs were banned by the DCGI in 2007. At that time too, the important issue of patients’ health, safety and economical interest, got converted into a legal quagmire. Many adversely affected FDC drug players chose to go to the court of law to protect their business interest, and also successfully managed to obtain a ‘Stay’ order from the Madras High Court.

Consequently, those 294 irrational FDCs, banned by the Union Ministry of Health on health and safety grounds, continued to be promoted, prescribed and sold to patients across India, without any hindrance, whatsoever.

The matter continues to remain sub judice, as we deliberate the issue here. Thus, whether the recent gazette notification on the ban of irrational FDCs would immediately be implemented, unlike the past ban, or the history would repeat itself, is indeed a big question mark, at this juncture.

Would this ban have similar outcome?

As discussed, close to a decade after the serious legal fall-out of the ban of 294 irrational FDCs in 2007, another mega ban of 344 irrational FDCs has been announced by the Government, through a Gazette Notification dated March 11, 2016. Some well known brands, such as, Corex, Phensedyl, Crocin Cold and Flu, D-Cold Total, Nasivion and Vicks Action 500 Extra, among others, reportedly come under this ban now. Here is the complete list of 344 banned FDCs.

According to the Government, the reason for banning these drugs is that ‘they involve risk to humans and safer alternatives were available.’

Nevertheless, manufacturers of some of these mega brands have again obtained an interim injunction on the ban for their respective products, from the Delhi High Court.

Sometime during the day, i.e. on March 21, 2016, the honorable Delhi High Court is expected to take up this patient-centric issue. It apparently smacks a blatant self-serving interest of the concerned irrational FDC manufacturers, that defeats the core purpose and value of pharma products for their users.

Like most other issues, the Court directive on this issue, as well, would ultimately prevail, without any shade of doubt.

Is it a ‘bolt from the blue’ for the pharma industry?

Many industry watchers feel that this recent ban has not come as a ‘bolt from the blue’ for the pharma players, at all, as is being claimed by a section of the pharma industry. Even the Union Ministry of Health has, reportedly, clarified the following points on the recent notification:

“We have tried to bring objectivity to the issue by roping in the best of scientists to study the effects of these FDCs.”

“Show cause notices were also issued to more than 344 companies and they were given time to make further representations after the expert committee gave their recommendations. Some of them did not even care to respond. Everybody was given ample opportunity. After that, the move was initiated. It was done after much examination.”

“It is necessary and expedient in the public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use, of the said drugs in the country.”

It is worth noting, at least, one of these well known pharma brands was, reportedly, banned in one of our neighboring countries – Sri Lanka, in 2012, for wide-spread drug misuse, long after its marketing approval in the country.

Some key events leading to the recent ban:

Besides the above articulation by the Union Ministry of Health, it is worth noting, especially, the following key developments to ascertain, whether this ban came suddenly to the irrational FDC manufacturers, and without any prior warning or appropriate communication:

The issue of manufacturing licenses being granted by some states for FDCs without prior approval of Central Drugs Standard Control Organization (CDSCO), was first discussed by the Drugs Technical Advisory Board (DTAB) in the year 2000, though without any major tangible outcome till 2007.

In 2007, Government banned 294 FDCs, and the consequent court proceedings had ‘Stayed’ this ban.

Expressing huge concern on pharma malpractices related to irrational FDCs, the Parliamentary Standing Committee on Health and Family Welfare in its 59^th report (2012) also had flagged this issue. The lawmakers observed in the report that manufacturing licenses for large numbers FDCs were being issued by the State Drug Authorities, without prior approval of the Central Drugs Standard Control Organization (CDSCO), in violation of rules. The committee also noted that multiple FDCs, which are available in India had been rejected by the drug regulators in Europe, North America, and Australia, while for many others never had marketing approval applications submitted outside India (Section 7 of [6]).

Subsequently, in June 2013, CDSCO announced the “Policy Guidelines for Approval of Fixed Dose Combinations (FDCs) In India.”

According to CDSCO, just 1193 FDCs were approved by the DCGI, since 1961 till November, 2014. Thus, all drug manufacturers should clearly know, which FDC has been approved by the DCGI, and when, leaving no scope for any ambiguity in this area. Thus, there should be no problem in total conformance to the above ‘FDC Policy Guidelines’ by these drug producers.

In the same year – 2013, a public notice was also, reportedly, issued, calling all those drug players manufacturing FDCs to apply with the requisite fee, in the prescribed form to the DCGI office, providing the required details.

In 2014, a six-member committee, chaired by Prof. (Dr.) Chandrakant Kokate, Vice Chancellor, KLE University, Jawaharlal Nehru Medical College, Belgaum, Karnataka, was formed to expedite the review process of the applications.

The Kokate Committee has, reportedly, reviewed about 6,600 FDCs, so far, and classified them under four categories – irrational, require further deliberations, rational and require additional data generation.

According to a report, 963 FDCs were found under the irrational category, providing reasons in detail for each.

In 2016, the Government finalized its action, based on the Report of Kokate Committee and also the response received (or still not received despite requests) from the concerned FDC manufacturers.

The March 11, 2016 Gazette Notification banned 344 ‘irrational’ FDCs, ruffling many feathers, but understandably to protect patients’ health interest.

On March 14, 2016, in response to an appeal against this ban through a writ petition, first by Pfizer, the Delhi High Court reportedly granted the company a stay, pending the next court hearing on March 21, 2016. Subsequently, several such stay orders by the honorable Delhi High Court have been issued with the same date of hearing.

Adverse health and economic impact on patients:

Besides serious health risks, the patients also suffer from a huge adverse economical impact, in rupee value terms, by consuming much avoidable irrational FDC formulations, which are generally more expensive than single ingredient drugs, if taken separately at times of necessity or convenience.

The ban of 344 FDCs is estimated to cover over 2,500 brands, in different therapy categories, including chronic diseases, where medicines are taken for a long period of time. Thus, a large number of patients were consuming these irrational formulations for a long period of time without any inkling of their necessity and more importantly serious adverse health impact that these irrational FDCs could cause.

To quantify how much have the patients collectively spent on these banned medicines, in the rupee value terms, I shall quote from the estimates of one of the well reputed and much quoted pharma retail audit and market research organization of India – AIOCD Pharmasofttech AWACS Pvt. Ltd.

According to its report of March 13, 2016, Indian Pharmaceutical Industry would lose Rs. 3,838 Crore (MAT), which is 3.1 percent of the turnover of the Indian Pharmaceutical Market (IPM), when calculated based on the retail sales of these FDCs in the last 12-month period.

Paraphrasing the same finding, one can logically conclude that Indian patients withstood an adverse economic impact of Rs. 3,838 Crore in a 12-month period, by spending on these unnecessary and irrational FDCs of dubious value, besides health risks.

To my surprise, some of the MNC pharma players contribute a major chunk to this avoidable expenditure of the patients, besides associating and avoidable health risks.

Quoting similar credible data, it is also possible to give company-wise break-up in this area, which, in my view, may not be meaningful here.

Two Critical issues to address:

Although, a lot of water has since flown down the bridges, a large number of irrational FDCs are still in the market, exposing patients to possible health hazards and economical hardship.

In this blog, I discussed this core issue in two of my articles, one on July 15, 2013 titled, “FDC Saga: Defiant Manufacturers, Sloppy Regulators and Humongous Inaction”, and the other on May 18, 2015 titled, “Booming Sales Of Unapproved Drugs: Do We Need ‘Safe In India’ Campaign For Medicines?”.

I reckon, the following two would still remain the critical issues, which need to be addressed, expeditiously, once and for all, for patients’ sake:

Stringent compliance with the latest CDSCO requirements by all the manufacturers of FDCs in India must be ensured. Any non-conformance should attract strong punitive measures, through a transparent process.

Whether such drugs are being widely misused, creating a grave risk for health and other safety hazards, must be ascertained periodically, based on credible data.

An important example:

Just the other day, Reuters reported that one of the largest pharma companies operating in India, was selling a FDC of the antibiotics cefixime and azithromycin, without approval of the DCGI.

Interestingly, this particular FDC has reportedly not received marketing approval in the major global pharma markets, such as, the United States, the United Kingdom, Germany, France or Japan.

After the ban of this irrational FDC, the company was compelled to stop manufacturing and sales of this powerful antibiotic cocktail that poses huge health risk to patients.

This Reuters report also states, the drug ‘had been promoted and administered as a treatment for a broad array of illnesses, including colds, fevers, urinary tract infections, drug-resistant typhoid and sexually transmitted diseases.’ It also found chemists who were selling the drug to prevent post-operative infection and for respiratory problems.

Many doctors and health experts have been saying that the spread and misuse of antibiotic combinations may be contributing to antibiotic resistance in India.

FDC approval must be hard evidence-based:

Since all pharmaceutical products, whether available as a single ingredient, or FDC formulations, are globally considered as ‘Evidence-Based Medicines’. Such evidences are established through robust, stringent and well regulated clinical trials for obtaining marketing approval from the drug regulators, unlike most ‘traditional medicines’.

Following this well-established global norm, and as recommended by even the World Health Organization (WHO), all irrational FDCs must be identified through a transparent and medical science-based process, and banned forthwith by the Government.

Establishing safety and efficacy for all FDCs through clinical trials, just like any other single ingredient drug, introduced for the first time in India, whenever it happens or had happened in the past, inadvertently or otherwise, should be a ‘must happen’ regulatory requirement, for all time to come.

Profit making interest through introduction of a plethora of irrational FDCs, should never be allowed to overshadow patients’ health and economical interest.

The bogey of even ‘25 to 30-year-old FDCs’ now being banned:

Some section of the industry is also raising this point, vociferously, protesting against the bans of their respective old and top-selling FDC brands, which have now been considered by the Government as irrational, and questioning: ‘why now?’

This point is irrelevant, as not taking action ever, against a wrong doing allowed over a long period time, does not make an irrational FDC formulation a rational one, for all time to come.

Moreover, this recent action of the drug regulator can not be considered as unique either. With the advancement of medical science, in the past years too, the DCGI issued banned notifications, covering many old FDCs, considering those ‘irrational combinations’ at a given point of time, such as, analgin + pitofenone, vitamins B1 + B6 + B12, cyproheptadine + lysine, just to name a few.

Conclusion:

As is known to many, pharmacovigilance is still at a very nascent stage in India. Consequently, ‘Adverse Drug Reactions (ADR)’ or ‘Adverse Drug Events’ reporting are still abysmally poor in the country. No information on ‘Adverse Drug Events’, as claimed by the manufacturers of these irrational FDCs, should, therefore, in no way mean that these drugs are safe and efficacious and beyond any reasonable doubt.

Although the laxity of the drug regulator in this area can’t also be condoned, in any way, the enormity of the risks posed by irrational FDCs to the innocent patients, is indeed mind boggling.

If the manufacturing and sale of all irrational FDCs are not legally stopped, even after a long and rigorous scientific and medical scrutiny by the experts, the patients in the country would, unfairly, continue to remain exposed to huge health and economic risks, without any fault of theirs. This is exactly what happened in 2007 also, when, after the stay order of the ban notification for 294 irrational FDCs by the honorable Madras High Court, all those FDCs continued to be promoted, prescribed and sold to patients across India, unhindered… but at whose cost?

Yet again, the gazette notification of the Government on the recent ban on 344 FDCs, has gone for judicial scrutiny, at least, for some money spinning key brands of the large pharma players.

This time, however, there is one significant difference, the Government seems to be far more assertive and committed to ensure that only safe medicines are available in the market, despite reported intense advocacy by the industry. This commitment on the part of the Government is also evident from the media report that the (DGCI) has again sent a new list of additional 1,200 FDCs for a probe to the panel, which recommended the ban of 344 irrational FDCs in the last week, and that too, after the court stay order on the latest ban.

Further, a senior a senior official in the Health Ministry has, reportedly, reiterated that the Government will stand firm on its decision, and will support the ban with robust data, in the Delhi High Court.

Would history repeat itself, this time now? We, at least, would get a sense of it, as the proceeding of the honorable Delhi High Court commences today, on this issue.

Either way, it will possibly send a clear signal, whether the triumph of commercial profit motive with irrational FDCs would continue, unabated, over patients’ health, safety and economic interests, at least in the foreseeable future.

By: Tapan J. Ray

For Drug Safety Concern: “Whistleblower’s Intention Should Be Nationalistic”

Posted on March 14, 2016 by Tapan Ray

In the recent weeks, three significant developments related to the Pharmaceutical Industry in India, have triggered rejuvenated concerns in the following critical areas:

A. Overall drug safety standards in the country

B. Self serving interest, rather than patients’ interest, dominate the prescribing decisions

C. Government assurance to American Trade Organization on ‘Compulsory License (CL)’ in India.

These important issues fall under three key regulatory areas of India, as follows:

The Central Drugs Standard Control Organization (CDSCO)
The Medical Council of India (MCI)
The Indian Patent Office

It is worth mentioning here that the Department Related Parliamentary Committee on Health and Family Welfare in its 59^th Report, placed before both the houses of the Parliament on May 08, 2012, on the functioning of the Central Drug Standards Control Organization (CDSCO), begins with the following observations:

Medicines apart from their critical role in alleviating human suffering and saving lives have very sensitive and typical dimensions for a variety of reasons. They are the only commodity for which the consumers have neither a role to play nor are they able to make any informed choices except to buy and consume whatever is prescribed or dispensed to them, for the following reasons:

Drug regulators decide which medicines can be marketed
Pharmaceutical companies either produce or import drugs that they can profitably sell
Doctors decide which drugs and brands to prescribe
Consumers are totally dependent on and at the mercy of external entities to protect their interests.

Most importantly, all these concerns, if not properly clarified and appropriately addressed by the Government, soon enough, have the potential to create an adverse snowballing impact on the uniform access to affordable quality medicines, for all sections of the society in India.

Under this backdrop, I shall discuss in this article briefly, my perspective on each of these critical areas, as they are today, and not just the drug safety concerns.

The headline of this article is expected capture not only the prevailing mood of some key regulators, but also their inertia to address critical healthcare concerns and above all how the core public health related issues are getting lost, and the trivial ones are gradually occupying the center stage.

A. Overall drug quality and safety  standards in India:

A Public Interest Litigation (PIL) suit, filed against the Drugs Consultative Committee and the Central Drugs Standard Control Organization (CDSCO), was listed on the Supreme Court website for hearing on March 11, 2016.

The PIL has been filed by one Dinesh Thakur, requesting the Supreme Court to lay down guidelines by which manufacturers could be made liable for violating drug standards and also give a direction to the government to set up a ‘Drug Approvals Review Committee’ for examining criminality in the manner in which faulty drug approvals were granted.

Many may recall that the same Dinesh Thakur worked for Ranbaxy from 2003 for two years, and is now the Chief Executive of MedAssure Global Compliance based in Florida, US. Thakur’s Company now advises pharma manufacturers on drug safety and quality standards.

As reported by Reuters, Thakur had earlier exposed how the erstwhile largest drug maker of India, Ranbaxy Laboratories, failed to conduct proper safety and quality tests on drugs and lied to regulators about its procedures. Consequently, USFDA fined Ranbaxy US$500 million for violating federal drug safety laws, and making false statements to the US regulator.

This news report further states: “Indian Parliamentary Committee, thereafter, reportedly demanded an investigation and the drugs regulator committed to one in 2013. Thakur received a statement from the health ministry last year, seen by Reuters, showing no inquiry had begun.”

On the last Friday, however, the Supreme Court of India refused to entertain this PIL of Dinesh Thakur, saying it does not have time to adjudicate academic issues, such as, need for guidelines to regulate quality of medicines.

The core issue:

The core issue here is not at all the above PIL, not at the very least. The issue is the much reported concern being expressed, over a period of time, regarding the drug safety standards in India. The reasons include breach of of data integrity, and gross violation of the ‘Good Manufacturing Practices’ standards. Such instances are being detected, almost regularly, by the foreign drug regulators, in several manufacturing facilities run by many large and small Indian drug producers.

It is well vindicated by the fact that around 45 Indian drug manufacturing plants have been banned by the USFDA alone, from shipping generic drugs to the United States, as these were considered unsafe for consumption of patients in the US. Some other foreign regulators too had taken similar action, citing similar reasons. The USFDA website specifies the details of gross violations made in each of these cases.

Ironically, all such facilities can manufacture and sell their drugs in India, as they conform to the quality requirements of the Indian drug regulator. Consequently, the Indian patients consume even those medicines, which are considered unsafe by the USFDA for American patients, innocently, as and when prescribed by the doctors.

Arising out of these incidents, when asked about the drug safety standards in India, and the public health-safety, instead of giving credible and action oriented answers for public reassurance, some of the apparently brazen replies of the DCGI are quite stunning for many stakeholders, both within and outside the shores of India.

I would now quote below just a few of those replies, just as examples.

“…Whistleblower’s Intentions Should Be Nationalistic” - DCGI:

According to Reuters, it has received the following response from the Drug Controller General of India (DCGI), on the above PIL related to the drug safety standards in India:

“We welcome whistleblowers, we have got great respect, but their intentions should be genuine, should be nationalistic… I don’t have any comment on this guy.”

Thus, many industry watchers feel that in a situation like this, the honorable Supreme Court of India would possibly require to intervene, just as what it did on alleged ‘Clinical Trial’ malpractices in the country or for drug price control, solely for public health interest.

The same attitude continues:

Such brazen response of the Central Drug Regulator, and that too on a serious subject, is indeed bizarre. It becomes increasingly intriguing, as the same attitude continues without any perceptible meaningful intervention from the Ministry of Health.

For example, on February 22, 2014, in the midst of a more intense scenario on a similar issue, instead of taking transparent and stringent measures, the DCGI was quoted by the media commenting:

“We don’t recognize and are not bound by what the US is doing and is inspecting. The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.”

On February 26, 2014, presumably reacting to the above remarks of the DCGI, the American Enterprise Institute reportedly commented, “Indian drug regulator is seen as corrupt and colliding with pharma companies…”

Such apparently irresponsible and loose comments keep continuing, despite the 2012 report of the Parliamentary Committee of India alleging collusion between some pharmaceutical companies and officials of the CDSCO, which oversees the licensing, marketing and trials of new drugs. The report also commented that the agency is both chronically under-staffed and under-qualified.

Some possible remedial measures:

As the saying goes, “better late than never”, considering all these continuing developments, it is about time to reconsider some of the key recommendations of Dr. R. A. Mashelkar Committee on a similar subject and make amendments in the relevant Act accordingly, soon, to facilitate creation of a robust with high accountability ‘Central Drugs Authority (CDA)’. It would introduce a centralized licensing system for drug manufacturing, along with stringent drug safety standards; besides, sale, export and distribution of drugs. Perhaps, the draft bill on CDA is now lying in the heap of archival documents with the change in Government.

Why does India need CDA?

I believe, the formation of a robust CDA with high accountability, besides meeting with drug safety concerns, would provide the following significant benefits, both to the Industry and also to the Government:

Achieving uniform interpretation of the provisions of the Drugs & Cosmetics Act & Rules
Standardizing procedures and systems for drug control across the country
Enabling coordinated nationwide action against spurious and substandard drugs
Upholding uniform quality standards with respect to exports to foreign countries from anywhere in India
Implementing uniform enforcement action in case of banned and irrational drugs
Creating a Pan-Indian approach to drug control and administration
Evolving a single-window system for pharmaceutical manufacturing and research undertaken anywhere in the country.

B. Self serving interest dominates the prescribing decision:

That the self serving interest, rather than patient interest, dominate the prescribing decision, was vindicated by a key announcement of the Medical Council of India (MCI) last month.

In February 2016, apparently succumbing to continuous and powerful external pressure, the MCI announced an amendment in a clause of its Code of Ethics Regulations 2002, exempting doctors’ associations from the ambit of its ethics code, as applicable to doctors now across the country. Prior to the amendment, this section used to read as: “code of conduct for doctors and professional association of doctors in their relationship with pharmaceutical and allied health sector industry”.

In other words, it means that the professional associations of doctors will no longer come under the ambit of ethics regulations, legitimizing their indulgence in the identified unethical and corrupt practices, by receiving gifts in cash or kind from the pharma or healthcare industry.

A large section of the key stakeholders believes that this amendment would help creating an additional large space for the pharmaceutical marketing malpractices to thrive, unabated, at the cost of patients.

The latest report of the Parliamentary Standing Committee on MCI:

In its 92nd Report, the Department-Related Parliamentary Standing Committee on Health and Family Welfare titled, “The Functioning of Medical Council of India”, presented to the Rajya Sabha and laid on the Table of Lok Sabha on 8th March, 2016, the Committee observed on this amendment as “an action that is ethically impermissible for an individual doctor cannot become permissible, if a group of doctors carry out the same action in the name of an association.”

The report also noted the failure of MCI to instill respect for a professional code of ethics in the medical professionals and take disciplinary action against doctors found violating the code of Ethics, etc.

The Committee called for a complete restructuring of the MCI, since it believes that the Council has failed as a regulator of medical education and the profession. Casting serious aspersions on the functioning of the MCI, the house panel of the Parliament recommended that the Act under which the MCI was set up be scrapped and a new legislation be drafted “at the earliest”.

The report castigated the health ministry:

The lawmakers castigated the Health Ministry in this report saying, “The committee also finds it intriguing that instead of intervening to thwart attempts of MCI at subverting the system, the ministry meekly surrendered to MCI.”

While summing up, the report states, “the Committee exhorts the Ministry of Health and Family Welfare to implement the recommendations made by it in this report immediately and bring a new Comprehensive Bill in Parliament for this purpose at the earliest.”

How will it pan out now?

I reckon, it will now be immensely interesting now for all concerned to follow, how does the Government deal with this report to curb, among others, the strong interference of mighty and powerful vested interests to continue with the rampant pharma marketing malpractices, at the cost of patients in India.

C. Reported Government assurance on ‘Compulsory License’:

On March 3, 2016, a media report quoted a submission by the US Chamber of Commerce to the office of the US Trade Representative (USTR) as follows:

“While the Government of India has privately reassured (American) industry that it would not use compulsory licenses for commercial purposes, a public commitment to forgo using (this) would enhance legal certainty for innovative industries.”

This is an interesting development, primarily because there are a number of legal provisions for granting Compulsory Licenses (CL) in the Indian Patents Act 2005, including, when a drug is not widely available, extremely expensive and some other situation. In some these provisions, law should follow its own course and there is no legally permissible scope for Government’s administrative interference. Grant of CL for Nexavar of Bayar is one such example, and incidentally, that’s the sole CL that India has granted, so far, from the date of amendment of the country’s Patents Act in 2005.

Thus, a blanket assurance of not invoking any of the provisions of the CL, as provided in the Indian Patents Act 2005, if true, would possibly require to pass through intense legal scrutiny, as that would adversely impact the access to key medicines in a necessary situation, for the public health interest.

So far, India has amply demonstrated to all, time and again, that the country does not grant a CL at the drop of a hat. That situation should continue to encourage and protect innovation.

Nevertheless, “a written public commitment to forgo using the CL provisions for enhancing legal certainty for innovative industries,” as demanded by the US Chamber of Commerce, appears to be unreasonable, goes against the spirit of India’s Patents Act, and perhaps is not legally tenable either, unless the IP Act is amended accordingly in the Parliament.

Conclusion:

All these three areas, as discussed above, are critical from the healthcare perspective of the country.

Ironically, while deliberating on the subject, the capability, credibility and competence of some of the key regulators of the country, are being repeatedly questioned. These doubts emanate not just from Tom, Dick and Harry, but from an illustrious spectrum of constitutional institutions of India, spanning across the lawmaking Parliament, through its various committee reports, to the ultimate legal justice provider – the Supreme Court of India, through is various orders and key observations.

Regrettably, in this specific space, which is primarily related to healthcare, nothing seems to be changing on the ground, since long. The same tradition continues, without any visible sense of urgency, even from the Government.

On the contrary, we now read a new genre of comments, even from a key regulator, on the stakeholder concerns. For example, reacting to concern on drug safety standards, instead of articulating tangible actions to usher in a perceptible change, the chief action taker reportedly specified a totally judgmental and an outlandish requirement: “…Whistleblower’s intentions should be Nationalistic.”

Together with these incidents, the key public healthcare concerns of India too, are now apparently getting drowned in the high decibel ‘Nationalistic’ versus ‘Anti-nationalistic’ cacophony. But, the hope still lingers… for a change…for our nation’s sound health!

By: Tapan J. Ray

Healthcare: Unwrapping The Union Budget (2016-17)

Posted on March 7, 2016 by Tapan Ray

February 29, 2016 was the day of high expectations for many, especially to get to know the focus areas of public resource allocations of the incumbent governments in its third year of office. Healthcare sector too awaited eager to see something substantial in the resource allocation, that would make a fundamental difference in the public health systems and services in India.

The general expectation was high, as its main ruling party had promised to deliver a robust healthcare reform in its Election Manifesto 2014, when it will be voted to power. Some of those critical promises are as follows:

“India needs a holistic health care system that is universally accessible, affordable and effective and drastically reduces the out of pocket spending on health.

NRHM has failed to meet the objectives and will be radically reformed.

The Party accords high priority to health sector, which is crucial for securing the economy.

The overarching goal of healthcare would be to provide, ‘Health Assurance to all Indians and to reduce the out of pocket spending on health care’, with the help of state governments.

The current situation calls for radical reforms in the healthcare system with regards to national healthcare programs and delivery, medical education and training and financing of healthcare.”

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

Over three years have passed since then, unfortunately even the new and comprehensive healthcare policy is not in place, just yet.

In that backdrop, we all witnessed in the budget presentation, a well-wrapped package for healthcare in India. The ‘attractive’ packaging label, listing each element of its broad content, was outwardly impressive and attracted almost instant eulogy from a number of industry commentators.

In this article, I shall first present before you, the healthcare measures announced by the Finance Minister Mr. Arun Jaitely in his Budget speech (2016-17), and then would unwrap the package to discuss briefly the implications of each of these three key elements, and the possible impact.

Union Budgetary Proposals on healthcare:

While proposing his Union Budget Proposal (2016-17), the Minister mostly covered ‘healthcare’ in points 52, 53, 54 and 55 of his speech, as follows:

A. Improving access to healthcare:

While proposing a key measure to improve access to healthcare, the Minister acknowledged before the Parliament:

Catastrophic health events are the single most important cause of unforeseen out-of-pocket expenditure which pushes lakhs of households below the poverty line every year.

Serious illnesses of family members cause severe stress on the financial circumstances of poor and economically weak families, shaking the foundation of their economic security.

In the above backdrop, the Minister proposed that, in order to help such families, the Government will launch a new health protection scheme, which will provide health cover up to Rs. One lakh (Rs. 100,000) per family. For senior citizens, age 60 years and above, belonging to this category, an additional top-up package up to Rs. 30,000 will be provided.

B. Availability of quality medicines at affordable prices:

Acknowledging the fact that making quality medicines available at affordable prices has been a key challenge for the country, the Minister reiterated that the Government will reinvigorate the supply of generic drugs. Moving towards this direction, 3,000 Stores under Prime Minister’s Jan Aushadhi Yojana will be opened during 2016-17.

C. Addressing an important need of end-stage renal disease patients:

The Minister informed the Parliament that around 2.2 lakh new patients of End Stage Renal Disease gets added in India every year, resulting in additional demand for 3.4 crore dialysis sessions. With approximately 4,950 dialysis centers in India, largely in the private sector and concentrated in the major towns, the demand is only half met. Every dialysis session costs about Rs. 2,000 – an annual expenditure of more than Rs. 3 lakhs. Besides, most families have to undertake frequent trips, often over long distances, to access dialysis services, incurring heavy travel costs and loss of wages.

To address this situation, the FM proposed to start a ‘National Dialysis Services Program’. Funds will be made available through PPP mode under the National Health Mission, to provide dialysis services in all district hospitals. To reduce the cost, he proposed to exempt certain parts of dialysis equipment from basic customs duty, excise/CVD and SAD.

Unwrapping the healthcare budget proposal:

Let me hasten to add at this stage that I have not seen the fine prints of each of these proposals, as yet. My analysis is solely based on the budget speech.

A. Improving access to healthcare:

At Rs. 19,037 crores, the budgetary allocation for the ‘National Health Mission (NHM)’ remains almost the same as the previous year. Overall investments to improve healthcare infrastructure still remaining absolutely meager, the ad hoc strategy of the Government to improve access to healthcare is an insurance-centered, rather than universal, free and cashless health services, as was earlier suggested by the ‘High Level Expert Group (HLEG)’ constituted earlier by the Government.

According to the analysis of National Sample Survey (NSS) data for 2014, published in the Economic&PoliticalWeekly dated August 15, 2015, only 13.1 percent of rural and 12 percent of urban residents are covered by government-funded insurance schemes, though the official data states 25 percent coverage. The NSS data also shows an increase in the out-of-pocket expenditure in these areas.

This has happened, even after the promotion of the Governments own insurance-based schemes, such as, the RSBY by the Central Government and also similar schemes by the State Governments, such as, Arogyasri in Andhra Pradesh, over a decade.

Additionally, there are many other reports, which clearly highlight that just pushing for increased insurance coverage, does neither help the poorest of the poor of society, nor does it ensure better and more efficient financial protection.

A paper of October 9, 2013 titled, “Universal Health Coverage – Why health insurance schemes are leaving the poor behind” reiterates that funding through progressive taxation is the key to achieving ‘Universal Health Coverage’. Even the poorest countries can raise more revenue for health through taxes. Oxfam estimates that improving tax collection in 52 developing countries could raise an additional US$269 billion, which is enough to double health budgets in these countries.

The world over, and mostly in the OECD countries, serious doubts are still being expressed about the effectiveness of targeted insurance-based health schemes, instead of public funded focus on ‘Universal Health Care’.

Looking in isolation, while the measure of incremental health insurance coverage, as proposed by the Minister, seems to be a good intent to improve access to healthcare to some people, but is devoid of a clearly charted holistic pathway, based on the lessons learnt from the past. Just the announcement of intent may, therefore, not be effective on the ground.

Currently, India has the Rashtriya Swasthya Bima Yojana (RSBY), launched by the Labor and Employment Ministry on April 1, 2008, to provide health insurance coverage to ‘Below Poverty Line (BPL)’ families. RSBY coverage extends to five members of a family-head of the household, spouse and up to three dependents, who are entitled to hospitalization coverage of up to Rs 30,000 for most diseases. In this insurance scheme, the beneficiaries require to pay only Rs 30 as registration fee, while Central and state governments pay premium to the insurer.

It is still not clear to me, whether, the newly announced insurance coverage is a separate scheme all together with details to be announced later or a part of RSBY initiative.

Besides all these, the fundamental question, however, that would still keep haunting, how would the existing mostly rickety rural brick and mortar healthcare infrastructure; non-availability of right medicines at the right time and at the right places; acute shortages of medics and paramedics, satisfactorily address the incremental needs, thus created?

B. ‘Pradhan Mantri Jan-Aushadhi Scheme’:

This does not seem to be a new initiative, at all. Jan-Aushadhi is an ongoing campaign launched by the Department of Pharmaceuticals in 2008, in association with Central Pharma Public Sector Undertakings (PSU), to provide quality medicines at affordable prices to the masses. Jan Aushadhi Stores (JAS) are being set up to provide generic drugs, which are available at lesser prices, but are equivalent in quality and efficacy as expensive branded drugs.

The Department of Pharmaceuticals had proposed to open at least one JAS in each of the 630 districts of the country, so that the benefit of “quality medicines at affordable prices” is available to at least one place in each district of India. If the initiative becomes successful, depending on the cooperation of all stakeholders, the scheme was to be extended to sub divisional levels as well as major towns and village centers by 2012. However, after 5 years, i.e. up to February, 2013, only 147 JAS were opened, and out of those only 84 JASs are functional.

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

The tardy progress of the scheme was largely attributed to:

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

With all the available information, it appears that the same old and unsuccessful scheme, even during the tenure of the present Government, since the last 3 years, has been repackaged and announced with a new name “Pradhan Mantri Jan Aushadhi Scheme” in the Union Budget 2016-17.

There is no doubt, however, the intent of ‘Pradhan Mantri Jan-Aushadhi Scheme’ of 2016 is as laudable as the “Jan-Aushadhi Scheme”, launched by the Department of Pharmaceuticals in 2008, was at that time, but will it start working now, all of a sudden, despite sustained failure?

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

C. National Dialysis Services Program:

The proposal for the ‘National Dialysis Services Program’ to provide dialysis services in all district hospitals, especially, due to a staggering number of around 2.2 lakh patients of ‘End Stage Renal Disease’ in India every year, is yet another laudable intent in isolation, though it emerges just as an ad hoc measure in the healthcare space of the country, sans the new National Health Policy.

Conclusion:

In my article last week titled, “Healthcare In India (2016-17): Whither Goest Thou?”, I wrote, as the new ‘National Health Policy’ is still not in place, we may, at best see in the Union Budget Proposals (2016-17), some ad hoc measures for healthcare.

While unwrapping this budget speech of the, it appears that on a broader perspective the measures proposed in the budget have turned out exactly that way.

Nonetheless, the proposal of the Finance Minister for a special patent regime with a 10 percent rate of tax on income from worldwide commercialization of patents, which are developed and registered in India, is an excellent one, by any standard, for the innovators.

With frugal public health expenditure of just around 1 percent of GDP, as compared to 3.5 percent of China and 5 percent of Brazil, with larger GDP base, successive Governments of India has been blatantly neglecting public healthcare, for far too long, which continues even today.

At a time, when the Government is mulling making health a fundamental right for Indian citizens, similar to education, and making denial of health an offense, besides its earlier other promises, these budgetary measures are disappointing to many.

Overall, the Union Budget Proposals, made by the Finance Minister for 2016-17, falls far too short of reasonable expectations of any deserving citizen of the country. Neither does any such healthcare measure appear holistic to me, besides being sustainable, as I unwrap the Minister’s healthcare package and take a closer look at it.

By: Tapan J. Ray

Healthcare In India (2016-17): Whither Goest Thou?

Posted on February 29, 2016 by Tapan Ray

The Union Budget 2016-17 will be proposed today by the Finance Minister before the Indian Parliament. As many critical questions are currently being raised about the real health of the Indian economy, across the globe, the Union Finance Minister shoulders an onerous task to address all those apprehensions, beyond any further doubt.

Yesterday, in his monthly radio program ‘Mann Ki Baat’, Prime Minister Modi himself said, “Budget 2016 is my exam, 125 crore people will test me.” A large section of people also would probably view Union Budget 2016-17 in a similar way.

That said, we all know, that the system or the process of annual Union Budget presentation before the Parliament need not be considered as the primary platform to announce various policies of the Government to propel economic growth of the nation. Nevertheless, it certainly underscores the key focus areas, where the Government would prefer deploying country’s financial and other resources, through appropriate budgetary allocations, to effectively meet the key short and long term national goals.

Simultaneously, of course, the Finance Minister would also explain the measures that he proposes for raising the required wherewithal for the same.

The Economic Survey report 2015-16:

The Economic Survey report of the Government for 2015-16, tabled before the Parliament on February 26, 2016, reiterates a grim healthcare situation in India, for a vast majority of its citizens.

The report also underscores, that the average cost of treatment in private hospitals, excluding child birth, is currently about four times than that of public healthcare facilities. This alarming situation, fueled by the meager public health infrastructure in the country, severely limits healthcare access to many in the country. Its primary reason being, a large number of Indians are unable to incur so high out of pocket health expenditure.

A situation like this, brings to the fore the challenges that India faces in providing affordable and accessible healthcare to all those who need it most, the Survey document commented.

Thus, with limited resources and competing demands in the health sector, it is essential for the government to prioritize its expenditure in the sector, the report recommends.

Healthcare deserves a priority focus:

Healthcare, I believe, is one such domain that has been attracting a priority focus in all the developed and a large number of developing nations, since long. In this critical area, however, various national Governments in India have been just expressing its laudable intents, over a period of time. Unfortunately, no political dispensation, so far, has implemented anything hugely impactful to make its citizens feel a huge difference in this critical area, especially, by translating the promised intents into reality and keeping the nose to the grindstone.

Besides many other robust reasons, commercially too, the Indian healthcare industry is one of the largest growing sectors contributing around 10 percent of the GDP, employing around 4 million people.

The D-Day:

Today is the D-Day for the Financial Year 2016-17. We shall get to know soon, in which direction would public healthcare go, as we step into another brand new financial year, and in the third Union Budget of the Government in power.

On December 7, 2015, I wrote an article in this Blog on this issue, titled, “Healthcare: My Expectations From Union Budget (2016-17)”.

My expectations on healthcare budget allocations:

In the above article, I articulated my overall expectations on the allocations for healthcare in 2016-17 Union Budget proposals, as follows:

Increase total public health expenditure from the current 1.2 percent to at least 2.0 percent of the GDP and then raise it 2.5 percent over a period of next three years.

The main source of financing for public health should remain general taxation by levying ‘Health Cess’, quite in line with with ‘Swachh Bharat Cess’ at the rate of 0.5 percent on all taxable services, besides adding a similar tax on non-essential and luxury items.

Primary focus areas:

If something similar to the above budgetary provision is made for public health in India, the details would require to be worked out, if not done already, in the following five primary focus areas, as I envisage:

A. Infrastructure and capacity building:

- Focused and well-identified investments in building high quality public health infrastructure and well-skilled human resources for rural India on priority.

- Villages, based on population, would be identified by the respective State Governments.

B. Increasing access to quality public healthcare:

- Free universal access to primary care services to start with, across the country,

- Free drugs, free diagnostics and free emergency care services in all public hospitals of the country and for all.

- Free emergency response and patient-transport systems across the country, for all.

C. Strengthening the supply chain:

- Quality drug and diagnostics procurement system by the Central Medical Services Society (CMSS) of the Government needs to be modernized, strengthened and made more efficient with real time data, for easy availability of all required drugs and diagnostics in all public hospitals at the right time and in the right quantity.

- Today, a large number of life saving drugs and diagnostics is highly temperature sensitive. Thus, adequate cold chain facilities are to be created right from transportation to storage in public hospitals for all such products, maintaining their required efficacy and safety standards for patients.

D. Increasing awareness for disease prevention:

- Intensive multi-pronged, multi-channel and door to door campaigns by the para-medics to increase awareness for identified disease prevention.

E. Performance incentive:

- To achieve the desired level of success and increase the motivation level in a sustainable way, budgetary provisions to be made for a system of well-structured individual and team performance incentive scheme, when the key implementers exceed expectations by achieving the set goals well before schedule.

- Commensurate punitive measures for failure also to be put in place, simultaneously.

I shall not broach upon the area of Research and Development (R&D) for drugs and diagnostics here, as that could probably be considered in a holistic way under overall innovation, science and technology budget allocation required for the country, as a whole.

Conclusion:

February 29, 2016 is the moment of truth, of yet another year-long expectation in the key focus areas of the Government for resource mobilization and its meaningful deployment.

It is worth noting, however, that the much awaited “National Health Policy” has not been put in place before the Union Budget 2016-17, which could have given an indication to all, about the road map that the Government intends to follow in the healthcare domain of India.

Thus, it is possibly too late now to identify the specific health projects based on majority of citizen’s immediate health needs, from a well-articulated Health Policy for the country. Consequently, charting an action plan for joint implementation by the Central and the State Governments in unison, and making budgetary provisions accordingly for this year, to start with, may not just be feasible.

In the above situation, despite the recommendations of ‘The Economic Survey report 2015-16’, we may, at best see in today’s Union Budget, some ad hoc measures in this space. In any case discussing all these at this hour would just be a matter of speculation. Nevertheless, like many persons, I too keep my fingers crossed.

In any case, we all shall get to know today, the Finance Minister’s comprehensive budgetary proposals for this year, including healthcare. Till then, at least for 2016-17, the same question will keep haunting: Healthcare In India: Whither Goest Thou?

By: Tapan J. Ray

Against Pharma Marketing Malpractices: A Gutsy Step

Posted on February 22, 2016 by Tapan Ray

January 7, 2016 edition of ‘The Financial Times (FT)’ reported that responding to escalating pressure on the drug industry, related to its ‘Conflict of Interest’ with the doctors and other related professionals, GlaxoSmithKline (GSK) has decided taking a very unorthodox step.

According to this news report, GSK has decided not to promote its brands by making payments to doctors in any form. The company also strongly expressed its belief that to refurbish the dented image of the industry, in general, its competitors, as well, would start following the same steps, sooner than later.

Whatever it may be, GSK has apparently decided to avoid the above ‘conflict of interest’ and not to ride on the trendy wave for drug promotion, any longer.

Although, many restrictions have already been put in place by different countries, to curb these practices to the extent required, many pharma companies always find effective ways to circumvent those restrictions, as many report highlights.

In this scenario, GSK has taken a bold and calculated decision to swim against the tide. Respecting public outcry and sensitiveness on the subject, it has decided against engaging paid physician speakers, as an integral of the brand marketing strategy, any longer. More importantly, this decision of the company is absolutely voluntary, transparent, and its faithful implementation level can also be monitored externally.

The consequences of this ‘Conflict of Interest’:

Available reports indicate that the consequences of alleged marketing malpractices of any kind, attract some serious financial consequences for the pharma players, provided of course, if one gets caught, especially in the United States or Europe.

A February 24, 2014 article highlights that in the last few years alone, pharmaceutical companies have agreed to pay over US$13 billion to resolve only U.S. Department of Justice allegations of ‘fraudulent marketing practices’.

Dwelling on the subject, a November 6, 2014, BBC News commented, “Imagine an industry that generates higher profit margins than any other and is no stranger to multi-billion dollar fines for malpractice.”

It is worth noting, all those pharma players paying hefty fines due to alleged marketing misadventures of humongous proportion, also prominently display their well-crafted code of ethics of pharma marketing practices in their respective websites, vowing for strict voluntary adherence. Nevertheless, the (mal)practice goes on, unabated.

Did a recent deterrent work in America?

Despite recent enactment of “Physician Payments Sunshine Act”, such practices of pharma companies continue unabated even in the World’s largest pharma market – the United States.

As is known by many, the ‘Physician Payments Sunshine Act’ is a healthcare law enacted in the United States in 2010 to increase transparency of financial relationships between health care providers and pharmaceutical manufacturers.

This Act requires manufacturers of drugs, medical devices and biologicals that participate in US federal health care programs to submit annual data on payment and other transfers of value that they make to physicians and teaching hospitals. The data submission period is followed by 45 days for physicians to review their ‘Open Payments’ data and dispute errors before the public release.

On July 1, 2015, ‘ProPublica’ – an independent, non-profit newsroom that produces investigative journalism in the public interest, published an article titled, “Dollars for Docs: How Industry Dollars Reach Your Doctors.” Quoting the public database, it reported that in 2014, 1,630 pharma companies in the United States disclosed a hefty total payment of US$ 3.53 billion to 681,432 doctors. The maximum total payment received by a single doctor during this period was US$ $43.9 million.

Published names of ‘Top 20 Companies’:

According to ‘ProPublica’, the money that the following 20 companies spend on interactions with doctors in the United States, excluding research and royalties, is as follows:

Pfizer: $30M,
Janssen Pharmaceuticals: $20.5M
Astrazeneca Pharmaceuticals: $19.1M
Forest Laboratories: $17.2M
Allergan: $15.5M
Otsuka America Pharmaceutical: $15M
Sanofi and Genzyme: $14.6M
AbbVie: $13.5M
Genentech: $12.9M
Intuitive Surgical: $12.8M
Novo Nordisk: $12.4M
Depuy Synthes Sales: $12M
Bristol Myers Squibb: $11.9M
Eli Lilly: $11.7M
Teva: $11.6M
Novartis: $11.5M
Boehringer Ingelheim: $10.8M
Stryker: $10.3M
Merck Sharp & Dohme: $10.3M
Takeda: $9.68M

GlaxoSmithKline not featuring in the list:

Interestingly, I could not locate GlaxoSmithKline (GSK) featuring in this specific list of the top 20 companies in the United States. Some industry watchers comment that this could well be an outcome of other unorthodox measures taken by GSK earlier to revamp its reputation, dented by the widely reported Chinese bribery scandal and also a huge settlement of US$3 billion with the Government of the United States, for alleged marketing malpractices. Whatever it is, GSK has now initiated some tangible policy decisions in this regard, unlike most of its counterparts.

Alleged pharma malpractices are rampant in India too:

Frequent reports of Indian media have already triggered a raging debate in the country on the same subject. It has also been reported that a related case is now pending before the Supreme Court against a Public Interest Litigation (PIL) for the hearing.

On May 08, 2012, the ‘Department Related Parliamentary Standing Committee on Health and Family Welfare’ presented its 58th Report to both the Lower and the Upper houses of the Indian Parliament. The committee, with a strong indictment against the Department of Pharmaceuticals (DoP), observed that the DoP should take decisive action, without any further delay, in making the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ mandatory, so that effective checks could be ensured on ‘huge promotional costs and the resultant add-on impact on medicine prices’.

Unfortunately, nothing substantive has happened on the ground regarding this issue as on date, excepting announcement of voluntary implementation of the DoP’s ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’, effective January 1, 2015 for six months for its assessment. Thereafter, the date extension process on the voluntary implementation of the UCPMP has become a routine exercise for the DoP, on the pretext of continuing discussion on the subject with the pharma trade associations and other stakeholders.

Nevertheless, incidences of alleged marketing malpractices are still unfolding today and getting dragged into the futile public debate. In a situation like this, I reckon, the Government is expected to play a more proactive role by all, instead of maintaining the status quo, any longer.

‘Voluntary practice’ concept alone, has not worked, anywhere:

Strong internal and external business performance pressures, while navigating through turbulent business environment with strong headwinds, could temporarily unnerve even the seasoned managers with nerves made of steel, as it were. It has been happening all the time, now more frequently, despite having stringent ‘voluntary pharma marketing practices’ codes in place, for many different reasons.

This has been vindicated by a recent research published by ‘PLOS Medicine’ on January 26, 2016.

The study states that European Union law prohibits companies from marketing drugs off-label. However, in the United Kingdom (UK), as in some other European countries, but unlike the United States, pharma industry self-regulatory bodies are tasked with supervising compliance with marketing rules. The objectives of this study were to characterize off-label promotion rulings in the UK compared to the whistleblower-initiated cases in the US and also) shedding light on the UK self-regulatory mechanism for detecting, deterring, and sanctioning off-label promotion.

The paper provided credible evidence of the limited capacity of the UK’s self-regulatory arrangements to expose marketing violations. It recommended that the UK authorities should consider introducing increased incentives and protections for whistleblowers combined with US-style governmental investigations and meaningful sanctions.

Thus, all-weather ‘voluntary practice of ethical pharma marketing code model’ alone, is either failing or has failed, almost everywhere in the world. GSK’s is a novel, but solo attempt and may not necessarily be imbibed by others.

Appropriate regulations and robust laws, instilling not just the ‘fear of God’ to the violators, but also promising justice to all, would always be a strong deterrent in those trying situations, especially in countries like, India, unless of course, any person or a legal entity is a hardcore manipulator with its key focus just on profiteering.

Restoring tarnished image:

GSK has taken the above bold step to restore its tarnished image, after receiving body blows related to several scandals, as it were. Commendably, it did not continue doing the same, unlike many others. Instead, the leadership of the Company demonstrated sensitivity to public outrage.

GSK won’t be a solitary example of pharma marketing malpractices. There are other large drug companies too, who even after meeting with similar public disgrace, keep charting the same old path to maximize brand sales by paying for the doctors, either directly or in several other forms, as many reports have alleged.

To offset all such marketing related expenses, and thereafter earn a huge profit, many of them keep the new drug prices exorbitantly high, adversely impacting the access of those drugs to many of those, who need them the most. This is besides taking hefty annual increases on existing brand pricing, even when inflation is very low to moderate.

Access to drugs for all needy patients is ‘Government responsibility’:

To justify access barrier to high priced drugs for a large number of patients globally, most pharma players and their trade associations have a ready answer in their advocacy toolkit. It says, ensuring access to drugs for all needy patients is the responsibility of the Government, not of the drug companies.

As a result, the trust deficit between the pharma industry and the general public is increasing, further denting its image. At present, when many national Governments are initiating action or are contemplating to do so, to contain such insensitive practices, the industry probably would require to pause for a while, take a step back and ponder – what next?

Restoring the tarnished image of the drug industry is a challenging ball game, far beyond the capabilities of even the richest pharma associations of the world, and their over-paid lobbyists. Crafty creation of any facade to hoodwink all, is no longer working to achieve their self serving purposes. Today, the public, in general, seems to understand much more about their reasonably affordable healthcare needs and wants, than what these trade associations’ possibly think about them.

Otherwise, why would Hillary Clinton ‏@HillaryClinton – one of the strongest contenders for American Presidency this time, would tweet on January 28, 2016 addressing her voters and admirers with the following vow:

“We will go after pharmaceutical companies that gouge patients with pricing. They are wrong, and we will stop them.”

My experience tells me that astute pharma CEOs, by and large, still command much higher credibility than their trade associations. Thus, the top leadership of the respective organizations would require taking the ‘image revamping exercise’ in their own hands, directly. It is essential to publicly demonstrate that most of them are aligned and in sync with the emerging new paradigm of changing aspirations, needs and wants of the patients and other key stakeholders. Future business excellence would demand inclusive growth. GSK is just an example of a CEO’s bold response to address this challenge of change – ‘a small step but a giant leap’ in this direction.

Conclusion:

In my view, all these contentious practices are basically being prompted by the strong intent of most of the pharma CEOs to ‘play safe’, in order to deliver expected shareholder value.

Any unorthodox approach to rebuild the tarnished image is usually risky, generally frowned upon and discouraged by the industry. Other vested interests often join them too. All these retarding forces express grave apprehensions on any fresh look by a company to mend fences with its key stakeholder – the patients and the public, in general.

The recent GSK example is no exception. Apprehensions have already been expressed, whether this untested fresh thinking, against a widely perceived corrupt practice of paying physician speakers for indirect brand promotion would really be able to boost its image, without cutting into revenue. Some would take a step further and question, would a rejuvenated image ultimately fetch expected growth in sales revenue and profit?

Only time will tell us the consequences of this uncommon and unorthodox decision taken by a courageous leader in the pharma industry.

In India, even the Government seems to have gone into a deep slumber on this issue. Despite reported discussions with the stakeholders several times, Government’s UCPMP still remains voluntary, with the DoP holding the same old ground, where it started from on January 1, 2015. It is difficult to fathom, whether intense industry lobbying is influencing a long overdue decision in favor of the patients’ overall interest.

However, there is good news also. According to a February 6, 2016 media report, ‘The Medical Council of India (MCI), for the first time ever, is set to notify specific punishments for errant doctors based on the value of favors or freebies received from drug players, under the Indian Medical Council (Professional Conduct, Etiquette and Ethics) (Amendment) Regulations, 2015.

That apart, to revamp its dented image, the decision of GSK against paid physician speakers as an integral part of brand promotion, is not just a gutsy step with a sharp focus on restoring business ethics and values, but more laudably a voluntary one. Would others follow it too, including in India?

By: Tapan J. Ray

Democratization of Healthcare: An Evolving Trend Driven By Cutting-Edge Technology

Posted on February 15, 2016 by Tapan Ray

We have stepped on to a fascinating era of yet another disruptive innovation in a newly carved out space of the healthcare domain.

Such initiatives are driven by path breaking ideas, which are being translated into reality with the application of cutting-edge technology. All these are aimed at providing a plethora of unique healthcare related solutions in the cyberspace to various stakeholders, especially to patients through inexpensive smartphones of various types.

Although the process has just begun, but is moving at a rapid pace. In virtually no time, as it were, it is showing a great potential of delivering more accurate and affordable healthcare solutions to a large number of the population globally, particularly in the developing nations.

‘Democratization of Healthcare’:

The ‘patient empowerment’ of such kind, with technology enabled the power of personalized healthcare knowledge and information in an organized manner, has been termed as ‘The Democratization of Healthcare.’

The critical point to ponder, therefore, whether this fast developing state of art technological advancement has the potential of delivering a novel and much affordable process of disease treatment and management, in the real world. As it happens, the new paradigm would shift the focus of key stakeholders from doctors to patients, in a genuine sense, and almost irreversibly.

In this article, I shall deliberate on this wonderful emerging scenario.

A recent reiteration raises hope:

The following reiteration of one of the largest and most reputed tech giant of the world raises general hope that this process would soon come to fruition:

‘The democratization potential of healthcare interests most of us, as the injustice of fantastic healthcare available in some parts of the world, and others suffering needlessly.”

The above profound comment was made on a radio show – ‘Conversations on Health Care’, by none other than the Chief Operating Officer, Jeff Williams of Apple Inc. on January 4, 2016 and was reported accordingly by ‘appleinsider.com’ on January 06, 2016.

Jeff Williams also indicated in his talk, how smartphone technology can be harnessed for therapeutic purpose in disease treatment, as well. Citing an example, he said, detecting autism at an early age is a key to future treatment, as doctors can intervene – albeit to a limited degree – as long as the brain is still developing.

He referred to a study that found not just the potential in app-based smartphone screening of children, but can even go much further by delivering therapy and treatment.

The rapid progress of technology in this direction is very real, as ‘Apple’ and other smartphone health app developers are stretching the commoditization of computer technology to serve health sciences. In not so distant future, with relatively inexpensive smartphones and supporting health apps – the doctors and researchers can deliver better standards of living in severely under-served areas like Africa, where there are only 55 trained specialists in autism, Williams said.

Triggers a key shift in focus:

As I said before, unleashing the power of technology in healthcare solutions through smartphones will bring a fundamental shift in focus of all concerned, from medical doctors to ordinary patients.

This transformation seems to be rather imminent now, as equipped with detailed knowledge of various types of individual health and disease related information through their smartphones, the patients would position themselves in the driver’s seat, demanding more for affordable treatment of diseases.

Dr. Eric Topol, the author of the book titled, “The Patient Will See You Now”, thus very appropriately said, “MDs will no longer be considered ‘medical deities’, but rather professionals with whom patients will consult to get the proper treatment on the path of least resistance.”

Consequently, the pharma players and other related service providers would require to ‘walk the talk’ by being ‘patient centric’ in the true sense, and definitely not by using this profound term, as one of the tools of their mostly self-serving, advocacy campaigns.

Empowering patients:

As Dr. Eric Topol said, smartphone applications that can monitor throughout the day, such as, heart rate and rhythm, blood pressure, take and interpret an electrocardiogram, capture X-rays and analyze ultrasound, have the potential to reduce patient visits to doctors, cut costs, speed up the pace of care and give more power to patients. He emphasized though, digital apps won’t replace physicians. The patients would still be seeing doctors, but the doctor-patient relationship will ultimately be radically altered.

As an illustration, it is worth mentioning here, that taking a significant step forward in this direction, the U.S. Food and Drug Administration (USFDA) has already approved ECG apps by for consumers, which have been validated in many clinical studies.

Examples of Smartphone Apps for patients:

Smartphone apps are now available for different user segments. In this section, I shall focus only on patient-centered apps capable of performing a wide array of functions, such as managing chronic disease, lifestyle management, smoking cessation and even self-diagnosis.

I am quoting below just a few of these interesting apps, as reported in an article published by ‘The Online Journal of Public Health Informatics (OJPHI)’ on February 5, 2014:

A. For diabetic patients, over 80 apps on the Android platform alone, offer a variety of functions. These include self-monitoring blood glucose recording, medication or insulin logs, and prandial insulin dose calculators.

Yet another diabetes intervention app integrated communication between patients and a healthcare provider. Here, the patient would log fasting blood sugars, daily eating behaviors, medication compliance, physical activity and emotions into a mobile online diary. A remote therapist with access to these diaries would then formulate personalized feedback to the patient.

‘WellDoc’ is reportedly one such company that has already received approval of the US FDA for its mobile-enabled diabetes management program, and is being paid for by health insurers as they would for a pharmaceutical product.

B. For smoking cessation and alcohol addiction apps are also available. At least 47 iPhone apps for smoking cessation and another one called – ‘A-CHESS’ (Alcohol Comprehensive Health Enhancement Support System) helps preventing relapse in alcoholic dependency and harnesses mobile technology to improve treatment and motivation.

C. For asthma and allergic rhinitis patients, an app called ‘m.Carat’, developed at Faculdade de Medicina da Universidade do Porto, Portugal, , helps recording their exacerbations, triggers, symptoms, medications, lung function tests and visits to the doctor or the hospital. The users of this app can also receive disease education, medication information, task notifications, and synchronize records with an online database to better control their symptoms.

D. For psychiatric patients, available smartphone apps offer benefits of ambulatory monitoring, that randomly prompts the patient to self-report psychotic symptoms multiple times throughout the day.

E. For sickle cell disease another app allows patients access to an online diary for recording pain and other symptoms.

F. For patients with dementia, ‘iWander’ app assists the affected individuals with daily living, by providing audible prompts to direct the patient home, sending notifications and GPS coordinates to caretakers, or by calling local 911 (US emergency) services.

G. For HIV (human immunodeficiency virus) and STD around 55 unique smartphone apps are available. These are used for education, prevention, testing and to provide other resources.

Self-diagnosis without a medical visit:

The above article also states that patients may even use smartphone apps to attempt self-diagnosis without a medical visit. Patients with a camera-enabled smartphone can use apps to take photographs of skin lesions and send these to a remote server for computer analysis and/or review by a board certified dermatologist. However, such apps are still not without their pitfalls, which are being addressed by the scientists, expeditiously.

Nevertheless, informed debate has already started in search of an appropriate direction for self-diagnosis with the help of robust smartphone apps, without any in-person medical visits.

Need for ‘Regulatory control’ and ‘certification’ of health apps:

I hasten to add, all such smartphone health apps should not be allowed to come to the market without stringent regulatory control and a well thought out the certification process.

As in the United States, where the health apps are being assessed by the U.S. Food and Drug Administration (US FDA), in India too the Drug Controller General of India (DCGI) or any other appropriate and designated authority should approve and certify all such smartphone health apps, before the market launch.

‘Trust deficit’ poses a critical challenge to pharma industry:

Since the health apps opportunity is new, and still in its evolutionary stage, pharma industry, in general, does not seem to have fully accepted yet, that the process of ‘Democratization of Healthcare’ has already commenced. I reckon, the progress in this direction is unstoppable now. Nevertheless, many drug companies apparently continue to prefer sticking to the same proven path that had fetched enormous success for them in the past and, of course, also its associated business models.

Besides health apps, the democratization process of healthcare includes other technological platforms too, such as, social media and video communications, which have started to bring healthcare into patients’ homes. To be successful in a situation like this, gaining ‘patient trust’ has become more important today than ever before, for all concerned.

Unfortunately, the drug companies, generally speaking, continue suffering from an increasing ‘trust deficit’ of the key stakeholders. This has been vindicated by a September 9, 2013 study of Makovsky Health, which found:

Pharma websites continued to rank low in terms of traffic, with just 9 percent of Americans visit them for health information.

WebMD is the most frequented online source for healthcare information (53 percent)

Almost a fourth of consumers (24 percent) use at least one or a combination of social media channels – including YouTube video channels, Facebook sites, blogs, and Twitter feeds with links to other resources – to seek healthcare information

The writing on the wall:

Some major global pharma players apparently have clearly seen the writing on the wall, and started collaborating with the developers of various types of digital health apps.

Quoting from the May 02, 2014 edition of ‘MobileHealthNews”, I am citing below, just as an illustration, the initiatives taken in this space by some of the drug majors:

Pfizer (2014) had backed startup Akili in the development of a mobile game to help diagnose patients with Alzheimer’s. The game could also be used in the treatment or detection of ADHD and autism, among other conditions.

Johnson & Johnson’s subsidiary, Janssen Healthcare Innovations (2013), launched the new version of its free Care4Today medication reminder app and platform – Care4Today Mobile Health Manager 2.0. It has also overhauled Care4Today medication adherence app.

Sanofi US (2013) and the Prostate Cancer Foundation announced the creation of Prost8Care, an SMS system to help prostate cancer patients and their families understand treatment processes.

AstraZeneca (2013) announced a pilot with Exco InTouch to help patients suffering from Chronic Obstructive Pulmonary Disease (COPD), with mobile and online tools.

Sanofi’s (2012) iBGStar device became the first US FDA cleared iPhone-enabled blood glucose meter.

GlaxoSmithKline (2012) offered a free asthma management app called MyAsthma, for iPhone and Android users. The app’s core offering is an Asthma Control Test (ACT), which is a simple 30-second test providing users with an index score of how well they are managing their asthma overall.

The potential in India:

In India, ‘Democratization of Healthcare’ is believed to be more broad based, with a third of all Indian mobile users expected to own a smartphone by 2017.

This is vindicated by the Press Release of Telecom Regulator TRAI, India, pharma, drug, playersy Authority of India (TRAI) of December 30, 2015. It states, the Wireless Tele-density in India is 79.39 as on October 31, 2015. The shares of urban and rural wireless subscribers were 57.61 percent and 42.39 percent, respectively, during the same period.

Conclusion:

The process of ‘Democratization of Healthcare’ is gaining momentum with the digital health app developers flooring the gas pedal. Even the global tech giant – Apple, has expressed its support and vow of taking rapid strides in this direction.

As this fascinating process unfolds, the final disease treatment decision, from various medical options available, is expected shift from doctors to patients, and may be their closest relatives. In tandem, patients would learn to take ownership of their physical and mental health conditions for disease prevention of various types, besides general fitness.

The patients, empowered with relevant digital information and knowledge, on their health status, including the pace of disease progression, would play a pivotal role not just in reducing disease burden, but also in making overall cost of individual healthcare more affordable. Additionally, access to healthcare, especially in the developing world like India and in its hinterland, will be improved significantly.

Digital apps are not just limited to patients’ use, these are being developed with equal speed for doctors, diagnostic centers, and clinical trials, just to name a few. All these would substantially reduce healthcare costs and add speed to various disease treatments.

In this golden pathway, there are some thorns too, mostly in the form of important regulatory issues, which need to be sorted out, expeditiously. Increasing ‘Trust Deficit’ of stakeholders on the drug companies is yet another hurdle, especially when the primary focus of all would shift from doctors to patients. However, it appears, the pharma players will eventually have no other choice, but to willy-nilly mold themselves accordingly, primarily for survival and thereafter progress.

As I see it today, the fast evolving trend of ‘Democratization of Healthcare’, driven by cutting-edge technology, is virtually unstoppable now. The only question is how soon will it happen?

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

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