Tag Archives: Devices

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.

Honing Patient Outcomes With WHDs

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On November 01, 2019, San Francisco-based Fitbit, Inc. announced that it has entered into a definitive agreement to be acquired by Google LLC for approximately US$ 2.1 billion. Many believe, though, the value of Fitbit lies in the health data that its wearables capture for its large base of users.

According to the CEO of Fitbit, currently the Fitbit brand supports more than 28 million active users around the globe who rely on these wearable products ‘to live a healthier, more active life.’ With Google’s resources and global platform, Fitbit will be able to accelerate innovation in the wearables category, scale faster, and make health even more accessible to everyone, he added.

The article – ‘The Real Reason Google Is Buying Fitbit,’ published in the Time magazine on November 04, 2019 makes some interesting points, such as the following:

  • The fast-growing healthcare tech space could be worth US$24 billion by 2020, says an estimate from Statista.
  • Although, Google has been working on cardiovascular health, diabetes and more, it hasn’t been publicly pushing healthcare as a business proposition, just yet.
  • Whereas, Google’s rivals, most notably Apple, have embraced healthcare as the next big battleground in the tech world, attracted by the promises of big profits for those who can help simplify a byzantine healthcare system.

Nonetheless, the Fitbit acquisition would facilitate Google’s entry into the Wearable Health Devices (WHDs) market in a big way, alongside other big players, such as, Apple and Samsung.

Driven by the most likely scenario of increasing usage and usefulness of WHDs, several pharma players are sniffing huge underlying commercial opportunity in this space, alongside being demonstrably patient-centric. Thus, my today’ article will deliberate whether or not WHDs will be able to offer a cutting edge to innovative drug marketers, by continually honing patient outcomes. Let me initiate this discussion by fathoming the importance of WHDs in the fast transforming digital world.

The importance of WHDs in the digital world:

‘Mary Meeker‘s 2019 Internet Trends Report’ highlights, about 51 percent of the global population is now connected to the internet, with the majority of users based in China, India and the United States. However, global internet user growth has slowed down by 6 percent and it’s becoming increasingly harder to get the rest of the world online.

In this background, especially - ‘As patients become more involved in making decisions about their health care, research shows, the result is increased satisfaction and improved health outcomes.’Consequently, the report spotlights healthcare digitization where consumer adoption of digital health tools is increasing rapidly. Some of the top areas, in terms of their speed of adoption, were listed as follows:

  • Online Health Information
  • Online Provider Reviews
  • Mobile Tracking
  • Wearables
  • Live Video Telemedicine

This gives a sense of how fast the WHDs are gaining importance for the consumers. Interestingly, Intouch Group also points out that wearables are now being used more to manage a diagnosis rather than just fitness trackers. Adding further, it pointed out – ‘Apple’s ResearchKit is an example of what CEO Tim Cook calls the “democratization of healthcare,” in that it provides health data directly to consumers so they can manage their health.’

A recent study on the scope of wearables: 

The scope of WHDs was aptly corroborated in a recent article – ‘The Rise of Wearable Technology in Health Care,’ published in the JAMA Network Open on February 01, 2019. The paper concludes, the general principle of commercially available ubiquitous wearable computers bodes well for our future ability to measure, track, and understand patient physiological data and behavior both in the hospital and at home.

The ability to capture such data, then applying machine learning to get the evolving health trends and sending alerts to patient accordingly – nurses, and physicians are instantaneously getting empowered to deliver patient outcomes. The fact that the alert can come easily via the patients’ smartphones that a significant part of the global population now carries with them, leading to further democratization of health care.

The Economist  also predicted, by 2020 – 80 percent of the adult population of the world would have a smartphone in their pocket. Therefore, this development opens up an entirely new world of real-time data acquisition, monitoring, and intervention, the paper underscored.

Giving a relevant example, it highlighted: ‘On December 6, 2018, Apple rolled out a software upgrade that turns the Apple Watch Series 4 into a personal electrocardiogram.’ The researchers further added, while WHDs’ fidelity may not yet exactly match medical-grade monitors and devices, these are “good enough” coupled with around-the-clock capabilities, real-time data capture, storage, and analytics and seem likely to provide real value.

The opportunities with WHDs:

Both from the health and business perspectives, WHDs are opening new vistas of opportunities for all stakeholders in the healthcare space, such as, patients, doctors, care providers and also pharma companies. This was enunciated in several studies, such as one, titled ‘Wearable Health Devices – Vital Sign Monitoring, Systems and Technologies,’ published by Sensors (Basel, Switzerland) on July 25, 2018.

This paper also reiterated: ‘Wearable Health Devices (WHDs) are increasingly helping people to better monitor their health status both at an activity/fitness level for self-health tracking and at a medical level providing more data to clinicians with a potential for earlier diagnosis and guidance of treatment. The technology revolution in the miniaturization of electronic devices is enabling to design more reliable and adaptable wearables, contributing to a world-wide change in the health monitoring approach.’

Thus, a big excitement is currently palpable around the technology related to WHDs. Many more opportunities are expected to unfold for continuation of the ascending trend. With the entry of big global tech giants such as, Apple and now Google, besides scores of small startups, WHDs of many types have started entering into the healthcare, carrying a promise to improving outcomes and creating a unique patient experience in the disease treatment process.

Improves outcomes, creates a unique disease treatment experience:

Echoing many other experts in this area, I also believe that WHDs have covered a lot of ground by now – expanding its usage from fitness trackers to diagnosis of disease and then monitoring the progress both during and after treatment. Current usages of WHDs are mostly for non-infectious chronic diseases, such as diabetes, cardiovascular conditions, sleeping disorders, obesity and treatment compliance, besides others. The list is gradually expected to expand.

Apparently, encouraged by this trend, more pharma players are now moving into this area for significant brand value for augmentation through better patient outcomes – apace with providing a unique disease treatment experience for suffering individuals.

The scope in India:

As WHDs have a close link with both Internet and Smartphone penetration, let me try to weigh the potential of the wearables, in view of the current status of both in the country.

According to the India Internet 2019 Report by Internet and Mobile Association of India (IAMAI), the following three points are indeed noteworthy, besides others:

  • With 451 million monthly active internet users at the end of financial year 2019, India is now second only to China in this regard.
  • Urban India with 192 million users had almost the same number of users as rural India. However, in terms of percentages or penetration, given the disparity of population distribution in urban and rural India, urban India had a considerably higher penetration level.
  • In rural India, a sizable portion does not have access to the Internet, and provides a huge opportunity for growth which will contribute to an increase in the overall Internet population over the next few years, it said.

Similarly, according to the Statista report, for 2017, the number of smartphone users in India was estimated to reach 299.24 million, with the number of smartphone users worldwide forecast to exceed 2.3 billion users by that time, and was projected to be nearly 2.7 billion by 2019.

These numbers speak for themselves on the underlying opportunities of WHDs – both globally and locally. Accordingly, large pharma players have already started teaming up to deliver better patient outcomes, leveraging the value of WHDs.

Pharma players teaming up to deliver better patient outcomes with WHD:

There are several such examples. Nevertheless, to illustrate the point, let me cite one such recent instance of Abbott Laboratories announcing a deal on February 20, 2019 with Novo Nordisk to make diabetes management easier by linking technologies of the two companies. The deal will allow integration of insulin dose data for Novo Nordisk’s pre-filled and connected pens with its ‘FreeStyle’ Libre mobile app and cloud-based system.

‘Abbott’s ‘FreeStyle’ Libre Continuous Glucose Monitoring (CGM) system will read glucose levels through a sensor that can be worn on the back of the upper arm eliminating the need for routine finger pricks. Through the FreeStyle LibreLink app users can capture and view their real-time glucose levels, their eight-hour glucose history, and how their glucose is currently changing on their smartphone.’

Yet another report highlighted, ‘Google sister-company Verily is teaming with big pharma on clinical trials.’ On May 21, 2019, the company announced strategic alliances with the pharmaceutical companies Novartis, Sanofi, Otsuka and Pfizer to help it move more deeply into the medical studies market. The goals for Verily, and its pharma partners, are to reach patients in new ways, make it easier to enroll and participate in trials, and aggregate data across a variety of sources, including the electronic medical record or health-tracking wearable devices,’ the report emphasized.

Conclusion:

It seems clear that in the rapidly transforming digital world, many drug companies are realizing the criticality of making their business operations sine qua non with the evolving trend is essential. This is not just for the organization progress, but also for long-term survival of the business. In the midst of this exciting technological environment, the potential value of WHDs to deliver better patient outcomes is being brought to the fore, primarily by the pure tech companies.

Figuring out the magnitude of the new opportunity, several pharma companies have thrown their hats in the ring, primarily in the form of collaborative deals. This ushers in a new phase in the healthcare space. Mostly because, such initiatives will have to be patient-centric for providing a unique patient experience with the drugs, in the disease treatment process. As India too, is taking rapid strides for penetration of digital technology in its ‘Health for All’ initiatives, the use of WHDs for better and cost-effective patient outcomes isn’t a pipe dream, any longer.

The evolving scenario, therefore, opens yet another door for the pharma players to grow their business, not just with drugs offering differential value, but also by making even a ‘me-too’ drug perform better, leveraging the potential of WHDs, effectively. From this perspective, continuously honing patient outcomes with WHDs, appears to be a unique tool for pharma marketers to make use of – in search of excellence.

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.

 

Drugs & Devices: Chasing Never-Enough Profit And Price Control

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On July 20, 2016, the Union Ministry of Health of India announced the addition of Coronary Stents to the National List of Essential Medicines (NLEM) 2015 with immediate effect, bringing them under the Drug Price Control Order.

Reacting sharply to this development, the medical device industry commented, with an undertone of threat, that this price cap could stop manufacturers from introducing technologically advanced stents in India.

However, without contributing to any further knee-jerk reaction, let me try to analyze in this article, whether the never-enough profit motive of the imported stent manufacturer prompted the Government to resort to price control for these life saving devices.

The use of stent:

In the treatment of coronary artery diseases, cardiac stents are now widely preferred in India, just as many other countries of the world. These are small expandable tubes, usually made of metal mesh, and are used to treat narrowed or weakened arteries in the body. 

One of its most extensive usages is in patients with Coronary Heart Disease (CHD), caused by the buildup of plaque, where stents are used to open narrowed arteries and help reduce the symptoms, such as, chest pain or angina, or to help treat a heart attack. This procedure of a percutaneous coronary intervention (PCI) is called angioplasty. 

According to the report of an experts’ sub-committee formed by the Government in October 2015, around 25 percent of deaths in India is attributed to Cardio Vascular Disease (CVD). Coronary Artery disease (CAD) is the commonest CVD accounting for 90-95 percent of all CVD cases and related deaths.

However, for a large majority of the Indian population, the cost of angioplasty is prohibitively high. A patient may have to shell out anywhere between around Rs. 60,000 and Rs. 150,000 for a stent coated with drugs, called Drug Eluting Stent (DES), to curb restenosis, according to published reports.

Even for most Government staff, the cost of angioplasty could well be several times more than their maximum reimbursable limit fixed for angioplasty. Thus, only around 3 out of 1000 needy coronary heart disease patients are treated with angioplasty in India, as compared to 32 in the United States.

An opportunity to shape up:

Despite DES being notified as drugs under the Drugs and Cosmetics Act, 1940, the coronary stents did not feature in the National List of Essential Medicines (NLEM) prior to the above notification, and therefore, were not covered by the Drug Price Control Order (DPCO), so far.

For a long time, this situation offered an important opportunity to the imported stent manufacturers to shape up with responsible pricing…but did they?

Why is angioplasty cost so high?

While trying to find out a credible answer to the above question, the following details on DES of Abbott Healthcare are worth looking at. This information was sourced from a Maharashtra FDA report, and referenced by Rema Nagarajan in her article published in the Times of India on September 25, 2014 to highlight why is DES so expensive for patients in India.

Although, pricing details are of 2014, nevertheless, it gives a flavor of the prevailing situation:

Cost Break-Up/Unit Cost per Unit (Rs.)
DES imported into India at 40,710
Sold to Distributor Sinocare at 73,440
Distributor Sold to Hinduja Hospital 1,10,000
Patient charged 1,20,000 (threefold increase of import price)

(Source: Maharashtra FDA report)

The saga of ‘Market driven pricing’:

Both the drug and the device companies apparently make valiant efforts to package such ‘arbitrary’ pricing as so called ‘Market Driven’ ones, though such price tags keep crippling many cardiac patients financially too. Ironically, the saga still continues.

Taking advantage of the free-pricing environment in India for Coronary Stents, to attain market dominance many global majors, possibly believe that they can print any Maximum Retail Price (MRP) on their import cost. It was happening even when the Government does not levy any customs duty on stents. Do these companies ignore its optics too? Who knows? 

Like most drugs, market forces do not play any significant role in the medical device pricing too, globally.

In June 2013, a research study published in the ‘American Heart Journal (AHJ)’, compared the use of Bare-Metal Stents (BMS), Drug-Eluting Stents (DES), and Balloon Catheters according to company presence in the hospital. It concluded that Medical Representative (MR) presence was associated with increased use of the concerned company’s stents during percutaneous coronary interventions. The effect was more pronounced with the use of DES, and resulted in the higher procedural cost of US$ 250 per patient.

In this particular study, it was found that DESs were used in about 56 percent of the cases, when the MRs concerned were at the hospital, against 51 percent when they weren’t there.

The situation is not terribly different in India too, where also the medical choices are often influenced by the drugs and device makers through, much discussed, dubious means.

The market:

According to a market research report of ‘Future Market Insights (FMI)’ dated May 09, 2016, the coronary stent market of India was of US$ 481 million in 2015, and by the end of 2016 is expected to reach at US$ 531 growing at a CAGR of 14.0 percent over the forecast period of 2016 – 2026.

This study segmented the market on the basis of the following product types:

  • Drug Eluting Stent (DES)
  • Bare Metal Stent (BMS)
  • Bioresorbable stent (BVS) 

DES segment is expected to exhibit the highest growth and the BMS segment a stable growth, during the forecast period. This is mainly attributed to the emergence of new and more effective stents in the market, the report highlights. 

The market is dominated by the imported stents. Abbott, Medtronics, Meril Lifesciences and Boston Scientific, hold together around 60 percent share of the Indian market.

In India, nine of the 11 domestic stent manufacturers are located in Surat and Vapi of Gujarat. These stents are picking up the market share currently hovering around 30 percent, costing even less than half, as compared to the imported ones.

The Government stepped in:

When the industry did not seem to shape up, despite the regulatory opportunity available to keep the stents out of the NLEM, the media started writing about it, strongly and quite frequently. These were intended to bring some sanity into the imported and advanced Coronary Stent pricing system. Still nothing changed, and the Government had to step in.

Ultimately, in October 2015, the Union Ministry of Health constituted a sub-committee of expert cardiologists under the chairmanship of Prof. Y.K. Gupta, Head of the department of pharmacology, All India Institute of Medical Sciences (AIIMS). The mandate of this sub-committee was to examine the issues relating to the essentiality of coronary stents, and recommend whether the coronary stents should be included in the NLEM.

Accordingly, after a series of in-depth discussion with various stakeholders, which included stent manufacturers and the patient groups, the sub-committee recommended the inclusion of two categories of coronary stents, namely the DES and BMS in the NLEM. This suggestion was in response to “the enormous need of percutaneous coronary intervention, or angioplasty with stent.”

By a notification on July 20, 2016, the Ministry of Health announced that the sub-committee has submitted its report to the Government, and after thorough examination of the report, its recommendations have been accepted for implementation with immediate effect.

This decision of the Government is expected to set the stage for the National Pharmaceutical Pricing Authority (NPPA) to work out ceiling prices, which are expected to be 40 percent to 70 percent less than the current prices for these stents.

Conclusion:

For the last several years, many stakeholders, including the media and the Government, have been expressing grave concern over the exorbitant prices of the Coronary Stents.

Earlier in 2015, following a petition, even the Delhi High Court directed the Government to monitor the prices of stents in the market.

Indian drug price regulator, the NPPA, and some state FDAs too flagged the point that although locally manufactured stents are much cheaper, doctors and hospitals continue to use the imported ones, for various commercial and other reasons. As a result, the situation remained the same, adversely affecting the health of a large number of cardiovascular patients in India.

The last week’s decision of the Indian Government for inclusion of coronary stents in the NLEM, needs to be viewed under the backdrop of steep increase in the incidence of CHD in India. It clearly poses a significant public health hazard, where the cost of stents becomes a key treatment barrier for the majority of the patients incurring out-of-pocket health expenditure.

Price control of drugs and devices may not be the best way to improve their access to the most of the Indian population. Nevertheless, considering the high out-of-pocket expenditure for health care in the country, instead of behaving responsibly, doesn’t the drug and the device makers’ mindless chase after ‘never-enough profit’ objectives, often prompt the imposition of regulatory price control?

The fact that many global drug and device manufacturers, even after posting over 30 percent standalone net profit growth in India, continue cribbing incessantly about the stifling Regulatory and Intellectual Property Right (IPR) environment in the country, vindicates the above point well, possibly beyond any reasonable doubt.

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.