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

Posted on September 7, 2025 by Tapan Ray

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

Navigating Potential US Tariffs: Challenges and AI-Driven Opportunities for Indian Pharma

Posted on August 9, 2025 by Tapan Ray

India’s pharmaceutical industry, reportedly supplying 47% of US generic drugs and exporting $27.9 billion in FY24, faces the threat of 10-25% US tariffs under a potential Trump policy. Major players like Sun Pharma, Dr. Reddy’s, Cipla, Lupin, and Aurobindo, reportedly deriving 30-50% of revenues from the US, must prepare despite tariffs not yet being imposed. This article examines the challenges and AI-driven opportunities, emphasizing the need to protect the Indian Patents Act, 2005, during US trade talks, with Indian and global examples.

Challenges of Potential US Tariffs:

Profit Margin Pressures: Generics operate on 10-15% margins. A 10% tariff could cut EBITDA by 1-2%, while 25% could slash profits by 5%, hitting firms like Aurobindo and Zydus Lifesciences. Raising prices risks losing US market share, where generics fill 90% of prescriptions.
Supply Chain Risks: The US lacks immediate alternatives to India’s generics. Building US facilities could take 3-5 years and cost six times more. Tariff uncertainty could worsen the 271 US drug shortages in Q3 2024.
Competitiveness Threats: Tariffs could erode India’s cost edge, especially if competitors face similar tariff. This deters investment in India’s 20% global generic supply share.
Strategic Uncertainty: Tariff uncertainty complicates planning. US facilities need 12-24 months for FDA approvals and $50-100 million, risky without clear policies.

AI-Driven Opportunities:

AI can help Indian pharma navigate tariff threats by boosting efficiency and exploring new markets. Key strategies include:

1. AI-Driven R&D for High-Value Products:

AI accelerates development of high-margin biosimilars and specialty drugs, less tariff-sensitive.

Indian Example: Sun Pharma, reportedly used AI in 2024 to optimize ILUMYA (tildrakizumab) trials, cutting costs by 20% and time by six months.
Global Example: Pfizer’s 2023 Watson AI partnership reduced rare disease drug development time by 30%, saving $120 million. Indian firms can use similar tools.

2. Supply Chain Optimization:

AI enhances supply chain resilience, cutting costs and preparing for tariffs.

Indian Example: Dr. Reddy’s 2024 SAP AI platform, reportedly optimized atorvastatin inventory, reducing logistics costs by 15%.
Global Example: Merck’s 2022 Blue Yonder AI system saved $100 million annually, cutting stockouts by 25%. Indian firms can adopt similar tools.

3. Market Diversification:

AI identifies new markets like Africa and ASEAN, reducing US reliance.

Indian Example: Cipla’s 2024 Salesforce Einstein Analytics, reportedly boosted East African exports by 25%, adding $50 million in revenue.
Global Example: Novartis’ 2023 AWS AI expanded Southeast Asia sales by 18% ($200 million). Indian firms can target similar markets.

4. AI-Enhanced Manufacturing:

AI optimizes production, lowering costs to offset tariffs.

Indian Example: Biocon’s 2023 Bangalore AI facility, using Rockwell Automation, reportedly improved insulin production efficiency by 22%, saving $30 million.
Global Example: Roche’s 2024 Siemens AI platform in Switzerland cut antibody production costs by 15%. Indian firms can invest similarly.

5. AI in Regulatory Compliance:

AI streamlines FDA compliance, ensuring market access.

Indian Example: Aurobindo’s 2024 Deloitte AI tool, reportedly cut FDA audit preparation time by 40% for metformin.
Global Example: Amgen’s 2023 Accenture AI system improved biologics approval rates by 25%. Indian firms can adopt similar tools.

Strategic Recommendations:

Invest in AI: Allocate 5-10% of revenues to AI, following Sun Pharma’s, reportedly $500 million R&D model.
Protect Patents Act: In US trade talks, like the UK FTA, India must uphold the Indian Patents Act, 2005, especially Section 3(d), to preserve affordable generics.
Secure Trade Agreements: Push for a US trade deal targeting $500 billion by 2030 to avoid tariffs.
Diversify Markets/Products: Use AI to prioritize high-margin drugs and new markets.
Partner with AI Leaders: Collaborate with Google, IBM, or SAP for tailored AI solutions.

Conclusion:

Potential US tariffs threaten Indian pharma’s profits, supply chains, and competitiveness, but they also spur innovation. AI can enhance R&D, supply chains, market diversification, manufacturing, and compliance. Examples from Sun Pharma, Dr. Reddy’s, Cipla, Biocon, Aurobindo, Pfizer, Merck, Novartis, Roche, and Amgen show AI’s potential. India must protect the Indian Patents Act, 2005, in US trade talks to maintain its generics edge. By embracing AI and strategic advocacy, India can turn tariff threats into opportunities to lead globally.

By: Tapan J. Ray

Sources:

Trump Tariff to Push Indian Pharma Co to Embrace AI, Cost-Efficient R&D | analyticsindiamag.com
Donald Trump tariff relief for now: India’s pharma sector navigates an uncertain US trade future – Times of India
How Trump tariffs could impact Indian pharma’s $8.7 bn dream run – India Today
Trump Tariffs: Impact & Opportunities in Indian Pharma – www.moneymuscle.in
The future of India-US pharmaceutical trade – www.pharmaceutical-technology.com
Indian Pharma Braces For Trump Tariff Fallout – Forbes India
Indian pharma companies escape Trump’s reciprocal tariffs, for now – www.livemint.com
5 Indian Pharma Companies That Could Be Impacted by Trump’s Tariff Move – www.equitymaster.com
Indian Pharmaceutical Alliance Annual Report 2024 – www.ipa-india.org
US FDA Drug Shortage Database, Q3 2024 – www.fda.gov
India-UK FTA: Safeguarding the Indian Patents Act – www.financialexpress.com

Pills and Payments: India’s Unethical Drug Marketing Problem

Posted on June 27, 2025 by Tapan Ray

The recent exposé by The Economic Times, titled “Rx Name Unethical practitioners,” published on June 19, 2025, which brought to light allegations of a prominent global pharmaceutical company sponsoring extravagant foreign trips for doctors in violation of ethical codes, serves as an urgent reminder, yet again, of the persistent and deeply entrenched malpractices plaguing India’s pharmaceutical marketing landscape. While India proudly holds the title of “pharmacy of the world,” this distinction is increasingly overshadowed by unethical practices that jeopardize public health, distort prescribing patterns, and erode trust in the medical profession.

The Anatomy of Malpractice: A Systemic Issue:

The incident, highlighting the Department of Pharmaceuticals (DoP) apparently shielding names despite clear breaches, underscores a systemic failure in accountability. Unethical marketing manifests in various forms:

“Freebies” and Inducements: Offering gifts, money, travel, and hospitality directly influences prescribing behavior. This leads to unnecessary prescriptions, a preference for expensive branded drugs, and the over-medicalization of minor ailments.
Misleading Claims: Companies make unsubstantiated or false claims, misleading both professionals and the public, often with dangerous health impacts as highlighted by the Supreme Court.
Undue Influence in CME: Company-sponsored educational events often serve as thinly veiled marketing opportunities, subtly promoting specific products.
Lack of Transparency: The refusal to disclose names of doctors involved in unethical practices exemplifies pervasive opacity, shielding wrongdoers.

Why Self-Governance (UCPMP) Is Not Working and Malpractices Persist:

Despite the notification of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024, malpractices continue to thrive. This is primarily because the UCPMP, even in its revised form, relies heavily on self-governance, which has proven ineffective.

Why Self-Governance Fails:

Not a Full Law: While the UCPMP 2024 has moved from “voluntary” to “quasi-statutory,” it still isn’t a strong, legally binding law passed by Parliament. This means there are no direct legal punishments for violations. The DoP can only “recommend” action to other bodies or associations, lacking the power to impose immediate, significant fines or sanctions. Companies know this, which reduces their incentive to fully comply.
Weak Punishments and Enforcement: The penalties under the UCPMP are often too light to deter large pharmaceutical companies, for whom the profits from unethical practices far outweigh a mere reprimand or expulsion from an industry association. Enforcement relies heavily on industry associations themselves (through Ethics Committees for Pharmaceutical Marketing Practices – ECPMPs). This creates a conflict of interest, as these associations are made up of the very companies they are supposed to regulate. There’s a natural tendency for these committees to be lenient or prioritize industry interests over stricter compliance.
Lack of Proactive Investigation: Enforcement largely depends on complaints being filed. This means many unethical practices go unreported or unaddressed, especially when there’s an imbalance of power, making whistleblowing risky. The system isn’t designed for active investigation, but rather reactive response.
Deep-Rooted Culture of Incentives: The Indian pharmaceutical market is highly competitive. Companies face immense pressure to push their products. The ingrained culture of offering incentives, even subtle ones, has become a “cost of doing business.” When competition is fierce, relying on competitors to self-regulate fairly is often wishful thinking.
Loopholes and Vague Rules: Despite revisions, the code may still have gaps, or new, indirect ways companies promote drugs might not be clearly covered. For instance, the lack of mandatory public disclosure for payments made to doctors for research or advisory roles is a significant loophole that allows conflicts of interest to remain hidden.

In essence, self-governance simply isn’t strong enough to counter the massive financial incentives driving unethical marketing. It relies on goodwill and internal discipline in an industry where competitive pressures are intense, leading to a situation where the rules exist, but the teeth to enforce them are missing.

The Ripple Effect: Impact on Public Health and Trust:

These malpractices inflict significant harm: patients receive inappropriate or excessive treatments, leading to higher healthcare costs. Public trust in doctors and drug companies erodes, and market competition is distorted.

Moving Ahead: A Stronger Path to Ethical Marketing for Viksit Bharat:

Ensuring ethical pharmaceutical marketing practices is not just a matter of professional integrity; it is a fundamental pillar for achieving India’s cherished vision of Viksit Bharat by 2047. A developed nation thrives on a healthy, productive populace and a healthcare system rooted in trust and equity, free from commercial exploitation. The UCPMP 2024 is a vital starting point, but its success – and indeed, its contribution to this national ambition – hinges on taking critical next steps:

Make UCPMP a Full Law: The code must become legally binding with clear, stringent punishments directly under a parliamentary act. This means no more personal benefits for healthcare professionals, strictly enforced by law.
Stronger Oversight and Enforcement: Create an independent, empowered regulatory body with real power to investigate, impose significant penalties, and ensure timely resolution of complaints. Regular, proactive audits of marketing expenses, strong whistleblower protection, and, crucially, publicly naming companies and professionals found guilty are vital for accountability. Inspired by global best practices such as the US Physician Payments Sunshine Act, which mandates public disclosure of payments to healthcare providers, this level of transparency is critical. Better coordination between the DoP, National Medical Commission (NMC), Income Tax Department, and Competition Commission is also essential.
Empower Doctors and Promote Ethics: Medical schools must focus more on ethical practice. The NMC and State Medical Councils must consistently act against doctors who break rules. Encouraging doctors to prescribe generic drugs and supporting independent medical education are key steps.
Industry Must Adapt to Real Regulation: While industry associations can support compliance, the primary responsibility for enforcement must shift from self-regulation to an external, statutory body. Companies must be mandated to comply, not just encouraged.
Educate the Public: Inform people about their rights, how marketing can influence prescriptions, and the importance of generic alternatives. Also, encourage reporting of misleading drug ads.

Conclusion:

The path to ethical pharmaceutical marketing in India is challenging but vital. It needs a united effort from the government, regulators, drug companies, doctors, and the public. The June 19, 2025, revelations, as brought forth by The Economic Times, serve as a critical turning point. By committing to transform the UCPMP into a fully statutory and robustly enforced framework through the vital steps outlined above, we can effectively turn the bitter pill of malpractices into the sweet success of ethical healthcare, laying a crucial groundwork for a healthier, more prosperous, and truly developed ‘Viksit Bharat’ by 2047.

By: Tapan J. Ray

Revolutionizing Indian Pharma: The Rise of AI and Its Transformative Impact

Posted on March 13, 2025 by Tapan Ray

I find it fascinating that some well-established consulting firms like E&Y have recently published multiple reports on AI in the pharmaceutical industry. These reports, often released alongside industry events or as part of broader research initiatives, provide valuable insights rather than a single definitive publication.

Notably, these studies incorporate survey findings from industry executives and in-depth analyses of AI’s evolving role within the pharmaceutical sector. A closer examination of these reports reveals key takeaways that could inspire many:

AI is driving a major shift in pharmaceutical marketing – Around 50% of Indian pharmaceutical companies have launched AI-driven initiatives, with 25% advancing to full-scale implementation.
Adoption levels vary widely – The depth and scale of GenAI integration differ significantly across individual companies.
AI holds immense potential for productivity gains – Studies project an estimated 30-40% improvement in efficiency by 2030.

In essence, Indian pharmaceutical companies are increasingly recognizing AI’s transformative power in marketing and beyond. However, for this momentum to sustain, responsible AI governance and strategic investments in AI talent are crucial. While challenges remain, the trend signals a strong and growing commitment to AI adoption.

Its Game-Changing Impact:

AI, as it emerges, is not just enhancing pharmaceutical marketing in India—it’s redefining it, as I shall narrate below. With AI at the helm, many drug companies are unlocking unprecedented levels of efficiency, cost-effectiveness, and customer engagement. As adoption accelerates, the industry is poised for a radical transformation, delivering game-changing advantages:

Unparalleled Efficiency – AI-driven automation streamlines workflows, eliminates bottlenecks, and accelerates decision-making.
Strategic Cost Optimization – Smart resource allocation minimizes waste and maximizes return on investment.
Revolutionized Customer Engagement – AI enables hyper-personalized interactions, predictive insights, and real-time responsiveness.
Exponential Productivity Gains – AI-powered analytics and automation fast-track data processing and market intelligence.

Thus, I reckon, AI is no longer optional—it’s the driving force behind the next era of pharmaceutical marketing. As its influence deepens, Indian pharma is evolving into a smarter, faster, and more adaptive powerhouse, ready to meet the demands of an increasingly dynamic healthcare landscape.

A Look At The Depth of AI-Powered Transformation in Indian Pharma Marketing:

A large number of Indian pharmaceutical companies are rapidly integrating AI into their marketing strategies, revolutionizing efficiency, engagement, and precision. Here are key examples of AI-driven innovations in some key areas across the industry, as compiled from available documents:

Predictive Analytics for Sales Forecasting – Sun Pharma uses AI to anticipate sales trends, optimize inventory, and tailor regional marketing strategies.
Chatbots for Customer Interaction – Cipla employs AI-powered chatbots to provide real-time responses, enhance engagement, and disseminate product information.
Programmatic Advertising – Dr. Reddy’s leverages AI to precisely target healthcare professionals and patient demographics, boosting campaign efficiency.
Content Personalization – Glenmark utilizes AI to deliver tailored digital content to healthcare providers based on their specialties and interests.
Market Basket Analysis – Torrent Pharma applies AI to analyze prescribing patterns, identifying cross-selling and bundling opportunities.
Sentiment Analysis – Lupin monitors social media and online discussions using AI-driven sentiment analysis to refine marketing strategies.
Virtual Reality (VR) for Product Demonstrations – Zydus Cadila combines AI with VR to create immersive product presentations for healthcare professionals.
Email Campaign Optimization – Biocon enhances email marketing with AI, optimizing content, subject lines, and timing for higher engagement.
Voice-Activated Assistance – Aurobindo Pharma develops AI-driven voice assistants to provide instant support to healthcare professionals.
Compliance Monitoring – Novartis India employs AI to ensure marketing materials adhere to regulatory standards, reducing compliance risks.

The large number of examples highlight AI’s growing influence in Indian pharma marketing, driving smarter, more effective, and highly targeted engagement with stakeholders.

Conclusion:

AI adoption in Indian pharmaceutical marketing is accelerating, with nearly 50% of companies initiating AI-driven projects and 25% moving toward full-scale implementation. Both domestic firms and multinational corporations (MNCs) operating in India recognize AI’s game-changing potential, driving investments to enhance efficiency, engagement, and regulatory compliance in India.

The details on AI adoption among Indian pharma companies and MNCs in India remain uncertain due to limited comparative data. However, significant investments—such as Amgen’s $200 million AI and data science center in Hyderabad (Reuters report, February 24, 2025)—reinforce AI’s growing role in shaping the future of the industry.

As AI continues to revolutionize drug marketing, Indian pharmaceutical companies and global players must focus on strategic implementation, responsible governance, and talent development. The future of pharma marketing in India will be defined by those who successfully leverage AI’s transformative power, ensuring smarter, faster, and more adaptive business strategies in an increasingly digital 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.

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

Posted on May 17, 2024 by Tapan Ray

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:

Innovate for patients: Develop targeted drugs and personalized treatments using AI-powered discovery and data analysis.
Expand access: Optimize supply chains and fight counterfeits with AI for affordability and patient safety.
Build trust: Use AI Chatbots for patient education and address concerns through social media analysis.
Be ethical: Prioritize data privacy and transparent AI for responsible use. Comply with the Uniform Code of Pharmaceutical Marketing Practices (UCPMP)
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

Unleash The Power of RWE in Indian Pharma Marketing

Posted on February 10, 2024 by Tapan Ray

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

Drug Prescription In Generic Names Only, No Branded Generics

Posted on August 20, 2023 by Tapan Ray

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

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

Posted on August 7, 2023 by Tapan Ray

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

A chronology of some recent events:

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

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

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

A long saga of events:

Yes, as it appears from the following backdrop:

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

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

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

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

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

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

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

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

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

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

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

The government ponders making technological interventions for patients:

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

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

This time it’s a two-pronged action:

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

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

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

Conclusion:

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

Patients’ trust in the healthcare system relies on the availability of reliable medication. When patients have confidence in the drugs they are prescribed, they are more likely to comply with treatment regimens, leading to better health outcomes.

A strong pharmaceutical sector that focuses on safe and effective drugs can foster economic growth by generating revenue, creating jobs, and attracting investments. It can also stimulate research and development efforts.

A reputation for producing quality drugs can boost India’s position as a global leader in pharmaceuticals, attracting international collaborations and partnerships.

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

By: Tapan J. Ray

PILMAN

A Tapan Ray Website

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Drug Prescription In Generic Names Only, No Branded Generics

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