With Covid’s Second Wave ‘A Nation In Distress’ – Why?

Posted on April 19, 2021 by Tapan Ray

If someone tries to see a silver lining in the disruptive Covid-19 pandemic, besides its vaccine rollout in some countries, there will be at least one. As of April 17, 2021- over 119 million patients (India – over 12 million), reportedly, have recovered out of 141 million (India – over 15 million) of Covid infected patients.

But this can’t mask the grim reality of over 18 million patients remain still infected, with over 3 million deaths (India – 175,673), since the beginning of the Covid menace. In the Indian perspective, this is the highest ever incidence of death – in absolute numbers – for any reason, so far. Now comes the Covid second wave with its more devastation onslaught on human lives and other consequences for the nation.

In this article, I shall explore this area, as apparently a Tsunami-like the second Covid wave starts sweeping across the India states, posing a greater danger than the first one, to the lives and livelihoods of millions of Indians, yet again. Let me start with a perspective, leading to the current situation.

No clinically proven drugs, as yet:

There aren’t any definite or clinically proven drugs after completion of Phase III studies, as yet, for curing patients from Covid infection. Nor are there any such well proven vaccines with fully known efficacy, safety, time interval between two doses, duration of prevention from Covid infection, in the future. All drugs and vaccines are currently being used under ‘emergency use’ approval by country drug regulators, based on interim results.

At the very onset of Covid-19 first wave, other than some attempts of repurposing older drugs, the world did not have any proven drugs to fight against this deadly infection. The old antimalarial drug Hydroxychloroquine – was tried first, followed by other medications, such as, Lopinavir/Ritonavir. Both created a huge global demand and subsequent shortages, including in the pharmacy of the world– India. Subsequently, W.H.O discontinued hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19 based on interim clinical trial data. These results showed, hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care.

At the beginning of the second wave of Covid-19, one of the latest repurposed drugs – remdesivir that is being widely used, especially for hospitalized patients, is also facing a shortage, even in the pharmacy of the world. Interestingly, even ‘Remdesivir has little or no impact on survival, WHO trial shows’.

Also – no clinically fully proven Covid-19 vaccines, as yet:

Possibly, the second-best antidote as of date, against rapidly mutating Covid-19 – after Covid-appropriate behavior by all, comes vaccines. All comes with ‘emergency use’ approval, based on interim results only, and with several challenges. These include efficacy against all mutating Covid-19 variants, exact safety profile, dosage interval and duration of protection. Interestingly, on April 16, 2021, Pfizer indicated that ‘Covid-19 vaccine recipients will “likely” need a third dose between six to 12 months after they’re fully vaccinated and suggested vaccinations for coronavirus could be needed every year.’ In this evolving scenario, Indian experts also acknowledge that - abidance to the defined health norms stays as a lifeguard, and will remain so for an indefinite period.

Several countries, including India, are making, and gradually expanding requisite arrangements to vaccinate their population. Whereas a large number of countries – mostly in the developing world, are still awaiting access to Covid vaccines. Meanwhile, another issue has started bothering many, which the April 10, 2021 issue of The Guardian had captured in its headline – ‘Global Covid vaccine rollout is threatened by a shortage of vital components,’ besides manufacturing capacity constraints compared to the current demand.

Global challenges with Covid vaccines in 2021:

As things have progressed with Covid vaccines, thus far, the year 2021 doesn’t seem to be a smooth run to vaccinate people across the world, deriving a significant outcome against the battle of this global menace. This gets vindicated by the following numbers, as published in the ‘Down to Earth’ magazine on April 13, 2021.

According to the Johns Hopkins University, United States, as of April 12, 2021, only 773 million Covid-19 vaccines had been administered across the world. This means, only a little more than 2 per cent of the world’s adult population, has been inoculated so far.

According to data analytics firm Airfinity, the world will manufacture 9.5 billion doses by the end 2021. Whereas immediate global need exceeds 14 billion doses to vaccinate the entire adult population.

According to Gavi – The Vaccine Alliance, this represents almost three times the number of vaccines the world was producing in the pre-pandemic period for other diseases.

In the midst of these, inoculation with, at least, two major Covid-19 vaccines – one from AstraZenecaand other from Johnson & Johnson, have raised safety concern in the United States and many European countries. These ongoing developments complicate Covid vaccine challenges further.

The Indian scenario – ‘a nation in distress?’

Despite building new and a workable emergency health infrastructure by several state governments to combat Covid-19 pandemic, the fierce attack of the second wave with mutating Covid-19 virus, has already made these bursting at the seams. The article - ‘A tsunami of cases’: desperation as Covid second wave batters India, appeared in ‘The Guardian’ on April 14, 2021, captures this desperate struggle of the nation. Another recent report depicted with grim pictures, how India is grappling with the second wave of Covid-19, terming it as ‘a nation in distress.’ There are enough indications that India’s fragile health infrastructure has already collapsed in some places.

According to another news item on April 14, 2021, more than 111 million people has been vaccinated in India, by that time. Notably, this number was achieved after fears of AstraZeneca’s Covishield vaccine shortages, which subsequently prompted the Indian Government to temporarily halt its exports by the Pune-based vaccine manufacturer – Serum Institute of India (SII).

Going by another estimate, if the current momentum continues, India would be able to vaccinate 40% of its population by December 2021, and 60% of the population by May 2022. The report cautions that ‘the non-availability of vaccines may scuttle the pace.’ As per the W.H.O release, three in five Indians need to be vaccinated, to reach herd immunity. For which, the country needs 145 crore doses of vaccine by May 2022. India currently has the capacity to manufacture 100 crore-130 crore doses per year, as per a Rajya Sabha committee report. Another report of April 10, 2021 also highlights, ‘at least 10 states in India have reported a vaccine shortage and many vaccine centers have been reported shut.’

My wife and I also experienced the Covishield vaccine shortage in Mumbai. Our scheduled online appointment for vaccination through Co-Win website of the Government at Sir HN Reliance Hospital,Girgaon, Mumbai, for April 17, 2021, was cancelled. At past 10 pm on April 16, 2021, the hospital rang us up to inform that they have closed their Covid vaccination center till fresh vaccine stocks reach them.

To combat the Covid pandemic – ‘Pharmacy of the World’ goes local:

Yes, to combat the Covid pandemic, the ‘Pharmacy of the World’ goes local for some critical Covid drugs and vaccines, several times in the past. This happened earlier with drugs, like Hydroxychloroquine, when India banned its export to cater to the domestic need for Covid treatment. It happened again now, as ‘Remdesivir, API and formulation were placed under Export ban on 11.04.2021.’

Similarly, India has now, reportedly, put a temporary hold on all major exports of the AstraZeneca’sCoronavirus vaccine (Covishield in India), made by the SII, amid an increase in domestic demand due to a surge in infection. As the news item highlights: ‘It will also affect supplies to Gavi, the W.H.O backed vaccine alliance, through which more than 190 participating economies – 98 higher-income and 92 low and middle-income, are expected to get vaccine doses.’ Such temporary measures are now necessary for India to effectively respond to India’s Covid fight – especially the vaccine crunch.

India’s current vaccine imbroglio, as Covid second wave strikes hard:

Besides the SII, a second Indian company — Hyderabad-based Bharat Biotech, was given permission in January for emergency use of its Covaxin, developed in collaboration with the ICMR. Although, Bharat Biotech can make 12.5 million doses each month, these will be a small proportion of the doses administered in the country, so far.

To effectively respond to the prevailing vaccine crunch, Indian Government already approved the ‘emergency use’ of Sputnik V vaccine, which will be imported till its domestic production commences. Further, the country’s health authorities have now decided to consider the grant of ‘emergency use’ approval of several other internationally developed vaccines, such as, Pfizer – BioNTech double-dose vaccine and Johnson & Johnson’s single-shot vaccine. At least, till then, India’s vaccine imbroglio to vaccinate all adult population in the country, irrespective of age – particularly when Covid second wave is not sparing the young adults, is expected to continue.

Conclusion:

The jaw-dropping pandemic situation, and the pathway to deal with this crisis, especially in India, is getting increasingly complicated in every passing day. As reported on April 16, 2021, Covid-19 is now fooling RT-PCR tests – the most reliable type of Covid test as on date. It is so alarming because: ‘A false negative report is bad for the patient as they might delay consulting a doctor. It’s also bad for others, as the patient might not isolate, and spread the virus around,’ as the report underscores. It has started happening because: ‘Multiple mutations in the coronavirus over 15 months are making parts of it unrecognizable to lab tests.’

Experts are trying to fathom, whether or not more people are dying in India’s Covid second wave, as compared to the equivalent time period of the first wave. This causes an added cause of great concern because, in the six months before the start of the second wave (from September 2020 to January 2021), India’s overall case fatality rate (CFR) was only around 1.1%. This means only 1.1% of cases resulted in deaths. Currently, at the very beginning of the second wave, CFR has already increased to 1.3% and remains below peak levels seen in the first wave – as of date.

Above all, many people – virtually from all social, political, religious and economic strata, are openly flouting the basic norms of Covid appropriate behavior, as daily seen on different TV news channels. Ironically, these are happening at a time, when Indian health care infrastructure is creaking against the enormous and devastating power of the second wave Covid pandemic.

‘Pharmacy of the world’ has also gone local for some critical Covid-19 drugs and vaccines, to save lives and livelihoods of the Indian population, having no other better alternative in sight, at this hour. Isn’t this a sign of ‘A Nation in Distress’ that makes a fervent appeal to all of us, at least, to behave properly – by religiously following the lifesaving Covid guidelines?

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

Pharma ‘Chatbots’: For Better Stakeholder Engagement

Posted on July 29, 2019 by Tapan Ray

The critical value of meaningful interaction and engagement with individual customers – responding to their specific needs, is fast drawing attention of many businesses, for sustainable performance excellence. The same is happening in the pharma industry, as well. Creative use of this process leveraging modern technological support systems, would also provide a unique scope of cutting-edge brand service differentiation, in well researched areas.

That, it is a very important focus area for the pharma players, is no-brainer. Nonetheless, what really matters most is the novelty in strategizing such interactions and engagements, especially with patients and doctors. I also wrote about it in my article, titled ‘Indian Pharma To Stay Ahead of Technology Curve,’ published in this blog on May 22, 2017. Over two years ago, I clearly indicated there that application of AI via digital tools, called ‘Chatbots’ – the shorter form of ‘Chat Robot’, is one of the ways that pharma may wish to explore this area.

Illustrating this point in that article, I mentioned that on March 05, 2017, a leading bank in India announced the launch of an AI-driven Chatbot named Eva, coined from the words Electronic Virtual Assistant (EVA), to add more value to their services for greater customer satisfaction. ‘According to reports, Eva is India’s first AI driven banking Chatbot that can answer millions of customer queries on its own, across multiple channels, immediately.’

In this article, I shall dwell on this interesting area, with a primary focus on pharma sales and marketing, and assess the progress made in this space, thus far, by several drug companies, including some Indian players. Let me start by recapitulating the basic function and purpose of ‘Chatbots’ in pharma.

Pharma ‘Chatbots’ – the function and purpose:

Simply speaking, pharma ‘Chatbots’ are also AI-powered, fully automated virtual assistants. Its basic function is to mimic one-to-one human conversation on particular areas, as desired by the user. Likewise, its basic purpose is to genuinely help and assist the customers who are in search of right answers to specific disease related questions, in a one-to-one conversational format, having a higher source-credibility.

In that process, ‘Chatbots’ can effectively satisfy the patients and doctors by providing them the required information, immediately. In tandem, pharma companies also reap a rich harvest, by developing not just a trust-based healthy relationship with them, but also in building a robust corporate brand – creating a long-term goodwill that competition would possibly envy.

Effective customer satisfaction is an area that can’t be ignored:

In the digital age, a new type of general need is all pervasive, with its demand shooting north. This is the need to satisfy a voracious appetite among a large section of the population for all types of information, with effortless and prompt availability of the required details – as and when these come to one’s mind.

When such information need relates to health concern of a person, such as – available treatment options against affordability, or drug price comparisons – factoring in effectiveness, safety concern – exactly the same thing happens. Most individuals won’t have patience even to write an email and wait for an answer, even the wait is just for a short while.

In the current scenario, it will be interesting to fathom, how would a pharma company, generally, interact or engage with such patients, to further business and creating a possible long-time customer? Some companies have started responding to this need – effectively and efficiently, by providing easy access to information through ‘Chatbots’, created on advances AI platforms. But, such players are a few in number.

Can pharma also think of ‘Chatbots’, like ‘Siri’ or ‘Alexa’?

Today, several people are using standalone and branded Chatbot devices in everyday life, such as, Siri (Apple), Alexa (Amazon), Cortana (Microsoft) or Google Now (Android). Interestingly, many industries, including a few companies in pharma, have also started developing their own version of ‘Chatbot dialog application systems.’

Industry specific ‘Chatbots’ are designed to meet with some specific purpose of human communication, including a variety of customer interaction, information acquisition and engagement – by providing a range of customized services to the target group.’ ‘Siri’ or ‘Alexa’ or the likes, on the other hand, are all-purpose general Chatbots, though, for everyday use of individuals. Thus, the question that comes up, in which areas pharma companies can use Chatbots to add value to their interactions and engagements with patients, in general, and also doctors.

Where to use ‘Chatbots’ as a new pharma marketing channel?

Some of the findings on the application of ‘Chatbots’, especially in pharma sales and marketing, featured in the CMI Media publication in December, 2016. It found that drug companies have a unique scope to leverage this new sales and marketing – channel, by developing ‘Chatbots’ in the company represented therapy areas. Following are just a few most simple illustrations of possible types ‘Chatbots’ for interaction and engagement with patients, which can be designed in interesting ways:

That can answer all types of patient questions on specific diseases, educate them about the disease and available treatment options with details.

That allows patients or physicians to get all relevant information about the prescription drugs that they require to prescribe for patients to start treatment, including potential side effects, adverse events, tolerability, dosing, efficacy and costs, besides others.

Once a treatment option is chosen, a third kind of Chatbot can help with patient adherence to treatment, provide reminders when the treatment should be administered, explain how to properly dose and administer the treatment, and other relevant information.

Chatbots could also be useful for doctors and nurses:

As the above paper finds, ‘Chatbots have value for serving healthcare professionals as well, for example:

When, physicians and nurses want to understand the pathogenesis, pathophysiology, and/or progression of a specific disease in their patients.

Although, such content may also be available on disease state awareness sites, but branded Chatbots would make that content readily available in more of an FAQ format.

When health care professionals would like to get data around safety/toxicity, or information about dosing strengths, calculations, and titrations, while using specific brands.

Chatbots can also be effectively utilized by the drug manufacturer to gain deep insights into customer behavior across all touchpoints, to enhance end-to-end customer experience, as I wrote in this blog on July 02, 2018. The data created through this process, can also be put to strategic use to design unique brand offerings.

Need to chart this frontier with caution:

Pharma, being a highly regulated industry in every country of the world, with a varying degree, though, the ‘Chatbot’ development process should strictly conform to all ‘Dos’ and ‘Don’ts’, as prescribed by the regulators of each country. Each and every content of the ‘Chatbot’ should pass through intense, not just regulatory, but also legal and medical scrutiny. Yet another, critical redline that ‘Chatbots’ should never cross is the ‘privacy’ of any individual involved in the process.

Three critical areas to consider for pharma ‘Chatbots’:

Effective pharma ‘Chatbots’ are expected to get ticks on all three of the following critical boxes:

Meeting clearly defined unmet needs of patients in search of a health care solution or most suitable disease treatment options.
Brand value offerings should match or be very close to the targeted patients’ and doctors’ expectations.
Should facilitate achieving company’s business objectives in a quantifiable manner, directly or indirectly, as was planned in advance.

Pharma has made some progress in this area, even in India:

To facilitate more meaningful and deeper engagements with patients, some drug companies, including, in India, are using ‘Chatbots.’ Here, I shall give just three examples to drive home the point – two from outside India and one from India.

October 23, 2018 issue of the pharma letter reported, a study from DRG Digital Manhattan Research found, ‘Novo Nordisk and Sanofi brands rank best for the digital type 2 diabetes patient experience.’ The article wrote, about some pharma players ‘facilitating deeper engagement through the use of automated tools like Chatbots to triage inquiries and get patients the answers they need faster, and through interactive content like quizzes and questionnaires that pull patients in and help them navigate health decisions,’ as follows:

Novo Nordisk‘s diabetes website includes an automated Chat feature dubbed “Ask Sophia,” helping patients access disease and condition management information more quickly.

Likewise, Merck & Co‘s website for Januvia employs interactive quizzes to educate patients and caregivers.

Similarly, on November 23, 2018, a leading Indian business daily came with a headline, ‘Lupin launches first Chatbot for patients to know about their ailments.’ It further elaborated, the Chatbot named ‘ANYA’, is designed to provide medically verified information for health-related queries. The disease awareness bot aims to answer patient queries related to ailments,’ the report highlighted.

Chatbots – global market outlook:

According to the report, titled ‘Healthcare Chatbots – Global Market Outlook (2017-2026),’the Global Healthcare Chat bots market accounted for USD 97.46 million in 2017 and is expected to reach USD 618.54 million by 2026 growing at a CAGR of 22.8 percent.

The increasing demand for Chatbot ‘virtual health assistance’, is fueled primarily by the following two key growth drivers, the report added:

Increasing penetration of high-speed Internet.
Rising adoption of smart devices.

Conclusion:

With the steep increase of the usage of the Internet and smart phones, general demand to have greater access to customized information is also showing a sharp ascending trend, over a period of time. A general expectation of individuals is to get such information immediately and in a user-friendly way.

Encouraged by this trend, and after a reasonably thorough information gathering process, mainly from the cyberspace, many patients now want to more actively participate in their treatment decision making process with the doctors. This new development has a great relevance to drug companies, besides other health service providers. They get an opportunity to proactively interact and engage with patients in various innovative ways, responding to individual health needs and requirements, thereby boosting the sales revenue of the corporation.

The unique AI-driven technological platform of pharma ‘Chatbots’, is emerging as cutting-edge tools for more productive stakeholder engagement – so important for achieving business excellence in the digital world. The recent growth trajectory of ‘Chatbots’ in the health care space, vindicates this point.

By: Tapan J. Ray

‘Diversity And Inclusion’: A Missing Link For Indian Pharma

Posted on June 25, 2018 by Tapan Ray

Inadequate access to affordable health care to a vast majority of the population has been a favorite topic of debate, since long, globally. This discourse is generally centered around the least developed and the developing world, such as India. However, in the recent time, the reverberations of the same can be heard even from the most developed countries, like the United States.

Possible solutions in this area generally encompass several tangible issues, e.g. high cost of drugs and care, alleged unethical practices of the providers, infrastructure bottlenecks – to name a few. Curiously, despite the availability of an increasing number of innovative drugs, state of the art facilities and diagnostics, brilliant healthcare professionals and so on, disparities in the degree of access to all these, between different members of the civil society, keep steadily mounting.

This cascading socioeconomic issue, creating a widening the trust deficit, especially on pharma, throws a critical management challenge for long term sustainability of business, if not survival too.

Transformation to a customer-oriented, profit-making organization:

Building a profit-making organization is not an easy task. However, transforming a profit-making organization to a profit making through customer-centric policies, is several times more challenging. That’s because, making a true external customer-centric organization gets kick started from a significant cultural change within the organization. Systematically creating a pool of requisite internal customers (employees), with diverse background, experience, gender, belief, perspective, talent and, more importantly, ably supported by the organizational vision of inclusion, forms the nerve center of this transformative process. No doubt, why the quality of ‘Diversity and Inclusion (DI)’ culture of an organization is assuming the importance of a differential success factor in business excellence.

The August 25, 2016 E&Y article, titled “Embracing customer experience in the pharmaceutical industry” epitomizes its relevance by articulating: “It is the companies that focus on continuously delivering a better customer experience to build a trusted and transparent relationship over time that will win in the market. They will not only acquire customers that will remain loyal, but also win advocates that will refer the company or brand to more customers.”

The missing link:

It is now being widely established that creating a culture of ‘Diversity and Inclusion (DI)’ across the organization, is of critical importance to maintain sustainable business excellence, with a win-win outcome. Going a step forward, I reckon, although, this is an arduous task for any organization, but an essential one – even for long-term survival of a business. However, today, the very concept of DI is apparently a ‘missing link’ in the chain of sustainable organizational-building initiatives, particularly for most Indian pharma companies.

The role of DI in making a customer-centric business:

Health care customers, like many others, are generally of diverse backgrounds, financial status, ethnicity, gender, health care needs, expectations, and also in their overall perspective. Thus, to make a customer-centric organization for greater market success, and drive product and service innovation accordingly, pharma companies need to deeply understand them, empathetically. A competent pool of well-selected employees with diverse backgrounds, race, ethnicity, gender, perspectives, could facilitate this process, more effectively. However, the company should also create an environment and culture of inclusion for all to listen to each other’s well-reasoned views – expressed uninhibited and fearlessly for this purpose.

In making this process more effective to add a huge tangible and intangible worth to the business, pharma players need to untether the employee potential through empowerment, making them feel valued and grow. This would also help immensely in charting newer pathways of all-round success in many other high-voltage complexities of pharma business.

‘Why diversity matters’?

That diversity within an organization matters in several ways, has been established in several studies. For example, the February 2015 article, titled “Why diversity matters”, of McKinsey & Company says, “More diverse companies are better able to win top talent, and improve their customer orientation, employee satisfaction, and decision making, leading to a virtuous cycle of increasing returns.” The analysis found a statistically significant relationship between a more diverse leadership team and better financial performance (measured as average EBIT 2010–2013).

Why is inclusion so important?

In a large number of organizations that include Indian pharma, senior management staffs generally seem to appreciate hearing more of what they want to hear. This culture quickly percolates top-down – encompassing the entire company, probably with a few exceptions. Personal ‘likes’ and ‘dislikes’ of various nature and degree spread wings within many organizations. Such a situation is created from intrinsic apathy to patiently listen to and accept another employee’s viewpoint – even on critical customer-centric issues. Employees, in that process, also get branded as ‘argumentative’ and often ‘disloyal’, if not a ‘socialist’. The major decisions often get biased accordingly – sometimes unknowingly.

Whereas, inclusion entails empowerment and close involvement of a diverse pool of employees with dignity, by recognizing their intrinsic worth and value. Moving towards a culture of inclusion would require creation of an organizational desire to communicate professionally and learn how to listen to each other’s well-thought-through arguments with interest.

The business should accept that it is not really important in getting along with everybody on all issues – every time. Neither, does it make sense for professionals to develop personal ‘likes’ or ‘dislikes’ on other fellow colleagues, based on issue-based differences, while finding out ways and means to improve organizational performance, image or reputation. Inclusion helps employees to learn to work closely, despite personal differences on all important issues.

Has Global pharma industry started imbibing DI?

Yes, many global pharma majors, such as, GSK, Novartis and Merck and several others, have started practicing DI as a way of organizational life and culture. Some of them like GSK India has put it on its country website. But, generally in India, the scenario is not quite similar. Though, many head honchos in the country talk about DI, the February 16, 2017 edition of Bloomberg/Quint carried a headline “Most Indian Companies Do Not Value Diversity At Board-Level Hirings,” quoting Oxfam India.

A voluntary survey of ‘company diversity’ conducted by US-based DiversityInc at Princeton, ranks the companies on four key areas of diversity management: talent pipeline, equitable talent development, CEO/leadership commitment, and supplier diversity. It revealed an interesting fact in its 2016 study. The survey reported, while diversity continues to improve in the overall perspective, its ‘Pharma 50’, as a group, ‘is right in the middle of the industry pack when benchmarked against the Fortune 500.’ The survey also brought to light significant differences in the levels of gender, national, and ethnic diversity even at the company boards and executive committees of individual companies. Nonetheless, some global pharma entities are taking significant steps in this direction. But, these are still early days in many organizations.

Conclusion:

The E&Y article quoted above, also says that pharma “customers are becoming resistant to push sales and marketing, and are instead preferring to relate to the overall experience provided in their pull interactions with the company. The customer experience will be the next battleground for the pharmaceutical industry. The deployment of a customer experience capability is a transformational journey in often unchartered territories. The key to success is to start early and drive a process that is both rigorous and iterative, allowing the organization – and its customers – to learn along the way and always to be ready with the next best action in place.” DI, I reckon, plays a critical role in attaining this goal.

Pharma companies are also realizing that building a profit-making organization with blockbuster high-priced, high-profit making molecules, such as Sovaldi is possible, but this may not be sustainable. It isn’t an easy task either, not anymore. There lies the urgency of transforming a profit-making organization to a profit making through customer-centric business entity. This process, I repeat, is several times more challenging, but the business success is much more sustainable.

Organizational transformation of this nature is prompting the global pharma majors to use Diversity and Inclusion (D&I) while achieving their key financial and people goals. Both D (Diversity) and I (inclusion) work in tandem for taking any fairness-based organizational decisions, irrespective of whether it’s staff or customer decision.

DI has the potential to help an organization to create and chart new and more productive pathways almost in all functions within the company – right from R&D, communication, service delivery to market access. In all these initiatives, customer focus to occupy the center stage – for a win-win outcome – significantly reducing the degree of difficulty for access to affordable medicines. DI is not a panacea to mitigate this problem totally, but would help significantly, nonetheless – with the help of employees with diverse background but having fresh eyes. Many global pharma majors have initiated action in this direction. However, in Indian pharma business generally, DI still remains a missing link, as it is seen today.

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.

Why MNC Pharma Still Moans Over Indian IP Ecosystem?

Posted on May 14, 2018 by Tapan Ray

Improving patient access to expensive drugs, paving the way for entry of their cheaper generic equivalents, post patent expiry, and avoiding evergreening, is assuming priority a priority focus area in many countries. The United States is no exception, in this area. The Keynote Address of Scott Gottlieb, Commissioner of Food and Drug at the 2018 Food and Drug Law Institute Annual Conference inWashington, DC by, on May 3, 2018, confirms this. Where, in sharp contrast with what the MNC Pharma players and their trade associations propagated, the US-FDA commissioner himself admitted by saying, “Let’s face it. Right now, we don’t have a truly free market when it comes to drug pricing, and in too many cases, that’s driving prices to unaffordable levels for some patients.”

Does US talk differently outside the country?

At least, it appears so to many. For example, in April 2018, the Office of the United States Trade Representative (USTR) released its 2018 Special 301 Report. In this exercise, the USPTO names the country’s trading partners for not adequately protecting and enforcing Intellectual Property (IP) rights or otherwise deny market access to U.S. innovators that rely on the protection of their IP rights.’ Accordingly, U.S. trading partners are asked to address IP-related challenges, with a special focus on the countries identified on the Watch List (WL) and Priority Watch List (PWL).

In 2018, just as the past years, India continues to feature, along with 11 other countries, on the PWL, for the so called longstanding challenges in its IP framework and lack of sufficient measurable improvements that have negatively affected U.S. right holders over the past year.

From Patient access to affordable drugs to Market access for Expensive Drugs:

Curiously, the USTR Report highlights its concerns not just related to IP, but also on market access barriers for patented drugs and medical devices, irrespective of a country’s socioeconomic compulsion. Nevertheless, comparing it to what the US-FDA Commissioner articulated above, one gets an impression, while the US priority is improving patient access to affordable drugs for Americans, it changes to supporting MNC pharma to improve market access for expensive patented drugs, outside its shores.

Insisting others to improve global IP Index while the same for the US slides:

In the context of the 2018 report, the U.S. Trade Representative, reportedly said, “the ideas and creativity of American entrepreneurs’ fuel economic growth and employ millions of hardworking Americans.” However, on a closer look at the U.S. Chamber of Commerce’s annual Global IP Index for 2018, a contrasting fact surfaces, quite clearly. It shows, America, which once was at the very top of the overall IP Index score, is no longer so – in 2018, the world rank of the US in offering patent protection to innovators, dropped to 12^thposition from its 10^thglobal ranking in 2017. Does it mean, what the US is asking its trading partners to follow, it is unable to hold its own ground against similar parameters, any longer.

Should IP laws ignore country’s socioeconomic reality?

MNC Pharma often articulated, it doesn’t generally fall within its areas of concern, and is the Government responsibility. However, an affirmative answer, echoes from many independent sources on this issue. No wonder, some astute and credible voices, such as an article titled “U.S. IP Policy Spins Out of Control in the 2018 Special 301 Report”, published by the Electronic Frontier Foundation on May 01, 2018, termed 2018 Special 301 Report – ‘A Tired, Repetitive Report.’ It reiterates in no ambiguous term: ‘The report maintains the line that there is only one adequate and effective level of IP protection and enforcement that every country should adhere to, regardless of its social and economic circumstances or its international legal obligations.

The ever-expanding MNC Pharma list of concerns on Indian IP laws:

The areas of MNC Pharma concern, related to Indian IP laws, continues to grow even in 2018. The letter dated February 8, 2018 of the Intellectual Property Owners Association, Washington, DC to the USTR, makes these areas rather clear. I shall quote below some major pharma related ones, from this ever-expanding list:

Additional Patentability Criteria – section 3 (d): The law makes it difficult for them to secure patent protection for certain types of pharma inventions.

TADF (Technology Acquisition and Development Fund)is empowered to request Compulsory Licensing (CL) from the Government:Section 4.4 of India’s National Manufacturing Policy discusses the use of CL to help domestic companies access the latest patented green technology.This helps in situations when a patent holder is unwilling to license, either at all or “at reasonable rates,” or when an invention is not being “worked” within India.

India’s National Competition Policyrequires IP owners to grant access to “essential facilities” on “agreed and nondiscriminatory terms” without reservation. They are not comfortable with it.

Regulatory Data Protection: The Indian Regulatory Authority relies on test data submitted by originators to another country when granting marketing approval to follow-on pharma products. It discourages them to develop new medicines that could meet unmet medical needs.

Requirement of local working of patents: The Controller of Patents is empowered to require patent holders and any licensees to provide details on how the invention is being worked in India. Statements of the Working, (Form 27),must be provided annually.Failure to provide the requested information is punishable by fine or imprisonment. It makes pharma patent holders facing the risk of CL, if they fail to “work” their inventions in India within three years of the respective patent grant.

Disclosure of Foreign Filings: Section 8 of India’s Patent Act requires disclosure and regular updates on foreign applications that are substantially “the same or substantially the same invention.” They feel it is irrelevant today.

Pharma MNCs’ self-serving tirade is insensitive to Indian patient interest:

Continuing its tirade against some developed and developing countries, such as India, the US drug manufacturers lobby group – Pharmaceutical Research and Manufacturers of America (PhRMA) has urged the office of the US Trade Representative (USTR) to take immediate action to address serious market access and intellectual property (IP) barriers in 19 overseas markets, including India, reports reported The Pharma Letter on February 28, 2018. It will be interesting to watch and note the level active and passive participation of India based stakeholders of this powerful US lobby group, as well.

Government of India holds its ground… but the saga continues:

India Government’s stand in this regard, including 2018 Special 301 Report, has been well articulated in its report released on January 24, 2018, titled “Intellectual Property Rights Regime in India – An Overview”, released by the Department of Industrial Policy and Promotion Ministry of Commerce and Industry (DIPP). The paper also includes asummary of some of the main recommendations, as captured in the September 2016 Report of the High-Level Panel on Access to Medicines, constituted by the Secretary-General Ban Ki-Moon of the United Nations in November 2015. Some of these observations are as follows:

WTO members must make full use of the TRIPS flexibilities as confirmed by the Doha Declaration to promote access to health technologies when necessary.

WTO members should make full use of the policy space available in Article 27 of the TRIPS agreement by adopting and applying rigorous definitions of invention and patentability that are in the interests of public health of the country and its inhabitants. This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred.

Governments should adopt and implement legislation that facilitates the issuance of Compulsory Licenses (CL). The use of CL should be based on the provisions found in the Doha Declaration and the grounds for the issuance left to the discretion of the governments.

WTO members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license.

Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities.

Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfill the rights to health.

The DIPP report includes two important quotes, among several others, as follows:

Joseph Stiglitz, Nobel Prize for Economics (2001) – an American Citizen:

- “If patent rights are too strong and maintained for too long, they prevent access to knowledge, the most important input in the innovation process. In the US, there is growing recognition that the balance has been too far tilted towards patent protection in general (not just in medicine).”

- “Greater IP protection for medicines would, we fear, limit access to life-saving drugs and seriously undermine the very capable indigenous generics industry that has been critical for people’s well-being in not only India but other developing countries as well”.

Bernie Sanders, an American Citizen and Senior U.S. Senator:

- “Access to health care is a human right, and that includes access to safe and affordable prescription drugs. It is time to enact prescription drug policies that work for everyone, not just the CEOs of the pharmaceutical industry.”

- “Healthcare must be recognized as a right, not a privilege. Every man, woman and child in our country should be able to access the health care they need regardless of their income.”

Conclusion:

Why is then this orchestrated moaning and accompanying pressure for making Indian IP laws more stringent, which apparently continues under the façade of ‘innovation at risk’, which isn’t so – in any case. But, cleverly marketed high priced ‘me too’ drugs with molecular tweaking do impact patient access. So is the practice of delaying off-patent generic drugs entry, surreptitiously. Instead, why not encourage Voluntary Licensing (VL) of patented drugs against a mutually agreed fee, for achieving greater market access to the developing countries, like India?

Whatever intense advocacy is done by the vested interests to change Indian patent laws in favor of MNC pharma, the intense efforts so far, I reckon, have been akin to running on a treadmill – without moving an inch from where they were, since and even prior to 2005. The moaning of MNC Pharma on the Indian IP ecosystem, as I see it, will continue, as no Indian Government will wish to take any risk in this area. It appears irreversible and is likely to remain so, for a long time to come. The time demands from all concerned to be part of the solution, and not continue to be a part of the problem, especially by trying to tamper with the IP ecosystem of the country.

By: Tapan J. Ray

Providing Unique Patient Experience – A New Brand Differentiator

Posted on March 5, 2018 by Tapan Ray

“Pharma industry, including the patients in India are so different from other countries. Thus, any strategic shift from conventional pharma brand marketing approach – going beyond doctors, won’t be necessary.”

The above mindset is interesting and may well hold good in a static business environment. But, will it remain so when ‘information enabled’ consumer behavior is fast-changing?

“Shall cross the bridge when we come to it” – is another common viewpoint of pharma marketers.

Many might have also noted that such outlooks are not of just a few industry greenhorns. A wide spectrum of, mostly industry-inbred marketers – including some die-hard trainers too, subscribe to it – very strongly.

Consequently, the age-old pharma marketing mold remains intact. Not much effort is seen around to reap a rich harvest out of the new challenge of change, proactively. The Juggernaut keeps moving, unhindered, despite several storm signals.

Against this backdrop, let me discuss some recent well-researched studies in the related field. This is basically to understand how some global pharma companies are taking note of the new expectations of patients and taking pragmatic and proactive measures to create a unique ‘patient experience’ with their drugs.

Simultaneously, I shall try to explore briefly how these drug companies are shaping themselves up to derive the first-mover advantage, honing a cutting edge in the market place. This is quite unlike what we generally experience in India.

As I look around:

When I look around with a modest data mining, I get increasingly convinced that the quality of mind of pharma marketers in India needs to undergo a significant change in the forthcoming years. This is because, slowly but surely, value creation to provide unique ‘patient experience’ in a disease treatment process, will become a critical differentiator in the pharma marketing ball game. Taking prime mover advantage, by shaping up the change proactively for excellence, and not by following the process reactively for survival, would separate the men from the boys in India, as well.

Patient experience – a key differentiator:

A recent report titled, “2017 Digital Trends in Healthcare and Pharma”, was published by Econsultancy in association with Adobe. This study is based on a sample of 497 respondents working in the healthcare and pharma sector who were among more than 14,000 digital marketing and eCommerce professionals from all sectors. The participants were from countries across EMEA, North America and Asia Pacific, including India.

Regarding the emerging scenario, the paper focuses mainly on the following areas:

Pharma companies will sharpen focus on the customer experience to differentiate themselves from their competitors.

‘The internet of things (IoT)’ – the rapidly growing Internet based network of interconnected everyday use computing devices that are able to exchange data using embedded sensors, has opened new vistas of opportunity in the pharma business. Drug players consider it as the most exciting prospect for 2020.

Virtual Reality (VR) and Augmented Reality (AR) have started filling critical gaps in pharma and healthcare technologies and systems. Their uses now range from training doctors in operating techniques to gamifying patient treatment plans. Over 26 percent of respondents in the study see the potential in VR and AR as the most exciting prospect for 2020.

Commensurate digital transformation of pharma industry is, therefore, essential.

Prompts a shift from marketing drugs to marketing outcomes:

The above study also well underscores a major shift – from ‘marketing drugs and treatments’ – to ‘marketing outcome-based approaches and tools’, both for prevention and treatment of illnesses. This shift has already begun, though many Indian pharma marketers prefer clinging on to their belief – ‘Indian pharma market and the patients are different.’

If it still continues, there could possibly be a significant business impact in the longer-term future.

Global companies have sensed this change:

Realizing that providing a unique experience to patients during the treatment process will be a key differentiator, some global companies have already started acting. In this article I shall highlight only one recent example that was reported in March 01, 2018.

Reuters in an article on that day titled, “Big pharma, big data: why drugmakers want your health records,” reported this new trend. It wrote, pharma players are now racing to scoop up patient health records and strike deals with technology companies as big data analytics start to unlock a trove of information about how medicines perform in the real world. This is critical, I reckon, to provide a unique treatment experience to the patients.

A recent example:

Vindicating the point that with effective leverage of this powerful tool, drug manufacturers can offer unique value of their medicines to patients, on February 15, 2018, by a Media Release, Roche announced, it will ‘acquire Flatiron Health to accelerate industry-wide development and delivery of breakthrough medicines for patients with cancer.’ Roche acquired Flatiron Health for USD 1.9 billion.

New York based Flatiron Health – a privately held healthcare technology and services company is a market leader in oncology-specific electronic health record (EHR) software, besides the curation and development of real-world evidence for cancer research.

“There’s an opportunity for us to have a strategic advantage by bringing together diagnostics and pharma with the data management. This triangle is almost impossible for anybody else to copy,” said Roche’s Chief Executive Severin Schwan, as reported in a December interview. He also believes, “data is the next frontier for drugmakers.”

Conclusion:

Several global pharma companies have now recognized that providing unique patient experience will ultimately be one of the key differentiators in the pharma marketing ballgame.

Alongside, especially in many developed countries, the drug price regulators are focusing more on outcomes-based treatment. Health insurance companies too, have started looking for ‘value-based pricing,’ even for innovative patented medicines.

Accordingly, going beyond the product marketing, many drug companies plan to focus more on outcomes-based marketing. In tandem, they are trying to give shape to a new form of patient expectation in the disease prevention and treatment value chain, together with managing patient expectations.

Such initiatives necessitate increasing use advanced data analytics by the pharma marketers to track overall ‘patient experience’ – against various parameters of a drug’s effectiveness, safety and side-effects. This would also help immensely in the customized content development for ‘outcomes-based marketing’ with a win-win intent.

Providing unique ‘patient experience’ is emerging as a new normal and a critical brand differentiator in the global marketing arena. It will, therefore, be interesting to track how long the current belief – ‘Pharma industry and the patients in India are so different from other countries’, can hold its root on the ground, firmly. Or perhaps will continue till it becomes a necessity for the very survival of the business.

By: Tapan J. Ray

Antimicrobial Resistance: A Recent Perspective

Posted on February 19, 2018 by Tapan Ray

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

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

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

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

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

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

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

Global initiatives for a multi-pronged concerted action:

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

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

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

1. The world leaders’ initiative:

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

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

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

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

2. Country-specific initiatives:

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

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

3. Pharmaceutical industry initiatives:

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

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

Global progress assessment of AMR initiatives in 2018:

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

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

Twenty-eight antibiotics are in late stages of development:

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

Some major initiatives in India:

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

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

Another matter of huge worry in India:

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

Extensive use unapproved of fixed dose combination (FDC) antibiotics is contributing to the rising rate of AMR in India, which is already one of the highest in the world.

Out of the 118 of FDC antibiotics being sold in India, only 43 (36 percent) were approved by the CDSCO. These 118 antibiotic formulations are being sold in 3307 brand names and manufactured by 476 entities. Of these, 464 were Indian manufactures, and 12 were MNCs.

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

Conclusion:

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

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

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

By: Tapan J. Ray

Blockchain: Pharma Keeps An Eye On The Ball

Posted on January 22, 2018 by Tapan Ray

On April 24, 2017, The Wall Street Journal (WSJ) came out with an interesting headline, “Dubai Aims to Be a City Built on Blockchain.” Some may have taken note of it seriously. However, a vast majority of its readers possibly equated the article with something, which is far from reality – like a distant dream.

However, looking at the rapid transformational phase of digital technology, nothing apparently is a dream – not even ‘a distant one.’ The following recent example, in a similar but not exactly the same context, would vindicate this point.

On January 09, 2018, Reuters reported with a headline, “JPMorgan’s Dimon regrets calling bitcoin a fraud.” Interestingly, at a conference held in September 2017, the same Dimon – the Chief Executive of JPMorgan, had commented: “The currency isn’t going to work. You can’t have a business where people can invent a currency out of thin air and think that people who are buying it are really smart.”

I cited the example of ‘Bitcoin’ while deliberating on ‘Blockchain’, primarily because ‘Bitcoin’ – an unregulated virtual or cryptocurrency was built on ‘Blockchain’ technology. This technology reportedly facilitates absolutely transparent, smooth, safe and corruption-free transaction of ‘Bitcoin’, without any third-party intervention at any stage.

Currently, moving beyond Bitcoin, many industries – including pharma, have started finding various uses of Blockchain in their respective businesses. Domain experts envisage, this technology has the potential to offer game changing values – revolutionizing various business processes.

In this article, I shall focus on how the healthcare industry, in general, and more specifically some global pharma players are contemplating to leverage the path breaking ‘Blockchain’ technology to add unprecedented value in the business. The technology being rather a complex one, I shall put it across in a way that an ordinary man like me can easily absorb. Which is why, I start with the first basic question that comes to the fore: ‘What exactly is ‘Blockchain’?

‘Blockchain’:

‘Blockchain’ is a technology that was reportedly conceptualized by an anonymous individual or a group known as Satoshi Nakamoto, in 2008. It was implemented in 2009, as a core component of ‘Bitcoin’ transactions – in an altogether different form of Internet. The technology provides in its network access to transparent digital information that no user can corrupt or probably even hack, leave aside taking copies. The December 13, 2017 article, featured in the Computerworld on this ‘Most disruptive tech in decades’, describes Blockchain as:

“Blockchain is a public electronic ledger – similar to a relational database – that can be openly shared among disparate users. It creates an unchangeable record of their transactions, each one time-stamped and linked to the previous one. Each digital record or transaction in the thread is called a block (hence the name), and it allows either an open or controlled set of users to participate in the electronic ledger. Each block is linked to a specific participant.”

“Blockchain can only be updated by consensus between participants in the system, and when new data is entered, it can never be erased. The Blockchain contains a true and verifiable record of each and every transaction ever made in the system.”

“As a peer-to-peer network, combined with a distributed time-stamping server, Blockchain databases can be managed autonomously to exchange information between disparate parties. There’s no need for an administrator. In effect, the Blockchain users are the administrators.”

Blockchain has, therefore, been meticulously designed to reveal any interference with the contents, ensuring a very high level of data security and access for all its users. Thus, many domain experts justifiably believe, what ‘open-source’ software did almost two and half decades ago, ‘Blockchain’ technology is possibly on a similar threshold of changing much of the ball game in Information Technology (IT), globally.

Big corporate houses of several industries, such as Fintech, Healthcare and Shipping envisage that ‘Blockchain’ technology has a great potential, as they start making limited use of it. It is still in its infancy for scalable use in most industries, probably other than ‘Bitcoin’ transactions.

Use of ‘Blockchain’ in pharma and healthcare:

Let me now explore the potential of ‘Blockchain’ in healthcare and pharma. A paper titled, “Healthcare rallies for Blockchains: Keeping patients at the center” by IBM Institute for Business Value, provides some important insight on its application in healthcare sector. This study is based on a survey of 200 healthcare executives in 16 countries, conducted by The Economist Intelligence Unit. The key highlights are as follows:

16 percent of pharma and healthcare respondents expected to have a commercial Blockchain solution at scale in 2017, as compared to 15 percent of the Banks and 14 percent of Financial enterprises. Thus, it appears, the adoption of Blockchain by healthcare entities are taking place at a faster pace than the other two.

6 in 10 anticipate Blockchains will help them access new markets, and new and trusted information they can keep secure.

7 in 10 of them expect the greatest Blockchain benefits to be in clinical trial records, regulatory compliance and medical/ health records.

Accordingly, the authors posed a few questions: How valuable would it be to have the full history of an individual’s health? What if every vital sign that has been recorded, of all the medicines taken, information associated with every doctor’s visit, illness, operation and more, could be efficiently and accurately captured – and securely stored?

If and when all this is put to scalable use, the designated users will get access to the historic and real-time patient data of various types, of high credibility. In turn, it is expected to significantly reduce many other costs, including the cost towards data reconciliation. Consequently, the quality and coordination of care would rise manifold, with lesser risk, if at all. I shall give below just a couple of examples to drive home the point:

I. Adds credibility and value to Clinical Trials:

The issue of not reporting around half of all clinical trial data, conducted by pharma players while obtaining marketing approval for innovative products, has become a topic of raging debates, across the world. The reason for the same is apparently the intent for the deliberate creation of an information-gap, by cherry picking more favorable trial data. This could eventually lead to compromising patient safety, seriously.

Allegations continue for not just mostly favorable trial data being presented to drug regulators and policymakers to obtain marketing and other approvals, but also for product promotion to doctors. This prompts many believing, “if the clinical trials are supported by Blockchain solution, all results, protocols, and other related information would be time-stamped and immutable, resulting in less data snooping and errors.” Consequently, it would help enhance the dwindling public trust on pharma, especially in this area.

II. Adds unprecedented security and transparency in SCM:

Another example of its effective use is in making a tamper-evident pharma Supply Chain Management (SCM), with unprecedented built-in security features to prevent drug counterfeiting and circulation of substandard drugs. Moreover, ‘Blockchain’ would ensure supply chain tracking even at the individual Stock Keeping Unit (SKU) level by establishing proof of ownership for specific sources of any product. This is especially important in the backdrop of the WHO report, highlighting that 30 percent of such drugs are sold primarily in developing countries.

Global pharma keeping an eye on the ball:

An article titled, ‘Big Pharma Seeks DLT Solution for Drug Costs’, published on January 09, 2018 by the CoinDesk – a digital media and information services company, discussed on this fascinating subject.

It reported, at least, three global pharma heavyweights – Pfizer, Amgen and Sanofi, are pondering, whether ‘Blockchain could be used to actually save lives?’ To achieve this goal with combined efforts, they are now exploring a Blockchain framework to streamline the process of developing and testing new drugs. These early initiators believe, as areas such as this, are of industry-wide importance, there is a need to create a growing momentum for collaboration on foundational issues. And, Blockchain framework that can address the current issues in drug development and clinical trials, will fetch a win-win outcome, both for the innovators and patients, besides other stakeholders.

To reduce the time and cost of bringing new drugs from research labs to patients, improved data management and movement is critical. Blockchain technology could hasten this process, by automating communication between pharma companies, researchers and patients. At the same time, it will ensure a very high level of data integrity, which is so important for health and safety interest of patients.

This area has assumed greater relevance in the recent years, when pharma innovators are facing different challenges to bring new, more personalized drugs to market – faster and at affordable prices, the paper highlights.

Areas of initial use by Indian pharma:

In my article “SCM: Embracing Technology For Patients’ Safety”, published in this Blog on December 18, 2017, I discussed a similar point, not in context of ‘Blockchain’, though. I wrote that by a notification dated January 05, 2016, the Directorate General of Foreign Trade (DGFT) has made encoding and printing of unique numbers and bar codes as per GSI Global Standard mandatory. This would cover tertiary, secondary and primary packaging for all pharmaceuticals manufactured in India and exported out of the country to facilitate tracking and tracing.

Although, the ‘Track and Trace’ system in India for drugs is currently applicable only to pharma exports, will ultimately cover drugs in the domestic market, as well. This is evident from a draft proposal of the Government to the stakeholders in June 2015, in this regard.

Blockchain-based public electronic ledgers that can be openly shared among disparate users, creating an unchangeable record of their transactions, with each one time-stamped and linked to the previous one, would be of immense importance for all concerned towards the reliability of medicines in India.

Similarly, as Indian players venture into more complex clinical trials, such as with biosimilars, Blockchain could catapult the narrative on reliability of Indian clinical data to a much higher level of trust.

Blockchain has come to stay:

As I said in the beginning, ‘Blockchain’ technology has started coming to the fore of many discussions and debates, mainly for its critical role in transparent transaction and distribution process of the cryptocurrency – Bitcoin.

December 16, 2017 issue of the Gulf News reported that UAE’s central bank is working on a joint cryptocurrency, based on Blockchain, with its counterpart in Saudi Arabia. Just prior to that, in August 31, 2017 issue of the Financial Times also reported: “Six of the world’s biggest banks have joined a project to create a new form of digital cash that they hope to launch next year for clearing and settling financial transactions over Blockchain, the technology underpinning bitcoin.”

And just this month, we got to know about the combined efforts of Pfizer, Amgen and Sanofi, to use a Blockchain framework for streamlining the process of developing and testing new drugs.

Besides many other industries, even several Governments are envisaging to unleash the transformative potential of Blockchain in various Governance processes. It may include the confidential data procured and used by Governments to confirm the identity or identification of individuals for different purpose, or even to ensure that the country’s election process is transparent and beyond corruption.

An expression of interest on the use of Blockchain by some State Governments in India, gets reflected in what the Chief Minister (CM) of Maharashtra said while inaugurating the Maharashtra Technology Summit (MTECH), jointly organized by FICCI and Govt. of Maharashtra in Mumbai on January 17, 2018.

The CM clearly indicated, as Blockchain can transform the e-governance, the State Governments must start interacting with technology providers to make Public delivery of goods and services transparent. This will reduce the trust deficit between businesses, and citizens with government departments. He admitted, in the space of technology, ‘Blockchain is one level up and it’s not just Internet of Thing, but it is Internet of trust, Internet of values, that can change the entire space of governance’.

Conclusion:

Blockchain may be just a technological component, but, nonetheless, a game changing one. Thus, the good news is, several pharma players are also taking great interest to step into this never ever experienced – and a new kind of digital paradigm.

It is heartening to note that a number of global pharma head honchos, such as of Novartis, Takeda, and several others, are creating a new global position of chief digital officer. GSK, reportedly, is the latest one to initiate similar step.

Indian pharma players, I reckon, can also reap a rich harvest, both tangible and intangible, by putting ‘Blockchain’ technology in place. It may start with building a transparent, incorruptible ‘Track and Trace’ system for medicines, in addition to achieving high degree of international reliability in its clinical trials, especially on biologic drugs.

The benefits built into the Blockchain technology for pharma, apparently, are far too many than perceived constraints to leverage it effectively. Encouragingly, global pharma seems to be keeping an eye on the ball – but what about Indian pharma?

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

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