Pharma To Leverage The Art of Turning Challenges Into Opportunities, Now

Posted on July 20, 2020 by Tapan Ray

Since, the dawn of the year 2020, the human population living in different countries, across the world are facing ‘lockdowns in different forms. Although essential, it severely restricts normal daily essential and other important activities of all. A large number of populations in India, is also experiencing the same – for nearly 4 months, almost at a trot, as on date.

The fear of getting infected by COVID-19, fueled by uncertainty about a comprehensive way to surely avert infection and apprehension about what happens if someone gets infected, have been haunting many for several months. Moreover, the possible impact of several related essential measures, such as, social distancing and wearing a mask mostly while being outdoors, on both life and livelihood, is profound. It has already started causing an unprecedented – both physical and mental stress on many individuals, besides the economy of the nation.

Living amid ‘lockdown’ conditions is not just an unpleasant experience for all, it’s almost a ‘prison like’, experience for a vast number of people – particularly, both young and old with comorbidly. “It’s very similar to being trapped in a bunker with no access outside,” as expressed by a person with similar issues, which, may be construed as a universal feeling of common individuals. Interestingly, this was quoted in an article - ‘What patients need right now’, published in the Reuters Events Pharmaon July 07, 2020. The article also highlighted that many other fellow sufferers, especially non-Covid-19 patients, are enduring pandemic enforced isolation without much hope. “They are staying in limbo until help is available and adapting to the worsening of their health conditions,” the article added.

Further, as captured in the McKinsey article – ‘COVID-19 and commercial pharma: Navigating an uneven recovery,’ published on April 21, 2020 – not just patients, health care professionals including doctors, are also facing unprecedented challenges. Especially, because of the need to address fundamental changes in the treatment of patients with conditions other than COVID-19. This is happening across medical specialties and therapeutic areas, besides of course in advising and treating patients with suspected and confirmed cases of COVID-19.

In some instances, some doctors do also worry about their financial security, as practices and health systems face unprecedented financial issues, the above article emphasized. However, at the same time, many of them are now rapidly adjusting how they deliver care, such as through increased use of telemedicine in different forms and ways, the survey found. Which is why, the support they need from pharma companies is also changing.

Taking cognizance of these critical developments, pharma players would require rewriting their playbook for business operations and for its urgent implementation. This article will focus on this important area of pharma business, by leveraging the art of turning a problem or a challenge into an opportunity.

Leveraging the art of turning a challenge into an opportunity:

Turning a problem or challenge into an opportunity in managing business operations, isn’t a cup of tea of all managers, across domains. More so, when it’s caused by an unprecedented disruptive change, such as the Covid-19 pandemic.

The first and the foremost prerequisite from a manager is a mindset to make it happen – driven by uncluttered thinking, with a clear focus on what needs to be achieved, how and when – step by step. Each element of a change has to be analyzed in-depth – supported by credible data, with possible barriers envisaged on the way. In tandem, weighing the chances of success in these initiatives based on data – and not gut feeling, within a predetermined timeframe will be critical. The net outcome of this process will help pharma players acquire a differentiated competitive edge for excellence, amid today’s all-pervasive quandary.

Under this backdrop, leveraging the art of turning a problem or challenge into an opportunity – in an organized manner, for a successful outcome of the present and future pharma business, appears to be a crying need.

The points to ponder:

Effectively moving in this direction will call for – at its very onset, a careful and unbiased data-based assessment of several critical areas, which will include:

Whether customer engagement platforms, medium, processes and also the core content of communication of pre Covid-19 days remain equally relevant today, and will remain so in the foreseeable future, for productive business outcomes.

Mapping changes with the extent for each, in all touchpoints of disease treatment processes is important – involving both patients and doctors, and simultaneously capturing their new preferences in those areas.

Arriving at what strategic and tactical changes the new normal calls for, to effectively engage with especially, non-Covid patient treating doctors and non-Covid infected patients, for other disease areas.

How doctors are delivering care, particularly to these patients today?

Accordingly, the pathway for required changes has to be charted out in detail, specifying the end point of each, on a time-bound and ongoing basis. The good news is, several pharma players have already taken several praiseworthy initiatives to combat this crisis.

What pharma companies have done so far:

So far, many pharma companies – both global and local, have taken some commendable steps to address the immediate fallouts of the crisis. These include,

Repurposing old medicines – starting from hydroxychloroquine, remdesivir to dexamethasoneand probably beyond. All these drugs are currently being used for the treatment of Covide-19, although conclusive scientific evidences are still awaited – for most of such repurposed drugs.

Indian generic drug manufacturers either have started or increased production of most these drugs.

Covid-19 vaccine development started almost immediately, including the homegrown ones.

As the above McKinsey article – ‘COVID-19 and commercial pharma: Navigating an uneven recovery,’ also reconfirms, now most pharma companies are largely focusing on ‘the immediate crisis, including by facilitating access to medicine; supporting HCP, institution, and patient needs in new ways; safeguarding employees; and enabling employees to operate in a new environment.’

The areas where pharma needs to focus more amid immediate crisis:

Another, responsibility of pharma to help tide over the immediate crisis, is to ensure that critical drugs, such as remdesivir, do not go in short supply. And also, avoiding unnecessary hype on a COVID-19 vaccine, which a global CEO termed as a grave disservice‘ to the public.

Nearer home, it also happened – not by any pharma company, but by the country’s premier, state-run medical research organization – the Indian Council of Medical Research (ICMR). The head of the ICMR has announced that India is planning to launch the Covid-19 vaccine by August 15, 2020. This was later retracted under heavy adverse criticism.

Future focus areas need to be in sync with the changing customer behavior:

While converting several challenges into opportunities in sync with the future requirements of their business operations, drug companies should try to derive the first mover advantages. For this purpose, creative use of almost real-time data will be vital. In this endeavor, I reiterate, one of the top priorities will be to ensure that all touchpoints of the consumer engagement process take into account the changing customer behavior, as captured by data.

To have a productive value delivery system in the new normal, cerebral use of modern technology-based tools and platforms could provide a sharp cutting edge. A similar process may be adopted – even a stage earlier – during the differential value creation process of the business. Nevertheless, the name of the game for the future, would still remain delighting the customers at all the touch points, especially while navigating through strong headwinds.

Another major impact area of pharma business:

The onslaught of Covid-19 pandemic has also resulted in some significant behavioral changes among many health care consumers. These spans across several areas, as I wrote earlier. For example, a number of surveys have revealed that fewer number of non-Covid-19 patients are now visiting doctors’ clinics.

The study quoted by the above McKinsey article highlights some important points in this regard, such as:

Among surveyed HCPs, 82 percent report declines in patient volumes, with more than half describing the declines as “significant”.
40 percent of the surveyed patients reported having a doctor cancel an appointment, while an additional 30 percent or so canceled the appointments themselves.
Half of surveyed physicians worry that their patients will not be able to receive timely care for new or existing conditions, particularly those that are not COVID-19 related.
The overall reduction in volume is widespread, but variation exists. For example, the number of oncology-related visits have declined far less than those related to cardiology or dermatology, perhaps reflecting patient or physician perceptions of urgency.
Such data represent a snapshot of a time still early in the trajectory of this crisis, but the HCPs surveyed expect the trends to continue—and to accelerate, potentially.

Another challenge is surfacing, the talent gap to squarely deal with the crisis.

The problem of talent gap, an opportunity?

While preparing a company to succeed amid new challenges of the new normal, pharma leadership will notice some critical talent gaps in important areas of business. This is indeed a problem or a challenge. But can this also be converted into a new opportunity? … I guess, this is an opportunity of reskilling the company to meet with the future challenges, to move ahead at a faster pace.

In pursuit of this goal, top pharma decision makers may wish to evaluate a well-balanced mix of two approaches:

Reskilling competent existing employees for the new world.
Hiring new and ready – suitable talents, for immediate results.

Conclusion:

Reuters reported last Friday, with over 1 million Covid-19 cases, ‘India joins U.S., Brazil in the grim Coronavirus club.’ As on July 19, 2020 morning, the recorded Coronavirus cases in the country reached 10,77,874 with 26,828 deaths. According to the Indian Medical Association (IMA), the spike in the number of Covid-19 cases in India has resulted in the community spread of the Coronavirus disease. It further added: “This is now an exponential growth. Every day the number of cases is increasing by more than around 30,000. This is really a bad situation for the country.” The pace of climb continues going north.

Meanwhile, the Prime Minister of India has also urged all concerned to convert Covid-19 related challenges into opportunities. He said, it’s time to initiate reforms in several areas of governance by all the Indian State Governments.

Call it, the Prime Minister’s advice, or a basic management tool – most appropriate to leverage at this hour, the concept is worth considering by pharma players, as well, instead of getting overwhelmed by the crisis. Thus, in my view, it’s about time for pharma companies to identify critical Covid-19 related challenges, both immediate and also of the future – and convert those into opportunities – powered by technology-based cerebral inputs, in the new world order.

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

Time For Pharma To Leverage ‘The Break In The Clouds’

Posted on July 6, 2020 by Tapan Ray

A ‘break in the clouds’ is now clearly visible in the dark and overcast sky – witnessing a global havoc caused by the Coronavirus pandemic in the healthcare space – with its severe socioeconomic consequences. The name of the game to combat this gargantuan crisis in a heavily restricted environment with success, is adding ‘error-free speed’ in all aspects of the planned countermeasures.

This isn’t a very easy task, either. And certainly, is possible with well-integrated digital interventions. From this perspective, one can construe this situation as ‘break in the clouds’ that can be leveraged by pharma companies for digital transformation of their respective business operations.

It may also be interpreted as a blessing in disguise, because such transformation will empower the companies to take appropriate effective measures with speed. When effectively leveraged, such strategic steps will help pharma players in two ways. One, to contain the virus spread while ensuring access to care through business operations. And the second, will help propel the organization to move ahead, even within such a crisis. However, the ‘Digitalization’ process is multifaceted, having, at least two fundamental prerequisites. In this article, I shall focus on this strategic space.

Alternative ways to provide health care is fast gaining ground:

The product and service delivery models of pharma companies are generally built around the concept of physical presence of patients while consulting a doctor or other health care providers. However, Coronavirus pandemic has triggered some significant changes in this area. Let me illustrate this point with some contemporary references.

As the recent L.E.K paper – ‘COVID-19 and the Acceleration of Digital Health in APAC’ emphasized – ‘by sheer necessity, governments and regulators have also reduced the barriers to participation and uptake for remote engagement of consumers, enabling access to care despite social distancing measures,’ during the pandemic. Moreover, a technical guidance paper, published by the World Health Organization (W.H.O) on April 1, 2020 on strengthening health systems against COVID-19, also recognizes ‘telemedicine’ as an alternative model for delivery of care to ensure the continuous running of essential health care.

COVID-19 will take health system digitalization to a new level:

The above L.E.K paper also pointed out – in the days and months ahead, COVID-19 will accelerate the ‘digitalization’ of health systems to a new level. Especially when, healthcare stakeholders adopt a more urgent, no-holds-barred strategy to stem the rising tide of infections. L.E.K article predicted, the new ways of working and behaviors, forged and refined in the heat of battle against COVID-19, will not be easily put “back in the box.” Consequently, this increasingly digitalized reality will force a paradigm shift in the healthcare ecosystem, the paper concluded.

‘A virtually perfect solution’ to neutralize Covid-19 impact:

Another paper - ‘Virtually Perfect? Telemedicine for Covid-19,’ published in the NEJM on April 30, 2020 wrote, disasters and pandemics pose unique challenges to health care delivery. It underscored, ‘Though telehealth will not solve them all, it’s well suited for scenarios in which infrastructure remains intact and clinicians are available to see patients.’ It also indicated, telemedicine may be a virtually perfect solution, particularly where such infrastructure is available.

‘Governments must reimagine healthcare delivery’:

That ‘Telemedicine can be a COVID-19 game-changer’ - both now, and in a post-pandemic world, was also articulated by another article, published by the World Economic Forum on May 13, 2020. It suggested: ‘Governments must reimagine healthcare delivery in the face of COVID-19.’

This is mainly because, hospitals and several other places where the COVID-19 battle is raging – have become risky places for both patients and healthcare workers. Although, several measures are being taken to limit transmission from such places, those are still ‘insufficient to stop overstretching of healthcare systems that were already overwhelmed before COVID-19,’ the article observed.

The good news is, in sync with the recommendation of the World Health Organization (W.H.O) for the use of telemedicine as an alternative model to boost clinical performance and optimize service delivery, India has also recognized its telemedicine facility. The Government finds it as ‘a blessing in disguise in time of Covid-19’ and has urged - ‘it’s already high time to recognize telemedicine as a mandatory technology for responding to the current pandemic.’

Health consumers started utilizing digital platforms during lockdown:

hanger, As I wrote in my article of April 27, 2020, being literally locked down at home, a good number of healthcare consumers in India, are utilizing innovative digital platforms, mostly for common illnesses or follow-up consultations, such as:

For medical consultation on digital platforms, e.g., Skype, Facetime etc.
Getting diagnostic tests done at home by requesting through digital apps,
Sending test reports to doctors digitally,
Getting doctor’s prescription through digital mode,
Ordering medicines through e-pharmacy apps by uploading prescriptions,
Getting medicines delivered at home after e-payment,
Repeating the same process whenever required.

I also mentioned there, the use of telemedicine in several different, unconventional formats, is also gaining momentum, signaling its greater potential in the years ahead. It seems a reality today, as strict compliance with ‘social distancing’ guidelines is one of the basic requirements of health safety for all.

Does pharma have any other prudent choice now to be effective?

Traditionally, health care industry almost in all countries, is structured on the model of in-person interactions between patients and their clinicians. As the article – ‘Covid-19 and Health Care’s Digital Revolution,’ published in the NEJM on June 04, 2020 wrote, ‘clinical workflows and economic incentives have largely been developed to support and reinforce a face-to-face model of care, resulting in the congregation of patients in emergency departments and waiting areas during this crisis.’

Realizing that this model of care contributes to the spread of the virus to uninfected individuals who are seeking evaluation, many health care consumers are now postponing the needed care or looking for a digital solution for common ailments, to begin with.

In this environment to be effective – pharma players don’t seem to have any other choice but to transform their business operations and scaling up operating systems with the power of digital technologies, as the article indicated. Although, some digital technologies, including telemedicine, have existed for decades, they have had poor penetration into the market for different considerations. But, it’s a transformed situation today, exhibiting a groundswell for the same.

Groundswell for digital transformation in pharma?

COVID-19 pandemic is creating a groundswell for an early digital transformation in the health care space where pharma industry plays a very critical role. If one observes carefully, it is not difficult to fathom the change in behavior and practices of health care consumers. Thus, it calls for commensurate changes in the operating models of the drug players, to keep the kettle boiling, at the very least.

Consequently, the need for integrated digital interventions, quite akin to ‘Zoom’ – replacing many long in-person meetings. Changes of such nature and significance won’t just come and go. These are here to stay to add speed, convenience and cost-effectiveness in business operations, even if Coronavirus disappears, eventually.

The shape and talent need of future organizations will be prompted by such changes, facilitated by digital technologies and Artificial Intelligence (AI). However, digital transformation isn’t just a ‘switch-on’ operation of drug companies, as and when they would wish. Moving towards this direction will call for an unbiased assessment of, at least two prerequisites, for each player.

Two important prerequisites:

As both personal lives and also the work lives of almost all professionals and entrepreneurs, along with the customer behavior, have metamorphosed significantly, commensurate changes need to be implemented in all these areas, urgently. One area where a quantum change has taken place almost unknowingly – mainly driven by the human instinct of survival in a crisis, is the use of various state-of-the-art digital platforms. These include, the way businesses and professionals interact with each other for productive engagements.

Many studies have unraveled this process, such as the one – ‘Seizing the moment in digital’, published in the eye for pharma on May 28, 2020. It underscores two critical prerequisites for any digital transformation of businesses. These are to assess – first, how compatible will this transformation be with the existing organization culture and the same of its top leadership.

If any barrier surfaces, the organization would need to ask, whether its business is ready for a commensurate cultural transformation to make it work productively. The second one is, the capability – it may not be just the technical capability – internal or outsourced to go digital, but more importantly, the capability to run the transformed business to fetch desired results.

Conclusion:

The world is still in the midst of a global crisis, triggered by the Coronavirus pandemic. It is quite far from even plateauing in India. As on July 5, 2020 morning, crossing half a million mark, the recorded Coronavirus cases in the country have reached 673,904 with 19,279 deaths. And its climb continues.

Thus, amid a virtually unfathomable Covid-19 crisis, it will be foolhardy to predict what will happen next. However, as one joins the dots of some significant development, a perceptible trend emerges through the break in the clouds. This is unlikely to vanish anytime soon, and is very likely to be a new normal. Many articles from various thought leaders, such as one of McKinsey Digital - ‘The COVID-19 recovery will be digital’, published on May 14, 2020, vindicated a ground swell for the same. Yet another interesting article of May 11, 2020, termed the Covid-19 pandemic as a black swan event – ‘pushing towards a digital future.’

That said, digital transformation for a drug player will call for an unbiased assessment of two critical prerequisites – culture and capability, to deliver a meaningful outcome. Be that as it may, all indicators confirm that this is undoubtedly a critical time for pharma to leverage the ‘break in the clouds’ in pursuit of excellence – in the new normal.

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.

Enhancing Pharma Brand Experience In The New Normal

Posted on June 22, 2020 by Tapan Ray

In these days of unprecedented and all-pervasive disruptions – almost in every facet of life – caused by an unknown virus, scramble to find an effective solution for saving lives and livelihoods, still continue. The discomfiture seems to be omnipresent across the healthcare space.

On its upside, pharma witnessed an unparalleled surge in various collaborative activities both in the search for a cure and also in preventing the infection. The downside is, conclusive scientific evidences are still not available for these drugs – except one that was unraveled just on June 16, 2020. On the contrary, after granting emergency authorization on March 30,2020, for use of hydroxychloroquine and chloroquine in Covid-19 infection, the US-FDA on its own, revoked it on June 15, 2020 for lack of conclusive evidence.

Amid initiatives of saving lives, pharma industry – besides trying to be a part of saving livelihoods – alongside others, is also gearing up to restart its demand generation activities, and move ahead, as the looming crisis continues, unabated.

From the pharma industry perspective, this new beginning, as it were, in a scenario that was never envisaged in the past, would require two most critical ingredients, amongst several others, more than ever before. It is another major transformation, where pharma leadership would require encouraging:

A change in mindset with a fresh pair of eyes to find game-changing opportunities in the new normal.

Mapping end-to-end customer journey to enhance their experience in the changing business scenario.

This article will focus on the relevance of these two areas, for the drug companies to come out with flying colors, yet again, in a difficult situation.

Evolving changes in the pharma ecosystem:

That the evolving ecosystem is changing the life sciences value chain and creating new opportunities to capture future value by providing end-to-end solutions, was also highlighted in the EY report - “Today for tomorrow: realizing the potential of Life Sciences 4.0.” This was released in February 2020, as Covid-19 started changing the world and the way businesses operate.

To successfully navigate through such fast-changing healthcare landscape, ‘companies need to develop an exponential mindset that leverages technology for business model reinvention and empowering the workforce,’ the report emphasized.

As moving in this direction with agility is critical, drug companies will require a leadership team of a different mindset, who can ferret out path-breaking opportunities amid ‘never before’ problems. Mainly because, the strategy for success will be quite different from the traditional recent practices. Enhancing contemporary and personalized value of product and service offerings to healthcare consumers – with end-to-end solutions, won’t be everybody’s cup of tea in the shifting paradigm.

Let me explain some basic changes in the traditional sales and marketing domain to drive home this point.

Some basic changes in the traditional sales and marketing practices:

Until Covid-19 battle is decisively won by a vast majority in the planet earth, by acquiring either a vaccine-induced or herd-immunity – maintaining social distancing and strict compliance with other health norms will remain in force. Besides, a palpable fear among a large population from getting infected by the Coronavirus, is unlikely to vanish soon. From this angle, many traditional pharma demand generation activities may not be as productive as they used to be, such as:

Meeting doctors the way one used to in the past for a face to face prescription demand generation activity, will be different. Moreover, per doctor call time may increase significantly – with a commensurate increase in cost, impacting average yield per call.

All marketing events, requiring the participation of many doctors under one-roof, namely – large symposia, Continuing Medical Education (CME) or even sending doctors by air for educational group-tours or even sponsoring any other medical events, may be challenging now.

Changing mindset of doctors, triggered during a long national ‘Lockdown’ period to remain updated from different sources in the cyberspace, may continue, prompting lesser interaction with drug company representatives.

There are many other areas, which different companies may consider a great commercial value, would also need to be identified – as the pharma companies restart their prescription demand generation activities. Nonetheless, equally important is to zero-in to alternative strategic approaches, soon.

Zeroing-in to alternative strategic approaches with a new mindset is critical:

There could be several strategic approaches for this area. One such is, mapping the end-to-end customer journey in the changing situation, to enhance their brand experience during this process. As the time is very limited now, being ‘right the first time’, will be crucial for pharma marketers. Otherwise, competition will prevail.

Any game-changing approach at this time, will call for a fresh pair of eyes, having a contemporary mindset. ‘I did it this way before’ approach will not work, as the situation is unprecedented, and there are no footsteps to follow. Thus, I reckon, the organization will require taking the following measures based on a predictive mindset and actionable insight:

Selecting a right leadership team who can accurately define the changes in each touch-points of a disease treatment process.

Creating a ground swell of the need for the proposed changes – explaining the benefits of each.

Prompt mitigation of any resistance that may surface during this process.

Identifying the loose knots in the process of strategy implantation.

Choosing the implementation team with right competence, mindset and agility in achieving the set goals, across the business domains.

Providing continuous training, problem-solving support – ensuring an all-time learning mindset for all in the selected team.

Initiating an emotional omnichannel engagement to take all stakeholders on board – with aligned messages – for desired outcome.

Assigning accountability to each one, for achieving agreed results.

The biggest hurdle in the business transformation process:

In tandem, another key point also to be borne in mind. Because, with each passing day, some new finding in Covid-19 disease area – some good news for drug and a vaccine development, or could even be another crisis, may keep unfolding. The team should always remain on course, despite limited resources and other business challenges.

Many will know, the biggest hurdle for any transformation process is culture. Open minds of all concerned will make the process easier. With traditional business practices, it will be complex to navigate through the current situation. Therefore, a change in people’s mindset in the new situation, is a fundamental requirement to restart the pharma industry – in full steam.

The core objective needs to be understood by all:

The core objective during the entire process of such transformation, is to enhance a patient-centric brand experience – throughout its customers’ journey, seeking an end-to-end disease treatment solution. The process would, in turn, require a deep understanding of the emotions, requirements and related preferences of the customers. This is critical to establish a meaningful human connection, virtual or otherwise, with them.

Nevertheless, it will entail data-based and detail mapping the customers’ journey, while seeking an effective treatment solution for the disease that one is suffering from. Accordingly, creating a patient-centric content to build a brand persona, alongside crafty dissemination of the same for the target groups, through omnichannel platforms, will need to be diligently worked out. More important is its execution with military precision, by emotionally connecting the intended stakeholders to deliver a unique brand experience.

Conclusion:

Like many other countries, ‘unlock down’ process related to Covid-19 pandemic has already started in India, with varying degree at different places, though, depending on the nature of intensity and spread of the infection. However, the number of Coronavirus infected cases continues to maintain a steep ascending trend. As on June 21, 2020 morning, the recorded Coronavirus cases in the country reached 411,727 with 13,277 deaths.

The unlocking process of critical pharma industry activities has also started rolling. However, the new beginning has to be in sync with the fast-evolving changes in the pharma ecosystem. Many processes and deliverables, including formulation and implementation of an effective strategy for the same, will no longer be a replica of the traditional ones, as it were.

Similarly, to find game-changing opportunities in the pharma sales and marketing space, the marketers will need a change in their current mindset and having a fresh pair of eyes. This will be essential for an unbiased and effective mapping of end-to-end customer journey to enhance their unique brand experience. In tandem, it will help create key brand differentiators with cutting edges, for business excellence in the new normal.

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.

Shifting Pharma Supply Chain Strategy From Global To Local

Posted on June 8, 2020 by Tapan Ray

Alongside large-scale disruptions of many critical industrial operations, Covid-19 global pandemic took the wind out of the sail of pharma supply chain, as well, at the very onset of lockdowns. This happened in many countries around the world, including the largest global pharma market – the United States, and also in ‘the pharmacy of the world’ – India.

That there were such disruptions in India, both in procurement and logistics, during the national lockdown, was widely reported in the media. Besides product non-availability, cost of goods also went up significantly in several cases.

From this perspective, I shall deliberate in this article, how different countries are contemplating to respond to any similar crisis in the future, primarily to safeguard patients’ health interest, despite some opposition, though. To drive home the points, I shall cite examples from India and the United States, as specified above.

Supply Chain vulnerability of the ‘largest pharma market of the world’:

There are several examples to vindicate such vulnerability, both for the US and also India. From the US perspective, the country’s supply of generic and branded medicines are, reportedly, heavily rely on emerging markets, like India and China.

This point has now ‘come under close scrutiny of the American policy makers, as COVID-19 sends shockwaves through the industry. According to the US Food and Drug Administration, China and India represent 31 percent of the plants that are registered with the US to supply Active Pharmaceutical Ingredients (API), as of August 2019. The details are as hereunder:

Place	United States	European Union	India	China	Rest of the world	Canada
%	28	26	18	13	13	2

It is worth noting, the number of facilities in China supplying APIs has, reportedly, more than doubled since 2010 – to 13 percent of all those serving the US market.

Examples from India:

The outbreak of Coronavirus had just not shut factories in China - impacting supplies and leading to fears of a shortage of drugs and medicines. It happened in India, too. Several critical supply chain issues were reported during this period. For example, a major Indian drug manufacturing hub - Baddi,reportedly, was either shut down or operated with reduced capacity, since COVID-19 pandemic related national lockdown.

Its impact also got captured by the twitter handle of the former USFDA Commissioner – Scott Gottlieb. He twitted, “Drug supply chain at risk as Asia’s largest pharmaceutical manufacturing hub in Baddi (an industrial town in southwestern Solan district of Himachal Pradesh, India) is declared a #COVID19 containment zone – forcing many pharma units to slow or stop operations.”

Supply Chain vulnerability of the ‘pharmacy of the world’:

Supply Chain vulnerability related to the domestic issues in India, can possibly be sorted out by the country’s decision-making authorities. However, the country’s vulnerability arising out of the reasons originating in the other countries, needs a greater priority focus of the nation.

As is widely known – India caters to about 20 percent of the world’s generic drug supply. However, according to Bloomberg, 70 percent of the country’s imports of APIs come from China, ‘totaling US$ 2.4 billion of India’s US$ 3.56 billion in import spending for those products each year.

Consequently, ‘pharma companies in the country are dependent on China for two-thirds of the chemical components needed to make them.’ Exposures of such nature are now coming on to the center table – mostly triggered by Covid-19 pandemic, both in India, as well as in the United States.

India is reevaluating its import dependence from China:

To illustrate this point, let me begin with some related recent developments. While reevaluating the import dependence, India has taken both immediate and medium to long term measures – at the policy level.

The immediate reaction of India to Covid-19 outbreak, was to shift focus on local with restricted export of common medicines, such as paracetamol and 25 other pharmaceutical ingredients and drugs made from China. Curiously, prior to the national lockdown, on March 17, 2020 by a written reply the Government had informed the Indian Parliament about the import of APIs /drugs and the extent of the country’s dependence on China for the same.

Be that as it may, to protect the local interest, the above ban was followed by another export ban of the age-old malarial drug - hydroxychloroquine, ‘touted by President Trump as a possible weapon in the fight against Covid-19,’ but has been in short supply, globally. Interestingly, India produces around 47 percent of the U.S. supply of hydroxychloroquine. Thus, understandably, Indian Government had to partially lift this ban after the U.S. President Donald Trump sought supplies for the United States.

For medium longer-term measures, while announcing a ₹20 lakh crore stimulus package, Prime Minister Narendra Modi articulated that Covid-19 pandemic had taught India to ramp up domestic production and create supply chains to meet internal demands. Earlier, for safeguarding ‘national healthcare security’, the Government had allocated US$ 1.2 billion for the pharma industry to be self-reliant, by reducing its import dependence, especially for APIs. The government also wants to finance the construction of three bulk drugs with an investment of ₹300 Crores.

The United States is reevaluating import dependence from one region:

The Fierce Pharma article of June 03, 2020 also reported a shifting focus of supply chain from global to local, as the United States seeks to ‘onshore’ drug production, with the fallout of Covid-19 pandemic looming large on its drug supply chain.

U.S. legislators have argued that ‘U.S. reliance on drugs made or sourced outside the country has created a security issue that could be addressed by erecting parallel supply chains stateside and eliminating reliance on potential bad actors abroad.’ Accordingly, they have put forward ‘a raft of legislation’ that would seek to “onshore” drug manufacturing at the expense of major producers abroad.

Its biggest obstacle could be the pharma industry and its lobbyists:

Nevertheless, the same article also underscores that the biggest obstacle to that plan could be the pharmaceutical industry and its lobbyists on Capitol Hill. This is because, PhRMA - the industry’s biggest lobbying group, has pushed back against Congressional support for a supply chain shake-up. It said, “Policymakers must take a long-term, more holistic look at global pharmaceutical manufacturing supply chains before jumping to rash proposals that may cause significant disruptions to the U.S. supply of medicines.”

Will it happen in India?

My article, published in this blog on February 03, 2020, also focused on this issue. There I had emphasized, about five years back - the Government of India had also announced on February 25, 2015 – terming ‘2015 – Year of Active Pharmaceutical Ingredients’ (API). This came after ascertaining that over-dependence on imports of bulk drugs or API, especially from China, is detrimental to India’s health interest. This decision was also in sync with the freshly announced, and well-publicized government objective regarding ‘Make in India’, I wrote.

Two years down the line from the above date, on July 15, 2017, eHEALTH publication also deliberated on this issue in an article – ‘Why over dependence on APIs imported from China is harmful for India?’ However, not much change has been witnessed till date, in this regard. The same vow is now being taken afresh. Nonetheless, let me hasten to add, Covid-19 has changed the life of all – in several respects. Thus, no one can possibly vouch with a high degree of certainty what can happen hereafter, as we move on.

Conclusion:

As the ‘Lockdown. 05’ or ‘Unlock down. 01’ begins in India – the ‘pharmacy of the world, as on June 02, 2020 morning, the recorded Coronavirus cases in the country reached 247,040 with 6,946 deaths. India is now racing ahead with its number Covid-19 cases, surpassing Italy and Spain, occupying the global fifth rank, in this regard. Whereas, the top ranked pharma market in the world – the United States, where Covid-19 struck hard before India, recorded 1,988,545 cases with 112,096 deaths, on the same day.

Thus, the need to have a fresh look at the strategic design of pharma supply chain is being felt in both these countries. The requirement for becoming less global and more local is attracting a priority focus of Governments in both countries. With an increasing State-push for safeguarding the health security of the country, the need to reshape pharma supply chain – call it transient or otherwise, is now more palpable than ever before.

By: Tapan J. Ray

Covid-19: Will Pharma Deliver What It Can Do The Best, Soon?

Posted on May 25, 2020 by Tapan Ray

The news of a bright possibility of finding magic bullets to significantly tame, if not totally annihilate Covid-19, is coming almost every passing day. As expected, these are being initiated mostly by drug companies, alongside various academia, located in several countries of the world, including India. It rekindles hope to return to some kind of normalcy in daily life, work and business.

However, the hype created around each of these, either too early or based on some anecdotal reports, apparently driven by the desire for a windfall commercial gain, may be counterproductive. That some remedial measures to tackle the notorious virus will come very soon, could influence a number of decisions of those who are engaged in managing the situation.

The pressing need to restart the economic activity – come what may, even before the first wave of Covid-19 subsides in a developing country like, India, comes along with a strong storm signal. Balancing life with livelihood has never been so difficult ever. In tandem, it poses a great challenge also for the pharma industry to demonstrate what it stands for the society, such as:

Bringing scientifically proven, safe and effective drugs and vaccine, in a specified timeframe falling close to the realm of a genuine possibility.

Making these drugs and vaccines available, at an affordable price and accessible to all, globally.

In this article, I shall focus on the relevance of these two critical expectations of all, where, incidentally, pharma is expected to do and deliver the very best – particularly against the prevailing and near-chaotic scenario. Let me begin with the first point first.

A great challenge:

Understandably, the above task is not a piece of cake due to many reasons. For example, according to a leading pharma trade association in the United States, ‘On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average.’

Thus, logically, a new drug molecule for Covid-19 can’t possibly be expected, by any stretch of imagination, within the next 12 to 18 months. What one can possibly expect for the same is, repurposing older drugs for the same. Quite logically, steps are being taken in this direction. However, even for such drugs, a clinical trial would take ‘six to seven years on average.’ Considering the urgency to combat the Covid-19 pandemic, can a fair clinical trial be completed in the next 12 to 18 months?

Therefore, the challenge in hand for the drug companies, even considering a super fast-track regulatory assessment and approval in 12 to 18 months, appear a pretty tough proposition. The challenge gets more complex, if Covid-19 starts changing.

A new issue is unraveling:

Recently, a new dimension got added to the mounting challenge of coming out with an effective drug or vaccine to fight Covid-19 pandemic, as evident from the Bloomberg article of May 20, 2020. It carries a headline ‘China’s New Outbreak Shows Signs the Virus Could Be Changing.’

It reported, Chinese doctors are seeing the Coronavirus manifest differently among patients in the new cluster of cases of their northern provinces of Jilin and Heilongjiang, compared to the original outbreak in Wuhan. Apparently, it indicates that the pathogen may be changing in unknown ways, complicating efforts to manage the infection. Although, more details need to be unraveled in this area, this incident could flag a fresh uncertainty over the virus mutation that may hinder current efforts of developing safe and effective drugs and vaccine for Covid-19.

Still no available drugs and vaccine for Covid-19 with proven clinical efficacy:

‘The Lancet’ article of April 02, 2020 – ‘‘Global coalition to accelerate COVID-19 clinical research in resource-limited settings’ has also emphasized the above point. It reiterated, there is still no available vaccine against Covid-19 infections and no drug with proven clinical efficacy, although there are several candidates that might be effective in prevention or treatment.

As of March 24, 2020, there were 332 COVID-19 related clinical trials, 188 of which were open for recruitment and 146 trials are preparing to recruit. These clinical trials were either planned or being carried out, mostly in China, South Korea, Europe and North America. However, not many trials were planned in south and southeast Asia, Africa, and central and South America at that time, the article pointed out. But the hype for the availability of drugs continues to reverberate, generally in the media reports. Nevertheless, the work is still in progress.

Some unproven hype as on date?

Despite so much of publicity on availability of drugs for the treatment and prevention of Covid-10, starting from Chloroquine and Hydroxychloroquine, which the US President Donald Trump called a “game changer” for Coronavirus – right up to Remdesivir, none has demonstrated scientifically proven clinical efficacy, as yet.

For example, the latest clinical trial results for Covid-19 on 15000 people, published in The Lancet on May 22, 2014 found, hydroxychloroquine and chloroquine did not benefit patients with the Coronavirus, either alone or in combination with an antibiotic. Moreover, the drugs caused an increased risk of cardiac arrhythmia. Earlier, ‘The BMJ’ article of May 14, 2020 also found that the administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard care alone in mild to moderate Covid-19 infections. This study also noted, adverse events with the recipients of hydroxychloroquine were higher than non-recipients.

On the other hand, in India, as reported on May 23, 2020, the Union Health Ministry has issued an advisory expanding the pool of people to be given the anti-malarial drug hydroxychloroquine (HCQ) as a prophylactic to prevent them from contracting the infection.

Similarly, even Gilead had stated in its Press Release of April 29, 2020: ‘Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19,’ besides some initial success reports. Notably, in India, Union Health Ministry has also recommended the use of anti-HIV drug combinations Lopinavir and Ritonavir for high-risk group patients, although there is no proven clinical evidence for its efficacy and safety in Covid-19 patients, if not against the use of this combination therapy.

Commercial activity progresses even before evidence-based regulatory approval:

Although, a single clinically proven drug is yet to come out, commercial activities for some of these drugs – in a near desperate situation – based apparently on hype created, including by the US President, have progressed or progressing. This had happened for hydroxychloroquine and has now started happening for remdesivir.

Almost every passing day one finds yet another repurposed drug being put on clinical trial by a different company, probably for similar reasons. There is nothing wrong on that, but which drugs work and which do not, must be evaluated in a more cohesive manner and sooner.

The good news is, the World Health Organization (WHO), which is concerned with recommendations for ‘administering unproven treatments to patients with COVID-19 or people self-medicating with them,’ has announced the “Solidarity” clinical trial for the new Coronavirus treatments. This is an international clinical trial, aimed at the scientific assessment of 4 treatment options to slow the disease progression or improve survival rate for COVID-19 patients.

Otherwise, a strong desire for people to survive – ‘somehow’, will prevail in this desperate situation, over what these medicines can actually deliver. Even drug companies never experienced in the past or even could even envisage such a pandemic at this humongous global scale.

A similar scenario is witnessed with some major vaccine development initiatives. For example, stock markets soared with the early signs of viral immune response of the much publicized experimental Covid-19 vaccine being developed by Moderna Inc. However, a few days later, after ‘parsing the data to gauge the company’s chances of success’ by the analysts, it was reported: ‘It’s too soon to assume success for Moderna Inc’s COVID-19 vaccine.’ Curiously, it continues to happen in the early days with almost all such well publicized initiatives. Nonetheless, the pursuit to find out safe, effective and clinically proven drugs and vaccine continues.

Which is why, bringing scientifically proven safe and effective drugs and vaccine sans the early hype, in a specified time, falling close to the realm of a genuine possibility, becomes a key deliverable of pharma players, in this situation. That said, it brings me to the second point where pharma and biotech companies are widely expected to meet the other expectations of all – making these drugs and vaccines available, affordable and accessible to all, globally.

Making Covid-19 drugs and vaccines available, affordable and accessible to all, globally:

Again, this seems to be an equally tough call for most drug players, as has been happening, generally. But Covid-19 drugs and vaccines are just not for saving life, these are also intimately related directly to the livelihood of a very large global population, especially in the developing nations, like India. Therefore, ‘Coronavirus vaccine should be for everyone, not just those who can afford it,’ as articulated in the article, published in the STAT news on March 05, 2020.

This apprehension arises among many in the United States, as well. Mainly because, as reported in the above article, vaccine coming out of the two vaccine development projects funded by the U.S. government, one by Sanofi and another by Johnson & Johnson, may not be affordable to all Americans.

Further, quite a number of countries in the world lack resources, infrastructure, and health care personnel to detect the virus and prevent it from spreading quickly and easily among populations. In which case, without drugs and vaccines, the number of cases is likely to grow exponentially, putting stress on already burdened health care workers and facilities. Consequently, it will make harder to provide timely care for those who are ill. Thus, vaccines will be an important tool for preventing such a catastrophe.

For those with resources – ‘rich countries and rich people,’ a Covid-19 vaccine will certainly be valuable to save lives. However, for most people in all countries, including India, it may be essential for the livelihood, as well. Without it, they will suffer disproportionately and unnecessarily, the article concluded. Thus, in this hour of multiple crisis of global dimension, the drug players are expected to come forward, making these drugs and vaccines available, affordable and accessible to all, globally – a task where they can deliver the best, compared to others.

Conclusion:

Amid ‘Lockdown.4’ in India, as on May 24, 2020 morning, the recorded Coronavirus cases have mounted to 131,920 with 3,869 deaths. By the way, on the same day, the most populated country in the world – China, where Covid-19 struck first in December 2019, records 82,974 cases with 4634 deaths, so far.

That apart, Covid-19 is a very special situation for all countries, probably more than what happened during the 1918 Spanish flu pandemic, for several reasons. Comparing these two pandemics, especially during the lockdown period, has been common. Due to this pandemic, as many as 675,000 people, reportedly died only in America, many of them were previously healthy young adults. Almost similar situation is on the horizon with the Covid-19 pandemic.

Agreed, that the overall healthcare infrastructure and global scientific resources to combat these two pandemics may not be comparable. But even in the context of the 21^st century, this is a very critical global situation, for both – saving life and also the livelihood. Thus, for pharma and biotech companies ‘this is not a time to make money’, as the chief executive officer of Serum Institute of India, which is helping produce a vaccine for Covid-19 developed by Oxford, puts it succinctly. Be that as it may, the answer to the two questions that I started with, still remains elusive.

By: Tapan J. Ray

Come Covid-19 Drug And Vaccine, Pharma Will Get Back To The Traditional Mode

Posted on May 18, 2020 by Tapan Ray

‘Corona will remain a part of our lives for a long time. But at the same time, we cannot allow this to happen that our lives will be confined only around the corona. We would wear masks, follow two yards distance and pursue our goals. Therefore, the fourth phase of lockdown, lockdown 4, will be completely redesigned, with new rules,’ said the Prime Minster of India, during his televised address to the nation on May 12, 2020.

Many countries around the world, have already decided to move ahead, phasing out Covid-19 lockdowns cautiously, in a manner that each country will deem appropriate. Alongside, in line with many other industries, several pharmaceutical companies seem to have also started accepting this new reality. For example, Novartis, which reportedly, started digitizing its sales and marketing even before the COVID-19 pandemic, has hit the fast forward button.

This is evident from what Novartis said: “We were already on a journey in terms of our commercial model where digital and other channels and virtual detailing were becoming a bigger part of our mix.” The Company is planning an omnichannel digital launch for its latest new product – Tabrecta for metastatic lung cancer. This was prompted by the very sensitive situation that the world is going through ‘and the extra burden that’s put-on physicians and patients” as the pandemic continues - the company clarified.

This leads to the key question, are most companies on the same wavelength as Novartis, in this area? Or, a large majority of drug players, is still nurturing the hope that prescription demand generation activity from doctors and hospitals will soon return to the traditional mode of what was prevailing during pre-Covid-19 pandemic days? This flows from an age-old experience – a large number of sales or medical representatives have always spearheaded the demand generation mechanism for any patented or brand-generic medicine.

Still, for many it is difficult to even think of any quantum shift in this space, as the traditional core mechanism continues, despite so much hype of digitalizing pharma operations. Whereas, several others do feel, at least, a Covid-19 vaccine or a drug for its effective treatment, which, apparently, are almost knocking at the door, will bring the current situation back to the previous normal. Will vaccine or an effective drug be a panacea to win the war of Covid-19 pandemic, decisively? In this article, I shall dwell on this subject. To set the ball rolling, let us fathom whether or not coming out with a safe and effective Covid-19 vaccine, in a jiffy, is rather a certainty.

Is Covid-19 vaccine a certainty?

No doubt, a large majority of people believe, a vaccine to prevent COVID-19 is perhaps the best hope for ending the pandemic, as Mayo Clinic has also said so. However, it also records the following major apprehensions or challenges in developing a COVID-19 vaccine, based on the research data:

Ensuring vaccine safety
Providing long-term protection
Protecting older people

On May 12, 2020, at the US Senate hearing about the path forward from pandemic lockdowns in the United States, NIAID director Anthony Fauci also said, there’s “no guarantee” any of the vaccines in testing will be effective, though based on his knowledge of other viruses, he is “cautiously optimistic.” Thus, projections about how COVID-19 will play out, are still mostly speculative.

Why ‘projections about how COVID-19 will play out are still speculative’?

A recent article – ‘How the COVID-19 Pandemic Could End,’ published in the ‘Scientific American,’ also commented so. It said, the end game will most likely involve a mix of everything that checked past pandemics:

Continued social-control measures to buy time,
New antiviral medications to ease symptoms,
And a vaccine.

Citing the famous example of the H1N1 influenza outbreak of 1918–1919, it said, doctors and public health officials had far fewer weapons than they do today. Thus, the effectiveness of control measures, such as school closures depended on how early and decisively, they were implemented. Over two years and three waves, the pandemic infected 500 million and killed between 50 million and 100 million. It ended only as natural infections conferred immunity on those who recovered.

Which is why, as on date the pursuit to achieve all three goals as mentioned above, would likely to continue. That said, a safe an effective Covid-19 vaccine will be the most preferred way to stop rapid transmission of the Coronavirus outbreak. However, this comes with a critical caveat.

Would the entire population need to be vaccinated?

Experts believe, unless a vaccine is administered to all of the world’s eight billion inhabitants who are not currently sick or recovered, COVID-19 is likely to become endemic. It will circulate and make people sick seasonally—sometimes very sick. But if the virus stays in the human population long enough, it will start to infect children, showing mild symptoms.

In that process, children appear less likely to develop severe disease if they get re-infected as adults. Thus, the combination of vaccination and natural immunity will protect many of us. ‘The Coronavirus, like most viruses, will live on—but not as a planetary plague,’ the ‘Scientific American,’ article concluded.

Covid-19 end game to involve a mix of those that checked past pandemics:

Let us now look at the possible mix of the Covid-19 end game, which were involved in checking the past pandemics, one by one:

Continued social-control measures to buy time:

The social control measures would include compliance with the prescribed social distancing norms, in tandem with aggressive testing for the infected individuals, isolating them, and quarantining their contacts. These measures were well tested in the past epidemics and useful if followed well, by all.

Therefore, from the pharma industry perspective, getting back to the traditional ‘pre Covid-19 mode’ of prescription demand generation mechanism, will indeed be challenging for most drug players.

Availability of well-tested antiviral medications to ease Covid-19 symptoms:

So far, there is no scientifically and well-tested medications for the treatment of Covid-19. However, many different medications are under clinical trials in various parts of the world. So far, most hyped among them appears to be remdesivir, an experimental antiviral developed by Gilead for the treatment of Ebola.

However, the clinical study result of ‘Remdesivir in adults with severe COVID-19,’ published in The Lancet on April 29, 2020 found that the dose regimen of intravenous remdesivir used in the study, was adequately tolerated, but did not provide significant clinical or antiviral effects in seriously ill patients with COVID-19.

The World Health Organization (WHO) also, reportedly, announced a large global trial, called ‘Solidarity’, to find out whether any of those drugs can treat infections with the Covid-19. In India, several drug companies are also testing the water, with their shortlisted drugs, such as, Zydus Cadila want to test a form of interferon, usually used against hepatitis B and C, as a potential treatment for COVID-19. More trials on remdesivir are ongoing, let us keep our fingers crossed.

Interestingly, Gilead has, reportedly, signed nonexclusive licensing agreements with five Indian generic drug makers – Cipla, Mylan, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences, to produce COVID-19 therapy remdesivir for low- and lower-middle income countries. Under the agreements, Gilead will share its manufacturing know-how with them to help gear up remdesivir local production. Moreover, each of these companies will be allowed to set the price for its own generic version of the drug.

In any case, scientifically proven safety and efficacy of any drug or vaccine for the prevention or treatment of Covid-19, is yet to be known. Hence, for all individuals, strict compliance with social distancing measures is the only way to avoid this highly contagious infection. The same is also applicable to doctors and sales representatives while working in the field, at least, till an effective Covid-19 vaccine or drug comes.

Affordability and access to Covid-19 drug and vaccine:

Assuming that a safe, effective and clinically proven vaccine or a drug for Covid-19 will be available sooner than what experts anticipate now, yet another critical issue needs to be resolved, soon. This is related to their affordability and access, to contain the mortality and morbidity of the disease, for a vast majority of the population, especially in the developing nations, like India.

Even Gavi noted: ‘In the race to produce a safe and effective vaccine against the COVID-19 virus, one of the many challenges will be the cost of developing the vaccine and eventually getting it to the vast number of people worldwide who will need it.’ However, it is generally anticipated that ‘COVID-19 vaccine or a drug may end up costing people a small fortune.’ Another article also echoed the same sentiment by saying, ‘Covid-19 treatments won’t work if people can’t afford them.

However, India’s Serum Institute based at Pune, has announced that it is ready for 20-40 million vaccine shots at Rs 1,000/dose, by September-October 2020. The company is ‘’putting its weight behind an Oxford University-led consortium, which announced the start of human clinical trials on April 23 and is one of the first such projects to get underway globally.’

At the same time, another report emphasized: “Even after India approves the Coronavirus vaccine, it might not be possible to produce more than 10-20 million doses in the first year,” again raising the availability and access issue for a Covid-19 vaccine, as and when available in India.

Conclusion:

As on May 17, 2020 morning, the recorded Coronavirus cases continue to climb sharply to 90,927 with 2,872 deaths.. Moreover, on May 13, 2020, the world Health organization has also warned that “this virus may become just another endemic virus in our communities, and this virus may never go away.” Thus, the world has to live with it. By the way, the accuracy of many Covid-19 test kits has also been widely questioned. This reportedly includes speedy Abbott test, as well.

In this scenario, people may have to necessary live with social distancing norms and the practice of wearing a mask outside the home, always. Besides, the template for relief from Covid-19 becomes more complex, particularly considering availability, affordability and access to a safe and effective drug or vaccine in India, as and when these will come. Taking these together, the end game for Covid-19 in the foreseeable future, becomes anybody’s guess.

Coming back to the pharma industry, curiously, some people are still hoping for ‘business as usual’ in the traditional pre-Covid-19 mode, although the writing on the wall is increasingly getting clearer. The only alternative that people can possibly follow under the circumstances, is strict compliance to social distancing norms, which pharma companies, doctors, healthcare consumers and others would also require to adhere to, with as much earnest. Thus, envisaging a return to pre-Covid-19 prescription generation mode, may not be prudent choice, anymore.

By: Tapan J. Ray

What A New Microbe Can Man Can’t?

Posted on March 23, 2020 by Tapan Ray

Our world is indeed so fascinating, where mankind is in possession of a predictable lethal power to annihilate fellow citizens of any country or countries – just in minutes or hours or days, as it would decide. Whereas, any sudden attack of an unpredictable crippling power of unknown microbes, can make the same mankind feel helpless – grappling to save lives of the citizens – along with its socioeconomic fabric.

Because of the sudden nature of such crippling attacks, mankind is put to fight against time to build a new arsenal of medicines and vaccines – while defending itself under an umbrella of preventive measures. It’s not that such a situation was never envisaged. On the contrary, as we shall see below, the warning from the same came from several credible sources. Even Bill Gates during a TED Talk five years ago had warned: “If anything kills over 10 million people in the next few decades, it’s most likely to be a highly infectious virus rather than a war – not missiles, but microbes.”

A few years later, the 2018 publication of the World Health Organization (WHO) – ‘Managing epidemics,’ articulated a similar cautionary note, which I am quoting in verbatim: “We are continuously learning about the unpredictable powers of nature. This is nowhere more true than in the continuous evolution of new infectious threats to human health that emerge – often without warning – from the natural environment.” Elaborating the point, it further cautioned: “Given the effects of globalization, the intense mobility of human populations, and the relentless urbanization, it is likely that the next emerging virus will also spread fast and far. It is impossible to predict the nature of this virus or its source, or where it will start spreading.”

Ironically, in about a year’s time, by end 2019, a new Coronavirus broke out in Wuhan of China. From January to March 22, 2020, 13,569 people, reportedly, died globally due to Coronavirus (Covid 19) infection. In India, as I write as I write during 14 hours long public curfew, 341 confirmed cases and 6 deaths have been reported. This outbreak has now shaken, almost the entire world – more than even before. The reverberation of the life-shattering impact of the disease, is now being felt and heard across all the facets of human life, including social, economic and political. Thus, the broad point to ponder in this article: Why the mankind can’t do what a new microbe can?

Various elements to it:

There are various elements of the above broad issue. A comprehensive response to which would involve, at least, two critical sub-questions:

Was it avoidable? If so, to what extent?
Or, at least, could its overall impact have been blunted?

Moving in that direction, let me try to explore some important facts that may help taking an unknown microbe bull by the horn, if such calamity strikes again – unannounced, in future.

None of these facts were unknown:

As we have seen above, the possibility of emergence and a sudden crippling strike of a new microbe was not unknown, including the warning of a global crisis from the W.H.O. Besides, ‘nearly 50,000 men, women and children are dying every day from infectious diseases; many of these diseases could be prevented or cured for as little as a single dollar per head.’

Another interesting report: ‘Global rise in human infectious disease outbreaks,’ published in the Journal of the Royal Society interface on December 06, 2014, presents more facts. It says: Since 1980, over the last 30 years till 2014, outbreaks of infectious disease mostly caused by bacteria and viruses are steadily increasing with different health impact in different countries.

Several reasons for the high death rate related to infectious disease:

Several reasons could be attributed to high death rates for infectious disease, despite the availability of a large number of powerful antibiotics in the world, which include the following:

Developing nations with lesser access to drugs.
Fast development of Antimicrobial Resistance (AMR) owing to misuse and abuse of antibiotics.
Emergence of new bacteria and viruses, such as, Covid19 catching the population off-guard, as is being warned by top experts, from time to time.

Several times in the past, I wrote on the subjects of access to medicine, Antimicrobial Resistance (AMR), as well as the recent Coronavirus outbreak. Nevertheless, for this specific discussion, I shall focus only on the second and the third points, in the reverse order, with a different perspective.

Fresh threats of new infections are ongoing:

As the 2018 paper of ‘Managing epidemics’, published by the World Health Organization (WHO) had articulated – besides new microbial pandemics, the history of previous viral outbreaks can also possibly repeat themselves. That means: ‘A new HIV, a new Ebola, a new plague, a new influenza pandemic are not mere probabilities. Whether transmitted by mosquitoes, other insects, contact with animals or person-to-person, the only major uncertainty is when they, or something equally lethal, will arrive.’

As these being ‘newer’ types – just as Covid19 is so different from commonly occurring Flu - in all probability would be unique viruses with unique characteristics. For example, as the W.H.O describes, while Seasonal Flu cannot be stopped, countries still have the chance to limit cases of Covid19, through stringent implementation of scientific protocols. More, importantly, Covid-19 seems to lead to much more severe disease than Seasonal Flu strains.

Effective solution of both – the new and the new forms of known viruses, would require successfully navigating through tough challenges, involving multiple areas, such as, medical, technological, social, economic and political. No doubt, the world has progressed a lot in this area. But, effective ‘capacity building’ to combat the sudden onslaught of any deadly microbial pandemic, still remains an unfinished agenda.

The world has moved a lot, but still needs to accelerate capacity building:

Just in 2018, the world remembered the devastating Great Flu pandemic of 1918 on its 100th anniversary. Although, it lasted only a few months, claimed 50 million to 100 million lives worldwide. The book - ‘Influenza: The Hundred Year Hunt to Cure the Deadliest Disease in History,’ provided a glimpse of that scenario. Interestingly, Flu still kills about 1 percent of those infected by this virus. Whereas, about 3.4 percent of Covid-19 cases have been fatal, as on date, according to the W.H.O.

A comparison of these two pandemics will include both the similarities and the differences. The most striking similarity being – in both the global pandemics, most people are just not afraid, but are also getting panicked.

Whereas, the key differences between the two episodes are – the quality health care infrastructure in today’s globalized world, speed of diagnosis and the versatility of available drugs – even for ‘repurposing’, as being done in the present situation. Now, many people understand the need of putting the exposed persons in isolation – or under quarantine, besides co-operating with various infection control measures, as prescribed by the health authorities. In the midst of this crisis, an ongoing and very related critical issue remains virtually ignored - fast developing AMR, as I mentioned above.

Fast developing AMR continues taking many lives:

In this article, instead of dwelling on the cause of AMR and how to address it, I would rather focus on the current threats that AMR poses and will pose in the future, if not addressed on a war footing, collectively.

The latest details in this area are available from the paper – ‘The Antimicrobial Resistance Benchmark 2020’, published by the Access to Medicine Foundation. It emphasized that infectious diseases are still the cause of “more than 500,000 deaths each year, including more than 200,000 infant deaths. In India, for example, resistance exceeds 70 percent for many widespread bacteria.” As I mentioned in one of my previous articles that the 2017 Review Article, titled ‘Antimicrobial resistance: the next BIG pandemic,’ has termed India as ‘the AMR capital of the world.’ Even a 2020 news report says: Two million deaths are projected to occur in India due to AMR by the year 2050.

The current status:

The following two reports of WHO, published in January 2020, unfolded some interesting facts:

The analysis demonstrated, although, many drug companies are making enough investments to discover and develop innovative medicines, anti-infective therapy area does not feature there for most companies. As the reports unraveled:

Not just a declining trend of investment, even the current clinical pipeline remains insufficient to tackle the challenge of AMR.
With large drug companies continuing to exit the field, primarily due to commercial considerations, small and medium-sized enterprises (SMEs) are entering this space, but not with as much resources and other wherewithal.
All the eight new antibacterial agents, approved since July 01, 2017, offer limited clinical benefits.
One new anti-TB agent, pretomanid, developed by a not-for-profit organization, has been approved for use within a set drug-combination treatment for MDR TB.
The current clinical pipeline contains 50 antibiotics and combinations and 10 biologicals. Six of these agents fulfil at least one of the innovation criteria; only two of these are active against the critical MDR Gram-negative bacteria, with a major gap in activity against metallo-β- lactamase (MBL) producers.

As the AMR situation is getting worse, globally, unlike any possible repetition of a new microbial attack in the future, AMR isn’t a future problem. It needs to be addressed here and now. Fixing the problem does not require a scientific miracle. It demands a very human solution, spearheaded by the R&D based drug companies, the academia and the Governments, collectively. The reasons of why it is not happening - is known to many, but how to chart an effective pathway for its meaningful resolution – possibly isn’t. The signal today is loud and clear that infectious diseases are reemerging and threatening human lives – be it due to AMR or a sudden attack by a new microbe such as Covid19.

Conclusion:

It is loud and clear that infectious diseases will continue to reemerge in various shapes, forms and virulence – having the incredible power of shaking the world, including the most powerful and developed nations, as we all are experiencing today. As and when Covid19 pandemic gets over, and it will, learning from the past situation and picking up the global best practices to combat and decisively win over any such future crisis, will be critical. But, this is easier said than done – going by the past.

All concerned can feel it today, without any shade of doubt. There is no room for complacency in this regard, for anyone, regardless of having the best of health care infrastructure, diagnosing facilities, state of the art treatments of all types, including vaccines, for a wide range of number of life-threatening conditions.

As the W.H.O said, ‘The microbes didn’t go away. They just went out of sight. Instead, the focus turned to chronic, noncommunicable diseases, which came to receive much more attention. But nature was by no means in retreat. In fact, it seemed to return and took many health institutions and decision makers by surprise.’

It’s, therefore, high time for all to read the writing on the wall. A time to accept and realize that, when it comes to an unpredictable, crippling power of bringing the entire world to virtually a grinding halt – making even the most powerful nations feel helpless and highly vulnerable – what a new lethal microbe can do in one go, even the most developed and the powerful nation can’t. An all-time preparedness against biological threats, therefore, has emerged as a new normal.

By: Tapan J. Ray

Coronavirus Outbreak: Drug Shortage, Treatment And Unease – A Review

Posted on March 9, 2020 by Tapan Ray

The Coronavirus outbreak has reached a “decisive point” and has “pandemic potential”, said the Director General of the World Health Organization (W.H.O), reportedly, on February 27, 2020, urging governments to act swiftly and aggressively to contain the virus. He further added, “We are actually in a very delicate situation in which the outbreak can go in any direction based on how we handle it.” Alerting all, he appealed, “this is not a time for fear. This is a time for taking action to prevent infection and save lives now.”

As on March 08, 2020 – 106,211 coronavirus cases (view by country) were reported globally, with 3,600 deaths and 60,197 patients recovered. Thus, the most relevant question now is the level of preparedness of each country, to prevent a possible epidemic, which may even strike at a humongous scale. This will be relevant for both, the countries already infected with a coronavirus – in a varying degree, as well as, those who are still out of it.

From the drug industry perspective, equally pertinent will be to assess on an ongoing basis its impact on the medical product supply-chain and further intensifying ongoing efforts to find the ‘magic bullet’ – an effective remedy, partly addressing the unease of all, on this score. In this article, I shall try to ferret out the current status on these points, based on available and contemporary data.

The impact assessment has commenced:

While on the current impact assessment, I shall restrict my discussion on the largest pharma and biological market of the world – the United States (US) and of course, our own – India, starting with the former. On February 14, 2020, the US released a statement of the Commissioner of Food and Drugs Administration titled, ‘FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad.’ Highlighting the proactive actions of the regulatory agency, the statement recorded:

“We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages.” Adding further, he revealed that the US-FDA is in touch with regulators globally and has added resources to quickly spot “potential disruptions or shortages.”

Whereas in India, the Chemicals and Fertilizers Ministry has also announced: “The Government of India is closely monitoring the supply of APIs/intermediates/Key starting materials (KSMs) which are imported from China and the effect of the outbreak of a novel coronavirus in China on their supply.”

The current status:

As this is an ongoing emergency exercise, on February 27, 2020, by another statement, the US-FDA reported the first shortage of a drug, without naming it, due to the COVID-19 outbreak. It identified about 20 other Active Pharmaceutical Ingredients (APIs) or finished drug formulations, which they source only from China. Since January 24, the US-FDA has, reportedly, been in touch with more than 180 manufacturers of human drugs to monitor the situation and take appropriate measures wherever necessary. However, the prices of some key ingredients have already started increasing.

Back home, on March 03, 2020, Reuters reported, the Indian Government has asked the Directorate General of Foreign Trade (DGFT) to restrict export of 26 APIs and other formulations, including Paracetamol, amid the recent coronavirus outbreak. Interestingly, these 26 active pharmaceutical ingredients (APIs) and medicines account for 10 percent of all Indian pharmaceutical exports and includes several antibiotics, such as tinidazole and erythromycin, the hormone progesterone and Vitamin B12, among others, as the report indicated.

It is unclear, though, how this restriction would impact the availability of these medicines in the countries that import from India, especially formulations, and also China. For example, in the United States, Indian imports, reportedly accounted for 24 percent of medicines and 31 percent of medicinal ingredients in 2018, according to the U.S. Food and Drug Administration. Be that as it may, it still remains a reality that China accounted for 67.56 per cent of India’s total imports of bulk drugs and drug intermediates at USD 2,405.42 million in 2018-19.

Prior to this import ban, a report of February 17, 2020 had flagged that paracetamol prices have shot up by 40 percent in the country, while the cost of azithromycin, an antibiotic used for treating a variety of bacterial infections, has risen by 70 percent. The Chairman of Zydus Cadila also expects: “The pharma industry could face shortages in finished drug formulations starting April if supplies aren’t restored by the first week of the next month,” as the news item highlighted.

No significant drug shortages reported, just yet:

From the above details, it appears, no significant drug shortages have been reported due to Coronavirus epidemics in China – not just yet. Moreover, the Minister of Chemicals and Fertilizers has also assured: ‘No shortage of drug ingredients for next 3 months.’ He further added: ‘All initiatives are being taken to ensure there is no impact of the disease in India.’

However, on March 03, 2020, W.H.O, reportedly has warned of a global shortage and price gouging for protective equipment to fight the fast-spreading coronavirus and asked companies and governments to increase production by 40 percent as the death toll from the respiratory illness mounted. Moody’s Investors Service also predicted, coronavirus outbreak may increase demand, but poses a risk of supply chain disruptions, especially for APIs and components for medical devices sourced from China.

In view of these cautionary notes, especially the health care and regulatory authorities, should continue keeping the eye on the ball. More importantly, commensurate and prompt interventions of the Government, based on real-time drug supply-chain monitoring, along with the trend of the disease spread, will play a critical role to tide over this crisis.

In search of the ‘Magic Bullet’:

Encouragingly, on February 16, 2020, the National Medical Products Administration of China has approved the use of Favilavir, an anti-viral drug, for the treatment for coronavirus. The drug has reportedly shown efficacy in treating the disease with minimal side effects in a clinical trial involving 70 patients. The clinical trial is being conducted in Shenzhen, Guangdong province. Formerly known as Fapilavir, Favilavir was developed by Zhejiang Hisun Pharmaceutical of China. A large number of other promising R&D initiatives are being undertaken, in tandem, by brilliant scientific minds and entities to find an effective treatment for this viral disease. To give a feel of it, let me cite just a few examples, both global and local, as below.

Pfizer Inc. has announced that it has identified certain antiviral compounds, which were already in development, with potential to treat coronavirus-affected people. The company is currently engaged in screening the compounds. It is planning to initiate clinical studies on these compounds by year-end, following any positive results expected by this month end.

Several large and small pharma/biotech are now engaged in developing a vaccine or a treatment. Gilead has, reportedly, initiated two phase III studies in February 2020, to evaluate its antiviral candidate – remdesivir, as a treatment for Covid -19. Takeda is also exploring the potential to repurpose marketed products and molecules to potentially treat COVID-19, besides developing a plasma-derived therapy for the same. Pipeline candidates of other companies are in earlier stages of development, as reported.

Whereas in India, Serum Institute of India (SIL) is collaborating with Codagenix, a US-based biopharmaceutical company, to develop a coronavirus cure using a vaccine strain similar to the original virus. The vaccine is currently in the pre-clinical testing phase, while human trials are expected to commence in the next six months. SII is expected to launch the vaccine in the market by early 2022.

Zydus Cadila, as well, has launched a fast-tracked program to develop a vaccine for the novel coronavirus, adopting a two-pronged approach, a DNA based vaccine and a live attenuated recombinant measles virus vectored vaccine to combat the virus. These initiatives seem to be a medium to long-term shots – laudable, nonetheless.

Current off-label drug treatment for coronavirus:

Some of the drugs, reportedly, being used in China to treat coronavirus include, AbbVie’s HIV drug, Kaletra and Roche’s arthritis drug – Tocilizumab (Actemra). However, none of these drug treatments have been authorized yet by drug regulators, to treat patients with coronavirus infection.

According to the Reuters report of March 04, 2020, China’s the National Health Commission, in its latest version of online treatment guidelines, has indicated Roche’s Tocilizumab for coronavirus patients who show serious lung damage and elevated level of a protein called Interleukin 6, which could indicate inflammation or immunological diseases.

However, there is no clinical trial evidence just yet that the drug will be effective on coronavirus patients and it has also not received approval from China’s National Medical Product Administration for use in coronavirus infections. Nonetheless, Chinese researchers recently registered a 3-month clinical trial for Actemra on 188 coronavirus patients. According to China’s clinical trials registration database, the period of trial is shown from February 10 to May 10.

Is coronavirus becoming a community transmitted infection?

Even while grappling with an increasing number of COVID-19 positive patients, the Indian Government is showing a brave front, as it should. However, it has also confirmed “some cases of community transmission.” This unwelcome trend makes India the part of a small group of countries, including China, Japan, Italy and South Korea, where community transmission of the virus has taken place. This is a cause of an additional concern.

Although, there has been no significant drug shortages reported yet, shortages of hand sanitizers,recommended for frequent use by the W.H.O and other competent bodies, as they can, reportedly kill Covid-19. Similarly, N95 masks useful to prevent the spread of the disease, have also disappeared, adding more fuel to fire, if not creating a panic-like situation, for many.

Conclusion:

Most global drug players with a business focus on branded – patented drugs, are not expected to fight with the supply disruptions. As reported, ‘Several top drugmakers – including Pfizer, Johnson & Johnson, Bayer, Merck KGaA and Roche—recently confirmed to FiercePharma that they have stock policies in place to minimize the impact.”

But, for the generic drug industry the disruption in the supply chain may have a snowballing effect. For example, as the March 03, 2020 edition of the New York Times (NYT) reported – supply chain disruption in sourcing some APIs from China is being felt most acutely in India, as the Government decided to stop exporting 26 drugs, most of them antibiotics, without explicit government permission. The same article also highlighted the possible multiplier effect of this development with its observation: “That’s a problem for the rest of the world, which relies on India’s drug makers for much of its supply of generic drugs. India exported about $19 billions of drugs last year and accounted for about one-fifth of the world’s exports of generics by volume”, it added.

As on date, there is no known cure for coronavirus infection. The magic-bullet has yet to be found out. However, over 80 clinical trials has, reportedly, been launched to test coronavirus treatments. This includes, repurposing older drugs, as well. Recently, only Favilavir, an anti-viral drug, has been approved for treatment for coronavirus by the National Medical Products Administration of China.

Coming back to the unease of many in India, the country’s perennial shortages of doctors, paramedical staff, hospital beds, adequate quarantine facility for a large number of patients and fragile public healthcare delivery system, still pose a humongous challenge in this crisis. More so, when just in the last week, U.S. intelligence sources, reportedly, told Reuters that ‘India’s available countermeasures and the potential for the virus to spread its dense population was a focus of serious concern.’

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

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Coronavirus Outbreak: Drug Shortage, Treatment And Unease – A Review