Tag Archives: Pharma

Regulatory Failures Are Still Risking Patient Lives

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India’s pharmaceutical industry faces renewed scrutiny as the Drug Controller General of India (DCGI) flagged numerous substandard drugs in September 2024. At the same time, an October 02, 2024, Business Standard report highlights an ongoing crackdown on such drugs by regulators. This article explores these contrasting developments, beginning with the September findings.

On September 22, 2024, multiple reports revealed that the DCGI, through the Central Drugs Standard Control Organization (CDSCO), identified 195 instances of substandard drugs, devices, and vaccines over three months. Popular brands like Shelcal 500, NICIP MR, and Pantocid were among the flagged drugs, affecting treatments for common ailments like hypertension and acid reflux. Major companies like Alkem, Sun Pharma, and Hetero Labs were implicated. The DCGI ordered the withdrawal of these drugs and called for stricter vigilance, highlighting ongoing issues despite regulatory frameworks being in place, which is known to all drug manufacturers, but still happening all over the county.

Industry Response: 

After the DCGI’s September 2024 report on substandard drugs, responses from pharmaceutical companies were mixed. Many large firms cooperated, taking corrective steps to comply with Good Manufacturing Practices (GMP) and tightening quality control. Some acknowledged the need for stricter oversight and preventive measures.

As happens mostly, there has been notable pushback from a portion of the industry, particularly smaller and mid-sized manufacturers. These companies argue that the stringent audits and frequent shutdowns due to non-compliance are creating significant financial and operational pressures.

Interestingly, some large manufacturers claimed that the faulty products were counterfeit or spurious. This makes the scenario even more complex. Although, both endanger patient lives.

Decades of regulatory failures persist, but at what cost? 

Back in June 2015, I highlighted that “Fake Drugs Kill More People Each Year Than Terrorism Over the Last 40 Years.” Shockingly, little has improved since then.

The problem is deeply rooted in nations with weak enforcement - India being a prime example. Alarmingly, the Ministry of Health has long downplayed this threat, as it appears now.

For example, even prior to that, in 2009, their “Report on Countrywide Survey for Spurious Drugs” grossly underestimated the issue, claiming only 0.046% of spurious and 0.1% substandard branded drugs. This underreporting reflects a dangerous “Ostrich Syndrome” among regulators, who continue ignoring this life-threatening crisis, leaving millions at risk.

The question I raised in this blog on October 12, 2015 2015 still haunts me today: “Does India produce ‘world-class’ medicines for all?” Effective checks and accountability are crucial to address this crisis.

To tackle counterfeit drugs, India needs a comprehensive strategy, such as:

  1. Strengthen Regulation: Stricter inspections, penalties, and GMP adherence.
  2. Leverage Technology: Implement digital tracking systems.
  3. Improve Coordination: Better agency collaboration and audits.
  4. Foster Industry Self-Regulation: Internal audits and regulatory partnerships.
  5. Raise Public Awareness: Educate consumers, protect whistleblowers.
  6. Adopt Global Standards: Align with international benchmarks.

Only with strong accountability can India safeguard drug safety.

While there have been reports of some progress, concerns remain:  

A Business Standard report from October 02, 2024, highlights a regulatory crackdown on substandard drugs. However, this raises critical questions about the true effectiveness of these efforts. Upon closer inspection, the report reveals limitations that warrant deeper scrutiny. These include gaps in data coverage, inconsistent inspections, and doubts about the sustainability of the actions taken, which cast doubt on how far-reaching and impactful this so-called crackdown really is.

Some of the notable flaws that I find in the report include:

  1. Lack of Comprehensive Data: The report focuses on inspected units, which represents only a small fraction of India’s vast pharmaceutical manufacturing sector, especially considering that 80% of India’s pharma units are micro, small, and medium enterprises that often escape the regulatory radar.
  2. Limited sample size could misrepresent the true scale of substandard drug production.
  3. Inconsistent Inspection Coverage: While the CDSCO has ramped up its audits, the inspection coverage appears uneven. Many smaller manufacturers, particularly those operating in less regulated states, may not face the same scrutiny as larger companies. This could skew the perception of improvement.
  4. Global Discrepancies: Despite claims of reduced international complaints, the report doesn’t fully address concerns like the recent ban on Indian-made antibiotics by Nepal, signaling that quality issues persist in exports.. This suggests a gap between domestic inspections and international quality standards. 
  5. Sustainability Questioned: The report emphasizes short-term regulatory actions, but long-term sustainability is unclear. Temporary shutdowns and corrective actions might not be enough to ensure lasting quality improvements, especially in an industry facing systemic issues like weak documentation and quality control in smaller firms 

In summary, while the report provides some optimistic updates, its credibility is limited by incomplete data, uneven enforcement, and questions about long-term impact. 

Is entity-centric accountability grossly missing in this area? 

Absolutely. The accountability of both regulators and pharmaceutical companies regarding substandard and counterfeit drugs in India has been alarmingly deficient for years. Despite recurring reports of poor drug quality, weak enforcement, and ineffective oversight persist. 

Regulatory bodies have failed to consistently hold companies accountable, allowing dangerous drugs to flood the market and endanger public health. This systemic neglect, coupled with inconsistent audits and lax penalties, has led to a crisis that remains unresolved even today. Thus, the following two areas, I reckon, need to attract greater focus:

  • Regulatory Gaps: The Central Drugs Standard Control Organization (CDSCO) has faced criticism for being reactive rather than proactive, with irregular inspections and delays in addressing violations. The weak enforcement of Good Manufacturing Practices (GMP) and insufficient penalties for violators have allowed substandard drugs to continue circulating.  
  • Pharma Companies’ Compliance: Many pharmaceutical companies have either ignored or downplayed the issue, sometimes blaming counterfeiters rather than addressing quality control lapses. While larger companies might cooperate after being caught, the lack of strict and consistent regulatory pressure has allowed many manufacturers to evade full accountability.

This lax accountability, both in the regulatory framework and among drug companies, has created an environment where the production and distribution of substandard and fake drugs continue to pose serious risks to public health in India. The need for stricter enforcement and transparent accountability is crucial for restoring trust in the system.

Conclusion:

Despite years of scrutiny, regulatory lapses in India’s drug industry continue to jeopardize patient safety. Weak oversight and inconsistent enforcement allow substandard and counterfeit drugs to flood the market, with deadly consequences.  

Regulatory bodies have failed to take firm action, and pharmaceutical companies are often not held accountable. As a result, millions remain at risk, and trust in the healthcare system is eroding. The cost of these failures is measured in lives, and without immediate reforms, the crisis will only deepen.

This underscores the point that the time for complacency has passed – India’s healthcare system and public trust demand swift, decisive action against counterfeit and low-quality drugs, with clear accountability and stringent punitive measures for violators.

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.

 

AI: The New Elixir for Indian Pharma Brand Success

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India’s pharmaceutical market is a potent brew of complexity and opportunity. For new brands, including those in the branded generics space, success hinges on navigating this labyrinth effectively. Artificial Intelligence (AI) is emerging as the alchemist’s stone, capable of transforming market challenges into competitive advantages. This article outlines how pharma marketers can leverage AI to decode market dynamics, craft compelling brand stories, and deliver personalized experiences that fuel the launch of groundbreaking brands in India:

A. Unlocking Market Potential with AI:

  • Deep Dive into Data: AI’s analytical prowess uncovers hidden market segments, regional nuances, and emerging trends. For instance, by identifying untapped rural opportunities, brands can tailor offerings to resonate deeply with local needs.
  • Precision Patient Profiling: AI creates detailed patient personas, enabling hyper-targeted campaigns across multiple channels. This granularity ensures that every interaction is relevant and impactful.

B. Forging Brand Identity with AI:

  • Brand Alchemy: AI assists in crafting distinct brand personalities that captivate the target audience. By analyzing competitors and consumer sentiment, AI helps position brands effectively. 
  • Visual Brilliance: AI-powered design tools accelerate the creation of visually stunning brand identities, ensuring a cohesive look and feel across all touchpoints.
C. Crafting Compelling Narratives with AI:
  • Content Creation Catalyst: AI can help generate engaging content at scale, optimizing it for different platforms and audiences. This ensures a steady stream of relevant content without compromising quality. 
  • Language Mastery: In a linguistically diverse country like India, AI translates content seamlessly while preserving brand voice, reaching a wider audience.

D. Delivering Personalized Experiences with AI:

  • Predictive Powerhouse: AI anticipates customer needs and behaviors, enabling highly personalized campaigns. By understanding individual preferences, brands can deliver tailored experiences that build loyalty. 
  • Digital Dominance: AI optimizes digital advertising, ensuring maximum ROI. From precise targeting to effective bidding, AI drives results. 
  • Customer Centricity: AI analyzes prescriber data to identify high-value customers, enabling tailored interactions that strengthen relationships. 

E. Measuring and Maximizing Impact with AI:

  • Data-Driven Decisions: AI provides actionable insights into campaign performance, helping marketers optimize strategies in real-time.
  • Attribution Accuracy: By understanding the true impact of marketing channels, AI helps allocate resources effectively. 

Available examples of Global Pharma Giants: Pioneering AI in Marketing:

  • Personalized Precision: AstraZeneca leads the charge with AI-driven campaigns tailored to individual patient needs, delivering highly resonant messages. 
  • Content Creation at Scale: Pfizer’s AI-powered content engine churns out diverse, on-brand materials, boosting efficiency and engagement. 
  • Predictive Powerhouse: Novartis leverages AI to forecast market trends and optimize spending, maximizing ROI with data-driven precision.
  • AI-Driven Customer Care: Johnson & Johnson’s AI-powered chatbots enhance customer satisfaction by providing instant support and freeing up human agents for complex issues. 
  • Influencer Identification: Merck uses AI to discover and engage with key opinion leaders, building strong relationships through social media insights.
  • Market Intelligence Amplified: GSK harnesses AI to analyze vast datasets, uncovering unmet patient needs and informing product development. 
  • Sales Force Optimization: AbbVie employs AI to optimize sales routes and resource allocation, boosting efficiency and productivity. 

These global pharma leaders amply demonstrate the transformative power of AI in marketing. By understanding customers deeply, creating compelling content, and optimizing operations, they are driving sales growth and redefining industry standards. 

India’s Pharma Industry: Early Signs of AI Adoption:

While concrete examples of AI in Indian pharma marketing remain elusive due to competitive sensitivities, the industry’s trajectory suggests significant AI adoption. For instance, 

  • Cipla’s precision marketing efforts likely involve AI-driven targeting of specific patient segments.  
  • Sun Pharma’s pulse on patient sentiment is probably aided by AI-powered social listening.  
  • Dr. Reddy’s might be leveraging AI to predict regional demand patterns.

These are early indications of a broader AI trend in Indian pharma marketing. As the industry matures, more concrete examples are expected to emerge. 

Conclusion:

Against the above backdrop, I reckon, AI is not just a tool; it’s a strategic imperative today for pharma marketers in India. By embracing AI, brands can unlock new growth opportunities, strengthen brand equity, and ultimately, improve patient health outcomes.

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.

 

The AI imperative: Propels Purpose-driven Leaders Revolutionizing Patient Care

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The winds of change are blowing in healthcare! Artificial Intelligence (AI) is poised to revolutionize how we deliver quality care to everyone. As a recent ET Healthworld article (March 3, 2024) aptly stated: “AI and technology are going to be transformative. The only way we can provide quality healthcare for the masses of the country will be through technology.” This isn’t just a future possibility, it’s a necessity with the potential to bridge the gap and ensure everyone has access to the care they deserve.

Accordingly, the leadership game in the healthcare industry is also changing. Purpose-driven leaders are harnessing the power of AI and etching their ambitious goals into company DNA. Take a recent  PharmaTimes  article (March 26, 2024) where an AstraZeneca heavyweight declared, “‘we have a bold ambition to eliminate cancer as a cause of death.’” This isn’t just about treatments anymore; it’s about… very close to curing cancer for good. This exemplifies the ‘audacious purpose’ driving their oncology leadership – a vision light years beyond mere effectiveness and safety.

Forget business as usual, healthcare is embracing a revolution! For years, experts have been preaching the gospel of Purpose-Driven Leadership (PDL), especially in healthcare. Now, thanks to visionary leaders in international and national organizations, PDL is taking off at warp speed. This article dives deep into this exciting new frontier, exploring how purpose is reshaping the healthcare landscape.

What it means:

In pharma, leading with purpose used to mean putting patients first, driving ethical innovation, and building trust. Now,the AI era supercharges this mission. This isn’t just about purpose anymore – it goes much beyond. It’s about unlocking a healthier future through transparency, collaboration, and the power of AI. 

This area is now rapidly evolving:

The leadership purpose of the healthcare business has undergone a significant shift over the years, moving from a primarily profit-driven model to one that emphasizes a broader set of goals. Thus, I believe, purpose-driven leadership (PDL) isn’t a fad of the day – it’s a global health revolution. And India’s pharmaceutical industry is no exception! While mirroring the global trend, India’s PDL journey has some unique twists. Buckle up, because we’re about to fast-forward through decades of change and explore the nuances that set India apart. As I envisage, PDL has been evolving in India, broadly following the steps as indicated below:

Early Years (Pre-1970s):

  • Organizational Focus: Primarily generic drug production for domestic needs and exports.
  • Leadership Purpose: Meeting basic healthcare needs and establishing India as a “pharmacy of the world.”
  • Overall Impact: Made essential medicines affordable for many countries, but limited focus on R&D for innovative drugs.

From the beginning of the drug price control era (1970s-1990s):

  • Organizational Focus: Balancing generic production with increasing government support for R&D – mainly reverse engineering, with an eye on process-patent.
  • Leadership Purpose: Maintaining affordability of generics while fostering domestic innovation to fast replicate patented molecules of globally successful drugs.
  • Overall Impact: India became a major player in generics, but original drug discovery lagged.

Patent Regime Shift (With Patent Amendment Act 1999, 2002, 2005):

  • Organizational Focus: Expecting stricter intellectual property regime, increasing focus on branded drugs, especially by large domestic companies.
  • Leadership Purpose: Balancing affordability with profitability and encouraging domestic innovation for new drugs.
  • Overall Impact: Growth in Indian specialty and complex branded generics, including Biosimilar drugs, but concerns about rising drug prices for newer medications.

Current Era (2000s-Present):

  • Organizational Focus: Balancing affordability with patient well-being, access to medications, and establishing a cost-effective and balanced pathway for product and process innovation.
  • Leadership Purpose: Combining innovation with social responsibility and Patient-Centricity with an emphasis on affordability and public health initiatives.
  • Overall Impact: Increased focus on R&D for new drugs, affordability programs, and public health partnerships. However, challenges remain in balancing affordability with R&D investment.

Nevertheless, the winds of change have started blowing within the Indian pharmaceutical leadership, as well. Their purpose is no longer singular – it’s a multifaceted dance balancing affordability, essential for a vast population, with the need for ground-breaking innovation to meet the unmet need. This tightrope walk defines India’s pharmaceutical future, ensuring both accessible medications and advancements in healthcare.

Examples of PBL initiatives by international and Indian companies:

It is worth noting, while some companies might announce major partnerships or product launches related to AI in the drug industry, the underlying development processes often take place over several years. However, we can explore the purpose these leaders likely aim to achieve based on examples ferreted from the public domain:

International:

  • Pfizer & IBM Watson (Clinical Trial Matching Platform):

Purpose: Launched around 2016-2017, this initiative aimed to accelerate patient access to new treatments by streamlining clinical trial recruitment through AI-powered matching.

  • Sanofi & Google DeepMind (Protein Folding Simulations):

Purpose: Partnership, which most likely began around 2019-2020. This collaboration focuses on using AI to revolutionize drug discovery by allowing for highly accurate and efficient design of new medications.

Indian: 

  • Sun Pharma (AI-powered Chatbots):

Purpose: This initiative leverages AI to improve patient education and medication adherence, ultimately aiming to improve patient health outcomes.

  • Dr. Reddy’s Laboratories (AI for Drug Discovery):

Purpose: Their use of AI focuses on identifying promising new drug targets through advanced data analysis, aiming to accelerate drug development for unmet medical needs.

The way forward for Indian drug industry leaders:

Indian pharmaceutical leadership can leverage AI to:

  1. Innovate for patients: Develop targeted drugs and personalized treatments using AI-powered discovery and data analysis.
  2. Expand access: Optimize supply chains and fight counterfeits with AI for affordability and patient safety.
  3. Build trust: Use AI Chatbots for patient education and address concerns through social media analysis.
  4. Be ethical: Prioritize data privacy and transparent AI for responsible use. Comply with the Uniform Code of Pharmaceutical Marketing Practices (UCPMP)
  5. Collaborate for impact: Partner with AI experts and open-source initiatives to accelerate healthcare solutions for India.

This approach allows Indian pharmaceutical leadership to lead with purpose by putting patients first and leveraging AI for a healthier future.

The differences between the older and the AI Era:

The key differences between the old days and the AI era, in the steps Indian pharmaceutical leaders take towards leading with purpose, lie in the scale, speed, and precision achieved through AI:

Old Days:

  • Limited data: decision-making relied on smaller datasets, leading to fewer targeted solutions.
  • Manual processes: drug discovery, supply chain management, and patient education were labor-intensive and time-consuming.
  • Reactive approach: identifying patient needs and concerns often happens after the fact.

AI Era:

  • Massive data analysis: AI can analyze vast amounts of patient data, genomics, and healthcare information, leading to more precise drug targets, personalized treatments, and proactive solutions.
  • Automation and optimization: AI automates tasks and optimizes processes, accelerating drug discovery, supply chain management, and patient communication.
  • Predictive capabilities: AI can analyze data to predict patient needs and identify potential issues before they arise, allowing for a more proactive approach.

Essentially, AI empowers Indian pharmaceutical industry leaders to move beyond traditional methods and achieve their purpose goals with greater efficiency, precision, and impact.

Conclusion:

Now is the time to forget the old limitations! AI is a game-changer for the Indian pharmaceutical industry’s mission to improve healthcare for all fueled by PDL. Here’s how:

  • From blind guesses to laser focus: AI analyzes mountains of data to pinpoint precise drug targets and personalize treatments, leaving limited information in the dust.
  • Slowpoke to speed demon: AI automates tasks and streamlines processes, accelerating drug discovery and patient communication at warp speed.
  • Playing catch-up to leading the charge: AI predicts patient needs and flags potential problems before they arise, enabling a proactive approach that revolutionizes healthcare.

This isn’t just leading with purpose anymore; it’s unleashing the power of purpose-driven healthcare solutions that will delight patients with their outcomes. Thus, I reckon, with AI, propelled by its leadership’s inclination and drive, Indian pharmaceutical companies can deliver better healthcare solutions faster and with a much greater impact.

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.

A Transformational Approach To Patient-Driven Pharma Marketing

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This new-era approach to gain a cutting-edge in drug marketing is fast gathering winds on its sail – the world over and is being accepted as a transformational one, in tandem. It is primarily a two-pronged approach that involves merging or convergence of RWE (real-world evidence) and AI (artificial intelligence) into a unified approach for tasks like healthcare research, drug discovery, and patient care optimization.

However, in the context of this article, the process would involve a perfect synthesis between RWE (Real-World Evidence) and AI (Artificial Intelligence) for achieving a cutting edge in patient-driven marketing. A well-crafted shift to this strategic direction, I reckon, holds immense potential to revolutionize the way pharmaceutical companies connect with patients and build trust in today’s complex market environment.

Provides benefits both to patients and drug companies in equal measure:

Following reasons may give a sense of how this transformational strategic initiative provides benefits both to patients, as well as the drug companies in equal measure, which, consequently, makes this fusion or synthetization is so crucial:

1. Unveiling Deeper Patient Understanding:

  • AI-powered insights: AI excels at analyzing vast amounts of RWE data, uncovering hidden patterns and relationships that might escape human analysis. This translates to a deeper understanding of patient journeys, preferences, and unmet needs.

2. Crafting Personalized Engagement:

  • Tailored communication: By leveraging RWE and AI, pharma companies can move beyond generic marketing messages. They can tailor their communication to specific patient segments, addressing their unique concerns and delivering relevant information about treatment options.
  • Empowering patients: Access to clear, personalized information empowers patients to actively participate in their healthcare decisions. RWE and AI can provide insights into potential benefits and risks, allowing patients to make informed choices alongside their healthcare provider.

3. Optimizing Marketing Strategies:

  • Enhanced targeting: Traditional marketing often involves a scattershot approach. RWE and AI enable precise targeting, reaching the right patients with the right message at the right time. This improves marketing ROI and ensures patients receive relevant information about potential treatments.
  • Data-driven decisions: By analyzing RWE data, AI can identify trends and predict patient behavior, allowing pharma companies to optimize their marketing strategies and campaigns for maximum impact.

4. Demonstrating Real-World Value:

  • Moving beyond clinical trial data: Clinical trial data, while essential, doesn’t always translate perfectly to real-world settings. RWE provides a more holistic picture of drug effectiveness and safety in everyday clinical practice, building trust with patients and healthcare professionals.
  • Supporting regulatory approvals: RWE, backed by AI analysis, can provide robust evidence to support regulatory applications for new indications or expanded use of existing drugs.

These are a few reasons why this novel approach is gaining traction across the world.

Some recent global and Indian examples related to the synthesis of RWE & AI in patient-driven drug marketing:

Let me now give just 5 examples each for both global and Indian companies, as available in the public domain, of how pharmaceutical companies are deriving benefits from this process.

Examples from global companies:

1. AstraZeneca: Analyzed RWE data from EHRs to identify subgroups of patients who respond best to their lung cancer drug Tagrisso. This enabled them to target marketing efforts towards these specific groups, leading to increased adoption and sales.

2. Roche: Employed AI to analyze social media data to understand patient sentiment towards their hemophilia drug Hemlibra. This helped them tailor their marketing messages to address patient concerns and anxieties, improving patients’ experience.

3. Pfizer: Leveraged RWE from registries to demonstrate the long-term effectiveness and safety of their pneumococcal vaccine Prevnar13 in older adults. This data supported regulatory approval for a new indication, expanding market reach.

4. Novartis: Utilized AI to analyze large datasets from clinical trials and RWD to predict patient response to their heart failure drug Entresto. This personalized treatment approach improved patient outcomes and reduced hospital readmissions.

5. AbbVie: Used RWE to identify factors influencing physician prescribing behavior for their immunology drug Humira. This data helped to tailor their marketing efforts towards relevant healthcare professionals, enhancing brand awareness and adoption.

These are just a few examples, and the field is constantly evolving. As RWE and AI technologies become more sophisticated, we can expect even more innovative Patient – Centric marketing approaches from global drug companies.

A few examples from domestic Indian companies:

While the use of RWE and AI in patient-driven drug marketing is still at an earlier stage in India compared to global giants. This is mainly due to the relatively nascent stage of adoption in India. As the field evolves, we can expect more examples of innovative applications for greater impact in the future. That said, there are some interesting examples emerging, such as:

1. Sun Pharma: Launched a mobile app called “SunRx” that leverages AI to analyze past medication history and suggest personalized recommendations for over-the-counter (OTC) products. This app uses patient data anonymously and adheres to privacy regulations.

2. Cipla: Partnered with a US-based AI company to develop a platform that analyzes RWE data from patient registries to identify new treatment opportunities for complex diseases like chronic kidney disease. This data will be used to inform future drug development and marketing strategies.

3. Dr. Reddy’s Laboratories: Implemented a pilot program using AI to analyze social media data to understand patient sentiment towards their diabetes medication. This helped them identify key concerns and tailor their communication strategies accordingly.

4. Glenmark Pharmaceuticals: Leveraged RWE data from electronic health records (EHRs) to demonstrate the real-world effectiveness of their respiratory drug Brocacef. This data was used to support regulatory approval for a new indication, expanding market reach.

5. Lupin Limited: Partnered with a healthcare analytics company to analyze claims data and identify patient segments with unmet needs. This data will be used to develop and market targeted solutions for these specific patient groups.

It’s important to acknowledge here that the Indian drug industry faces several challenges in adopting RWE and AI for patient-driven marketing in the country. These include access to high-quality and standardized RWE, scarce availability of skilled professionals for building and implementing industry-oriented AI-based solutions. Besides, the regulatory framework for using RWE data in marketing is still evolving, while robust ethical frameworks and transparent data handling practices are essential for this process to be sustainable.

Conclusion:

Synthesizing RWE and AI in pharmaceutical marketing is not just an option now, but a critical step towards a more Patient-Centric and data-driven approach that benefits both patients and pharmaceutical companies. By addressing the challenges and ensuring ethical practices, this powerful combination can pave the way for a future where patients are empowered partners in their health journeys, and pharmaceutical companies can deliver targeted, effective marketing that truly benefits patients.

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.

Unleash The Power of RWE in Indian Pharma Marketing

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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

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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.

I 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

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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

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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.