Tag Archives: Vikshit

Pills and Payments: India’s Unethical Drug Marketing Problem

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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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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

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

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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

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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.