Tag Archives: India

Access Denied, Ethics Demanded: India’s Pharma Detailing at a Turning Point

Posted on by
Reply

June 11, 2025 — The Economic Times reports that a prominent pharmaceutical industry association has urged the Union Health Ministry to reconsider its directive that bars medical representatives (MRs) from physically meeting doctors in central government hospitals. The industry argues that the move could restrict vital information flow and undermine drug accessibility, especially in remote regions.

This reaction comes just days after the Directorate General of Health Services (DGHS), through a circular dated June 4, 2025, issued a policy prohibiting in-person MR interactions in government hospitals. Instead, it mandates that all product-related communication occur via digital means—email or secure portals.

While some may see this as a step toward dismantling the traditional MR role, that interpretation misses the point.

In my view, this is not about eliminating medical representatives. It’s about transforming their role to match the ethical, digital, and scientific expectations of modern healthcare.

A System Already Poised for Change:

For decades, medical reps have been the primary channel through which pharmaceutical companies reached doctors—armed with product samples, promotional material, and persuasion tactics. In a market dominated by branded generics, this model shaped prescribing patterns significantly.

But the rules of the game are changing.

Doctors today demand data, not just messaging. Patients expect affordability and transparency. Regulators are watching. And the public increasingly values ethics over incentives in medical decision-making.

The DGHS circular doesn’t disrupt an efficient system—it corrects an imbalance that had gone unaddressed for far too long.

The Realities Behind Branded Generics:

Branded generics – off-patent drugs sold under specific brand names – make up over 70% of India’s domestic pharma market. These are often promoted aggressively through MRs, which:

  • Reinforces prescriber loyalty to brands
  • Contributes to higher out-of-pocket costs for patients
  • Distorts rational prescribing by emphasizing brand recall over clinical evidence

While these drugs have expanded access, the promotional tactics surrounding them need a serious reset.

Patented Drugs and the Innovation Dilemma:

At the other end are patented drugs – cutting-edge, research-driven therapies. These often remain inaccessible due to cost, late launches, and barriers in public procurement.

India’s Section 3(d) of the Patent Act rightly filters out frivolous patents, curbing “evergreening” strategies. But challenges around access, affordability, and information persist—even with innovative treatments.

In both generics and patented drugs, the way pharma communicates with doctors has come under scrutiny – and rightfully so.

The DGHS Directive: A Paradigm Shift:

The DGHS ban marks a fundamental policy shift, especially in government healthcare institutions that serve millions. Its goals are clear:

  • Ensure doctors’ prescribing decisions remain scientifically neutral
  • Reduce brand-driven influence in public hospitals
  • Promote evidence-based and peer-reviewed sources of drug information

This is not an anti-industry move. It’s a pro-patient, pro-transparency, and pro-science correction.

Not the End – but the Reinvention – of Medical Reps:

Let me say it plainly:

This is not the end of medical representatives. It is the beginning of their evolution.

The policy signals that the old “brand-push” model is obsolete—but the need for credible, well-trained, scientifically literate pharma liaisons remains stronger than ever.

What the New MR Must Look Like:

  • From Pitch to Precision:
    Reps must transition from product promoters to scientific communicators—sharing real-world evidence, safety data, and treatment comparisons.
  • From Doorstep to Digital:
    With hospitals restricting physical visits, MRs must now master digital communication tools—email, webinars, and secure doctor platforms.
  • From Prescription Goals to Knowledge Sharing:
    Companies should measure reps on their ability to engage ethically, not push volume. Focus must shift to educational impact.
  • From Influence to Integrity:
    Upskilling in medical writing, therapeutic areas, and regulatory guidelines can reposition MRs as Medical Science Liaisons (MSLs) or digital medical educators.

Pharma’s Call to Action:

To thrive in this changing landscape, companies must:

  • Launch non-promotional CME programs
  • Organize hospital-approved scientific sessions
  • Build secure, compliant digital channels
  • Train MRs in ethical engagement, clinical literacy, and communication skills
  • Collaborate with medical councils and regulators to rebuild trust

Conclusion:

Industry resistance is expected. But clinging to outdated methods won’t work in a system demanding credibility over convenience.

The DGHS directive is not a crackdown. It’s a wake-up call. A moment to reflect, restructure, and reimagine how pharma and medicine should interact in a digital-first, ethics-forward India.

Medical representatives are not being shown the door. They are being shown a new direction—toward greater respect, responsibility, and relevance.

The future of pharma lies not in access at any cost, but in engagement with integrity.

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.

 

Closed Doors, Open Channels: India’s Ban on Medical Reps in Govt Hospitals Reshapes Pharma Engagement

Posted on by
Reply

The June 3, 2025, directive from the Directorate General of Health Services (DGHS), banning medical representatives (MRs) from meeting doctors in central government hospitals, marks a pivotal policy shift in India’s evolving healthcare ecosystem. It signals a firm step toward delinking clinical decisions from commercial influence—particularly in public institutions where millions of patients depend on subsidized or free medical treatment.

Issued by DGHS Director Sunita Sharma, the directive mandates strict compliance from hospital officials, effectively barring pharmaceutical sales representatives from physically accessing doctors within government hospital premises. Instead, MRs have been advised to share scientific updates, product information, and procedural advancements through digital platforms like email or other non-intrusive channels.

This move aligns with the Indian government’s broader push to promote generic drug prescriptions, minimize undue influence from pharmaceutical marketing, and uphold the ethical integrity of public health systems.

Understanding the Implications: A Two-Sided Coin:

Advantages of the DGHS Ban:

  1. Reduces Conflicts of Interest:
    Government-employed doctors are expected to prioritize cost-effective treatments, especially generics. This restriction curbs the risk of biased prescribing practices that favor brand-name drugs driven by promotional efforts rather than patient outcomes.
  2. Rebuilds Public Trust:
    Patients—especially those from low-income backgrounds—can now feel more assured that medical prescriptions are based purely on clinical judgment, not marketing tactics.
  3. Fosters Evidence-Based Prescribing:
    Doctors may increasingly depend on peer-reviewed research, institutional protocols, and academic updates rather than potentially biased promotional content from MRs.
  4. Supports Smaller and Generic-Only Companies:
    Large pharmaceutical firms with aggressive marketing budgets have long held an advantage. By cutting off direct promotional access in government hospitals, the directive levels the playing field for smaller, innovation-driven or generic-focused companies.

Challenges and Concerns

  1. Information Gaps for Physicians
    MRs are often the primary source of updates on new drug launches, dosage changes, safety alerts, and emerging therapies. Without an effective alternative, doctors could miss crucial therapeutic advancements.
  2. Communication Breakdown
    The absence of a regulated, real-time channel may hinder the timely dissemination of important updates like drug recalls, contraindications, or revised usage guidelines.
  3. Potential Spillover to the Private Sector
    If this approach extends to private hospitals, it could severely disrupt the pharma sales model and widen the communication gap between drug manufacturers and prescribers.
  4. Impact on Employment
    Thousands of MRs, whose roles have traditionally depended on face-to-face detailing, may face job losses or be forced to transition into unfamiliar roles.

How Pharma Can Adapt: Strategic Remedial Measures:

Pharmaceutical companies must act swiftly and smartly to align with the new reality. Below are actionable pathways to ensure continued, ethical engagement with healthcare professionals:

1. Invest in Digital Medical Platforms:

  • Build secure, doctor-only portals offering clinical literature, prescribing information, and continuing medical education (CME) modules.
  • Create apps where physicians can request drug updates or schedule virtual sessions with medical experts.

2. Deploy Medical Science Liaisons (MSLs):

  • Replace promotional visits with interactions led by trained MSLs who provide evidence-based insights, answer complex clinical queries, and maintain strict compliance with non-promotional norms.

3. Collaborate with Medical Institutions:

  • Partner with hospital departments and medical councils to conduct scheduled scientific sessions, like pharmacology briefings or journal clubs, vetted by ethics committees for neutrality.

4. Prioritize Peer-Reviewed Communication:

  • Shift the focus from brand promotion to publishing clinical data in reputable journals and conference proceedings to build scientific credibility organically.

5. Reskill the Field Force:

  • Train MRs for hybrid roles in digital marketing, pharmacovigilance, medical writing, or regulatory affairs.
  • Equip them with skills in non-promotional communication, data analysis, and virtual engagement tools to remain relevant in the new ecosystem.

Conclusion:

Ethical Reform, Strategic Opportunity:

The DGHS directive marks a turning point in India’s pharmaceutical policy landscape—one that reflects global trends toward transparency, ethics, and data-driven healthcare. While it challenges the long-standing model of pharmaceutical detailing, it also opens doors for a new paradigm: ethical, digital, and education-based engagement.

For pharmaceutical companies, this is more than a restriction—it’s an opportunity to reset their value proposition and become trusted scientific partners in the healthcare journey.

By: Tapan J. Ray

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

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

Posted on by
Reply

(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.

The Unseen Terror: Fake Drugs Claim More Lives Than Terrorism in India

Posted on by
Reply

In May 2025, the Union Health Ministry acknowledged in a response to the Lok Sabha that over 7,500 drug samples failed quality tests across India in the previous year, with spurious drugs reported from nearly every major state. The admission, buried in a routine reply, drew sharp criticism from public health experts who warned that the government was normalizing a crisis of mass scale.

This stark admission reveals more than a quality control failure — it points to a chronic, systemic threat that continues to escape urgent national reckoning. Why, then, do deaths of innocent Indians caused by fake or spurious drugs fail to trigger the same outrage, media scrutiny, and policy response as terrorist attacks — such as the one that recently shook the nation?

Terrorism, rightly, provokes collective anger, fear, and decisive action. It disrupts lives, societies, and the national psyche. But when another threat kills even more people every year, acts silently, and feeds off weak institutions — it too warrants being treated as a public emergency.

This comparison is not meant to diminish the horror of terrorism. Rather, it is to confront the staggering neglect of a parallel, preventable crisis. Fake drugs — spurious, substandard, or deliberately mislabeled medicines — kill more Indians annually than terrorism has in decades, yet the political and public response remains muted, fragmented, and disturbingly indifferent.

Fake Drugs: India’s Hidden Epidemic

India is often celebrated as the “pharmacy of the world,” supplying affordable generics globally. But that very scale makes it vulnerable to the systemic menace of fake drugs. According to a 2022 government survey, around 4.5% of drug samples tested in India were substandard, and 0.3% were spurious. While these numbers may seem small, they translate into millions of doses affecting patient outcomes.

Independent estimates, including those from the WHO, suggest that up to 10% of medicines in India’s supply chain may be fake or substandard. That figure increases dramatically in rural areas and among unregulated or informal sellers.

In 2022 and 2023, India-made cough syrups linked to the deaths of over 100 children in Gambia and Uzbekistan exposed the cracks in India’s drug quality surveillance. But such tragedies aren’t just export scandals — similar failures occur domestically, often undocumented and buried in private grief.

Terrorism vs. Fake Drugs: A Deadly Disparity

Let’s look at the numbers:

  • Terrorism-related deaths in India (2023): Less than 100, according to the South Asia Terrorism Portal.
  • Estimated deaths due to fake drugs (India, annually): 200,000–250,000, based on WHO extrapolations and Indian health sector data.

In other words, fake drugs kill as many Indians in one year as terrorism has in over two decades.

Yet, compare the national response:

  • We have a Ministry of Home Affairs-led anti-terror infrastructure, counter-terrorism forces, and international collaborations.
  • In contrast, India’s drug regulation is fragmented, underfunded, and chronically understaffed — with one drug inspector for every 200+ pharma units in some states.

Fake Drugs as a Public Health and Security Threat

Fake drugs don’t just cause death. They:

  • Undermine treatment of tuberculosis, malaria, HIV, and non-communicable diseases.
  • Fuel antibiotic resistance, now one of India’s top health threats.
  • Shatter public trust in doctors, hospitals, and medicines.
  • Waste public health budgets on ineffective procurement and recalls.

Their proliferation is enabled by:

  • Weak state-level enforcement
  • Political protection of unscrupulous manufacturers
  • Unregulated online drug sales
  • A vast informal medical economy, especially in Tier II–IV cities and rural India

Regulatory Paralysis: A Broken System?

Despite repeated alerts from the WHO, Parliamentary Committees, and even the judiciary, India’s drug regulatory ecosystem remains broken.

Key challenges:

  • CDSCO has jurisdiction only over a few functions; state drug controllers handle licensing and inspections.
  • Punishment for producing fake drugs is weak — most cases drag for years and end with acquittals or token fines.
  • A 2021 Parliamentary report found that even quality testing labs were under-equipped, with backlogs of over a year.

What India Must Do — Immediately

This is not an issue of awareness but of political will and systemic reform. India must:

  1. Strengthen and effectively implement the New Drugs, Medical Devices and Cosmetics Bill with strong enforcement provisions.
  2. Deploy a national track-and-trace system across the pharma supply chain, from factory to pharmacy.
  3. Invest in independent drug-testing labs in every state and digitize their data for public transparency.
  4. Shut down informal and unlicensed drug retailers through coordinated action by health, law enforcement, and revenue departments.
  5. Launch a public awareness campaign akin to anti-tobacco or anti-dowry campaigns, warning of the risks of fake medicines.

Conclusion: 

India has built a global reputation on pharmaceutical strength — but that strength is only as credible as the quality of every tablet sold, domestically and abroad.

Fake drugs may not detonate like a bomb, but their effects are just as lethal. It’s time India recognized this silent terror for what it is: a mass-scale threat to life, public health, and national reputation.

Let’s not wait for more headlines, more funerals, and more international embarrassments. Let’s fight fake drugs with the urgency we reserve for terrorism.

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.


Curbing Patent Evergreening: Advancing Innovation and Health Equity for a Vikshit Bharat

Posted on by
Reply

As published in The Economic Times of April 27, 2025:  India’s Commerce and industry minister - “Piyush Goyal stated that India frequently receives requests to extend pharmaceutical patents for minor modifications. He criticized this practice, known as ‘evergreening,’ for prioritizing corporate profits over global healthcare access.’

Against the above backdrop, I reckon, as India strides toward the goal of becoming a ‘Vikshit Bharat by 2047’, we must dismantle the hidden structural barriers that undermine self-reliance, stifle true innovation, and deny affordable healthcare to our people. One such barrier- largely invisible to the public yet devastating in its impact- is the global pharmaceutical industry’s misuse of patent evergreening.

This practice – where companies file successive, often trivial, secondary patents to extend monopolies on old drugs—chokes competition, delays biosimilars, and imposes crippling costs on patients and health systems. It is not innovation; it is legal manipulation.

India, through its bold and visionary Section 3(d) of the Patents Act, has stood almost alone in resisting this exploitation. But as pressures continues to mount from powerful trade lobbies and multinational corporations, India’s resolve is being tested.

Evergreening: Innovation’s Parasite?

The concept of evergreening is deceptively simple but deeply corrosive. When the primary patent on a blockbuster drug nears expiry, companies file dozens—or even hundreds – of minor patent claims on formulations, delivery methods, or metabolites. These “secondary patents” are designed not to protect new inventions, but to delay affordable alternatives.

Consider Humira, a biologic drug that should have gone off-patent in 2016. Through aggressive evergreening, its U.S. monopoly was extended until 2023, amassing over $240 billion in revenue—while millions of patients waited for cheaper biosimilars.

This is not an isolated case. Imatinib, Rituximab, Enbrel, and many more biologics have seen similar fates in Western markets. These tactics have turned the global patent system into a tool for rent-seeking, rather than discovery.

If allowed unchecked, this model will undermine India’s biosimilar leadership, strain our healthcare budgets, and compromise our ambition to be a Vishwa Guru in inclusive, ethical innovation.

Section 3(d): Bharat’s Intellectual Firewall:

India’s response—crafted in the 2005 Patents Act and embodied in Section 3(d)—rejects trivial innovations from being patented. It is not anti-IP; it is pro-science, pro-accountability, and pro-Bharat.

This legal firewall has enabled Indian companies to launch biosimilars for some of the world’s most expensive biologics—at a fraction of global prices. It is why cancer patients in India don’t pay $100,000 a year for treatment. It is why generic drug diplomacy became India’s soft power during COVID-19.

Weakening Section 3(d), under global trade pressure or lobbying, would open the floodgates to evergreening in India—replacing our public health logic with corporate greed.

Vikshit Bharat Demands Patent Integrity in true sense:

To achieve the Vikshit Bharat vision, India must be both an innovation hub and a justice champion. This requires moral clarity and policy courage on the patent front.

  1. Make evergreening unprofitable: Reform examination practices, increase patent office scrutiny, and use AI to flag secondary patent abuse. No drug should get 20 more years of monopoly for marginal tweaks.
  2. Preserve Section 3(d) as a global model: Far from being “TRIPS non-compliant,” Section 3(d) should be exported to other nations. India can lead a coalition of countries in the Global South to challenge evergreening through WTO forums.
  3. Empower biosimilar innovation as strategic sector: Just as India leads in generic vaccines; we must become the world’s biosimilar leader. This is not just a market opportunity – it is a sovereignty imperative.
  4. Expose evergreening through transparency: Let public databases track all secondary patents filed, so regulators, researchers, and citizens can hold bad actors accountable.

The Moral Choice for Vikshit Bharat:

Evergreening is not merely a legal trick—it is a moral failing, where life-saving treatments are hoarded for profit. If Bharat is to be vikshit (developed) in the truest sense, then access to medicines cannot be a privilege—it must be a right.

By resisting evergreening, India is not rejecting innovation—it is defending its soul. It is declaring that patents are a means to progress, not tools of profiteering.

Let the world know: a Vikshit Bharat will not inherit broken systems—it will lead with better ones. And in doing so, it will set a new global gold standard for innovation with integrity.

Reclaiming Patent Integrity for Vikshit Bharat: Making Innovation Work for All:

As India marches toward Vikshit Bharat 2047, the vision of a developed, self-reliant nation hinges not just on economic growth, but on systems that are fair, future-ready, and aligned with national interest. Nowhere is this truer than in healthcare and pharmaceuticals—sectors critical to both public welfare and strategic sovereignty.

India has already earned global recognition as the “Pharmacy of the World” by supplying affordable generics and vaccines to over 200 countries. Yet, to fully realize the Vikshit Bharat vision, we must go further: from low-cost manufacturing to innovation leadership. This requires building an ecosystem where patent law rewards true invention without compromising access—a system that puts Janta (the people) and Jan Arogya (public health) at the center.

A Broken Global Model and India’s Course Correction:

The traditional model of pharmaceutical innovation is under stress. While patents were designed to incentivize breakthrough research, the global biopharma industry is increasingly plagued by “evergreening”—the strategic use of secondary patents to extend monopolies on blockbuster drugs long after their primary patents expire.

Section (3d) of the Indian Patents Act is not just a legal provision. It is a civilizational ethos: that science must serve society. That the gains of innovation should be shared, not hoarded. That Bharat’s development must include the last mile, the last person.

Patent Integrity Alongside Leadership in Ethical Regulation Are Pillars of Vikshit Bharat:

For India to become a global innovation hub under Vikshit Bharat, we must lead not only in discovery but in ethical regulation. There are three strategic imperatives:

  1. Safeguard India’s patent standards: Attempts to dilute Section 3(d) through trade pressure or lobbying must be firmly resisted. Weakening this clause would not attract innovation—it would enable exploitation. A Vikshit Bharat sets the rules, not follows them.
  2. Modernize our patent ecosystem: While the spirit of our law is sound, enforcement is uneven. Nearly 70% of drug patents granted in India are secondary in nature. We must invest in capacity-building at the Indian Patent Office, deploy AI-based scrutiny tools, and uphold transparency and scientific rigor in patent examination.
  1. Champion biosimilar access as global public good: With rising non-communicable diseases and biologics dominating pipelines, affordable biosimilars are critical to Jan Arogya. India has the scientific talent and manufacturing prowess to lead this space. But unless we protect our regulatory autonomy, we risk becoming dependent again—this time not for vaccines, but for cancer and autoimmune therapies.

A Message to Stakeholders: Innovation Must Serve Bharat:

To global pharmaceutical companies, Indian regulators, and policymakers: this is not a call to reject IP, but to restore its legitimacy. Secondary patents, when used as tools for revenue preservation rather than discovery, undermine public trust, delay life-saving access, and divert resources from genuine innovation.

The world is watching. As India negotiates trade agreements, leads the Global South, and shapes digital and health diplomacy, our stance on patent fairness will define not just our domestic health outcomes, but our moral authority on the world stage.

Conclusion: Building a Bharat That Heals and Leads:

A Vikshit Bharat is not just an economic powerhouse—it is a nation where healthcare is affordable, innovation is inclusive, and laws reflect both wisdom and will. By defending the integrity of our patent regime and leading global reform on evergreening, India can prove that development does not mean adopting broken models—it means offering better ones.

Let India show the world that Atmanirbharta in healthcare is not just about making in India—it is about thinking for India, and leading for the world.

By: Tapan J. Ray

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

MAGA vs. Viksit Bharat: Trump’s Tariffs And India’s Pharma Dreams

Posted on by
Reply

A high-stakes clash poses a potential threat to PM Modi’s ‘Viksit Bharat’ Vision, exposing India’s pharmaceutical vulnerability and forcing a strategic reckoning.

The resurgence of Donald Trump’s “America First” MAGA (Make America Great Again) agenda casts a long, ominous shadow over PM Narendra Modi’s ambitious “Viksit Bharat” project, particularly for India’s globally significant pharmaceutical industry. This isn’t just about trade; it’s a potential paradigm shift that could redefine India’s economic trajectory and healthcare landscape. While temporary exemptions offer a fragile shield, the looming threat of reciprocal tariffs, a weaponized tool of Trump’s trade policy, creates a climate of profound uncertainty. It threatens to dismantle India’s carefully constructed aspirations to become a global drug powerhouse by 2047, a cornerstone of its “Viksit Bharat” vision.

PM Modi’s “Viksit Bharat” isn’t merely a development plan; it’s a national ambition, a vision of India as a developed nation, powered by sustained economic growth, robust infrastructure, and accessible, affordable healthcare. A crucial pillar of this vision is India’s enhanced global economic standing, driven by strong manufacturing and export capabilities, including the pharmaceutical sector. But Trump’s MAGA doctrine, with its protectionist zeal and “America First” rhetoric, directly challenges this ambition, placing India’s hard-won gains squarely in the crosshairs.

The Perilous Equation: A Deep Dive into the Threats:

These may include the following areas:

1. Tariff Warfare: Economic Devastation Looms: The specter of crippling tariffs isn’t just a trade dispute; it’s an economic assault. It threatens to dismantle India’s generic drug exports, a linchpin of its revenue, investment, and growth. This could trigger a domino effect, impacting related industries and slowing down India’s overall development.

2. Supply Chain Chaos: Medicine Shortages and Political Fallout: MAGA’s reshoring push, while aimed at boosting US manufacturing, risks fracturing established global supply chains. This could lead to increased costs and potential medicine shortages in the US, creating political fallout and further escalating trade tensions.

3. Regulatory Roadblocks: Impeding Innovation and Competitiveness: Stricter US regulations and increased scrutiny, driven by a “buy American” ethos, could create significant barriers for Indian drug approvals. This would not only slow down the introduction of affordable generics but also impede innovation and erode India’s competitive edge.

 4. IP Showdown: A Clash of Patent Rights and Access to Medicines: A heightened focus on US intellectual property could trigger clashes over patent laws and drug pricing, impacting access to affordable medicines both in the US and globally. This could create a moral and economic dilemma, pitting patent rights against public health.

India’s Counterstrategies: A Call for Strategic Agility:

My top-of-mind strategic areas in this space will be as follows:

Essential Medicine Leverage: A Negotiating Tool: India’s role in providing cost-effective generics, crucial for lowering US healthcare costs, gives it a degree of negotiating power. This leverage must be strategically deployed in trade negotiations.

Market Diversification Blitz: Beyond US Dependence: Rapid expansion into European, Latin American, and African markets is no longer a strategic option; it’s an urgent necessity. India must reduce its dependence on the US market to mitigate the impact of potential tariffs.

“Atmanirbhar Bharat” Acceleration: Building Domestic Strength: The MAGA threat necessitates a swift and decisive push for self-reliance in API production. This is not just about reducing dependence; it’s about building a robust domestic pharmaceutical ecosystem.

Strategic Alliance Building: A Global Counterbalance: Forging robust partnerships with other nations, particularly those with shared strategic interests, can create a global counterbalance to US trade pressures.

The Economic and Geopolitical Fallout: A Ripple Effect: 

The possible scenario as I envisage today may cause a ripple effect encompassing some of the areas as mentioned below:

- Economic Disruption: Beyond the Pharmaceutical Sector: Reduced exports would impede India’s growth trajectory, impacting overall development and potentially triggering a ripple effect across other sectors.

- Healthcare Strain: A Burden on the Nation: Increased costs and potential drug shortages would burden India’s healthcare system, making it harder to achieve the “Viksit Bharat” goal of accessible, affordable care.

 - Global Image Damage: Eroding Trust and Investment: Trade disputes could tarnish India’s reputation as a reliable global partner, eroding trust and deterring foreign investment and technology transfers.

- Trade Strategy Overhaul: A Rapid Reorientation: A rapid diversification of trade partners, and the creation of new trade agreements will be required.

Conclusion:

The Bottom Line of this rapidly evolving scenario would be a high-stakes geopolitical chess game. While current exemptions provide temporary relief, the threat of future tariffs looms large, casting a shadow over PM Modi’s “Viksit Bharat” vision. India faces a critical test, demanding strategic agility and resilience. The outcome will depend not only on economic factors but also on the complex geopolitical landscape, particularly the US’s strategic view of India as a counterweight to China. The stakes are high, and the clock is ticking.

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.

 

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

Posted on by
Reply

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:

  1. Predictive Analytics for Sales Forecasting – Sun Pharma uses AI to anticipate sales trends, optimize inventory, and tailor regional marketing strategies.
  2. Chatbots for Customer Interaction – Cipla employs AI-powered chatbots to provide real-time responses, enhance engagement, and disseminate product information.
  3. Programmatic Advertising – Dr. Reddy’s leverages AI to precisely target healthcare professionals and patient demographics, boosting campaign efficiency.
  4. Content Personalization – Glenmark utilizes AI to deliver tailored digital content to healthcare providers based on their specialties and interests.
  5. Market Basket Analysis – Torrent Pharma applies AI to analyze prescribing patterns, identifying cross-selling and bundling opportunities.
  6. Sentiment Analysis – Lupin monitors social media and online discussions using AI-driven sentiment analysis to refine marketing strategies.
  7. Virtual Reality (VR) for Product Demonstrations – Zydus Cadila combines AI with VR to create immersive product presentations for healthcare professionals.
  8. Email Campaign Optimization – Biocon enhances email marketing with AI, optimizing content, subject lines, and timing for higher engagement.
  9. Voice-Activated Assistance – Aurobindo Pharma develops AI-driven voice assistants to provide instant support to healthcare professionals.
  10. 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.

Regulatory Failures Are Still Risking Patient Lives

Posted on by
Reply

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.