Tag Archives: Regulatory

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

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.

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.

 

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.


Regulatory Failures Are Still Risking Patient Lives

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India’s pharmaceutical industry faces renewed scrutiny as the Drug Controller General of India (DCGI) flagged numerous substandard drugs in September 2024. At the same time, an October 02, 2024, Business Standard report highlights an ongoing crackdown on such drugs by regulators. This article explores these contrasting developments, beginning with the September findings.

On September 22, 2024, multiple reports revealed that the DCGI, through the Central Drugs Standard Control Organization (CDSCO), identified 195 instances of substandard drugs, devices, and vaccines over three months. Popular brands like Shelcal 500, NICIP MR, and Pantocid were among the flagged drugs, affecting treatments for common ailments like hypertension and acid reflux. Major companies like Alkem, Sun Pharma, and Hetero Labs were implicated. The DCGI ordered the withdrawal of these drugs and called for stricter vigilance, highlighting ongoing issues despite regulatory frameworks being in place, which is known to all drug manufacturers, but still happening all over the county.

Industry Response: 

After the DCGI’s September 2024 report on substandard drugs, responses from pharmaceutical companies were mixed. Many large firms cooperated, taking corrective steps to comply with Good Manufacturing Practices (GMP) and tightening quality control. Some acknowledged the need for stricter oversight and preventive measures.

As happens mostly, there has been notable pushback from a portion of the industry, particularly smaller and mid-sized manufacturers. These companies argue that the stringent audits and frequent shutdowns due to non-compliance are creating significant financial and operational pressures.

Interestingly, some large manufacturers claimed that the faulty products were counterfeit or spurious. This makes the scenario even more complex. Although, both endanger patient lives.

Decades of regulatory failures persist, but at what cost? 

Back in June 2015, I highlighted that “Fake Drugs Kill More People Each Year Than Terrorism Over the Last 40 Years.” Shockingly, little has improved since then.

The problem is deeply rooted in nations with weak enforcement - India being a prime example. Alarmingly, the Ministry of Health has long downplayed this threat, as it appears now.

For example, even prior to that, in 2009, their “Report on Countrywide Survey for Spurious Drugs” grossly underestimated the issue, claiming only 0.046% of spurious and 0.1% substandard branded drugs. This underreporting reflects a dangerous “Ostrich Syndrome” among regulators, who continue ignoring this life-threatening crisis, leaving millions at risk.

The question I raised in this blog on October 12, 2015 2015 still haunts me today: “Does India produce ‘world-class’ medicines for all?” Effective checks and accountability are crucial to address this crisis.

To tackle counterfeit drugs, India needs a comprehensive strategy, such as:

  1. Strengthen Regulation: Stricter inspections, penalties, and GMP adherence.
  2. Leverage Technology: Implement digital tracking systems.
  3. Improve Coordination: Better agency collaboration and audits.
  4. Foster Industry Self-Regulation: Internal audits and regulatory partnerships.
  5. Raise Public Awareness: Educate consumers, protect whistleblowers.
  6. Adopt Global Standards: Align with international benchmarks.

Only with strong accountability can India safeguard drug safety.

While there have been reports of some progress, concerns remain:  

A Business Standard report from October 02, 2024, highlights a regulatory crackdown on substandard drugs. However, this raises critical questions about the true effectiveness of these efforts. Upon closer inspection, the report reveals limitations that warrant deeper scrutiny. These include gaps in data coverage, inconsistent inspections, and doubts about the sustainability of the actions taken, which cast doubt on how far-reaching and impactful this so-called crackdown really is.

Some of the notable flaws that I find in the report include:

  1. Lack of Comprehensive Data: The report focuses on inspected units, which represents only a small fraction of India’s vast pharmaceutical manufacturing sector, especially considering that 80% of India’s pharma units are micro, small, and medium enterprises that often escape the regulatory radar.
  2. Limited sample size could misrepresent the true scale of substandard drug production.
  3. Inconsistent Inspection Coverage: While the CDSCO has ramped up its audits, the inspection coverage appears uneven. Many smaller manufacturers, particularly those operating in less regulated states, may not face the same scrutiny as larger companies. This could skew the perception of improvement.
  4. Global Discrepancies: Despite claims of reduced international complaints, the report doesn’t fully address concerns like the recent ban on Indian-made antibiotics by Nepal, signaling that quality issues persist in exports.. This suggests a gap between domestic inspections and international quality standards. 
  5. Sustainability Questioned: The report emphasizes short-term regulatory actions, but long-term sustainability is unclear. Temporary shutdowns and corrective actions might not be enough to ensure lasting quality improvements, especially in an industry facing systemic issues like weak documentation and quality control in smaller firms 

In summary, while the report provides some optimistic updates, its credibility is limited by incomplete data, uneven enforcement, and questions about long-term impact. 

Is entity-centric accountability grossly missing in this area? 

Absolutely. The accountability of both regulators and pharmaceutical companies regarding substandard and counterfeit drugs in India has been alarmingly deficient for years. Despite recurring reports of poor drug quality, weak enforcement, and ineffective oversight persist. 

Regulatory bodies have failed to consistently hold companies accountable, allowing dangerous drugs to flood the market and endanger public health. This systemic neglect, coupled with inconsistent audits and lax penalties, has led to a crisis that remains unresolved even today. Thus, the following two areas, I reckon, need to attract greater focus:

  • Regulatory Gaps: The Central Drugs Standard Control Organization (CDSCO) has faced criticism for being reactive rather than proactive, with irregular inspections and delays in addressing violations. The weak enforcement of Good Manufacturing Practices (GMP) and insufficient penalties for violators have allowed substandard drugs to continue circulating.  
  • Pharma Companies’ Compliance: Many pharmaceutical companies have either ignored or downplayed the issue, sometimes blaming counterfeiters rather than addressing quality control lapses. While larger companies might cooperate after being caught, the lack of strict and consistent regulatory pressure has allowed many manufacturers to evade full accountability.

This lax accountability, both in the regulatory framework and among drug companies, has created an environment where the production and distribution of substandard and fake drugs continue to pose serious risks to public health in India. The need for stricter enforcement and transparent accountability is crucial for restoring trust in the system.

Conclusion:

Despite years of scrutiny, regulatory lapses in India’s drug industry continue to jeopardize patient safety. Weak oversight and inconsistent enforcement allow substandard and counterfeit drugs to flood the market, with deadly consequences.  

Regulatory bodies have failed to take firm action, and pharmaceutical companies are often not held accountable. As a result, millions remain at risk, and trust in the healthcare system is eroding. The cost of these failures is measured in lives, and without immediate reforms, the crisis will only deepen.

This underscores the point that the time for complacency has passed – India’s healthcare system and public trust demand swift, decisive action against counterfeit and low-quality drugs, with clear accountability and stringent punitive measures for violators.

By: Tapan J. Ray

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

 

A Game-Changing Non-Covid Drug Approval In the Pandemic Milieu

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Amid high decibel deliberations on Covid-19 pandemic, something similar to groundbreaking happened – involving Biosimilar drugs, in just a couple of months ago. On July 28, 2021, in the Eldorado of the pharma industry, the US-FDA approved  the first ‘interchangeable’ biosimilar drug, for wider access to modern and much affordable treatment of diabetes. This is expected to open new vistas of opportunity for biosimilar drugs, in general, across the world.

The development is even more interesting, as the product named Semglee belongs to India’s largest biopharmaceutical company - Biocon Biologic. It’s an ‘interchangeable’ biosimilar insulin glargine, referencing Sanofi’s, reportedly  the second best-selling product in 2020 - Lantus. Notably, the Biocon product was launched in 2020 without the ‘interchangeability’ designation.

Although, the patent of this long-acting insulin (glargine) – used to treat diabetes type I and II, expired during 2015, in 2020 also Lantus generated some 2.7 billion U.S. dollars worldwide. Many envisage, the approval of this first ‘interchangeable’ biosimilar insulin glargine will foster stronger competition in the insulin market, which is currently dominated by a handful of brands, like Lantus – and characterized by their stubbornly high prices.

In today’s article, I shall focus on what it means to pharma marketers for greater market access to ‘interchangeable’ biosimilar drugs.

What ‘interchangeability’ really means:

As I wrote in my article on July 31,2017, there are two key barriers to improving patient access to biosimilar drugs, and one of which is the issue of their ‘interchangeability’ with original biologic drugs. It means, besides being highly similar, a biosimilar drug would require indisputable clinical evidence – that it gives the same result to patients, just as the original biologic medicine.

Thus, lack of the ‘interchangeability’ designation makes many physicians hesitant to switch, for all those existing patients who are on expensive original biologic drugs, to less expensive available biosimilar alternatives. Only new patients in that case, are prescribed biosimilar drugs, sans ‘interchangeability’ label from the drug regulator, especially in the US.

Overcoming a tough barrier to biosimilar market growth:

This was echoed by another article on ‘Interchangeability’ of biosimilars, published in the Pharmaceutical Journal on July 22, 2020. It wrote, ‘One of the hurdles in the adoption of biosimilars is the lack of interchangeability with reference biologics.’ While interchangeability is an important issue for doctors, ‘different definitions and regulatory frameworks that exist in the United States, Europe and other jurisdictions add to the complexity.’

What the ‘interchangeable’ designation of Semglee will really mean, in terms of affordability to patients, was lucidly explained in an article, published in the AJMC – the center for Biosimilars – on July 29, 2021. It underscored: ‘An interchangeable designation means that Semglee can be substituted for Lantus automatically by pharmacists without physicians’ permission.’ As reported, Semglee will cost nearly 3 times less than the list price of Sanofi’s Lantus, which in 2019 clocked in at $283.56 for a single vial and $425.31 for a box of five pens, in the US.

Are interchangeable biosimilars superior to other biosimilars?

The ‘interchangeable’ designation is not meant to suggest that such biosimilars are superior to ones without this label. However, to obtain the ‘interchangeable’ designation, biosimilar manufacturers are required to perform ‘switching studies.’ These provide evidence that patients who are using originator’s biologic drug, when switch to a comparable biosimilar, do not experience higher rates of adverse events or decreased efficacy. The same has also been clearly explained in the AJMC article of July 29, 2021, as mentioned above.

But, if marketed well, ‘interchangeable’ biosimilars can provide a cutting edge to encourage consumers to switch to the less-expensive ‘interchangeable’ versions of the original higher priced biologic drugs. Consequently, more economical ‘interchangeable’ biosimilars would carve out a larger market share, creating a win-win situation. For patients, it will expand affordable access to biologic drugs- and for the company increased revenue from the expanding biosimilar market, as several studies point out.

Expanding biosimilar market:

According to the IQVIA report of March 04, 2021, the global biosimilars market currently shows double-digit growth and is expected to maintain a similar level of uptake in the coming years. This will be driven by the rising incidence of chronic diseases and the cost-effectiveness of biosimilars, especially as more stringent cost-containment measures are likely – post COVID-19 pandemic.

The paper concluded, biosimilars will continue to register impressive growth in their market share, aided by patent expiries and regulatory improvements which will permit easier and more rapid market access. Many pharmaceutical companies – having witnessed this trend, are now preparing to leverage the biosimilar opportunity. However, marketing large molecule biosimilar drugs will not be quite the same as marketing small molecule generics. 

Estimated savings to patients with biosimilars – in Covid-19 context:

As the IQVIA Institute estimates, over the next five years biosimilars could globally contribute a cumulative $285 billions of savings to patients and payers. To put this in context, it says, over the same period, around $150 billion will be spent on COVID-19 vaccines. According to a senior IQVIA official, as quoted by Reuters Events of July 2, 2021: “The five-year savings from biosimilars could almost double the amount of incremental spending that will be going out to get everybody vaccinated around the world.”

Going by the IQVIA data, biosimilars are between 20% and 50% more affordable. And this is especially at a time when affordability drives a lot of healthcare - sustainability that has emerged as a major issue during the pandemic.

Conclusion:

Currently, in many countries of the world, alongside Covid vaccination drive in top gear, creation of a disruptive pandemic-specific – a robust health infrastructure for the future, is yet to be in place. More importantly, public health facilities, especially in India, are still struggling hard to meet affordable health care needs of patients – sans restrictions or apprehensions of getting infected by Covid-19.

Against this backdrop, the very first approval of an ‘interchangeable’ biosimilar drug, in the Eldorado of pharma business – the US, brings a new hope to many patients, in 2021. An expectation of reducing their healthcare burden, significantly. This will happen, as the prescribers muster enough confidence to advise patients switching from highly expensive original biologic to more affordable ‘interchangeable’ biosimilar drugs, as and when these are launched.

In tandem, with this growing new confidence, others – even ‘non-interchangeable’ biosimilar drugs, will be able to deliver more value being, besides greater affordability – wider access to sustainable-treatments for patients.

This comes, possibly with a caveat. Biosimilar drug marketers will need to chart a new marketing frontier, without holding on to their pre-covid strategies – especially for large molecule biosimilar drugs.

From this perspective, the US-FDA’s regulatory approval of the first ‘interchangeable’ biosimilar insulin to Sanofi’s high-priced Lantus, carries a game-changing potential in the biosimilar drug market, for astute pharma marketers to leverage.

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.

Unfettered ‘Access To Drug Innovation’ – An Oxymoron?

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The mass paranoia, as it were, over Covid pandemic has now started fading with drug regulators’ ‘emergency approval’ of several Covid -19 vaccines, and its free of cost access to all, generally in most countries. As the endgame of the pandemic, supposedly, depends on the speed of Covid-19 vaccination, the drug industry’s public reputation in the interim period, driven by its rapid response to the crisis, got an unsurprising boost (62%). This was captured by the Harris Poll, released on March 15, 2021.

Interestingly, soon after the high of 62% approval rating, the decline began. It came down to 60% in May and then 56% in June 2021—and now down three more percentage points, according to the Harris Polls that followed. No wonder, why the FiercePharma article of August 24, 2021, carried a caption: ’Pharma’s reputation drops again. Could it foreshadow a return to the bottom?’

Further, in the new normal, especially when customer expectations and requirements from drug companies have significantly changed, MNC Pharma industry still appears to be in the old normal mode in this space. It still, reportedly, ‘believes that the need for innovation must be balanced with the necessity for more accessible medicines, within a robust IP and regulatory environment,’ in India.

The hidden purpose of the same could possibly be, as several industry watchers believe – availing benefits of greater access to one kind innovation, making access to other kind of innovation more difficult. Consequently, two critical points are reemerging, even in the new normal, as follows:

  • Aren’t Indian IP and regulatory ecosystems still conducive enough for MNC pharma players’ access to drug innovation?
  • In the name of greater access to pharma product innovation, are they creating barriers to pharma process innovation, delaying market access to complex generics and Biosimilar drugs – besides systematically eroding consumer confidence on such products?

In this article, under the above backdrop, I shall try to explore why the epithet – ‘access to drug innovation’ is considered an oxymoron – with contemporary examples from around the word, including India.

Aren’t Indian IP and regulatory ecosystems conducive to drug innovation? 

This allegation doesn’t seem to hold much water, as several successful local initiatives in Covid-19 vaccine development will confirm the same. Besides, already marketed Covaxin, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and Zydus Cadila’s ZyCov-D, there are several others waiting in the wings. These include domestic drug makers like, Hyderabad based Biological-E, Bengaluru-based medical pharma startup’s – Mynvax, and Pune-based Gennova Biopharmaceutical’s m-RNA vaccine candidates. However, only critical difference is – Indian made Covid vaccines are more affordable and accessible to patients, as against those manufactured by MNCs, such as, Pfizer, Moderna and J&J.

If we look back to the old normal, one will also find similar instances of new drug discovery in India, which deliberated in my article of September 02, 2013. Let me give just a couple of examples below:

  • Ranbaxy developed and launched its first homegrown ‘New Drug’ for malaria - Synriam, on April 25, 2012
  • Zydus Cadila announced in June 2013 that the company is ready for launch in India its first New Chemical Entity (NCE) for the treatment of diabetic dyslipidemia –Lipaglyn.

Hence, meager wherewithal for R&D notwithstanding, as compared to the MNCs, Indian pharma players don’t seem to find the country’s IP and regulatory ecosystems not conducive to innovation of affordable new drugs with wider patient access.

Off-patent drugs also involve another type of major innovation:

Discovering an NCE is, unquestionably, a product of drug innovation. Similarly, developing a new – cost-effective, non-infringing manufacturing process to market off-patent drugs, like biosimilars, also involve another type of major innovation. Intriguingly, when the MNC pharma industry talks about ‘access to innovation’, the latter type of innovation isn’t publicly acknowledged and included in their drug innovation spectrum. This practice, reportedly, remains unchanged in their advocacy campaign, even in the new normal.

However, the fact is, the manufacturers of off-patent drugs, such as biosimilars, also need to follow a major innovative process, for which they require access to innovation. This was also captured in an editorial of the newsletter – Biosimilar Development. The deliberation addressed the question - Do biosimilars fit into the innovation paradigm? The editor began by articulating – hardly anyone publicly argues that the development of new manufacturing process of Biosimilar drugs is not an innovation. The industry can’t call them as a copy of an existing innovation, either.

This is also vindicated in the Amgen paper, published on February 11, 2018. It acknowledges, “Unlike small molecule generic drugs, biosimilars are not identical to the reference biologic or to other approved biosimilars of the same reference biologic, because they are developed using different cell lines and undergo different manufacturing and purification processes.” Moreover, biosimilars also carry a different International Nonproprietary Name (INN), because of their molecular differences from the reference drug. This has been specified in the nonproprietary naming Guidance document of the US-FDA of January 2017.

From this perspective, the next question that logically follows: Is process innovation as important as product innovation?

Is process innovation as critical a capability as product innovation?

This question was unambiguously answered by a pharma industry-centric Harvard Business Review(HBR) article – ‘The New Logic of High-Tech R&D’, published in its September–October 1995, issue. The paper emphasized, for the commercial success of a product ‘manufacturing-process innovation is becoming an increasingly critical capability for product innovation.’

When to meet patient-needs ‘access to innovation’ an oxymoron: 

‘Access to innovation’ is an interesting epithet that is often used by many drug companies for meeting unmet needs of patients. However, the same is also often used to create barriers to meeting unmet needs of more patients with cheaper biologic drugs, like Biosimilars, immediately after their basic patent expiry. This is mostly practiced by creating a patent thicket. Hence, drug companies’ advocacy for greater access to innovation is an oxymoron to many.

The same was echoed in another article – ‘How originator companies delay generic medicines,’ published by GaBI. It wrote, such practices delay generic entry and lead to healthcare systems and consumers paying more than they would otherwise have done for medicines. These include the following:

  • Strategic patenting
  • Patent litigation
  • Patent settlements
  • Interventions before national regulatory authorities
  • Lifecycle strategies for follow-on products.

A very recent piece on the subject, published by Fierce Pharma on August 31, 2021, vindicates that the patent life extension through the patent thicket is happening on the ground – denying patients access to cheaper equivalent, especially of off-patent biologic drugs within a reasonable time period. It highlighted:

  • The exclusivity of AbbVie’s Humira, which hit the market in 2002 and generated nearly $20 billion in sales last year was extended by 130 patents.
  • The same company has applied for 165 patents for its another blockbuster Imbruvica. Launched in 2013, Imbruvica has already generated sales of $5.3 billion for AbbVie.

No wonder, why in February 2021, during a Senate Finance Committee hearing, Sen. John Cornyn blasted the company saying:

“I support drug companies recovering a profit based on their research and development of innovative drugs,” Cornyn said. “But at some point, that patent has to end, that the exclusivity has to end, to be able to get it at a much cheaper cost.”

More reports are also available on attempts to erode consumer confidence in Biosimilar drugs, as compared to the originals.

Work for innovation sans eroding consumer confidence in Biosimilars: 

Making affordable new drugs and vaccines available to patients with ‘access to innovation’, deserves inspiration from all concerned. Curiously, even in the new normal, some big companies continue trying to erode consumer confidence in off-patent drugs, especially Biosimilars and complex generics.

For example, an article on Biosimilars moving to the center stage, published in the Pharmaceutical Executive on August 12, 2021, quoted an interesting development in this space. The article highlighted that US legislators are now ‘eyeing measures to deter innovator promotional messages that disparage follow-on competitors.’ This initiative was spurred by US-FDA criticism of an Amgen promotional communication for undermining consumer confidence in Biosimilars to its Neulasta (pegfilgrastim) injection.

On July 14, 2021, US-FDA’s Office of Prescription Drug Promotion (OPDP) sent a letter to Amgen carrying a caption ‘FDA notifies Amgen of misbranding of its biological product, Neulasta, due to false or  misleading promotional communication about its product’s benefit.

The letter, as reported in the above article, criticized the company for making a false claim of greater adverse events with the injection system used by Biosimilars compared to the Amgen product. OPDP advised Amgen and other firms to “carefully evaluate the information presented in promotional materials for reference products, or Biosimilar products” to ensure correct product identification and avoid consumer confusion.

Conclusion:

When the point is, creating a conducive ecosystem to promote access to innovation, it should be patient-centric – always, and, more so in the new normal, considering changing needs and expectations of health care customers.

The innovation of usually pricey new molecular entities, no doubt, meets unmet needs of those who can afford these. Whereas, manufacturing process innovation expands access to the same molecule, particularly when they go off-patent, by making them affordable to a vast majority of the population.

But powerful industry lobby groups continue pressing harder for unfettered ‘access to innovation’ with greater relaxation of the IP and regulatory framework of countries, like India. The situation prompts striking a right balance between encouraging more profit by helping to extend patent exclusivity and encouraging greater access to off-patent cheaper Biosimilars as soon as the basic patent expires.

The bottom-line is, both need to be actively encouraged, even if it requires new laws to discourage practices like, creating patent thickets or undermining the use of generics or Biosimilars, and the likes. The good news is lawmakers have started deliberating on this issue – along with increasing public awareness, which gets reflected in the pharma industry’s current reputation ratings.

Left unresolved soon, such piggyback ride on ‘access to drug innovation’ bandwagon to serve self-serving interests, would continue denying speedy entry of cheaper Biosimilars. From this perspective, it isn’t difficult to fathom, why unfettered access to drug innovation is considered an oxymoron, by many.

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.

India Not To Vaccinate All For Covid Control: Upsides And Unknowns

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With 9.46 million cases and 137,621 deaths, India has currently the world’s second-highest number of coronavirus infections, behind only the United States, reported Reuters on December 01, 2020.

Fathoming seriousness of rapidly unfolding Covid induced all round disruptions across the nation, on October 17, 2020, the Indian Prime Minister issued a clarion call. He called for full preparedness of the country to ensure speedy access to Covid vaccines for every citizen.

However, the above view was subsequently changed. On December 02, 2020, quoting Union Health Ministry of India, it was reported, ‘the Government has never spoken about vaccinating the entire country.’ The Director General of the Indian Council of Medical Research (ICMR) said, “the Indian government is of the opinion that vaccination against the deadly pandemic may be needed only to the extent of ‘breaking the chain.’ If we’re able to vaccinate a critical mass of people and break virus transmission, then we may not have to vaccinate the entire population.”

Why the PM said ‘Covid vaccines for every citizen’ at that time?

In my view, what the PM said made perfect sense at that time. This is also vindicated by a fact-based interesting discussion in The Wire on July 16, 2020, carrying a title – ‘How Effective Does a Vaccine Need to Be to Stop the Pandemic? It quoted an in-depth study concluding, “a vaccine with an efficacy as low as 60% could still stop the pandemic and allow society to return to normal. However, most, if not all of the population would have to be vaccinated.”

This research article, titled ‘Vaccine Efficacy Needed for a COVID-19 Coronavirus Vaccine to Prevent or Stop an Epidemic as the Sole Intervention,’ was published in The American Journal of Preventive Medicine (AJPM) on July 15, 2020. The study found that the vaccine has to have an efficacy of at least 70% to prevent an epidemic and of at least 80% to largely extinguish an epidemic without any other measures (e.g., social distancing).

The PM’s observation will make even better sense, while taking into account the draft ‘Regulatory Guidelines for Development of Vaccines with Special Consideration for Covid-19 vaccine in India. This guidance document for vaccine developers was issued by the Central Drugs Standard Control Organization (CDSCO), and was reported by the media on September 23, 2020. It also says, among other specifics, a COVID-19 vaccine candidate should show at least 50 per cent efficacy during phase III of clinical trials for it to be widely deployed.”

Why health ministry’s current plan of not vaccinating all, also makes sense:

Indian Health Ministry’s latest assessment that vaccination against the deadly pandemic may be needed only to the extent of ‘breaking the chain,’ also makes sense in the rapidly emerging contemporary scenario.

It makes sense, considering, even the World Health Organization (WHO) experts have, reportedlypointed to a 65%-70% vaccine coverage rate as sufficient to reach population immunity, based on scientific reasons. This raises the subsequent question of who in India will get priority for vaccination.

The priority group for Covid vaccination in India:

As reported on November 26, 2020, according to the Principal Scientific Advisor of India, about 300 million people will be part of the first ‘wave’ to receive Covid vaccines in India. This number includes, health care workers, totaling 30 million, police personnel and those above 50 and those younger with underlying illnesses that make them vulnerable. However, everything in this area doesn’t seem to be as clear or straight forward as is widely expected. India’s Covid vaccination plan still seems to be a work in progress.

India’s Covid vaccine plan is still a work in progress:

This is evident from many reports, such as one of December 01, 2020. This report says, experts still believe that the government should spell out whether the vaccination should be confined to only uninfected individuals or encompass everyone. These reports may vindicate the murmur in the corridors of power that many details of Covid vaccination in India are yet to crystallize.

Let me quote the Indian Prime Minister in this regard, as he is not only the head of the current Government, but is also the national voice on all contemporary issues in the external world.

Interestingly, on November 24, the Prime Minister himself acknowledged: ‘Will go by scientific advice on Covid vaccine, don’t have many answers yet.’ He made it clear that he did not yet have answers to:

  • Vaccine dosage
  • Pricing or sourcing

Although, his Government has been in touch with local and global vaccine developers, nations and multilateral institutions to ensure vaccine procurement, the PM added.

Curiously, unlike what the Principal Scientific Advisor of India, reportedly articulated on November 26, 2020, just a couple of days before that, on November 24, 2020, the PM has put it quite differently.He then said, priority groups for vaccine administration would be fixed based on state inputs and added that additional cold storage must be created by states. These confirm, India’s final plan on Covid vaccination is still a work in progress.

The Covid vaccination plan is still evolving in India:

Interestingly, on December 04, 2020, in an all-party meeting chaired by the Prime Minister, it was further announced - the first set to receive the Covid -19 vaccine will be about one Crore frontline health workers and the next will be two Crore armed forces, police, and municipal personnel. Besides, around 27 Crore senior citizens, too, would be receiving the vaccine. Thus, the Government’s vaccination plan seems to be still evolving. Meanwhile, something sensational happened in the global race for having a Covid vaccine for a country’s population.

Curiously, much before the commencement of Covid vaccine prioritization discussion in India, on September 14, 2020, it was reported that China is also not going for its entire population. They are prioritizing frontline workers and high-risk populations in its fight against the new Coronavirus.

The first emergency-use authorization for a Covid-19 vaccine happened:

On December 02, 2020, both the local and global media, such as The Wall Street Journal (WSJ) reported: ‘The U.K. became the first Western nation to grant emergency-use authorization for a Covid-19 vaccine, clearing a shot developed by Pfizer Inc. of the U.S. and BioNTech SE of Germany to be distributed in limited numbers within days.’

In the war against Covid pandemic, it also marks a key milestone in efforts to translate a promising new vaccine technology into a widely available shot, the report highlighted. It was developed, tested and authorized and is now poised to be distributed amid a pandemic that has sickened tens of millions of people and killed more than 1.4 million around the world, the news article added.

Interestingly, the U.K could make it happen, even before the United States, where this vaccine is now being reviewed by the USFDA, where a similar authorization could come later this month and a rollout before the end of the year. It’s noteworthy that the USFDA Commissioner has defended the pace of review of Pfizer’s COVID-19 vaccine on the grounds that a thorough assessment is needed to reassure a skeptical public.

NIAID director of the US also believes so, and has claimed, “We have the gold standard of a regulatory approach with the FDA.” This brings us to the question – will Pfizer’s Covid vaccine be available in India soon?

Will Pfizer’s Covid vaccine be available in India soon?

Just a day after U.K’s emergency approval of Pfizer’s Covid vaccine to be rolled out to the public early next week, Pfizer, reportedly, said, the Company is in discussions with many governments around the world, and “… will supply this vaccine only through government contracts based on agreements with respective government authorities and following regulatory authorization or approval.”

However, as reported on December 06, 2020, Pfizer has now sought approval from the DCGI for emergency use authorization of its Coronavirus vaccine. In its application dated December 4, Pfizer India has sought approval to “import the vaccine for sale and distribution in the country, besides waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.”

It’s worth noting, conducting Phase III clinical trials on Indian volunteers has, so far, been a pre-requisite for the DCGI to give authorization to a particular investigational Covid vaccine. For example, AstraZeneca-Oxford vaccine is, reportedly being tested in a phase-3 trial on over 1,600 subjects in India by Serum Institute. So is the Sputnik V, developed by Russia, and touted as the world’s “first registered Covid-19 vaccine” after it received Russian regulatory approval in early August 2020.

Further, the head of the Indian National Task Force on COVID-19, had also said the arrival of the Pfizer vaccine in India might take some months. This is, reportedly for two reasons. One, the vaccine has stringent temperature requirements (-75 degree Celsius), which make it unviable for the current cold-chain logistics in India. And the second, could possibly be, its Indian clinical trial requirements, as has been the practice of even Russia approved Sputnik V vaccine.

Thus, it appears, India is now looking at the vaccines being developed by Oxford-AstraZeneca or Bharat Biotech against the pandemic, as these are expected to complete clinical trials and seek a regulatory approval at an early date.

Upsides and unknowns of the current status of Covid vaccines in India:

Along the obvious upsides, such as – not all in the country needs to be vaccinated and, at least, one Covid vaccine is widely expected to come shortly that is being manufactured in India, there are several critical unknown factors, too. For example, apace with several similar articles, the research paper titled, ‘Will covid-19 vaccines save lives? Current trials aren’t designed to tell us,’ published in The BMJ on October 21, 2020, also raised this issue.

It pointed out: “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.” Yet the current phase III trials are not actually set up to prove either, it emphasized. None of the trials currently underway are designed to detect a reduction in any serious outcome, such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus.

Conclusion: 

As of December 06, 2020 morning, India recorded a staggering figure of 9,644,529 of new Coronavirus cases with 140,216 deaths. The threat of subsequent waves for further spread of Covid infection now looms large in many states. The Prime Minister of India is also intimately involved in search of a meaningful solution to end the pandemic.

In this scenario, that a Covid vaccine is coming so soon, is a very good news, undoubtedly. There are several obvious upsides of this development, alongside many critical unknown areas, including how long the immunity will last after administration of a Covid vaccine. Incidentally, ‘Moderna vaccine-induced antibodies last for 3 months’ says NIAID study. Even in India a ‘Minister tested positive after the first dose of vaccine.

I am sure, the right answers will surface as the research will progress. Meanwhile, there doesn’t seem to be any other alternative sans vaccines, to kick start the globalized world – for a holistic and inclusive long-term progress, economic prosperity and, if not survival with dignity, for all.

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.