India’s Pharmacy Frontier: Blurring Lines and Battling for Balance

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As we witness, India’s pharmaceutical landscape is undergoing a profound transformation, driven by technological advancements and shifting consumer preferences. The traditional brick-and-mortar retail pharmacy, a familiar fixture in every neighborhood, now faces a formidable challenger: the burgeoning online pharmacy sector. This evolving scenario is not merely a commercial rivalry but a complex interplay of accessibility, economics, regulatory lacunae, and deep-seated concerns over public health, frequently drawing the ire of established chemist bodies.

The Evolving Scenario: A Digital Shift:

For decades, the retail pharmacy has been the cornerstone of medicine dispensing in India. Its strengths lie in immediate access for acute needs, personalized advice from local chemists, and the trust built through long-standing community relationships. However, this largely unorganized sector, comprising millions of fragmented outlets, often grapples with wafer-thin margins and the pressures of price control.

Enter the online pharmacy, a disruptor propelled by India’s soaring internet penetration and smartphone adoption. E-pharmacies offer unparalleled convenience, allowing consumers to order medicines from the comfort of their homes and receive doorstep delivery, a service that proved indispensable during the COVID-19 pandemic. They often entice customers with deep discounts, a wider range of medicines (including those hard to find locally), and value-added services like e-consultations and diagnostic bookings. The sector has witnessed remarkable growth, with projections indicating it will capture a significant share of the overall pharmaceutical market. Major players like Tata 1mg, PharmEasy, Netmeds (backed by Reliance Retail), Apollo Pharmacy (with its Apollo 24×7 platform), Amazon Pharmacy, and Flipkart Health+ have rapidly expanded their reach, with Amazon Pharmacy recently announcing shipments to every functional pin code in the nation, including remote areas. This reach is particularly beneficial for those in rural or underserved regions with limited access to physical drugstores.

Beyond mere delivery, online platforms excel in digital record-keeping, which can enhance traceability and potentially reduce the circulation of counterfeit drugs if properly regulated. They also foster a growing demand for over-the-counter (OTC) products and wellness supplements, aligning with a national shift towards preventive healthcare.

AIOCD’s Ardent Objections:

The rapid ascent of online pharmacies has not been without significant resistance, primarily from the AIOCD, the powerful representative body for retail chemists. Their objections stem from a fundamental concern for patient safety and the perceived existential threat to traditional businesses.

The AIOCD consistently argues that online pharmacies operate in a legal gray area. They highlight that the existing Drugs and Cosmetics Act, 1940, and its Rules, 1945, do not specifically govern online drug sales. The permission for doorstep delivery granted in March 2020 was a temporary measure for the pandemic, which the AIOCD claims is now being “misused by online platforms” and should be revoked. In April 2025, the Drugs Technical Advisory Board (DTAB) was reportedly set to review the continuation of home medicine delivery following AIOCD’s strong objections.

Some of the reported AIOCD concerns include:

  • Lack of Prescription Validation: A central worry is the potential for medicines, especially Schedule H and X drugs (requiring strict prescription), to be dispensed without proper verification, leading to self-medication, drug addiction, and misuse.
  • Quality and Authenticity: Fears abound regarding the sale of fake, expired, or unlicensed products, with traditional chemists arguing that rapid delivery models, such as Swiggy-PharmEasy’s proposed 10-minute delivery, could compromise quality control and thorough checks.
  • Data Privacy: The handling of sensitive patient health data by online platforms raises significant privacy concerns.
  • Unfair Competition: Deep discounting by e-pharmacies is seen as an unfair trade practice, creating an uneven playing field and severely impacting the livelihoods of millions of traditional chemists.
  • Regulatory Loophole: The AIOCD contends that online pharmacies are circumventing established laws that mandate physical licensed premises for drug distribution. Their recent opposition to RailTel Corporation’s proposal to invite bids from online pharmacies for home delivery to railway hospitals underscores their stance that online pharmacies remain illegal in India.

The Regulatory Landscape: A Work in Progress:

The legal status of online pharmacies in India remains ambiguous, leading to frequent legal tussles. While the Drugs and Cosmetics Act and Rules vaguely apply, a dedicated framework is conspicuously absent.

In August 2018, the Union Health Ministry published Draft Rules for the “sale of drugs by e-pharmacy” to amend the Drugs and Cosmetics Rules, 1945. As my knowledge goes, these draft rules, though yet to be finalized and notified, proposed significant provisions:

  • Mandatory Registration: E-pharmacies would require registration with the Central Drugs Standard Control Organization (CDSCO) and pay a fee.
  • Periodic Inspection: Premises would be inspected every two years.
  • Data Localization: Patient data would need to be stored in India and kept confidential.
  • Prohibition of Advertising: E-pharmacies would be barred from advertising drugs.
  • Customer Support and Grievance Redressal: Mandatory 24/7 customer support with a registered pharmacist for queries.
  • Prohibition of Schedule X Drugs: Sale of tranquilizers, psychotropic drugs, narcotics, and habit-forming drugs would be prohibited.

Despite these drafts, finalization seems to have been repeatedly delayed due to stakeholder objections and legal challenges. Various High Courts, including the Delhi High Court, have intervened, urging the government to expedite the policy formulation. The CDSCO has also issued show-cause notices to several online firms for alleged violations.

Simultaneously, government initiatives like Digital India, Ayushman Bharat, and the National Digital Health Mission (NDHM) are actively promoting digital healthcare solutions, indirectly fueling the growth of e-pharmacies by fostering a more digitally savvy healthcare ecosystem. This creates a dichotomy: a push for digital adoption on one hand, and a lack of clear regulation on the other.

The Way Forward: Coexistence and Comprehensive Governance:

In my view, the path ahead for India’s pharmacy sector demands a nuanced approach that acknowledges the benefits of digital innovation while robustly safeguarding public health and ensuring fair competition, such as.

  1. Expeditious Finalization of E-Pharmacy Regulations: The most critical step is the immediate finalization and notification of a comprehensive regulatory framework. This framework must clearly define the operational guidelines for online pharmacies, including stringent norms for prescription verification, drug storage, logistics, data security, and accountability. It should also establish a clear distinction between aggregator models and inventory-based models.
  2. Addressing Safety and Quality Concerns: Regulations must incorporate mechanisms to prevent the sale of spurious or expired drugs online. This could involve mandating blockchain technology for drug authenticity tracking, stricter penalties for non-compliance, and transparent track-and-trace systems for all online dispensed medicines. The concerns regarding “10-minute deliveries” need specific guidelines to ensure patient safety is not compromised for speed.
  3. Leveling the Playing Field: While online pharmacies offer discounts, a balanced approach is needed. Regulations could explore ways to mitigate predatory pricing practices that disproportionately harm traditional chemists, perhaps through floor prices for certain drug categories or by promoting fair trade practices.
  4. Promoting Omnichannel Healthcare: The future likely lies in a hybrid model. Many e-pharmacies are now opening physical stores, while traditional chains like Apollo have embraced online platforms. This omnichannel strategy allows businesses to combine the convenience of online services with the trust and immediate access of physical outlets, creating a more holistic patient experience.
  5. Leveraging Technology for All: Technology should not be exclusive to online players. Initiatives to digitize retail pharmacies, provide them with better inventory management systems, and integrate them into national digital health ecosystems can empower them to compete effectively and serve their communities better.
  6. Public Awareness and Education: Educating consumers about the risks and benefits of both online and offline channels is vital. Campaigns should highlight the importance of valid prescriptions, verifying drug authenticity, and understanding return policies.

Conclusion:

The online versus retail pharmacy debate in India is a microcosm of a larger digital transformation. The evolving scenario demands a regulatory compass that navigates the complexities of innovation, competition, and public welfare. Only through a well-defined, robust, and adaptable regulatory framework can India truly harness the potential of digital healthcare, ensuring that accessibility, affordability, crucially and patient safety are not compromised in the race to the digital frontier. The coexistence of both online and retail models, operating under a clear and equitable legal regime, will ultimately best serve the diverse healthcare needs of the Indian populace.

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.

 

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

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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

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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.

Robust Patents, Not Tweaked Monopolies: India’s Practical Route to Affordable Medicines

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In April 2025, the United States Trade Representative (USTR) released its annual Special 301 Report, once again placing India on its “Priority Watch List” for intellectual property (IP) concerns. The report highlights persistent issues, particularly in the pharmaceutical sector, citing challenges such as potential patent revocations, discretionary application of patentability criteria under the Indian Patents Act, and prolonged patent grant processes.

While the USTR acknowledges India’s efforts to modernize its patent system—such as the finalization of the Patents (Amendment) Rules, 2024, aimed at reducing burdens on patent applicants—it maintains that significant concerns remain. These include high customs duties on IP-intensive products and inadequate IP enforcement mechanisms.

India, however, defends its stance, emphasizing that its IP regime is fully compliant with the World Trade Organization’s TRIPS Agreement and is designed to balance innovation incentives with public health needs. The country asserts that its legal provisions, particularly Section 3(d) of the Patents Act, are crucial in preventing “evergreening” – a practice where pharmaceutical companies make minor modifications to existing drugs to extend patent monopolies without significant therapeutic benefits.

Balancing Innovation and Access:

India’s approach to pharmaceutical patents is rooted in its commitment to public health. The Patents Act, 1970, particularly Section 3(d), prevents the patenting of new forms of known substances unless they result in enhanced efficacy. This provision aims to curb “evergreening,” where minor modifications are used to extend patent monopolies without significant therapeutic benefits.

India’s patent regime also includes mechanisms like pre-grant opposition, allowing stakeholders to challenge patent applications, ensuring that only genuine innovations receive protection.

Some Recent Case Studies: Upholding the Balance:

1. Johnson & Johnson’s Bedaquiline Patent Rejection (2023):
The Indian Patent Office rejected J&J’s attempt to extend its patent on bedaquiline, a critical tuberculosis drug, citing lack of enhanced efficacy. This decision paved the way for generic versions, improving access for patients.

2. Novartis’ Entresto Application Denied (2022):
Novartis’ patent application for the heart failure drug Entresto was denied due to lack of inventive step, preventing potential market monopolization.

3. Roche’s Trastuzumab (Herceptin) Patent Lapse:
Facing legal challenges, Roche allowed its patent on the breast cancer drug Herceptin to lapse in India, enabling the production of affordable biosimilars by Indian companies.

Global Pressures vs. Domestic Realities:

Despite international pressure, India’s IP policies prioritize access to affordable medicines. The country’s stance is not anti-innovation but seeks to prevent monopolistic practices that hinder public health.

India’s role as a major supplier of generic medicines globally underscores the importance of its balanced IP approach. Diluting these safeguards could adversely affect access to essential medicines worldwide.

The Way Forward:

To strengthen its position, India should:

  • Enhance R&D Investment: Boost funding for pharmaceutical research, particularly in neglected diseases.
  • Streamline Patent Processes: Implement measures to reduce patent grant delays while maintaining rigorous examination standards.
  • Maintain Legal Safeguards: Preserve provisions like Section 3(d) to prevent patent evergreening. It ensures that only real therapeutic advances get patents, preserving access to affordable medicines while still rewarding meaningful R&D.
  • Engage Internationally: Continue constructive dialogues with global partners to address IP concerns without compromising public health priorities.

Conclusion:

Let me reemphasize here that Section 3(d) does not prohibit incremental innovation – it simply filters out superficial tweaks that offer no therapeutic benefit and are aimed primarily at extending monopolies and delaying broader patient access to medicines.

Thus, in my view, India’s pharmaceutical IP regime exemplifies a pragmatic approach that balances the protection of genuine innovations with the imperative of public health. By resisting patent abuses and ensuring access to affordable medicines, India sets a precedent for equitable healthcare globally.

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

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

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

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

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

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

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

Unlocking Market Potential with AI:

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

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

Crafting Distinctive Brand Identities with AI:

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

Accelerating Content Creation:

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

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

Personalizing Engagement with Healthcare Providers:

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

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

Measuring Impact and Maximizing ROI:

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

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

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

Start Small:

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

Scale Smart:

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

Build a Future-Ready Team:

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

Measure and Iterate:

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

Conclusion: 

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

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

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

Are you ready to start and get your team moving?

By: Tapan J. Ray

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

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

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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

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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.