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

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.

UCPMP 2024: Game Changer or False Dawn?

On March 12, 2024, the Department of Pharmaceuticals (DoP) of the Government of India notified the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024.

Having gone through the details, many construe that aiming to finally clean up pharmaceutical marketing practices in India, as demanded by many stakeholders – including the Supreme Court of India, the new one released by the DoP in March 2024 still appears to be a ‘work in progress.’ One therefore, wonders whether UCPMP 2024 is a step forward or status quo in establishing desirable standards for pharma business ethics in India.

In this article, let me dwell on this issue, highlighting examples of some key points in this regard.

Some key points to take note of:

There are several key points to take note of some examples, which will include:

  • Unlike its predecessor, the 2024 UCPMP removes the word “voluntary” but doesn’t explicitly make the code mandatory. It requests industry associations to implement the code.
  • The code doesn’t explicitly prescribe penalties for pharmaceutical companies beyond removal from industry associations (if they are members).
  • Doctors who violate ethical codes can face license suspension and fines under the National Medical Commission (NMC) guidelines. However, the NMC’s stricter 2023 code revisions were put on hold due to industry pressure.

Thus, several issues, including the following, need to be answered, beyond any ambiguity whatsoever. That said, let me start with how the UCPMP 2024 brings both opportunities and challenges for Indian drug companies, and then we will try to fathom whether the new code as it presents today will prove to be a game changer to improve the quality of ethical standards, especially, in Indian pharmaceutical marketing. 

UCPMP 2024 – some key challenges for drug companies:

A.  Marketing Revamp:  The new UCPMP demands a complete overhaul of marketing practices and strategies. Companies need to find new, compliant ways to educate doctors about their products, likely focusing on:

  • Scientific Data and Value Proposition: Stronger clinical trial data and highlighting a drug’s actual benefits will be crucial.
  • Transparency and Credibility: Building trust with doctors through clear, accurate information and high-quality educational materials is essential.

B.  Salesforce Transformation: Medical representatives, previously reliant on personal connections, now need expertise in:

  • Scientific Communication: Effectively engaging doctors with the science behind the drug.
  • Product Knowledge: Deep understanding of the drugs they are promoting.
  • Potential Sales Slump: Stricter marketing might lead to a decline in sales, particularly for established brands that rely heavily on promotion. Companies need to adapt their sales strategies to address this.

Effectively navigating these challenges requires significant investments in:

  • R&D: Stronger focus on research and development to create innovative drugs with a clear value proposition.
  • Data-Driven Marketing: Utilizing data science to understand doctor needs and target marketing efforts effectively.
  • Salesforce Training: Upskilling representatives in scientific communication and product knowledge.

By adapting their approach, Indian drug companies can leverage UCPMP as an opportunity to move towards a model focused on the quality and scientific merit of their products.

UCPMP 2024 – some key opportunities for drug companies:

The UCPMP 2024, while presenting challenges, also offers some key opportunities for Indian drug companies to thrive:

  • Level Playing Field: The ban on gifts and incentives removes an unfair advantage for larger companies. This allows smaller or generic drug companies to compete based on the merits and affordability of their products.
  • Focus on Innovation: With less emphasis on promotion, companies may be incentivized to invest more in R&D, leading to the development of new, innovative drugs with stronger scientific backing.
  • Building Brand Trust: Transparency and accurate information mandated by UCPMP can help companies build trust with doctors and patients alike. This strong reputation can be a valuable asset in the long run.
  • Data-Driven Marketing: The shift towards data-driven marketing allows for targeted communication based on doctor needs and preferences. This can be more cost-effective and lead to better engagement with healthcare professionals.
  • Focus on Patient Education: UCPMP encourages companies to provide clear information directly to patients. This can empower patients to make informed decisions about their healthcare and potentially increase the demand for effective medication.

By capitalizing on these opportunities, Indian drug companies can:

  • Differentiate themselves: By focusing on innovation and patient-centricity, they can carve out a niche in the market.
  • Building long-term value: Investing in R&D and building trust with doctors can lead to sustainable growth and brand loyalty.
  • Becoming more competitive globally: A focus on innovation and scientific merit can help Indian companies compete effectively in the international pharmaceutical market.

Interestingly, the UCPMP presents a chance for Indian drug companies to move away from an outdated marketing model and embrace a more ethical and sustainable approach. By focusing on innovation, data-driven marketing, and building trust, they can seize this opportunity to become leaders in the global pharmaceutical industry.

Is UCPMP 2024 a game changer or a false dawn?

Having said all this, the question still remains whether UCPMP 2024 is a game changer or a false dawn. I reckon, while aiming to curb unethical practices in the pharmaceutical industry, questions linger about its effectiveness. Let’s delve into both sides of the argument:

A Game Changer:

  • Stronger Stance: The removal of “voluntary” from the code suggests a stricter approach compared to its predecessor.
  • Focus on Transparency: Provisions like mandatory expenditure disclosure for conferences organized by pharma companies could increase transparency.
  • Addressing Travel & Hospitality: Discouraging pharma-funded travel and hospitality for doctors might reduce undue influence.
  • Potential for Improved Ethics: A well-enforced UCPMP could lead to a more ethical environment where marketing focuses on the merits of drugs rather than lavish incentives.

False Dawn:

  • Missing Teeth: The lack of clear penalties beyond industry association removal for pharma companies raises concerns about enforcement.
  • Rollback of NMC Code: The NMC’s stricter code for doctors with potential financial penalties was rolled back due to industry pressure. This weakens the overall impact.
  • Ambiguity on Non-Member Companies: The code’s effectiveness might be limited if pharmaceutical companies outside industry associations are not held accountable.
  • Uncertain Implementation: The success of UCPMP hinges on robust implementation and a clear mechanism to address violations.

Conclusion:

From the above perspective, the true impact of UCPMP 2024 remains to be seen. While it has positive intentions, its effectiveness depends on stricter enforcement mechanisms, penalizing violations, and ensuring all companies are held accountable. Only time will tell if UCPMP 2024 ushers in a new era of ethical practices or remains a symbolic but unenforced reform.

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

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

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.

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.

 

 

Drug Prescription In Generic Names Only, No Branded Generics

The World Bank Report released on April 07, 2023 highlights that patients’ Out-of-Pocket (OoP) expenses as a percentage of their total healthcare expenditure in India still accounted for as high as 50.59%. This means that patients in India generally pay for the majority of their healthcare costs themselves, rather than through insurance or government funding. The high level of OoP expenses in India has been a major problem for many patients, even today. Studies indicate it often leads to financial hardship, especially for low-income families.

A number of factors contribute to the high level of OoP in the country, as a whole, with regional variations. According to several studies, the healthcare costs in India are rising faster than inflation, making it increasingly difficult for more people to afford the care they need, especially for life threatening ailments, such as cancer.

Different union governments while in power have taken several steps to address this problem, such as, in 2018, the launch of the Pradhan Mantri Jan Arogya Yojana (PMJAY), a national health insurance scheme. It provides free coverage for poor and vulnerable families. The PMJAY is expected to have helped in reducing OoP for some patients, but it is not yet clear how much of an impact it has had overall.

On April 24, 2017, I asked on this blog – would drug ‘Prescriptions in Generic Names Be Made A Must in India?’. Interestingly, in August 2023, a new circular from the National Medical Commission (NMC) notified professional conduct regulations for Registered Medical Practitioners (RMP), including guidance to doctors on drug prescriptions.  This has raised a furor, as it were, among many medical practitioners and their associations. In this article, I shall deliberate on the pros and cons of this decision and its practicality in India. Let me start with the rationale behind such thinking, as I see it.

The rationales behind drug prescription only in generic names in India:

As I see it, there are several rationales behind doctors prescribing drugs only under generic names in India. Here are some of the most important ones:

  • Cost savings: Generic drugs are typically much cheaper than brand-name drugs. This is because generic drugs do not have to go through the same expensive clinical trials and marketing campaigns as brand-name drugs. As a result, they can be sold at a much lower price. This can save patients a significant amount of money, especially for expensive medications. 
  • Increased access to medicines: The lower cost of generic drugs can make them more accessible to people who might not otherwise be able to afford them. This is especially important in India, where a large proportion of the population lives below access, the poverty line. Generic drugs can help to ensure that everyone has access to the medicines they need. 
  • Improved competition: The availability of generic drugs can lead to increased competition in the pharmaceutical market. This can drive down prices even further and benefit patients.
  • Reduced risk of counterfeit drugs: Generic drugs are regulated by the government and must meet the same quality standards as brand-name drugs. This means that patients can be confident that they are getting a safe and effective product, regardless of whether it is a generic or brand-name drug. Counterfeit drugs, on the other hand, are often made with substandard ingredients and can be dangerous to take. By prescribing generic drugs, doctors can help to reduce the risk of patients getting counterfeit drugs. 
  • Transparency and accountability: In addition to these benefits, prescribing drugs under generic names can also help to promote transparency and accountability in the pharmaceutical industry. When doctors prescribe drugs under generic names, it is easier for patients to compare prices and choose the best option for their needs. This can help to drive down prices and improve the quality of care. 

A draft regulation was notified in 2022 for comments by all concerned:

For this purpose, a draft regulation was issued by the National Medical Commission (NMC) on May 23, 2022, for comments by all concerned, before it becomes mandatory in 2023. The NMC has also stated that it will take steps to ensure that the quality of generic drugs is maintained. The NMC will work with the Drug Controller General of India (DCGI) to ensure that generic drugs meet the required quality standards.

The final notification goes beyond drug prescription in generic names:

On August 03, 2023, The National Medical Commission (NMC) notified the professional conduct regulation for Registered Medical Practitioners (RMP). It not only provides guidance to avoid branded generic drugs and prescribing drugs with generic, non-proprietary and pharmacological names only, but also, restricts doctors from getting involved in any third-party educational activity like Continuing Professional Development, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector. 

It justified its decision by saying, “India’s out-of-pocket spending on medication accounts for a major proportion of public spending on health care. Further, generic medicines are 30% to 80% cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down health care costs and improve access to quality care.” The notification also provided guidance on telemedicine consultation and prescriptions.  

The Indian Medical Association (IMA) Protested against it:

The Indian Medical Association (IMA) submitted a memorandum to the Indian regulator, the National Medical Commission (NMC), on February 7, 2023, protesting against the compulsory prescription of generic drugs. The memorandum argued that the regulations would harm patients and doctors, and that they were being implemented without proper consultation with stakeholders.

The IMA also stated that the regulations would violate the fundamental right to freedom of speech and expression of doctors. The memorandum said that doctors should be free to prescribe drugs based on their medical judgment, and that they should not be forced to prescribe generic drugs.

The IMA’s protest is significant because it is the first major challenge to the NMC’s regulations on compulsory prescription of generic drugs. The protest could have a significant impact on the implementation of the regulations, and it could also lead to changes in the regulations.

It is important to note that the IMA is not the only organization that has expressed concerns about the NMC’s regulations. Several other medical associations have also expressed concerns, and some doctors have also spoken out against the regulations.

The controversy over the NMC’s regulations is likely to continue for some time. It is important to note that there are valid concerns on both sides of the issue. It is also important to remember that the regulations are still in the early stages of implementation, and that it is too early to say what their long-term impact will be.

A few reasons why doctors in India may be hesitant to prescribe drugs under generic names. 

Here are some of the most common reasons:

  • Lack of awareness: Some doctors may not be aware of the benefits of generic drugs. They may believe that brand-name drugs are always better than generic drugs, even though this is not always the case. 
  • Influence from pharmaceutical companies: Pharmaceutical companies often give doctors incentives to prescribe their brand-name drugs. This can create a conflict of interest for doctors, who may be more likely to prescribe brand-name drugs even if they believe that generic drugs are just as effective.
  • Patient demand: Some patients may specifically ask for brand-name drugs, even if generic drugs are available. This can put pressure on doctors to prescribe brand-name drugs, even if they believe that generic drugs are a better option.
  • Quality concerns: There have been some cases of counterfeit generic drugs being sold in India. This can lead to doctors being hesitant to prescribe generic drugs, as they may be concerned about the quality of the drugs.

Some ways to encourage doctors to prescribe generic drugs:

  • Educate doctors about the benefits of generic drugs. Doctors need to be aware of the benefits of generic drugs in order to be willing to prescribe them. They should be taught about the cost savings, increased access, and improved quality of generic drugs.
  • Reduce the influence of pharmaceutical companies on doctors. Pharmaceutical companies should not be allowed to give doctors incentives to prescribe their brand-name drugs. This would help to ensure that doctors are prescribing drugs based on the best interests of their patients, rather than on financial considerations. 
  • Encourage patients to ask for generic drugs. Patients should be aware of the benefits of generic drugs and should ask their doctors to prescribe them whenever possible. This will help to create a demand for generic drugs and encourage doctors to prescribe them. 
  • Improve the quality control of generic drugs. The government should take steps to improve the quality control of generic drugs in India. This would help to reduce the risk of patients getting counterfeit drugs. 

By taking these steps, we can encourage doctors to prescribe generic drugs and make them more accessible to patients. This would help to save patients money, improve access to medicines, and reduce the number of counterfeit drugs in circulation.

Conclusion:

I now revert to this month’s notification of the National Medical Commission (NMC) on the professional conduct regulation for Registered Medical Practitioners (RMP), providing  new guidance for drug prescriptions in India. It clearly indicates that doctors should avoid prescribing branded generic drugs, instead prescribe drugs with generic, non-proprietary and pharmacological names only. ‘However, in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, the practice of prescribing generic names only, can be relaxed,’ it elaborated.

Weighing the pros and cons of this notification, I reckon, despite the reasons articulated by doctors and their associations, besides the branded generic manufacturers, there are many benefits to prescribing drugs under generic names only. Generic drugs are typically much cheaper than brand-name drugs, and they are just as effective. They can also help to reduce the number of counterfeit drugs in circulation, besides several other benefits, as cited above. As a result, doctors should be encouraged to prescribe generic drugs whenever possible. Let me hasten to add, changing the prescribing practices of doctors and addressing concerns about the quality of generics can be a complex and gradual process.

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.