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Drug Data Exclusivity in India: Innovation Catalyst or Affordability Risk for Indian Pharma?

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For over four decades, India’s pharmaceutical industry has been built on a powerful moral and economic proposition: that life-saving medicines should be affordable, accessible, and globally available from Indian manufacturing prowess. This principle transformed India into the “pharmacy of the developing world.” But as the industry now aspires to move decisively from generics to innovation, a new question has begun to unsettle policymakers, industry leaders, and public-health experts alike:

How should India protect pharmaceutical innovation without diluting its legacy of access?

It is this unresolved tension that has resurfaced sharply following a December 2, 2025, Economic Times report on the sharp divergence between the Ministry of Commerce & Industry and the Ministry of Health & Family Welfare over whether India should formally adopt Drug Data Exclusivity (DDE) norms. What appears at first glance to be a technical regulatory debate is, in reality, a defining policy moment for the future trajectory of Indian pharma.

What Is Drug Data Exclusivity—and How Is It Different from Patents?

Drug data exclusivity, as we know, protects the clinical trial data generated by an innovator company from being referenced by regulators to approve generic versions for a fixed period – typically 5–10 years, depending on the country.

This protection:

  • Exists independent of patent status
  • Can apply even after a patent expires
  • Prevents generics from relying on originator data, forcing them to repeat costly trials

In short:

  • Patents protect inventions
  • Data exclusivity protects information

This distinction is vital – because exclusivity over data can delay competition even when the patent monopoly has legally ended.

How Data Exclusivity Is Often Used to Extend Market Monopoly:

Globally, data exclusivity has increasingly been used not merely as innovation protection – but as a commercial weapon to prolong monopoly pricing.

The Humira Case (AbbVie): A Global Cautionary Tale

Humira is one of the world’s best-selling drugs, generating over USD 200 billion in lifetime revenue. While its primary patent expired in 2016, AbbVie constructed a dense patent thicket supported by regulatory protections, delaying biosimilar competition for years in key markets. During this extended protection:

  • Annual treatment costs exceeded USD 70,000 per patient
  • Biosimilars entered much later than legally necessary
  • Healthcare systems absorbed massive avoidable costs

This pattern - where regulatory exclusivities outlive patents - is exactly what concerns Indian public-health policymakers.

Why the Debate Is So Sensitive in the Indian Context:

India is not just another pharma market. It is:

  • The largest supplier of generic medicines globally
  • A key provider of HIV, TB, oncology, and vaccine supplies to LMIC nations
  • The backbone of India’s own public health programs

Any policy that artificially delays generic entry directly impacts:

  • Government procurement costs
  • Insurance claim ratios
  • Out-of-pocket patient spending
  • Export affordability for Africa, Latin America, and Southeast Asia

In India, monopoly pricing is not an abstract economic concern – it directly determines treatment access at population scale.

Does India Need Data Protection to Encourage Innovation? Yes – but Carefully:

There is no denying a fundamental truth:
Discovering new drugs is expensive, risky, and capital-intensive.

Indian pharma’s next growth phase depends on:

  • New chemical entities (NCEs)
  • Biosimilars with true differentiation
  • Complex injectables
  • Cell & gene therapies

For this shift, global investors and MNC collaborators do seek assurance that proprietary data will not be freely copied immediately. The Commerce Ministry’s argument is therefore not without merit.

The real policy question today is not whether to protect data, but:

How much protection is necessary – without crossing into long-term price monopoly?

The Hidden Danger: Data Exclusivity as the New Patent Thicket:

India has already seen how evergreening strategies can extend monopolies through:

  • Secondary patents
  • Polymorph claims
  • Incremental formulations
  • Combination patents

If long periods of mandatory data exclusivity are added on top, India risks creating:

  • Dual monopolies (patent + data)
  • Effective market lock-outs even after legal patent expiry
  • Price protection without scientific novelty

In practical terms, this could mean:

  • Cancer medicines remaining expensive 10–12 years after original discovery
  • Biosimilars delayed despite manufacturing readiness
  • Insurance penetration becoming unaffordable
  • Public procurement budgets exploding

What Kind of Data Protection Could Work for India – Without Falling into a Monopoly Trap?

This is where India must design a bespoke regulatory architecture, not copy-paste US or EU models.

1. Limited Exclusivity Window Only for First-in-Class Drugs

India could grant 3–5 years of data exclusivity strictly for:

  • First-in-class molecules
  • Novel biological pathways
  • Orphan or rare disease drugs

Not for:

  • Me-too molecules
  • New strengths
  • New dosage forms
  • Fixed-dose combinations without therapeutic novelty

This ensures protection only where real innovation exists.

2. Automatic Public-Health Override Clause

India must retain the unconditional right to:

  • Waive exclusivity during public-health emergencies
  • Apply compulsory access for national programs
  • Support Jan Aushadhi-linked drug expansion

This keeps constitutional right to health superior to commercial protection.

3. No “Back-Door” Extension Beyond Patent Life

A strict rule must apply:

If the core patent has expired, data exclusivity cannot reset monopoly.

This prevents situations like:

  • Patent expiry in Year 20
  • Data exclusivity extending till Year 28

Such structures undermine the very logic of patent law.

4. Differential Rules for Small-Molecule Drugs vs Biologics

Biologics involve:

  • Higher R&D risk
  • Greater manufacturing complexity

India could explore:

  • Short exclusivity for chemical drugs
  • Slightly longer (but capped) exclusivity for biologic drugs
    - without mirroring western 12-year biologic lock-ins.

Why Blind Western Replication Will Hurt India:

The US and EU built their exclusivity regimes when:

  • Their innovation ecosystems matured decades ago
  • Public health spending was largely state-covered
  • Insurance penetration was near universal

India’s reality is different:

  • Out-of-pocket expenditure still dominates healthcare
  • Insurance depth is expanding but not universal
  • Government health budgets remain price-sensitive

A western-style exclusivity framework would therefore:

  • Raise medicine prices structurally
  • Shrink export competitiveness
  • Weaken India’s generics leadership
  • Strain Ayushman Bharat-type programs

Strategic Risk: India’s Export Leadership Could Erode:

Nearly 40% of US generics come from India. If:

  • Indian approval timelines slow
  • Domestic generics get delayed by exclusivity
  • Costs rise due to repeated trials

Then:

  • Latin America, Vietnam, and even Africa could gradually replace India as low-cost generic hubs.

Data policy, therefore, is not just a health issue – it is a geopolitical manufacturing strategy question.

A Balanced Policy Can Actually Strengthen Indian Innovation:

If calibrated well, data protection can:

  • Encourage Indian NCE discovery
  • Attract selective global R&D alliances
  • Improve valuation of Indian biotech assets
  • Keep public programs protected
  • Preserve generics growth

But if miscalibrated, it can:

  • Lock patients into long-term high-price regimes
  • Shut MSME generics out
  • Increase healthcare inflation structurally
  • Damage India’s moral leadership in access to medicines

Conclusion: 

India Must Choose Smart Protection, Not Blind Protection

The current Commerce–Health Ministry divergence reflects a deeper ideological conflict:

  • Commerce protects capital
  • Health protects citizens

India’s answer cannot lie at either extreme.

The country must refuse both:

  • Data anarchy that disincentivizes innovation
  • Data absolutism that entrenches monopoly

The correct path, in my view, lies in:

Time-bound, novelty-linked, override-protected, India-specific data protection.

If India gets this balance right, it can become:

  • A true bio-innovation hub
  • Without ceasing to be the pharmacy of the poor

That, I reckon, is the real opportunity before Indian policymakers today.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors

Sources:

  1. The Economic Times, December report on Commerce & Health Ministries split over Drug Data Exclusivity
  2. US FTC & Senate hearings on AbbVie–Humira patent thicket strategy
  3. WHO reports on TRIPS, data protection & access to medicines
  4. Indian Patents Act, 1970 – Section 3(d) & compulsory licensing provisions
  5. National Pharmaceutical Pricing Authority (NPPA) publications

 

India’s Healthcare Is Still Not Patient-Friendly – Why ‘Patient Centricity’ in Pharma Remains a Slogan More Than a System

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Executive Summary:

Despite constant advocacy around “patient centricity,” India’s healthcare ecosystem – from pharma to hospitals – continues to show deep structural gaps. Safety failures, unethical marketing practices, opaque pricing, and hospital-level exploitation still undermine patient trust. This article uses illustrative (not exhaustive) examples to show how these gaps persist, and where genuine patient-friendly efforts do exist.

When “Patient First” Breaks Down: 

1. Safety & Ethics Failures:

India’s recent crises show that patient safety is still vulnerable to systemic weaknesses.

One of many examples demonstrating quality lapses:

  • In October 2025, India declared three pediatric cough syrups — Coldrif, Respifresh-TR, and ReLife — toxic and unsafe due to diethylene glycol (DEG) contamination linked to child deaths.
  • The WHO issued global alerts after detecting dangerous DEG levels.
  • State regulators admitted major inspection gaps, including unfilled drug-inspector vacancies.

This is one form of patient-unfriendly failure – but quality lapses have surfaced repeatedly in other categories of medicines too.

2. Unethical Marketing Practices — Still Alive Despite UCPMP 2024:

A representative example among many:

  • The Department of Pharmaceuticals found AbbVie Healthcare India sponsored a luxury trip for 30 doctors to Paris/Monaco — a clear UCPMP violation.
  • No meaningful penalties were disclosed, reinforcing that enforcement remains weak.

This case is merely one of many unethical influences still shaping prescribing behavior.

2.1 UCPMP 2024 Exists, but Enforcement is Toothless:

  • The UCPMP 2024 code outlines strict ethical rules for pharma.
  • But without statutory backing or punitive powers, the code’s deterrence remains limited.

This is just one sign of India’s “soft touch” regulatory culture.

3.. Hospitals & Doctors: Patient-Centric in Theory, Revenue-Centric in Practice:

Again, the following are illustrative examples, not isolated incidents.

3.1 Overbilling, Procedure Inflation & Revenue Targets

Numerous investigations and patient testimonies reveal:

  • Corporate hospitals often impose internal monthly revenue targets on doctors.
  • Unnecessary surgeries, implants, and prolonged hospital stays are pushed to meet business objectives.
  • Vendor-tied implants and consumables result in inflated pricing for patients.

These patterns show a recurring conflict between patient welfare and institutional profit.

3.2 Diagnostic Overuse Driven by Referral Incentives

  • Mandatory MRIs, CT scans or lab panels for non-critical conditions.
  • Referral chains that reward doctors or hospitals for test volume.

These widespread practices worsen India’s already high out-of-pocket spending burden.

4. Pharma’s Patient-Friendly Efforts: Encouraging, but Limited in Scale:

Many pharma companies run genuinely helpful programs — but they serve only a fraction of patients.

Below are examples among many such programs, not an exhaustive list:

3.1 Roche India — Blue Tree Program

  • Patient counselling, home-delivery support, and navigation for oncology patients.

3.2 Intas Foundation — National Patient Support Network

  • Chronic and rare disease support across 27+ states and 100+ hospitals.

3.3 Sun Pharma — Patient Support for Palbociclib + Mobile Health Units

  • Access initiatives plus rural MHUs serving underserved regions.

3.4 Pfizer India — PAP India App

  • Digital enrolment for patient assistance programs.

3.5 Cipla — Breathefree Initiative

  • Lung health education and inhaler-use training for asthma/COPD patients.

These initiatives demonstrate that patient-centricity is possible — yet remain limited in reach compared to the scale of India’s disease burden.

4. The Core Problem: Structural Incentives Aren’t Patient-Centric:

India’s healthcare suffers from a systemic incentives gap:

  • Pharma is rewarded for sales, not health outcomes.
  • Hospitals optimize for revenue, not evidence-based care.
  • Regulators focus on paperwork, not rigorous inspection.
  • Patients lack pricing transparency and grievance redress.
  • Outcome reporting by pharma support programs is almost nonexistent.

Until incentives shift, “patient centricity” will continue to be a marketing phrase rather than a structural reality.

5. What Must Change:

For Pharma

  • Publish measurable patient-outcome data from PAPs.
  • Link marketing incentives to adherence, satisfaction, and patient outcomes — not prescription volume.
  • Adopt independent audits for safety and access programs.

For Hospitals & Doctors

  • Prohibit revenue-linked professional targets.
  • Mandate transparent cost disclosures before treatment.
  • Establish patient-rights cells with independent oversight.

For Regulators

  • Give UCPMP statutory authority with real penalties.
  • Fill all drug-inspector posts and accelerate surprise audits.
  • Mandate public reporting of safety violations.

For Patients/Citizens

  • Demand transparent bills, treatment rationale, and alternatives.
  • Report overcharging and unethical promotions.

Conclusion:

India’s healthcare and pharma ecosystem will only become patient-friendly when safety, ethics, transparency, and accountability become non-negotiable pillars of the system — not optional CSR-style add-ons.

“Patient centricity” must shift from being a promotional narrative to becoming a structural design principle. Until then, the current contradiction will continue -loud advocacy, thin implementation, and uneven patient experiences.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors.

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.

Key Sources:

  1. Roche India — The Blue Tree Program (official): Roche India corporate page. Roche India+1
  2. Intas Foundation — Patient Assistance Program (official): IntasFoundation.org. intasfoundation.org+1
  3. Sun Pharma — Palbociclib launch & PAP (press release): Sun Pharma press/materials. Sun Pharmaceutical Industries+1
  4. Pfizer PAP India — app and program (official): Pfizer India / Google Play listing / press. Google Play+1
  5. Cipla — Breathefree (official): Breathefree / Cipla patient site. breathefree.com+1
  6. Contaminated cough syrups & DEG child deaths (peer-review & Reuters coverage & WHO alert):PMC/NCBI article on Gambia incident (background), Reuters & WHO reports on 2025 India DEG incidents, BMJ coverage. BMJ+3PubMed Central+3Reuters+3
  7. State FDA inspection capacity & audits (Times of India coverage post-syrup crisis): reporting on inspector vacancies and limited audits. The Times of India
  8. AbbVie India foreign-trip investigation / DoP reprimand / related coverage: Times of India, New Indian Express and Economic Times coverage of the 30-doctor Paris/Monaco trip and ensuing probes. The Times of India+2The New Indian Express+2
  9. UCPMP 2024 documentation & commentary (DoP / legal FAQs): Department of Pharmaceuticals UCPMP material and Cyril Shroff client alert. Also Supreme Court push to give UCPMP statutory force (LiveLaw). Cyril Amarchand Mangaldas+2Department of Pharmaceuticals+2
  10. Academic/analysis on drug safety, DEG incidents & systemic failures: IJME, BMJ and other peer-reviewed commentaries on cough syrup poisoning, and reporting on systemic enforcement gaps. Indian Journal of Medical Ethics+1

In the Age of AI, Why Emotional Intelligence Is the New Competitive Edge in Indian Pharma Marketing

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In today’s AI-driven world — where scientific excellence, product claims, and competitive pricing are no longer enough to differentiate pharmaceutical companies — Emotional Intelligence (EI) is rapidly emerging as the new strategic advantage in Indian pharma marketing. As doctors face shrinking time, patients demand empathy, and competition intensifies, EI is proving to be the missing link for building trust, deepening engagement, and achieving sustainable performance excellence.

Why Emotional Intelligence Matters More Than Ever in Indian Pharma:

Even the most advanced products or AI-powered tools cannot replace human connection — something that defines healthcare.

EI impacts every core dimension of pharmaceutical performance:

1. Restoring Trust in Doctor–MR Interactions

Doctors today expect representatives who listen and respect their time, not brand pushers.
EI helps MRs:

  • Sense the physician’s mood and priorities
  • Tailor dialogue to communication preferences
  • Build trust through authenticity and empathy

A high-EI interaction doesn’t “sell” — it solves.

2. Making Patient Engagement Truly Patient-Centric

Patients living with chronic illness carry emotional burdens.
EI enables:

  • Simplified, judgment-free communication
  • Recognition of fears and frustration
  • Better adherence through compassionate guidance

3. Lifting Internal Team Performance

High-EI leaders inspire productivity by creating psychologically safe environments — crucial in an industry with intense monthly expectations.

4. Strengthening Corporate Reputation

An EI mindset naturally drives ethical behavior, transparency, and patient-first decision-making in an era of growing scrutiny.

Present Reality: Indian Pharma Is Awakening to EI:

Historically, pharma training focused heavily on product knowledge and activity KPIs.
Today, however:

  • EI is entering training rooms, but inconsistently
  • Activity metrics still overshadow engagement quality
  • Digital transformation often lacks emotional design
  • Yet — early movers are showing how EI can create real competitive advantage

This shift marks the beginning of a more evolved era of Indian pharma marketing.

Real-World Examples: Indian Pharma Teams Practicing Emotional Intelligence:

Below are recent, documented examples where EI has been incorporated meaningfully into high-impact pharma initiatives.

1. Biocon’s Compassion-Driven Oral Cancer Screening Program

Through its community-based mHealth screening initiative, Biocon trained nurses and health workers to approach villagers with empathy — addressing stigma, fear, and anxiety around cancer.

EI in action:

  • Listening to personal fears
  • Delivering sensitive conversations culturally
  • Building trust in early detection

This empathetic approach dramatically improved screening acceptance.

2. Sanofi India’s Diabetes Health Managers

Sanofi deployed trained counselors who support insulin-dependent patients like a trusted guide — not a salesperson.

One such counselor, Awmi, helped a frustrated patient overcome fear, confusion, and adherence lapses by listening and simplifying routines.

EI impact:

  • Reduced anxiety
  • Better therapy adherence
  • Stronger patient–company relationship

A clear example of EI translating into outcomes and brand loyalty.

3. EI-Driven Oncology Engagement by Indian Pharma Teams

Oncology professionals in India increasingly focus on the emotional journeys of patients and caregivers.

Their approach includes:

  • Breaking information into emotionally digestible pieces
  • Addressing stigma, fear, and guilt
  • Supporting caregiver stress

EI here directly improves therapy acceptance and patient outcomes.

4. Novartis’ Arogya Parivar: Empathy at Scale

Arogya Parivar succeeds because it prioritizes understanding over messaging:

  • Health educators speak in regional languages
  • Communication is culturally tuned
  • Trust precedes product discussion

Empathy embedded in strategy strengthened both impact and sustainability.

5. Janssen India’s Holistic Disease-Management Programs

Janssen integrates emotional and psychological well-being into patient and community engagement, particularly in immunology and mental health.

EI isn’t an add-on — it’s part of their treatment ecosystem.

The Path Indian Pharma Must Still Cover:

To unlock EI’s full potential, the industry must address persistent gaps:

1. EI must evolve from “soft skill” to strategic capability

- EI should be treated as a differentiator — not a training checkbox.

2. KPIs must reward quality, not just quantity

- The industry must move beyond call averages toward relationship metrics.

3. Digital transformation must incorporate human-like empathy

- Pharma apps, CRMs, and patient platforms must engage with emotional nuance.

4. EI must be role-modeled by leadership

- Authenticity, empathy, and ethical clarity must flow downward from the top.

5. EI must become measurable and incentivized

- If trust-building behaviors matter, they must be part of the reward system.

Conclusion: 

EI Is the New Currency of Competitive Advantage

As the Indian pharmaceutical industry navigates shrinking access, rising expectations, and intense competition, emotionally intelligent engagement has become indispensable.

AI can enhance productivity.
But EI is what builds trust.

Companies that integrate Emotional Intelligence holistically — from field force capability to patient engagement to leadership culture — will not only outperform competitors but also elevate the quality and ethics of healthcare in India.

Those that ignore it will find themselves outpaced by a more emotionally attuned industry.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors.

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

Sources of Examples Cited:

  1. Biocon — mHealth Oral Cancer Screening Programme
    OPPI–EY Report: Reimagining Pharma and Healthcare in India (2023)
  2. Sanofi India — Diabetes Health Managers
    The Economic Times — “Pharma companies using health managers to help patients and earn revenues”
  3. Oncology Patient Engagement Trends
    TheOncoDoc – Redefining Oncology Pharma Marketing in India
  4. Novartis — Arogya Parivar Initiative
    Pharmaceutical Executive (PharmExec) – Country Report: India
  5. Janssen India — Holistic Disease-Management Programs
    PharmExec – Country Report: India

US Biosimilar Overhaul: A Breakthrough Moment or a Strategic Test for Indian Pharma

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On 31 October 2025, the Economic Times (ET) headline— “US biosimilar norms to keep local drug cos in good health” - quickly became one of the most discussed topics across India’s biopharmaceutical circles.

For India, which is transitioning from a global generics’ powerhouse to an emerging biologics player, this shift is more than regulatory news. It marks a critical moment that could either accelerate India’s biopharma ambitions or expose deep structural gaps.

What Has the US FDA Changed?

The ET report highlights a few key regulatory shifts:

  • Reduced clinical trial requirements where scientifically justified
  • A more predictable and transparent review pathway
  • Lower development costs for manufacturers
  • Quicker regulatory timelines

These changes significantly lower the barriers for biosimilar entry into the US – the world’s most lucrative biologics market.

For Indian companies, this means faster commercialization of assets previously slowed by cost, litigation, and development complexity.

Why These Norms Matter Deeply for India:

1. The Big Leap Beyond Generics

India’s pharmaceutical success has historically been built on small-molecule generics. Biosimilars represent the next step – complex, high-value biologics requiring advanced R&D, analytics, and precision manufacturing.

A friendlier US regulatory landscape can:

  • Boost Indian biologics capabilities
  • Enhance India’s scientific reputation
  • Accelerate the transition from volume-based to value-based pharma exports

This is not incremental – it is transformational.

2. A Chance to Make Biologics Affordable – Globally and at Home

Indian biosimilars entering the US could push global prices downward, increasing patient access everywhere.

But the unanswered question remains:

Will India ensure the same benefits reach its own patients?

Historically, many biologics approved in India remain unaffordable. This opportunity must change that narrative.

3. Catalyst for Investment and Innovation

Success in the US market – considered the gold standard – often brings:

  • Investor confidence
  • International collaborations
  • High-value licensing deals
  • Technology transfer opportunities

If Indian firms reinvest this momentum into R&D, it can accelerate India’s shift toward a future where ‘innovated-in-India’ becomes as common as ‘made-in-India’.

4. Competitive Pressure on Originator Biologics

Lower-cost Indian biosimilars could challenge multinational biologics giants in their strongest market.

This may result in:

  • Reduced prices
  • Greater insurance coverage
  • Wider patient access

It positions India as a meaningful global competitor – not just a contract manufacturer.

But the Red Flags Are Too Important to Ignore:

A) Biosimilars Are Not Generics – Quality Risks Are Heightened

Biologics demand:

  • High-precision fermentation
  • Immunogenicity evaluation
  • Strong data integrity
  • Robust GMP compliance

Any compliance slip-up in the US biosimilar space could severely damage India’s credibility.

This is a risk India cannot afford.

B) Patent Barriers Will Still Be Tough

Even with simplified norms, US biosimilar entry often faces:

  • Patent thickets
  • Secondary patents
  • Litigation from innovator companies
  • Market-access hurdles

Indian companies will need smarter IP and litigation strategies – not just efficient manufacturing.

C) India’s Own Ecosystem Needs Modernization

India must strengthen:

  • Analytical labs for similarity assessments
  • Biologics manufacturing clusters
  • Cold-chain logistics
  • CDSCO guidelines
  • Pharmacovigilance systems

Without this, Indian biosimilars may flourish abroad while India continues lagging in domestic biologics availability and safety monitoring.

D) The Risk of Mission Drift

If export markets become the primary focus:

  • Domestic patients may remain an afterthought
  • Prices of biologics may not reduce meaningfully within India
  • Public health benefits may fall behind corporate goals

Balancing global ambition with national responsibility is crucial.

What India Should Prioritize Now:

For Indian Pharma Companies

  • Invest heavily in biologics R&D, analytics, and quality systems
  • Strengthen data integrity and regulatory compliance
  • Pursue strategic co-development partnerships
  • Ensure domestic market access for biosimilars – not merely exports

For Indian Policymakers and Regulators

  • Align CDSCO norms with US/EU biosimilar standards
  • Build biotech clusters and offer strategic incentives
  • Strengthen post-marketing surveillance
  • Use public procurement to promote affordable biologics for Indian patients
  • Encourage transparent pricing and competition

For Public Health Stakeholders

  • Monitor domestic pricing of biosimilars
  • Demand safety and immunogenicity transparency
  • Advocate access for oncology, autoimmune, and rare disease treatments

A Defining Moment: Opportunity vs. Responsibility

India stands at a strategic crossroads.

If industry, policymakers, and regulators move in alignment, India can become a global biosimilar powerhouse - known for quality, affordability, and innovation.

If not, this moment may turn into yet another case where India enables global affordability while failing to deliver it domestically.

“The true test of India’s biosimilar advantage will be measured not in US approvals – but in whether Indian patients finally gain access to affordable biologics.”

Quick Takeaways:

  • New US FDA biosimilar norms promise faster, less burdensome approval pathways.
  • Indian companies like Biocon, Intas, and Dr. Reddy’s stand to gain significantly.
  • But quality risks, patent barriers, and domestic-access concerns remain real.
  • India must upgrade its biologics ecosystem—not just chase US profits.
  • The real test: Will Indian patients benefit from this global opportunity?

Conclusion:

Closing Thought

The US FDA may have opened the door.
The world may be watching.
But only India can decide whether this moment becomes a turning point – or a missed opportunity.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors.

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.

When Pills Betray Trust

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Why India’s Drug Quality Crisis Demands a Mindset Reset?

A Familiar Headline, a Fading Sense of Shock:

It happened again.
According to The Economic Times (October 24, 2025), 112 drug samples failed quality tests in September — one even found spurious.

If that didn’t startle you, you’re not alone. These headlines have become as routine as morning tea. Public outrage brews for a moment, then cools before the next edition hits the stands.

But imagine if 112 aircraft failed safety checks in a single month — would anyone dare call that a “batch-specific issue”?
When it comes to medicines that enter human bodies and decide between sickness and survival, such excuses sound absurd. Yet, we’ve come to accept them.

That quiet acceptance is where the real danger begins.

When Data Lies, Patients Pay the Price:

As reported by The Economic Times on October 30, 2025, in a separate and alarming development — “Drug cos forging data for approval, mislabeling brands to be barred.”

If the first report showed what went wrong, this one revealed why - Forged data. Mislabeled brands. Corners cut in dossiers. It’s not just a lapse in manufacturing — it’s a collapse in ethics.

Let’s be honest: you can’t market “Make in India, Trust Globally” when the fine print whispers “Data Forged, Labels Fudged.” Somewhere between speed-to market and responsibility-to-patient, we’ve misplaced our moral compass.

And when that happens, it’s not just a regulatory failure — it’s a betrayal of trust.

Quality: Built In, Not Inspected In:

Each time such headlines appear, the reflex is predictable — emergency reviews, press statements, promises of stricter enforcement. All necessary. Yet, all reactive.

Because quality cannot be inspected in after production — it must be built in before it begins.
And that calls for something no checklist or audit can enforce: a fundamental change in mindset.

  • A corporate mindset that values patient safety above quarterly profits.
  • A regulatory mindset that prizes prevention over post-mortem.
  • A leadership mindset that refuses to normalize mediocrity when human lives are at stake.

This is not a question of capacity or compliance — it’s a question of conscience.

“You can’t inspect quality into a pill — it has to be built into the process, the mindset, the culture.”

From Blame Games to Shared Accountability:

Every time this issue resurfaces, the blame carousel spins:

  • Regulators point to resource gaps.
  • Companies point to complexity.
  • Everyone points to the system.

But systems don’t act — people do.

A regulator’s vigilance cannot replace a company’s integrity. Nor can corporate SOPs mask ethical indifference.

India’s recurring quality crises demand not louder warnings, but shared accountability — an honest partnership between regulators and industry that treats every tablet as a promise, not a product.

If we achieve that, the next set of headlines won’t read “112 Drug Samples Fail.” They’ll read: “India Sets New Global Benchmark in Drug Quality.”

A Dose of Humor — and a Hint of Hope:

Someone once quipped, “In India, we don’t recall drugs — we recall excuses.”
Clever. Painfully accurate.

But here’s the hopeful twist: India has achieved the impossible before.
We built vaccine networks the world now depends on.
We made medicines affordable to millions who once had none.
We can certainly lead in quality — if we decide to make integrity non-negotiable.

The prescription isn’t complicated:

  • Less denial, more diligence.
  • Fewer circulars, more conviction.
  • And a mindset that views every patient not as a market opportunity — but as a moral responsibility.

Because every failed sample isn’t just a number — it’s a risk to a trusting patient who believed the system would protect them.

It’s time it truly did.

“When data lies, patients pay the price.”
“Quality in pharma isn’t a regulatory requirement — it’s a moral one.”

Conclusion:

The Bottom Line

India has earned its title as the pharmacy of the world.
Now it must earn another — the pharmacy the world can trust.

That journey doesn’t begin with another inspection or circular.
It begins with a mirror — and a mindset.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors.

 

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


Sources & References

  1. “112 drug samples fail quality tests in September 1 found spurious: Govt” — PTI / ET Manufacturing (The Economic Times), October 24, 2025.
  2. “Drug cos forging data for approval, mislabeling brands to be barred” — The Economic Times, October 30, 2025.
  3. Background: Business Standard reports on CDSCO alerts and enforcement updates, 2024–25.

 

Beyond the Business Card: What Retirement Truly Gives Back

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A thought-provoking LinkedIn post by a highly accomplished veteran of the pharmaceutical industry — long retired, but still as insightful as ever — recently caught my attention. It sparked a series of reflections on an issue that deeply resonates with the evolving dynamics of our industry. That inspiration led me to write this article — and here it is.

When the Rush Finally Stops:— A reflection on life’s quieter rewards after leaving the corporate race

After decades in a demanding corporate life — where every day revolved around deadlines, decisions, and discussions — retirement often arrives as an unexpected silence. The phone calls slow down, invitations fade, and the once-crowded calendar turns blank. For many, it feels unsettling at first, as though the world has quietly moved on. Yet hidden within that quiet lies one of life’s most meaningful transformations.

The Habit of Pretending to Be Busy:

In the early phase, many retirees still pretend to be busy. It’s not deceit — it’s conditioning. After years of being constantly in demand, the idea of doing nothing feels almost unacceptable. So, they talk about “projects” and “commitments,” reassuring both themselves and others that they still matter. But over time, this need to appear busy fades. What remains is a deeper calm — the confidence that life need not be full to feel fulfilled.

The Gift of Time — and Freedom:

When the external noise subsides, the first gift is time — the one thing we always chased, yet never truly owned. Mornings become unhurried, walks feel longer, and even silence feels alive. Time, once ruled by deadlines, now flows freely — not as emptiness, but as freedom.

Rediscovering the Person Behind the Position:

Freed from professional identity, one begins to rediscover the person behind the position. For years, we defined ourselves by what we did; now we ask who we are. In that quiet self-inquiry begins a journey toward authenticity and inner clarity.

Staying Productive — But with Purpose:

Many top corporate leaders, used to constant relevance, seek new ways to remain productive — serving on boards, mentoring, writing, or starting ventures. The motivation shifts from power to purpose, from profit to impact. It’s no longer about proving worth, but about creating value that feels personally meaningful.

Relationships That Truly Matter:

Relationships too become more genuine. The ones that remain are not transactional but real — based on warmth, not utility. The circle may shrink, but it deepens. And solitude, once feared, becomes a trusted companion — giving space for reflection, gratitude, and creativity.

Conclusion:

A Return to Life, Not a Retreat from It:

Ultimately, retirement, I reckon, is not a retreat from life, but a return to it. One may lose attention and activity, but gains something far greater — awareness, authenticity, and quiet contentment. It marks not an ending, but a beginning that finally belongs entirely to you.

— By: Tapan J. Ray

Author, commentator, and observer of life beyond the corporate corridors.
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.

 

When Patents, Patients and Prices Collide

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Supreme Court Clears Natco to Launch Low-Cost Version of Roche’s Spinal Drug in India: A Judgment That Redefines Access and Innovation in India’s Pharma Landscape.

The Supreme Court of India has just recently refused to interfere with the Delhi High Court’s order allowing Natco Pharma to manufacture and market a generic version of Roche’s spinal muscular atrophy (SMA) drug, Risdiplam (Evrysdi). This landmark development doesn’t just mark a legal win for generics — it revives the deep, ongoing debate between patent protection and public access to life-saving medicines.

A Ruling That Speaks the Language of Access:

On October 17–18, 2025, Roche’s plea seeking an injunction against Natco was dismissed by the Supreme Court, which found no reason to interfere with the Delhi High Court’s earlier decision.

The Delhi court had refused to grant Roche interim relief, noting credible grounds to challenge the patent’s validity and the public-interest urgency of allowing cheaper treatment for SMA — a devastating genetic disorder that affects infants and children.

The court’s reluctance to grant an interim injunction places patient affordability front and center — and that changes the dynamics of pharma patent battles in India.

The Price Gap That Altered the Equation:

Roche’s Evrysdi reportedly costs several lakh rupees per bottle in India, putting it beyond the reach of most families. Natco’s generic version, as reported, could be priced over 90% cheaper — transforming what was once an impossible dream into a realistic treatment option.

This price gap didn’t just influence public sentiment; it played a significant role in shaping the courts’ stance. Judges openly recognized that blocking a low-cost version could effectively deny treatment to children with SMA — a life-and-death consequence.

Why the Supreme Court’s Refusal Matters:

The Supreme Court’s decision not to grant Roche an interim injunction reinforces a growing Indian legal trend: interim injunctions in pharma patent cases are no longer automatic.

Courts now weigh:

  • Patent strength and the credibility of validity challenges,
  • Irreparable harm to the innovator, and
  • Public interest, especially access to life-saving drugs.

This signals that the right to enforce a patent is conditional upon the broader social consequences of that enforcement.

Balancing Innovation and Access:

This case captures the perennial dilemma:

  • Innovators argue that strong patent enforcement is essential for recouping high R&D investments and incentivizing new drug development.
  • Public health advocates argue that patents cannot become instruments of exclusion in countries where millions live below the affordability line.

When prices put essential medicines out of reach, the courtroom becomes a public-health tool — not just a commercial arena.

The Natco–Roche case has forced policymakers, the judiciary, and especially the multinational pharmaceutical companies to re-examine that delicate balance.

Wider Ripples Across the Pharma Ecosystem:

This decision could shape the future of pharmaceutical litigation and policy in India in at least three ways:

  1. Fewer automatic injunctions:
    Courts are likely to scrutinize the public-health impact before granting injunctions for high-priced patented drugs.
  2. Pricing pressure on innovators:
    Multinationals may increasingly adopt tiered pricing, voluntary licensing, or expanded patient-assistance programs to avoid reputational and legal setbacks.
  3. Inspiration beyond India:
    India’s judicial balancing act could influence other developing countries grappling with rare-disease affordability and IP rights.

What It Means for Stakeholders:

  • For patients and caregivers: A crucial breakthrough — real hope for families fighting SMA who could never afford imported treatment.
  • For Indian pharma: A signal that robust patent challenges and ethical pricing can reshape access debates.
  • For global innovators: A call to re-engage with India through more collaborative models — not courtroom showdowns.

Access and innovation need not be enemies. The challenge is rewriting the incentives so they can be allies.

Conclusion:

A Broader Reflection:

This judgment underscores a truth India’s policymakers have long recognized — that patent law is not just about ownership, but about obligation. Society grants exclusivity to foster innovation, but that exclusivity loses legitimacy when it bars life-saving treatment for those who need it most.

While this verdict helps address immediate patient needs, the long-term path must include transparent pricing frameworks, stronger patent examination, and public–private partnerships to make rare-disease drugs sustainably accessible.

By: Tapan J. Ray

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

Sources and References:

  • Supreme Court of India order (October 2025)
  • Delhi High Court proceedings in Roche vs. Natco (2024–2025)
  • Reporting: Moneycontrol, The Economic Times, LiveMint, SwissInfo, Knowledge Ecology International

 

When ‘Vikshit Bharat’ Rings Hollow: A Tragedy That Exposes India’s Uneven Progress

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India’s vision of Vikshit Bharat promises inclusive growth and modern progress. Yet, when children die from contaminated cough syrup, that dream rings hollow. This article asks the hard question: can a nation truly be “developed” when its weakest citizens still fall victim to preventable failures of regulation, ethics, and accountability? 

The dream of Vikshit Bharat - a Developed India – resonates with every citizen who envisions a nation rising to its full potential. From economic growth to digital empowerment, it has become a rallying cry for progress. Yet, recent events force us to ask: are we truly building a developed India, or merely admiring a slogan that rings hollow amid painful realities?

Behind the glitter of big promises, uneven progress continues to surface in the most tragic ways. Recent events have cast a shadow of doubt over the sincerity of this mission – particularly the heartbreaking deaths of several children in India due to the consumption of contaminated cough syrup. A horrifying déjà vu of earlier incidents in countries like Gambia and Uzbekistan, this tragedy lays bare a stark and uncomfortable truth: the lives of Indian citizens often don’t seem to command the same level of regulatory seriousness as those of citizens abroad.

A Shocking Disparity: Export vs Domestic Standards:

What makes this tragedy even more difficult to digest is the regulatory loophole that has long existed in India’s pharmaceutical oversight. According to current Indian regulations, pharmaceutical companies are required to submit full analytical testing data for products being exported, especially to regulated markets. However, no such mandatory requirement exists for drugs being sold in the domestic market.

This raises an urgent and disturbing question: Are Indian lives being valued less than foreign ones?

If we are genuinely moving toward a “Developed India,” shouldn’t the health and safety of our own citizens be non-negotiable?

The truth is, such discrepancies are not isolated. They are symptomatic of a deeper, systemic issue that continues to plague many developing nations: a prioritization of global perception over internal accountability.

‘Vikshit Bharat’: A Dream Worth Pursuing, but Not Blindly

The idea of a developed India is not just about GDP growth, shiny new infrastructure, or digital breakthroughs. It is equally, if not more, about the quality of governance, public health, and the dignity of life for every citizen – especially the most vulnerable.

To be fair, over a period India’s journey toward development is undeniably impressive – but also uneven. The country has made commendable progress in several areas:

  • Digital India has revolutionized access to services.
  • Aadhaar and UPI have brought millions into the financial mainstream.
  • Make in India and Startup India have created a buzz of entrepreneurial energy.
  • Significant investments are being made in renewable energy, AI, and space exploration.

Yet, the foundations of a truly developed nation are not built on slogans, but on systems that protect, nurture, and value every citizen equally. And it is here that the gap between rhetoric and reality becomes painfully visible.

Regulatory Reform: The Need of the Hour

India’s pharmaceutical industry is known globally as the “pharmacy of the world.” But what does that mean when quality standards differ for exports versus domestic consumption?

This is not just a policy failure; it is an ethical lapse.

If we are serious about Vikshit Bharat, then regulatory reform must be prioritized:

  1. Uniform Testing Standards: All drugs, whether for export or domestic use, must meet the same rigorous safety and efficacy requirements.
  2. Transparency and Accountability: Regulatory bodies like CDSCO must be given independence, resources, and teeth to act decisively.
  3. Whistleblower Protection: Create legal mechanisms to protect and encourage industry insiders to report malpractices.
  4. Patient-Centric Policies: Every public health policy must answer one question: Is this in the best interest of Indian patients?

Walking the Talk Starts at Home:

A country cannot be considered developed if its children die due to something as preventable as toxic cough syrup. The real test of progress is how a nation treats its weakest, not how loudly it trumpets its ambitions.

While slogans like Vikshit Bharat can be powerful in uniting people under a common vision, they must be backed by policy integrity, institutional reform, and empathetic governance.

Only then will these words evolve from political catchphrases into a lived reality for every Indian—rich or poor, urban or rural, adult or child.

Conclusion: Final Thoughts

India stands at a critical juncture. The path to becoming a truly developed nation lies not just in celebrating achievements and criticizing the past, but also in acknowledging uncomfortable truths and acting decisively on them.

Until then, the promise of Vikshit Bharat will continue to ring hollow – not for lack of ambition, but for want of accountability.

Let Vikshit Bharat be more than a dream or a slogan. Let it be a commitment to justice, equality, and above all, humanity.

 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.