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From Share-of-Voice to Share-of-Outcomes: How Indian Pharma Is Rewriting Marketing

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If you zoom out on India’s pharma market over the past 18 months, one pattern jumps off the page: marketing is no longer just about pushing brands; it’s about owning moments across the care journey - from the first symptom search to diagnosis, therapy start, adherence, and even sustainability expectations from doctors and payers.

The winners are reframing “promotion” as evidence, services, platforms, and purpose—and doing it measurably. This post brings together recent Indian examples and global parallels so readers can see where India sits in a worldwide shift.

What’s New: Fresh Moves by Indian Pharma:

  • Corporate trust as a growth lever

Sun Pharma ran a large-scale multilingual corporate brand campaign in 2025 – TV, digital, OOH and OTT- explicitly positioning purpose to patients, physicians and talent. The campaign signals how corporate reputation is being deployed to protect and accelerate product launches.1

  • Consumerization & D2C pathways

Dr. Reddy’s launched a diabetes-focused direct-to-consumer platform, Celevida Wellness, aiming to combine commerce, education and services for people with Type 2 diabetes – an early Indian example of a product company building a services-and-data arm.2

  • Disease-first awareness, compliance-forward

Alkem’s Reliever-Free India outreach (large camp footprint and inhaler training) exemplifies how Indian firms are investing in disease-awareness programs that drive correct use and build measurable public-health outcomes.3

  • Sustainability in product differentiation

Lupin announced plans to use Honeywell’s Solstice Air (a near-zero‑GWP propellant) for pMDIs -moving sustainability into product choice and procurement conversations.4

  • Portfolio shaping for sharper marketing

Biocon sold its India branded formulations business to Eris Lifesciences to focus Biocon Biologics on biosimilars and specialty – an explicit marketing and commercial refocus through portfolio design.5

  • Performance media & culture-first acts

Mankind Pharma increased ad and promotion investment (FY25) and mounted high-frequency cultural placements (metro OOH, festival activations) while OTC brands like Micro Labs’ DOLO are leveraging sports partnerships for deeper regional penetration.6

Global Parallels: Comparable Strategic Moves Abroad:

  • Direct-to-consumer platforms – LillyDirect and PfizerForAll

Eli Lilly’s LillyDirect (launched Jan 4, 2024) and Pfizer’s PfizerForAll (2024) are examples of major global pharma firms building platforms that combine telehealth connections, patient resources and home delivery – aiming to own parts of the care journey and shorten friction between diagnosis and treatment start.7

  • Beyond-the-pill — Novo Nordisk & digital partnerships

Novo Nordisk has actively built digital partnerships and patient-support programs to improve onboarding, adherence and long-term outcomes for people on diabetes and obesity medicines -reflecting a strategic move from product to continuous care.8

  • Real-World Evidence & platform acquisitions — Roche + Flatiron

Roche’s acquisition of Flatiron (announced Feb 2018) showed how pharma can integrate oncology-focused EHR/data platforms to generate RWE that supports outcomes claims, clinical development and product positioning – an early example of platforms becoming central to commercial strategy.9

  • Performance and access-linked models

Across markets companies are experimenting with value/outcome-based contracting, digital therapeutics tie‑ups and service bundles that pay for verified starts or persistence rather than impressions – shifting commercial metrics from reach to results.

Why This Shift—Right Now:

  • Compliance tightening. Regulatory codes and disclosure expectations push companies away from gray‑area inducement and toward transparent, outcomes-oriented programs.
  • Platformized demand. E-pharmacies, marketplaces and hospital apps concentrate patient flows – owning (or partnering on) those flows creates a competitive moat.
  • Specialty and outcomes pressure. As portfolios skew to biologics and specialty care, market access increasingly depends on adherence, persistence and RWE-backed value propositions.
  • Sustainability salience. Green product attributes move from CSR to procurement levers in institutional tenders and buyer evaluations.

The Next: Plausible Futures:

A) Outcome-Backed Omnichannel

Marketing begins with adherence and persistence targets and reverse-engineers media, field and patient-support investments to hit those outcomes.

B) Platform Partnerships as Distribution

Co-branded digital pathways with hospitals, insurers and marketplaces replace many legacy trade schemes; contracts reward verified starts, not GRPs.

C) Green-Rx Differentiation

Climate credentials – low‑GWP propellants, recyclable packaging – become tender-winning features.

Risks to Watch:

  • Compliance surprises when disclosures don’t align with activations.
  • D2C initiatives without real services will have poor retention.
  • Superficial purpose claims invite backlash; purpose must map to measurable patient and system benefits.

Suggesting A Checklist:

Five actions pharma leaders can start this week:

  • Design for compliance: Turn UCPMP/Code needs into campaign requirements and audit trails.
  • Own one patient journey end-to-end: Launch a staffed PSP/D2C pilot for a flagship therapy and track 90‑day persistence.
  • Run twin-engine branding: Corporate trust campaigns + category growth programs measured separately.
  • Green your hero SKU: Brief R&D + procurement + brand to produce a climate-impact target and timeline.
  • Shape your portfolio for focus: Consider partnership/divestment to reallocate selling resources.

Conclusion: Closing Provocation:

For a decade Indian pharma marketing optimized messages and reach. The next decade will reward those who optimize behaviors and outcomes - with compliance, platforms and purpose built into launch plans from day one.

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.

Sources

  1. Sun Pharma corporate campaign press release / media note, May 2025 ↩
  2. Dr. Reddy’s Celevida Wellness press release, Oct 25, 2023 – Economic Times coverage ↩
  3. BW HealthcareWorld – Alkem Reliever-Free India coverage, 2023–24 ↩
  4. Honeywell & Lupin joint release, May 2025 – Times of India coverage ↩
  5. Reuters – Biocon divestment to Eris Lifesciences, Mar 14, 2024 ↩
  6. Exchange4Media / Storyboard18 – Mankind Pharma campaigns and filings, 2024–25 ↩
  7. Eli Lilly LillyDirect press release, Jan 4, 2024 / PfizerForAll press release, 2024 ↩
  8. Novo Nordisk – NovoCare and digital partnership resources ↩
  9. Roche acquisition of Flatiron press release, Feb 2018 ↩

Indian Pharma Marketing’s AI Moment: Lead the Change or Fall Behind

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(With An Actionable AI Adoption Checklist below for Indian Pharma Marketers)

India’s pharmaceutical market is one of the most complex and exciting in the world. With over 60,000 brands battling for attention, millions of patients, and a healthcare landscape rapidly evolving, marketing here is anything but straightforward.

For pharma marketing leaders – whether you head brands, commercial strategy, or sales and marketing – the challenge is clear: how do you cut through the noise and connect meaningfully with doctors and patients? Today, its answer squarely lies in Artificial Intelligence (AI).

Global Leaders Are Already Ahead – What About Us in India?

Globally, pharma giants like Pfizer, AstraZeneca, and Novartis have woven AI deep into their marketing playbooks. They use AI to understand doctors’ prescribing habits, create content faster, and personalize engagement at scale. Meanwhile, many Indian teams still rely on broad, one-size-fits-all campaigns, manual content production, and intuition-based decisions.

But the Indian market is changing fast. Expected to nearly double from $65 billion today to $120 billion by 2030 (IBEF, 2024), the competition will intensify. The doctors and patients you want to reach are getting digitally savvy and demand relevant, personalized communication.

Unlocking Market Potential with AI:

AI can sift through massive datasets – prescription trends, regional demand shifts, and social media chatter – and reveal opportunities that traditional methods miss.

For example, Dr. Reddy’s reportedly uses AI to forecast oncology and dermatology demand regionally, tailoring messaging and supply accordingly. However, only about 25% of Indian pharma marketers use AI for segmentation and forecasting (EY India, 2024), leaving a huge gap – and opportunity.

Crafting Distinctive Brand Identities with AI:

AI doesn’t just analyze data; it helps craft brands that stand out. Cipla used AI-powered sentiment analysis to sharpen respiratory care campaigns, winning industry awards in 2024. Instead of guesswork, you get real-time insights into what doctors and patients want.

Accelerating Content Creation:

Producing multilingual, compliant, and scientifically accurate content manually is slow and expensive. Pfizer reduced content production time by 40% globally using AI. Novo Nordisk India simplifies complex clinical data for doctors through AI tools.

For Indian marketers, this means faster, fresher, and more engaging content without exploding costs.

Personalizing Engagement with Healthcare Providers:

The old “one message fits all” approach is dead. AI enables personalized outreach tailored to each doctor’s specialty, region, and prescribing behavior.

Doceree’s AI-driven campaigns in India have delivered 2.5 times more engagement than traditional outreach, proving precision pays off.

Measuring Impact and Maximizing ROI:

Many marketers struggle to see which activities actually drive prescriptions. AI-powered attribution models provide clarity, showing exactly where marketing investments perform best.

EY (2024) reports that AI attribution improves ROI visibility by up to 60%, enabling smarter budget decisions.

An Actionable AI Adoption Checklist From Me for Indian Pharma Marketers:

Start Small:

  • Pilot AI-generated content for one key brand or therapy area.
  • Deploy AI-powered social listening to monitor patient and physician sentiment.
  • Test AI-driven prescriber segmentation to prioritize outreach.

Scale Smart:

  • Integrate AI into your CRM and Customer Lifecycle Management (CLM) systems for real-time insights.
  • Implement AI-enabled marketing attribution tools to optimize spend allocation.
  • Develop AI-driven personalized multi-channel campaigns.

Build a Future-Ready Team:

  • Train your marketing team on AI tools and data literacy.
  • Collaborate with AI-focused technology partners familiar with pharma compliance.
  • Establish cross-functional teams bridging marketing, IT, and analytics.

Measure and Iterate:

  • Use AI dashboards to monitor campaign performance continuously.
  • Reallocate budgets dynamically based on AI insights.
  • Regularly update AI models with new market and behavioral data.

Conclusion: 

Thus, I reckon: Today AI Is Not a Luxury – It’s Your Lifeline

The Indian pharma market is poised for explosive growth and complexity. The brands that win will be those that embrace AI – not as a trendy tool but as the core of their marketing strategy.

Whether you lead brand strategy, commercial marketing, or sales enablement, AI will keep you relevant, agile, and ahead.

Are you ready to start and get your team moving?

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.

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.

 

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.

With Covid’s Second Wave ‘A Nation In Distress’ – Why?

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If someone tries to see a silver lining in the disruptive Covid-19 pandemic, besides its vaccine rollout in some countries, there will be at least one. As of April 17, 2021- over 119 million patients (India – over 12 million), reportedly, have recovered out of 141 million (India – over 15 million) of Covid infected patients.

But this can’t mask the grim reality of over 18 million patients remain still infected, with over 3 million deaths (India – 175,673), since the beginning of the Covid menace. In the Indian perspective, this is the highest ever incidence of death – in absolute numbers – for any reason, so far. Now comes the Covid second wave with its more devastation onslaught on human lives and other consequences for the nation.

In this article, I shall explore this area, as apparently a Tsunami-like the second Covid wave starts sweeping across the India states, posing a greater danger than the first one, to the lives and livelihoods of millions of Indians, yet again. Let me start with a perspective, leading to the current situation.

No clinically proven drugs, as yet:

There aren’t any definite or clinically proven drugs after completion of Phase III studies, as yet, for curing patients from Covid infection. Nor are there any such well proven vaccines with fully known efficacy, safety, time interval between two doses, duration of prevention from Covid infection, in the future. All drugs and vaccines are currently being used under ‘emergency use’ approval by country drug regulators, based on interim results.

At the very onset of Covid-19 first wave, other than some attempts of repurposing older drugs, the world did not have any proven drugs to fight against this deadly infection. The old antimalarial drug Hydroxychloroquine – was tried first, followed by other medications, such as, Lopinavir/Ritonavir. Both created a huge global demand and subsequent shortages, including in the pharmacy of the world– India. Subsequently, W.H.O discontinued hydroxychloroquine and lopinavir/ritonavir treatment arms for COVID-19 based on interim clinical trial data. These results showed, hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care.

At the beginning of the second wave of Covid-19, one of the latest repurposed drugs – remdesivir that is being widely used, especially for hospitalized patients, is also facing a shortage, even in the pharmacy of the world. Interestingly, even ‘Remdesivir has little or no impact on survival, WHO trial shows’.

Also – no clinically fully proven Covid-19 vaccines, as yet:

Possibly, the second-best antidote as of date, against rapidly mutating Covid-19 – after Covid-appropriate behavior by all, comes vaccines. All comes with ‘emergency use’ approval, based on interim results only, and with several challenges. These include efficacy against all mutating Covid-19 variants, exact safety profile, dosage interval and duration of protection. Interestingly, on April 16, 2021, Pfizer indicated that ‘Covid-19 vaccine recipients will “likely” need a third dose between six to 12 months after they’re fully vaccinated and suggested vaccinations for coronavirus could be needed every year.’ In this evolving scenario, Indian experts also acknowledge that - abidance to the defined health norms stays as a lifeguard, and will remain so for an indefinite period.

Several countries, including India, are making, and gradually expanding requisite arrangements to vaccinate their population. Whereas a large number of countries – mostly in the developing world, are still awaiting access to Covid vaccines. Meanwhile, another issue has started bothering many, which the April 10, 2021 issue of The Guardian had captured in its headline – ‘Global Covid vaccine rollout is threatened by a shortage of vital components,’ besides manufacturing capacity constraints compared to the current demand.

Global challenges with Covid vaccines in 2021:

As things have progressed with Covid vaccines, thus far, the year 2021 doesn’t seem to be a smooth run to vaccinate people across the world, deriving a significant outcome against the battle of this global menace. This gets vindicated by the following numbers, as published in the ‘Down to Earth’ magazine on April 13, 2021.

  • According to the Johns Hopkins University, United States, as of April 12, 2021, only 773 million Covid-19 vaccines had been administered across the world. This means, only a little more than 2 per cent of the world’s adult population, has been inoculated so far.
  • According to data analytics firm Airfinity, the world will manufacture 9.5 billion doses by the end 2021. Whereas immediate global need exceeds 14 billion doses to vaccinate the entire adult population.
  • According to Gavi – The Vaccine Alliance, this represents almost three times the number of vaccines the world was producing in the pre-pandemic period for other diseases.

In the midst of these, inoculation with, at least, two major Covid-19 vaccines – one from AstraZenecaand other from Johnson & Johnson, have raised safety concern in the United States and many European countries. These ongoing developments complicate Covid vaccine challenges further.

The Indian scenario – ‘a nation in distress?’

Despite building new and a workable emergency health infrastructure by several state governments to combat Covid-19 pandemic, the fierce attack of the second wave with mutating Covid-19 virus, has already made these bursting at the seams. The article - ‘A tsunami of cases’: desperation as Covid second wave batters India, appeared in ‘The Guardian’ on April 14, 2021, captures this desperate struggle of the nation. Another recent report depicted with grim pictures, how India is grappling with the second wave of Covid-19, terming it as ‘a nation in distress.’ There are enough indications that India’s fragile health infrastructure has already collapsed in some places.

According to another news item on April 14, 2021, more than 111 million people has been vaccinated in India, by that time. Notably, this number was achieved after fears of AstraZeneca’s Covishield vaccine shortages, which subsequently prompted the Indian Government to temporarily halt its exports by the Pune-based vaccine manufacturer – Serum Institute of India (SII).

Going by another estimate, if the current momentum continues, India would be able to vaccinate 40% of its population by December 2021, and 60% of the population by May 2022. The report cautions that ‘the non-availability of vaccines may scuttle the pace.’ As per the W.H.O release, three in five Indians need to be vaccinated, to reach herd immunity. For which, the country needs 145 crore doses of vaccine by May 2022. India currently has the capacity to manufacture 100 crore-130 crore doses per year, as per a Rajya Sabha committee report. Another report of April 10, 2021 also highlights, ‘at least 10 states in India have reported a vaccine shortage and many vaccine centers have been reported shut.’

My wife and I also experienced the Covishield vaccine shortage in Mumbai. Our scheduled online appointment for vaccination through Co-Win website of the Government at Sir HN Reliance Hospital,Girgaon, Mumbai, for April 17, 2021, was cancelled. At past 10 pm on April 16, 2021, the hospital rang us up to inform that they have closed their Covid vaccination center till fresh vaccine stocks reach them.

To combat the Covid pandemic – ‘Pharmacy of the World’ goes local:

Yes, to combat the Covid pandemic, the ‘Pharmacy of the World’ goes local for some critical Covid drugs and vaccines, several times in the past. This happened earlier with drugs, like Hydroxychloroquine, when India banned its export to cater to the domestic need for Covid treatment. It happened again now, as ‘Remdesivir, API and formulation were placed under Export ban on 11.04.2021.’

Similarly, India has now, reportedly, put a temporary hold on all major exports of the AstraZeneca’sCoronavirus vaccine (Covishield in India), made by the SII, amid an increase in domestic demand due to a surge in infection. As the news item highlights: ‘It will also affect supplies to Gavi, the W.H.O backed vaccine alliance, through which more than 190 participating economies – 98 higher-income and 92 low and middle-income, are expected to get vaccine doses.’ Such temporary measures are now necessary for India to effectively respond to India’s Covid fight – especially the vaccine crunch.

India’s current vaccine imbroglio, as Covid second wave strikes hard:

Besides the SII, a second Indian company — Hyderabad-based Bharat Biotech, was given permission in January for emergency use of its Covaxin, developed in collaboration with the ICMR. Although, Bharat Biotech can make 12.5 million doses each month, these will be a small proportion of the doses administered in the country, so far.

To effectively respond to the prevailing vaccine crunch, Indian Government already approved the ‘emergency use’ of Sputnik V vaccine, which will be imported till its domestic production commences. Further, the country’s health authorities have now decided to consider the grant of ‘emergency use’ approval of several other internationally developed vaccines, such as, Pfizer – BioNTech double-dose vaccine and Johnson & Johnson’s single-shot vaccine. At least, till then, India’s vaccine imbroglio to vaccinate all adult population in the country, irrespective of age – particularly when Covid second wave is not sparing the young adults, is expected to continue.

Conclusion:

The jaw-dropping pandemic situation, and the pathway to deal with this crisis, especially in India, is getting increasingly complicated in every passing day. As reported on April 16, 2021, Covid-19 is now fooling RT-PCR tests – the most reliable type of Covid test as on date. It is so alarming because: ‘A false negative report is bad for the patient as they might delay consulting a doctor. It’s also bad for others, as the patient might not isolate, and spread the virus around,’ as the report underscores. It has started happening because: ‘Multiple mutations in the coronavirus over 15 months are making parts of it unrecognizable to lab tests.’

Experts are trying to fathom, whether or not more people are dying in India’s Covid second wave, as compared to the equivalent time period of the first wave. This causes an added cause of great concern because, in the six months before the start of the second wave (from September 2020 to January 2021), India’s overall case fatality rate (CFR) was only around 1.1%. This means only 1.1% of cases resulted in deaths. Currently, at the very beginning of the second wave, CFR has already increased to 1.3% and remains below peak levels seen in the first wave – as of date.

Above all, many people – virtually from all social, political, religious and economic strata, are openly flouting the basic norms of Covid appropriate behavior, as daily seen on different TV news channels. Ironically, these are happening at a time, when Indian health care infrastructure is creaking against the enormous and devastating power of the second wave Covid pandemic.

‘Pharmacy of the world’ has also gone local for some critical Covid-19 drugs and vaccines, to save lives and livelihoods of the Indian population, having no other better alternative in sight, at this hour. Isn’t this a sign of ‘A Nation in Distress’ that makes a fervent appeal to all of us, at least, to behave properly – by religiously following the lifesaving Covid guidelines?

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.

 

Shifting Pharma Supply Chain Strategy From Global To Local

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Alongside large-scale disruptions of many critical industrial operations, Covid-19 global pandemic took the wind out of the sail of pharma supply chain, as well, at the very onset of lockdowns. This happened in many countries around the world, including the largest global pharma market – the United States, and also in ‘the pharmacy of the world’ – India.

That there were such disruptions in India, both in procurement and logistics, during the national lockdown, was widely reported in the media. Besides product non-availability, cost of goods also went up significantly in several cases.

From this perspective, I shall deliberate in this article, how different countries are contemplating to respond to any similar crisis in the future, primarily to safeguard patients’ health interest, despite some opposition, though. To drive home the points, I shall cite examples from India and the United States, as specified above.

Supply Chain vulnerability of the ‘largest pharma market of the world’:

There are several examples to vindicate such vulnerability, both for the US and also India. From the US perspective, the country’s supply of generic and branded medicines are, reportedly, heavily rely on emerging markets, like India and China.

This point has now ‘come under close scrutiny of the American policy makers, as COVID-19 sends shockwaves through the industry. According to the US Food and Drug Administration, China and India represent 31 percent of the plants that are registered with the US to supply Active Pharmaceutical Ingredients (API), as of August 2019. The details are as hereunder:

Place

United States

European Union

India

China

Rest of the world

Canada

%

28

26

18

13

13

2

It is worth noting, the number of facilities in China supplying APIs has, reportedly, more than doubled since 2010 – to 13 percent of all those serving the US market.

Examples from India:

The outbreak of Coronavirus had just not shut factories in China - impacting supplies and leading to fears of a shortage of drugs and medicines. It happened in India, too. Several critical supply chain issues were reported during this period. For example,  a major Indian drug manufacturing hub - Baddi,reportedly, was either shut down or operated with reduced capacity, since COVID-19 pandemic related national lockdown.

Its impact also got captured by the twitter handle of the former USFDA Commissioner – Scott Gottlieb. He twitted, “Drug supply chain at risk as Asia’s largest pharmaceutical manufacturing hub in Baddi (an industrial town in southwestern Solan district of Himachal Pradesh, India) is declared a #COVID19 containment zone – forcing many pharma units to slow or stop operations.”

Supply Chain vulnerability of the ‘pharmacy of the world’:

Supply Chain vulnerability related to the domestic issues in India, can possibly be sorted out by the country’s decision-making authorities. However, the country’s vulnerability arising out of the reasons originating in the other countries, needs a greater priority focus of the nation.

As is widely known – India caters to about 20 percent of the world’s generic drug supply. However, according to Bloomberg, 70 percent of the country’s imports of APIs come from China, ‘totaling US$ 2.4 billion of India’s US$ 3.56 billion in import spending for those products each year.

Consequently, ‘pharma companies in the country are dependent on China for two-thirds of the chemical components needed to make them.’ Exposures of such nature are now coming on to the center table – mostly triggered by Covid-19 pandemic, both in India, as well as in the United States.

India is reevaluating its import dependence from China:

To illustrate this point, let me begin with some related recent developments. While reevaluating the import dependence, India has taken both immediate and medium to long term measures – at the policy level.

The immediate reaction of India to Covid-19 outbreak, was to shift focus on local with restricted export of common medicines, such as paracetamol and 25 other pharmaceutical ingredients and drugs made from China. Curiously, prior to the national lockdown, on March 17, 2020 by a written reply the Government had informed the Indian Parliament about the import of APIs /drugs and the extent of the country’s dependence on China for the same.

Be that as it may, to protect the local interest, the above ban was followed by another export ban of the age-old malarial drug - hydroxychloroquine, ‘touted by President Trump as a possible weapon in the fight against Covid-19,’ but has been in short supply, globally. Interestingly, India produces around 47 percent of the U.S. supply of hydroxychloroquine. Thus, understandably, Indian Government had to partially lift this ban after the U.S. President Donald Trump sought supplies for the United States.

For medium longer-term measures, while announcing a ₹20 lakh crore stimulus package, Prime Minister Narendra Modi articulated that Covid-19 pandemic had taught India to ramp up domestic production and create supply chains to meet internal demands. Earlier, for safeguarding ‘national healthcare security’, the Government had allocated US$ 1.2 billion for the pharma industry to be self-reliant, by reducing its import dependence, especially for APIs. The government also wants to finance the construction of three bulk drugs with an investment of ₹300 Crores.

The United States is reevaluating import dependence from one region:

The Fierce Pharma article of June 03, 2020 also reported a shifting focus of supply chain from global to local, as the United States seeks to ‘onshore’ drug production, with the fallout of Covid-19 pandemic looming large on its drug supply chain.

U.S. legislators have argued that ‘U.S. reliance on drugs made or sourced outside the country has created a security issue that could be addressed by erecting parallel supply chains stateside and eliminating reliance on potential bad actors abroad.’ Accordingly, they have put forward ‘a raft of legislation’ that would seek to “onshore” drug manufacturing at the expense of major producers abroad.

Its biggest obstacle could be the pharma industry and its lobbyists:

Nevertheless, the same article also underscores that the biggest obstacle to that plan could be the pharmaceutical industry and its lobbyists on Capitol Hill. This is because, PhRMA - the industry’s biggest lobbying group, has pushed back against Congressional support for a supply chain shake-up. It said, “Policymakers must take a long-term, more holistic look at global pharmaceutical manufacturing supply chains before jumping to rash proposals that may cause significant disruptions to the U.S. supply of medicines.”

Will it happen in India?

My article, published in this blog on February 03, 2020, also focused on this issue. There I had emphasized, about five years back - the Government of India had also announced on February 25, 2015 – terming ‘2015 – Year of Active Pharmaceutical Ingredients’ (API). This came after ascertaining that over-dependence on imports of bulk drugs or API, especially from China, is detrimental to India’s health interest. This decision was also in sync with the freshly announced, and well-publicized government objective regarding ‘Make in India’, I wrote.

Two years down the line from the above date, on July 15, 2017, eHEALTH publication also deliberated on this issue in an article – ‘Why over dependence on APIs imported from China is harmful for India?’ However, not much change has been witnessed till date, in this regard. The same vow is now being taken afresh. Nonetheless, let me hasten to add, Covid-19 has changed the life of all – in several respects. Thus, no one can possibly vouch with a high degree of certainty what can happen hereafter, as we move on.

Conclusion:

As the ‘Lockdown. 05’ or ‘Unlock down. 01’ begins in India – the ‘pharmacy of the world, as on June 02, 2020 morning, the recorded Coronavirus cases in the country reached 247,040 with 6,946 deaths. India is now racing ahead with its number Covid-19 cases, surpassing Italy and Spain, occupying the global fifth rank, in this regard. Whereas, the top ranked pharma market in the world – the United States, where Covid-19 struck hard before India, recorded 1,988,545 cases with 112,096 deaths, on the same day.

Thus, the need to have a fresh look at the strategic design of pharma supply chain is being felt in both these countries. The requirement for becoming less global and more local is attracting a priority focus of Governments in both countries. With an increasing State-push for safeguarding the health security of the country, the need to reshape pharma supply chain – call it transient or otherwise, is now more palpable than ever before.

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.