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The Indian Drug Industry’s Looming Talent Crisis – A Recent Landscape

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India’s pharmaceutical industry, a global generics and drug manufacturing powerhouse, is facing a critical talent deficit. The shortage of skilled professionals is impeding innovation, drug development, and the industry’s overall competitiveness.

This challenge, exacerbated by recent industry dynamics, demands immediate attention to unleash the sector’s full potential. In today’s article, I shall dwell on this area.

Talent challenges and focus areas:

The industry is facing a significant talent crunch. Here’s a breakdown of the key challenges with recent, specific examples:

1. Skill Shortage:

The industry demands expertise in areas like regulatory affairs, data science for clinical trials, biosimilars, and gene therapy. However, the current education system and skill development programs haven’t kept pace with this evolving landscape.

Example: A 2023 report by TeamLease points out a growing demand for professionals with expertise in regulatory affairs, particularly, those adept at navigating international regulations for drug approvals. This is crucial as Indian companies increasingly target overseas markets.

2. The Great Resignation Impact:

Example: A 2024 article in The Economic Times highlighted a recent exodus of mid-level managers from several Indian pharma companies. The report cited factors like stagnant salaries, lack of growth opportunities, and a competitive job market as reasons for the increased job hopping.

3. Competition for Talent:

Example: A recent news piece in BioSpectrum Asia (May 2024) discussed the fierce competition for experienced professionals in the biosimilars space. Companies like Biocon and Reliance Life Sciences are aggressively hiring and offering lucrative packages to attract top talent in this rapidly growing field.

4. Lack of Industry-Academia Collaboration:

Example: A joint report by FICCI (Federation of Indian Chambers of Commerce and Industry) and Ernst & Young (2023) highlighted the growing gap between the skills taught in universities and the practical needs of the pharma industry. The report urged closer collaboration between industry and academia to ensure curriculum updates reflect current industry requirements.

5. Diversity Issues:

Example: A 2024 study by Express Pharma revealed that despite comprising a significant portion of the workforce, women hold only around 15% of leadership positions in the top 20 Indian pharmaceutical companies. This highlights the need for targeted initiatives to promote women into leadership roles.

In such a scenario, some may obviously ask, what is my recommendation or the ways some companies are trying to address this issue. Here below is my prescription:

A prescription – A Multi-Pronged Approach, with Indian examples: 

Re-skilling and Up-skilling:

Example: Dr. Reddy’s Laboratories, reportedly launched targeted training programs to equip existing employees with data science skills for clinical trial design and analysis. This approach empowers the current workforce and addresses the immediate skill gap.

Industry-Academia Collaboration:

Example: Lupin, as reported, partnered with IIT Delhi to establish a joint research center focused on drug delivery systems. This collaboration bridges the gap between academic knowledge and industry applications, better preparing graduates for real-world challenges.

Fostering Diversity and Inclusion:

Example: According to reports, Biocon’s “Women in Biopharma Leadership” program provides mentorship, training, and networking opportunities for aspiring women leaders. This initiative tackles the under-representation of women in leadership roles and unlocks the industry’s full talent potential.

As I discussed in my earlier article, ‘Diversity And Inclusion: A Missing Link For Indian Pharma‘ (June 25, 2018), the Indian pharma industry faces a critical talent shortage.

Building a Strong Employer Brand:

Example: Companies like Cipla can invest in employer branding initiatives to showcase their work culture, growth opportunities, and commitment to diversity. This can attract talent seeking a fulfilling career path and a positive work environment.

Leveraging Technology: Implementing AI-powered talent acquisition platforms can streamline recruitment processes and identify suitable candidates from a wider pool, including those from non-traditional educational backgrounds.

Conclusion:

By addressing these challenges through strategic investments in skill development, nurturing industry-academia partnerships, and fostering a more inclusive work environment, the Indian pharmaceutical industry can build a robust and future-proof talent pool. This will be equipped to drive innovation and ensure its continued success in the global market to maintain its competitive edge, sustainably.

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 D&I Is A Powerful Growth Driver For Pharma Industry

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‘Diverse India’ now needs an ‘inclusive society’, vowed the Prime Minister of India, after his massive electoral win on May 23, 2019. Many may consider a part of it as rhetoric, notwithstanding, as and when the government policy of Diversity and Inclusion (D&I) gathers wind on its sail, the realization of its importance would reverberate – even in the corporate world, including the pharma industry, especially in India.

I discussed this subject in my article of June 25, 2018 ,in the context of transforminga pharma company to a customer-oriented, profit-making organization, with implementation D&I within the organization. However, in this article, I shall deliberate, over and above, the current status of D&I in the pharma industry, why most drug companies are still not leveraging it as one of the powerful business growth drivers. While opening this discussion, let me recapitulate what these two words mean to us, and their importance in the drug industry.

Recapitulating D&I:

As there are several, but similar definitions of D&I, I am quoting below just one – from the Ferris State University. It goes, as follows:

  • “Diversity is the range of human differences, including but not limited to race, ethnicity, gender, gender identity, sexual orientation, age, social class, physical ability or attributes, religious or ethical value system, national origin, and political beliefs.”
  • “Inclusion is involvement and empowerment, where the inherent worth and dignity of all people are recognized.”

The relevance and importance of D&I as a corporate growth policy for the drug industry is immense. It will not just, help them recognize and create business policies, based on diversity in people – a wide range of human differences in their consumers or potential consumers. In tandem, it will also help promote, and sustain a sense of belongingness with the society and communities where it operates – their values, beliefs, expectations and desire for a healthy living.

D&I begins within the company, and for the customers:

There are clear indications that many pharma companies are slowly, but surely realizing that for a consistent and sustainable financial performance the whole approach to business needs to undergo a metamorphosis. One such area of transformation, is a sharp focus on effectively satisfying a set of well-defined expectations of both their external and internal customers.

This journey begins with the creation of a Diverse and Inclusive (D&I) workplace. Nevertheless, the key goal remains – meeting expectations of the society where the drug companies operate, including a diverse set of customers – by saving and improving their quality of life, with affordable and accessible medicines.

While talking about diversity to Business Insider on January 10, 2018, GlaxoSmithKline CEO Emma Walmsley also reiterated, for a future facing employer in an industry, D&I should be a priority corporate strategy – for aggressively modernizing the business.

D&I ‘may be most important in the health care industry’:

This has been well-articulated even in the Workforce – a multimedia publication, where it says: D&I ‘may be most important in the health care industry, where the workforce needs to be both business savvy and socially empathetic to serve their increasingly diverse communities.’

Quoting another CEO, a different article titled, ‘Diversity and inclusion in the pharma industry’, published in PMLiVE on June 27, 2018, emphasized: ‘The global Biopharma industry is one of the most powerful and important industries today, directly affecting the lives of billions of people around the world on a daily basis. In order to understand and meet the critical unmet medical needs of patients, the industry must represent the population it serves.’

D&I is a growth driver for an organization:

“Many successful companies regard D&I as a source of competitive advantage. For some, it’s a matter of social justice, corporate social responsibility, or even regulatory compliance. For others, it’s essential to their growth strategy.” This was highlighted in the January 2018 research paper of McKinsey titled, ‘Delivering through Diversity.’

The article further elaborates: ‘D&I is a powerful growth strategy for an organization because it creates ‘a diverse and inclusive employee base – with a range of approaches and perspectives – would be more competitive in a globalized economy.’

Importantly, this research established a statistically significant correlation between greater levels of diversity and inclusion in company leadership and a greater likelihood of outperforming the relevant industry peer group on a key financial performance measure – profitability.

Some drug companies are moving in this direction:

That some drug companies are gearing up to adopt this growth strategy, but still there is a lot of ground to cover in this area, gets reflected in the December 2018 ‘Diversity & Inclusion Benchmarking Survey’ of PwC. The survey included 183 corporate respondents from 5 regions and 15 countries. As many healthcare organizations have publicly declared their commitment to D&I, the study wanted to measure how they have translated strategy into execution and what impact it is leaving on the employee experience. The following are some of the key findings

  • While D&I is a stated value or priority area for 68 percent of organizations, only 51 percent of respondents disagree that diversity is a barrier to progression at their respective companies. Thus, ‘Diversity still remains a barrier to progression.’
  • Only 4 percent of healthcare organization’s D&I programs reach the highest level of maturity.
  • D&I program goals are quite varied. For about 38 percent it’s a way to attract and retain talent – 25 percent – a way to comply with legal requirements – 17 percent to achieve business results – 13 percent to enhance the external reputation and 8 percent to respond to customer expectations.
  • Interestingly, in 39 percent of cases there was no D&I program-leader in place, 32 percent cases the person reports to senior executives, 19 percent of cases the responsibility was assigned to staff with non-D&I responsibilities and only in 10 percent of cases – the leader is a peer to C-suite.
  • Only 29 percent leaders are tasked with specific D&I goals.

These may not be the points to cheer about – not yet, nonetheless, the survey findings send a clear signal about the beginning of D&I in the pharma industry.

Two facets of D&I for a pharma company:

As I said before, D&I is more important in the health care space, especially for drug companies, where the employees across the organization not just be business savvy with patient orientation, but also be inclusive and socially compassionate to benefit the diverse communities.Thus, there are two clear facets, I reckon, around which organizational D&I policies, especially for pharma players, should be formulated, as follows:

  • For employees within the organization.
  • For stakeholders outside the organization – putting patients at the core of the business strategy.

The above PwC survey is on the first one – D&I for employees within the organization. However, a holistic D&I policy requires dovetailing business savviness with a socially empathetic mindset to serve increasingly diverse communities, is even more challenging.

More challenging is dovetailing business savviness with social empathy: 

To serve increasingly diverse communities, dovetailing business savviness with socially empathetic mindset, appears to be more challenging for the pharma industry, in general. Its manifestations are varied, such as, dented image or its declining reputation – leading to trust deficit with many stakeholders, including patients. Likewise, one of primary causative factors that give rise to such manifestations is considered to be in the drug pricing area.

The current scenario in this area has been captured in a paper titled, ‘Curbing Unfair Drug Prices’, published by The Yale Global Health Justice Partnership (GHJP), Yale Law School, Yale School of Public Health, National Physicians Alliance and Universal Health Care Foundation of Connecticut. The article unambiguously states, the high cost of prescription drugs is unsustainable, wherever it is. Spending on prescription drugs is increasing, either for different payers, or directly to patients through ‘out of pocket’ expenditure – at a faster pace than any other component of health care spending. Consequently, it is forcing many patients to skip doses of critical medicines, and several others to choose between their health and necessities, like food and rent.

The paper adds: “Meanwhile, the pharmaceutical industry continues to launch new drugs at exorbitant prices, increase prices of many old drugs without justification, and reap record profits. Evidence has unequivocally shown that high drug prices are not linked to the actual costs of research, development and manufacturing. Instead, inflated drug prices are a result of drug manufacturers’ power to charge whatever price the market will bear. The need for legislative action is urgent.”

One of the most recent examples of such jaw-dropping drug price was reported by Reuters, along with many others, on May 25, 2019 as: “Swiss drug maker Novartis on Friday won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy (SMA), the leading genetic cause of death in infants and priced the one-time treatment at a record $2.125 million.”

That said, achieving this facet of D&I, is not just desirable, but also necessary to gain a sharp and well-differentiated competitive edge in sustainable financial performance. It is noteworthy that to be successful in this area, one of the key requirements is to assign specific accountability for D&I to that individual, where the bucks stop.

Assigning specific accountability for D&I implementation:

Yet another article titled, ‘Diversity and Inclusion: A Pharma 50 Perspective’, published in PharmExec on June 23, 2016, asserted that there is little point in tackling diversity without solving for inclusion.

It underlined: ‘Whereas diversity is the hardware bringing different machines together, inclusion is the software that brings the system to life.’ The authors suggested, as many others would: ‘Hiring a chief diversity officer can help, accelerating the process at the highest levels.’

Conclusion:

The good news is, the above McKinsey research study also found: ‘Corporate leaders increasingly accept the business imperative for D&I, and most wonder how to make it work for their firms and support their growth and value creation goals.’ The article reiterated the correlation between D&I and company financial performance. Thus, to effectively leverage this factor, developing a robust corporate D&I strategy aimed at both – the employees and the society, at large, appears to be the right choice.

From this perspective, a diverse and inclusive pool of employees, with varied range of approaches and perspectives are expected to meet both business expectations and the health needs of the society with more innovative ideas. Consequently, this deserves to be an organizational growth strategy, having a sharp competitive edge. It is mainly because, the initiative will uncover newer and unconventional pathways for providing greater access to affordable medicines, to save and improve the quality of many more lives. As the process rolls-out, it will keep gathering critical momentum, with support from all around and, more importantly, the enormous goodwill that the D&I strategy will attract from public, in general.

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.

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

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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.

Alzheimer’s Disease: Robs Memory: Steals Dignity: Escapes Treatment

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At a well reputed Mumbai Club, quite unexpectedIy, I bumped into Sumeet (name changed). It has indeed been a long while since we met at his home in South Mumbai. He came there with his wife Shilpa (name changed). Sumeet, was literally an icon of yesteryears in every respect, a bright engineer with MBA and a much-accomplished leader of his time who retired at the turn of the new millennium.

“How are you Sumeet da?”, I started off cheerfully, as he was looking all around.

“Very well, very well and you?”, he replied softly with a faint quivering of his lips, but without any eye contact.

“I am good Sumeet da, but have you recognized me?” I queried with apprehension.

Turning his face towards Shilpa, Sumeet hesitatingly replied, “No. But have we met before?”

The innocent question struck me as lightning from nowhere, making me a bundle of emotion momentarily. With a lump in my throat and clenching my fists, I struggled hard to regain my composure.

Sumeet, one of the the brightest of brights, from earlier years of our generation, is now a victim of a dreaded illness called Alzheimer’s Disease (AD). The disease has robbed him of his priceless memory, changed his behavior beyond recognition, kidnapped him from his own self, and has stolen most of his much-valued dignity in life, mercilessly.

Alzheimer’s Disease (AD) in brief:

Alzheimer’s Disease (AD), as known to many, is the most common form of dementia, accounting for 60 to 80 percent of all cases, that results in serious memory loss and other intellectual and behavioral traits of individuals, serious enough to interfere with a person’s daily life and tasks.

AD has been defined as, a neurodegenerative type of dementia, in which the death of brain cells causes memory loss and cognitive decline. The total brain size shrinks with AD, as the tissue has progressively fewer nerve cells and connections. Brains affected by AD would always show tiny inclusions in the nerve tissue, called plaques and tangles.

Plaques are found between the dying cells in the brain – from the build-up of a protein called beta-amyloid, while the tangles are within the brain neurons and from a disintegration of another protein, called tau.

Though the abnormal protein clumps and inclusions in the brain tissues are always present in AD, there could be another underlying process also that is actually causing the disease, which scientists are not sure of, as yet.

Be that as it may, with the progression of the disease, besides memory loss, AD precipitates other serious symptoms, such as, deepening confusion about events, time and place; mood and behavior changes; unfounded suspicions about family, friends and even professional caregivers; disorientation; other behavior changes; then difficulty speaking, swallowing and walking. At a late stage, the patients lose the ability to carry on even a conversation and respond to their environment.

Cause:

Although the causes of AD are not quite clear to the scientists, as yet, the disease results from a combination of genetic, lifestyle and environmental factors that adversely affect the brain over a period of time.

Scientists opine that in less than 5 percent of the cases, the causative factors of the AD are specific genetic changes that can almost definitively indicate that a person would develop AD. According to published reports, while the strongest risk gene found so far is apolipoprotein e4 (APOE e4), other risk genes have not been conclusively confirmed, just yet.

Survival rate:

According to published reports, the survival rate of AD patients, after their symptoms become noticeable to others, can range from 4 to 20 years, depending on health conditions, the average being 8 years. In the United States, AD is the sixth leading cause of death.

Not a normal part of the aging process:

Although majority of people with AD are over 60 years of age, it is not just a disease of old age. Up to 5 percent of cases the disease may strike even younger people in 40s or 50s. Women are found to be more prone to AD than men.

Prevalence:

The World Health Organization (WHO) declared dementia, in general, as a priority condition in 2008, through the Mental Health Gap Action Program.

Each year, the total number of new cases of dementia worldwide has been reported as nearly 7.7 million, which means one new case every four seconds.

According to AC Immune SA of Switzerland, AD will be one of the biggest burdens of the future society showing dramatic incidence rates. Over 44 million people were now affected with AD worldwide. Since the incidence and prevalence of AD increase with age, the number of patients will grow dramatically as our society gets older. By 2050 the patient numbers are expected to triple, touching 135 million AD patients worldwide.

India:

According to another report titled, “Priority Medicines for Europe and the World – A Public Health Approach to Innovation” By Béatrice Duthey, Ph.D published on 20 February 2013, the fastest growth of AD in the elderly population is now taking place in China, India, and their south Asian and western Pacific neighbors and has become a major public health concern as the population ages.

AD is the most common kind neurodegenerative disease in India. There are reportedly around 5 million dementia patients in the country of which, roughly 70 to 80 per cent have AD. This number is expected to double by 2030, and the costs involved are expected to increase three times. Besides drugs, costs of ‘care giving’ for AD patients are also expected to rise significantly.

The market and economic impact:

According to AC Immune SA, AD market is currently estimated at US$ 5 billion annually and is expected to exceed US$ 20 billion by 2020.

The global economic impact of AD is shown by its worldwide cost of US$ 640 billion, exceeding 1 percent of gross world product. It can be seen as the most significant health crisis in the 21st century. The 2010 annual costs of treating and caring for patients was  $183 billion in the US alone. This figure is expected to increase to $ 1.1 trillion in 2015.

AD is becoming the third most expensive disease, counting for 30 percent of the US healthcare costs. The medical costs for Alzheimer´s Disease patients are three times higher than for other older patients. Moreover, AD patients mostly live at home resulting in high impact on family’s health, emotional well being, as well as their employment and financial security.

India:

Many elderly people in India live with AD without any treatment, accepting the condition as an unavoidable one and related to the aging process of an individual.

The present day costs of maintaining a patient with AD in India, who has been diagnosed, are reportedly any where between Rs. 50,000 to Rs. 4,50,000. Additionally, many elderly couples are just not frail and living alone these days, as their children may be working in a far off country.

Currently, AD market in India is reportedly around US$ 50 million, growing around 25 percent. More disease awareness initiatives are expected to accelerate the market growth by manifold. Sun Pharma is the market leader in the AD segment. Other, key players are Dr. Reddy’s Laboratories (DRL), Torrent, Glenmark, Ranbaxy, Cipla and Alkem

In fact, Cipla recently reportedly announced an investment of US$ 21 million in Chase Pharmaceuticals of the United States, which is an early-stage drug development company focused on developing novel approaches to improve treatments for Alzheimer’s disease.

In addition, DRL is also making rapid strides in this area. In 2013, the company launched generic Donepezil Hydrochloride tablets for AD in the US market.

Treatment:

There is no cure for AD as of date. There is no disease-modifying treatment for AD even in the global market, either.

Since 2003, there has not been any single innovative drug launched in the global market either for prevention or cure of AD. The available drugs cannot stop the progression of the disease. They just temporarily slow the worsening of dementia symptoms. The situation gets even more complicated as the disease is usually diagnosed late, when already 70 percent of the nerve cells in the brain are dead.

Global researchers are looking for new treatments to alter the course of the disease and improve the quality of life for people suffering from this dreaded disease.

For the treatment of AD, the U.S. Food and Drug Administration (FDA) has approved two types of medications, namely,

-      Cholinesterase inhibitors, such as, Aricept, Exelon, Razadyne, Cognex

-      Memantine, such as, Namenda to treat the cognitive symptoms (memory loss, confusion, and problems with thinking and reasoning) of the disease.

Many doctors prescribe both types of medications together, along with Vitamin E for cognitive changes.

However, Aricept is the only cholinesterase inhibitor approved to treat all stages of AD, from moderate to severe.

Although, Tacrine (Cognex) was the first cholinesterase inhibitor approved, very few doctors prescribe this drug today because of more serious side effects.

According to The Alzheimer’s Association, the world’s leading voluntary health organization in Alzheimer’s care, support and research; the current treatments for AD at a glance are as follows:

Treatments at a glance:

Generic Brand Approved For Side Effects
donepezil Aricept (Eisai/Pfizer) All stages Nausea, vomiting, loss of appetite and increased frequency of bowel movements.
galantamine Razadyne (Janssen) Mild to moderate Nausea, vomiting, loss of appetite and increased frequency of bowel movements.
memantine Namenda/Ebixa (Actavis/Lundbeck) Moderate to severe Headache, constipation, confusion and dizziness.
rivastigmine Exelon (Novartis) Mild to moderate Nausea, vomiting, loss of appetite and increased frequency of bowel movements.
tacrine Cognex (Pfizer) Mild to moderate Possible liver damage, nausea, and vomiting.
vitamin E Not applicable Not approved Can interact with antioxidants and medications prescribed to lower cholesterol or prevent blood clots; may slightly increase risk of death.

India:

In India the treatment is much the same. Besides, patented versions, relatively cheaper generic equivalents of all these drugs are available in the country.

On going drug trials: 

As there are no effective therapies for AD, this therapy segment remains at the top of the list for unmet needs, globally. Disease-modifying therapies could transform this market appreciably.

At the Alzheimer’s Association International Conference held in Copenhagen, Denmark from July 12 to 17, 2014, scientists described five trials that may prevent the onset of the neurodegenerative disease in people not yet experiencing cognitive decline, as follows:

  • Gantenerumab and Solanezumab: Two experimental drugs, , both of which are antibodies designed to bind to amyloid and prevent it from forming brain-damaging plaques.
  • Solanezumab: An experimental anti-amyloid compound.
  • The trial will first pilot a screening test for two genes to see if it can accurately predict risk of mild cognitive impairment. The next phase of the trial will test an experimental compound designed to delay symptoms of mild cognitive impairment and Alzheimer’s disease in people without symptoms.
  •  Crenezumab: Anti-amyloid antibody
  •  An immunotherapy that prompts the body’s immune system to produce antibodies against amyloid protein, and a beta-secretase inhibitor that blocks the production of certain forms of amyloid.

According to Alzheimer’s Disease Therapeutics and Diagnostics: World Market 2013-2023 the following global players hold greatest potential. In particular, the analysis investigates these companies:

• Pfizer
• Eisai
• Actavis
• Lundbeck
• Novartis
• TauRx Therapeutics
• AC Immune.

A large pharma industry association of the United States has indicated in a report that dedicated researchers are currently working on nearly 100 medicines in development for Alzheimer’s and other dementias. These could give future patients a new hope for a future free of AD.

Conclusion:

AD can strike anyone at any time without any visible warning whatsoever. It then robs the person’s memory, steals the individual’s dignity of life, evades all available current treatments, till it is able to extinguish slowly and agonizingly the last flicker of life, mostly much sooner than otherwise it would have been.

Like many other countries, India – the world’s 2nd largest population, is also facing a crisis in dealing with the growing number of AD patients.

These patients require constant support from family/professional caregivers along with medical attention. The progression of the disease leaves patients mostly in semi-vegetative states, at times for years.

If no cure is available for AD, arresting the disease progression becomes a major health challenge in the country. Currently only short term symptomatic treatment is available. Neither is there any organized mechanism for early diagnosis of AD with specific markers, which could lead to early intervention with the most appropriate and effective drugs to address the disease sooner.

Alzheimer’s Disease that turns millions of otherwise boisterous individuals, like Sumeet, into living dead, snatching away everything that a life would possibly demand at its minimum, must feature in the areas of focus of the new national heath policy of India under the new dispensation.

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.

Revised Mashelkar Committee Report recommends inclusion of ‘incremental innovation’ under patentability criteria.

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In 2006, the Government of India appointed a Technical Expert Group (TEG) chaired by the eminent scientist and the then Director General of the Council of Scientific and Industrial Research (CSIR) Dr. R.A. Mashelkar, with the following terms of reference:1. Whether it would be TRIPS compatible to limit the grant of patent for pharmaceutical substance to new chemical entity or to new medical entity involving one or more inventive steps.2. Whether it would be TRIPS compatible to exclude micro-organisms from patenting.The TEG submitted its report to the Government on December 29, 2006. However, due to some ‘technical inaccuracies’ Dr. Mashelkar sought the permission of the Government on February 19, 2007 “to re-examine and resubmit the report, which meets with the requirements of the highest standards’’. This request was acceded by the Government on 7th of March 2007.

Much water had flown down the bridge thereafter, which we shall not deliberate upon here. Ultimately in March 2009 the TEG submitted its revised report.

In terms of overall content, the revised report is similar to the previous one, which was withdrawn earlier.

Conclusions of the revised TEG report:

The conclusions of the report against the terms of references given to the TEG are as follows:

1. “It would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only, since it prima facie amounts to a ‘statutory exclusion of a field of technology’. However, every effort must be made to provide drugs at affordable prices to the people of India. Further, every effort should be made to prevent the grant of frivolous patents and ‘ever-greening’. Detailed Guidelines should be formulated and rigorously used by the Indian Patent Office for examining the patent applications in the pharmaceutical sector so that the remotest possibility of granting frivolous patents is eliminated.”

2. “Excluding micro-organisms per se from patent protection would be violative of TRIPS Agreement.”

Does section 3(d) warrant an amendment now?

It is indeed interesting to note that under Para 5.11 the TEG says, “the committee was not mandated to examine the TRIPS compatibility of Section 3(d) of the Indian Patents Act or any other existing provision in the same Act. Therefore, the committee has not engaged itself into these issues.”

However, in Para 5.32 the report observes the following:

“Innovative incremental improvements based on existing knowledge and existing products is a ‘norm’ rather than an ‘exception’ in the process of innovation. Entirely new chemical structures with new mechanisms of action are a rarity. Therefore, ‘incremental innovations’ involving new forms, analogs, etc. but which have significantly better safety and efficacy standards, need to be encouraged.”

With this observation, TEG has also clarified the scope of section 3(d), indirectly though.

The report further recommends, “detailed Guidelines should be formulated and rigorously used by the Indian Patent Office for examining the patent applications in the pharmaceutical sector so that the remotest possibility of granting frivolous patents is eliminated.”

What next?

It will be interesting to watch what the Department of Industrial Policy and Promotion (DIPP) does with this revised report. As we have seen that the report categorically states:

“It would not be TRIPS compliant to limit granting of patents for pharmaceutical substance to New Chemical Entities only, since it prima facie amounts to a statutory exclusion of a field of technology”

And

“Innovative incremental improvements based on existing knowledge and existing products is a ‘norm’ rather than an ‘exception’ in the process of innovation. Entirely new chemical structures with new mechanisms of action are a rarity. Therefore, ‘incremental innovations’ involving new forms, analogs, etc. but which have significantly better safety and efficacy standards, need to be encouraged.”

Therefore, taking these two recommendations together my questions are as follows:

1. Will the DIPP conclude that Section 3(d) of the Patent Acts 2005 is not TRIPS compliant?

2. If so, will the DIPP recommend an amendment of this section sooner to encourage ‘incremental innovation’ within the country?

3. If not, will the DIPP clarify now the need, purpose and the importance of this report?

By Tapan 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.