Accelerating Footfalls In Less Charted Pharma Marketing Frontiers

Having experienced unprecedented disruptions, especially in the pharmaceutical and biopharmaceutical business, many global and local drug majors, are rethinking their marketing strategies. These have, no doubt, been prompted by the challenges of change, which are sometimes stark, but more often than not - nuanced.

Many of them are now, therefore, charting into less charted or even uncharted frontiers of pharma marketing warfare. Most companies had no choice, though, but to embrace new approaches, at least as a stopgap, to reach their target audience – hoping to revert to pre-pandemic practices, ultimately.

Interestingly, some pharma majors could envisage that long-term focus on many of these new and innovative areas – more effectively than even the pandemic lockdown time, could be a game-changer in the business. Accordingly, they tried to adapt, several of these approaches, quickly and effectively – for sustained excellence in the post-COVID paradigm.

In this article, I shall focus with several global and local, publicly available examples, of innovative pharma marketing approaches that are now being tried by several top drug companies in the post-COVID period.

I. Continuation of pandemic induced innovative approaches – global examples: 

  • Virtual Conferences and Events: Experiencing success with virtual events and conferences during the COVID-19 pandemic, many pharma companies are leveraging this digital space to reach out to healthcare professionals and patients. These events now include webinars, selected virtual conferences, and online workshops.

Pfizer, reportedly, held its first virtual investor day in September 2020, which was attended by thousands of participants from around the world. The company also organized several virtual events to educate healthcare professionals about its vaccine.

  • Social Media Marketing: The use of social media marketing is also increasing in the pharmaceutical industry. Companies are using platforms such as Facebook, Twitter, and LinkedIn to reach out to their customers and engage with them on a regular basis to build long-term relationships.

For example, Novartis, among a few others, is using social media to promote core values of its products and engage with customers. The company has built a strong presence on social media platforms where it shares news and updates about its products and research, as well.

  • Influencer Marketing: Many companies are partnering with influencers in the healthcare industry to promote their products. These influencers can be doctors, nurses, patient advocates, or even celebrities who are passionate about health and wellness. Influencer marketing can help companies reach a wider audience and build trust with their customers.

The French pharma major – Sanofi, has partnered with celebrity chef and diabetes advocate Charles Mattocks who was diagnosed with type 2 diabetes in 2011. The objective is to raise awareness about diabetes and promote the company’s diabetes products through social media and other channels.

  • Patient Education Programs: Companies are investing more on patient education programs to educate patients about their health conditions and treatment options. These programs can include online resources, mobile apps, and support groups. By providing patients with accurate and reliable information, companies can improve patient outcomes and build brand loyalty.

Merck, another global player, developed an online resource called MerckEngage to educate patients about their health conditions and treatment options. The platform provides patients with information about various health topics, including diabetes, cancer, and heart disease.

II. Continuation of pandemic induced innovative approaches – Indian examples: 

Some Indian pharma players are also not far behind in several innovative areas for business excellence in the post pandemic paradigm. Following are some of those examples from Indian pharma companies, as available in the public domains. These seem to have attracted greater focus in the pandemic period, and are continuing even today, with undiluted focus:

Virtual Conferences and Events: Illustratively, Lupin has been using virtual events to promote its products in the post-COVID period. The company is organizing virtual conferences and webinars to reach out to healthcare professionals and other customers. Similarly, Sun Pharma launched a virtual conference for healthcare professionals to discuss the latest developments in the field of dermatology.

Digital and Social Media Marketing:  Several Indian pharma companies are increasingly adopting digital marketing “strategies to reach out to their customers. Companies are using social media, online ads, email marketing, and other digital channels to promote their products and services.

For example, Dr. Reddy’s Laboratories continue using social media platforms like LinkedIn, Twitter, and Facebook to engage with healthcare professionals and consumers. Even, Cadila Healthcare, reportedly, has been using search engine optimization (SEO), pay-per-click (PPC) advertising, and social media marketing to reach out to its customers.

Telemedicine: With the rise of telemedicine during the pandemic, pharma companies are partnering with Telehealth/Telemedicine platforms to reach out to patients. Companies like Cipla have partnered with telemedicine platforms to offer online consultations and delivery of medicines to patients’ doorsteps. Sun Pharma has also been using telemedicine to reach out to its customers and has partnered with telemedicine providers to offer its products to patients who cannot visit a doctor in person.

  • Direct-to-Consumer (DTC) advertising: DTC advertising is gaining popularity among Indian pharma companies. With the rise of online pharmacies, companies like Abbott and Pfizer are launching DTC campaigns to increase disease and treatment awareness programs directly to consumers.
  • Collaborations and partnerships: Indian pharma companies are increasingly collaborating with other players in the healthcare ecosystem to provide integrated solutions. For example, as mentioned above, Lupin has partnered with a health-tech firm to offer a platform for online consultations and home delivery of medicines.
  • Greater patient-centric approaches: Some Indian pharma companies are adopting more patient-centric approaches for more effective omnichannel patient engagement initiatives. For example, Dr. Reddy’s Laboratories have launched an initiative to educate patients on the proper use of medicines and the importance of adherence to treatment.

As the industry continues to evolve, we can expect to see more companies adopting newer and more innovative marketing strategies to engage with their customers.

Summary:

Many of the above examples are pandemic triggered innovative approaches to keep the neck above water during unprecedented business disruptions in the pharma industry. Interestingly, some companies are not just continuing but further sharpening these initiatives in the post pandemic days. Moreover, it’s good to note that these are now being implemented by the concerned sales and marketing teams with greater gusto and zeal.

The point to ponder, therefore, is pharma industry ready now to excel amid start and more often nuanced – the challenge of change? To respond to these challenges effectively, more companies now need to seriously evaluate and consider adapting such strategic footsteps, first as pilot studies and then gradually scale up, for business excellence in the contemporary period.

Let me hasten to add, in this ball game pharma leadership mindset change to act decisively, after accurately studying – based on data-science, to ascertain where and how to change could well be a win-lose situation. However, the good news is, recent data vindicate the accelerating footfalls in many these less or even un- charted pharma marketing frontiers, both globally and locally.

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.

Focus More To Create Patient-Perceived Value of Brand Outcomes

Healthcare providers, including many drug companies aim to create a beneficial effect on patients with their respective products and services. However, and more importantly, these benefits need to be such that recipients are able to sense, feel, and perceive as they expect – or may often go much beyond their expectations.

In this endeavor, when the perceived value of health care offerings exceeds the perceived cost of the products or services, the beneficiaries get naturally delighted. Conversely, when the perceived cost of the product weighs more than the perceived benefits, especially when it is incurred in lieu of some other essential living expenses, the patients accept the benefits grudgingly – without having any choice, or alternatives. The situation often fuels growing healthcare activism, across the globe and more involving expensive patented products.

Such expectations of many customers have increases manifold during Covid-19 pandemic, as many studies highlight. Thus, creating a win-win situation while aiming for a beneficial effect on patients, would call for in-depth understanding of the complex changes in the value delivery process. This is critical for all in the health care environment, and particularly the pharma marketers.

In today’s article, I shall dwell on some recent developments in this area, beginning with the basic need for in-depth understanding of the complex changes in the value delivery process. This process flows from ascertaining what have and have not changed in pharma industry’s new normal. The core intent is to find an answer to the key question: Should markers now need to focus much more on creating patient-perceived value of brand outcomes to business excellence?

Understanding complex changes in the value delivery process:

In today’s scenario – amid expressive customers, to get to know the needs, wants and expectations of the target audience, pharma marketers would need to listen to them carefully, and capture the same as they are – in an organized way. In-depth analysis of the data, thus captured, would help marketers chart a cutting-edge strategic pathway – converting data into actionable insights, in pursuit of excellence.

Covid-19 pandemic expanded digital media use even by older age group: 

Many studies have shown, since the onset of Covid-19 pandemic, the use of digital media for various purposes, including health care products ad services, has increased among older age groups, more than ever before.

One such April 2021 Press Release of AARP Research was captioned, ‘Tech Usage Among Older Adults Skyrockets During Pandemic.’ It reported, technology enabled older adults, to better weather – the isolation of the pandemic, started using digital platforms and social media, from ordering groceries to telehealth visits to connecting with loved ones.

More specifically, in the present context, the study found, among others - ‘50+ use of smartphones increased dramatically. For instance, use for ordering groceries grew from 6% to 24%; use of personal health increased from 28% to 40% for activities like telehealth visits, ordering prescriptions, or making appointments; use of health and fitness information increased 25% to 44%; and use of financial transactions increased 37% to 53%.’

Another AARP publication on September 2021 was captioned: ‘Personal Tech and the Pandemic: Older Adults Are Upgrading for a Better Online Experience.’ It also articulated: ‘Texting, email, social media, and video chatting have become commonplace as the COVID-19 pandemic has forced people to remain home, separated from friends and family. More than 80% of those 50-plus said they use technology in some form to stay connected, many on a daily basis.’

I hasten to add that the above study, although was conducted in the United States, the overall trend is expected to be similar in India – of course, with varying numbers. Be that as it may, the new opportunity of listening to customers from their reach, use, interactions, and conversations through digital channels, and sieving out relevant information from the same, needs to be adequately leveraged.

This space could provide high-quality data, when used in a structured manner, for in-depth understanding of the pandemic-triggered changes in customer dynamics. No wonder, why some major pharma players’ greater focus on listening intently to healthcare customers’ conversation is assuming increasing criticality, today. This process would also help immensely while delivering value of affordable access to contemporary innovative drugs.

Increasing criticality of affordable access to contemporary innovative drugs:

Alongside the pre-Covid 19 ailments, new disease complications in the pandemic – or, now, in endemic-prone areas, would enhance manifold the criticality of the value of access to innovative drugs – for all to be up and running. This area, was well articulated in a similar context in the article, published in the Pharmaceutical Executive on September 20, 2021.

The authors reiterated, ‘Patient affordability and access enablement, along with health system sustainability and affordability, are critical factors that impact current patient access to these innovations as well as sustained future access to new innovations.’

Many pharma companies, who have both resources and knowledge to develop and supply new and innovative medicines at scale, are already talking about it, even in the new normal. But, they would now need to walk the talk with a greater sense of inclusivity that can be seen and felt by all. Let me cite a very recent example in this area from the Covid-19 perspective.

A recent example in this area from Covid-19 perspective:

An encouraging recent development about affordable access to innovative drugs was reported by The New York Times on October 27, 2021. It reported: ‘Merck has granted a royalty-free license for its promising Covid-19 pill to a United Nations-backed nonprofit in a deal that would allow the drug to be manufactured and sold cheaply in the poorest nations, where vaccines for the coronavirus are in devastatingly short supply.’

More, such examples, also involving treatment in other critical disease areas, would have a salutary effect, even on the public image of the concerned pharma innovators. The ball seems to have started rolling in this direction, as evident from the key findings of the ‘2021 Access to Medicine Index’.

2021 Access to Medicine Index’ elucidates the point:

The ‘2021 Access to Medicine Index’, published by the Access to Medicine Foundation, on January 26, 2021, reiterates the increasing criticality of affordable access to contemporary innovative drugs. It adds, with the resources and the knowledge to develop and supply new medicines at scale, pharma players have a responsibility to ensure these are made available to people regardless of their socioeconomic standing.

The key findings of the report include the following:

  • Eight companies adopt processes to systematically address access to medicine for all new products
  • Less than half of key products are covered by pharma companies’ access strategies in poorer countries.
  • R&D for COVID-19 has increased, yet another pandemic risk goes unaddressed.

In sync with other experts, the report further emphasizes, ‘Pharmaceutical companies have the power to address affordability by refining their access strategies; and the ability to strengthen supply chains and support healthcare infrastructures. Considering their size, resources, pipelines, portfolios and global reach, these companies have a critical role to play in improving access to medicines.’

Why affordable access to innovative drugs is more critical in India:

The much-deliberated issue of why affordable access to innovative drugs is so critical in India, was aptly analyzed in an article, published by Brookings on March 03, 2020. The backdrop of the discussion was the W.H.O data on global health expenditures that compares out-of-pocket expenditure (OOPE) as a proportion of current health expenditure.

It revealed, India does much worse in comparison to the world average of OOPE. This was 65% for India versus the world average of around 20%, in 2016, with a similar scenario as compared to other Asian countries.  It specified, Thailand and China have reduced the proportion of OOPE over time, while Sri Lanka and Bangladesh witnessed an increase over time.

Conclusion:

The current healthcare spectrum of possibilities to address these issues haven’t changed significantly, since then. Interestingly, this is despite the increasing need of innovative drugs that’s keeping pace with the complexity in the health care environment since the onset of Covid-19 pandemic.

Thus, the criticality of affordable access to contemporary innovative drugs in the new normal, deserves an out of the box solution. Even today, OOPE continues to remain very high in India, and mostly for outdoor patient treatments. Thus, it is imperative that pharma marketers should focus more to create greater patient-perceived (not self-perceived) value of brand outcomes, in an innovative way – for business excellence in the new normal.

By: Tapan J. Ray    

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

Covid 2.0 Rampages India As Top Echelon Policy Makers Ignore Science

‘India is in the endgame of COVID,’ announced the union health minister of India, just in the last month – March 08, 2021. Although, it was then clearly known to medical fraternity that today’s Covid vaccines won’t be magic bullets against rapidly mutating new Coronavirus. Interestingly, a scientific-data based MIT study, published last year – on July 01, 2020 predicted that India might record the highest ever in the world – 287,000 new Coronavirus cases per day, by February 2021. At that juncture also Covid vaccines were expected to be available in India before that predicted time frame. The MIT study warning received a wide coverage even in India - by almost all news dailies, on that very month of the last year. The national Covid management team did not seem to have taken it seriously, along with others. These include, besides the top echelon of governance – a vast majority of Indians – across the social, political, religious and economic strata.

The fallout of such callousness – both at the individual Covid-appropriate behavior level, as well as Covid governance level, have been more disastrous than what was forecasted even in the above MIT study. The ferocity and scale of the second Covid-19 wave in India did not just overwhelm the nation, but raised grave concern across the world too. On April 22, 2021, India recorded the world’s biggest ever single-day rise with 314,835 new cases of Covid-19, causing death to 2,104 people. The very next day, this number increased to 332,730 new cases with 2263 deaths.

But, the peak of the Covid second wave hasn’t come, just yet. According to a mathematical model developed by a team of scientists from the IIT Kanpur and reported by news media on April 22, 2021, the number of active covid-19 cases in India during the second wave is expected to peak in May. The daily infection count is expected to exceed 350,000 cases. In this article, I shall dwell on three specific areas – acknowledging that the current scenario is the outcome of national misjudgment, if not a humongous misgovernance to prepare India for Covid 2.0:

  • Current struggle of India’s fragile and long-ignored health care infrastructure.
  • Need to neutralize some general misgivings on Covid vaccines and associated dilemmas.
  • Who is equipped to save people, if no external remedial measures remain unavailable for some more time?

India’s fragile and long-ignored health infrastructure can’t take anymore:

Amid this calamity, India has run short of oxygen, hospital beds, important Covid medicines, including Remdesivir. Curiously, reports keep coming incessantly confirm and reconfirm: ‘Ever since the second wave of the pandemic started, the healthcare systems in India have been teetering on the brink, with many hospitals unable to handle the relentless inflow of patients whilst also running short of beds, oxygen cylinders and other essentials.’

Doctors and many health care workers are overwhelmed by the massive scale of the human tragedy and in tears, as they articulate: ‘Many lives could have been saved had there been enough beds, oxygen supplies, ventilators and other resources – if the healthcare system had been better prepared for the second wave.’

The Supreme Court intervened, noting the ‘grim situation’ in the country:

Meanwhile, the Supreme Court of India, reportedly, ‘Suo motu’ (on its own) took note of the grim situation in the country and the havoc caused due to shortage of Oxygen cylinders in hospitals. Consequently, on April 22, 2021, the top court said, ‘it expected the Centre to come out with a “national plan” on the supply of oxygen and essential drugs for treatment of infected patients and method and manner of vaccination against the disease.’  The Delhi High Court also observed, “We all know that this country is being run by God,” coming down heavily on the Centre over the Covid-19 management.

Some Covid vaccine related misgivings and dilemmas:

Many people are raising questions of the efficacy of two currently available Covid vaccines in India – Covishield and Covaxin, especially against our probably ‘desi’ double mutant variety of Covid-19. The trepidation increased manifold when India’s former Prime Minister – Dr. Manmohan Singh got Covid infected after taking two doses of Covaxin. Or, reports, such as: ‘Sri Lanka reports six cases of blood clots in AstraZeneca vaccine recipients, 3 dead.’ Incidentally, these vaccines were made in India. Some may not possibly know that both the issues have been deliberated by the Indian scientists, who haven’t expressed any concern, as yet. This has to be shared with all by all concerned, soon. Let me explore some of these related issues, as follows:

Re-infection after taking Covid vaccines:

Regarding re-infection rate after taking two doses of Covid vaccines, the scientists have now released data establishing that only a very small fraction of those vaccinated with either Covaxin or Covishield, have tested positive. In any case, instances of a few “breakthrough” infections do not undermine the efficacy of the vaccines, they added.

The ICMR has also clarified, “These vaccines definitely protect against disease. However, the immune response begins to develop usually two weeks after every dose and there are variations within individuals, too. Even after the first dose, if exposure to the virus happens, one can test positive.”

Efficacy of Covishield and Covaxin against double mutant strains:

Notably, both – the Indian Council of Medical Research (ICMR) and the Centre for Cellular and Molecular Biology (CCMB) have announced last week that Covishield and Covaxin protect patients even from the ‘double mutant’, B.1.617, variety of Covid-19. Scientists believe that the “double mutant” is responsible for the sudden spike in the number of cases in Maharashtra and other parts of the country. They had earlier feared that this “double mutant” or B.1.617, may escape the immune system and thus vaccines may not offer protection from this strain of the novel coronavirus.

Reported risk of blood clotting with Oxford-AstraZeneca’s Covid-19 vaccine:

No cases of blood clotting have come to light in India. However, a government panel of experts is,reportedly, investigating for any domestic cases of blood clotting, even mild ones, as a side effect of the two COVID-19 vaccines being administered in India. According to India’s leading virologist Gagandeep Kang, “blood clots reportedly caused as a result of Oxford-AstraZeneca’s Covid-19 vaccine amount to a very small risk.”

As reported on April 24, 2021, the United States has also decided to immediately resume the use of Johnson & Johnson’s Covid-19 vaccine, ending a 10-day pause to investigate its link to extremely rare but potentially deadly blood clots. These details, I reckon, need also to be shared with all people, soon, in order to neutralize any doubt on administering Covid vaccines.

Covid vaccine availability and pricing:

Recent media reports highlight, at least six states of India – Andhra Pradesh, Chhattisgarh, Haryana, Maharashtra, Odisha and Telangana – are facing Covid vaccine shortage, as Covid 2.0 overwhelms India. Most of these states have already apprised the Centre of the situation, as the Supreme Court of India also seeks the details from the center about its current status.

As on April 22, 2021, India has administered over 135 million vaccine doses, where each individual will require two doses. Whereas, as published in Bloomberg on April 23, 2021, ‘1 billion Covid-19 vaccines have been administered around the world.’ The good news is, effective May 01, 2021, everyone above the age of 18 years will be eligible to get vaccinated. The Central Government will also lift its singular control on supply and delivery of Covid-19 vaccines in a bid to tackle the massive rise of cases that have crippled the country’s health infrastructure.

That said, the key question that follows – would Covid vaccine manufacturers be able to meet this increasing demand in India, when there already exists more demand than its supply? According to Niti Aayog Covid-19: Vaccine availability will improve by July 2021. The two major vaccine manufacturers in India are also indicating broadly similar time frame.

Meanwhile, amid a deadly second wave of Covid infections, a third Coronavirus vaccine - Russia’s Sputnik V, has been approved for emergency use in India. Incidentally, Sputnik V’s approval came not before India overtook Brazil to become the country with the second-highest number of cases globally. According to its local distributor – Dr. Reddy’s Laboratories, India will start receiving Russia’s Sputnik V vaccine by end May.

Be that as it may, it is still unclear whether enough Covid vaccine doses will be available right from May 1, 2021, to start inoculating all Indians above 18 years of age, across the length and breadth of the country. Besides, SSI’s decision to fix the rate of Covishield vaccine for private hospitals and state governments, has attracted sharp criticism from the Opposition, who argued that there was no logic in charging the state governments a higher price, when the Centre is getting the same vaccine at Rs 150 per dose.

This question surfaces, especially when SII Chief himself acknowledged that they are making profit even with Rs.150/per dose price as the pandemic ravages the nation. A news item of April 24, 2021 also underscores ‘Serum Institute’s Rs.600/dose for Covishield in private hospitals is its highest rate in the world.’ Nonetheless, price sensitivity to Covid vaccines during the pandemic is not specific to India.

Shareholders of Pfizer, J&J, reportedly, are also pushing for detailed COVID-19 pricing strategies of the respective companies, at their annual meetings. Curiously, at the same, yet another report highlights: ‘With the competition struggling, Pfizer’s COVID vaccine sales could hit $24B this year.’ Amazing!

India utterly overwhelmed, angry outbursts of concern beyond its shores:

Witnessing the nature of rampage caused by Covid 2.0 in India, global press blames the Indian top policy makers for utter failure to anticipate and tackle the devastating second wave. For example, The Guardian of the UK flashed a headline on April 21, 2021 – ‘The system has collapsed’: India’s descent into Covid hell.’ It further elaborated: ‘Many falsely believed that the country had defeated Covid. Now hospitals are running out of oxygen and bodies are stacking up in morgues.’ The Times, UK was harsher. It reported, ‘Modi flounders in India’s gigantic second wave.’ It further added: ‘Record levels of infection have put huge strain on the health service and highlighted the perils of complacency in the nationalist government.’

The New York Times reported on April 23, 2021: ‘India’s Health System Cracks Under the Strain as Coronavirus Cases Surge.’ The report also cited examples of ‘recent political rallies held by Mr. Modi that have drawn thousands, as well as the government’s decision to allow an enormous Hindu festival to continue despite signs that it has become a super spreader event.’

Conclusion:

Keeping aside the responsibility, or rather lack of it, of the National Covid governance team, individual Indians – like you and me – can’t in any way shy away from our own responsibility of compliance to Covid appropriate behavior, religiously. We are equally responsible, at least, for our own lives and fate. Even today, many of those who are wearing a face mask, are wearing in the chin – keeping the nose exposed – forget about double masking! Moreover, how many of us were or are eligible for Covid vaccination till date, but did not or could not take?

Curiously, Covid 2.0 is no longer striking mostly the poor urban population, living in slums or hutments, or the migrant laborer. Nor it is attacking mainly the senior citizens or people with co-morbidities. More young people, including children are getting infected in Covid 2.0. In Covid 2.0 – over 90 per cent of Covid new cases concentrate in in high rise and other buildings in major cities, like Mumbai. While urban slums account for just 10 per cent. On April 24, 2021, Bloomberg also reported, ‘India’s Urban Affluent Hit By New Virus Wave After Dodging First.’

Terming Covid 2.0 as concerning and scaring‘, Tata Sons Chairman also said, ‘India needs to get as many different Covid-19 vaccine licenses as possible. And replicate multiple factories on a war footing to ramp up production in order to meet the requirements as the country reels under the devastating second wave of the pandemic.’ It’s incredible, how a small country in the Indian subcontinent – Bhutan with limited resources, got its vaccination plan right and carried out, reportedly, the world’s fastest immunization drive.

Coming back to the last year’s above MIT study forecast for 2021 Covid situation in India. It goes without saying that this one, among several others, was based on credible data. It also brought to the fore the scientific reasons of consequences for not following the norms of Covid appropriate behavior. Looking back and coming back to real life scenario of date, one thing becomes crystal clear. When science is ignored, both at the highest echelon of national governance where the buck stops – or at the individual, social, religious or political level – it is virtually inevitable that a disaster would strike. And in most cases, it will strike hard – very hard. Much beyond what a human can withstand to survive. We have choice for survival – even in today’s frightening scenario. Let’s individually and collectively behave, as the science demands. Life and livelihood are important – for all of us.

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.

 

 

Multichannel Marketing: Two Important Pharma Trends

On September 6, 2018, Reuters reported the announcement of GlaxoSmithKline (GSK) that it would cut about 650 positions in the United States related to a global restructuring program. This includes 450 Medical (sales) Representatives (MR). Similar announcements on job cuts for MRs by other pharma companies are being made since the last several years. Last week’s GSK announcement was the continuation of the same process. This prompts me to use the aforementioned global news while focusing on two important emerging trends in the pharma industry, as we witness today.

In the rapidly digitalized world, several broader questions are often raised today. These include whether or not e-detailing in the pharma industry will eliminate the role of MRs, or for that matter will digital marketing replace the pharma print media? As the concept of ‘multichannel marketing’ (MCM) gains momentum, finding right answers to these questions or at least the right trends are assuming as much importance for business success. As I don’t have any specific answers to these queries, in this article, let me discuss just two of these emerging trends, as appears to me.

Importance of multichannel marketing in pharma:

Many pharma companies are fast realizing that their customers, such as doctors, patients and others, are showing increasing interest in getting the requisite product or treatment related information from multiple readily available channels or sources. These are accessible both in digital and print platforms, which are often of independent origin. Such behavioral preferences of pharma customers are contrary to what was mostly happening in the past, globally. However, in the pharma world of contemporary India the same old traditional path of product information flow, from drug companies through Medical Representatives to doctors, continues, by and large.

Looking ahead, ‘multichannel marketing’ for pharmaceutical and biologic products is being generally considered as the recipe for commercial success of brands. Thus, pharma players are trying to engage their customers more through multiple channels, both directly or indirectly. This is happening in many countries of the world. It is a matter of time, I reckon, that majority of large to medium Indian drug manufacturers will also follow suit.

Two interesting trends:  

As multichannel marketing in pharma catches up, I find some interesting developments. These are outcomes of different channels getting balanced, based on customer preferences. Let me underscore, these are customers’ perceptions in the real world and not what the drug companies and their associates usually think, hence are worth considering. The two emerging trends, in my view, are as follows:

1. Although, the role of Medical Representatives is still important, but not as indispensable as was in the past.

2. Despite high decibel discussion over digital media, print media is still very relevant.

1. Impact on the role of Medical Representatives (MR): 

“There is an ongoing debate about the effectiveness and impact of the traditional sales representative, with some arguing to discontinue the role while others sense an opportunity to improve both rep productivity and efficiency.” This was articulated in a McKinsey & McKinsey paper titled, “Death of a sales model or not.” The same article also says, even those who champion the role, point out that using richer analytics, better leadership and aligned incentives to deliver stellar results in many geographies.

To comprehend what is really happening in this area, I would quote below from two important global survey reports, with a sincere wish that similar surveys are carried out in India too. Although, these two surveys are different in nature, but address the same basic issue.

A. ZS’s Access Monitor 2014 survey:

According to this survey, “Representatives access to physicians continues to decline, particularly in certain specialties and areas of the country. Overall, close to half of all doctors in the United States are now considered “access restricted” to varying degrees.” It further says: “Since the initial ‘Access Monitor’survey in 2008, access has steadily fallen, with 77 percent of physicians considered “accessible” that year, compared with 65 percent in 2012, 55 percent in 2013 and 51 percent in 2014.

In another important finding the same study captured that “the pharmaceutical and biotech industry wastes approximately USD 1.4 billion in infeasible calls. (A call is considered infeasible if a best-in-class sales rep can’t deliver it.) The cost of infeasible calls appears to have plateaued, as companies have largely squeezed out sales force inefficiencies— making alternative channels the best path to improving access and customer engagement.”

B. CMI/Compas Media Vitals research 2018:

Despite such debate, doctors still value face to face interaction with MR, across the world. However, the digital tools and platforms of various types are increasingly used as the source of both new and existing product information, including updates.

According to CMI/Compas Media Vitals research 2018, as shown in the Table I below, doctors’ dependence on MR for information on new and existing products now stands at 51 percent and 46 percent, respectively. Similarly, for product updates their dependence stands at just 39 percent. The above McKinsey & McKinsey paper also predicts that the number of MR will gradually decline as the multichannel marketing initiatives pick up.

That said, in Table I – dinner meeting ranks seven and peer to peer information comes in the third place. Digital sources when put together now occupy a significant part of the doctors’ preferences for obtaining product information.This is also clear from the Table I that the doctors have started showing interest e-detailing, as well.

Table I:  How do you want to receive information from pharma companies, for:

In % New Products Existing Products Product Update
E-detailing

15

16

13

EHR

16

16

26

Reps’ Email

21

7

27

Medical Journal

22

19

12

MSL

24

23

14

Pharma Brand E-Mail

24

21

28

Direct Mail

32

29

29

Peer-to-peer

47

40

21

Dinner Meetings

49

45

24

Representatives

51

46

39

(Source CMI/Compass Media Vitals 2018)

Dinner Meetings:

As I said before, “Dinner Meetings” were rated as the second most preferred choice of the doctors for getting new and existing product information, in the above Table I. This is interesting, especially when one reads it along with the findings of the research paper, published in the August 2016 issue of JAMA Internal Medicine. The study concluded with: “The receipt of industry-sponsored meals was associated with an increased rate of prescribing the promoted brand-name medication relative to alternatives within the drug class.” The paper also clarified that “the findings represent an association, not a cause-and-effect relationship.”

2. Print media remains relevant despite digital push:

The research by CMI/Compass Media Vitals 2018 has also shown that despite the abundant availability of online versions of various medical publications, many doctors still prefer to read the print format of the same Journal, as shown below in the Table II:

Table II. How do doctors read medical Journals? 

Online/Digital format (%)

Print format (%)

47

53

(Source CMI/Compass Media Vitals 2018)

Although, the professional portals are the most used to get the requisite information by the doctors, print journals still rank number three, after peer-to-peer information.

That print media is still relevant for the doctors to know about drugs, was confirmed by another study, as shown in Table III:

Table III. Print media is still relevant:

Professional Portal Colleagues Print Journals CME Meetings Online Journals Drug Ref. App In Person Speaker program
72% 67% 66% 66% 53% 53% 53% 53%

(Source :Kantar Sources & Interactions report from September 2017)

It is noteworthy that ‘online journals’ rank number 5, after ‘CME meeting’.

Conclusion:

Despite Millennials in India mostly prefer reading news online through digital media, print media has still remained relevant and growing too. So are the television channels, regardless of easy availability of anytime streaming of all types of news, videos, TV serials and even movies.

Moreover, with increasing preference of digital media by an increasing number of populations, reliance of many industries such as Fast-Moving Consumer Goods (FMCG) haven’t totally shifted from magazine and newspaper advertisements, alongside targeting their customers through digital platforms. The same is expected to happen with various print formats in multichannel pharma marketing, where the physical presence of MRs still play an important role. Thus, to create a greater impact on doctors, patients and other stakeholders, pharma marketers are expected to leverage the best of both print and digital world in the form of comprehensive MCM initiatives. It could well be more on digital platforms and less with print materials, as we move on.

The new role of MRs was epitomized in an interview of the Sales Director, Roche, UK, published in the eyeforpharma on January 26, 2018. In the words of the sales director: “For us, in our market, the traditional showing a visual aid and some messages with the HCP is dead… But the face to face meeting is certainly not. Its role, however, will be more about adding value, about finding the right patients for the right drug.” He further highlighted, “the clear challenge that stands before the pharmaceutical industry’s sales organizations; a world where access to physicians is diminishing, trust in the information the industry provides is dwindling, and having a costly sales force is increasingly hard to defend.”

Against this backdrop, regardless of MCM, the role of those MRs who will be in sync with the requisite applications of technology in their focus areas of work, will continue to remain relevant, though they will be lesser in number. A few of them will also stand out and shoulder higher and higher professional responsibilities in the industry.  Be that as it may, in my view, these two emerging trends are expected to gather a strong tailwind, at least in the medium to long term, heralding the dawn of a new era in the Indian pharma industry.

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.

Rebalancing Skill Sets In Pharma Sales And Marketing

A disturbing trend against much needed more job creation across the world, has been well captured in a May 2016 MIT article. It concluded through several complex mathematical models that: “As more tasks performed by labor are being automated, concerns that these new technologies will make labor redundant have intensified.”

However, despite well-hyped concerns in this area, ongoing rapid advancement of technology and other related innovation haven’t yet caused any alarming level of unemployment anywhere in the world, nor it possibly will. Several instances of gradual reduction in the number of routine and traditional jobs due to such automation, are generally related to a lesser level of hard skill sets. As we shall see below, many industries require doing so in the modern times, for long term sustainability of business.

In tandem, promising high tech jobs requiring state or the art hard skill sets are getting created too, though are fewer in number. Nevertheless, the number of brilliant startups has increased by manifolds, during the same period. This change is inevitable, mostly in any science and technology driven industry, e.g., banking sector, where most of human operated bank tellers have made way to ATM machines.

A recent vindication:

Vindicating this point, as it were, on May 18, 2017, Reuters reported that Swiss pharma major Novartis, as a part of its “ongoing global transformation” initiative launched last year to create a unified operating model, will cut around 500 traditional and routine jobs in Switzerland, and add 350 in high-tech areas. Immediately thereafter, for similar reasons, the company announced the elimination of another 250 jobs in the United States.

Jobs are important to all for a living. Any job loss, irrespective of the nature of business compulsion, is indeed unfortunate. That said, whether we like it or not, such evolving trends are the stark realities, and expected to continue or even accelerate in the years ahead for higher growth in productivity, especially involving the routine and traditional tasks.

Pharma industry, though a science-based one, loss of routine and traditional jobs due to technological advancement is fortunately still much less as compared to other similar industries. This is primarily due to the continuation of the traditional business models in the pharma sector, requiring a huge number of human intervention, which call for a different balance of soft and hard skill sets.

However, crystal gazing the future, it appears quite likely that there will be a strong need to rebalancing the required soft and hard skills in the drug industry. The contour of my discussion in this article will be on pharma sales and marketing. 

Skill – the ability to do something well:

The Oxford dictionary defines ‘skill’ as ‘the ability to do something well’. Similarly, the term ‘ability’ has been defined by it as ‘possession of the means’. Thus, ‘skill’ means ‘possession of the means to do something well’. It is an absolute must in all professions, including pharma sales and marketing.

Skills broadly fall into two categories – hard and soft skills. Hard skills involve specific knowledge and teachable abilities that can be defined and measured and are usually quantifiable.

Hard skills are individual proficiency in various scientific, technical, mathematical and even some artistic areas of creation, besides other related ones. In pharma sales and marketing arena of the near future, these include, among others, robust scientific knowledge-base to understand various aspects of drug molecules, content creation with astute market understanding, data generation and analysis through state of art analytics and research, software programing, digital savviness and social media expertise. Many of these skills are related to the Intelligent Quotient of an individual.

Soft skills, on the other hand, are less tangible and quantifiable, such as etiquette or personality development; work ethics, getting along with people, ability to listen patiently, overcoming objections, persuading others and a deep sense of accountability. Many of these skills are usually related to emotional intelligence of an individual.

Which one is more important?

Both hard or soft skills are useful, valuable and important. However, the mix of these two skills for high performance of any individual professional will generally depend on success requirements of a job in a specific macro business environment.

That said, it is important to note that most of the hard skills are taught and learnt mostly before a person’s entry into science, technology or various other craft or design based jobs. The related hard skills are essential for getting selected for specialized jobs. Whereas, softer skills are usually learned on the job, and through experience by all those who want to grow in the profession.

In this context, it may not be a bad idea for all pharma sales and marketing professionals to take a hard look at our own current soft and hard skill sets again, against rapidly changing demands of the business environment. Regardless of where we are now, it will be worth writing down on a piece of paper the type of each of these two skills, in order of their strengths, that we individually possess, which are good enough for achieving sustainable excellence in business performance and personal career progression. It may provide a broad sketch of where we stand today in the VUCA world.

The years ahead for pharma won’t be quite the same:

A strong wind of change has already started signaling that the years ahead for the pharma industry, won’t be quite the same as the bygone years nor like what it is today. Some, industry professionals have picked up this cue, while many are still in pursuit of replicating the traditional past with some digital tweaking here and there, whatever may be the reasons.

The current mix of skill sets of the sales and marketing professionals, quite perceptibly, tilts more towards sharpening the softer skills of the employees, as the traditional pharma business models prompt so.

Future need – rebalancing the skill sets:

To be a successful in the days ahead, pharma companies would need to dive deep into the cyberspace – just to be on the same wavelength with its important stakeholders, including, the Government.

Looking around, one witnesses many patients going digital at a faster pace than ever before. They enjoy the cyberspace while embracing the new ways of living life, such as – communicating digitally, chatting in WhatsApp sharing patient’s experience, interacting with online patient communities, and preferring data mining to know more about anything of interest. These activities also get them a sense of the differential advantages of various health care products, services and their cost, before or while consulting doctors and deciding what they can afford.

Similarly, many medical professionals are also not depending solely on the company representatives now to get relevant details on any medicinal product, device or services. Besides frequent interaction with their peer groups, they get such detail information from various websites run by independent, and credible expert groups.

Thus, one of the common arena for pharma stakeholder engagement and interaction would soon be the enigmatic Cyberspace. As the changing days come nearer, there is likely to be greater emphasis on the acquisition of talent having specialized hard skills in this area of sales and marketing.

This emerging scenario prompts rebalancing the mix of soft and hard skill sets with much greater care, and hire young sales and marketing professionals, accordingly to give shape to it. This process should commence now, as the present makes way for the future. This is so important because, the current trend of tweaking with many digital tools and devices mostly as interfaces, or for complementing in-person product detailing or for better field management, or even to draw up marketing and sales plans, may not yield the desired business results any longer, even for survival, as we move on.

Becoming digital natives?

According to the 2015 A.T. Kearney Report titled, “Time for Pharma to Dive into Digital”, pharma sales and marketing professionals must also become digital natives, providing content that is both up-to- date and appropriate for multiple digital channels. Moreover, they will have to be familiar with advanced analytics to monitor and measure actual consumption pattern, besides capturing in real time a huge sample of relevant data for deeper customer insights.

The new normal:

One of the biggest challenges would be in the approach to content development and management. Creating an interactive detailing toolbox for truly responsive customer engagement, requires a good deal of thought and quite complex coding. This would necessitate centralization of marketing content production, which is traditionally decentralized in many sales and marketing organizations. Similarly, the major focus of the sales force will shift from maximizing physician-call rates, to becoming a team of digital communication specialists, and coordinators who would ensure that the right channels are used at the right time.

As the November 2016 Accenture Report titled, ‘The Rebirth of The Pharmaceutical Sales Force’ underscores, the most successful pharmaceutical sales teams in the future will be those willing to define and servicing customers in new ways… and will use digital advances to change the conversation, and position themselves as committed to helping physicians improve health outcomes.

This expected change, I reckon, will put in place a new normal for pharma sales and marketing success in the years ahead.

In conclusion:

Young aspirants wanting to make a career in the pharma industry, may wish to take note of this evolving trend of inevitable changes. They may wish to get well-considered views on the same of a couple of experts’ having no conflict of interest, for a careful and independent personal assessment. These budding strivers should realize that the final actionable decision on developing requisite hard and soft skill sets for a successful take off in their respective working lives, should preferably be taken only by themselves, and none else.

An August 2015 article of McKinsey & Company titled, “The road to digital success in pharma” articulates that the pharma companies, though can play a central role in the digital revolution of healthcare, are running hard to keep pace with changes brought about by digital technology. But soon there may not be any other option left for achieving business excellence.

While the nation is taking strides to transform itself into ‘Digital India’, the pharma companies operating in the country can’t possibly afford to remain far behind. Willy-nilly, they will soon need to realign their business processes accordingly, as there may not be any further scope for individual pharma players to operate within the same old cocoon of tradition bound activities, and still survive.

To meet the new and tougher demands for excellence in pharma sales and marketing, the urgent need of the changing time lies squarely outside the box. To usher in a requisite transformation in the current business model, it calls for a series of well-calibrated, much researched, and bold steps – skillfully rebalancing the crucial soft and hard skill sets, achievable within a realistic and self-determined timeframe.

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.

Drug Price Control in India: When A Local Media Goes Against, A Global CEO Doesn’t

‘Variety is the spice of life’, as the good old saying goes. The week, just gone by, was indeed packed with a wide variety of surprises, well encompassing various important areas, some of which are as follows:

  • Effective November 08, 2016 midnight, Indian currency notes of ₹500 and ₹1000 denominations ceased to remain legal tenders. This demonetization followed extensive media coverage, both national and international, on unprecedented administrative and public chaos around this otherwise bold and good intent.
  • The same day witnessed much unexpected triumph of Trump as the 45th President-Elect and the Commander-in-Chief of the United States of America. It is entirely a different matter though, that post-election, millions of Americans reportedly took to streets across the United states to vent their fury over the billionaire’s election victory.
  • On November 07, 2016, a well-known Indian business daily, ‘The Economic Times’, in its editorial, apparently expressed its solidarity with the pharma industry, in general, to do away with drug price control in India. The key reason for this advocacy, as I could sense, is to encourage the drug players to grow by making more profits. I respect this view of the editor will all humility. However, the point that I am unable to ferret out though, what happens to especially the poor patients in such an eventuality. With hands-on experience in the pharma industry over several decades, it appears to me that the editorial suggestions, as well, grossly lack in requisite depth of understanding of the core issue.
  • On November 09, 2016, quite opposite to what the above editorial of ‘The Economic Times’, the current global CEO of GlaxoSmithKline – Sir Andrew Witty, in an interview, strongly argued in favor of the necessity of drug price control in India, that improves access to medicines for a vast majority of the country’s population. To substantiate this point Sir Andrew said in another interview on the same day, “We’ve seen demand of products jump 45 percent after the price is cut by 20 percent. The problem arises when we don’t have supply to cater to the demand, leaving patients frustrated. A bit more predictability (on the part of government) will help.”
  • As if this diametrically opposite views are not enough, on November 10, 2016, the well-known civil society organization – ‘All India Drug Action Network (AIDAN)’, reportedly sent legal notices to the CEO of Niti Aayog CEO and secretaries to the Health Ministry, Department of Pharmaceuticals and Department of Industrial Policy and Promotion over their talks to cut the powers of the National Pharmaceutical Pricing Authority (NPPA). AIDAN has termed this Government move “anti-national” and “anti-people”, further adding that it affects an ongoing case at the Supreme Court over various aspects of the drug price control.

In this article, I shall restrict myself to the pharma related issue of the past week, especially on the interesting advocacy through editorial, against the drug price control in India. Simultaneously, I shall also underscore its relevance in the country, primarily to improve access to medicines for millions of Indians, as articulated by one of the leading voices from the global pharma industry.

Is the yardstick of judging pharma industry different?

This particular question floats in my mind because of several reasons. One such is, almost regularly sponsoring fully paid trips for doctors, especially in an exotic foreign land, by many pharma companies. Such practices of the drug companies are generally inferred, more often than not spearheaded by a large section of the media, as dubious means of the organization to entice, or influence prescribing decisions of physicians in favor of their respective high priced brands, ignoring the health and economic interest of patients.

In similar context, just after having a quick glance over a not so important article, written on various operations at the headquarter of a global drug company situated in a beautiful locale of the world, when one focuses the fine print at the end as a disclaimer, which reads: “This reporter was in (name of the country) on an invitation by (name of the global company)…, do the readers arrive at the same conclusion on ‘gratification’, as above, and its consequent possible outcome on pharma related writings of these reporters?

Can the concerned members of the ‘Fourth Estate’ possibly claim desired intellectual independence in their analysis of a situation involving such companies or their trade associations, even after the above disclaimer? Or for that matter, related publications too, which allow acceptance of such avoidable ‘gratis’ by its reporters? Shouldn’t such incidences, whenever these happen, irrespective of who availed these, be perceived in the same light?

In the current scenario, this issue is something for us to seriously ponder. This is mainly because, for following similar practices, why should there be two different yardsticks to gauge the quality of professional independence of two different otherwise highly respectable professions?

This reminds me of a great pharma reporter, writing for an internationally acclaimed business daily, mainly on the drug industry and healthcare. I met him in India a few years back on his invitation. Although, I shall not take either his or his paper’s name. This is to show respect to our free and frank interaction. He flew down to India with his employer paying all the pharma reporting work related expenses. He met with all those in the Indian drug industry that he wanted to, primarily to capture the nuances of the thought pattern of large and small Indian pharma players. I was so impressed with his intellect, and independent professional outlook, like all those who met him during his that specific visit to India. Even now, I can feel his independent perspective, as I read his articles. It would be great to experience similar feelings, while reading pharma related articles and editorials, in various publications of my own country. At the same time, I shall be delighted to be proved wrong regarding any such possibilities in this area.

That said, I shall now move on to the relevance of drug price control in India.

Any relevance of drug price control in a ‘Free Market Economy’?

No doubt, this is a very pertinent question. Equally pertinent answers are also available in a 2014 paper titled, “Competition Issues in the Indian Pharmaceuticals Sector” of Delhi School Economics (DSE). The paper deals with issues related to failure of ‘Free Market Economy’, despite intense competition, especially for branded generic drugs in India.

Quoting a practicing surgeon, the DSE article states: “Sometimes it could be just plain ignorance about the availability of a cheaper alternative that makes doctors continue to prescribe costlier brands. But one cannot ignore the role of what is euphemistically called marketing “incentive”, which basically mean the inappropriate influence pharmaceutical companies exert on doctors. This runs deep. Hospitals choose to stock only certain drugs in their in-house pharmacies and insist that hospitalized patients buy drugs only from the hospital pharmacy. Drug companies sell drugs to hospitals at a price much lower than what the patient is charged, further incentivizing the hospital to stock their products. The cheaper brands often get left out in this game.”

Further, in an ideal free-market economic model, for all approved branded generics with exactly the same formulation, having the same claimable efficacy, safety and quality standards, though marketed by different pharma companies, competitive forces should prompt some parity in their pricing.

Any generic brand with exactly the same formulation as others and offering the same therapeutic value, but costing significantly more, should ideally attract a lesser number of customers, if and where purchase decisions are taken by the consumers directly. However, for prescription medicines it’s not so. The well proven process of consumers exercising their own choice to select a brand, mostly influenced by advertising or word of mouth, does not happen at all.

The Government attributes ‘Market Failure’ for pharmaceuticals:

In its price notification dated July 10, 2014, the NPPA has categorically stated the following:

  • There exist huge inter-brand price differences in branded-generics, which is indicative of a severe market failure, as different brands of the same drug formulation, which are identical to each other in terms of active ingredient(s), strength, dosage, route of administration, quality, product characteristics, and intended use, vary disproportionately in terms of price.
  • It is observed that, the different brands of the drug formulation may sometimes differ in terms of binders, fillers, dyes, preservatives, coating agents, and dissolution agents, but these differences are not significant in terms of therapeutic value.
  • In India the market failure for pharmaceuticals can be attributed to several factors, but the main reason is that the demand for medicines is largely prescription driven and the patient has very little choice in this regard.
  • Market failure alone may not constitute sufficient grounds for government intervention, but when such failure is considered in the context of the essential role of pharmaceuticals play in the area of public health, which is a social right, such intervention becomes necessary, especially when exploitative pricing makes medicines generally unaffordable and beyond the reach of most and also puts the huge financial burden in terms of out-of-pocket expenditure on health care.

Civil Society echoed the same sentiment:

In this context, it is important to note that seven large Civil Society Organizations in a letter of August 20, 2014 addressed to Mr. Ananth Kumar, the present Minister of Chemicals and Fertilizers with a copy to Prime Minister Modi, articulated similar views, as follows:

“Limiting all price regulation only to a list of 348 medicines and specified dosages and strengths in the DPCO 2013 goes against the policy objective of making medicines affordable to the public. The National List of Essential Medicines, a list of 348 rational and cost-effective medicines, is not the basis for production, promotion and prescription in India. In reality the most frequently prescribed and consumed medicines are not listed in the NLEM.”

Last week, AIDAN has also indicated that the reported Government move to curtail the power vested on the NPPA for drug price, affects an ongoing case at the Supreme Court over various aspects of the drug price control.

Are medicines cheapest in India…really?

It is often highlighted that medicines cost much cheaper, if not the cheapest, in India. This is too simplistic a view on this subject. It compares the prevailing Indian drug prices in Rupee, against the prices of similar drugs in other countries, just by simple conversion of the foreign currencies, such as, US$ and Euro into Rupee. To make the comparison realistic and credible, Indian drug prices should be compared against the same in other countries, only after applying the following two critical parameters:

  • Purchasing Power Parity and Per Capita Income
  • Quantum of per capita ‘Out of Pocket Expenditure’ on drugs

The Department of Pharmaceuticals (DoP) with the help of academia and other experts had earlier deliberated on this issue in one of its reports on patented drug pricing. The report established that post application of the above two parameters, medicines in India are virtually as expensive as in the developed world, causing great inconvenience to the majority of patients in the country.

Hence, common patients expectedly look for some kind of critical intervention by the Government, at least, on the prices of essential drugs in India.

‘Cannot do away with Drug Price Control’ – said the New Government:

On August 24, 2015 in an interview with a national business daily, V K Subburaj, the Secretary of the Department of Pharmaceuticals commented, “Price control on drugs a shot in the arm for health care” and “the Government cannot do away with it.”

He argued, “A large section of the population is poor. Suddenly, your system is disturbed if you have to spend more on drugs. Drugs are an important component of health care expenditure.”

Accepting the fact that in India, big and small companies investing in research would need more money, Mr. Subburaj said, “In India, we can’t afford to remove controls as the burden of disease is high.”

All stakeholders expect that there is some predictability in what the Government says. Can the stand taken by the policymakers change in just a year’s time, probably wilting under industry pressure?

Conclusion:

The drug price control in India is in vogue since 1970, uninterruptedly. The retail audit data continue to indicate that the growth of the Indian pharma industry, over the last four and half decade long price control regime, has been nothing less than spectacular. This would consequently mean, increasing consumption of drugs, leading to improved access to medicines in India, including its hinterland, though may still not be good enough. Sir Andrew Witty of GSK also articulated the same view, just the last week. It’s a different story altogether that some of the industry sponsored expensive market surveys attempt to wish it away.

Coincidentally, at the commencement of drug price control regime in India in 1970, almost all the players in the ‘Top 10’ pharma league table of the country, were multi-national drug companies. Today the situation has just reversed. Out of ‘Top 10’, about seven are home grown drug companies. Many of these companies were born post 1970. Without frequent M&As by the pharma MNCs, this number could have been probably higher today.

By the way, what’s the span of drug price control in India really – just about 18 percent of the total domestic pharma market now? Around 80 percent of the local drug market continues to remain in the ‘free-pricing’ and ‘high-profit’ zone.

When it comes to profitability, it is worth mentioning, the promoter of the so called ‘low margin’ generic pharma company – Sun Pharma, is the second-richest person in India. He created his initial wealth from India, despite ostensible ‘growth stunting’ price control.

Keeping this in perspective, is it not baffling to fathom the reason behind a local business publication’s apparently endorsing the advocacy initiatives of pharma industry against drug price control through an editorial, when a well-regarded global pharma CEO expresses a strong favorable view in this regard?

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.

Nutraceuticals: Make The Fragile Regulatory Space Robust, Soon

In the space between drugs and nutrition, there is an intriguing ‘gray area’ with significant business relevance, especially in India.

In a related publication, A.T. Kearney – a leading global management consulting firm has elaborated it as below:

“At one end of this natural nutrition spectrum, are functional foods and beverages as well as dietary supplements, aimed primarily at maintaining health. On the other – more medical end of the spectrum, are products aimed at people with special nutritional needs. In the middle, is an emerging gray area of products that have a physiological effect to reduce known risk factors, such as high cholesterol, or appear to slow or prevent the progression of common diseases such as diabetes, dementia or age related muscle loss.”

Falling in the middle of the spectrum, a large number of Nutraceuticals clearly blur the line between food and drugs, in many cases. In India, there is no clearly defined legal and regulatory status for such Nutraceuticals, just yet.

Why a robust regulation required for Nutraceuticals?  

The scholarly article of S.H. Zeisel (Professor of Nutrition, University of North Carolina at Chapel Hill Nutrition) titled, “Regulation of Nutraceuticals,” Science 5435, 1853–1855 (1999) highlighted that in many cases when the dosages of food supplements exceed those of a normal diet, there could well be a drug-like bioactivity of a nutrient.

An example of the nutrient tryptophan may suffice to illustrate this point briefly. At higher dosage tryptophan can exhibit drug-like activity, as it is the precursor of serotonin, which is extensively used to treat insomnia. Many of such points are yet to draw the regulators’ attention in India as much as it should, as yet.

Marketing drugs as ‘food supplements’?

Marketing drugs as food supplements to evade Drug Price Control Order (DPCO) by some pharma players, of all sizes and scale of operation, is not an uncommon practice in India. The National Pharmaceutical Pricing Authority (NPPA), reportedly, pointed it out sometime around 2009.

Not just for pricing reason, but more importantly for consumers’ health and safety, the Central Drugs Standard Control Organization (CDSCO) should address this issue now with a greater sense of urgency, as the market for Nutraceuticals and health supplements is reportedly growing at a brisk pace today. According to a Frost & Sullivan report, the total Indian Nutraceuticals market in 2015 was expected around US $ 5 billion. 

In the absence of any clear and robust regulatory guidelines, most Nutraceutical products, with a spectrum of therapeutic claims, are virtually self-categorized as food supplements, which are not covered under the Drugs and Cosmetics Acts in India.

Currently in the country, Nutraceuticals and functional foods are covered under the definition of ‘food’ as per Section 22 of Food Safety & Standards Act (FSSA), 2006. These food products have been categorized as Non-Standardized/Special Food Products. Accordingly, Food Safety and Standards Authority (FSSAI) of India have described Nutraceuticals as:

“Naturally occurring chemical compound having a physiological benefit or provide protection against chronic disease, isolated and purified from food or non-food source.”

Though categorized as nutritional supplement, the product packs of such Nutraceuticals usually do not carry any “FSSAI’ logo, which signifies conformance to the food safety standards of India, for the benefit of consumers.

Recommendations are many, but no comprehensive action yet:  

To give an example, many Nutraceuticals contain vitamins in varying quantity. However, most of these products seem to carefully avoid Schedule V guidelines for vitamin content to avoid being categorized as drugs, and thereby coming under strict regulatory requirements. Self-categorizing these products as ‘food supplement’, helps bypassing this issue, as on date.

Such ongoing practices related to Nutraceuticals need to be viewed keeping in perspective, some of the recent key recommendations made by the Drugs Technical Advisory Board (DTAB) of the CDSCO, on Schedule V related formulations.

The minutes of the 70th. meeting of the Drugs Technical Advisory Board (DTAB) held on August 18, 2015, recorded the acceptance of the report of its sub-committee on vitamins, which recommended, among others, some of the following guidelines:

  • Ingredients which are covered under the range as prescribed under schedule “V” of the Drugs and Cosmetics Rules for Tablets, capsules, granules are 18 classified as a drug, while those powders like Farex, Oats and Cereal fortified vitamins are exempted from the provisions of chapter IV under schedule K of Drugs and Cosmetics Rules.
  • Ingredients which fall below the range as prescribed under schedule “V” shall be classified as food. However, if there is a claim for treatment, mitigation or prevention of any diseases or disorder, then it will be classified as a drug. 
  • Ingredients which are within Recommended Daily Allowance (RDA) levels, but fall under the range as prescribed under schedule V Drugs and Cosmetics Rules shall be classified under drug as it is already mentioned in the rules. 
  • Products containing ingredients which are neither covered under Schedule V nor fall within RDA, these can be classified as unprovable products under Drugs and Cosmetics Rules, unless otherwise specifically permitted by the Licensing Authorities of drugs based on major purpose of the item (like food/drug).
  • Whenever there are additional ingredients than those given in schedule V, including some of herbal ingredients, a separate and conscious view has to be taken about the safety and efficacy of the drug
  • Any product containing herbal ingredients shall be dealt with by the food or drug authority based on the above principles. 

The same subcommittee, on June 12, 2015, after discussing each of some specified products, with a claim of falling in non-drug category, as per directions of the Hon’ble High Court of Patna, recommended categorization of some of the well-known brands brands, such as, Revital (Ranbaxy) and A to Z capsules (Alkem) as drugs. The sub-committee report was then uploaded in the CDSCO website for stakeholders’ comment.

Could there be ‘irrational FDC ban’ like an issue with Nutraceuticals?

The answer to this question is anybody’s guess at this point of time. However, such a possibility can be just wished away either.

This lurking fear stems from the recent notification of FSSAI dated March 30, 2016, which states as follows:

“It has been decided that till the standards of Nutraceuticals, food supplements and health supplements are finally notified, the enforcement activities against such food business operators may be restricted to testing of these products with respect to requirements given in the draft notification on such products of September 9, 2015″.

However, it clarifies that the companies will get an exemption, if such products were available in the market before the Food Safety and Standards Act came into effect in 2011, or if product approval was pending on August 19, 2015.

The key objective of the above September 9, 2015, FSSAI draft notification was to ensure that Nutraceuticals, health and food supplements and other such products are not sold as medicines with therapeutic claims. Thus, asking the industry players to send their suggestions and objections to the proposal, this draft notification indicates, among others, that all such products should: 

  • Adhere to the proposed permissible limits of various minerals, vitamins, plant or botanical-based ingredients, among others.
  • Adhere to the proposed list of food additives used in all these categories of products, besides labelling norms, every package must carry the words “Food” or “Health Supplement” and prominently display “Not for Medicinal Use” on the label. 
  • Give a disclaimer on the package that the food or health supplement should not be used as a substitute for a varied diet.
  • Clearly indicate on the label that “this product is not intended to diagnose, treat, cure or prevent any disease”, besides information on recommended dosages, among others.

As this notification is expected to cover all products, which are marketed as food supplements, many Nutraceuticals manufacturers, reportedly, fear that it could effectively mean a ban on virtually all those brands, self-categorized as food or nutritional supplement, and launched post 2011.

If it happens, the saga of ban of a large number of irrational Fixed-Dose Combinations (FDCs) of drugs, that includes some top-selling pharma brands and is now sub judice, could get extended to the Nutraceuticals sector too. 

Nonetheless, the bottom-line is that a robust mechanism to effectively regulate and monitor Nutraceuticals in India, is yet to see the light of the day. 

Crazy marketing of Nutraceuticals: 

Despite regulatory and marketing restrictions to the therapeutic claims for this category of drugs, Nutraceuticals are mostly promoted to the doctors, just as any other ethical pharma products in India.

Consequently, these are widely prescribed by the medical profession, not just as nutritional supplements, but also for the treatment of disease conditions, ranging from obesity to arthritis, osteoporosis, cardiovascular conditions, diabetes, anti-lipid, gastrointestinal conditions, dementia, age-related muscle loss, pain management and even for fertility. All these are generally based on off-label therapeutic claims of the respective manufacturers.

Being advertised in the mass media too:

To illustrate this point, I would give an example of a well known brand in India. As I see from the Government records, i.e. from the minutes of the 68th meeting of the DTAB sub-committee held on June 12, 2015 that it had recommended Revital’s (Ranbaxy) categorization under drug.

As we all know that, as per drugs and Cosmetics Act of India, drugs cannot be advertised in the mass media, except Schedule K drugs, such as Aspirin and paracetamol. In that sense, I find it difficult to fathom, how is Revital then, which highlights a naturally occurring substance fortified with vitamins and minerals, advertised even on the Television, along with a top celebrity endorsement?

A recent notification on phytochemicals:

As I mentioned in my article in this Blog on December 21, 2015, titled “Nutraceuticals: A Major regulatory Step That Was Long Overdue”, partly responding to the growing demand for regulatory intervention in this important matter, on November 30, 2015, by a gazette notification, the Government of India included phytopharmaceutical drugs under a separate definition in the Drugs & Cosmetics (Eighth Amendment) Rules, 2015, effective that date.

This regulatory action followed the rapidly growing use of these drugs in India, which includes purified and standardized fraction with defined minimum four bio-active or phytochemical compounds.

On the ground, this significant regulatory measure would require the pharma players to submit the specified data on phytopharmaceutical drugs, along with necessary applications for conduct clinical trial or import or manufacture of these products in the country. 

However, this is no more than half-measure in this direction. Hopefully, this will be followed by final action on the DTAB recommendations on vitamins, and final notification of FSSAI on standards of Nutraceuticals, food and health supplements. A well-integrated action of the CDSCO and FSSAI, would possibly help to contain the unregulated proliferation of various types of Nutraceutical products coming into the Indian market, prescribed by the doctors and consumed by the people, sans any scientific evidence based efficacy, safety and quality standards.

Manufacturers’ business interest also can’t just be ignored:

While there is a pressing need to enforce regulatory discipline for claimed efficacy, safety and high quality standards for the Nutraceuticals to protect consumers’ health interest, commercial interest of such drug manufacturers can’t also just be ignored. If that happens, it will be unfair.

Thus, one of the ways to encourage the manufacturers to expand this market, I reckon, could well be categorizing the Nutraceuticals offering health benefits, under a separate category altogether, which will be kept out of any form of drug price control.

Conclusion:

The manufacturers of Nutraceuticals still keep charting in a very relaxed regulatory space. Currently, there is no robust and transparent process in place to standardize and scientifically evaluate safety and efficacy of these products on an ongoing basis. This scenario should not be allowed to continue, any longer.

Appropriate control of standardized Nutraceutical manufacturing, regular monitoring of the same and scientific evidence-based marketing approval process of all such products, therefore, require to be well-well regulated. The requirement for stringent conformance to the set cGMP standards would ensure desired safety, efficacy and high quality of nutraceutical products for the consumers.

The recent decisions of the Union ministry of Ayush for setting up a structured regulatory framework, within the CDSCO, for all Ayush drugs and to allow marketing of any new Ayurvedic medicine only after successful completion of clinical trials to ensure its safety and efficacy, are indeed encouraging.

Just as Ayurvedic products, all Nutraceuticals, not being essential medicines, should always be kept outside price control in any form. It should happen in tandem with the Government’s taking a bold step to make the prevailing fragile regulatory space for the Nutraceuticals a robust one, creating a win-win situation for all. 

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.