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Ticking Some Right Boxes Biosimilar Drugs’ Acceptance Gaining Steam in India

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Looking at a broader canvas, on September 19, 2023, a credible international report flashed a headline, ‘Biosimilars making inroads into Humira sales, but docs still cautious on switching: Spherix.’ This is based on a survey of U.S. healthcare specialists, including 80 dermatologists, 83 gastroenterologists and 81 rheumatologists.

This is indeed a significant development in the realm of biologic and biosimilar drugs, internationally. If this trend gathers a strong wind on its sales, it will effectively address the need for affordable biologic drugs, especially in life threatening ailments.

According to another January 05, 2023 report, Humira, which dominated the top of the global pharmaceutical brand ranking charts between 2012 and 2022, has slipped in 2023 to no 3 in ranking as it lost its last patent protection in the US in May 2022. Doctors’ gradual acceptance of biosimilars and the price could be a key differentiator among the competitors, potentially hastening Humira’s sales decline.

On July 31, 2017, I wrote an article in this blog captioned “Improving Patient Access To Biosimilar Drugs: Two Key Barriers.” Interestingly, 6 years down the line, reflecting the same sentiment – the above September 19, 2023, report also noted that ‘efficacy remains “top of mind” as prescribers’ leading concern for adalimumab (Humira) biosimilars, followed by safety concerns and an overall lack of cost savings.’

In today’s article, I shall particularly focus on the latest developments in India and the initiatives taken by the concerned stakeholders in this area. Let me start with a quick recap of biosimilar drugs, in my understanding, so that we all are on the same page while discussing the subject.

A quick recap: 

As we know, biologic drugs are medicines made from living organisms, such as bacteria, yeast, or cells. They are used to treat a wide range of conditions, including cancer, autoimmune diseases, and infectious diseases. Biosimilar drugs are highly similar copies of original biologic drugs that have gone off patent and are typically less expensive than the original biologic drugs. However, there are still some existing barriers to doctors’ fast and wider acceptance of biosimilar drugs by many.

Current global barriers to doctors’ fast acceptance of biosimilar drugs:

  • Lack of awareness and education: Many doctors are not familiar with biosimilar drugs or the regulatory process that oversees them. This lack of awareness may lead to skepticism and hesitation about prescribing biosimilar drugs to patients.
  • Concerns about safety and efficacy: Some doctors are concerned that biosimilar drugs may not be as safe or effective as biologic drugs. These concerns are often based on a misunderstanding of the regulatory process for biosimilar drugs. 
  • Financial incentives: Some doctors may be reluctant to prescribe biosimilar drugs because they receive financial incentives from biologic drug manufacturers. These incentives can take the form of speaking fees, consulting fees, and research grants. 
  • Regulatory uncertainty: In some countries, the regulatory framework for biosimilar drugs is still evolving. This uncertainty can make it difficult for doctors to know which biosimilar drugs are safe and effective, and how to use them effectively. 

Some contemporary examples show that these barriers still exist:

As shown by the following contemporary data available to the public:

  • In 2022, a study published in the journal JAMA found that only 25% of US doctors were aware that biosimilar drugs are just as safe and effective as biologic drugs.
  • In 2023, a study published in the journal Annals of Rheumatic Diseases found that only 30% of rheumatologists in the UK were willing to prescribe biosimilar drugs to their patients. 
  • In 2023, a study published in the journal Cancer found that oncologists in the US were more likely to prescribe biologic drugs to their patients if they had received financial incentives from biologic drug manufacturers. 
  • In 2023, a report published by the European Commission found that the regulatory framework for biosimilar drugs in the EU is still complex and fragmented.

Measures being taken to address these barriers, globally?

There are a number of things that can be done to address the barriers to doctors’ fast acceptance of biosimilar drugs. These include:

  • Education and outreach: More needs to be done to educate doctors about biosimilar drugs and the regulatory process that oversees them. This education should come from a variety of sources, including medical schools, professional organizations, and pharmaceutical companies.
  • Financial transparency: Pharmaceutical companies should be required to disclose all financial payments they make to doctors. This transparency will help to reduce the potential for conflicts of interest.
  • Regulatory harmonization: The EU should work to harmonize the regulatory framework for biosimilar drugs across member states. This will make it easier for doctors to prescribe biosimilar drugs to their patients.

By addressing these barriers, it is possible to increase the acceptance of biosimilar drugs and make them more accessible to patients. This will lead to lower healthcare costs and improved patient outcomes.

Indian scenario of biosimilar drugs, issues and actions:

As reported, India is a global leader in the production and development of biosimilar drugs. The Indian biosimilar market is expected to reach $30 billion by 2025. Biosimilar drugs in India are typically 30-70% cheaper than original biologic drugs. For example, a vial of the biologic drug Herceptin costs around INR 1 lakh, while a vial of the biosimilar drug Trastuzumab costs around INR 30,000.

The key reasons for price arbitrage:

The price difference between biosimilar drugs and original biologic drugs is due to a number of factors, including:

  • Lower development costs: Biosimilar drugs are less expensive to develop than original biologic drugs because they do not require the same level of research and clinical trials. 
  • Increased competition: There is more competition among biosimilar manufacturers, which drives down prices. 
  • Government support: The Indian government provides financial incentives to biosimilar manufacturers, which also helps to keep prices low. 

Biologic drugs, especially biosimilar insulin, some medications for cancer and a variety of autoimmune diseases, have been proved to be very effective for patients. That said, original biologic drugs can also be very expensive. Biosimilar drugs are making these drugs more affordable for patients.

Indian stakeholder initiatives and support is essential:

Indian key stakeholders are also supportive of the biosimilar industry and have taken a number of steps to promote its growth. Some of the recent ones are: 

  • In 2022, the Indian government announced a new policy that will give preference to biosimilar drugs in government procurement. This policy is expected to save the government billions of dollars in healthcare costs.
  • In 2023, the Indian government launched a new awareness campaign to promote the use of biosimilar drugs. The campaign is targeting doctors, patients, and healthcare policymakers.
  • In 2023, a number of leading private hospitals in India announced that they would be switching to biosimilar drugs for a range of conditions. These hospitals include Apollo Hospitals, Fortis Healthcare, and Max Healthcare.
  • In 2023, the Indian Pharmaceutical Alliance (IPA) released a report that found that the use of biosimilar drugs in India had increased by 20% in the past year. The report also found that the use of biosimilar drugs was expected to continue to grow in the coming years.

These are just a few examples of the growing acceptance of biosimilar drugs in India. As more and more doctors and patients become aware of the benefits of biosimilar drugs, we can expect to see their use continue to grow in the coming years.

State-specific advantages for greater acceptance of biosimilar drugs in India: 

As available from different reports, the following are some specific examples of state-specific advantages that have led to the greater acceptance of biosimilar drugs in India:

  • In 2022, the government of Maharashtra launched a scheme to provide financial incentives to doctors who prescribe biosimilar drugs. Under the scheme, doctors who prescribe biosimilar drugs to at least 20% of their patients are eligible to receive a bonus of up to INR 10,000 per month.
  • In 2023, the government of Gujarat launched a campaign called “Biosimilar Drugs: Safe, Effective, and Affordable.” The campaign aims to educate doctors and patients about the benefits of biosimilar drugs and to dispel any myths or misconceptions about them. 
  • The states of Karnataka and Telangana have a number of leading biopharmaceutical companies that are developing and manufacturing biosimilar drugs. These companies are working with doctors and hospitals in these states to promote the use of biosimilar drugs. 

As a result of these advantages, the acceptance of biosimilar drugs is growing rapidly in some states in India. For example, in Maharashtra, the use of biosimilar drugs increased by 25% in the past year.

Conclusion:

Against the above backdrop, I reckon, the acceptance of biosimilar drugs is gaining steam in India now. This is due to a number of factors, including rising costs of original biologic drugs, government support, growing availability of biosimilar drugs, and increasing awareness and education.

It is important to note that biosimilar drugs are just as safe and effective as original biologic drugs, but they are much more affordable. This is making it possible for more patients to access the treatment they need, especially for life-threatening ailments. 

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.

 

New Digital Tools To Protect From Infection, Neutralize Covid-19

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There seems to be some light at the end of the dark tunnel of a serious biological threat that the world is passing through, since the nightmarish last seven months. The COVID-19 pandemic has spread to 213 countries and territories, and the number of new cases is continuously rising. According to reports, the severity of the situation has already re-shaped our society, more than ever before.

In tandem, reports are arriving from most countries, testifying the tremendous commitment of the governmental, scientific and clinical communities, to help local populations dealing with the pandemic. Scientists are still far from having a complete picture of the pathophysiology of this dangerous disease, including its long-term implications on individuals.

Amid this challenge, round the clock search for a life-saving and long-term pathway to outmatch the fast-spreading Covid-19, seems to be coming to fruition, soon. If everything materializes as expected, Covid-19 vaccines may be available by the end of this year or at the beginning of the next year. If it happens, this will be a record in the history of any vaccine development process, as the normal ‘mind to market’ period to deliver a scientifically proven, safe and effective vaccine is normally around 10 years. That said, there always exists a gap between the cup and the lip, as the saying goes.

No doubt, vaccines will be the best way to bring the new Coronavirus under a tight leash to help normalize life, restore livelihoods, and putting a nation’s economy back to the growth trajectory. The good news is, alongside this magic bullet, the power of technology is exploring other technological measures to keep the virus at bay, wherever possible. In this article, I shall focus on this interesting area.

Let me hasten to add, the value offerings of these devices can’t be compared with the long-term benefits that vaccines will offer in containing this global pandemic. Nevertheless, the questions still remain, when will a well-documented, safe, effective and affordable vaccine hit the market?

W.H.O expects to deliver 2 billion doses of vaccines by end 2021:

According to a News Release of July 15, 2020, by the World Trade Organization (W.H.O): ‘Seventy-five countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility, which aims to:

  • Accelerate the development and manufacture of COVID-19 vaccines.
  • Guarantee fair and equitable access for every country in the world.

The goal of COVAX is to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO pre-qualification, by the end of 2021. Besides W.H.O, other experts are also cautiously optimistic about the availability of Coronavirus vaccines ‘soon’. Here also the question may crop up: how soon is ‘soon’?

How soon is ‘soon’ – for sooner availability of Covid-19 vaccines?

Experts have opined, a vaccine would normally take years, if not decades, to develop. However, in this unprecedented global health crisis, researchers hope to achieve the same amount of work in only a few months, following the ‘fast track’ regulatory pathway. Let me give a sense of the prevailing buzz around the availability of some of these vaccines.

Going by what the Chief Executive Officer (CEO) of Serum Institute of India said about Oxford-AstraZeneca developed vaccine, many expect their availability by the end of the current year in India. The Company CEO, reportedly, said on July 22, 2020: “By November, we hope to launch the vaccine if the trials are positive and if the Drug Controller of India blesses it and says it is safe and effective.”

Further, on July 28, 2020, Moderna Inc. and Pfizer Inc. also launched two 30,000-subject trials of Covid-19 vaccines that could clear the way for regulatory approval and widespread use by the end of this year, as the companies announced. Notably, both vaccine candidates rely on a new technology that allows for faster development and manufacturing than traditional vaccine production methods, but does not have an extensive track record.

According to another report of July 30, 2020, Russia said, the world’s first COVID19 vaccine to be ready by August 12, 2020. The vaccine is being developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology.

India’s indigenous experimental Coronavirus covid19 vaccine candidate, developed by Bharat Biotech, is also undergoing phase 1 and Phase 2 trials at 12 sites spanning across India. The initial results are positive. Earlier, ICMR had announced its launch on August 15, 2020. However, specialists in this area feel, ‘the August 15 timeline seems totally unrealistic, if not entirely impossible.’

Be that as it may, most experts still think a vaccine is likely to become widely available by mid-2021, about 12-18 months after the new virus, known officially as Sars-CoV-2, first emerged. Bringing to the market a Covid-19 vaccine, no doubt, will be considered as a ‘huge scientific feat,’ but ‘there are no guarantees it will work’ for all. It’s also a point to ponder that ‘Coronaviruses already circulate in human beings. They cause common cold symptoms and we don’t have vaccines for any of them’ just yet, as the report highlights.

It’s, therefore, a clear possibility that a well-documented, safe and effective Covid-19 vaccine may not be available, at least, in the next 6 months. Moreover, access to an affordable Coronavirus vaccine by the global population will also not happen in a jiffy. In that case, it is encouraging to note that other cutting-edge technological initiatives are also moving ahead with a great speed, to bring the rapid transmission of the new Coronavirus under a tight leash.

Novel, non-medical tech initiatives to contain the Covid-19 spread:

As potentially lethal Covid-19 is overwhelming the world, besides search for new drugs, faster diagnosis to fight the infection – and most effective preventive measure – vaccines, several non-medical tech initiatives are also underway. Many of these are quietly heading forward in search of user-friendly solutions, not just to ‘take the pressure off overworked health care workers’, but also ‘to stop the spread of the disease.’ These are all running parallel to offer technology driven disease treatment-options during this global health crisis.

An interesting paper from the European Parliamentary Research Sevice (EPRS), also vindicates some critical developments in this area. It focuses on technology-based solutions for various pressing pandemic-related problems. Let me illustrate this point with one example each, in the areas of ‘taking the pressure off overworked health care workers’, and in ‘stopping the spread of the disease.’

Technology to ‘take the pressure off overworked health care workers’:

Even in India, one hears quite a lot about the hardship of overworked health care workers. Various unconventional ways were also prescribed for the nation to encourage them. Some of these aren’t inexpensive, either. From this perspective, one such application is robotics technology. It can be effectively used as an intelligent solution to reduce the risk of person-to-person transmission − especially in pandemic hotspots. As the above EPRS article highlighted, many countries are now deploying robots in other areas also to ‘take the pressure off overworked health care workers,’ such as:

  • To disinfect whole hospitals,
  • Decontaminate public and private sites,
  • Handle biohazardous waste,
  • Deliver food and medication to infected patients,
  • Taking patients ‘ temperatures and act as medical assistants.

For example, an Israeli-made AI-powered robot assistant is, reportedly, being used in hundreds of hospitals, medical centers, nursing homes, and corporate buildings in Asia. This is to help minimize human-to-human contact as millions of people take precautions due to the novel Coronavirus outbreak worldwide. By the way, Israel is now a good friend of India, too.

Technology ‘to stop the spread of the disease’:

On June 01, 2020, Science Daily reported, the researchers at Penn State, the University of Minnesota and two Japanese universities, have found that a personal, handheld device emitting high-intensity ultraviolet light to disinfect areas by killing the novel Coronavirus, is now feasible.

Another report of July 10, 2020 also brought to the fore that the researchers from the University of Houston have created a new air filter that virus tests at the Galveston National Laboratory found can kill 99.8 percent of COVID-19 instantly. The filter could be useful for killing COVID-19 in public places, such as, in airports and airplanes, in office buildings, schools and cruise ships, besides other closed spaces such as schools, hospitals and health care facilities. Thus, the ability of this “catch and kill” air filter to control the spread of the virus could be very useful for society,” confirmed another report.

On July 29, 2020, an Indian business news daily wrote, ‘Bengaluru-based Organization De Scalene has received clearance from the US Food and Drug Administration (USFDA) and the European Union to license and manufacture Scalene Hypercharge Corona Canon (Shycocan).’ The device disables the virus’ capability to infect, by flooding electrons in closed areas. It is claimed that Shycocan ‘has the ability to neutralize 99.9% of the Coronavirus that might be floating in the air in closed spaces.’

Although, it is not an alternative to medicines that can cure infected people or preventive vaccines, the device can be used to keep Covid-19 at bay, at least, till vaccines arrive. Thus, going by these developments, one gets a sense of various non-medical technological activities post Covid-19 pandemic outbreak. Especially about, how today’s technological whiz kids are working alongside the medical scientists to take the sting out of Covid-19 onslaught.

Conclusion:

The Lancet article – ‘Applications of digital technology in COVID-19 pandemic planning and response,’ published on June 29, 2020, also made similar observations. It said: ‘With high transmissibility and no effective vaccine or therapy, COVID-19 is now a global pandemic.’ In this scenario, to contain the spread of a highly transmissible virus, countries that have quickly deployed digital technologies in various critical areas to contain the spread of the infection, may emerge as front-runners in managing disease burden, the paper concluded.

As of August 02, 2020 morning, the recorded Coronavirus cases in India reached a staggering 1,751,919 with 37,403 deaths. Recent Sero-surveys also show COVID-19 peaks in the country is still far away. It is very likely that a vast majority of the population will survive the Covid-19 catastrophe, even if only the existing systems are followed. But, just surviving is neither the reason nor the purpose of life. What most people want today is finding out a comprehensive way for – ‘jaan bhi and jahan bhi’ (life also, the world also).

Understandably, on July 31, 2020, W.H.O has also reiterated: “The pandemic is a once-in-a-century health crisis, the effects of which will be felt for decades to come.” Under this backdrop, unleashing the potential of new non-medical digital tools, as illustrated above, seem to be of immense benefit – not just to protect many more people from the infection, but also to neutralize Covid-19 effectively, especially in India.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

In Pharma’s Moment of Truth “What You Do is Who You Are”

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It’s a time when pharma industry will be tested, both by its external and internal customers – more than ever before. Looking back, in search of footprints on the sand is no answer either, as there isn’t any. But, a decision on moving ahead has to be made by each drug company in any case – charting a strategic pathway, in search of business excellence, if not for survival. A possibility looms large that the crisis may even overwhelm a company, if any, ill-conceived or ill-thought through steps are taken.

In that sense, the moment of truth has arrived for the industry – a time when ‘what different you do’ in the value delivery process of the business, will decide ‘who you are.’ One’s ability to lead the company or even follow the leadership, to navigate through this crisis, would determine the present and future success of the corporation. This isn’t an easy task. The evolving processes would be challenging to implement, and the traditional mindset may often act as a retarding force, as it were. In this article, I shall explore this critical area with recent examples, as far as possible.

Ability to fathom its most critical component is the bedrock for next steps:

The most critical component in this situation is the ability to make a careful and unbiased assessment of – how different would the ‘new normal’ be from the ‘old normal.’ The focus should not be on the barriers in making the necessary strategic changes, which I hear too often – but how to steer the business through this unprecedented crisis, regardless tough barriers on the way.

Covid-19 threat isn’t going to go away anytime soon:

However, one thing is for sure – no one knows, not just in India, but globally how big the crisis is, and will assume what form, when and how long. Let me give just three illustrations in this area that will be easily understood by all:

  • Initially, experts used to say, face masks are required only for those having symptoms and people close to them. “Masks are not required for those who doesn’t have symptoms. Whereas, the same experts are saying these days, “data now emerging about asymptomatic patients spreading the infection across the country, masks play an important role in containing the spread.” Thus, one is required to wear a face mask always while going outdoors.
  • Explaining the mode of disease spread, earlier, many experts, including the W.H.O, said that COVID-19 virus is primarily transmitted between people through respiratory droplets and contact routes. Thus, a mask is needed when one goes outdoors. Whereas, now the same experts, including the W.H.O, have confirmed that Coronavirus can be airborne indoors. In that case, one may need to wear a mask even indoors.
  • On April 23, 2020 the Director-General of Indian Council of Medical Research (ICMR), reportedly, claimed that the situation is stable, and the country has been able to ‘flatten the curve.’ But on May 09, 2020, Director, AIIMS, reportedly, said, “Currently, the cases are continuing to grow at a flat rate, sometimes even more. So, it is very difficult to predict when the peak will come; but it is likely to peak around June or July…” Whereas, an MIT study, which has also been reported in the press reveals, “India might see 2.87 lakh Covid cases per day by February 2021.”

These instances drive home the point – although a serious threat of Covid-19 infection will continue in the foreseeable future, but the way it will manifest itself, and the fresh precautionary measures that will deem necessary, may change with time. Let me give one more example of increasing threat of getting re-infected by Coronavirus by already infected individuals has heightened today than in the past.

The battle tactics need to be updated:

Strategy for war against Covid-19 onslaught may broadly remain similar. But the battle tactics in the multiple fronts need to be updated on an ongoing basis. This needs to be based on increasing or narrowing of the spectrum of threat and other critical factors, as scientific evidences will reveal from time to time.

For example, as is unfolding today, a large number of already infected people, particularly living in areas with high population density, may not necessarily develop any long-term immunity against the Coronavirus infection. Such a possibility will have a wide impact on any business strategy in the new normal that an organization may contemplate.

The rationale for constantly updating battle tactics:

Let me now focus on the rationale for constantly updating battle tactics based on scientific evidences with a few contemporary examples. The study, published in the Nature Medicine on June 18, 2020, found that individuals recovering from Covid-19 infection may have immunity only for 2-3 months. Although, it may not necessarily be construed that a recovered person can get re-infected, but any vaccine that may eventually come may need to address such issues, which seems to be a tough call.

Alongside, findings of another large research – Spain’s Coronavirus antibody study, published in The Lancet on July 06, 2020, has also cast doubt on the feasibility of herd immunity as a way of tackling the Coronavirus pandemic. As the BBC News reported on July 07, 2020 - based on these findings, Prof. Danny Altmann, British Society for Immunology spokesperson and Professor of Immunology at Imperial College London has made similar comments on effective vaccine development initiatives.

He said, the study would, “reinforce the idea that faced with a lethal infection that induces rather short-lived immunity, the challenge is to identify the best vaccine strategies able to overcome these problems and stimulate a large, sustained, optimal, immune response in the way the virus failed to do.”

“What You Do is Who You Are”: 

As the saying goes: “What You Do is Who You Are.” With this fast-evolving scenario, pharma leadership will need to effectively address a dual strategic game plan to outmaneuver the barriers of the Covid-19 pandemic:

  • Putting in place a robust operating strategy for customer value delivery process of the business.
  • Capturing the details of new Covid19 related ongoing developments to constantly hone the battle tactics in several different fronts.

Both the above processes will involve picking up all such validated research findings, mostly on the run. Mostly because, such issues may impact both internal and external customers of the organization, besides competition. Therefore, factoring-in each of those new developments, while constantly sharpening the war strategy and battle tactics in the fast-evolving scenario, will be of crucial. And, what you think or do in this situation will determine who you are – what type leadership traits you exhibit to face the challenges of the new normal, effectively.

Two types of leadership in the new normal:

Amid challenges of the present crisis, I reckon, top leadership will find two broad types of domain leaders – ‘pro-tradition’ and ‘pro-change’ – both will have successful past track records. They need to be identified for appropriate strategic tasks.

As is known to many, a good number of successful leaders are operating through decades around the concept of physical presence of patients while consulting a doctor or other health care providers. Several of them seem to be still unsure about the extent of organizational and operational changes required to face this unprecedented crisis, head-on. Even today, some of them keep trying to impress others by citing instances of what they did so well in the past.

There is nothing wrong in that. But, the business environment and requirements of those days were different – quite different from today’s demand. Curiously, many of such good leaders, with impeccable past success records, seem to be more bothered about seemingly insurmountable barriers on the way. They are afraid of migrating away or jettisoning the traditional pathway of success. Probably, the fear of failure – after achieving success for a long time, is the reason. I consider these successful professionals as ‘pro-tradition’ leaders.

There are also examples of another type of leaders. They are generally younger, looking forward with a contemporary mindset, nurture a can-do spirit with a resilience to bounce back, even in difficult times. Which is why, any transient fear of failure doesn’t usually overwhelm them. And, these leaders, I reckon, may be broadly termed as ‘pro-change’ leaders.

Keeping aside, past success records or future success potential of pharma leaders, in the current scenario – what they actually think or do in the changing environment to steer the organization out of this never-before crisis, will indeed determine ‘who they are.’

A contemporary initiative sets an example:

Top leadership of several drug companies, such as those at Novartis, is leading the way for a change management as the new situation will demand – by setting examples for others. These leaders seem to be taking note of all changes, as discussed above, while giving shape to a strategy, and reshaping the same based on data, as and when required. Interestingly, more technology professionals are getting attracted to pharma operations during Covid-19 pandemic than ever before, as a recent research report unfolds. This is a good omen for pharma and needs to be leveraged, effectively.

The findings of a new research report:

A new research report from Novartis -  A Powerful Pairing,  emphasizes: “The global COVID-19 pandemic sparked a seismic shift in the adoption and scaling of digital technologies across the healthcare sector at a pace never before seen. Almost overnight, organizations had to dial-up their efforts to develop, manufacture and ultimately bring medicines to patients in a socially distant world.” The survey brings out some interesting points, such as:

  • 86 percent of respondents believe the time has come for digital healthcare, and many of them are interested in taking part.
  • Regardless of the sector they currently work in, the two industries that technology professionals would consider switching to, are technology and healthcare and pharma (49 percent for each). This interest rises to 58 percent for workers based in India and 55 percent for those based in China. They feel, Covid-19 pandemic has made them more aware of medical causes around the world and how important they are. Through work in this sector, they can save countless human lives.
  • 52 percent of technology talent sees innovation potential in the healthcare and pharma sector, with the top reason to apply for a job being the opportunity to innovate through technology.
  • 89 percent technology professionals say that data science is important to the development and delivery of healthcare industry solutions and services.

Conclusion:

Surging ahead to reach a million mark, as on July 12, 2020 morning, the recorded Coronavirus cases in the country reached 850,358 with 22,687 deaths. With a record high of 27,755 daily cases yesterday, the pace of climb continues.

It’s now virtually a writing on the wall that India will have to sail through the unprecedented Covid-19 pandemic for quite some time, where unprecedented leadership interventions will be of critical importance – even in pharma. This endeavor will also call for selective induction of competent technology professionals in all pharma business domains, as required. The challenge involves not just carving out the ‘war strategy’, as it were, against Covid-19, but also continually honing the ‘battle tactics’ in multiple fronts – mostly on the run, for desired outcomes.

The situation calls for taking an in-depth inventory of an organization’s existing human resources, based on success ingredients required to turn the tide, which, I reckon, should also be the starting point in this venture. In this moment of truth – standing at the cross-roads of the drug industry, there is no further room for top pharma leadership to procrastinate the decision-making process. All competent professionals should be taken on board. In tandem, both – seemingly ‘pro-tradition’ and ‘pro-change’ leaders, should be encouraged to realize that in the new normal “What You Do is Who You Are” in the future pharma business.

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.

Would ‘Complex Generics’ Attract More ‘Authorized Generics’?

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Despite increasing numbers of alleged scams involving generic drugs, both in the United States and also in India, even involving many large generic drug manufacturers, the traditional generic drug market, keeps growing globally. Although, the current growth is in mid-single digit, the market can’t be ignored, either.

That apart, enormous pricing pressure, squeezing bottom line and cutthroat competition, are prompting many companies, including Big Pharma, to craft different strategies to excel in this market. One such involves a shift in business focus from relatively low priced traditional generic drugs to comparatively higher priced complex or specialty generic medicines with a few competitors.

In this emerging situation, a lurking apprehension does surface for many. If the margin is good and the prices of these complex or specialty generics, are much higher than traditional ones, won’t it prompt more ‘Authorized Generics’ coming into the market? Won’t that jeopardize the interest of other generic drug makers? In this article, I shall explore this area, along with its possible consequences. Before doing that, it will be worthwhile to give an overview of the generic market, before recapitulating what are ‘Authorized’ and ‘Complex’ generics.

How lucrative is the generic drugs market now?

According to the latest report by IMARC Group, the global generic drug market size reached US$ 340 Billion in 2018 and is expected to be at US$ 475 Billion by 2024, growing at a CAGR of 5.3 percent during 2019-2024 period.

The key market growth drivers remain, increasing number of product patent expiration, higher prevalence of chronic diseases and different government initiatives to encourage faster generic launch, including the United States. The pace of increase is faster in the emerging markets, like India. However, unlike India, non-branded generic drugs, rather than branded generics, are dominating most the markets.

Although, Central Nervous System (CNS), cardiovascular, dermatology, oncology and respiratory are among the dominant segments in the market, CNS and Cardiovascular segments are the two largest ones in this market. North America holds the largest market share, with more than 88 percent of total prescriptions being written for generic drugs in the U.S., as the report highlights. Despite this scenario, to mitigate huge pricing pressure, cutthroat competition and low margin, many drug players are preparing to move into specialty or complex generics.

The size and growth of complex or specialty generics market: 

The April 2019 report by Research and Markets- “Specialty Generics Market: Global Industry Trends, Share, Size, Growth, Opportunity and Forecast 2019-2024″ states, the global specialty generics market reached a value of US$ 44.8 Billion in 2018. By 2014, its value is expected to reach US$ 88.9 Billion with a much higher CAGR of 11.9 percent, in 2019-2024 period.

Which drugs would belong to this market?

According to the ‘White Paper’ titled, ‘Complex Generics: Maximizing FDA Approval Prospects’ of Parexel, the following are some examples of complex generics; the list continues to grow as more products are being added in this category every day:

  • Complex Active Pharmaceutical Ingredients (APIs), examples being Enoxaparin, Low Molecular Weight Heparin, Glatiramoids, Iron Carbohydrate Complexes etc.
  • Complex Formulations, examples being Liposomes, abuse-deterrent generics, parenteral microspheres.
  • Complex Route of Delivery, such as topical ointments and locally acting GI drugs.
  • Complex Drug-Device Combinations, such as DPI, MDI, nasal sprays, and transdermal systems.

These types of complex and high-cost generics, besides some off-patent biologic products and even Biosimilar drugs, are often used to treat complex and life-threatening diseases, such as, cancer, Hepatitis C, and many others. Complex generics are expected to eventually own a significant percentage of the total generic drugs market, as a number of big-ticket specialty drug molecules will go off patent in the ensuing years.

The major advantages of complex generics:

Some of the major advantages of the complex generics market over traditional generics are as follows:

  • Complex manufacturing requirements with higher capital costs – thus, higher price, better margin, fewer players, lesser competition.
  • Increasing prevalence of life-threatening diseases, besides, cost containment measures from the government and healthcare providers, are pushing the demand of these drugs.

Indian companies are also entering the fray: 

As the share of specialty medicines in global spending in 2017 increased to 32 percent from 19 percent in 2007, Indian drug players also could sniff the opportunity in this space. Just as Sun Pharma, reportedly shifted its focus from once lucrative traditional generics medicines to specialty drugs, amid continued price erosion in its biggest market – the US, many others are also joining the fray.  The Indian players who are, reportedly, investing in complex generics include, Aurobindo Pharma, Dr. Reddy’s Labs, Cipla, Lupin, Glenmark and Cadila.

More specifically, with the contribution of specialty medicines to overall pharmaceutical spend in the US, Germany, France, Italy, UK, and Spain – almost doubling over the last 10 years, this trend is likely to gather momentum, as the above report indicated. Accordingly, commensurate strategic actions aimed at this segment by many companies, both global and local, are clearly now visible.

Some strategic initiatives:

In preparation of a major shift in the strategic focus on complex generics, key examples of some of the important initiatives of different companies will include the following:

  • Big generic players wanted to be bigger in the global market through M&A, such as Teva acquired Allergan’s generic business, Mylan bought Abbott Laboratories’ generics businessAbbott Laboratories’ non-U.S. developed markets specialty and branded generics business. Similarly, Endo International acquired Par Pharmaceuticals. In India the mega deal of Sun Pharma acquiring Ranbaxy in 2015. In the same year, Lupin acquired New Jersey-based generic drugs firm GAVIS to boost its presence in the US.
  • Novartis sold its 300 ‘troubled’ U.S. generics to India’s Aurobindo for US$ 1B, as the entire generics industry faced unrelenting pricing pressure in the U.S.’ Whereas, Novartis’ wants to focus higher-margin assets like Biosimilars and complex generics.
  • Pfizer is set to combine its off-patent drug unit Upjohn with Mylan, to create a new business with its own off-patent branded and generic drug lines. The merger will bring together Pfizer medications such as Lipitor and Viagra with Mylan’s EpiPen, used to halt life-threatening allergic reactions.
  • Owing to margin pressure and other reasons, some of the Indian drug players also decided to enter into higher margin complex generics space, pursuing both organic and inorganic routes. There are several such examples, such as: In January 2017, Zydus Cadila announced acquisition of Sentynl Therapeutics Inc., a US based specialty pharma company specialized in marketing of products in the pain management segment. And in October 2017, Lupin acquired US-based Symbiomix Therapeutics LLC to expand Lupin’s US women’s health specialty business in the highly complementary gynecological infection sector.

Any flip side of complex generics business for the Indian players? 

Although, driven by mainly higher profit margins and tough entry barriers, many generic players with the requisite wherewithal, find complex generics business more attractive to focus on, there’s a flip side to it, as well. This is, post patent expiry, innovator companies may be encouraged to introduce more ‘Authorized Generics’, creating a tough competitive environment for other generic players to compete with them. This brings us to the question of what are ‘Authorized Generics?’

Authorized Generics:

According to the USFDA, the term ‘Authorized generic’ is used to describe an approved brand name drug that is marketed without any brand name on its label. It is exactly the same product as the branded one, and may also be marketed by another company with the innovator company’s permission. Generally, an ‘Authorized Generic’ is launched at a lower price than the brand name drug.

Moreover, ‘Authorized Generics’, despite being the generic version of patented molecule, are mostly marketed by the patent holders themselves, both pre and post patent expiry. While a separate NDA is not required for marketing an ‘Authorized Generic’, USFDA requires that the NDA holder notify the FDA, if it markets an ‘Authorized Generic. The NDA holder may market both the ‘Authorized Generic’ and the brand-name product at the same time. Interestingly, the USFDA has approved around 1215 ‘Authorized Generics’ as of September 30, 2019.

Advantages of ‘Authorized Generics’ over ‘Traditional Generics’:

The key advantage of ‘Authorized Generics’ over traditional generic drugs is, while traditional generic drugs can be marketed only after patent expiry of the innovator drug, ‘Authorized Generics’ can be marketed even before patent expiry. In other words, innovator companies or their authorized collaborators can make lower priced ‘Authorized Generic’ versions available on their behalf, under their own new drug application (NDA). ‘Authorized Generics’ may be made available to patients even before patent expiry to out-maneuver the conventional generic drug makers, in advance, on price, quality and doctors’ confidence in the original drug.

According to several reports, over the past years, ‘many innovator drugs companies have been launching Authorized Generics, simultaneously with the first Abbreviated New Drug Applications (ANDA) filer’s launch of its generic drug product.’ However, the question remains how do the stakeholders perceive the ‘Authorized Generics’?

Perception of ‘Authorized Generics’:

Studies are available analyzing the impact of ‘Authorized Generics’ on the pharma market and also on the stakeholders. In this article, I shall refer to a comprehensive research study, titled ‘Authorized Generics: Effect on Pharmaceutical Market,’ published in the International Journal of Novel Trends in Pharmaceutical Sciences (IJNPTS), on February 29, 2012, which came out with the some notable findings.

Generally, there isn’t any doubt, either on the fact that ‘Authorized Generics’ provide the identical experience that the patient receives from the brand drug but at a lower price. Nor is there any question over greater confidence of doctors while prescribing these drugs. However, the researchers wrapped up the discussion by stating: It is difficult to conclude that the ‘Authorized Generics’ practice should be continued or banned. Though Indian pharmaceutical companies are dealing with generic drugs – 42 percent of the respondents were in favor of ‘Authorized Generics’ practice, whereas 58 percent opposed it. Thus, the overall perception of ‘Authorized Generics’, appears to be a mixed bag.

Conclusion:

There are free flowing arguments both in favor and against the ‘Authorized Generics.’ The article titled, ‘Drugmakers Master Rolling Out Their Own Generics to Stifle Competition,’ published in the Kaiser Health News (KHN) on August 05, 2019, captures it well.

It quoted the spokeswoman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, a powerful pharma lobby group saying, an Authorized Generic drug “reduces prices and results in significant cost savings.” Whereas the critics say, “Authorized Generics hurt long-term competition and often perversely increase costs, even in the short term.”

The detractors further expressed, ‘Authorized Generics’ don’t just steal sales from existing generic rivals, they erode incentives to make generic drugs. A professor at the University of California, Hastings College of the Law, who studies pharma was also quoted in this article saying, this practice can “stave off generic competition and make sure that generics can’t get much of a foothold when they do get to market.” Adding further he said: “That’s the game. And drug companies have become masters at this.”

As the Kaiser Health News highlighted, Eli Lilly announced launch of the ‘Authorized Generic’ version of Humalog insulin in March 2019 for US$137 a vial, at half the price of its brand name version costing US$237. This was reasoned by the company as a considerate move to address the need of those patients who can’t afford the price of the brand – Humalog. Curiously, even some analysts believe that ‘Authorized Generics’ may help explain why relatively few true generics are reaching the market despite a surge in approvals, especially in the United States.

Against the above backdrop, the drug policy makers need to ponder, would ‘complex generics’ of different companies face greater challenges from ‘Authorized Generics,’ playing a spoilsport for the rest in this ball game?

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.

 

 

Antimicrobial Resistance: A Recent Perspective

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On January 23, 2018, at the World Economic Forum in Davos, Switzerland – the first independent analysis of pharmaceutical industry efforts to tackle antibiotic drug resistance, was published by the Netherlands based Access to Medicine Foundation.

The issue of Antimicrobial Resistance (AMR) was brought under focus by the World Economic Forum (WEF) not for the first time at Davos in 2018. Its 2013 Annual Report on global risks, also underscored the gargantuan health hazard that AMR poses to mankind. It said, we live in a bacterial world where we will never be able to stay ahead of the mutation curve. A test of our resilience is how far the curve, we allow ourselves to fall behind. It’s indeed a profound statement!

In that sense, the AMF analysis is important. More so, when the global population is virtually at the threshold of facing a situation very similar to pre-antibiotic era, where even a common infection used to pose threat to a life. And now, a fast-developing AMR to many effective antibiotics or even super-antibiotics, are making them almost redundant in many serious conditions. Consequently, around 700,000 people die every year only due to antimicrobial resistance, the world over.

The World Health Organization (WHO) also reiterated its grave concern in this area by a news release on September 20, 2017. It cautioned, “Antimicrobial resistance is a global health emergency that will seriously jeopardize progress in modern medicine.” Against that backdrop, in this article, I shall dwell on some latest developments in this area, both globally and also in India.

Dire need for newer antibiotics – but dry R&D pipeline:

At the very outset, let me flag another critical area that is intimately related to this concern. An article titled, “Where Are the Antibiotics?”, published by the AARP Foundation adds more to this growing concern. It writes, in an era when many breakthrough innovative drugs are curing some of our most deadly afflictions, the quest for meeting the unmet medical needs, seems to have shifted away from development of critically needed breakthrough antibiotics to effectively address AMR, for various reasons.

The author further highlighted that between the time penicillin was discovered in 1928, and the 1970s – 270 antibiotics were approved – a robust arsenal of powerful drugs that kept almost all bacterial infections at bay. However, since then, research into new antibiotics has declined dramatically. Today, just five of the top 50 big drug companies are reportedly developing innovative antibiotics – the article reiterates.  Nevertheless, some recent developments in this area can’t be ignored, either, which I shall touch upon in this discussion.

Global initiatives for a multi-pronged concerted action:

It is understandable that there are no magic bullets to address the fast-growing menace of AMR. It calls for a multi-pronged strategy with well-orchestrated concerted efforts for its effective implementation with military precision. Following are the three primary constituents who should lead from the front in the battle against AMR, as I reckon:

  • The world leaders
  • Each country, individually
  • Pharmaceutical industry, both global and local

The medical profession, including hospitals, nursing homes, the retail chemists and individual patients, also play a significant role to alleviate this problem, especially in India and other developing countries. But, I shall keep that as a subject for a separate discussion, altogether. Let me now touch-upon the first three constituents, one by one, as follows:

1. The world leaders’ initiative:

Realizing that failure to act on AMR will result in a global health and financial crisis, the world leaders met to address this growing menace. Accordingly, on September 21, 2016, the United Nations General Assembly (UNGA) passed a declaration aimed at slowing the spread of antibiotic-resistant superbugs. At this meeting in New York City, the top UN leaders successfully urged all governments to sign a political declaration to tackle the problem of AMR, both globally and in their respective countries. The joint declaration requires each country to develop a 2-year plan to protect the potency of antibiotics for both livestock and humans. The progress of the initiative for each country at the end of those 2 years will be evaluated. However, in this article, I shall focus only on the agreed human-specific actions, which include the following:

  • Antibiotics should be prescribed only when they are absolutely necessary
  • A massive education campaign about antibiotic resistance.
  • Greater monitoring of superbugs to understand the scope and magnitude of the problem.
  • Safeguarding current antibiotic stockpile.

The leaders suggested that people should be encouraged to help prevent the crisis from turning into a death sentence for millions, with the steps, such as:

  • Get available vaccines to prevent illness
  • Stop asking doctors for antibiotics when they have the cold or flu, as antibiotics treat neither
  • To urge their political leaders to commit to action in combating antibiotic resistance.

2. Country-specific initiatives:

In September 2016, just a year after the UNGA high-level meeting on AMR, an update by the United Nations Foundation reported that 151 countries out of 195 WHO member states have responded. The overall response includes the following, among others:

  • 85 percent of countries are developing or have developed National Action Plans (NAC).
  • 52 percent of countries have a fully developed plan with ‘One Health’ approach that seeks to unify human and veterinary medicine, agriculture, and food providers against the progression of AMR by reducing agricultural antimicrobial use.
  • 52 percent of Low and Middle-Income Countries (LMICs) have national-level measures in place on ‘Infection Prevention and Control (IPC)’ measures in human healthcare.

3. Pharmaceutical industry initiatives: 

I shall cite only the latest commendable developments in this area, as I see it. On Jan. 21, 2016 a document titled the ‘Declaration on Combating Antimicrobial Resistance’, was launched, again, as part of the World Economic Forum at Davos, Switzerland.

For the first time, 85 pharmaceutical, biotechnology, generic-drug, and diagnostic companies agreed on a common set of principles for global action to support antibiotic conservation and the development of new drugs, diagnostics, and vaccines. The document, outlining several critical measures the government and industry must take to increase antibiotic effectiveness worldwide, was also drafted and signed by nine industry associations spanning 18 countries.

Global progress assessment of AMR initiatives in 2018:

This brings me back to where I started from, while analyzing what happened in this regard a year after the above declaration was signed. On January 23, 2018, at the World Economic Forum in Davos, Switzerland – the first independent analysis of pharmaceutical industry efforts to tackle drug resistance, was revealed by the AMF. It found companies are developing new drugs, as well as dismantling the incentives that encourage sales staff to oversell antibiotics, setting limits on the concentration of antibiotics in factory wastewater released into the environment, and tracking the spread of superbugs.

In the AMR Benchmark, GSK and Johnson & Johnson lead among the largest research-based pharmaceutical companies. A separate ranking of manufacturers of generic antibiotics features Mylan, Cipla, and Fresenius Kabi Global, in the leading positions. While Mylan leads the generic medicine manufacturers, Entasis, reportedly, leads the biotechnology group. 

Twenty-eight antibiotics are in late stages of development:

The other key findings of the 2018 study include mention of 28 antibiotics that are in later stages of development, targeting pathogens deemed critical AMR priorities by the WHO, and/or US Centers for Disease Control and Prevention. However, only two of these 28 candidates are supported by plans to ensure they can be both made accessible and used wisely if they reach the market. Be that as it may, the benchmark finds room for all companies to improve in this space, the report indicated.

Some major initiatives in India:

The good news is, ‘The National Policy for Containment of Antibacterial Resistance’, with similar objectives, was put in place in India by the Directorate General of Health Services, Ministry of Health & Family Welfare, way back in 2011. Further, on March 20, 2015, to strengthen the surveillance of antimicrobial resistance (AMR) in the country, Indian Council of Medical Research (ICMR) had set up a National Antimicrobial Resistance Research and Surveillance Network (AMRRSN) to enable compilation of national data of AMR at different levels of health care.

Again, in February 2017, the Indian Council of Medical Research (ICMR)  has put a new ‘Treatment Guidelines for Antimicrobial Use in Common Syndromes’, to achieve the same objectives. Despite this, as many medical experts opine, a large number of General Practitioners (GP), including hospitals, nursing homes continued over-prescribing antibiotics. Alarmingly, considered as the last line of defense antibiotics by many doctors – Colistin and Carbapenem resistant infections have also been reported from several Indian hospitals. All this adds further fuel to the AMR fire.

Another matter of huge worry in India:

The February 04, 2018 article titled, ‘Threats to global antimicrobial resistance control Centrally approved and unapproved antibiotic formulations sold in India,’ published in the British Journal of Clinical Pharmacology, highlight serious hurdles for controlling antimicrobial resistance in India, which has had parliamentary investigations into the failures of the country’s drug regulatory system. The study was conducted by researchers from Queen Mary University in London, Newcastle University and Lakshya Society for Public Health Education and Research in Pune. Some of the key findings of the study are as follows:

  • Extensive use unapproved of fixed dose combination (FDC) antibiotics is contributing to the rising rate of AMR in India, which is already one of the highest in the world.
  • Out of the 118 of FDC antibiotics being sold in India, only 43 (36 percent) were approved by the CDSCO. These 118 antibiotic formulations are being sold in 3307 brand names and manufactured by 476 entities. Of these, 464 were Indian manufactures, and 12 were MNCs.

The authors recommend work on understanding why unapproved formulations are being prescribed by medical professionals.

Conclusion:

As the above AARP Foundation article highlights, like all living beings, bacteria constantly evolve to survive. While encountering a new antibiotic, they quickly find ways to evade it, and continue to live or exist. Some have even developed cell wall like virtually impregnable shields, as it were, keeping antibiotics out. Others pump antibiotics out when they get in. Several deadly bacteria have even devised ways to deactivate antibiotics.

The comments made in the article titled, ‘The Future of Antibiotics and Resistance,’ published by The New England Journal of Medicine (NEJM) on January 24, 2013, is also worth noting. It says, the converging crises of increasing resistance and collapse of antibiotic research and development are the predictable results of policies and processes we have used to deal with infections for 75 years. If we want a long-term solution, the answer is not incremental tweaking of these policies and processes. Novel approaches, based on a reconceptualization of the nature of resistance, disease, and prevention, are needed.

The bottom line still remains, AMR is a humongous threat to the global population, not just in India. While its awareness is gradually increasing, much more painstaking work remains to be done by all, both individually and collectively, to contain this global health menace. It’s our responsibility to protect the well-being of our future generations.

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.

India urgently needs a total overhaul and reform of its public healthcare system with a holistic approach – NRHM and RSBY are laudable initiatives.

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Over a period of time India had made significant improvement in various critical health indicators despite frugal public health spending by the government, which is just around 1 percent of GDP of the country. Such a low government spend towards public health takes India to the bottom 20 percent of countries of the world, in this respect.Overall progress of the country’s public healthcare system is, consequently, commensurate to the nation’s spending towards this vital sector. Only 35 percent of country’s population has now access to affordable modern medicines. Even many ASEAN countries are far ahead of India in their achievements towards public healthcare services. Such a grim scenario prompts us to understand the infrastructural and financial dimensions of the public healthcare system of the country to enable us to suggest appropriate reform measures for this sector to the policy makers.Very recently, the Prime Minister of the country Dr. Manmohan Singh indicated the intent of his government to raise the government spending towards public health to around 3 percent of the GDP. Health being a state subject in India, both the State and Central Governments will need to take their best foot forward towards this direction.

Fund Allocation towards public healthcare:

In the Eleventh Five Year Plan, the fund allocated by the government towards public healthcare shows a significant increase. The launch of ‘National Rural Health Mission (NRHM)’, which emphasizes community based monitoring along with decentralized planning and implementation augers well for the nation and vindicate, at least, the resolve of the government towards this direction.

Impediments to make NRHM a great success:

There are some serious infrastructural requirements to scale-up NRHM and make it successful. These are as follows:

1. More number of specialists, doctors, nurses and paramedics

2. More medical colleges and nursing schools

3. Less developed states should be financially and technologically helped to create public healthcare infrastructure

4. The student teacher ratio to be enhanced in specialties and super specialties from the current level of 1:1 to 2:1

5. Capacity building at the Medical colleges of the State Governments needs to be considered without further delay

6. The number of post-graduate medical seats needs to be increased, all over the country.

It is envisaged that all these critical steps, if taken with missionary zeal, will help increasing the number of post-graduate specialists from the existing level of 13000 to 18000, in the next five years.

Healthcare delivery:

Even if all these are achieved public healthcare delivery will still remain a key issue to achieve the country’s objective to provide affordable healthcare to all. The poor and marginalized people of our society must be covered adequately by the public healthcare system to the best extent possible.

Improving access:

To improve access to public healthcare services for the common man, India very badly needs structural reform of its public healthcare system, with a clear focus on preventive healthcare. This will in turn help the country reduce the burden of disease.

Healthcare financing:

In 2001 The Journal of Health Management in a study using National Health Accounts (NHA) as a tool of analysis reported:

“76 per cent of health sector revenues come from private sources, of which almost 50 per cent go to private providers and 21 per cent are spent on drugs. Further, 7 per cent of household out-of-pocket expenditure is used as non-drug expenditure for using government facilities for out-patient and in-patient treatment. This has important policy implications for the government.”

Along with increasing healthcare needs across all sections of the society, especially in the low income and the backward states, a very high percentage of out-of-pocket household expenditure towards healthcare, low public budgetary allocations and sluggish health outcomes, are calling for a robust healthcare financing model for the country.

Why is healthcare financing so important in a developing country like, India?

The largest number of poor population of the world resides in India. It has been reported that around three-fourth of over one billion population of the country earns less than two dollars a day. Coupled with poor hygienic condition this section of population is more prone to various illnesses, especially tropical diseases. India is one of those very few emerging economic super powers where around 90 percent of its population is not covered by any form of health care financing.

Under such circumstances, it has been widely reported that the poor very often will need to borrow money at a very high rate of interest or sell whatever small assets they own, further eroding their capability to come above the poverty line, in the longer term.

Thus to provide adequate health insurance cover to the marginalized section of the society including a large number of the rural population, the country is in a dire need to develop a workable and tailor-made healthcare financing model instead of pushing hard the existing ones. This tailor-made model should also include the domiciliary treatment, besides costs of hospitalization.

New healthcare reform process in India should include the healthcare system in its entirety with a holistic approach, starting from access to healthcare to its management and delivery, strengthened by a robust micro-healthcare financing system.

Rashtriya Swasthya Bima Yojna (RSBY): A good initiative by the government:

To partly address the above issue, on October 1, 2007 the Government of India announced a health insurance scheme for the Below Poverty Line (BPL) families in the unorganized sector called Rashtriya Swasthaya Bima Yojna (RSBY).

In RSBY, BPL families are entitled to more than 700 in-patient medical procedures with a cost of up to 30,000 rupees per annum for a nominal registration fee of 30 rupees. Pre-existing medical conditions are covered and there is no age limit. Coverage extends to the head of household, spouse and up to three dependents.

RSBY appears to benefit those people who need it the most. However, how effective will be the implementation of this scheme, still remains a key question. If implemented exactly the way the scheme was conceived, it has the potential to address the healthcare financing issue of around 28 percent of the population currently living below poverty line.

The initial response of RSBY has been reported to be good, with more than 46 lakh BPL families in eighteen States and Union Territories having been issued biometric smart cards, so far.

Conclusion:

To provide affordable healthcare services to all, India urgently needs a total overhaul and reform of its public healthcare system with a holistic approach. The steps so far taken by the government with the launch of NRHM and RSBY are laudable, but are these enough?

By Tapan 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.

Dire need of quality ‘Cold Chain’ infrastructure for pharmaceuticals in India and its efficient management through Public Private Partnership initiatives.

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Why Cold Chain for pharmaceuticals?Drugs are complex entities and many of these are temperature sensitive in nature. This entails them requiring precise and continuous temperature conditions in transit in order to retain their potency and resultant efficacy.Many life saving drugs including biotech products and vaccines fall under such category. Any break in the cold chain process for such drugs can lead to immediate denaturing or deterioration in their quality parameters. It is imperative that a careful consideration is given by all concerned including government agencies mainly at the seaports and airports while providing storage space at their warehouses for such drugs.

Current bottlenecks and lack of proper cold chain infrastructure:

Currently in India there are bottlenecks at the Airports and Seaports that include authorities not being able to assure cold room space despite getting advance notices from the pharmaceutical companies about the possible unloading of large consignments of temperature sensitive products.

Some of the other gaps include improper training and refresher courses for the handling staff who handle such products at the ports. Storage of Pharmaceutical products along with meat and food products is against the GMP norms.

Cold Chain medicines require different and special temperature control:

Cold Chain Medicines require special temperature controlled Cold storage. There are two commonly recommended temperatures specified on labels of cold chain products:

1. Products requiring temperature between 2 to 8 degree centigrade

2. Products requiring temperature around -10 to -20 degree centigrade

Cold Chain should be an uninterrupted series of storage and distribution activities which will maintain required temperature range of 2 to 8 degree centigrade or -10 to -20 degree centigrade as per products requirements.

Proper Cold Chain Management system is essential to ensure right product quality:

Proper Cold Chain Management of pharmaceuticals will ensure that the right quality of such products is maintained not only during storage but during transportation also to meet regulatory specifications. There is a greater focus and stringent regulatory guidelines/standards are in place today in the developed markets around the world for strict adherence to right storage and transportation process for cold chain sensitive pharmaceuticals.

It should be kept in mind always that Cold Chain products are mostly sensitive biological substances that can become less effective or lose potency if not properly stored.

Some examples:

Products requiring 2 to 8 degree storage will not be effective if:

i. They are frozen or stored below 2 degree centigrade
ii. Exposed to temperatures above 8 degree centigrade
iii. Exposed to direct sunlight or fluorescent light

The loss of potency is cumulative and irreversible. If products are exposed to conditions outside the established range, the quality may be adversely affected, reducing their assigned shelf life, diminishing their effectiveness or making them ineffective. The exposed product may look just as the same – the loss of potency may not be visible.

World class SOPs for Cold Chain storage and handling facilities are essential :

Quality of storage and handling of Cold Chain Pharmaceutical products at Airports and Seaports in the course of export from or import into India requires special care and attention. Since multiple products are stored and handled at Seaports/ Airports, personnel may not be able to appreciate the special need for Cold Chain pharmaceuticals’ storage & handling. Thus, there should be Standard Operating Procedures (SOPs) for storage and handling of pharmaceuticals laid down by the Port Management authorities, so that the personnel handling pharmaceuticals strictly adhere to the pre-set norms.

Pharmaceutical products requiring cold chain facilities are rapidly growing in numbers:

Pharmaceutical Products for which efficient Cold Chain facilities are required are rapidly growing in numbers. In their movement across the supply chain from the manufacturers to the patients, the medicines are handled and stored by various stakeholders like transporters, Airports, Seaports, Distributors, Stockists, Retailers etc. Since the storage and handling of Cold Chain Pharmaceuticals Products are unique, an uninterrupted Cold Chain is to be maintained in the entire supply chain network without any discontinuity, even for a short while. This will ensure that medicinal products of high quality reach the patients, always. it is, therefore, very important for all concerned stakeholders to ensure maintenance of proper Cold Chain facilities.

Government plan of “Pharma Zones” in India:

The Drugs Controller General of India (DCGI) has planned a separate dedicated controlled environment – ‘Pharma Zone’, within the cargo premises at Airports and Seaports for proper storage of Pharmaceutical products in line with Good Manufacturing Practices and Good Distribution Practices so as to assure right quality, safety and efficacy of Pharmaceutical products, which are to be either imported or exported.

Currently no ‘Pharma Zones’ in India:

At present there are no ‘Pharma Zones’ in India. However, Mumbai International Airport Private Limited (MIAL) has created 4 new cold rooms for pharmaceuticals. It has been reported that the new Cargo Terminal of Delhi International Airports Limited (DIAL), which is expected to be commissioned later in the year, will have around 4000 square metres of additional cold room capacity compared to the current cold room capacity of 400 square metres. Similarly, MIAL is also planning for a dedicated Cold Room facility for Pharmaceutical Products in their new set–up.

Need for outsourcing Cold Chain services:

In the developed markets of the world there are private cold chain storage and third party logistics providers to offer contract logistics and storage services especially to cater to the growing demands of the Biopharmaceutical segment, which is now the fastest growing manufacturing sector within global pharmaceutical industry.

It is expected that spend of the Biopharmaceutical companies towards outsourcing of cold chain facilities will grow by over 10% to 15% for the next three to five years in the developed markets. India being the second largest producers of Biopharmaceuticals after China, similar opportunities exist in the country.

In India some renowned international courier companies like DHL and World Courier have been reported to have developed an efficient cold-chain management process, especially for the pharmaceutical companies to properly maintain the cold chain in their logistics network.

Conclusion:

A world class cold chain infrastructure and its efficient management within the country will help immensely to Indian domestic pharmaceutical companies, as well, as they are exploring more and more opportunities to export Biopharmaceuticals in the global market. To achieve this objective modern cold chain warehouses and their efficient management as per regulatory guidelines will play a key role in ensuring right product quality standard that India will export.

Over a period of time cold-chain management practices of global standards will be required to achieve this goal. Currently for both import and export of cold-chain sensitive pharmaceuticals, as indicated above, the available infrastructural facilities pose to be one of the key challenges encountered by the industry to maintain high product quality during shipment and warehousing at the ports. Individual pharmaceutical companies like Eli Lilly, India have their own vehicles equipped with cold-chain management systems for transportation of their cold chain sensitive products.

Greater initiative by the DCGI in particular in this area, in collaboration with the Indian pharmaceutical industry, sooner, is absolutely essential. For the patients’ sake.

By Tapan 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.

Leverage Information Technology (IT), Health Insurance and ‘Jan Aushadhi’ initiatives to address the burning issue of ‘Access to Affordable Integrated Healthcare to all’ in India.

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Despite so much of general focus, stringent Government control, debate and activism on the affordability of modern medicines in India, a vast majority of Indian population still do not have access to basic healthcare facilities.The degree of poor access to healthcare in general may vary from state to state depending on economic resources and the quality of governance. However, despite the success of the Government to make medicines available in India cheaper than even Pakistan, Bangladesh and Sri Lanka, it has been reported that about 65% of Indian population still do not have access to affordable modern medicines compared to 15% in China and 22% in Africa.Lack of adequate healthcare infrastructure:

One of the key reasons of such poor access is lack of adequate healthcare infrastructure. As per the Government’s own estimate of 2006, India records a shortage of:

1. 4803 Primary Health Centres (PHC)
2. 2653 Community Health Centres (CHS)
3. Almost no large Public Hospitals in rural areas where over 70% of the populations live
4. Density of doctors in India is just 0.6 per 1000 population against 1.4 and 0.8 per 1000 population in China and Pakistan respectively , as reported by WHO.

Moreover, doctors themselves do not want work in rural areas, probably because of lack of basic infrastructural facilities. We have witnessed public agitation of the doctors on this issue, in not so distant past.

National Health Policy and Healthcare Expenditure:

Two key primary focus areas of the Government, everybody agrees, should be education and health of its citizens. Current National Health Policy also planned an overall increase in health spending as 6% of GDP by 2010. However India spent, both public and private sectors put together, an estimated 5% of GDP on healthcare, in 2008.

If we look at only the spending by the Government of India towards healthcare, it is just 1.2% of GDP, against 2% of GDP by China and 1.6% of GDP by Sri Lanka, as reported in the World Health Report 2006 by WHO.

During the current phase of global and local financial meltdown, as the government will require to allocate additional resources towards various economic stimulus measures for the industrial and banking sectors, public healthcare expenditure is destined to decline even further.

The silver lining:

However we have seen the United Progressive Alliance (UPA) Government allocating around US$2.3 billion for the National Rural Health Mission (NRHS). The Government announced that NRHS aims to bring about uniformity in quality of preventive and curative healthcare in rural areas across the country.

Inefficient healthcare delivery system:

Despite above silver lining of additional resource allocation, the net outcome does not appear to be so encouraging even to an eternal optimist, because of prevailing inadequacy within the system.

The reasons for such inadequacies do not get restricted to just rampant corruption, bureaucratic delay and sheer inefficiency. The way Government statistics mask inadequate infrastructural facilities is indeed equally difficult to apprehend. A recent report from ‘The Economist’, which reads as follows, will vindicate this point:

‘…around 20% of the 600,000 inhabited villages in India still have no electricity at all. This official estimate understates the extent of the problem, as it defines an electrified village—very generously—as one in which at least 10% of households have electricity’.

Leveraging the strength of Information Technology (IT) to considerably neutralize the system weaknesses:

One of the ways to address this problem is to utilize the acquired strengths of India wherever we have, to neutralize these weaknesses. Proficiency in ‘Information Technology’ (IT) is one of the well recognized key acquired strengths that India currently possesses. If we can optimally harness the IT strengths of India, this pressing healthcare issue could possibly be addressed to a significant extent.

One such IT enabled technology that we can use to address rural healthcare issues is ‘cyber healthcare delivery’ for distant diagnosis and treatment of ailments. Required medicines for treatment could be made available to the patients through ‘Jan Aushadhi’ initiative of the Department of Pharmaceuticals (DoP), by utilising the Government controlled distribution outlets like, public distribution system (ration shops) and post offices, which are located even in far flung and remote villages of India.

Please use the following links to read more about these subjects:

http://www.tapanray.in/profiles/blogs/healthcare-services-in-india

http://www.tapanray.in/profiles/blogs/jan-aushadhi-medicines-for

Sources of Healthcare financing in India:

Currently the sources of healthcare financing are patchy and sporadic as follows, with over 70% of the population remaining uncovered:

1. Public sector: comprising local, State and Central Governments autonomous public sector bodies for their employees

2. Government health scheme like:

• ‘Rashtriya Swasthya Bima Yojana’: for BPL families to avail free treatment in more than 80 private hospitals and private nursing homes.
• ‘Rajiv Gandhi Shilpi Swasthya Bima Yojana’ by Textile Ministry: for weavers.
• ‘Niramaya’ by Ministry of Social Justice and Empowerment: for BPL families.

3. Private sector: directly or through group health insurance for their employees.

4. ‘Karnataka Yeshavini co-operative farmers’ health insurance scheme: championed by Dr. Devi Shetty without any insurance tie-up.

5. ‘Rajiv Aarogyasri’ by the Government of Andhra Pradesh for BPL families: a Public Private Partnership initiative between Government, Private insurance and Medical community.

6. Individual health insurance policies.

7. External Aid like, Bill & Melinda Gate Foundation, Clinton Foundation etc.

Grossly inadequate health care financing in India, out of pocket expenses being over 70%:

Proportion of healthcare expenditure from financing source in India has been reported as follows:

• Central Government: 6%
• State Government: 13%
• Firms: 5%
• Individual Health Insurance: 3.5%
• Out of pocket by individual household: 72.5%

Need for Health Insurance for all strata of society to address the issue of affordability:

Even after leveraging IT for ‘cyber healthcare diagnosis’ and having low priced quality medicines made available from ‘Jan Aushadhi’ outlets of DoP, healthcare financing to make healthcare delivery affordable to a vast majority of the population will be an essential requirement.

According to a survey done by National Sample Survey Organisation (NSSO), 40% of the people hospitalised in India borrow money or sell assets to cover their medical expenses. A large number of populations cannot afford to required treatment at all.

Hence it is imperative that the health insurance coverage is encouraged in our country by the government through appropriate incentives. Increasing incidence of lifestyle diseases and rising medical costs further emphasise the need for health insurance. Health insurance coverage in India is currently estimated at just around 3.5% of the population with over 70% of the Indian population living without any form of health coverage.

Conclusion:

Therefore, in my view an integrated approach by leveraging IT, appropriately structured Health Insurance schemes for all strata of society, supported by well and evenly distributed ‘Jan Aushadhi’ outlets, deserves consideration by the Government. A detail and comprehensive implementable plan is to be prepared towards this direction to address the pressing issue of improving ‘Access to Affordable Integrated Healthcare’ to a vast majority of population in India, if not to ALL.

By Tapan 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.