Unleash The Power of RWE in Indian Pharma Marketing

An IQIVIA event titled, “RWE in 2024: Recognizing opportunity and demonstrating value with confidence,” held on October 25-26, 2023, made several interesting observations such as:

  • The future of healthcare is being reshaped and RWE is playing an increasing role in revolutionizing patient care, drug development, and healthcare policy.
  • Generative AI and new technologies create new opportunities and ways of working, increasing acceptance of RWE by regulators and payers, and ever-evolving and diverse patient needs.

In recent days, post-launch of a new product, several drug companies, although more globally and some locally, are using Real-World Evidence (RWE) to showcase how their product is providing value - not just clinically and economically, but also from a humanitarian perspective, in a real-life situation. Besides, RWE is also increasingly being used to improve product detailing outcomes, taking a quantum leap in enhancing brand awareness among prescribers.

Thus, while exploring the emerging space of RWE, I shall focus in this article on the increasing importance of leveraging this area for greater effectiveness of pharmaceutical marketing strategies, especially in India. To be on the same page with my readers, let me start with a quick recap of what I really mean, as I use this terminology.

RWE – A quick recap:

As I talk about “using Real-World Evidence (RWE) in pharmaceutical marketing,” I mean ‘leveraging Real-World Data (RWD)’ to gain insights that inform and shape marketing strategies for pharmaceutical products. Obviously, this could raise a pertinent question – why RWE is gaining ground in drug marketing now.

Why is RWE gaining ground in recent pharmaceutical marketing globally?

The growing popularity of RWE in recent drug marketing, globally, can be attributed to several key factors, as flagged in various studies. Some of these include:

1.  Addressing limitations of clinical trials: While clinical trials provide valuable insights, they often have limitations. RWE complements clinical trials by offering insights into how drugs perform in the real world, addressing these limitations.

2.  Evolving regulatory landscape: Top regulatory agencies of the world like the US FDA and EMA are now recognizing the value of RWE. This incentivizes drug companies to embrace RWE for marketing purposes.

3.  Advancements in data analytics: Sophisticated data analytics techniques and tools are enabling researchers to extract meaningful insights from complex RWE datasets. This allows for more robust and reliable evidence generation, enabling marketers to create more effective sales and marketing strategies. In one of my articles -‘Data-giri’: Critical For A Rewarding New Product Launch, written on December 24, 2018, I deliberated on this area. 

4.   Precision medicine: The rise of precision medicine necessitates understanding how drugs work in specific patient subgroups. RWE can identify these subgroups and their responses to treatment, facilitating targeted marketing campaigns.

5. Transparency and Patient-Centricity: Patients and healthcare professionals increasingly demand transparency and real-world evidence to support treatment decisions. RWE demonstrates a commitment to transparency and provides evidence grounded in real-world settings, fostering trust and confidence. 

As data analytics capabilities continue to advance and regulations evolve, we can expect RWE to play a more prominent role in shaping future pharmaceutical marketing strategies. 

Real-Life Advantages of using Real-World Evidence (RWE) in Indian pharmaceutical marketing:

A.   Increased relevance and credibility, including more accurate measuring of cost-effectiveness.

B.   Improved decision-making, enabling more targeted marketing campaigns and improved resource allocation.

C.   Added regulatory benefits, as it can provide additional evidence to support claims of effectiveness and safety, potentially influencing regulatory decisions and gaining new indications for existing drugs.

D.   Help become more patient-centric, as utilization of RWE findings enhance quality of communication with patients and healthcare professionals – fostering trust and transparency. RWE can also help identify areas where current treatments are inadequate, prompting research and development efforts towards better solutions.

Challenges to consider:

  • Data quality and access: Ensuring data quality and ethical access to patient data remains a challenge in India.
  • Data analysis expertise: Utilizing complex RWE data effectively requires skilled data analysts and statisticians.
  • Regulatory framework: The regulatory framework in India for RWE is still evolving, requiring careful navigation.

Despite these challenges, the potential benefits of RWE for Indian pharmaceutical marketing appear to be significant. By overcoming these hurdles and embracing RWE with collective advocacy, when required – pharmaceutical companies can gain valuable insights, improve decision-making, and ultimately serve patients better.

Some recent international examples of RWE in pharmaceutical marketing:

Here are some recent international examples of how pharmaceutical companies are using real-world evidence (RWE) in their marketing strategies:

1. Novartis:

  • Campaign: Leveraged RWE from a large observational study to demonstrate the effectiveness of their drug Entresto in reducing heart failure hospitalizations in real-world patients compared to other standard treatments. This evidence supported claims beyond the initial clinical trials and resonated with healthcare professionals.
  • Results: The campaign helped increase market share for Entresto and positioned it as a more effective option for managing heart failure.

2. AstraZeneca:

  • Campaign: Utilized RWE from claims data to identify specific patient sub-populations most likely to benefit from their oncology drug Tagrisso. They then targeted these segments with personalized marketing messages highlighting the drug’s effectiveness in their specific situation.
  • Results: This data-driven approach led to a significant increase in prescriptions for Tagrisso among the targeted patient groups.

3. Sanofi:

  • Campaign: Analyzed RWD from multiple sources to understand the real-world disease burden and treatment patterns for diabetes in different regions. This information informed their marketing strategy by tailoring messaging and product offerings to specific regional needs and patient populations.
  • Results: This data-driven approach enabled Sanofi to develop more relevant and targeted marketing campaigns, potentially increasing market share in key regions.

4. Roche:

  • Campaign: Used RWE from registries and claims data to track the long-term safety and effectiveness of their cancer drug, Avastin, in real-world patients. This ongoing monitoring allowed them to proactively address potential safety concerns and update their marketing messages accordingly.
  • Results: By demonstrating transparency and commitment to patient safety, Roche maintained trust and confidence in Avastin, even after initial safety concerns emerged in clinical trials.

The above examples possibly showcase how RWE can be used for various marketing objectives, including:

  • Demonstrating real-world effectiveness beyond clinical trials
  • Targeting specific patient segments for personalized marketing
  • Building trust and confidence through safety monitoring
  • Tailoring marketing strategies to regional needs

Nevertheless, it’s important to note that these are just a few examples, and the specific ways RWE is used in marketing will vary depending on the company, drug, and market conditions. Be that as it may, these examples illustrate the growing trend and potential of RWE as a valuable tool for pharmaceutical marketing strategies.

Some Indian examples of RWE in pharmaceutical marketing:

While specific examples from current marketing campaigns might be limited, the Indian pharmaceutical industry, as I fathom, is actively exploring the potential of RWE, and we can expect its impact on marketing strategies to grow in the future.

That said, from publicly available data, I can offer some general examples that demonstrate the growing interest and potential applications of RWE in the Indian drug industry:

1. Sun Pharma:

  • Partnered with IQVIA to leverage real-world data for clinical research and potentially future marketing insights.
  • Developed a real-world data platform aimed at understanding treatment patterns and patient outcomes, which could inform future marketing strategies.

2. Cipla:

  • Collaborated with Pharm Easy to analyze anonymized prescription data, potentially generating insights for targeted marketing campaigns.
  • Invested in building data analytics capabilities, suggesting an intent to utilize RWD for various purposes, including marketing.

3. Dr. Reddy’s Laboratories:

  • Partnered with Apollo Hospitals to create a real-world data platform focusing on disease registries and patient outcomes, paving the way for future RWE -   based marketing strategies.
  • Established a dedicated data science team, indicating an interest in leveraging RWD for various applications, potentially including marketing.

4. Torrent Pharmaceuticals:

  • Entered a strategic partnership with IQVIA to utilize real-world data for market research and potentially inform future marketing decisions.
  • Invested in building data analytics capabilities, suggesting an intent to utilize RWD for various purposes, including marketing.

5. Lupin:

  • Partnered with Pfizer to analyze real-world data on the effectiveness of their co-developed tuberculosis treatment, which could potentially inform future marketing efforts.
  • Invested in digital health initiatives, which can generate real-world data that could be utilized for future marketing strategies.

It’s important to remember that these are just examples of companies investing in RWD and RWE, and not necessarily evidence of direct use in current marketing campaigns. Nonetheless, they showcase the growing trend and potential for future applications in the Indian pharma industry.

Recently reported couple of other developments and initiatives in India:

  • The Indian Society for Clinical Research (ISCR) released a white paper in 2022 outlining recommendations for implementing RWE in India, highlighting its potential for drug development, regulatory submissions, and post-marketing surveillance.
  • The IQVIA Institute for Human Data Science India was established in 2023 with the aim of advancing capabilities leveraging real-world data and analytics in the Indian healthcare ecosystem.

Conclusion:

In a recent publication named, ‘Real-world evidence comes of age for pharma’ - the global consulting company - PwC, has also reaffirmed the critical need to understand how medicine performs in the real world. The authors highlighted, RWE has the potential to transform the pharmaceuticals business – from driving increased efficiency and cost savings in drug development, to helping identify new patient populations for marketed drugs. This can, in turn, translate into higher profitability and shareholder returns, while driving value growth. The big challenge for industry leaders now is learning how to leverage RWE as a sustainable competitive advantage in a landscape that has changed dramatically over the past few years.

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.

 

How Pharma Growth Strategy Now Extends Beyond Human Intelligence

That the drug Industry’s growth strategy now extends beyond human intelligence, across the value chain, are being vindicated by several reports, around the world since several years. Illustratively, on September 1, 2019, Novartis and Microsoft announced a multiyear alliance which will leverage data & Artificial Intelligence (AI) to transform how medicines are discovered, developed and commercialized.

The trend is going north and fast. For example, on November 28, 2023 another such report highlighted yet another interesting initiative. It reported that to advance – mind boggling generative AI and foundation models. These extend the technology’s use beyond language models, for which Boehringer Ingelheim collaborates with IBM to accelerate its pace of creation of new therapeutics.

There isn’t an iota of doubt now that AI is rapidly transforming the pharmaceutical industry, including the way companies market their products. The technology is being used in a variety of ways to improve marketing effectiveness, reach new audiences, and personalize patient interactions, among many others.

wrote about the need to leverage AI in pharma marketing on July 26, 2021. However, in today’s article, I shall focus on the criticality of investment in collaborative partnership in the AI space including generative AI, to acquire a cutting edge in the business process, for performance excellence. Let me start with some specific areas of relevance of using AI in pharma marketing space:

Examples of the relevance of using AI in pharmaceutical marketing:

  • Personalized drug recommendations: AI can be used to analyze patient data and recommend the most appropriate drug treatments for each individual patient. This can help to improve patient outcomes and reduce the risk of adverse drug events.
  • Patient education and support: AI can be used to provide patients with personalized education and support materials. This can help patients to better understand their conditions and make informed decisions about their treatment options. 
  • Real-time feedback and insights: AI can be used to collect and analyze real-time feedback from patients. This feedback can be used to improve the effectiveness of marketing campaigns and develop new products and services.

Several years ago, on October 31, 2016, I wrote in this blog on the relevance of Artificial Intelligence (AI) in creative pharma marketing. Interestingly, today it appears that many pharmaceutical companies are fast realizing that AI is rapidly transforming the drug industry, in its entire value chain. Now from its relevance let me dwell on the examples of specific areas where the pharma companies have started leveraging AI in their marketing processes.

Several areas where pharma companies are using AI in marketing:

  • Improving marketing effectiveness with targeted advertising and audience segmentation: AI algorithms can analyze vast amounts of data to identify the most effective channels and messaging for specific patient populations. This allows pharma companies to reach the right people with the right message at the right time, maximizing the impact of their marketing campaigns. 
  • Reaching new audiences: AI can help pharma companies to identify and reach new patient populations that may not have been accessible through traditional marketing channels. This can be especially helpful for reaching patients with rare diseases or who live in remote areas. 
  • Patient journey mapping and engagement: AI can be used to track patient interactions with a company’s brand, from initial awareness to post-purchase behavior. This data can be used to create personalized patient journeys, providing the right information and support at each stage of the healthcare process.
  • Chatbots and virtual assistants: AI-powered chatbots can provide 24/7 customer support, answering patient questions and addressing concerns. Virtual assistants can also help patients manage their medications, schedule appointments, and track their health data. 
  • Personalized patient interactions: AI can help pharma companies to create personalized patient experiences that are tailored to the individual needs and preferences of each patient. This can lead to improved patient satisfaction and adherence to treatment plans. 
  • Predictive analytics and market forecasting: AI can analyze historical data and current trends to predict future market demand for specific products or therapies. This information can help pharma companies make informed decisions about product development, marketing strategies, and resource allocation. 
  • Targeted drug discovery and development: AI is being used to accelerate the drug discovery and development process by identifying potential drug candidates, predicting clinical trial outcomes, and optimizing the design of new therapies. 

These point out, with the use of AI in pharmaceutical marketing, drug players can reap a rich harvest of several important benefits. Now, let me illustrate this point with some of both global and local examples of companies in this area, from available reports.

Global examples of how pharma companies are using AI in marketing:

As reported:

  • Novartis is using AI to personalize patient interactions and improve adherence to treatment plans. 
  • Pfizer is using AI to develop targeted advertising campaigns that reach the right patients with the right message.
  • Merck is using AI to identify new drug targets and accelerate the drug discovery process.
  • AstraZeneca is using AI to improve patient safety and reduce adverse drug events.

It is also gathering momentum within Indian healthcare industry:

As AI technology advances across the globe, we can expect to see more and more innovative applications of AI within different areas of the Indian healthcare industry, including pharma marketing. Encouragingly, several organization specific initiatives are now being reported on the use of even generative AI in the healthcare space. These include, as reported:

1.  Targeted advertising and audience segmentation in India: 

  • Sun Pharma is using AI to target its marketing campaigns to specific patient populations based on their demographics, medical history, and online behavior. This has helped the company to increase the reach and effectiveness of its marketing campaigns. For example, in 2023, Sun Pharma partnered with an AI startup to develop a new algorithm that can identify potential patients for its diabetes medication Lipaglyn. The algorithm uses data from patient electronic health records, social media, and wearable devices to create a profile of each patient. This information is then used to target Lipaglyn ads to patients who are most likely to benefit from the medication.
  • Dr. Reddy’s Laboratories is using AI to segment its patient audience based on their risk of developing certain diseases. This information is then used to develop targeted marketing campaigns that promote the company’s preventive healthcare products. Illustratively, in 2023, Dr. Reddy’s Laboratories launched a new marketing campaign for its cholesterol medication Ezetimibe. The campaign uses AI to target ads to patients who are at risk of developing heart disease. The AI algorithm uses data from patient demographics, medical history, and lifestyle factors to identify patients who are at high risk.

 2. Patient journey mapping and engagement:

  • Apollo Hospitals is using AI to track patient interactions with its brand and create personalized patient journeys. This includes providing patients with relevant information and support at each stage of their healthcare journey, from diagnosis to treatment to follow-up care. Even in In 2023, Apollo Hospitals launched a new patient engagement platform that uses AI to provide patients with personalized information and support throughout their healthcare journey. The platform includes a chatbot that can answer patient questions, a virtual assistant that can help patients schedule appointments, and a personalized health dashboard that tracks patient progress.  
  • Fortis Healthcare is using AI to develop chatbots that can answer patient questions and provide 24/7 customer support. This has helped the company to improve patient satisfaction and reduce call center costs. As reported, Fortis Healthcare’s 2023 AI initiatives demonstrate their commitment to leveraging technology for better patient care, efficient operations, and improved healthcare experience. By integrating AI across various departments and functions, they are paving the way for a more intelligent and personalized future of healthcare in India. 

4. Predictive analytics and market forecasting:

  • Cipla is using AI to predict future market demand for its products. This information is then used to optimize the company’s supply chain and production processes.
  • Lupin is using AI to forecast the potential success of new drug candidates in clinical trials. This information is then used to make informed decisions about which drugs to invest in further development.

5.  Drug discovery and development: 

  • Glenmark Pharmaceuticals is using AI to identify potential drug targets and design new therapies. This has helped the company to accelerate the drug discovery and development process.
  • Syngene International is a contract research organization (CRO) that uses AI to analyze preclinical data and predict clinical trial outcomes. This information is then used to help pharmaceutical companies make informed decisions about their clinical trial programs.

Conclusion:

Despite a plethora of pathbreaking and business performance enhancement opportunities that advanced application of AI offers, there are also some key challenges, which need to be effectively addressed by engaging with the Indian policy makers and the regulators. These areas include:

  • Data privacy: Pharma companies need to be careful to protect patient data when using AI. This includes obtaining patient consent for data collection and using anonymized data whenever possible.
  • Transparency: Pharma companies need to be transparent about how they are using AI in their marketing campaigns. This will help to build trust with patients and regulators.
  • Regulatory compliance: Pharma companies need to ensure that their use of AI complies with all applicable laws and regulations.

That said, regardless of these challenges – as I wrote on July 15, 2019, about the potential of disruptive impact of AI in Indian pharma marketing – such initiatives are fast gaining momentum.

Which is why, more often, an organizational growth strategy has now the scope to germinate beyond the human intelligence of marketers. In this scenario, I reckon, those pharma companies who will be capable enough to overcome these challenges, whatever it takes, to get the best of rapidly advancing technology of AI – will be better positioned to excel in the future.  

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.

Harness Patients’ Quest For Trusted Information From Cyberspace

The controversy surrounding patients’ looking for health information online is virtually an ongoing one, for various reasons. Interestingly, it has been continuing at an accelerating pace for a long time. For example: “Eight in ten internet users have looked for health information online, with increased interest in diet, fitness, drugs, health insurance, experimental treatments, and particular doctors and hospitals,” reported Pew Research Center way back on May 17, 2005.

Nearly a couple of decades later, yet another research study, Reuters Events (Pharma & Healthcare) on July 12, 2023, reiterated the same, especially focusing on the role of drug companies in this fast-evolving scenario. It said, “Patients are increasingly having to research their own health needs. Pharmaceutical companies can help fill in information gaps for patients to protect trust in the healthcare sector.”

One may easily brush aside this trend, ascribing it as merely a western phenomenon, but probably at one’s own peril. In this article, therefore, I will discuss this issue against a contemporary Indian backdrop – in search of ways and means to leverage this opportunity through the pharma industry. Let me begin with contemporary Indian examples, as available in the public domain, giving a sense of the ground situation in this space.

Are Indian patients also increasingly trying to get online disease information?

Here below are some examples of recent studies confirming more patients are now seeking disease-related information online, before meeting their doctors:

  • A 2022 study by the Indian Medical Association found that 72% of Indian patients do some research on their condition online before meeting their doctor.
  • A 2023 survey by the Federation of Indian Chambers of Commerce and Industry found that 65% of Indian patients believe that it is important to be informed about their condition before meeting their doctor. 
  • A 2023 report by the National Health Portal of India found that the number of visitors to its website seeking information about diseases and conditions has increased by 20% in the past year. 

These are just a few illustrations that reinforce the ascending trend of Indian patients’ seeking out disease related online information, just as in other parts of the world.  

Any benefits to patients’ seeking such information online?

In my view, there are several benefits to patients seeking disease-related information before meeting their doctors, such as:

  • Patients can come to their appointment better prepared. By doing their research ahead of time, patients can come to their appointment with a better understanding of their condition, the different treatment options available, and what to expect. This can help them to make more informed decisions about their care. 
  • Patients can ask better and more relevant questions. By having a good understanding of their condition, patients can ask their doctor more specific and informed questions. This can help them to get the most out of their appointment.
  • Patients can feel more confident and empowered. By being informed about their condition and treatment options, patients can feel more confident and empowered to take control of their own healthcare. 

Is this a healthy trend that deserves to be encouraged?  

From a large number of studies, it appears that the increasing number of patients seeking online health and disease information has both pros and cons.

Pros: 

  • Patients can become more informed about their health and conditions. This can lead to better communication with doctors and more informed decision-making about treatment.
  • Patients can access information from a variety of sources, including medical websites, patient support groups, and social media. This can be especially helpful for patients with rare or complex conditions. 
  • Patients can find information that is tailored to their specific needs and interests. For example, they can find information about their condition in their native language or about treatment options that are available in their area. 

Cons:

  • The quality of online health information can vary widely. Some websites are more reliable than others, and it can be difficult for patients to assess the credibility of the information they find online. 
  • Patients may misinterpret information they find online or apply it to their own situation incorrectly. This can lead to anxiety, confusion, and even harmful health decisions.
  • Patients may delay seeking medical attention if they are self-treating based on online information. This can be dangerous, especially for patients with serious or life-threatening conditions. 

Overall, the pros of patients seeking online health and disease information outweigh the cons. However, it is important for patients to be aware of the potential risks and to take steps to ensure that they are getting accurate and reliable information.

Points to consider for patients who are seeking online health and disease information:

  • Use reputable sources, such as websites from government agencies, medical organizations, and universities. Here pharma companies can also play a very meaningful role. In this context, I also wrote an article on December 17, 2018 titled - Rewriting Pharma Strategy For ‘Doctor Google’ Era.
  • Be critical of the information you find online and don’t take it all at face value. Check multiple sources and talk to your doctor to confirm what you’ve read. 
  • Don’t use online information to self-diagnose or self-treat. If you have any concerns about your health, see a doctor. 
  • Patients can also talk to their doctor about how to use online health information safely and effectively. 

Role of pharma companies in this area:

As I mentioned above, pharmaceutical companies can play an important role in helping patients get credible online information on healthcare and disease information. The following are some of the many things they can do:

  • Create and maintain high-quality websites and social media pages that provide accurate and understandable information about diseases and conditions, treatment options, and clinical trials. These websites and pages should be easy to navigate and should be updated regularly with new information. 
  • Partner with other organizations, such as patient advocacy groups and medical associations, to develop and distribute educational materials about diseases and conditions. These materials can be made available online and offline.
  • Support research on how to best communicate health information to patients. This research can help pharmaceutical companies develop more effective ways to reach patients with credible information. 

Some global and Indian examples:

1. Some recent global examples of pharmaceutical companies taking steps to help patients get credible online information on healthcare and disease information:

  • Pfizer: In 2022, Pfizer launched a new website called “Pfizer Rx Path” that provides patients with information about their medications, including how to take them, potential side effects, and interactions with other medications. The website also includes a tool that allows patients to search for clinical trials for their condition. 
  • Novartis: In 2023, Novartis launched a new social media campaign called “#NovartisAnswers” that aims to provide patients with answers to their questions about diseases and conditions, treatment options, and more. The campaign features a series of videos and blog posts that are created in collaboration with medical experts. 
  • GlaxoSmithKline: In 2023, GlaxoSmithKline partnered with the patient advocacy group “Parkinson’s UK” to develop a new educational website about Parkinson’s disease. The website provides patients with information about the disease, its symptoms, and treatment options. It also includes a forum where patients can connect and share their experiences. 

By taking these steps, pharmaceutical companies can play an important role in improving patient health outcomes.

2. Some recent Indian examples of domestic pharmaceutical companies taking steps to help patients get credible online information on healthcare and disease information: 

  • Sun Pharmaceutical Industries: In 2022, Sun Pharmaceutical Industries launched a new website called “Sun Pharma Health” that provides patients with information about a variety of diseases and conditions, including COVID-19, diabetes, and cancer. The website also includes a section on “Patient Resources” that provides patients with tips on how to manage their health and medications.
  • Dr. Reddy’s Laboratories: In 2023, Dr. Reddy’s Laboratories launched a new social media campaign called “Dr. Reddy’s Health Talk” that aims to provide patients with answers to their questions about diseases and conditions, treatment options, and more. The campaign features a series of videos and blog posts that are created in collaboration with medical experts. 
  • Cipla: In 2023, Cipla partnered with the patient advocacy group “Diabetes India” to develop a new educational website about diabetes. The website provides patients with information about the disease, its symptoms, and treatment options. It also includes a section on “Living with Diabetes” that provides patients with tips on how to manage their diabetes and live a healthy life. 

By taking these steps, Indian pharmaceutical companies can also play a very important role in improving patient health outcomes in India.

In addition to the above examples, many Indian drug companies are using social media platforms like X (Twitter) and Facebook to educate patients about diseases and conditions. They are also partnering with doctors and other healthcare professionals to create informative content about healthcare. For example, in 2022, the Indian Pharmaceutical Alliance (IPA) launched a campaign called “IPA Health Talk” on Twitter. The campaign aims to provide patients with accurate and timely information about a variety of health topics. The IPA also partners with doctors and other healthcare professionals to create and share informative content about healthcare on its social media channels. 

These initiatives by Indian pharmaceutical companies are expected to help improve access to credible information on healthcare and disease for patients in India. Such endeavors are now well poised to increase manifold in the years ahead.

Conclusion:

Patients’ quest for trusted information from cyberspace is valuable because it can lead to better health outcomes. By having access to information about their conditions, treatment options, and clinical trials, patients can make more informed decisions about their healthcare. They can also become more empowered to advocate for themselves and to get the care they need.

However, it is important for patients to be aware of the potential risks of seeking health information online. The quality and accuracy of this information can vary widely, and it can be difficult for patients to assess the credibility of the information they find online. Patients should also be careful not to misinterpret information or to delay seeking medical attention if they are self-treating based on online information. 

Overall, the value of patients’ quest for trusted information from cyberspace outweighs the risks. By being informed and critical of the information they find online, patients can use cyberspace to improve their health and well-being.

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.

 

Ticking Some Right Boxes Biosimilar Drugs’ Acceptance Gaining Steam in India

Looking at a broader canvas, on September 19, 2023, a credible international report flashed a headline, ‘Biosimilars making inroads into Humira sales, but docs still cautious on switching: Spherix.’ This is based on a survey of U.S. healthcare specialists, including 80 dermatologists, 83 gastroenterologists and 81 rheumatologists.

This is indeed a significant development in the realm of biologic and biosimilar drugs, internationally. If this trend gathers a strong wind on its sales, it will effectively address the need for affordable biologic drugs, especially in life threatening ailments.

According to another January 05, 2023 report, Humira, which dominated the top of the global pharmaceutical brand ranking charts between 2012 and 2022, has slipped in 2023 to no 3 in ranking as it lost its last patent protection in the US in May 2022. Doctors’ gradual acceptance of biosimilars and the price could be a key differentiator among the competitors, potentially hastening Humira’s sales decline.

On July 31, 2017, I wrote an article in this blog captioned “Improving Patient Access To Biosimilar Drugs: Two Key Barriers.” Interestingly, 6 years down the line, reflecting the same sentiment – the above September 19, 2023, report also noted that ‘efficacy remains “top of mind” as prescribers’ leading concern for adalimumab (Humira) biosimilars, followed by safety concerns and an overall lack of cost savings.’

In today’s article, I shall particularly focus on the latest developments in India and the initiatives taken by the concerned stakeholders in this area. Let me start with a quick recap of biosimilar drugs, in my understanding, so that we all are on the same page while discussing the subject.

A quick recap: 

As we know, biologic drugs are medicines made from living organisms, such as bacteria, yeast, or cells. They are used to treat a wide range of conditions, including cancer, autoimmune diseases, and infectious diseases. Biosimilar drugs are highly similar copies of original biologic drugs that have gone off patent and are typically less expensive than the original biologic drugs. However, there are still some existing barriers to doctors’ fast and wider acceptance of biosimilar drugs by many.

Current global barriers to doctors’ fast acceptance of biosimilar drugs:

  • Lack of awareness and education: Many doctors are not familiar with biosimilar drugs or the regulatory process that oversees them. This lack of awareness may lead to skepticism and hesitation about prescribing biosimilar drugs to patients.
  • Concerns about safety and efficacy: Some doctors are concerned that biosimilar drugs may not be as safe or effective as biologic drugs. These concerns are often based on a misunderstanding of the regulatory process for biosimilar drugs. 
  • Financial incentives: Some doctors may be reluctant to prescribe biosimilar drugs because they receive financial incentives from biologic drug manufacturers. These incentives can take the form of speaking fees, consulting fees, and research grants. 
  • Regulatory uncertainty: In some countries, the regulatory framework for biosimilar drugs is still evolving. This uncertainty can make it difficult for doctors to know which biosimilar drugs are safe and effective, and how to use them effectively. 

Some contemporary examples show that these barriers still exist:

As shown by the following contemporary data available to the public:

  • In 2022, a study published in the journal JAMA found that only 25% of US doctors were aware that biosimilar drugs are just as safe and effective as biologic drugs.
  • In 2023, a study published in the journal Annals of Rheumatic Diseases found that only 30% of rheumatologists in the UK were willing to prescribe biosimilar drugs to their patients. 
  • In 2023, a study published in the journal Cancer found that oncologists in the US were more likely to prescribe biologic drugs to their patients if they had received financial incentives from biologic drug manufacturers. 
  • In 2023, a report published by the European Commission found that the regulatory framework for biosimilar drugs in the EU is still complex and fragmented.

Measures being taken to address these barriers, globally?

There are a number of things that can be done to address the barriers to doctors’ fast acceptance of biosimilar drugs. These include:

  • Education and outreach: More needs to be done to educate doctors about biosimilar drugs and the regulatory process that oversees them. This education should come from a variety of sources, including medical schools, professional organizations, and pharmaceutical companies.
  • Financial transparency: Pharmaceutical companies should be required to disclose all financial payments they make to doctors. This transparency will help to reduce the potential for conflicts of interest.
  • Regulatory harmonization: The EU should work to harmonize the regulatory framework for biosimilar drugs across member states. This will make it easier for doctors to prescribe biosimilar drugs to their patients.

By addressing these barriers, it is possible to increase the acceptance of biosimilar drugs and make them more accessible to patients. This will lead to lower healthcare costs and improved patient outcomes.

Indian scenario of biosimilar drugs, issues and actions:

As reported, India is a global leader in the production and development of biosimilar drugs. The Indian biosimilar market is expected to reach $30 billion by 2025. Biosimilar drugs in India are typically 30-70% cheaper than original biologic drugs. For example, a vial of the biologic drug Herceptin costs around INR 1 lakh, while a vial of the biosimilar drug Trastuzumab costs around INR 30,000.

The key reasons for price arbitrage:

The price difference between biosimilar drugs and original biologic drugs is due to a number of factors, including:

  • Lower development costs: Biosimilar drugs are less expensive to develop than original biologic drugs because they do not require the same level of research and clinical trials. 
  • Increased competition: There is more competition among biosimilar manufacturers, which drives down prices. 
  • Government support: The Indian government provides financial incentives to biosimilar manufacturers, which also helps to keep prices low. 

Biologic drugs, especially biosimilar insulin, some medications for cancer and a variety of autoimmune diseases, have been proved to be very effective for patients. That said, original biologic drugs can also be very expensive. Biosimilar drugs are making these drugs more affordable for patients.

Indian stakeholder initiatives and support is essential:

Indian key stakeholders are also supportive of the biosimilar industry and have taken a number of steps to promote its growth. Some of the recent ones are: 

  • In 2022, the Indian government announced a new policy that will give preference to biosimilar drugs in government procurement. This policy is expected to save the government billions of dollars in healthcare costs.
  • In 2023, the Indian government launched a new awareness campaign to promote the use of biosimilar drugs. The campaign is targeting doctors, patients, and healthcare policymakers.
  • In 2023, a number of leading private hospitals in India announced that they would be switching to biosimilar drugs for a range of conditions. These hospitals include Apollo Hospitals, Fortis Healthcare, and Max Healthcare.
  • In 2023, the Indian Pharmaceutical Alliance (IPA) released a report that found that the use of biosimilar drugs in India had increased by 20% in the past year. The report also found that the use of biosimilar drugs was expected to continue to grow in the coming years.

These are just a few examples of the growing acceptance of biosimilar drugs in India. As more and more doctors and patients become aware of the benefits of biosimilar drugs, we can expect to see their use continue to grow in the coming years.

State-specific advantages for greater acceptance of biosimilar drugs in India: 

As available from different reports, the following are some specific examples of state-specific advantages that have led to the greater acceptance of biosimilar drugs in India:

  • In 2022, the government of Maharashtra launched a scheme to provide financial incentives to doctors who prescribe biosimilar drugs. Under the scheme, doctors who prescribe biosimilar drugs to at least 20% of their patients are eligible to receive a bonus of up to INR 10,000 per month.
  • In 2023, the government of Gujarat launched a campaign called “Biosimilar Drugs: Safe, Effective, and Affordable.” The campaign aims to educate doctors and patients about the benefits of biosimilar drugs and to dispel any myths or misconceptions about them. 
  • The states of Karnataka and Telangana have a number of leading biopharmaceutical companies that are developing and manufacturing biosimilar drugs. These companies are working with doctors and hospitals in these states to promote the use of biosimilar drugs. 

As a result of these advantages, the acceptance of biosimilar drugs is growing rapidly in some states in India. For example, in Maharashtra, the use of biosimilar drugs increased by 25% in the past year.

Conclusion:

Against the above backdrop, I reckon, the acceptance of biosimilar drugs is gaining steam in India now. This is due to a number of factors, including rising costs of original biologic drugs, government support, growing availability of biosimilar drugs, and increasing awareness and education.

It is important to note that biosimilar drugs are just as safe and effective as original biologic drugs, but they are much more affordable. This is making it possible for more patients to access the treatment they need, especially for life-threatening ailments. 

By: Tapan J. Ray

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

 

Criticality of Bridging the Skill Gap in Today’s Indian Pharma Industry

To address the shortage of adequately skilled workers in the country, in 2023, the Government of India released a new version of the national skill development initiative called Pradhan Mantri Kaushal Vikas Yojana 4.0 (PMKVY 4.0). It is touted as a major upgrade over the previous versions of the scheme and aims to train 100 million people in different skills by 2024. This is expected to have a positive impact on the economy, creating new employment opportunities.

In this article, I shall deliberate on its current relevance in the Indian pharmaceutical industry. Let me start with some of the new features of this scheme and their relevance to the drug industry as I move on.

Some new features and details of the scheme:

As I see it, PMKVY 4.0 includes a number of new features and details over the previous versions, as follows:

  • A focus on high-demand skills: The scheme will focus on training people in high-demand skills, such as artificial intelligence, machine learning, and cloud computing.
  • A greater emphasis on apprenticeships: The scheme will encourage more apprenticeships, which will provide trainees with hands-on experience.
  • A focus on women and underrepresented groups: The scheme will make special efforts to train women and underrepresented groups.
  • A greater focus on quality: The scheme will have a stronger focus on quality assurance to ensure that trainees are getting the best possible training.

Similarly, the specific details of the scheme include:

  • The scheme will be implemented by the National Skill Development Corporation (NSDC).
  • The scheme will cover a wide range of skills, including IT, manufacturing, healthcare, and retail.
  • The training will be provided by a network of training providers, including government institutions, private training institutes, and industry partners.
  • The training will be free for all eligible candidates.
  • The scheme will also provide financial assistance to trainees to help them cover their living expenses during the training period.

Studies on the lack of a skilled workforce in the Indian pharma industry:

In tandem with the above, the lack of a skilled workforce in the Indian pharmaceutical industry has also emerged as a major concern in 2023. The industry is growing rapidly, creating a high demand for skilled workers.

Unfortunately, a huge shortage of adequately skilled workers keeps increasing. A contemporary study by the Indian Pharmaceutical Alliance found that the industry will need an additional 1 million skilled workers by 2025. Moreover, the National Skill Development Corporation (NSDC) has also identified the pharmaceutical industry as one of the top 10 industries facing a shortage of skilled workers. 

Factors contributing to this shortage:

Several factors have contributed to this shortage, including:

  • The rapid growth of the Indian pharmaceutical industry: The Indian pharmaceutical industry is growing at a rate of 10% per year. This rapid growth has created a demand for skilled workers that the industry is struggling to meet.
  • The increasing complexity of pharmaceutical manufacturing and marketing: Both are becoming increasingly complex, demanding employees with different skill sets. who have the knowledge and skills to operate complex equipment and follow strict procedures in the manufacturing process. Similarly, pharmaceutical marketing is also becoming increasingly complex due to the increasing number of regulations governing the industry, the growing importance of digital marketing, and the need to target a wider range of patients with varied demands and expectations. 
  • The lack of adequate training opportunities: There are not enough training opportunities available to meet the demand for skilled workers in the pharmaceutical industry. This is due to a number of factors, including the high cost of training and the lack of qualified trainers.
  • Mismatch between salary and expectations: There is often a mismatch between the salary offered and employee expectations. The average salary offered in pharmaceutical marketing is not as high as in other industries, such as technology. This makes it difficult to attract and retain skilled marketing professionals. 

The impact of the shortage of adequately skilled workers:

The shortage of skilled workers gives rise to negative consequences for the Indian pharmaceutical industry, such as:

  • Reduced productivity: The shortage of skilled workers is leading to reduced productivity in the pharmaceutical industry. This is because unskilled workers may lack the knowledge and skills to perform tasks efficiently.
  • Increased costs: The shortage of skilled workers is also leading to increased costs in the pharmaceutical industry. This is because companies have to pay higher salaries to attract and retain skilled workers. 
  • Quality problems: The shortage of skilled workers can also lead to quality problems in the pharmaceutical industry. This is because unskilled workers may not be able to follow GMP procedures correctly. Also, because unskilled marketing professionals may not be able to develop and implement effective marketing campaigns. 
  • Compliance issues: The shortage of skilled workers can also lead to compliance issues in the pharmaceutical industry. This is because unskilled workers may not be aware of the regulations that apply to the industry or the consequences of their violations on patients and society.

What the industry is doing today:

Some steps, though not considered enough by many, are being taken by the Indian pharmaceutical industry to address the shortage of skilled workers. Here are some specific recent examples:

  • Establishing training institutes: The industry is establishing training institutes to provide training to workers in the pharmaceutical industry. For example, the Indian Drug Manufacturers’ Association (IDMA) has established the IDMA Skill Development Institute in Hyderabad. The institute offers courses in pharmaceutical manufacturing, quality control, and regulatory compliance. 
  • Partnering with educational institutions: The industry is partnering with educational institutions to offer courses in pharmaceutical science and technology. For example, the Indian Pharmaceutical Alliance (IPA) has partnered with the National Institute of Pharmaceutical Education and Research (NIPER) to offer a diploma in pharmaceutical technology.
  • Promoting apprenticeships: The industry is promoting apprenticeships as a way to train workers in the pharmaceutical industry. For example, the Department of Pharmaceuticals (DoP) has launched the Apprenticeship Training Scheme for the Pharmaceutical Industry. Under the scheme, apprentices are paid a stipend and receive on-the-job training from experienced professionals.
  • Offering scholarships and grants: The industry is offering scholarships and grants to students studying pharmaceutical science and technology. For example, the IPA has launched the IPA Scholarship Scheme for Women in Pharmaceutical Sciences. The scheme provides scholarships to female students studying pharmaceutical sciences at the undergraduate and postgraduate levels.
  • Emphasizing on continuous learning: The industry is emphasizing on continuous learning for its employees. For example, several pharmaceutical companies offer their employees training programs and workshops on new technologies and regulations. 

Industry needs to work more closely with the government: 

The Indian pharmaceutical industry needs to work more closely with the government to address the shortage of skilled workers. The areas could possibly include:

  • Increasing the number of training institutes
  • Providing financial assistance to students studying pharmaceutical sciences
  • Relaxing the eligibility criteria for apprenticeships
  • Recognizing the skills of workers trained in other countries 

Where the government should take greater initiatives:

These areas may include the following:

  • Funding training programs
  • Partnering with educational institutions
  • Promoting apprenticeships

Conclusion: 

The shortage of skilled workers is a major challenge for the pharmaceutical industry. However, the industry is taking steps to address the challenge. There isn’t an iota of doubt in the contemporary pharma business environment that rebalancing the skill sets required, especially for employees in pharma sales and marketing, is more imperative today than ever before. Thus, it is important for the industry to continue to take steps to bridge the skill gap by addressing the shortage of its skilled workforce. This is essential today to maintain India’s position in the global market, at least as the reliable pharmacy of the world.

By: Tapan J. Ray

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

 

 

India’s Drug Quality Concerns: Is Light At The End of The Tunnel In Sight Now?

A brief chronology of some recent events on issues pertaining to patient-health-safety with drugs, as captured below, would possibly generate a mixed feeling for many. This includes a serious concern about, especially generic drug quality safety standards in India, on the one hand, and a ray of hope in the tools available to patients to know more about drugs that they have been prescribed. In this article, I shall dwell on this area. My intent is to bring to the fore the vital point – Is the beginning of the end of a long dark tunnel in sight now?

 A chronology of some recent events:

As reported on July 16, 2023, while talking on the subject, “Pharmaceutical Quality — What are we missing?”, the Drug Controller General of India (DCGI) made a notable comment. He, reportedly, said that the poor quality of drugs exported from India to foreign countries had tarnished the image of the country in the international market. The DCGI further added, pharmaceutical quality has become a subject of discussion on the global platform and the international community has started doubting whether India is capable of making quality pharmaceuticals for the global population.

He underscored, “We boast of our country as the pharmacy of the world, but it seems that it is too difficult to maintain the top position for long. If the position is lost, it will be painful and difficult to restore the faith of the international community. Further, we will lose the opportunity to serve the whole humanity of the world. The responsibility of the loss will not only fall on the manufacturers, but equally on all the stakeholders.”

Alongside, a news report on August 01, 2023, brings some hope in this regard, which I shall elaborate in course of this deliberation.  

A long saga of events: 

Yes, as it appears from the following backdrop:

Over the last several decades, there have been many instances where international drug regulators, including the U.S. FDA, expressed concerns about the quality standards of Indian manufactured drugs. These concerns have generally been related to specific manufacturing facilities – ranging from top domestic manufacturers to smaller ones, raising an uncomfortable apprehension – does India produce ’World-Class’ medicines, for all? 

About a decade ago, one of the most well-known cases was in 2013 when the U.S. FDA issued an import alert on products from the Ranbaxy Laboratories facility in India due to data integrity and manufacturing quality issues. This led to significant scrutiny of other Indian pharmaceutical companies as well. Issues related to data integrity, product quality, and good manufacturing practices lead to inspections, warning letters, import alerts, or other regulatory measures.

It continued. For example, around that time, even Sun Pharmaceutical Industries, one of India’s largest pharmaceutical companies, received a warning letter from the U.S. FDA in 2015 (Source: U.S. FDA). Similarly, Wockhardt, another top Indian pharmaceutical company, faced regulatory scrutiny in 2013 when the U.S. FDA issued an import alert and seized products manufactured at their facility in India. The FDA raised concerns about violations of good manufacturing practices and data integrity issues at the facility. This led to recalls of several products and affected the company’s reputation. (Source: Reuters).

As the juggernaut kept moving, on  December 08, 2016, I wrote in this blog, “Even Smaller Countries Now Question Indian Drug Quality Standard.” On March 04, 2023, the Mint reported, “Death of children in Gambia linked to consumption of India made cough syrups, as the US CDC report states.”  

As I write, the veracity of impact of such incidences remains as serious, if not more, although instances seem to be much fewer. For instance, as reported by Reuters on August 01, 2023: “India has directed Riemann Labs, a manufacturer linked to cough syrup deaths in Cameroon, to stop manufacturing activities, the country’s health ministry said in a statement on Tuesday.”

Thus, On May 27, 2019, I again wrote about: “Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India” in this blog– and that was not the first time I flagged this menace in the country against patient safety.

Even big Indian pharma continued to be struggling with GMP issues:

Big Indian pharma companies are also involved in issues related to lapses in high drug quality standards even recently. Such as, even in 2021, Dr. Reddy’s Laboratories, received a warning letter from the U.S. FDA after an inspection of their manufacturing facility in India. The letter cited violations of good manufacturing practices, data integrity issues, and inadequate investigations of product complaints. Source: The Economic Times). Just a year before, in 2020, the U.S. FDA noted several observations related to good manufacturing practices and quality control. (Source: Moneycontrol).

Drug regulators fight the fire as and when it comes up:

Both the state drug regulators and the Drug Controller General of India (DCGI) fight the fire at the respective manufacturing locations, as and when these come up. No significant actions on the ground for patient safety against such drugs were visible on the ground.  

For example, as reported on August 03, 2023: “Following recent incidents of several countries reporting deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) which were revised in 2018, bringing them on par with World Health Organization (WHO) standards.”

The government ponders making technological interventions for patients:

There are early signs of the government trying to embrace technology for patients’ safety. For example on November 17, 2022, the Union Health Ministry released a gazette notification no 823Eimplementing the Drugs (Eighth Amendment) Rules, 2022, making it mandatory for pharmaceutical companies to affix a QR code on the pack of top 300 formulations from August 1, 2023. A QR code, as reported, will contain the unique product identification code, generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacture, expiry date and manufacturing license number.

This was part of the Ministry’s ‘track and trace’ mechanism, and of course, an intent at that time. However, a specific timeline for implantation has now been clearly enunciated.

This time it’s a two-pronged action:

For the first time, I think, a two-pronged action has been announced by the government – an enabling action for patients on the one hand against a strong punitive measure for the errant drug manufacturers on the other:

According to the above gazette notification of the Union Ministry of Health, on August 01, 2023, the central government announced stricter regulations for drug authentication and transparency by imposing mandatory QR codes on drugs. This will be effective from the same day. Patients will now be able to check the QR code on their medicines to ensure their authenticity. 

On August 03, 2023, the government set a deadline for adopting WHO-standard good manufacturing practices for drug manufacturers. Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year. 

Conclusion:

Besides all important patient safety, there are, at least, three other important factors for manufacturing high quality drugs for all and on an ongoing basis, sans lapses, as below:

  • Patients’ trust in the healthcare system relies on the availability of reliable medication. When patients have confidence in the drugs they are prescribed, they are more likely to comply with treatment regimens, leading to better health outcomes. 
  • A strong pharmaceutical sector that focuses on safe and effective drugs can foster economic growth by generating revenue, creating jobs, and attracting investments. It can also stimulate research and development efforts.
  • A reputation for producing quality drugs can boost India’s position as a global leader in pharmaceuticals, attracting international collaborations and partnerships.

Which is why, from the entire perspective, as above, amid India’s drug quality concerns, I reckon, one may still tend to wonder now – Is a light in sight now at the end of the dark and long tunnel? 

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.

 

Meeting India’s Unmet Biologic Drug Needs Some Global Synergy Evident – But Patients Need More

Many reports have vindicated the rapidly growing importance of biologic drugs in the treatment of a wide range of complex ailments. These include autoimmune diseases, cancers, hormonal irregularities, anemia, and to prevent various diseases such as vaccines, have drawn healthcare experts’ attention globally.

As defined by experts, Biologics are larger, more complex molecules compared to traditional small molecule pharmaceutical drugs. Unlike traditional pharmaceuticals, they require some components from a living organism to be manufactured.

The critical importance of biologic drugs lies in their ability to provide innovative treatment options, address unmet medical needs, and significantly impact patient outcomes in various disease areas. Towards this endeavor, a clear pathway for focused initiatives is warranted, especially in countries like India.

This article will explore this domain to get a sense of how much and how fast the country is progressing in this space, having huge healthcare significance, for all. Let me start with a quick recap on the areas of seminal importance of biologic drugs – to help all to be on the same page – as I start this deliberation.

The critical importance of biologic drugs:

The critical importance of biologic drugs, I reckon, lies in their unique properties and therapeutic potential:

Targeted Therapies: Designed to interact with specific molecules or receptors in the body, allowing for targeted treatment. This specificity can enhance the efficacy of the drug while reducing potential side effects on healthy cells and tissues.

Novel Treatment Options: Offer novel treatment options for diseases that were previously difficult to manage or had limited treatment options. They have revolutionized the management of conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, and certain types of cancer.

Personalized Medicine: Paving the way for personalized medicine, as it can be tailored to individual patients based on factors like genetic profiles or specific disease characteristics. This approach allows for more precise and effective treatment strategies.

Disease Modification: Unlike some traditional drugs that primarily alleviate symptoms, biologics can often modify the underlying disease process. They can target specific pathways or molecules involved in disease progression, potentially leading to long-term benefits and improved outcomes.

Improved Quality of Life: Has the potential to significantly improve the quality of life for patients living with chronic or debilitating conditions. By effectively managing symptoms and slowing disease progression, they can reduce pain, disability, and the need for other interventions.

It is important to note that biologic drugs are complex to manufacture, often require specialized infrastructure, and can be costly. No wonder why the India specific research paper - published on January 18, 2023 commented: “Although various biologic drugs are already available, they are still not within reach of the common person due to financial constraints.”  This prompts me to explore with examples some of the key issues that Indian patients confront while meeting this health need.

Patient access to original biologic drugs in India faces several key barriers:

Patient access to original biologic drugs in India faces several key barriers, including: 

1. Cost and Affordability:

- Trastuzumab (Herceptin): The cost of a single course of Herceptin, used in the treatment of breast cancer, can range from several lakhs to crores of rupees, making it financially burdensome for many patients in India.

- Eculizumab (Soliris): Eculizumab, used in the treatment of rare blood disorders, can cost several lakhs of rupees per month, making it unaffordable for most patients.

2. Limited Healthcare Coverage:

- Many health insurance policies in India have limitations or restrictions on coverage for expensive biologic drugs, requiring patients to bear a significant portion of the cost out of pocket.

- Some government-funded healthcare schemes, such as the Pradhan Mantri Jan Arogya Yojana (PMJAY), may have restrictions on coverage for expensive biologic therapies, limiting patient access.

3. Regulatory Barriers:

- The approval process for biosimilar versions of original biologic drugs could face delays in India. For example, the biosimilar version of Trastuzumab (Herceptin) faced delays in obtaining regulatory clearance, resulting in delayed patient access to more affordable alternatives.

- The regulatory requirements for original biologic drugs can be complex and time-consuming, leading to delays in drug approvals and subsequent patient access.

4. Limited Local Manufacturing:

- Drugs like Bevacizumab (Avastin) and Adalimumab (Humira) used in India are often imported, leading to supply chain challenges and potential delays in availability.

- Limited local manufacturing of certain original biologic drugs can result in dependence on imported versions, leading to potential pricing issues and supply disruptions.

5. Physician Awareness and Education:

- Some physicians may have limited awareness or familiarity with prescribing guidelines and clinical benefits of certain original biologic drugs. This can result in underutilization or hesitation in prescribing these therapies.

- Lack of specific training and education programs for physicians regarding the latest advancements in original biologic drugs can impact their knowledge and confidence in prescribing them.

6. Patient Education and Understanding:

- Patients may have limited knowledge about the availability and benefits of original biologic drugs. For instance, patients with chronic diseases like rheumatoid arthritis may not be aware of the benefits of newer biologic treatments over traditional therapies.

- Lack of patient education about the appropriate use and potential side effects of original biologic drugs can lead to hesitancy or misconceptions among patients, affecting their willingness to pursue these therapies.

These specific examples illustrate how cost, limited healthcare coverage, regulatory barriers, limited local manufacturing, physician awareness, and patient education can act as barriers to patient access to original biologic drugs in India.

Healthcare impact of inadequate access and availability of biologic drugs in India:

The inadequate access and availability of biologic drugs in India can have several significant healthcare impacts: 

Suboptimal Disease Management: Biologic drugs often provide highly effective and targeted treatments for complex diseases such as cancer, autoimmune disorders, and rare genetic conditions. The lack of access to these therapies can result in suboptimal disease management, leading to poorer patient outcomes, increased disease progression, and reduced quality of life for affected individuals.

Delayed or Incomplete Treatment: Inadequate access to biologic drugs can result in delays or interruptions in treatment. For chronic or progressive diseases, timely initiation and consistent use of these therapies are critical. Delayed or incomplete treatment can compromise the effectiveness of interventions, leading to prolonged disease activity, exacerbation of symptoms, and potential irreversible damage in some cases.

Increased Healthcare Burden: Without access to appropriate biologic therapies, patients may require more frequent hospitalizations, emergency room visits, or other healthcare interventions to manage their conditions. This can place an additional burden on healthcare systems, leading to increased healthcare costs and strain on resources.

Reduced Treatment Options: Biologic drugs often represent the most advanced and effective treatments available for certain diseases. Inadequate access to these therapies limits treatment options for patients, forcing them to rely on less effective or outdated treatments. This restricts the ability of healthcare providers to offer the best available care to patients, potentially leading to compromised treatment outcomes.

Health Inequity: Inadequate access to biologic drugs can exacerbate health inequities in India. Patients from lower socioeconomic backgrounds or those without sufficient insurance coverage may face greater barriers to accessing these expensive therapies. This can result in disparities in healthcare outcomes, with some individuals being unable to afford or access the best available treatments for their conditions.

Impact on Research and Innovation: Inadequate access to biologic drugs can hinder clinical research and innovation in India. Limited availability may reduce opportunities for conducting clinical trials and studying the effectiveness of these therapies in the local population. This, in turn, can hamper the development of new treatments and advancements in healthcare.

Addressing the inadequate access and availability of biologic drugs is crucial to ensure equitable healthcare outcomes, optimize disease management, and reduce the burden of complex diseases in India.  

Increasing need for biosimilar drugs in India and issues involved:

From the above perspective, increasing the availability of biosimilar drugs in India is crucial. Fostering competition may improve affordability. Thereby, it would increase access to essential therapies – bridging treatment gaps, disease management, healthcare system sustainability and foster market competition and innovation.

However, it can ensure that patients receive appropriate and effective treatments while addressing the healthcare challenges faced by a diverse population, only when some key barriers created for biosimilar drug entry, besides patent thickets, are also adequately addressed. One such way is creating a global synergy in this space by collaborating with MNC pharma – having deep pockets and other requisite wherewithal.

Some global synergy is evident in this critical healthcare space:

The good news in this space has started flowing. There have been several collaborations between multinational pharmaceutical companies (MNCs) and domestic Indian drug companies to develop even high potential interchangeable biosimilar drugs in India. Here are a few examples:

- Biocon and Mylan: Biocon has collaborated with Mylan, a global pharmaceutical company, to develop and market biosimilar products. This collaboration has resulted in the development and approval of biosimilar drugs such as Trastuzumab (Herceptin) and Adalimumab (Humira) in India. 

- Dr. Reddy’s Laboratories and Merck: Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, entered into a collaboration with Merck & Co., a global pharmaceutical company, to develop biosimilar versions of biologic drugs. This collaboration has resulted in the development and launch of biosimilars such as Pegfilgrastim (Neulasta) and Rituximab (Rituxan) in India.

- Cadila Healthcare and Novartis: Cadila Healthcare, an Indian pharmaceutical company, collaborated with Novartis, a multinational pharmaceutical company, to develop and manufacture biosimilars. This collaboration has resulted in the development of biosimilar drugs such as Rituximab (Ritucad) and Bevacizumab (Bevatas) in India.

These are just a few examples of collaborations between MNCs and Indian drug companies in the field of interchangeable biologic drugs. The landscape of collaborations and partnerships in this area is dynamic, and there may be more ongoing collaborations between companies to develop and commercialize biosimilars in India.

Conclusion:

Overall, patient access to biosimilar drugs in India is crucial for ensuring affordable and comprehensive healthcare, improving patient outcomes, and promoting a competitive pharmaceutical market. It helps address the challenges of access and affordability of biologic drugs, ultimately benefiting the well-being of patients across the country – promoting healthcare equity, and the sustainability of the healthcare system in the country. But patients need more…much more.

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.

‘Indian Pharma’s Apathy Towards Digital Marketing’ – A Misgiving Or Real?

As I gather from different sources, an increasing number of Indian pharma companies are increasingly embracing digitalization in their marketing operations, especially after the crippling experience during the Covid lockdown period. They realize the use of digital platforms would be a great enabler for them to reach a wider audience, promote their products, and engage with healthcare professionals more effectively, in any given situation. The depth, span, and speed of adaptation of this initiative is fast gathering momentum in the capable hands of astute marketers.

In this article, I shall explore this area to ferret out the fact, whether ‘The Indian pharma industry’s apathy towards Digital Marketing’ is a misgiving or still a reality. However, I would start with an important note about getting caught in some possible controversies due to occasional overenthusiasm in this space. 

Some possible reasons for a brouhaha or controversy:

There may be several reasons why a brouhaha or controversy could continue surrounding the use of digitalization in Indian pharma companies’ marketing operations. Some possible factors include:

  • Compliance and Regulatory Issues: Digital marketing practices must ensure full compliance with regulations set by regulatory bodies, such as the Drug Controller General of India (DCGI) and the Medical Council of India (MCI). Any violation of these regulations can lead to legal consequences and damage the reputation of the companies involved.
  • Misinformation, data Integrity and Misleading Claims: The widespread use of digital platforms can make it easier for misleading, breach of data integrity and false claims to be disseminated. Regulators and critics may raise concerns about the accuracy of information being shared and the potential impact on patient health. 
  • Privacy, cyberthreats and Data Security: The use of digital platforms involves the collection and storage of user data. Privacy concerns, including cyberthreatscan arise if pharmaceutical companies do not handle personal information responsibly or if patient data is compromised due to inadequate security measures. 
  • Unethical Practices: There have been instances where pharmaceutical companies have been accused of engaging in unethical practices in their marketing efforts. These may include off-label promotion (promoting a drug for an unapproved use), undue influence on healthcare professionals, or aggressive marketing tactics that prioritize sales over patient welfare. 

It is important to recognize that the specific reasons for the ongoing brouhaha on this topic may have further evolved. From this perspective, let me now focus on a few Indian examples where using digital tools and analytics could offer several advantages for domestic pharmaceutical companies, as available from different sources.  

Examples of some areas where Indian players are using digital tools:

Here are some recent examples of how Indian pharmaceutical companies have utilized digital tools and analytics in their marketing operations, as available in the public domain:

  • Enhanced Targeting: Aurobindo Pharma Limited has implemented data analytics to identify key customer segments for targeted marketing. By analyzing prescribing patterns and patient demographics, they tailor their marketing efforts to reach specific healthcare professionals and patient groups more effectively. 
  • Personalized Marketing: Biocon Limited has embraced digital tools to deliver personalized marketing content. Through their digital platforms, such as websites and mobile applications, they provide customized information about their products, disease education materials, and patient support resources.
  • Improved Marketing ROI: Lupin Limited has utilized digital analytics to measure the performance of their marketing campaigns. By tracking key metrics, such as website engagement, social media interactions, and email response rates, they can optimize their marketing spend and allocate resources to channels that yield higher returns. 
  • Efficient Resource Allocation: Sun Pharmaceutical Industries Ltd has leveraged digital tools and analytics to optimize resource allocation. They analyze market data and customer behavior to identify regions and healthcare facilities with the highest growth potential, enabling them to allocate their sales resources strategically.
  • Real-time Market Insights: Dr. Reddy’s Laboratories Ltd utilizes digital tools and analytics to monitor real-time market insights. By leveraging social listening tools and data analytics platforms, they stay updated on market trends, competitor activities, and customer feedback, enabling them to adapt their marketing strategies accordingly.
  • Improved Customer Engagement: Cipla Ltd has focused on improving customer engagement through digital channels. They utilize social media platforms, online forums, and chatbots to interact with healthcare professionals and patients, providing information, answering queries, and offering support. 
  • Streamlined Communication: Torrent Pharmaceuticals Ltd has implemented digital communication tools to streamline interactions with healthcare professionals. They utilize virtual meeting platforms, webinars, and online training sessions to engage with physicians, pharmacists, and other stakeholders more efficiently, eliminating geographical barriers.
  • Data-driven Decision Making: Glenmark Pharmaceuticals Limited leverages data analytics for data-driven decision making. By analyzing sales data, market trends, and customer feedback, they gain insights that inform their strategic decisions regarding product launches, marketing campaigns, and market expansion. 

These examples demonstrate how Indian pharmaceutical companies have harnessed digital tools and analytics while recomposing notes in a pharma marketing playbook to enhance their business operations. However, please note that specific initiatives and strategies are still evolving, and the extent of adoption may vary among different companies. 

Conclusion:

From the above perspective, I reckon, Indian drug companies are increasingly embracing digital toolsand analytics to enhance their marketing efforts. With the advancement of technology and the growing importance of digital channels, pharmaceutical players in India are recognizing the need to adapt and leverage digital tools to stay competitive and effectively reach their target audience. Hence, any feeling about the ‘Indian pharma industry’s apathy towards Digital Marketing’ seems to be a misgiving to me.

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.