Pharmaceuticals

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Phygital Marketing for Pharma: The Way Ahead

India is one of the important global leaders in the field of pharmaceuticals. As per a report by the Indian Economic Survey 2021, the market was valued to be around USD 42 billion and is expected to reach USD 65 billion by 2030. India also ranks 3rd in terms of pharmaceutical production by volume and is an important supplier of generic drugs to the world.

These momentous achievements are the evidence of rapid development taking place in every area of the pharmaceutical domain, right from manufacturing to the distribution and marketing of pharmaceutical products. The Phygital marketing approach is one such corroborating evidence of the pharmaceutical evolution.

The core of the traditional marketing approach were doctors and pharmacists as they were majorly responsible for effective market and sales of the pharmaceutical products. However, with advancements in technologies, various new avenues have opened up that led to higher consumer accessibility of the products, giving rise to Phygital marketing.

Phygital Marketing is a combination of various parameters such as pharmacists, content marketing, branding & campaigns, product reviews, and e-commerce that offers a blend of OTC (Over the Counter) & DTC (Direct to Consumer) platforms for a complete and satisfying customer experience. This also assists Pharma businesses to increase their revenue as well as profits.

Phygital marketing is an effective tool to build brands and businesses in the competitive domain of pharmaceuticals. It shows a promising future and offers a plethora of tools. The current need of the market is to understand its potential and ultimately make the best use of it.

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Working in the new normal

The global pandemic has taught us many lessons right from the first month itself. As a chairperson of Interlink, I am surprised by the resilience and innovation we have shown as an organization. Working from home due to the pandemic was new as well as challenging for us especially during the initial month, but it is interesting to note that even in such a situation, our growth never faltered. Surprisingly, switching to a virtual workplace, where all of us were working remotely, the efficiency and productivity increased.

The work from home scenario has changed my overall perspective, before this, I could never imagine going to my office only once a week and still getting the work done, nor could I imagine recruiting talents in a virtual interview. These are just a few examples of the changing trend. Furthermore, I believe that the upcoming generation and their inclination towards technology are one of the strongest assets that can be utilized productively.

Having said that, the path is not easy. Even though now the offices are gradually opening and the organizations are preferring a hybrid work model, its drawbacks are something to be considered, especially in the longer run.

In order for the organizational work pattern to be ready for the future, some key points need to be strategized upon:

  1. Nurturing talent must take priority: Even though the hybrid work models are people-friendly, as the leaders, it is our responsibility to prioritize nurturing talent as the dynamics of communications have changed with the hybrid work model.
  2. Future-ready: The future is heavily dependent on technology. A correct combination of future-driven organization policies and the usage of technology would enable businesses to sustain themselves in the longer run.
  3. Role distribution: An ideal organization is one where all the members get equal opportunity for growth, challenges and rewards. To achieve this, proper distribution of the roles must be essential among the team members. Hybrid work models pose challenges since the interactions between the members vary. Hence, special attention should be required.

The hybrid work model can be a combination of working on-site as well as working remotely. Some of the reasons for increased acceptance for hybrid work models are as follows:

  1. Work-life balance: It becomes easy for employees to balance their professional as well as their personal lives.
  2. Enhanced performance: An employee gains a lot of opportunities such as reduced traveling time and flexibility in completing the tasks. This increases the organization’s productivity and boosts employees’ confidence.

The future of the hybrid working model

The hybrid working models are the need of the hour in today’s scenario. As it is quite evident from the fact that various multi-national companies have begun adopting this policy. What began as a necessity amidst a global pandemic has now changed the game of today’s working model. Moreover, the hybrid working model offers an edge in terms of saving expenses on real estate or increases the trust between an employer and an employee. The profitability of such a model indicates that it will not go anytime soon.

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‘Atmanirbhar’ State of Mind through Entrepreneurship

Vision of PM Narendra Modi in making ‘Atmanirbhar Bharat’ is based on superior quality of talent, unending quest for new knowledge and technology, highly productive demographics of India and willingness to work hard to contribute to the nation which will ultimately contribute to the world.

PM Modi reminds one word of Ravindranath Tagore- “Ekla chalo re” (Lead even if you are alone) when he speaks about ‘Atmanirbhar’. It is an important streak of entrepreneurship where he needs to lead alone with the backing of science and technology to make himself competitive and create entry barriers for others which lead him towards ‘Atmanirbhar’ frame of mind.

As it stands today, GDP of India is at -7.9% and unemployment rate is to the tune of 7%. While majority of Indian population is staying in rural areas, government is also looking at strengthening few states like UP to come up with the excellence in all aspects of development inclusive of entrepreneurship.

The dilemma is when there are jobs yet they cannot be filled up as there is unemployability among the job seekers. It is due to the imbalanced educational system which we have been continuing since long. This necessitates that overall revamping of educational syllabus, industry academia participation and Outcome Based Education (OBE) is instituted and faculty is reskilled. This employability gap does not allow quotient of employability to be higher than quotient of unemployment.

Yes, there are reasons for unemployment coupled with lack of employability which becomes major challenge for India.

On one hand it may look like a challenge but on the other hand it’s the biggest opportunity. Those who accept this challenge and look as opportunities, they can create new businesses, new scientifically evidence-based products with the help of new technological innovations. Hence there is a chance of creating an environment for new normal entrepreneurship.

Four major factors for Indian unemployment

1.The major cause of rise in unemployment in India is the selection criteria which eliminates opportunity of job seekers due to reservations. This system may neglect deserving, skilled and suitable candidates.

2.In addition, another factor is India’s ever-growing population! The chase of unemployability on one hand and increasing population on the other hand creates lot of challenges to balance.

3.Rural and urban potential to provide jobs is at the moment disproportionate which creates a big gap between employability and unemployment.

4.Indian parents give lot of emphasis on educating their children irrespective of their economic status which provides an opportunity for many to start educational institutions. These increasing institutions over time creates a pool of candidates where at any given time reservoir of candidates is increasing and employability gets perplexed.

As a result, disillusionment, anger against job providers, depressive tendencies, loss of confidence and overall question of financial stability increases in those candidates who remained unemployed and get into the cycle of negativity which is not require among these candidates when they are young.

Employability is a key

Yes!  There is a huge mismatch in the understanding of the skill demand between industry and educational institutes. Huge pool of graduates passing every year are not right-skilled and oriented toward the job they are approaching. There is a big gap arising due to inability of educational institute in mapping the skills according to what is actually demanded by the industry.

Lack of formative assessment to recognize gaps in students, very few and inefficient industry-recognized programs and long-term internships for skilled based leaning are some major hurdles in the path of educational institute to fill the skill or employability gap in students.

Inability in filling this skill gap leading the graduation of batch of students with inadequate soft skills like public speaking, writing proficiency, data analysis, etc and deficiency of hard skills like problem solving, communication, leadership, etc. is the major cause of not becoming employable.

Many institutions have extended their hands towards industries and also started entrepreneurship and incubation cells to provide holistic development of students right from values to idea generation, creativity, passion and urge to create something meaningful and relevant to the society. These candidates are also incubated and given intellectual, infrastructural and technological assistants to incubate their thoughts and bring them in reality.

This is possible which will not only increase employability but also sow the seed of entrepreneurship.

What does it really mean by ‘Atmanirbhar’?  

This situation clearly depicts a black and white picture with the everlasting despair and no innovations. But as mentioned earlier, with increasingly exposed challenges, there exists light at the end of every dark tunnel; here the light is of Entrepreneurship lightening the path towards ‘Atmanirbharta’.

Entrepreneurship- A lifelong employment with passion and create a difference in society which is needed to be adopted and expanded in today’s scenario of unemployment. Entrepreneurship, in simple words is painting a thought with different colours on a black canvas!…Creation  with passion and creativity backed up by incubation and funding to create new concepts, new products, new ideas for the world.

Being an entrepreneur i.e., being ‘Atmanirbhar’ will help in much diversified ways in order to cope up with the current joblessness. Entrepreneurship will not only raise the personal standard of living but also support nation’s economy in some or the other way. Not only this but there are so many beneficial underlying consequences come with it and most important is – it will thrive job opportunities!

Other adventitious impacts arising with it will be community development, equitable redistribution of wealth, income, political power in the interest of country, new advancements in research and development, and so on. The list will be never ending if compared to the current scenario of unemployment.

Three major skills for Entrepreneurship

Skills required to march towards entrepreneurship combine a range of technical, personal and management skills. There is no established, simple skillset as these skills evolve with the business you are choosing and your own moral values.

 

 

The OECD (Organisation for Economic Co-operation and Development) has managed to put forth the three basic skills required for each entrepreneur such as-

  1. Technical – communication, environment monitoring, problem solving, technology implementation and use, interpersonal, organisational skills.
  2. Business management – planning and goal setting, decision making, human resources management, marketing, finance, accounting, customer relations, quality control, negotiation, business launch, growth management, compliance with regulations skills.
  3. Personal entrepreneurial characteristics – self-control and discipline, innovation, persistence, leadership, change management, network building, and strategic thinking.

Knowing Indian entrepreneurial environment, each entrepreneur must also learn and possess risk mitigation strategies and abilities to take decision and balance risks.

Entrepreneurial opportunities

Opportunities in India and abroad are seen in the areas of healthcare, education, technology, communication, food nutrition, and new drug development. Any one of these areas depending on the strengths of the candidates and like-minded people with the support of incubation centres, this reality of creating new entrepreneurs in India and making them ‘Atmanirbhar’ is definitely a good dream coming to reality possible.

 

References-

  1. https://economictimes.indiatimes.com/news/politics-and-nation/aatmanirbhar-bharat-mission-includes-a-vision-for-global-welfare-says-prime-minister-modi/articleshow/78448920.cms?from=mdr_accessed on 28.12.2020

2.Focus on entrepreneurial skills_https://skillspanorama.cedefop.europa.eu/sites/default/files/EUSP_AH_Entrepreneurial_0.pdf_accessed on 28.12.2020

3.Jonathan long_60 Reasons Why Entrepreneurship Is Amazing_

https://www.entrepreneur.com/article/243389_accessed on 28.12.2020

4.Main Causes of Unemployment in India_https://www.economicsdiscussion.net/articles/main-causes-of-unemployment-in-india/2281_accessed on 28.12.2020

5.Top reasons why entrepreneurship is important_https://www.europeanbusinessreview.com/top-reasons-why-entrepreneurship-is-important/_accessed on 28.12.2020

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The Lean Six Sigma Method

Lean Six Sigma (LSS) is a methodology that is often used in various industries acting as a tool for reducing waste, enhancing efficiency and creating a friendly and effective environment for the customers. This is a team-centric approach to increase the profitability of the business.

LSS is a combination of Lean Technique and Six sigma method which are used separately to improve business efficiency. While the Six Sigma method focuses on identifying and resolving variations in a process, the lean techniques focus on eliminating the waste generated in the process. The major principle behind this methodology is based upon five phases that are:

  1. Define phase: Define the problems and variables in a project
  2. Measure phase: Determining the flow of the process
  3. Analyze phase: Analysing the key problems and variables
  4. Improve phase: Suggest solutions and remedies
  5. Control phase: Supervising the solutions and remedies until stability is achieved

Various tools and techniques are employed in LSS, some of which are given below:

  1. Visual analysis: Pareto chart, Scatter diagram, Box plots, etc.
  2. Statistical analysis: Inferential statistics, ANOVA, the test of proportion, Chi-Square test, etc.
  3. Process analysis: Data boxes, TAKT time, Value Stream map, etc.

Every organization following the LSS methodology is divided according to the colored belts also known as LSS belts – Yellow belt, Green belt, Black belt and the Master belt. The Yellow belt generally includes people who are subject matter experts. They collect the data and interpret the results, utilizing a combination of problem-solving tools and techniques. The Green belt, on the other hand, consists of people who are project leaders and are experts in the LSS methodology. Their primary function is to supervise the yellow belt holders and determine the tools and techniques to be used. The black belt holders are the leaders who identify problems in the system and lead the team, additionally providing coaching to new members of the team in the LSS principles. The Master belt holder is the apex member of the organization who is not involved in the projects but is responsible for the overall management of the system, creating a portfolio for the projects, and division of roles and responsibilities.

Implementing the LSS methodology can be an essential tool for the pharmaceutical industry. For instance, it can identify and eliminate wastage in the drug development process. This would lead to an increase in speed and efficiency. LSS methodology can be a crucial tool in Quality control, identifying leaks in the process and thereby strengthening the process. It can be applicable in processes such as clinical trials, drug discovery processes, regulatory processes, etc. It benefits doctors, pharmacists, patients, and healthcare workers by providing quality service and cost.

Lean Six Sigma methodology is a tool to not only improve quality but also to enhance the performance of the process. However, the major challenge lies in successfully integrating the principles of the LSS into the pharma process since the latter is a complex process and it requires a flexible approach.

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Post pandemic future of work

Pandemic-induced disruptions in work largely involved innovative technologies and increasing trade links which are reshaping the businesses to the huge extent this time. Remote working is at its peak, yet, physical dimensions of working not going to vanish, sooner or later, as several industries require it for better existence. 

Traditional way of working is increasingly been replaced by modern ones, although, sectors like healthcare, where patients are still not comfortable with distanced-interactions with doctors, require a different thought to satisfy patients as well as safeguard healthcare workforce efficiently. 

As far as pharmaceutical sector is concerned, there are way better technologies which can be seen in the industry in the current scenario which highly benefiting the working environment as well as the workforce. As lab technicians and pharmacists are required in the areas where very little exposure to people and outer environment is involved, smooth working procedures are been employed so far in this area of pharma industry. 

Following Fig. 1 describes how post-pandemic future of work is evolving with the passing month-

Evolving working-styles and employees becoming increasingly adaptive towards it is a great thing to explore in the years ahead. It is the need of the hour to develop skills- strengthening programs for employees at work as not everyone is as flexible as new generation self-efficient employees. 

The question still remains unanswered about importance of resilience over efficiency. In today’s scenario, where number of organizations are focusing on streamlining the supply chains, roles of employees and workflow in order to acquire efficiency in the entire system. However, employing efficiency needs consideration of different aspects for making a future-proof organization. Hence, practicing resilience is one of the crucial aspects of business which requires considerable attention while developing efficient working force and systems. Change is inevitable, organizations should be trained in such a way that they can become flexible enough to overcome uncertain events which may happen in the future. 

Discussed ahead are certain aspects of business which can be considered superior while driving resilience in the work in post pandemic scenario-

  1. Future-perspective is essential

This can be the most important step while developing a resilient workforce. Future-proofing is a practice of making your employees educated and adaptable enough toward the uncertain future and business calamities.  Analyzing the changes happening in the surroundings of the business and being responsive to it makes employees much active and productive. 

Keeping them updated about the changing corporate trends is necessary to develop resilience. Investing more time in preparing for future changes can be highly beneficial for employees as well as the entire organization. 

  1. Building problem-solving potential

Problem-solving skills are must haves for resilient workforce. Having these essential skills will make the workforce ready for difficult times which might appear in the future. This crucial capability can be built in the employees by making them understand the situation and analyze it. This will not only sharpen those essential skills but also boost the performance of the organization to the next level.

  1. Prioritizing mental health 

Better mental health is necessary for better working. Pandemic resulted in stress, anxiety and depression like issue among the employees and organizations had to force the remote working. However, many companies are implementing online campaigns/programs like online team-building activities, sessions boosting metal health, etc. which are truly beneficial in increasing social interaction and among employees. 

  1. Training and learning is crucial 

Knowledge building is an important practice which every organization follows in order to keep their workforce updated. However, in evolving scenario, knowledge building has got immense importance as various organizations putting enormous effort in training and learning programs for employees so that they can efficiently excel in their tasks. As technologies been increasingly penetrating in different elements of the businesses, it has become essential to make the employees flexible toward advanced technologies by training and educating them about the same.

Learning opportunities through such training programs can boost productivity and performance of the employees. 

In the future-oriented scenario of working, driving resilience is the need of the hour. Uncertain future can give rise to unavoidable circumstances, for which, organizations have to be well-built in terms of workforce and advanced technologies.

About Author 

Mr. Ramanathan Hariharan

Mr. Ram has over 35 years of experience most of which was in executive leadership positions in Executive Education. Has strong expertise in leveraging learning to translate to work place performance.  He was the President of the Executive education and consulting business at the School of Inspired leadership till recently, helping them scale up the executive education business through new learning solutions, pedagogy and reach.

Prior to that he was the Senior Director and Head of Executive Education in the Indian School of Business from 2009 to 2016. Prior to that he was the Vice President in one of the largest training and consulting companies in India. Ram was also the founding Director and CEO of a boutique HR consulting firm which focused on helping organizations in their talent management, leadership development and transformation journeys.

While holding a management degree from XLRI, he was closely associated with delivering learning solutions to several companies in industry verticals ranging from automobiles, technology, ITES, telecom, banking and finance, oil and gas where he helps the organizations craft learning road maps and strategies to improve performance in the work place and creating high performance teams.

Summary

As the working styles and patterns are evolving vigorously in current scenario, driving resilience has received immense importance along with practicing efficiency and effectiveness. This article puts light on importance of resilience in the workforce of organization and certain ways to develop the same. 

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Generic Drugs and The Pathway to Future

Generic drug market, one of the positively impacted markets during pandemic had witnessed over $ 4911.6 billion of revenue in 2020 and expected to account for about $650.3 billion by 2025 with the CAGR of 9.6%.

One of the greatest reasons behind this astonishing growth would be increased healthcare expenditure during the pandemic and collapsing economies. Due to rising unemployment during the period of shutdown, governments of various nations employed several strategic initiatives in order to fulfil the ever-growing demand of cheaper substituents of pharma drug. And one of those initiatives was ensuring the availability of low-cost generics to the population. 

Moreover, factors like patent expiration of blockbuster drugs, increasing incidences of lifestyle diseases including acute and chronic conditions and rise in geriatric population are also positively propelling the generics market. 

Why generics were born?

Let’s have a look at 2As behind the origin of generic drugs-

Affordability

The company who holds the patent for particular drug (brand drug), applies its own pricing policy which make these drugs expensive and unaffordable for most of the population. On the other hand, for the generic drug, an off-patented brand drug, whose costings are decided through government interventions, are very affordable. This affordability is influenced by various aspects such as, companies making generic drugs need not repeat lengthy and costly research and development in laboratories as it is available readymade through patent-holding company. 

As generics were developed, people who were losing on crucial medications due to their higher prices, were able to afford the essential treatment for them and their loved ones without pouring all their life savings. 

Life-threatening health condition such as blood cancer, due to which many lives were sacrificed owing to non-affordability of branded medicine costing Rs. 1,14,400 per month, whose generic version is now available at as low as Rs. 11,400 per month. Same repeats for major heart disorders and other chronic illnesses. 

As per World Health Organization (WHO), in developed and developing countries, if the prescription of generics is increased by the medical professionals, the health expenditure can be reduced by huge 70 percent. 

Accessibility

Manufacturers holding patents for expensive brand drugs, used to enjoy the patent exclusivity for too long until FDA started taking serious efforts to prohibit extended ownership of such patent. To enhance the accessibility of such branded drugs to developing countries, who can’t afford the cost of research and development, this step of FDA was essential. 

Owing to this, essential drugs were available for various levels of society including rural areas. Chemists in rural areas never used to serve branded drugs due to high prices so the population had no enough access to crucial drugs. As alternative options like generics are more affordable, they are much accessible too for different groups of society belonging to different financial levels.  

Moreover, several generics give rise to price competition due to which patients are accessible to better treatment alternatives at same or lower prices. 

FDA’s routine evaluation of generic drug programs is resulting into increased funding for generics production, staff recruitment and other factors which making the generics scenario much approachable. 

For developing countries like India, this two factors, affordability and accessibility, were very crucial as back in 1960s, most of the Indians were not holding health insurance and the salary structure was too weak as compared to the western countries. Domestic production of low-cost generics was mandatory for India owing to such factors. 

Indian pharma was doing well in pharma market owing to its capabilities to produce cheaper medicines. In 2005. Indian signed an agreement with World Trade organization which significantly changed the pharma scenario in India and opened several opportunities. That agreement was none other than- Trade-Related Aspects of Intellectual Property Rights (TRIPS).

Today, India is known as world’s largest provider of generics.  As the medicines produced in India are 60% cheaper than the medicines produced in US, many western countries are outsourcing their production of medicines to India which nourishing the increasing globalization of Indian pharma industry. 

Future of generics

Innovations are going to rule the entire generics space in the coming years, innovators and manufactures will test their unique perspective toward this market to enjoy highest possible revenues. Discussed ahead are some future-oriented approaches which can be seen in generics field.  

Traceability mechanisms will intensify

Traceability will be one of the most crucial systems which need to be employed, compulsorily, by pharma companies in the coming years. When it comes to generics, counterfeit drugs are the issue of concern. For traceability of mainstream supplies containing fake drugs requires high-end technology like blockchain architecture which can be seen much prevalent in the future scenario. 

There are various architectures of blockchain which pharma industry will adopt in coming years in order to provide lifesaving information on the formulations. In addition to counterfeit alert, conformation status along with expiry date, non-conformities, etc., efficient waste management can also be achieved with improved workflow. 

Not only volume to value shift in the product can be seen, but quality of delivery will also be seen enhanced in the coming years. 

Complex generics and NDDSs will take a leap

In competitive generics market, Novel Drug Delivery Systems (NDDSs) and complex generics are major differentiating factors dominating the pharma market. For country like India, NDDS-based generics development is quite economical and less insecure. So, the industry can explore novel drug delivery-oriented approaches to serve upgraded generics in the future.

Moreover, complex generics, which are often employed for cancer like challenging diseases can be developed to the greater extent as the companies are adapting more expertise, sophisticated groundwork and development strategies required for complex generics. 

Use of Artificial Intelligence (AI) and 3D printing will skyrocket 

AI in current scenario tackling many challenges related to data management, in-house R&D, studying and repurposing old (or failed) drugs, etc., generic drug producers will extract highest possible advantages through AI related technologies.

AI is the future of pharma industry which will save generous amount of money and time required for complex processes of generic drug development and marketing. 

3D printing is one of the major technological revolution through which production of novel medicines and devices is way too easier as time investment required is lesser and the outcomes are amazing. When FDA approved first commercial 3D tablet called Spiratam (levetiracetam), 3D printing technology gained tremendous attention and it is poised to become a highly employed technology in pharma industry.

Bio generics will bloom

Although the generic biopharmaceuticals are not easily approved by regulatory systems owing to the complications associate with the replication of complex manufacturing processes of biopharmaceuticals, producers nowadays are exploring several ways to catch the norms essential to launch bio generics.

Drug producers will invest in large scale clinical programmes in order to generate efficacy and safety evidences for their bio generic drugs. Various efforts can be made to produce highly controlled quality system, manufacturing and even transportation and storage for bio generics to withstand stringent quality standards of biopharmaceutics. 

Generic companies will have to test some alternative and advanced strategies to scale-up in the coming years. Volume to value shift is necessary through innovative technological interventions. Digital technologies nowadays are effectively lowering the cost of healthcare and uplifting the high-quality generic production which is a good way to sustain in future. 

Besides this, number of patents are highly complex which can generate the risk of litigation as many a times products, devices, manufacturing processes are also patented.  This issue has to be handled wisely in order to prevent the loss of money and efforts. 

The future of generics is going to be full of innovations accompanied with sophisticated technologies in each and every process ranging from research and development, quality production and delivery to marketing of the product. Quality and safety will acquire immense attention and improved delivery will be a major game. Producers will find new ways to tackle current challenges associated with biosimilars and bio generics like complex formulations. With this, let’s hope that the future of healthcare will be much more affordable and accessible than ever.  

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MAXIMIZING INDIAN API OPPORTUNITIES

Corona virus disaster has turned out to be an eye-opening situation because of which many powerful nations have suffered and are still suffering. Number of small and big businesses are facing adverse impacts and Pharma industry is not an exception. China is the source of 40% of the global APIs & dominating 68.3% of chemical API market worldwide. In 2018, APIs exported from China accounted for 81% ($30 billion over $37 billion) of total value of exported Chinese pharmaceutical products. Indian pharmaceutical industry despite being a global market leader at generic drug formulations, largely depends on imported APIs from China. APIs which are used to manufacture at least 12 essential drugs such as paracetamol, ranitidine, ciprofloxacin, metformin, acetylsalicylic acid, ofloxacin, metronidazole, ampicillin, amoxicillin, ascorbic acid and some fermentation-based intermediates for which India solely depends on china.

I would not be wrong to say that the Covid-19 situation would not be so dire for Pharma industry if it was not China’s monopoly for major raw materials and chemical supplies. Domestic manufacturing potential was always neglected by Indians because of having 70% of imports from China for ages. Overdependency on imports always blocked our way toward Self-reliance. But I believe, every challenge comes with a solution. Although the Corona Virus crisis has turned the world upside down, many big nations including India are now trying to rise with new norms for life. In my opinion, our country has shown impressive moves during this period and is still blooming through this crisis.

The wise steps taken by Indian government for pharma during this crisis are one of the most important growth propelling factors. The government has now come up with two schemes for pharma; one is the PLI scheme which gives some financial incentives based on sales made by selected manufacturers for 41 products which covers around 53 APIs and the incentive ranges from 5-20% based on the incremental scales. That is going to help companies in terms of bridging the gap between the Chinese prices and India price to some extent. The second scheme which the government has come up with is the bulk drug park and this scheme is primarily to provide easy access to world class common infrastructure which will be located in these parks where companies can come, set up and make use of the common infrastructure. And this is again for a period of five years. As we need to build our strength, the government has come up with these schemes which should help in compensating price gap between China and India to some extent.

India is both competitor and customer of the Chinese API industry

We are currently the largest producers of generic medicines with a share of 20% of total global production, catering to over 60% of world’s demand. Third-largest medicine market in the Asia Pacific region with Well-established, strong local manufacturing capabilities, with an international export profile are the factors which are really highlighting our identity as ‘Pharmacy of the world’. India is by far the world’s champion of drug master files (DMFs). Drug master files (DMFs) are voluntary submissions to the import country authority, and contain confidential information about human drug products. APIs belongs to the Type II of DMFs, which is concerned with drug substance, material used in their preparation, or drug product. While China holds 12% of DMFs from the U.S., India holds almost half of them. Being the largest holder of DMSs gives India the edge to export higher-value APIs, enlarging the industry’s attractiveness. Indians generally speak better English than Chinese, which facilitates pharmaceutical trade with developed countries. Access to low cost vaccines, affordable generics & HIV treatment from India are some of the greatest success stories in Indian pharmaceutical industry. It is now widely accepted that without the likes of Sun Pharmaceutical, Ranbaxy, Dr Reddy’s Laboratories, Cipla and dozens of smaller Indian companies, many African countries would not have been able to cope with the public health challenges they face. No wonder India is called the “pharmacy to the world”.

Source: India Pharma 2020, Propelling access and
acceptance, realising true potential, McKinsey & Company India,
Pharmaceuticals & Healthcare Report Q2 2020, Fitch Solutions

Specialty areas to concentrate in future:

HPAPIs

Nowadays, there is an area of interest in API domain called as HPAPI- High-potency active pharmaceutical ingredient, gaining its identity in Pharmaceutical market worldwide. They are APIs that require special handling due to toxicity and used in extremely small doses in finished drugs. Traditional examples of HPAPIs are cytotoxic compounds and sex hormones such as estrogen. Deeper analysis says that, the generic side of the industry will drive meaningful growth in the HPAPI market. Generics is one of the strongest domains in Indian pharma sector. Having said that, there exist bundles of opportunities in HPAPI sector for India. As per the latest report published by Research Dive, the global HPAPI market is estimated to generate 42,491.7 million and rise at a CAGR of 10.5% during the forecast period from 2020 to 2027. Oncology-focused medicines are one of the leading molecules creating maximum growth due to innovative pipeline candidates and upcoming generic entries. The Asia Pacific region is estimated to witness the fastest growth.

We are now emerging as a 2nd highest supplier base for generics with HPAPIs. Main API producers are headquartered in 24 different countries/territories, though most are based in either India or mainland China (Fig.1). New product introductions are a core growth driver for the generic API industry, and many of the upcoming opportunities are oncology-focused, high-potency compounds. Accordingly, many manufacturers across many territories have been making investments in HPAPI capabilities. Thus, companies should anticipate similarly high levels of competition as product markets develop. Looking at our nation who is blessed with ancient history of medicines and generic portfolio, profitable growth is anticipated in this area in near future. Rather than representing a well-differentiated, more insulated market segment, trends in HPAPIs are still aligned closely with the underlying dynamics of the pharmaceutical industry. Investments in this part should be viewed as essential steps to keep pace with the market.

                                        Source: NewpotTM, a Cortellis solution

API & data security

Now looking into API security, the potential for insider theft exists at every level of the pharmaceutical production and distribution chain. Individuals employed at production sites, distribution centres, and pharmacies are all potential insiders. The API is stored in a secured vault until it is ready for use. It is then moved to the production area, where it is combined with inactive ingredients to make the final dosage form like pills. The pills are then packaged and sent out to distributors, leaving the control of the original facility that made them. In this whole process, there are chances that a small quantity of APIs can be lifted unofficially. Manufacturers can’t afford to overlook such malpractices as most of the APIs are highly expensive. Fortunately, at the pharmaceutical distribution sites, most employees are professionally licensed pharmacists and pharmacy technicians, bound by the ethical standards and keenly aware that a breach would result in the loss of their licenses. Quality assurance (QA) plays a central role in pharmaceutical production, and it is used as an element of theft prevention as well. At production sites, manufactured pills are pulled at random for QA checks. While these checks are primarily intended to ensure accurate formulation, they also provide a check against the diversion of API that would lead to detectable changes in pill formulation. Some more protective measures to avoid Insider theft which can be taken in terms of staff are mentioned in fig.2.

Everyone would agree with the statement that the pharma industry is one of the most resistance industry when it comes to adopt new technology. In the past, when cloud computing technology was installed, security was a major problem and was a primary reason why pharma companies would stay far from it. However, with time and recent technological advancements, security has become the biggest benefit of adopting the cloud technology.

Now, multiple layers of security are added to critical business data. Data such as contacts, sales tracking, patient information, content, and strategies are all heavily protected by the cloud, ensuring that your marketing operations remain safe and secure. The cloud is secured by encrypting data to be transmitted over networks and placed in specific databases. This encryption also prohibits access by internal team members who do not have authorized access to the data, which eventually shuts the idea of accessibility by cyber hackers. There is no way back when it come to adopting technology. In my opinion, getting familiar with such technologies and deriving highest benefits out of it is the topmost necessity in today’s world and pharma industry has to be ready for this.

Way forward in API Manufacturing……

While surfing through one of the Analysis created by PwC, some of the recommendations grabbed my attension. They might not be easy to demonstrate immediately at this point but also are not unrealistic while planning for future strategies.

Some long term recommendations were:

1.Develop large clusters and provide plug-and-play infrastructural support in dedicated zones for manufacturing APIs-

  • Construct 2–3 large-sized dedicated zones and lease them to private players for operating manufacturing plants.
  • Set up common utilities such as solvent recovery and distillation plants, power and steam units, effluent treatment plants, common logistics centres, regulatory infrastructure and warehousing to make smaller units economically viable in these zones.
  • The following support can be looked at to encourage investments in mega parks: – stamp duty waiver – 50% subsidy on water and electricity for 5 years – SGST reimbursement – 75% for 5 years – 50% subsidy on expenses incurred for quality certification/patent registration – waiver on development charges, which are currently at 9% of property cost.
  • Evaluate strategic locations for these mega parks, e.g. union territories, where the centre can play a larger role in controlling costs such as like cost of land and utilities.

 

  1. Industry–academia initiatives-
  • Facilitate collaborations with institutions like National Institute of Pharmaceutical Education and Research (NIPER), Council of Scientific and Industrial Research (CSIR) labs and universities to improve process technologies (e.g. yield improvement).

 

  1. Facilitate alternative sources of import-
  • For APIs and intermediates of high strategic importance that cannot be manufactured domestically, due to lack of either raw materials or concerns relating to environmental hazards, the government needs to adopt alternative sources.
  • Initiatives to promote imports of intermediates and APIs from multiple sources to reduce monopoly in imports. An additional 10% subsidy can be provided if the imports are from sources other than China.

 

Although we are one of the topmost players in the generic market, we still have struggled for a longer time because of high dependence on China. Our domestic API industry has been deeply affected because of policies such as stricter implementation of pollution control norms, implementation of DPCO, 2013, lower import duties, and complete collapse of the indigenous fermentation industry. However, favourable schemes from the government and a supportive financial ecosystem to boost private and foreign is a light at the end of tunnel and reviving our API manufacturing capabilities. MNCs like GSK, Pfizer, Novartis have been here for many years. We need to invite them to manufacture for exports in India. We have to look at setting up a kind of platform where we will use technology for consolidating sourcing, supply chain, regulatory, quality approvals and aggregate all the discreet capacities available from individual companies. This will enable collaboration and alliances with large global and domestic pharma companies.

In the slightly longer term, the government may look at the Chinese model and work on developing clusters for API and also can fuel our HPAPI manufacturing powers. API security and surveillance technologies at industry level is also one of the major factors which has to be taken care of. An emergency is inevitable and it always affects in a very unpleasant manner if we are not fully prepared to deal with it. Self-reliance is must and we have to get habituated to it. India for India and India for global is the strategy that we need to follow. Afterall we have to give justice to ‘Make in India’.

 

 

by Rajkumar Natekar Rajkumar Natekar No Comments

Four Changing Paradigms of Healthcare

2020, known as the year of uncertainties, was a rollercoaster for the healthcare industry as it was forced to adapt a number of new approaches which may turn out to be blessings in disguise. The sector is evolving at a greater pace and trying to future-proof itself to the extent possible.

The focus has drastically shifted towards advance research in medicines and vaccines to fight the ongoing pandemic. Moreover, the synergy between herbal and conventional medicines is now a trending practice.  

In addition to this, the approaches are patient-centric as personalisation of healthcare is on the rise. So, looking at the fruitful transition in actions, better healthcare can be expected in coming years even in the developing countries like India. 

Discussed ahead are four changing paradigms of healthcare- 

Paradigm 1- Easier and advanced access to healthcare through IT

Unequal access to the healthcare facilities is one of the major concerns when it comes to availability of these facilities to different groups in the society. People living in rural areas, where the healthcare services are inadequate and biased, are described as the unhealthy part of the population.

However, due to pandemic, telehealth practices in the healthcare are on the rise, barriers are decreasing and access to public health facilities is increasing. Rising digitalisation in healthcare is resulting in increased efficiency, patient engagement and personalisation of health solutions. Several interventions like tele-appointments, real-time interactions, telediagnosis, tele-patient monitoring, and much more, are possible due to virtual assistance.

Moreover, owing to this IT- based approaches, health professional who are based abroad, can efficiently guide surgical procedures and other interventions here virtually. Due to increasing acceptance of telehealth, rural population can enjoy better and advanced healthcare in the coming years.

Paradigm 2- Proactive patient care 

Due to late diagnosis of health condition, there was always a risk of highly advanced disease stage leading to unmanageable consequences. However, as the healthcare structure is evolving, proactive patient care gaining traction. 

Early diagnosis is essential for managing deadly diseases like cancer and other chronic health conditions. Early detection and preventive measures can lead to improved survival rate in the future. 

In recent scenario, the preventive healthcare approaches surging with the interventions of nutraceuticals, traditional medicines and herbal supplements. Along with classic nutraceuticals, one of the most in-demand nutraceutical formulations are ‘natural immunity boosters’ which have gained a good traction in pandemic.

Moreover, In India, Ministry of AYUSH has led down a platform for immunity boosting traditional medicines during COVID. Contesting the tested or untested formulation are going on and there are certain natural products like Bacopa monnieri, for which enough clinical trials are available. However, claiming them for immunity against Corona, they definitely need trials. 

Paradigm 3- Integrative approaches

The concept of holistic wellness is getting established among the people like never seen before. Government actions are also inclined towards increased acceptance of Ayurveda and other integrative medicines. In pharmaceuticals, Drs’ prescriptions have increased for plant-based nutrition products along with vitamins and minerals as supplementary prescription which is evident from IMS.org or IVAC reports. In comparison to overall growth of pharmaceutical industry, the nutritional products, vitamins and minerals as nutrients, are growing faster than the total market.

Due to the pandemic, the focus has shifted from cure to prevention. Role of spices, Ayurvedic ‘kadhas’ and other traditional medicines came up as precaution for every family. In addition, the pandemic, lockdowns and working from homes further fostered the use of such traditional remedies. As a result, though it is not a direct competition to modern medicines, the perception of Ayurvedic or traditional medicines shifted to prevention. This is the reason why acceptance of traditional medicine is increasing. Also, due to rising alertness about therapies like acupuncture, massage, meditation, etc., healthcare can adopt new ways of treatments which are much holistic in nature.

Patient’s rehabilitation is also one of the matters of concern as many a times, post-surgery care is important in order to return to  a healthy lifestyle. Looking at the better approaches towards today’s healthcare, rehabilitation centres can become prevalent in coming years. 

Paradigm 4- Technological headway

The days when surgeries were not so precise and unassured are fading away. Increasing technological advancements in healthcare at various levels are effectively future-proofing the entire sector and billions of lives. 

Artificial intelligence (AI), one of the highly trending topics today, is making great moves in healthcare industry. Several advanced interventions which are not only timesaving but also very promising are empowering the current healthcare sector. AI is highly useful in the space of genomics and gene editing which can give rise to the drugs and treatments for various life-threatening diseases.

While reshaping and reimagining healthcare, affordable healthcare cost should also be taken into consideration as this aspect of healthcare services is very important. As more healthcare organisations implement tech-driven initiatives, cost factors are need to be balanced in order to make the healthcare services approachable for the patients belonging to various strata of the society.

by Rajkumar Natekar Rajkumar Natekar No Comments

Derma market overview – India

Discovered in ancient Egypt, dermatology practices in ancient times were primarily concentrated on treating skin cancers and major skin diseases. However, as these practices evolved, modern dermatology developed and hence the dermatology education in the medical schools. The products and treatments acquired regulatory boundaries under FDA which ensured the safety and efficacy of dermatological practices.

Dermatology, in today’s scenario, is no longer restricted in the boundaries of Dermatologists and their clinics. The practice has evolved and improved over the years, so has the process of skin care. Shift from chemical entities to more natural ones is one of the trends in skin care which has gained considerable attention in today’s scenario. Moreover, new generation consumers, having better penetration on social media platforms are now much aware about the ‘best’ skin care products. Discussing with general physicians, favorite ‘skin care blogger’, professionals at beauty salons is what the new scenario of skin care looks like. ‘Going to dermatologist and getting the skin treatments’ is
no longer the first choice for today’s consumers.

Moreover, as the dermatological products are increasingly going OTC, managing mild and moderate breakouts has become easy and convenient. The products essential for the basic needs of skin, improving texture and tone, managing sensitivity and maintaining blemish free skin are on the shelf of every drug store. Innovative products which are encompassing the market today are making the skin care products market highly lucrative and creating wonderful opportunities for future business.

Following is the overview of Indian skin care products market in 2021 and beyond-

Market overview-

  • The market value of the Indian skin care derma cosmetics products market in 2021 is $2,920.2 million.
  • It generated revenue of $750.3 million in 2019 and expected to account for $1,758.0 million in 2030, growing at a CAGR of 8.5% between 2020 and 2030.
  • Cream segment making excellent revenues in Indian skin care market.
  • Based on application/therapy, skin repair category is expected to grow at the highest CAGR during 2020-2030.

Brands and market players-
Based on brands, Avène accounted for largest share during 2014-2019 and is expected to witness fasted growth in Indian skin care derma cosmetic market in the years ahead. The brand offers a complete product range for all major skin concerns.

Major players in the Indian skin care derma cosmetic market- Unilever Group, The Procter & Gamble Company, Galderma S.A., Pierre Fabre S.A, Allergan plc, Shiseido Company Limited, Johnson & Johnson, The Estée Lauder Companies Inc., L’Oréal S.A., Beiersdorf AG, Clarins Group, Amorepacific Corporation, Avon Products Inc., NAOS, ZO Skin Health Inc., Oriflame Holding AG, Sebapharma
GmbH & Co. KG., Patanjali Ayurved Limited, Emami Limited, the Himalaya Drug Company, and Kao Corporation.

Regions and demographics

North India is the largest market for skincare derma cosmetics. The Garhwal hills of North India account for a high prevalence of dermatitis, skin appendages, acne, and eczema.

The highest Indian skincare derma cosmetics market CAGR is expected in the western part of the country in the near future.

Based on demographics, in India, female segment accounted for more than half of the in skin care products market in 2017. Female segment is expected to remain dominant in the future as well. However, the male segment in India is also expected to witness a significant CAGR, owing to rise in interest of men in maintaining their physical appearance.

Based on age group, the millennial segment will fetch highest revenue in skin care products. India has high millennial consumers.

Consumers shifting markets from synthetic to natural or organic skin care products would be interesting to watch as this trend is presenting potential opportunity for stockholders in Indian skin care products market.

Trending molecules-

  • CBD OIL (CANNABIDIOL)
  •  POLYHYDROXY ACIDS (PHAS)
  •  Glycolic acids
  •  Retinol
  •  Tea tree oil
  •  Bakuchiol
  •  Grapeseed oil
  •  hyaluronic acid
  •  Niacinamide
  •  Petroleum jelly
  •  Vitamin C
  •  squalene
  •  Castor oil
  • Salicylic acid
  •  Benzoyl peroxide
  •  Ceramides

Factors influencing growth of Indian skin care products market-

  • Presence of young demography
  • Increasing disposal income- Leading to higher investment in personal care products predominantly skin care.
  • Shift toward healthier lifestyle
  •  Increasing prioritization for Skin care – shift from a general idea of good-looking skin to the
    deeper concept of skin health
  • Influence of Korean skin care routine
  • Surging prevalence of skin diseases
  • Market players launching innovative and attractive products ranges in skin care
  • Rise in new product launches and approvals from regulatory bodies in India.
  • Market players are focusing on Mergers and Acquisitions to gain competitive edge

Trends to explore-

  • Microbiome- focused skin care
  • Celebrity skin influenced skin care
  • Products for blue-light (from tech screens) protection
  • Skin care products calming inflammation
  • Hand care (Pandemic- influenced)
  • Skin barrier repair-centric creams (to repair and strengthen skin barriers)
  • Refillable skin care products (Planet love)
by Rajkumar Natekar Rajkumar Natekar No Comments

How Biologics are going to be the Driving force for Indian Pharma

As the healthcare scenario is experiencing the paradigm shift from cure to care, preventive health has received generous importance and hence the biologics. Growing demand for vaccines, monoclonal antibodies and biosimilars are creating excellent business space for Indian pharma.

Indian pharmaceutical sector has great potential to earn the identity of global hub for manufacturing biologics. The ability to invent globally competitive, affordable and novel vaccines and biosimilars is emerging as one of the greatest driving forces for Indian pharma. As the industry is shifting from chemical-based drugs to biosimilars and biologics, this scenario presents excellent opportunities for Indian pharma industry in the space of life sciences and biotechnology.

Till September 2019, India received over 98 biosimilars approvals in the domestic market, more than any other country. Moreover, the approvals which we are receiving for biosimilars in regulated market, further boosting the confidence and willingness of Indian pharma players to contribute in global market shares. Owing to the rising domestic demand, potential and investments in biologics in India, according to the reports, more than 40 biosimilars reached clinical development stage in India which is far more than that of United states and similar to European Economic Areas.

Following elements will ensure India’s march towards achieving the title of ‘fastest-growing bio hub’-

Vaccines establishing strong presence

Fulfilling over 60% of global vaccine requirements, India is now the largest volume supplier of vaccines to public market. This is the outcome of ongoing critical focus on R&D and mass manufacturing. Moreover, companies in India increasingly investing in innovative approaches toward vaccines for common diseases further making the space lucrative. Some of the examples of this innovative approaches include typhoid conjugate vaccine, “eco-friendly” recombinant Hepatitis-B vaccine (free of cesium chloride and thiomersal) and Serum Institute’s liquid rotavirus vaccine of Bharat Biotech. Such approaches target different aspects like improving compliance, improving stability by adjusting formulations and several other fundamentals to upgrade and enhance existing products.

Moreover, government is also boosting India’s presence in vaccine market through funding and investing in R&D. Department of Biotechnology (DBT), the Ministry of Health and Family Welfare (MoHFW) and the Indian Council of Medical Research (ICMR) are playing wisely to propel the vaccine market.

Market players are driving biologics

Indian market players are all set to propel the growth of biologics and biosimilars in India and globally. Their efforts are paying off and positive outcomes are seen in terms of revenue generation and overall reputation in the international markets. Domestic biosimilars market generated over US$576 million in 2019 while achieving the growth rate of about 11% (2018 revenue- US$520 million).

By developing novel monoclonal antibodies (BIOMab EGFR for head and neck cancer treatment in 2006 and Alzumab (itolizumab) for psoriasis treatment in 2013), Biocon became very first company to launch indigenously developed novel biologics in India. In collaboration with global companies, these antibodies have been launched in many other countries which has greatly influenced Indian pharma industry to dive deeper in the world of biologics. The company aims to generate around INR7,460 crore by 2022 alone from biosimilars business. Looking at the revenue of INR1,951 crores in 2019-20, the target looks genuine too. Moreover, the company in collaboration with Mylan has entered in US market with their first biosimilars for Herceptin and Neulasta, which further opening the revenue streams for the nation.

Zydus Candila, who is exploring the use of long-acting interferon alpha-2b for treating Covid-19, can also generate significant opportunities for Indian biologics in international markets. The biosimilar version of this immunomodulator is already being commercially manufactured by the company for the treatment of Hepatitis B and C.

Government priority- bio-tech based drug development

Under ‘Make in India’ campaign, Indian government is actively promoting the biotech-based drug development in the country through various approaches including effective fundings and investments. Initiatives introduced by DBT and the Biotechnology Industry Research Assistance Council (BIRAC) are favourable enough to transform India into biotechnology-based innovation and research hub. Such initiatives are policy making, promoting industry-institute partnership, generating entrepreneurship cells, etc. Moreover, Public Private Partnerships are also motivated in order to captivate investments and fundings from investors, industry and other agencies.

Securing future with Biologics

Being the largest provider of generics globally, Indian is now looking for expansion beyond generics while exploring opportunities in biologics and biosimilars. More than 10 blockbuster biologics (with total revenue of USD 60bn) are losing their patents in next 2-3 years, creating amazing revenue stream for India through biotech sector. Moreover, first-time ANDA approval from USFDA makes the scenario even more favorable for Indian pharma.

We have over 200 biosimilars in pipeline with the collective contribution from more than 52 Indian companies. However, the number of companies penetrating the US and European market is significantly low despite of the largest number of approved biosimilars in India. One of the restraining factors could be nonalignment of India’s regulatory guidelines with these markets. More efforts are necessary in the regulatory space.

Moreover, strengthening testing requirements for biosimilars, improving animal testing and increasing the number of patients in clinical trials are some of the elements of development which need attention and efforts to emerge as a ‘fastest-growing bio hub’ in the future.
The article is written by Dr. Smarta and is published by Healthcare India Today

https://www.healthcareindiatoday.com/how-biologics-are-going-to-be-the-driving-force-for-indian-pharma/

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