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Pharma’s Digital Initiatives In India: A Missing Link

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An interesting study – designed to investigate the challenges that Health and Human Services (HHS) organizations face in implementing digital and data solutions, stands out today – for many reasons. One such being, this ‘multi-country survey’ project team had no inkling about the pandemic when the project was undertaken.

This study was conducted by a research team from Imperial College London’s Institute of Global Health Innovation (IGHI), and was sponsored by EY. The survey comprises of more than 2,000 global HHS professionals – from India, Australia, Italy, UAE, the UK and the US. 359 respondents were from India.

The research passed through the phase when Covid related disruptions was about to put HHS providers through the most extreme stress test in living memory. ‘While the outbreak was catastrophic in its effects, it presented the researchers with an exceptional opportunity to study the sector’s behavior during a pivotal moment,’ the paper noted.

From this perspective, today’s article will explore, from various different sources, across the world, how Covid-triggered rapid development and adoption of digital solutions are in the process of making a paradigm shift in the healthcare space. It spans across – health care service providers, its users, and practitioners – including pharma industry and the tech-solution developers.

Consequently, the question arises, would healthcare industry’s innovative spirit of 2020 is robust enough for taking a quantum leap in this space, as we move on. That space will span across – conceptualization and development of new health care products and services, alongside their consumption pattern and consumer behavioral dynamics. And, right up to the adoption of cutting-edge digital technology for commensurate delivery mechanisms. Let me start with some key findings in this area from the above report.

Some key findings – Global and India:

The findings of the Report titled, ‘Embracing digital: is COVID-19 the catalyst for lasting change?’ published on January 13, 2021, ferreted out some interesting facts, with details. These encompass both global and Indian scenario, in this area.

Some key findings – Global:

  • Pre-pandemic – just 18% of HHS providers had managed to embed digital tools in the way they work – mostly, due to lack of funds, regulatory restrictions, and risk aversion. However, the pandemic outbreak swept away many of these barriers, as 62% of organizations have now started using digital technologies and data solutions, globally.
  • 48% organizations are planning to continue investing in technology during the next three years, with 33% expecting more than 50%, and 19% more than 100% increase in investment.
  • While phone consultations are being offered by 81 % of HHS organizations (up from 39 % before the pandemic), 71 % of organizations offering video consultations (up from 22 % before the pandemic).
  • Respondents’ top objectives for future investment towards rapid adoption of digital solutionsinclude, transforming ways of working and service delivery, improving quality of care, reducing the administrative load, enabling better communications, and streamlining work processes.
  • However, 47% of respondents think, the introduction of digital and data solutions was a temporary measure to address challenges during the pandemic.

Some key findings – India:

The Covid-19 pandemic triggered fast acceleration of the adoption of digital technologies by the HHS in India, as well.

  • 51% of respondents from India reported that their respective organizations have increased the use of digital technologies and data solutions since the Covid-19 outbreak.
  • Increased staff productivity reported for 74 % of respondents’ organizations with 75% reporting that digital solutions have been effective in delivering better outcomes for patients and service users.
  • Remote consultations, such as, phone and video consultations have witnessed a greater increase in India than the global average. 86 % of Indian organizations are now offering phone consultation (up from 48 % before pandemic) and 83 % for video consultations (up from 33 % before pandemic).
  • Around three fourth of the respondents in India reported positive experiences with digital technologies and data solutions with the number of people using online consultations in India recording a threefold increase.

This encouraging trend and pattern needs to be consolidated, analyzed, and leveraged – for sharper actionable insights for the development of more contemporary products and services to delight the pharma and health care stakeholders.

A key missing link in India:

The digital health transformation of India’s healthcare system during Covid pandemic was also captured in another article, published by Elsevier Connect on February 23, 2021. It reiterated, although the pandemic has made an overall detrimental impact impacted on India, ‘it has brought about an avalanche of positive changes, including the adoption of digital health technologies and significant changes to the way care is delivered.’ Looking ahead, ‘With the launch of national public health initiatives, India has an incredible opportunity to become a digital health leader,’ the paper predicted.

However, the author also pointed out, unambiguously, that the health care crisis caused by the pandemic has also brought to the fore a key missing link – the need for updated and near real-time availability of trusted information. This observation is more relevant now than ever before, especially considering India’s National Digital Health Mission (NDHM).

National Digital Health Mission – a new ambition:

While addressing the nation on August 15, 2020, Prime Minister Narendra Modi announced the National Digital Health Mission of India. He said in his speech, “From today, the national digital health mission will begin. It will revolutionize the Indian healthcare sector. Every Indian will be issued a health ID that will act like a healthcare account, storing details of all the tests done, existing diseases, diagnoses, medicines prescribed.”

The objectives of the mission are to establish a core digital health database, creating a system of Electronic Health Records (EHR) based on international standards, establish data ownership pathways, so that patients become the owner of their health records, and promoting health data analytics and medical research. This initiative by any standard, is expected to be a game changer, as and when it comes to fruition.

Subsequently, on June 25, 2020, the Union Ministry of Health, reportedly, wrote to the principal secretaries (health) of all states and union territories, asking them to extend full support to the NHA to create four registries — doctors, health infrastructure, health IDs and personal health records of patients. It also instructed the states to send the required details within the stipulated timeline without breaching the norms of data privacy.

Need to avoid any possible missing link in the NDHM:

However, the Harvard Business Review article, published on June 12, 2020, asserted that the emergence of the COVID-19 pandemic not only presented a “mind-boggling array of challenges” exposed the limitations of the electronic health record (EHR) in helping physicians deliver care, especially in the United States.

It suggested: transformation of the EHR from an emphasis on a ‘person’s medical record’ – to an emphasis on their ‘plan for health’ and from a focus on ‘supporting clinical transactions’ to a focus on ‘delivering information’ to the provider and the patient, will be more meaningful.

Thus, it’s time for a new kind of EHR system in today’s perspective, as suggested by the HBR article, besides other domain experts. I am sure, competent authorities will take note of this transformation required in EHR initiatives to avoid any missing link in the new digital healthcare space in India.

As the above Elsevier Connect paper also observed, with the launch of national public health initiatives, such as, Ayushman Bharat and National Digital Health Mission (NDHM), India harbors an incredible opportunity to showcase its world class digital health ecosystem for all in the country.

To help fructify these projects, all key stakeholders – health care service providers, its users, and practitioners – including the pharma industry and the tech solution companies, need to get intimately involved with a common agenda in place. Falling behind may invite regrets, later.

Nonetheless, well before that – the common missing links in India - near real-time availability of credible data, trusted and verified information for adopting digital health for patients that will need to be provided by clinicians in a seamless manner, should be carefully identified and addressed.

New steps into digital healthcare are on the way:

Several new steps into digital healthcare have been taken in various countries of the world. One such initiative is ‘Internet Hospitals.’ These are basically an internet-medical-platform combining online and offline access for medical institutions to provide a variety of telehealth services directly to patients.

A Deloitte paper – ‘Internet Hospitals in China: The new step into digital healthcare,’ published on March 16, 2021 says: ‘Online hospitals are typically offshoots of offline medical organizations. The combination of Internet with health care will drive the medical industry’s transformation into a health service provider from a health care supplier, distributing resources equally and enhancing efficiency,’ moving ‘towards future smart health care.’

Conclusion:

Covid-19 has created a new focus on the digital health ecosystem in India, for accelerating the use of digital technology to radically advance health care systems and save lives. Today, many are experiencing that, big data, analytics, artificial intelligence, remote learning, and data inter-connectivity, can make a real difference to the work of HHS professionals in India.

Embracing digital with accelerated speed during the pandemic, has reportedly started making a significant positive impact on the cycle of the patient’s clinical assessment, treatment, and monitoring. With increasing use, it would reduce the cost of health care, improve patient access to affordable treatment and care services, when many patients’ journey for disease treatment will start online, and get directed to the optimal care setting either physically or virtually.

The article on health-tech, published in the Fortune India on February 20, 2021, has aptly concluded: ‘Eventually health technology infusion in the Indian healthcare ecosystem will be the route to enhance patient-centric healthcare accessibility, affordability, and sustainability. The advent of 5G technology in the country is poised to further catalyze this momentum.’ This, in turn, will facilitate ushering in more game changing steps into digital healthcare, creating a new ecosystem, greater awareness and a keen desire to remain healthy for all.

Thus, from the GIGO perspective, as defined by the Cambridge Dictionary, I reckon, in pharma’s digital initiatives, especially in India, a key factor needs to be carefully addressed. This is – fathoming existence of any missing link involving near real-time availability of trusted information and credible data generation, which could indeed be a great spoiler of any painstaking digital adoption project.

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

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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

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.

 

Post Covid-19 Lockdown: Is Pharma Industry Ready?

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It’s over a month now since national lockdown in India came into force to win the war against Covid-19. Many promises and apprehensions about whether or not Covid-19 will keep ravaging human life, continue surfacing. As it appears today, whatever best happens post May 03, 2020, the Coronavirus outbreak is going to change the way we live and the businesses used to operate, in many respects, till an effective vaccine comes, at the very least. This change also includes the health care, in general, and the pharmaceutical industry, in particular.

It is obvious now that Covid-19 will stalk the planet for a long time to come. On April 22, 2020, the World Health Organization (WHO) also reiterated: ‘Make no mistake, Coronavirus will be with us for a long time.’ This vindicates many apprehensions against an early promise of winning the Covid19 war decisively in 21-days or even by May 03, 2020, or whenever the national lockdown is phased-out in a calibrated manner. Further, W.H.O has also cautioned: “Most countries are still in the early stages of their epidemics. And some that were affected early in the pandemic are now starting to see a resurgence in cases.”

As on April 26, 2020, the recorded Coronavirus cases in India has sharply climbed to 26,496 and 825 deaths, with the Union Health Ministry saying on April 23, 2020: ‘Doubling rate of Covid-19 cases in country is now 10 days.’ Whereas, on the same day, Indian Council of Medical Research (ICMR) also said, ‘for now, it is very difficult to tell when a peak state of COVID-19 pandemic in the country will arrive.’

The life-changing disruptions that Covid19 has caused, and may continue to cause in the near future, has apparently made a significant impact, also on how the healthcare consumers think about the available disease treatment solutions, including buying medicines. Thus, in this article, I shall, focus on this area.

Why winning the Covid-19 war can’t be immediate: 

Covid-19 pandemic brought the drug industry under a sharp focus of the entire world, with an expectation to win the war against this deadly and invisible virus. This solution could be anything – an effective prevention, such as, with a vaccine, or a curing the infection with a drug, or even a mechanism that is able to make the virus less contagious. There are still no scientifically proven and approved drugs or vaccines for Covid-19. Although, many trial and error experiments are in progress, mainly based on anecdotes and gut-feeling, for the respiratory disease caused by Coronavirus.

The good news is, since January 2020, after scientists in China provided the virus’s genetic sequence, over 40 teams of global drug companies and the academia, are working on a vaccine and drugs for Covid-19. As of now, six Coronavirus vaccines are on clinical trial. Last Thursday, human safety trial of Oxford University developed Covid-19 vaccine, with the first two of 800 healthy volunteers, has commenced. Meanwhile, Serum Institute of India (SII) has tied-up with the Oxford University to manufacture the vaccine in India, if the trial succeeds.

Some bad news in this area also came by, such as, ‘remdesivir’ – the well-hyped drug, thought to be one of the best prospects for treating Covid-19, failed to have any effect during the first full trial. However, Gilead – the drug company developing this product has said, ‘the findings were inconclusive because the study was terminated early.’

The bottom-line is, although, first tests for more new vaccines may commence within a few months, the final regulatory approval of these will take much longer - at least 18 months, i.e. not before 2022, according to W.H.O. Meanwhile, some disruptive changes within current health care delivery systems, involving both behavior and transaction practices of key stakeholders, may prompt equally disruptive changes in the Indian health care delivery mechanisms. These changes are likely to have unforeseen impact on several pharma operations, critical for business excellence in the drug industry.

Commonly followed procedures for the Indian healthcare system:

The procedures that most health care consumers currently follow for healthcare in India, require patients to be physically present in most touchpoints of a disease treatment process. These include, doctors, chemist shops, hospitals, diagnostic clinics, among others. During the national lockdown period, redressal of non-Covid-19 related common health issues, has been a great challenge for many people, such as:

  • visiting a doctor
  • going to a hospital outdoor
  • procurement of medicines from retail shops for chronic conditions
  • visiting a diagnostic clinic even for follow-up – previously advised by a doctor

This happened primarily due to the need of compliance of social distancing and mostly out of fear of getting the Covid-19 infection. Fortunately, the available digital platforms to address the pressing common health issues, proved to be of immense help to many.

Pharma business has also been greatly impacted: 

Driven by initial panic buying of regular medicines by the people, for the lockdown period and may be beyond, monthly sales of pharma might show a spurt. But, that is unlikely to be the real picture for a medium to long term. Otherwise, like many other industry sectors, pharma business has also been greatly impacted by the Covid-19 outbreak, across its various domains – right from planned R&D – through manufacturing, sales and marketing – to supply chain.

The early adopters to the new normal will be the outright winners:

For example, meeting a doctor for product detailing following the conventional chain of activities, and simultaneously maintaining strict ‘personal distancing’ or ‘social distancing norms, may not be the same again. The changes required by the pharma companies to make this process effective and productive, may also be disruptive in nature.

No-one can accurately predict toady, how exactly the important business operations can be resumed, ensuring full health-safety for all and with compromising on the effectiveness and productivity of business. Nevertheless, one thing for sure, lockdown during Covid-19 pandemic has brought the possibility and the opportunity of going digital to the fore, for both – the healthcare business and also its consumers, including various other stakeholders. The early adopters to the new normal are expected to be the outright winners.

Green shoots of digitalization within healthcare consumers and providers: 

As digital transformation at health care consumers and providers level, gain a critical mass, the healthcare business would require to be not just digitalized, but also digitally innovative. The situation would demand from them to be much more ‘customer centric’ on digital platforms, as the locked down – homebound health care consumers, complying with ‘social distancing’ norms, get increasingly more digitally empowered.

Bain & Company in its March 20 ‘Brief’, titled ‘How the Coronavirus Will Transform Healthcare in China,’ discussed some of these issues from China perspective, which are already visible there. To illustrate this point in this deliberation from the Indian perspective, let me draw examples from the country’s health care consumers’ standpoint.

Is the traditional health care system slowly undergoing a metamorphosis?

The overall impact of Covid-19 outbreak in India has made visiting general practitioner’s (GP) clinics, pathological labs or even hospital emergency facilities, a tough challenge for many patients. This is primarily out of fear of getting a Coronavirus infection from others during the process, with strict compliance to ‘social distancing’ becoming a top priority for many. Consequently, traditional healthcare related activities in India, is likely to undergo an early metamorphosis.

Being literally locked down at home, a good number of healthcare consumers in India, are utilizing innovative digital platforms, 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 doctors 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.

An upside of the situation: 

The upside of the situation is, these patients are feeling more digitally empowered and self-reliant to get non-too-serious ailments addressed against all odds. Some of these practices, such as, online consultation with doctors, getting most of the medical tests done at home, buying medicines through e-pharmacies, I reckon, may continue even after calibrated withdrawal of the national lockdown in India.  The net impact of all could trigger a meaningful attitudinal change in patients, especially towards health care delivery processes, in general.

The healthcare industry is ready to log on to this digital mode? 

Many early adopters in the global pharma industry, are going for digitalization within various functional domains of the company, at a varying scale. This has started happening in India, as well. However, as social distancing becomes the new normal in the foreseeable future, how prepared are the pharma companies to adopt themselves with the increasing number of digitally empowered consumers, is still unclear. More importantly, how will the industry meet new demands at various points of transaction and interaction with various critical stakeholders, such as, doctors, in the post Covid-19 eraof social distancing, ensuring health safety of all?

Another requirement that should form the bedrock of the grand integrated corporate strategy of a customer-centric pharma business, necessarily, in the changing times. This is – all decisions in this area must be based on a huge pool of contemporary data, analyzed by sophisticated data analytics and thereafter, the strategic and tactical pathways need to be charted, desirably, through skillful application of Artificial Intelligence (AI), because of evolving complex and multi-dimensional health care needs of the consumers.

Alongside, telemedicine in different new formats – even for GP level consultations, besides, drug procurement through e-payment from approved e-pharmacies by uploading doctor prescriptions, signal a great potential in the years ahead. This appears to be very close to reality, especially, going by the W.H.O prediction for a long-haul Covid-19 battle, where compliance with ‘social distancing,’ is one of the basic requirements of health safety for all.

Conclusion:

‘Month of lockdown impedes virus – a long battle lies ahead’. As the former President of the Unites States twitted on April 25, 2020, ‘If we want life to approach anything like normal anytime soon, we need a comprehensive testing program. It’s not going to be cheap, but it will ultimately pay off many times over in saved lives, saved businesses, and saved jobs.’

In any case the crux of the matter is, Covid-19 is not going to vanish soon, even after scaling down of the lockdown in a calibrated way. Moreover, the fear, if not the panic of a large population in India and around the world, on the possibility of getting infected by Covid-19, will continue – till one does not get vaccinated or acquire ‘herd immunity’ in a different way. Meanwhile, related behavioral changes and habits, of a large number of people, including health care consumers, will continue taking place.

From this perspective, besides the existing ones, once the lockdown-period-converted ‘e-consumers’ of health care get used to the new digital mode of availing healthcare services against e-payments, it could have a snowballing impact on many others. That will help usher in a new paradigm of medical consultation, follow-up interaction, disease diagnosis, drug procurement and all related transactions, through digital platforms.

Having experienced the convenience and user-friendliness of the digital mode, during an extended period of social or physical distancing and other new normal, instead of time-consuming legwork, it seems unlikely that the majority will try to go back to the traditional mode of pre-Covid 19 era. In that situation pharma companies will have no option but to necessarily re-engineer the business operations, bringing disruptive digitalization at the center of any strategy formulation related to mainly patients and doctors, besides others.

Covid-19 prompted lockdown and the post lockdown period, I reckon, is unlikely to be a ‘switch-off’ and ‘switch-on’ type of a situation for anyone or any industry, as threat of getting Coronavirus infected will continue for quite some time. The need of the hour for pharma players in India, therefore, is gaining deep insight, through continuous data capturing and analysis, on each component of the changing market dynamics – prompted by Coronavirus pandemic. The point to ponder, therefore, is pharma industry getting ready for a possible disruptive change in the future environment?

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.

Acid Test For Excellence in Crisis Leadership

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On April 12, 2020 – in the morning of the day 19 of the national lockdown, India’s total number of Coronavirus positive cases reached 8,504 with 289 deaths. The country’s trajectory is reportedly  steeper than most Asian peers, such as Singapore, Japan, and Indonesia. Incidences of new infections and deaths are also rising faster. The report also highlighted a possible link between number of tests conducted and the number of confirmed cases across the States. The aggregated impact of Covid19 outbreak has created an unprecedented health, social and economic calamity, changing everybody’s life – now and beyond.

However, going by Prime Minister Modi’s announcement on March 24, 2020, the national lockdown to contain the pandemic should continue till April 14, 2020. But, the above scenario is creating a huge dilemma within almost all Coronavirus crisis management leadership in the States, with the final decision resting upon the Prime Minister of India. Meanwhile, on April 09, 2020, Odisha government decided to extend the lockdown until April 30, followed by Punjab, Maharashtra, Karnataka and Telengana on April 11, 2020. However, all will get to know India’s decision in this regard for the rest of India, as you read this piece today.

The top leaders of Asia, Europe and American continents are handling the grave situation differently, with a varying degree of success, so far. Everybody is watching different world leaders in action – each trying hard to gain control over the unprecedented crisis, making it an acid test for excellence in Crisis Leadership.

Three different types of needs for the country:

As I see, three specific types of needs of three specific classes of people in the social milieu, are emerging in India:

  • Only need is to save life from the disease, with not much problem in procuring other essential requirements – having enough wherewithal to pull through the critical period, better than most others.
  • Strong need exists to save life, but facing tough challenges in arranging for essential needs for daily living.
  • Need to save life, but feel desperate for the means of livelihood – to protect family and defendants from hunger, in a seemingly uncertain future.

In the current situation, while trying to contain the spread of pandemic effectively, the sufferings of especially, the second and third group, as stated above, also need to be addressed, ‘and this is much aided by a participatory democracy.’

An acid test for crisis leadership at the top:

The situation isn’t just a war against Covid19, but much beyond that. The Nobel Laureate Professor Amartya Sen at Harvard University  explained the situation so well in an article, published on April 08, 2020. He lucidly illustrated, that the needs of people in a natural calamity, such as Coronavirus caused a pandemic, are different from a conventional war – against an enemy country. Desirable leadership qualities are also significantly different.

As Professor Sen wrote, while managing a crisis situation during a conventional war, ‘a leader can use top-down power to order everyone to do what the leader wants – with no need for consultation.’ But, managing a crisis during a natural calamity, a leader should demonstrate skills for a ‘participatory governance and alert public discussion.’ Listening to public discussion makes the top leadership understand what needs to be done by the policy makers.

Another paper, titled “Steering Through the Storm,” published in the ‘People + Strategy’, also reiterated the same with different words. It emphasized, “during a crisis, like natural calamity, leaders should engage actively with their constituents whenever possible, distinguishing critical issues from less pressing needs, communicating risks, and maintaining readiness. Throughout the crisis, leaders should remain accessible and open to new sources of information, and take care of their own needs when necessary and appropriate.”

How different countries are demonstrating crisis leadership:

Like other countries, crisis leadership is now clearly visible even in India – right from 1 day ‘people’s curfew’, to the announcement of 21-day national lockdown for Covid19 outbreak. An interesting article, published in Forbes on March 10, 2020, deliberated on what China, Italy and the United States teach us about crisis leadership. These examples give a sense of how different countries, facing similar but country-specific problems with Covid19, reacted with remarkable ‘different approaches and results.’ I am paraphrasing below some recent illustrations on crisis leadership, as captured in the above paper:

China: China was the first country to face this calamity beginning in Wuhan of the Hubei province. With command and control leadership and decisive action China was able to immediately to garner and consolidate all its resources for an aggressive response. The World Health Organization called it as, “perhaps the most ambitious, agile and aggressive disease containment effort in history.” This includes closing down manufacturing sectors, sharing information widely, executing mass testing and quarantining millions of people. The Chinese government made the decision to absorb a significant economic cost to contain COVID-19 rather than potentially lose control and the result was effective - the number of new cases has steadily decreased in weeks’ time.

However, the downside of this type of leadership is the possible erosion of trust in the system. As the Atlantic documented, local Chinese officials reported the Covid19 outbreak to the federal government weeks after it began. They also understated the extent of the disease spread, until whistle-blowers stepped forward – and were subsequently punished. This delay probably cost China valuable time in containing the initial outbreak.

This demonstrates, under a command and control ‘crisis leadership’, when people are afraid to tell the truth and discouraged from speaking up, critical information may not reach leadership, until the problem intensifies, the paper added. That said, whether the COVID19 outbreak may have been contained earlier under different leadership conditions, cannot be concluded for sure, at least, in this case. However, official data release now shows more than doubling of new Coronavirus cases to 99 in Mainland China, on April 11, 2020. Moreover, newly reported asymptomatic Coronavirus cases also nearly doubled to 63 on the same day. Hence, the fire has still not been doused. The crisis lingers.

Italy: The catastrophic impact of Covid19 in Italy, helps identify some avoidable areas in ‘crisis leadership’. With rapidly changing and inconsistent messaging, the leaders possibly created panic and distrust among people of all kinds. The top leadership seems to have underestimated the potential spread of the virus, and was not acting in coordination with various groups and stakeholders to contain it, initially.

It happened, despite Italy is a democratic country, unlike China. But, the country, apparently, did not comply with the robust and critical ‘crisis leadership’ norm of fact-based ‘participatory governance and alert public discussion’, as discussed above. This reconfirms that ‘crisis leadership’ must be very careful in saying something they will end up contradicting later, while handling, especially a social calamity, like Covid19 outbreak.

The United States: With the fire of Covid19 outbreak spreading fast in the United States, one finds again, some basics of crisis management norms were missing in the top leadership of the oldest and a robust democracy of the world. Instead, President Trump demonstrated ‘a tendency to rely heavily on his inner circle rather than subject matter experts and to state opinions as facts.’ The President also contradicted experts on his own task force attempting to educate the public, most notably by consistently overstating the scientifically acknowledged timeline to create a vaccine and the preventive medicine combo. He also questioned the reported fatality rate of the virus.

This type of ‘crisis leadership’ is likely to fail in inspiring trust and confidence with the masses, the article concluded. This is evidenced by the current status of the country. The lethal firepower of Covid19 is still hitting the United States very hard, against all its might to fight the invisible enemy garnering all its resources and possibly taking more lives than what it lost, as on date, while fighting all its wars. As on April 11, 2020, the death toll from Coronavirus in the United States eclipsed Italy’s for the highest in the world, surpassing 20,000 marks.

Now let me focus on India, with my own assessment about the ‘crisis leadership’ while responding to this crisis, of course, initially.

India:

To get a perspective of Covid19 spread in South Asia on a relative yardstick, let’s look at the following Government released figures, as quoted in the Reuters report on April 08, 2020:

Country Ind Pak Afghan Sri Lanka Bangladesh Maldives Nepal Bhutan
Cases 5274 4072 444 189 218 19 9 5
Death 149 58 14 7 20 0 0 0

On April 11, 2020, the World Bank estimated, the ‘worst economic slump in South Asia in 40 years.’ Further, India, Bangladesh, Pakistan, Afghanistan, Sri Lanka and other three smaller nations, with 1.8 billion people and thickly populated cities, although have so far reported relatively few Coronavirus cases, could be the next hotspots for Covid19.

With this, let us look at the Covid19 narrative being unfolded in India, so far. In a lighter vein, following the interesting events with ‘sound’ and ‘light’, the ‘camera’ of time has indeed captured a commendable display of high quality ‘crisis leadership’ in India. Especially, under the given circumstances prevailing at that juncture. The leadership approach fits so well into one of the most critical requirements of crisis management – ‘participatory governance and alert public discussion.’

Even, some seemingly pointless events for some, at the end of the day, did raise morale of many in the fight against Covid19 outbreak, besides their level of participation and involvement in this crisis. Whether or not it is purely due to the personal charisma of the Prime Minister and his huge followings, also doesn’t matter much, as the point is, what really happened, instead of why it happened.

Besides, right from the declaration of ‘Peoples Curfew’ of March 22, 2020 to 21-day national lockdown, the Prime Minister has involved the State Chief Ministers, but also the leaders of opposition parties. Indian Council of Medical Research (ICMR) is also visible in the forefront. The net result is the support that the Prime Minster is getting from all, despite hardship – an epitome of ‘crisis leadership,’ as on date.

Thus, the beginning has been laudable, especially when India had no option but to enforce a lockdown, in one form or the other, without having enough testing kits, Personal Protective Equipment (PPE) for healthcare manpower and required health care infrastructure for quarantine or isolation of people. Let me explain this point with a very recent example.

According to a recent report, Covid19 test guidelines presumed that most patients in India acquired the virus from their travels abroad, or from someone who travelled abroad. Accordingly, with a limited number of kits, tests were conducted to zero in on these patients, isolating and quarantining them, to curb the spread of the virus. very focused with lesser requirements of the testing kits.

However, the data compiled by ICMR from random Coronavirus tests on patients with severe respiratory diseases, indicate that 38 percent of Covid19 patients with no travel or contact history have contracted the virus. On April 10, 2020, the Government said that the testing has now been increased to 16000 from earlier 5000-6000 people per day. This raises the vital question: has Covid19 outbreak in India has progressed or progressing from stage 2 to stage 3 of the outbreak, or has the community spread of the disease begun, the last and final stage being stage 4 – the scary virtually uncontrolled Coronavirus outbreak? Alarmingly, as has been widely reported, even on April 12, 2020: ‘Coronavirus in India: Several targets missed, still no sign of rapid testing kits.’ Currently, ‘India ranks extremely low in the Coronavirus-hit countries list based on the number of tests done per million population.’

Thus, the declaration of 21-day national lockdown on March 24, 2020, at the early stage of the Coronavirus outbreak in India was an unprecedented decision. Besides, containing the rapid disease spread, it gave India a small time-space to prepare itself – with more testing kits, Personal Protective Equipment (PPE) for healthcare manpower and adequate number of high-quality – isolation, quarantine and treatment facilities, equipped the disease specific requirements, such as, ventilators.

No matter what, the decision for a 21-day nationwide complete lockdown, giving priority to life over livelihood was a tough call to take for any leader. It indeed was a part of the critical test for excellence in ‘crisis leadership,’ at that point of time.

Conclusion:

Be that as it may, as the saying goes ‘proof of the pudding is in the eating,’ the acid test for excellence in ‘crisis leadership’, obviously, will be based on the quality of outcomes and the time it will take. This will include multiple key factors, such as, the speed of health, social and economic turnaround of a country, which is sustainable. Nevertheless, the crisis is far from being over – anywhere in the world, just yet, and the jury is still out.

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.

 

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

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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 

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

India’s Preparedness Against Biological Threats

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Recent Coronavirus outbreak poses a ‘very grave threat to the rest of the world’ – the head of the World Health Organization (WHO), reportedly said on February 11, 2020. Earlier, on January 28, 2020, it had changed the viruses’ risk-status from ‘moderate’ to ‘high’. As it creates a havoc in China, Coronavirus has recorded a limited spread in India, besides France, Canada, US, Japan, Thailand, Sri Lanka. This article will explore how prepared is India to tackle any similar biological threat to protect its citizens from a possible health catastrophe.

Let me begin by assessing pros and cons of the current initiatives of the Indian Government, both at the Center, as well as, in the States, in this regard.

The pros and cons:

Some of the ‘pros’, that the Ministry of Health and Family Welfare promptly initiated are as follows:

  • Updated Travel advisory for travelers visiting China. 
  • Discharge policy for suspected or confirmed novel Coronavirus (2019-nCoV) cases.
  • Guidelines on Clinical management of Severe Acute Respiratory Illness (SARI) in suspect/confirmed 2019-nCoV cases.
  • Guidance on surveillance for human infection with 2019-nCoV.
  • Guidelines for ‘Infection Prevention and Control in Healthcare Facilities’.
  • Guidance for sample collection, packaging and transportation for 2019-nCov.

The above steps are as commendable as some other prompt initiatives of the Ministry to stop Coronavirus from entering the country, such as leveraging technology for both thermal and symptomatic screening, especially at the high-risk airports.

However, according to global experts – India, along with several other countries are still ill prepared to face biological threats of a magnitude that we are now witnessing in China. On the other hand, according to February 12, 2020 publication of The World Economic Forum, there about a dozen of countries in the world who are best prepared for meeting similar health emergencies.

Similar calamity was predicted two years back by W.H.O: 

Interestingly, a similar situation was predicted by none other than Tedros Adhanom, Director General of the World Health Organization and was reported on February 15, 2018. He then said, “We have a problem. A serious one. At any moment, a life-threatening global pandemic could spring up and wipe out a significant amount of human life on this planet. The death toll would be catastrophic. One disease could see as many as 100 million dead.”

“This is not some future nightmare scenario,” he added. “This is what happened exactly 100 years ago during the Spanish flu epidemic.” Again: “A devastating epidemic could start in any country at any time and kill millions of people because we are still not prepared. The world remains vulnerable.”Explaining the reason for the same, the Director General pinpointed: “The threat of a global pandemic comes from our apathy, from our staunch refusal to act to save ourselves — a refusal that finds its heart in our indifference and our greed.”

Now, when the world is grappling with the menace of Coronavirus – may not be at the predicted global scale yet, those comments haunt us again. It flags each country’s preparedness to deal with such pandemic, as and when it strikes, unannounced.

‘Countries best prepared for health emergencies’ – and India:

The February 12, 2020 publication of The World Economic Forum, as indicated above, highlights several important realities of this subject. Let me quote below just two of these, which, I reckon, are the most profound:

  • National health security is fundamentally weak around the world, and none is fully prepared to handle such an outbreak.
  • Global biological risks are in many cases growing faster than governments and science can keep up.

Acknowledging these facts, based on the Global Health Security Index, the most prepared ones for epidemics or pandemics of all types were listed among 195 countries surveyed. Measured on a scale from 0-100, the US ranks as the “most prepared” nation (scoring 83.5). Next comes UK (77.9), the Netherlands (75.6), Australia (75.5) and Canada (75.3) featuring behind it.

Thailand and South Korea are the only countries outside of the West that rank in this category. China, the most populated country in the world – which is also at the center of the Coronavirus outbreak – is in 51st place, scoring 48.2. And, India, the second most populated country ranks 57 with a score of 46.5. The obvious question that comes up: Why India ranks so low in the Global Health Security Index, among 195 countries?

Knowing the risk – not enough, building capability is a must:

The above details will give a sense of risk exposure to pandemic or epidemic, like Coronavirus, for a country. As the experts point out, just knowing the level of risk exposures, is far from enough. Each Government has a fundamental duty to build capabilities for protecting its people from the disastrous consequences of any possible biological threat, as and when it strikes. This will call for taking quantifiable financial and other measures to fill the existing gaps in the epidemic and pandemic preparedness, as captured in many studies. 

India’s budgetary allocation for health remains frugal:

It gets reflected even in the Union Budget 2020-21for the health care sector. Although, the total allocation for the sector was about 10 percent higher from the year ago. The increase seems negligible, considering consumer price index inflation was 7.5 percent in December 2019, as analyzed by the publication Down to Earth on February 02, 2020.

The report said, over 50 percent of the increase will go into offsetting inflation and we don’t seem to be anywhere near achieving the target of allocating 2.5 percent GDP to health by 2025, as envisaged by even the current government.

More relevant to this discussion, the allocation towards schemes dealing with communicable diseases, in general, has remained unchanged, especially when ‘Indians are getting sick mostly due to infections’, according to NSSO study, as reported on November 25, 2019.

India’s ability to contain epidemic is much less than China:

In a relative yardstick, China, reportedly, has built a better health care infrastructure than India to respond to various health related needs of the country’s population, including emergency situation, such as Coronavirus. Some of the key reasons, for example, are as follows:

  • While India shows one of the lowest government-spend on public health care, as a percentage of GDP, and the lowest per capita health spend, China spends 5.6 times more. 
  • When Indians met more than 62 percent of their health expenses from their personal savings, as ‘out-of-pocket expenses’, the same is 54 per cent in China.
  • India’s ability to quarantine a large number of infected people is much limited as compared to China.
  • Health service delivery system, especially for over 70 percent of the rural population of India, lack adequate scientific and skilled manpower, alongside necessary emergency equipment to provide care to a large number of patients at the same time, if epidemics strike.
  • Around 74 percent of health care professionals happen to be concentrated in urban areas, catering to just a third of Indian population, leaving rural areas under-served, according to a KPMG report. Alongside, the country is 81 percent short of specialists at rural community health centers (CHCs).

Conclusion:

The recent Coronavirus outbreak sends a strong signal to public health authorities, across the world, about the task-cut out for them to catch the early signs of possible epidemics. Many countries, especially India, have much ground to cover to ensure the right level of preparedness in countering such unannounced biological threats.

Capacity building for prevention, early detection, taking medical countermeasures – to contain the fast spread of the deadly organisms, and effective treatment response at the earliest, is the need of the hour. India also needs to develop capabilities for rapid development of drugs and vaccines in such a situation, fighting against time. Quoting the National Institute of Virology, some recent reports indicate that India’s scientific expertise and manpower aren’t enough, just yet, to deal with similar crises.

India’s public healthcare system and its delivery mechanism are still not robust enough either to keep in quarantine or in providing effective treatment and care for a large number of patients during any epidemic situation.

Against this perspective, I reckon, India is still grossly underprepared to face any biological threat, if it strikes with all its might. In that sense, the scary Coronavirus episode may be construed as yet another wake-up call to break the perceived slumber of the Government, if not apathy, as it were.

Thus, the question that surfaces: Shouldn’t the country, at least now, deploy enough resources to protect its citizens from any possible biological threats and aggression, just as it does, to provide safety, security and well-being of the population against any other external or internal threats?

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.

Criticality of Drug Quality In The Moment Of Truth

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When global health emergencies strike unannounced – in the scale and magnitude of new coronavirus, it shakes the health care system of all countries, in varying degree though, irrespective of the robustness of the economy. In such situation, the robustness of health care infrastructure, stringent manufacturing quality standards, operational flexibility for seamless sourcing of all drug ingredients in the required quantities, besides speed and agility of the delivery system – are put to the acid test.

Anytime readiness to effectively neutralize this crisis is of utmost importance. Accordingly, the key national goal should be to create a robust ‘whole’ that is much more than the sum total of each of each of the above factors – a sturdy ‘drug security system’ for the country. The most populous country of the world – China may have succeeded in building a 1,600-bed hospital coronavirus hospital in just 10 days, completing on February 05, 20120. But it is still looking for necessary drugs from other countries, such as the United States.

Curiously, China hasn’t yet disclosed its reason. More so, when the country is the top global supplier of Active Pharmaceutical Ingredients (API), including antiretroviral (ARV) drugs, along with India, according to the World Health Organization (W.H.O). This draws many to look at the general apprehension on the questionable quality of drugs that China, allegedly, produces. But, could this be the reason?

Nevertheless, regardless of inquisitiveness to know the reason, the question mark on its drug quality remains. And this is also not the risk-taking time for any nation, as it could possibly endanger lives of scores of the impacted population. The criticality of drug quality in ‘The Moment of Truth,’ such as, the new coronavirus emergency, can only be wished away at one’s own peril.

On the other hand, the confidence expressed in India, as we shall see below, in ‘drug security’, just based on adequate ARV drug availability appears to be coming from a different plane, although the drug quality issue is exactly the same in India, if not more concerning. From the above perspective, my today’s article will focus on this subject, purely based on available data, starting with the request of the Chinese authorities for ARV drugs from the United States.

Chinese request for ARV drugs:

‘U.S. Drugmakers Ship Therapies to China, Seeking to Treat Coronavirus – AbbVie, Gilead, others respond to Chinese authorities’ requests for antiviral drugs to test effectiveness against deadly respiratory illness.’ This was reported by The Wall Street Journal (WSJ) on January 27, 2020. It goes without saying that these antiviral drugs also include Anti-Retrovirals (ARVs).

AbbVie Inc. and Johnson & Johnson  are among the drug makers that have begun shipping drugs approved to treat HIV, while Gilead Sciences Inc. is exploring whether it should send an antiviral therapy it is developing.

It isn’t known whether the drugs would be able to help contain the explosion of respiratory virus infections sweeping the country or provide relief to infected patients. Chinese authorities have requested the shipments to test the drugs’ effectiveness in containing the new coronavirus, the report added.

An intriguing difference between India and China:

Interestingly, China is looking for sourcing some of these ARV drugs from the United States and not from India, either – one of the top producers of these drugs, as W.H.O reported.

In contrast, according to an Indian report of February 04, 2020: ‘Leading domestic drug companies have said they are ready with supply of anti-retrovirals (ARVs) that seem to work in treating the novel coronavirus (2019-nCoV).’

As I said earlier, although, China hasn’t yet specified the reasons behind their decision on ARV drug import from the United States, but could it have any link on the internal general apprehension of these drugs quality, safety and effectiveness?

Acknowledging for a moment that this is global allegation on Chinese drugs, in general. So is regarding India, as we shall see below. Then where does India stand on this score, especially in view of the confidence with ARV drugs, as exhibited in the above media report from India? That said, the logical question that surfaces now – why is the request for ARV drugs?

Why ARV drugs?

Although W.H.O said that there is ‘No known effective treatments’ for new coronavirus, as yet, various reports do indicate the use of ARV drugs in the treatment of 2019-nCoV:

  • A combination of flu and HIV medications are helping treat severe cases of the new coronavirus in Thailand.
  • Chinese health officials are already administering the HIV and flu drugs to fight the coronavirus, but the combination of the three together in a cocktail seemed to improve the treatment.

The Scientist, on February 02, 2020 reported that large doses of the flu drug oseltamivir combined with HIV drugs lopinavir and ritonavir, reportedly, improved the conditions of several patients in Bangkok, Thailand.

Global dependence on Chinese and Indian generic drugs:

About 80 percent of the Active Pharmaceutical Ingredients (APIs), including many ARVs, which are used for manufacturing of drug formulations in the United States are said to come from China and other countries like India. This appeared in the article titled, ‘U.S. Dependence on Pharmaceutical Products From China,’ published by the Council on Foreign Relations (CFR) on August 14, 2019.

India’s dependence on Chinese APIs:

Latest statistics from Directorate General of Commercial Intelligence and Statistics tabled in the Parliament show that in 2017-18, Indian imports of APIs and drug intermediates from China increased to 68.36 per cent. The same at 67.56 per cent in 2018-19, still remained the largest share in total Indian imports, with the overall India’s dependence on imports going up by 23 per cent from 2016-17 to 2018-19.

As reported in the media on November 22, 2019, India’s national strategies, such as, “2015 – Year of Active Pharmaceutical Ingredients” or ‘Make in India’ campaign, to promote indigenous means of production continue to be relegated on paper. Even, the current National Security Advisor had warned that Chinese dependence on API can be a national security threat.

According to the Department of Pharmaceuticals (DoP), Chinese API imports are due to economic considerations, which are essentially cheaper and more cost-effective for the Indian drug manufacturers, the above report highlighted.

Against this backdrop, the above local media report indicating, leading domestic drug companies are ready to supply anti-retrovirals (ARVs), may invite more questions than answers. Added to this come the critical quality issues with drugs manufactured in China and India.

Quality issues with Chinese drugs:

Credible documents highlight, as China’s pharmaceutical industry is not effectively regulated by the Chinese government, its regulatory apparatus is inadequately resourced to oversee thousands of Chinese drug manufacturers. Even if Beijing made such oversight a greater priority. This has resulted in significant drug safety scandals.

Although, the drug quality related concerns seem to be even more related to India, the drug industry of the country, reportedly, remains in a denial over most of such charges involving drug-quality.

India tops with the most quality related FDA warning letters in 2019:

The author of the above article reiterates, ‘Americans are expecting India, which supplies a significant percentage of the finished drug supply in the U.S., to get its act together to improve the quality of the medicines it makes, I am afraid they will be waiting a long time for that to happen. The only solution is for American lawmakers to enact new regulations focused on holding those who intentionally put public health at risk to account.’

To avoid ‘your-opinion-versus-my-opinion’ type of a debate with this article, let us look at some hard facts. These are from the ‘warning letters’ on drug quality, issued to various pharma companies, across the world, by the USFDA’s Center for Drug Evaluation and Research (CDER). The details were well captured in an article, titled ‘The country with the most FDA warning letters in 2019,’ published by Pharma Manufacturing on January 20, 2020.

Some key CDER findings:

As I consider, the top three CDER findings may be summarized as follows:

  • In 2019, CDER issued dozens warning letters for manufacturing issues to pharma companies outside the U.S. One country in particular – India – received the highest number of letters.
  • CDER’s office of Manufacturing Quality Letters issued 43 letters to companies outside of the U.S. Of those letters:

-   20 were aimed at facilities in India.

-   With 11, China received the second most manufacturing quality warning letters.

-   The rest of the letters were distributed among plants in Europe, Costa Rica, Singapore, Turkey and others.

  • The data from CDER shows that India has the poorest rate of FDA inspections with acceptable outcomes (83 percent) — much lower than China (90 percent) and the U.S. (93 percent).

Conclusion:

Today, a host of effective drugs and vaccines are available to treat a number of both non-infectious and infectious ailments, including many life-threatening viral diseases. However, the effectiveness of these medicines in treating such diseases, as well as many other illnesses, gets significantly compromised by questionable quality and distribution of these medicinal products. Even way back, a similar concern was deliberated in an article captioned, ‘Substandard drugs: a potential crisis for public health’, published in the British Journal of Clinical Pharmacology (BJCP), on November 29, 2013..

It may ordinarily remain undetected, sans stringent and wide-scale regulatory scrutiny. Additionally, a number of involved countries still remain in a denial mode. It’s also a fact, several governments may not have wherewithal for the same, particularly when the manufacturing units are too many, such as in China and India.

However, when a critical national health emergency strikes, unannounced, like the new coronavirus, the moment of truth dawns. Obviously, the national governments would want to be risk averse and prefer sourcing the best of drugs, to rapidly contain the spread of the disease, saving more lives. It’s not difficult to fathom, either, any country is unlikely to admit this reality, in public, even while taking measures for the same.

China’s sourcing of ARV and other drugs from the United States may or may not be due to the drug quality reasons. Nonetheless, I reckon, the criticality of drug quality issues can possibly be best realized, mostly when the ‘Moment of Truth’ arrives. Unannounced! Just like a bolt from the blue!

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.

China Coronavirus And API Sourcing – A Threat… Or An Opportunity For India?

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‘2015 – Year of Active Pharmaceutical Ingredients’ (API), announced the Government of India by a Press Release on February 25, 2015. 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’.

Two years down the line, 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?’ It reiterated, India has proven capabilities in the generic drug formulations, but over dependence on China for sourcing – 70-75 per cent of APIs does not augur well for the Indian pharmaceutical sector. Because, as any interruption in supply from China can badly impact the sector, jeopardizing the health of millions of people, not just in India, but across the world, as well.

The reason for Indian drug formulation makers depending on China-supplied APIs, is mainly for its low cost, and not for any technological other reason, the article said. Regardless of the India’s announcement – ‘2015 as the year of API’, the API industry continued to struggle without much tangible support. Despite a lot of decisions still being in the pipeline, let me hasten to add, some inconclusive signs of early recovery have been captured in this space by some recent studies.

With the outbreak of the recent ‘coronavirus’ menace, the moment of truth has arrived in the country. On the one hand, it is posing a threat to the country’s API sourcing, on the other it could throw open a door of opportunity for Indian API manufacturers, as the Chinese API prices would start climbing up. But the question is, in which way it would evolve? In this article, I shall focus on this aspect of the new coronavirus menace, starting with a brief description of the background.

China coronavirus – when the alarm bell rang: 

According to the World Health Organization (WHO), on December 31, 2019, it was alerted to several cases of pneumonia in Wuhan City, Hubei Province of China. The virus did not match any other known virus, raising a great concern. No one knows how it affects people who are sick with it – how they can be treated, and what the countries can do to respond. One week later, on 7 January, Chinese authorities confirmed that they had identified a new virus.

What it does?

This new virus is a coronavirus, which is a large family of viruses that cause illnesses ranging from the common cold to more severe diseases, such as Severe Acute Respiratory Syndrome, such as SARS and MERS.

Since the virus, reportedly was first detected in Wuhan in people who had visited a local seafood and animal market, it is likely to have transmitted from an animal to humans. Nevertheless, several known coronaviruses are known to be circulating in animals that have not yet infected humans. The new coronavirus has been named novel coronavirus (2019-nCoV) and is the seventh coronavirus known to affect humans.

W.H.O has been working with Chinese authorities and global experts to learn more about it. However, because this is a coronavirus, which usually causes respiratory illness, the world body has circulated advice to people on how to protect themselves and those around them from getting the disease.

The damage, thus far:

Bloomberg on February 02, 2020 reported the death toll from the coronavirus outbreak has risen to 305, with 14,555 confirmed cases worldwide.  The first death outside of China took place in the Philippines on February 01. Alarmingly, 2019-nCoV infections have also spread to at least 15 other countries. These numbers keep increasing.

Nearer home, India, on January 30, 2020, also announced its first case. “One positive case of Novel Coronavirus – a student studying in Wuhan University — has been reported from Kerala,” said a statement released by the Health Ministry. On February 02, 2020, Reuters reported the second case of coronavirus in Kerala.

This scenario prompted the World Health Organization (WHO) to meet again on the last Thursday and declare the new coronavirus an international public health emergency.

The impact on the pharma industry:

Responding to the criticality of this situation, health authorities across the world are trying to put in place effective ways to overcome this crisis. In the healthcare space, medical scientists are ‘racing to develop a vaccine to protect people from the virus.’ One lab in California, reportedly. has plans for a potential vaccine to enter human trials by June or July this year.

Alongside, many are wondering about the looming threat that it poses on the API sourcing from China by the global pharmaceutical industry, including India. However, as I said earlier, some Indian experts, are also sensing an opportunity for country’s API manufacturers to fill the possible void, as it gets created.

API sourcing concern:

An exclusive survey conducted by Kemiex, titled ‘Coronavirus impact analysis for APIs, feed and food additives,’ among 97 life sciences professionals, published by them on January 20, 2020, reports some interesting findings. Some of the key ones are, as follows:

  • 85 percent experts foresee API and other ingredient supply disruptions, with 35 percent expecting a high and 50 percent envisaging a low impact.
  • Orders planned for the 1st quarter with delivery in 2nd quarter are expected to be mostly affected, while disruptions might continue a quarter. Only a minority believes the disruptions will last until year end or beyond 2020.
  • The biggest impact is expected from extended Chinese New Year holidays and delayed production start.
  • A first impact analysis based on preliminary information shows that only selected products such as amino acids (taurine…), certain vitamins and other APIs and additives could be affected.
  • European and other suppliers report readiness and stocks to secure delivery to end users during interruptions in China, or some of its districts. respectively.

However, other reports also underscore, with the proliferation of the new coronavirus the incidences of confirmed infection with clear symptoms and deaths are also expected to increase. This may lead the Chinese government to extend lock down several commercially important parts of the country. Which, in turn, could impact, among others, manufacturing and shipments of API and pharma ingredients for several months.

Some green shoots are now visible in India?

Quoting a JM Financial analysis, some media reports predicted, a worsening coronavirus crisis may benefit Indian API manufacturers, as it observed some green shoots in the Indian API manufacturing space. Analyzing the stocks of six local API manufacturers – Galaxy Surfactants Ltd., Fine Organic Industries Ltd., Navin Fluorine International Ltd., SRF Ltd., PI Industries Ltd. and UPL Ltd., it found that the stocks of these companies have beaten the market trend in recent years. They observed, the robust growth of these companies was fueled by end-user industries, and exports to China – which has closed many chemical facilities on environmental concerns.

Moreover, the increase in overall API demand – caused by shortages triggered by a serious disruption of API production in China’s Hubei province, and restriction of movement within China, is likely to drive the prices up with the spread of the epidemic. The cumulative impact of all this, would possibly help the Indian bulk drug manufacturers, significantly, helping India to tide over the API sourcing crisis.

Conclusion:

‘Scientists are racing to develop a coronavirus vaccine, but it could take years to reach the market,’ as media reports highlight. Meanwhile, researchers are, reportedly, also looking at ways of quickly repurposing existing antiviral drugs to see whether any might work against the new coronavirus.

The serious health menace caused by the new coronavirus that prompted the W.H.O to signal it as a global emergency, has also raised a serious concern on API sourcing. This is because, around 80 percent of the API used by drug formulation manufacturers is sourced from China.

Looking only at this aspect of the issue, and also from the Indian perspective, the point to ponder – is it all threat? Or a veiled opportunity worth cashing-on to neutralize, at least, a part of the API sourcing threat?

Against the backdrop of the Indian Government’s announcements, such as, ‘2015 – Year of Active Pharmaceutical Ingredients’ (API), alongside the well-publicized ‘Make in India’ campaign, and some recently reported green shoots in this area – the expectation of an ‘opportunity in waiting’, could well be a reality. Who knows? But, a lurking apprehension still lingers!

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.